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A randomized double-blind placebo-controlled trial of a standardized extract of Matricaria recutita, Foeniculum vulgare and Melissa officinalis (ColiMil) in the treatment of breastfed colicky infants
Abstract
The aim of this randomized, double-blind, placebo-controlled trial was to investigate the effectiveness and side effects of a phytotherapeutic agent with Matricariae recutita, Foeniculum vulgare and Melissa officinalis in the treatment of infantile colic.
93 breastfed colicky infants were enrolled, the diagnosis was made according to Wessel's criteria. After a 3 day observation period, the infants were randomly divided into two groups, one treated with phytotherapeutic agent (PA) and the other with placebo twice a day for 1 week. Crying time and side effects were recorded.
88 infants completed the trial: 41 in the PA group and 47 in the control. The daily average crying time for the PA was 201.2 min/day (SD 18.3) at the baseline and 76.9 min/day (SD 23.5) at the end of the study; for the placebo it was 198.7 min/day (SD 16.9) and 169.9 min/day (SD 23.1) (p < 0.005). Crying time reduction was observed in 85.4% subjects for the PA and in 48.9% subjects for the placebo (p < 0.005). No side effects were reported.
The present study shows that colic in breastfed infant improves within 1 week of treatment with an extract based on Matricariae recutita, Foeniculum vulgare and Melissa officinalis.
... Numerous aetiopathogenetic hypotheses have been requested to specify the cause of this problem under the title of the organicism and behavioral; it would seem that the infantile colic is the consequence of the synergistic interaction between both factors. The abnormal gastrointestinal function and allergic disorders subtitled in the organicism hypothesis lead to interventions such as substituting cow's milk with soy milk, protein hydrolysate (hypoallergenic), and using herbal tea (3). The infantile colic is a prevailing condition affecting 5 to 28% of the infants in the initial months of life (1). ...
... displays the process of the articles selection for this systematic review. Three studies had sufficient data to include in meta-analysis (3,8,9). A Foeniculum Vulgarein in combination with other herbal medicines was found to be more effective than control group on crying time on infantile colic (Standardized Mean Difference [SMD]=O.708; ...
... The aim of this systematic review and meta-analysis study was to assess whether fennel is effective on Infantile Colic. Four studies (3,(8)(9)(10) were included into systematic review and meta-analysis. In Savino et al.'s study crying time had been reduced in 85.4 and 48.9% of subjects for the phytotherapeutic agents and the placebo (P < 0.005), respectively. ...
... Infants with colicky symptoms responded with reduced crying time after taking a daily formulation containing 130 mg of lemon balm for 28 days [39]. Similarly, colicky infants also showed a daily significant reduction in crying time when using a formulation containing 38.75 mg/kg/day lemon balm administered for 7 days [40]. Both studies associated the reduction in crying time with lemon balm's calming properties and anti-anxiety effects. ...
... Unfortunately, there are no studies to date performing a direct comparison between populations for cognitive, sleep, or mood outcomes, making it challenging to ascertain whether lemon balm may be more efficacious for particular age groups. However, on reviewing the available evidence, there do appear to be consistent benefits to low mood and anxiety across the lifespan, with improvements in mood symptoms reported in children [39,40], young [29,45,46,49,51], middle-aged [52,58,60], and older [61,62,65,66] adults. It should, however, be highlighted that mood outcomes in infants are difficult by nature to measure, particularly in the insistence of colicky infants where neurogenic, gastrointestinal, microbial, and psychosocial factors contribute to symptoms [71]. ...
Background: There is renewed interest in the use of ancient herbal remedies for their potential health benefits, particularly in the psychological domain. One herb that is receiving growing attention is lemon balm (Melissa officinalis L.) which has received considerable interest for its influence on the brain. Lemon balm boasts an array of phytochemicals, including rosmarinic acid, citral, oleanolic acid, and ursolic acid, which are believed to underpin these effects on psychological well-being. Pharmacological evidence from animal and cellular work reveals that lemon balm and its components may modulate several brain signalling pathways, including GABAergic, cholinergic, and serotonergic systems. Results/Conclusions: Although further robust randomised controlled trials using lemon balm are required, existing research indicates that lemon balm holds promise as a calming agent exhibiting both anxiolytic and anti-depressant properties and can elicit cognitive and sleep-quality enhancement.
... Fennel and its herbal drug preparations are widely used for dyspeptic complaints such as mild, spasmodic gastric-intestinal complaints, bloating and flatulence (Chakurski et al., 1981) [29] . Different studies had shown that the extract of Foeniculumvulgare is effective in the treatment of colic in breastfed infant (Alexandrovich et al., 2003;Savino et al., 2005) [4,80] . ...
... Fennel and its herbal drug preparations are widely used for dyspeptic complaints such as mild, spasmodic gastric-intestinal complaints, bloating and flatulence (Chakurski et al., 1981) [29] . Different studies had shown that the extract of Foeniculumvulgare is effective in the treatment of colic in breastfed infant (Alexandrovich et al., 2003;Savino et al., 2005) [4,80] . ...
... min, p < 0.005), and these results were maintained fifteen days after the end of therapy (average crying time 82.1 min/day vs. 165.3 min/day, p < 0.005), No side effects were reported [34]. ...
... Indeed, no adverse effects were reported throughout a trial of fennel [31] and three of peppermint [36][37][38], as well as in two other studies with multiple herbal extracts [33,34]. ...
Different nutraceuticals are often considered by parents of infants and children with abdominal pain and disorders of the gut–brain interaction. Herb extracts and natural compounds have long been used in traditional medicine, but clinical pediatric trials are very limited. This narrative review based on relevant studies identified through a search of the literature in Pubmed and Medline updated to October 2023 focused on the effect of nutraceuticals in infantile colic, functional abdominal pain, and irritable bowel syndrome in children and adolescents. Significant reductions in colic episodes and crying time were reported in two studies on fennel (seeds oil or tea), in three studies on different multiple herbal extracts (all including fennel), in one study on Mentha piperita, and in at least two double-blind randomized controlled studies on Lactobacillus reuteri DSM 17938 and Bifidobacterium lactis BB-12 (108 CFU/day for at least 21 days) in breast-fed infants. Compared to a placebo, in children with functional abdominal pain or irritable bowel syndrome, a significant reduction in pain was reported in two studies supplementing peppermint oil capsules or psyllium fibers, and in one study on corn fiber cookies, partial hydrolyzed guar gum, a specific multiple herbal extract (STW-5), or vitamin D supplementation. To date, there is moderate-certainty evidence with a weak grade of recommendation on Lactobacillus reuteri DSM 17938 (108 CFU/day) in reducing pain intensity in children with functional abdominal pain and for Lactobacillus rhamnosus GG (1–3 × 109 CFU twice daily) in reducing pain frequency and intensity in children with IBS. Further large and well-designed pediatric studies are needed to prove the efficacy and safety of different herbal extracts and prolonged use of studied products in infants and children with pain disorders of the gut–brain interaction.
... fructus; Foeniculum vulgare or fennel) is an umbelliferous plant that is indigenous to southern Europe and the Mediterranean region. It has a long history of traditional herbal medicine use in both China and Europe, dating back to ancient times [5][6][7][8][9][10][11][12][13][14]. This herb has been employed as a natural remedy for various digestive ailments, such as flatulence, bloating, and indigestion. ...
... It also has galactagogue and emmenagogue properties [9]. F. fructus has hepatoprotective effects and may be used in pediatric colic [10,11]. In addition, it also functions as a 5-lipoxygenase inhibitor and is known to be effective in suppressing vomiting, gastrointestinal diseases, and anti-allergies [12]. ...
For centuries, Foeniculi fructus (F. fructus) has been used as a traditional herbal medicine in China and Europe and is widely used as a natural therapy for digestive disorders, including indigestion, flatulence, and bloating. The mechanism of F. fructus that alleviates functional dyspepsia was analyzed through network pharmacology, and its therapeutic effect on an animal model of functional dyspepsia were investigated. The traditional Chinese medicine systems pharmacology (TCMSP) database was used to investigate the compounds, targets, and associated diseases of F. fructus. Information on the target genes was classified using the UniProtdatabase. Using the Cytoscape 3.9.1 software, a network was constructed, and the Cytoscape string application was employed to examine genes associated with functional dyspepsia. The efficacy of F. fructus on functional dyspepsia was confirmed by treatment with its extract in a mouse model of loperamide-induced functional dyspepsia. Seven compounds targeted twelve functional dyspepsia-associated genes. When compared to the control group, F. fructus exhibited significant suppression of symptoms in a mouse model of functional dyspepsia. The results of our animal studies indicated a close association between the mechanism of action of F. fructus and gastrointestinal motility. Based on animal experimental results, the results showed that F. fructus provided a potential means to treat functional dyspepsia, suggesting that its medical mechanism for functional dyspepsia could be described by the relationship between seven key compounds of F. fructus, including oleic acid, β-sitosterol, and 12 functional dyspepsia-related genes.
... These are also summarized in Table 1, "Summary of clinically relevant findings". Fennel has been shown to reduce episodes of crying in infants with colic through four randomized controlled trials (RCT) [7] No safety signals were identified in these studies [8][9][10][11]. Dosage and formulation used in the controlled trials were inconsistent. Pediatric studies assessing the efficacy of fennel for FGIDs are lacking. ...
... A systematic review on herbs demonstrated the efficacy of fennel in different preparations (seed oil, tea, or in combination with other herbs such as Colimil ® ) to reduce episodes of crying in infants with colic (n = 461, age range 2-12 weeks old) through four randomized controlled trials (RCT) [7]. No side effects were reported in these studies [8][9][10][11]. ...
Chronic abdominal pain is one of the most common problems seen by both pediatricians and pediatric gastroenterologists. Abdominal-pain-related functional gastrointestinal disorders (AP-FGIDs) are diagnosed in children with chronic and recurrent abdominal pain meeting clinical criteria set forth in the Rome IV criteria. AP-FGIDs affect approximately 20% of children worldwide and include functional dyspepsia (FD), irritable bowel syndrome (IBS), functional abdominal pain (FAP), and abdominal migraine. IBS accounts for 45% of pediatric AP-FGIDs. The pathophysiology of functional abdominal pain involves an interplay of factors including early life events, genetics, psychosocial influences, and physiologic factors of visceral sensitivity, motility disturbance, altered mucosal immune function, and altered central nervous system processing. Treatment approaches are varied and can include dietary, pharmacologic, and complementary medicine interventions, as well as psychosocial support, depending on the many aspects of the disorder and the needs of the individual patient. There is a strong interest in complementary and integrative medicine approaches to pediatric pain from both patients, providers, and families. In this article, we discuss popular herbal treatments typically used in the field of complementary medicine to treat pediatric AP-FGIDs: peppermint oil, Iberogast®, cannabis, fennel, and licorice. While high-quality data are rather limited, studies generally show that these remedies are at least as effective as placebo, and are well tolerated with minimal side effects. We will need more placebo-controlled, double-blind, and unbiased prospective studies to document and quantify efficacy.
... It is native to Central Europe, the Mediterranean region, and Central Asia, having a well-documented ethnomedical reputation, especially as a sedative, antipyretic, antispasmodic, antihypertensive, anti-Alzheimer's, and antiseptic [3]. Above all, [4] stated that the use of lemon balm could be an effective and harmless measure for the treatment of infantile colic, both in breastfeeding and even for bottle-fed infants. The genus Thymus L. is one of the largest and most economically important genera in the Lamiaceae family [5]. ...
... W I = 100 − (100 − L * ) 2 + a * 2 + b * 2 1/2 (4) In addition, the browning index (BI) and the yellowness index (YI) were calculated using Equations (5) and (6): ...
In the context of the increasing lactation problems among breastfeeding women, the
development of a healthy lifestyle is needed. Different variants of pork, turkey, and beef meatballs, with added lemon balm (Melissa officinalis L.) and wild thyme (Thymus serpyllum L.) aqueous extract (6%), were obtained. These herbs were selected and used due to their antioxidant, antimicrobial, and lactogenic potential. Two thermal treatments, hot air convection (180 ◦C) and steam convection (94 ◦C), were applied for meatballs processing. The obtained meatballs were further subjected to a complex characterization. The functionality of the plant extracts was proved by the values of total content of polyphenols (2.69 ± 0.02 mg AG/g dw) and flavonoids (3.03 ± 0.24 mg EQ/g dw). FT-IR analysis confirmed the presence of trans-anethole and estragole at 1507–1508 cm−1 and
1635–1638 cm−1, respectively. Costumers’ overall acceptance had a score above 5.5 for all samples, on a scale of 1 to 9. Further analysis and human trials should be considered regarding the use of lactogenic herbs, given their health benefits and availability
... The results showed that the herbal extract significantly reduced crying time in infants within one week. [17] Another randomised controlled trial showed that fennel seed oil emulsion significantly reduced colic symptoms in infants. [18] An observational, retrospective case-control study evaluated parents' perception of the effectiveness of a proprietary herbal treatment, containing fennel (Foeniculum vulgare), anise (Pimpinella anisum), and mint (Mentha piperita) for IC. ...
Background. Complementary medicines (CMs) for infantile colic are widely available on the South African market, in various pharmacies and retail outlets, without the need for a prescription. Pharmacists therefore have an important role to play in educating patients about safe and appropriate use of CM products. Objectives. To investigate the perceptions and prescribing patterns of CMs for infantile colic by pharmacists and pharmacist assistants employed in the greater Johannesburg area. Methods. We used a quantitative approach with a descriptive survey design. A total of 100 pharmacists and pharmacist assistants registered with the South African Pharmacy Council completed a pen-and-paper questionnaire. Results. Many participants reported recommending both conventional and CMs for infantile colic and, overall, positive perceptions of CM were reported. Most participants agreed that they had a responsibility to counsel patients on the use of CM but felt that they needed to expand their own knowledge base. Conclusions. There appears to be a positive shift towards CM for the treatment of infantile colic; however, improved training is needed to ensure pharmacists and pharmacist assistants are better informed regarding CM products in order to give appropriate advice to patients.
... Comparing the therapeutic uses of the various plants reported in the present survey with those documented in our previous investigation, we found that only two plant species, F. vulgare, and P. anisum, were used for infantile colic in both studies. A clinical trial carried out in Italy confirmed the effectiveness of F. vulgare in treating infant colic when administered in combination with Matricariae recutita and Melissa officinalis (Savino et al., 2005). Some pediatric employments, traditionally acknowledged but previously unreported in Romania, were identified for four plant species: ear pain for Helianthus annuus, digestive diseases for H. perforatum, and respiratory disorders for T. serpyllum and T. tomentosa. ...
There is a limited number of studies focusing on ethnomedical practices in children, particularly in Eastern Europe. Romania has a rich history of using medicinal plants in ethnopediatric care, and our objective was to identify the medicinal plants currently employed in treating childhood illnesses in the southern region of the country.
Material and methods Our investigation used structured interviews, focusing on respondent demographics, local names of therapeutically employed herbs, the specific plant part(s) utilized, methods of preparation and administration, and local folk indications of taxa. A total of 326 mothers with children aged 0 to 18, hospitalized in the “Grigore Alexandrescu” Children Emergency Hospital Bucharest and residing in Southern Romania, were enrolled in the study. Use Value Citation Index (UV c ), Informant Consensus Factor (Fic), and Fidelity Level (FL) were calculated.
Results Twenty-five plants were identified for treating children’s diseases in Southern Romania. The majority of informants resided in urban areas, and mothers primarily acquired knowledge from family members and healthcare professionals. The herbs most frequently employed were Mentha spp. (UV = 0.509) for diarrhea, Matricaria spp . (UV = 0.301) for skin infections (Fic = 0.99) and digestive diseases (Fic = 0.98), and Calendula officinalis L. (UV = 0.365) for skin diseases (Fic = 0.99). Less utilized were Raphanus raphanistrum subsp. sativus (L.) Domin in respiratory diseases, Prunus avium (L.) L. stalks in urinary tract ailments, Helianthus annuus L. in ear infections, Allium sativum L. in intestinal parasitosis, Viola tricolor L. in hives, Triticum aestivum L. in dermatitis and Allium ursinum L. as a tonic. In 184 cases herbal treatment was used in conjunction with conventional medications. Education level correlated with the number of employed plants and the variety of treated ailments, while residency (rural vs. urban) did not. Both residency and education influenced plant procurement methods: rural background and, surprisingly, higher education were linked to a preference for harvesting rather than purchasing plants.
Conclusion Botanical remedies are still commonly used in the treatment of pediatric diseases in Southern Romania, although the variety of taxa seems reduced compared to the past. Further exploration is essential to unlock the maximum benefits of ethnopediatric practices.
... The study found that infants experienced sleepiness, constipation, and nausea. Nevertheless, none of these side effects were detrimental, and there was no distinction observed in the event of side effects between the herbal formula preparation and the placebo (Savino, Cresi, et al. 2005) ...
Colic is a multifaceted ailment with a wide range of therapeutic strategies. Infantile colic is often regarded as the most excruciating agony a newborn has ever experienced. Inconsolable crying, fussing, irritability, and abdominal discomfort are some of the classical presentations of infantile colic. In addition, infantile colic is associated with various gastrointestinal conditions and behavioral and neurodevelopmental complications. Although there is inadequate data to support successful treatment for infantile colic, a few frequently applied pharmaceutical interventions, such as dicyclomine, simethicone, and cimetropium, have not been recommended based on contemporary research. Lifestyle modifications such as lactase and probiotics supplements have indicated benefits in treating colic, but additional control studies will be a prerequisite to assess their efficacy. This review aims to provide in-depth information on colic, its pathophysiology, the therapeutic potential of medicinal plants with spasmolytic effects, and their possible mechanisms of action. Studies on several medicinal plants with spasmolytic activity, like Foeniculum vulgare, Carum carvi, Matricaria chamomilla, Zingiber roseum, Lavandula angustifolia, and Mentha pulegium have been included in this article. Furthermore, the study showed that the active compounds in these plants have a substantial antispasmodic activity that is safer and more effective than currently accessible synthetic medications.
... No side effects were reported. 52 A recent open-label single-group study was conducted in 30 colicky infants (age 3-16 weeks) evaluating the effect of a product containing Carbo vegetabilis (vegetable charcoal), Prunus spinosa (Blackthorne), Carum carvi (Caraway), Matricaria chamomilla (Chamomile), Foeniculum vulgare (Fennel), Zingiber officinale (Ginger), Melissa officinalis (Lemon Balm), and Mentha piperita (Peppermint). The product was administered 1.25 ml orally during a colic episode and repeated after 120 minutes, if needed, Average daily crying time was recorded using a modified Barr's diary and analysed after 7 and 14 days from recruitment. ...
Different nutraceuticals are often considered by parents of infants and children with abdominal pain and disorders of the gut-brain interaction. Herb extracts and natural compounds have long been used in traditional medicine, but clinical pediatric trials are very limited. This narrative review based on relevant studies identified through Pubmed-Medline literature search updated to October 2023, focused on the effect of nutraceuticals in infantile colic, functional abdominal pain and irritable bowel syndrome in children and adolescents. Significant reduction of colic episodes and crying time was reported in two studies on fennel (seeds oil or tea), in three studies on different multiple herbal extracts (all including fennel), in one study on Mentha piperita, and in at least two double-blind randomized controlled studies on Lactobacillus reuteri DSM 17938 and Bifidobacterium lactis BB-12 (108 CFU/day for at least 21 days) in breast-fed infants. Compared to placebo, in children with functional abdominal pain or irritable bowel syndrome a significant reduction of pain was reported in two studies supplementing peppermint oil capsules or psyllium fibers, in one study on corn fiber cookies or partial hydrolysed guar gum or a specific multiple herbal extract (STW-5) or vitamin D supplementation. To date, there is a moderate certainty of evidence with a weak grade of recommendation for Lactobacillus reuteri DSM 17938 (108 CFU/day) for reducing pain intensity in children with functional abdominal pain and for Lactobacillus rhamnosus GG (1-3 x109 CFU twice daily) for reducing pain frequency and intensity in children with IBS. Further large and well-designed pediatric studies are needed to prove efficacy and safety of different herbal extracts and prolonged use of studied products in infants and children with pain disorders of the gut-brain interaction.
... Vasorelaxant effects of Melissa officinalis extract with rosmarinic acid as the most abundant constituent was confirmed toward isolated thoracic aortic rings (Ersoy et al., 2008). In clinical trials with infants, lemon balm, as a component of a herbal medicine containing standardized extracts of Matricariae recutita, Foeniculum vulgare, and Melissa officinalis, has proven to be effective as a medicine that relieves colic-related symptoms (Savino et al., 2005). Melissa was also shown to be a very potent antidepressant agent. ...
Melissa officinalis (lemon balm) has a long history of being used in traditional medicine for the treatment of gastrointestinal tract disorders in human thanks to its spasmolytic and stress reducing effects. These pharmacological properties have been confirmed in laboratory animals. Unfortunately, in the case of veterinary medicine, the effect of lemon balm on gut contractility has been never subjected to a detailed investigation. On the other hand, there is urgent need of new drugs that could be safely used in animals for both, causative and symptomatic treatment. In broiler chicken, one of the major health concerns includes gastrointestinal disorders with gut hypermotility. Thus, it is crucial to verify the potential utility of Melissa officinalis extract in gastrointestinal dysmotilities. The aim of the study was to analyze the effect of lemon balm extract and some of its active ingredients on chicken intestine motility. The study was performed on isolated proximal and distal jejunum preparations collected from broiler chicken which underwent routine slaughter procedure. The effect of lemon balm and 3 phenolic acids (rosmarinic, chlorogenic, and lithospermic) was verified under isometric conditions, toward spontaneous and acetylcholine (ACh)-induced smooth muscle activity. Surprisingly, M. officinalis turned out to be rather a myocontractile agent as it increased ACh-provoked contractility of proximal and distal jejunum strips and also intensified the spontaneous activity of distal jejunum. Only in the case of proximal intestine lemon balm extract diminished the force of spontaneous motoric activity up to approx. Sixty-seven percent of the control conditions. None of the tested phenolic acids displayed analog effect with the whole plant extract. In fact in the case of ACh-induced contractility, the acids had the opposite, that is, myorelaxant, effect than the extract, with a small exception of lithospermic acid in distal jejunum. Thus, it is impossible to assign one or more individual constituents to the effect of the whole Melissa officinalis extract. The obtained results do not support the use of lemon balm extract in broiler diseases which are accompanied by gut motility disturbances, including diarrhea.
... The results showed a significant reduction in infants' crying compared to the control group. [29] In one study on inhalation aromatherapy, lavender was given within the first 24 hours after birth. Based on the findings, mothers' mood scores were significantly better in the intervention group in comparison to the control group. ...
Background:
Too much crying is a self-limiting problem and disappears within a few weeks. However, it can lead to maternal depression and parental stress. This study aimed to evaluate the effect of lavender oil inhalation on the duration of night crying within a week of intervention among infants with infantile colic.
Methods:
In this double-blind randomized clinical trial, the inclusion criteria for infants were being healthy, not taking any medications for colic, having an episode of crying two hours a day, and having a healthy mother. The intervention group received lavender oil inhalation and the control group received sweet almond oil inhalation for seven days. The data pertaining to the duration of crying were collected four times a day (morning, afternoon, evening, and night) via telephone contact. Mothers' mood scores were also assessed at the beginning of the study and on the seventh day of the intervention.
Results:
At first, the two groups were not different in terms of the duration of crying. After the intervention, however, a significant difference was observed in this regard on all seven days of the study (P < 0.001). Based on the results of the repeated measures analysis, the difference between the two groups was statistically significant (P < 0.001).
Conclusions:
The results showed that inhalation of lavender oil at low concentrations could reduce colic symptoms and improve maternal mood.
... Similar to the previous work, another study investigated the effectiveness and side effects of M. officinalis associated or not with Matricariae recutita and Foeniculum vulgare in infantile colic during one-week treatment. Again crying time was lessened in 85.4% of subjects compared to control (48.9%) while no side effects were reported [100]. ...
The authors would like to make a correction to the article [1]. The authors clarify that the reference [2] in the Fig. 5 caption is not cited in this review article in error. We apologise to readers for any inconvenience caused and state that the scientific conclusions are unaffected. This correction was approved by the Academic Editor. The references in the article have also been updated.
... A proprietary formula containing Chamomile, Fennel, and Lemon Balm demonstrated statistically better results in daily crying time and percentage of responders compared to the control group. 31 Another study observed that herbal tea containing Fennel, Chamomile, Liquorice, Vervain, and Lemon Balm effectively reduced colic in 57% of infants compared to placebo (26%) (P < .01). 32 A double-blind crossover study on 30 infants with colic showed the promising effect of Peppermint in relieving the symptoms compared to Simethicone. ...
Infantile colic is the most frequent reason of infant and parental distress. An open-label single-group clinical study was conducted primarily to evaluate the effect of 14-day colic relief remedy administration (1.25 ml orally during colic episode) on average daily crying time in infants compared to baseline. In addition, the percentage of responders, sleep pattern, frequency and severity of gastrointestinal symptoms, tolerability of the product and percentage population with relapse of symptoms post product discontinuation were evaluated. Thirty infants aged 3 to 16 weeks with no significant clinical illness were enrolled in the study with their caregivers. Daily inconsolable crying time and flatulence were significantly reduced ( P < .05) within a week of intervention and a sustained effect was observed after discontinuation of the product. The findings of the present study indicate that this product effectively reduced abdominal distension and pain, resulting in a significant decrease in the daily crying of the infants.
Trial registration: The study was registered with the Clinical Trials Registry India (CTRI) ( http://ctri.nic.in/Clinicaltrials/login.php ) bearing Reg. No: CTRI/2021/03/031762, Date: March 8, 2021.
... Similar to the previous work, another study investigated the effectiveness and side effects of M. officinalis associated or not with Matricariae recutita and Foeniculum vulgare in infantile colic during one-week treatment. Again crying time was lessened in 85.4% of subjects compared to control (48.9%) while no side effects were reported [99]. ...
Melissa officinalis L. is a plant of the Lamiaceae family known in numerous countries for its medicinal activities. This plant has been used since ancient times to treat different disorders, including gastrointestinal, cardiovascular, neurological, psychological conditions. M. officinalis contains several phytochemicals such as phenolic acids, flavonoids, terpenoids, and many others at the basis of its pharmacological activities. Indeed, the plant can have antioxidant, anti-inflammatory, antispasmodic, antimicrobial, neuroprotective, nephroprotective, antinociceptive effects. Given its consolidated use, M. officinalis has also been experimented with clinical settings, demonstrating interesting properties against different human diseases, such as anxiety, sleeping difficulties, palpitation, hypertension, depression, dementia, infantile colic, bruxism, metabolic problems, Alzheimer’s disease, and sexual disorders. As for any natural compound, drug, or plant extract, also M. officinalis can have adverse effects, even though the reported events are very rare and the plant can be considered substantially safe. This review has been prepared with a specific research strategy, interrogating different databases with the keyword M. officinalis. Moreover, this work analyzes the properties of this plant updating currently available literature, with a special emphasis on human studies.
... Rodent studies have shown that anethole, a chemical derivative of fennel oil, increases gastric emptying in mice, suggesting that it could be used for FD [51]. A clinical trial examined the effects of a formulation comprised of fennel, lemon balm, and German chamomile on gastric transit time, but this trial was unevaluable as infants were the studied population and thus the study fell outside of our inclusion criteria [52]. As a result, further investigation is needed to elucidate the relationship between fennel and gastric emptying in adults, and its potential impact on related upper GI conditions. ...
Nutritional ingredients, including various fibers, herbs, and botanicals, have been historically used for various ailments. Their enduring appeal is predicated on the desire both for more natural approaches to health and to mitigate potential side effects of more mainstream treatments. Their use in individuals experiencing upper gastrointestinal (GI) complaints is of particular interest in the scientific space as well as the consumer market but requires review to better understand their potential effectiveness. The aim of this paper is to review the published scientific literature on nutritional ingredients for the management of upper GI complaints. We selected nutritional ingredients on the basis of mentions within the published literature and familiarity with recurrent components of consumer products currently marketed. A predefined literature search was conducted in Embase, Medline, Derwent drug file, ToXfile, and PubMed databases with specific nutritional ingredients and search terms related to upper GI health along with a manual search for each ingredient. Of our literature search, 16 human clinical studies including nine ingredients met our inclusion criteria and were assessed in this review. Products of interest within these studies subsumed the categories of botanicals, including fiber and combinations, and non-botanical extracts. Although there are a few ingredients with robust scientific evidence, such as ginger and a combination of peppermint and caraway oil, there are others, such as melatonin and marine alginate, with moderate evidence, and still others with limited scientific substantiation, such as galactomannan, fenugreek, and zinc-l-carnosine. Importantly, the paucity of high-quality data for the majority of the ingredients analyzed herein suggests ample opportunity for further study. In particular, trials with appropriate controls examining dose–response using standardized extracts and testing for specific benefits would yield precise and effective data to aid those with upper GI symptoms and conditions.
... Italy [143] Randomized, double-blind, placebo-controlled ...
Melissa officinalis has long been used in folk medicine as an integrated pharmacy, used in the treatment of many diseases since ancient times, as a remedy for headaches, indigestion, abdominal cramps, and heart failure. Lemon balm is characterized by antibacterial, antiviral and antidiabetic properties. The therapeutic benefit of this species is that it contains a wide variety of secondary metabolites such as essential oils, flavonoids, phenolic acid, and terpenes. Lemon balm contains many secondary metabolites such as eugenol, octinol, octyin, octinone, citral, hexenol and haramin, in addition to high levels of rosmarinic acid, which is used to treat many diseases in the field of alternative medicine. Lemon balm essential oils are concentrated hydrophobic oils that contain volatile chemicals that are used in food processing, where they are added to food, and in the cosmetics and perfumery industry. Despite the enormous benefits of M. officinalis aromatic oils, they do have side effects if not used properly. They can cause skin irritations, especially in children. The essential oils of this plant are effective against many types of bacteria, such as Salmonella, Escherichia coli, Staphylococcus, Pseudomonas, Bacillus and have an effective antifungal activity, especially against Candida and yeasts.
... Italy [143] Randomized, double-blind, placebo-controlled ...
Medicinal plants are being used worldwide for centuries for their beneficial properties. Some of the most popular medicinal plants belong to the Melissa genus, and different health beneficial effects have already been identified for this genus. Among these species, in particular, the Melissa officinalis L. has been reported as having many biological activities, such as antioxidant, antimicrobial, antitumour, antiviral, antiallergic, anti-inflammatory, and also flatulence inhibiting effects. The beneficial properties of the Melissa officinalis, also known as “lemon balm herb”, can be related to the bioactive compounds such as terpenoids, alcohols, rosmarinic acid, and phenolic antioxidants which are present in the plant. In this updated review, the botanical, geographical, nutritional, phytochemical, and traditional medical aspects of M. officinalis have been considered as well as in vitro and in vivo and clinically proven therapeutic properties have been reviewed with a special focus on health-promoting effects and possible perspective nutraceutical applications. To evidence the relevance of this plant in the research and completely assess the context, a literature quantitative research analysis has been performed indicating the great interest towards this plant for its beneficial properties.
... Italy [143] Randomized, double-blind, placebo-controlled ...
... Respecto al uso en insomnio, se ha probado un efecto de mejora de la calidad del sueño (38,41,42,43,44). Las propiedades ansiolíticas de la Melisa se explican in vitro mediante la inhibición potente del GABA-T, una enzima diana en la terapia de la ansiedad, epilepsia y otros trastornos neurológicos y una alta afinidad por el receptor GABA-A (45,46,47). Además, se han encontrado propiedades neuroprotectoras, especialmente mejorando los procesos mnésicos (48,49,50). ...
El uso de las benzodiazepinas (BZD) ha ido incrementándose en los
últimos años. Son los fármacos más utilizados en el ámbito médico para
el tratamiento de los trastornos del ritmo sueño-vigilia y en los trastornos
de ansiedad. Poseen serios efectos adversos en tanto alteran la
arquitectura del sueño, provocan tolerancia y dependencia, incoordinación motora y debilidad muscular, y a mediano y largo plazo altera funciones cognitivas tales como la memoria y la atención. Se analizan las posibles alternativas a éstas medicaciones que pueden dar una respuesta similar o mejorada sin los efectos adversos mencionados. Entre ellas encontramos a las medicinas naturales o fitoterapia. Se
plantea como objetivo realizar una revisión bibliográfica que permita
determinar los actuales usos de plantas medicinales en los cuadros de
insomnio y en los trastornos de ansiedad. Se encontró que ciertas
plantas medicinales son una alternativa terapéutica segura y eficaz para
suplantar a las BZD en los trastornos del sueño y la ansiedad, cuando
su uso es responsable y respaldado con evidencia científica.
... It is reported that mixtures such as fennel, chamomile, licorice root, lemon balm found in herbal medicines can reduce colic attacks with antispasmodic activity [30][31][32] . Herbal medicines should be used by families under the control of a physician due to the sugar and alcohol they may contain [33][34] . In a study published in our country in 2009, physicians most frequently preferred drugs containing zinc and vegetable oil, simethicone drops secondly and syrup containing vegetable oil, fennel tea and apple oil less frequently [35] . ...
... The present study showed that mothers used fennel-anise tea and suppositories as well as simethicone. It has been reported that a herbal tea prepared with chamomile, verbena, licorice, fennel and lemon balm reduces crying spells in infants with colic when it is given to the infant 3 times a day (23). Biagioli et al. (24) stated that herbal agents, sugar, dicyclomine and cimetropium bromide should not be recommended for colicky infants. ...
Aim:
The aims of this study were to explore the infantile colic in infants from 1-6 months of age, and the mother’s practices to eliminate colic and the relationships between infantile colic scores and sample characteristics.
Materials and Methods:
This descriptive study included 232 mothers of infants who were admitted to the hospital for child monitoring at two university hospitals in the Aegean region. Information on demographics, colic characteristics, and practices of mothers to eliminate colic was collected.
Results:
According to reports of the mothers, 67.2% of the infants had colic, and 28.5% of the infants met all of the Wessel criteria. The average scale score of infantile colic was 65.2±12.6. To eliminate the colic, 67.6% of the mothers held their infants on their lap, 68.7% rocked them, 63.2% changed the position of their infants, 57.4% massaged the infants’ bellies, and 37.1% stated that they used a warm application.
Conclusion:
One out of every three-four babies in the study met the diagnosis of infantile colic according to Wessel criteria’s. The average score obtained from the infantile colic scale is quite high. Mothers usually use behavioral methods to prevent and reduce colic symptoms, they also use pharmacological and traditional methods in this study.
Keywords: Infantile colic, mother, practices
... Other studies also determined that fennel is effective in reducing colic symptoms and crying durations. 4,6,29,30 Savino et al. 30 also noted several adverse effects such as vomiting, sleepiness, constipation and loss of appetite among infants that were given phytotherapeutic agents. Moreover, it is known that herbal supplements calm babies down by reducing abdominal distension. ...
Objective: This study investigated the practices used by mothers of babies with infantile colic to reduce infantile colic and the mothers’ perceptions on the effectiveness of these practices.Materials and Methods: The sample of this descriptive study consisted of the mothers of 257 babies aged 4-12 months who were being monitored by two Family Health Centres in Istanbul. The data of the study was collected through a 26-item questionnaire on which the mothers could mark the t practices they used to reduce infantile colic. Results: The methods that were found the most useful based on the perception of the mothers were the mother’s avoidance of consumption of foods and drinks that produce gas (97%), chancing positions (96.7%), massage (95.7%), listening to the sound of a hair dryer (95.2%) and warmth treatment to the abdomen (91.7%). Conclusion: Consequently, the mothers performed effective and valid practices. However, it was found that the frequency of performing some practices that have high utilisation rates was low. Accordingly, it would be useful to inform the mothers of babies who are at the ages of 2 weeks-4 months at the time of their paediatric health monitoring about the effective and easily performed practices for reducing colic.
Secondary metabolites are often among the major players in plants’ function, stability, support, bioactivities,
defense mechanisms, and therapeutic applications. One of the major components of these metabolites is volatile
oils. Essential oils are considered one of the most important ways in which plants express themselves through
aroma. The oils are also one of the reasons for therapy, mood-upliftment, life processes, plants and dependent
organisms’ survival, joy, happiness, aesthetic beauty, and attractions in several realms, as well as for various
interactive species, including insects, animals, and humans. In addition, essential oils participate in modern
industries and worldwide healthcare systems. Aromatic plants and their extracted and distilled volatile oils have
been used in different systems of traditional medicine and in all ancient civilizations. They are also still used as
part of modern healthcare systems and in folkloric therapeutic and prophylactic applications. Therefore, the
chemistry, bio-based diversity, geographic sources, biological activities, and clinical applications of volatile oils
have gained the momentum and continued attention of researchers, culminating in several thousand publications
each year. This review provides updated information on the biological activities and current applications of
essential oils in medicine and other healthcare uses. The underlined biomechanistic details of the volatile oils’
biological effects are also encompassed. The collected data unambiguously supported the biological importance
of this class of secondary metabolites, especially in cancer, inflammation, and microbial infection management.
The information contained in the data also highlighted the therapeutic importance of these molecules in various
aspects of medicine.
For centuries, Foeniculi fructus (F. fructus) has been used as a traditional herbal medicine in China and Europe and is widely used as a natural therapy for digestive disorders, including indigestion, flatulence, and bloating. The mechanism by which F. fructus alleviates functional dyspepsia was analyzed through network pharmacology, and its therapeutic effect on an animal model of functional dyspepsia was investigated. The compounds, targets, and related diseases of F. fructus were studied utilizing the traditional Chinese medicine systems pharmacology (TCMSP) database. Information on the target genes was classified using the UniProt database. A network was built using Cytoscape 3.9.1, and functional dyspepsia-related genes were checked using the Cytoscape string application. The efficacy of F. fructus on functional dyspepsia, including gastroparesis and gastrointestinal motility, was confirmed by treatment with its extract in a mouse model of loperamide-induced functional dyspepsia. Seven compounds targeted twelve functional dyspepsia-associated genes. In a functional dyspepsia mouse model, F. fructus significantly suppressed the symptoms when compared to that in the control group. Our animal studies showed that the mechanism of action of F. fructus is closely related to gastrointestinal motility. Based on animal experimental results, the results showed that F. fructus provides a potential means to treat functional dyspepsia, suggesting that its medical mechanism for functional dyspepsia can be described by the relationship between seven key compounds of F. fructus, including oleic acid and β-sitosterol, and 12 functional dyspepsia-related genes.
Purpose
Infantile colic (IC) or fussing and crying behavior of unknown cause, affects up to 20% of the infant population and is one of the major reasons for parents to seek medical advice. Therapeutic options are limited and the key component for IC management is parental support. Fennel-based herbal treatments were shown to significantly reduce crying time. The current study was designed to evaluate the parent perception of effectiveness of a fennel-based commercially-available herbal treatment for IC (BabyCalm, Hisunit Ltd., Israel) using a retrospective online survey.
Design and methods
This was a real-world observational, case-control retrospective study. Parents of babies with IC symptoms, who either used the herbal product for their baby or did not use any product were invited to participate in an online survey during August–December 2019. The primary outcome was the perceived level of treatment success and symptom improvement.
Results
1218 parents of IC babies (48% females, 90% up to 3 months of age, 58% exclusively breast-fed) responded to the survey of whom 771 used the treatment. Significantly fewer IC-related symptoms were reported by parents who used the product compared to those that did not. Parents perceived the treatment as successful in 65% of the cases, reporting meaningful improvements within 30 min for 69%–79% of the symptoms.
Conclusions
The majority of parents perceived the herbal treatment as effective in rapid symptom reduction suggesting that this may provide a satisfactory solution for IC in the community.
Foeniculum vulgare Mill., commonly known as fennel, is one of the widespread plants that originated from Southern Europe and Mediterranean regions. This species is an economically important herb that has been used in traditional medicine and as a spice in culinary. The various parts and essential oil of fennel have been used widely in different ailments related to digestive, endocrine, reproductive, and respiratory systems. Based on their traditional uses, numerous pharmacological activities were reported by researchers such as antimicrobial, antiviral, anti-inflammatory, apoptotic, cardiovascular, antitumor, hepatoprotective, hypoglycemic, and memory-enhancing property. According to phytochemical investigations of F. vulgare, the flavonoids, phenolic compounds, fatty acids, and volatile compounds such as trans-anethole, estragole, and fenchone were reported as the major constituents responsible for various activities. This chapter presents an overview of the origin, distribution, taxonomic position, traditional uses, phytochemical, pharmacological, toxicological properties, and herbal formulations/products of F. vulgare. It also compiles available scientific evidence for the ethnobotanical claims and identifies gaps required to be filled by future research. F. vulgare has emerged as a good source of traditional medicine and provides a remarkable foundation for developing new drugs and the future.KeywordsFennelTraditional medicineCulinarySpicesPhytochemical composition
The increase of challenges in people's lives, daily problems as well as traumatic events could lead them to experience stress. Because of the side effects of current drugs, the recent medications are not sufficient to cure stress-related diseases; new approaches are needed in order to find more effective medications with fewer sideeffects. Ethnobotanical and ethnomedical research is increasingly recognized as a viable source of data and plausible pharmacological action of many plants. The review presents ethnobotanical information of the plants that have been used against stress-related diseases among local people of Turkey. In addition, a survey of the current literature on the topic aims to find new natural resources that will contribute to the development of drugs and bring them to the literature by scanning the scientific articles on the isolation and structure determination of the secondary metabolites of these medicinal plants, which have been already in use among the public for stressrelated disorders for centuries. This research is not only the first step in the research of promising new compounds against stress but it is also a presentation of data on medicinal plants of Turkey: Their medicinal parts, method of preparation, usage patterns and, if recorded, their dosages.
Functional dyspepsia (FD) is a gastrointestinal disorder with diverse symptoms but no structural or organic manifestations. Benachio-F® (herein named ‘BF-1’) is an over-the-counter liquid digestive formulated with multiple herbal extracts, which has been reported to improve symptoms of FD. A total two experiments were conducted. First, we examined whether BF-1 can modulate the progression of FD through two experimental rat models. A total of three doses (0.3x, 1x, 3x of the human equivalent dose) were used. In the gastric emptying model, both 1x (standard) or 3x (3-fold-concentrated) BF-1 enhanced gastric emptying was compared with that of vehicle-treated animals. In a feeding inhibition model induced by acute restraint stress, treatment with 1x or 3x BF-1 led to a similar degree of restoration in food intake that was comparable to that of acotiamide-treated animals. Among the constituents of BF, fennel is known for its choleretic effect. Thus, we next investigated whether a novel BF-based formula (named ‘BF-2’) that contains an increased amount of fennel extract (3.5-fold over BF-1), has greater potency in increasing bile flow. BF-2 showed a superior choleretic effect compared to BF-1. Furthermore, the postprandial concentration of serum secretin was higher in animals pretreated with BF-2 than in those pretreated with BF-1, suggesting that the increased choleretic effect of BF-2 is related to secretin production. Our results demonstrate that BF-1 can modulate the pathophysiological mechanisms of FD by exerting prokinetic and stress-relieving effects, and that BF-2 has a better choleretic effect than BF-1.
Worldwide many infants die every year due to malnutrition or disease. WHO advises breastfeeding as it is an inexpensive and effective form of feeding for saving life of infant’s health. Insufficient milk production in lactating mother is one of the main causes of death and malnutrition in infants. Main cause of milk deficiency is mother or child illness, preterm birth, mother-baby separation, lactation after long gape, anxiety, fatigue emotional stress, busy schedules, unhealthy life style of women’s and hormonal imbalance. This review aims to summarize that insufficiency of lactation should be treated in appropriate manner; there are substantial numbers of herbal drugs which are used to augment milk production in lactating mother. Alcoholic/Aqueous extract of different lactogenic drugs maintain or increase the lactation by different physiological changes in biological level. The systematic search for Herbal Medicine used as lactation considering all the articles published until 2021 through three scientific databases.
Infant colic is an inconsolable cry of unknown cause in healthy babies. Observed in about 20% of infants, the most common reason for seeking medical attention at an early age. Colic is associated with maternal stress and the most significant risk factor for shaken baby syndrome, and can also cause premature breastfeeding termination. Informing and supporting parents with crying babies is increasingly important, and some guidelines recommend it as a cornerstone of intervention in families with a baby with colic. Because of the high quality randomized trials, none of the behavioral, dietary, pharmacological, or alternative interventions can be recommended as the only effective treatment. Unfortunately, many mothers around the world associate their child’s anxiety with “dietary mistakes” in their diets, leading to further dietary restrictions as a preventative measure. At the same time, according to the recommendations of the experts of the IV Rome Criteria, dietary restrictions for infant colic in breastfeeding mothers can be recommended only if there is a suspicion of suspicion of tolerance of cow’s milk protein. It is also possible for any type of feeding to prescribe fennel and chamomile preparations, in particular, in the form of aqueous infusions, and when breastfeeding it is desirable to use a bottle and excessively large volumes, which can reduce the amount of milk in a woman. It is desirable to exclude unreasonable dietary restrictions in breastfeeding mothers by excluding the so-called “gas-forming products” and ineffective therapy, in particular simethicone preparations.
Fennel (Foeniculum vulgare) is a perennial herb native to the Mediterranean. It is used for its beneficial effects on the gastrointestinal system. The seed, which is the source of fennel’s active constituents, is commonly used as a tea for infantile colic, indigestion, dysmenorrhea, and lactation promotion. Fennel may be useful for endothelial dysfunction, infantile colic, irritable bowel syndrome, constipation, primary dysmenorrhea, menopause, sexual dysfunction, and hirsutism. It has antispasmodic, diuretic, antiinflammatory, analgesic, secretomotor, secretolytic, galactagogue, emmenagogue, and antioxidant effects. This chapter examines some of the scientific research conducted on fennel, both alone and in combination formulas, for treating numerous health conditions. It summarizes results from several human studies of fennel’s use in treating cardiovascular, gastrointestinal, genitourinary, and dermatological disorders. Finally, the chapter presents a list of fennel’s Active Constituents, different Commonly Used Preparations and Dosage, and a Section on “Safety and Precaution” that examines side effects, toxicity, and disease and drug interactions.
Lemon balm (Melissa officinalis) is a perennial herb in the mint family. In addition to its anxiolytic and gastro-intestinal effects, it has cognitive, anti-diabetic, and anti-thyroid effects and demonstrates antiviral efficacy against herpes simplex. It may be beneficial for bruxism, benign palpitations, dyslipidemia, diabetes, functional gastrointestinal disorders, premenstrual syndrome, dysmenorrhea, female sexual dysfunction, menopause, agitation of dementia, anxiety, insomnia, depression, attention-deficit/hyperactivity disorder, and HSV. This chapter examines some of the scientific research conducted on lemon balm, both alone and in combination formulas, for treating numerous health conditions. It summarizes results from several human studies of the herb’s use in treating oral and dental, cardiovascular, cardiometabolic, gastrointestinal, genitourinary, neurological, and psychiatric disorders, among others. Finally, the chapter presents a list of lemon balm’s active constituents, different Commonly Used Preparations and Dosage, and a section on “Safety and Precaution” that examines side effects, toxicity, and disease and drug interactions.
There are two types of chamomile most commonly used medicinally: German chamomile (Matricaria recutita/chamomilla) and Roman chamomile (Chamaemelum nobile). The former is the more well-known variety often used in teas, tinctures, creams, and essential oils. Chamomile is known to be safe for producing calming effects on the central nervous system, skin, and gastrointestinal tract. This chapter examines some of the scientific research conducted on chamomile, both alone and in combination formulas, for treating numerous health conditions. It summarizes results from several human studies of the herb’s use in treating oral and dental, ENT, cardiometabolic, gastrointestinal, genitourinary, musculoskeletal, and dermatologic disorders, among others. Finally, the chapter presents a list of chamomile’s Active Constituents, different Commonly Used Preparations and Dosage, and a Section on “Safety and Precaution” that examines side effects, toxicity, and disease and drug interactions.
Background
Premenstrual syndrome (PMS) and dysmenorrhea are prevalent disabling conditions and affecting the quality of life of women in reproductive age. Melissa officinalis exhibits multiple pharmacological properties, including anti-inflammatory, antispasmodic, analgesic, and antidepressant activities.
Objective
The aim of this study was to systematically review the effect of Melissa officinalis on PMS and primary dysmenorrhea.
Methods
A systematic search in English (Embase ،PubMed, ProQuest, Scopus, Clininaltrial.gov, Cochrane Library), and Persian (SID, Magiran, Iran Doc) databases to find articles were done in May 2020. All types of clinical trials were included. Two authors independently conducted the selection of articles and quality assessment and also extracted data. Standardized Mean Difference (SMD) was described as a measure of effect size due to the application of multiple tools to measure the severity of PMS. The quality of evidence was assessed using the GRADE approach.
Results
A total of 978 articles were obtained from databases. Ultimately, 7 articles were included in the study. Based on the results of these 7 studies, the consumption of Melissa officinalis improves the symptoms of PMS and primary dysmenorrhea after treatment, as compared to the control group. Also, from the meta-analysis results, the consumption of Melissa officinalis in the intervention group as compared to the control group, significantly reduces the mean severity of PMS's symptoms following treatment )SMD: -0.93; 95% CI: -.19 to -0.67; P=0. 88; I2=0%).
Conclusion
Due to the limited number of articles included in the meta-analysis, conducting well-designed clinical trials with large sample size to ascertain the effect of Melissa officinalis on PMS and primary dysmenorrhea, are recommended.
Medical Informatics in Primary care in kosovo
Evidence‐Based Answer Maybe. Fennel seed oil reduces crying time in infants with colic (SOR: B, small RCTs). The optimal amount or formulation of fennel is unclear.
Excessive gastrointestinal gas is commonly encountered by physicians and contributes to a number of symptoms including-eructation, aerophagia, gas-bloat syndrome, abdominal bloating and distension, and flatulence. Eructation is the audible escape of air from the esophagus into the pharynx and physiologically; there are two types of belches-gastric belch and supragastric belch. In a large US population study, aerophagia was found in 4.2 % of children. It is particularly common in patients with neurocognitive disabilities. Bloating refers to a sensation of abdominal fullness, whereas distention connotes visible or measurable increase in abdominal girth. An average adult passes flatus about 10 to 12 times per day, with an upper limit of 20 times a day. The frequency of flatus does not correlate with age or gender, although data on children are lacking.
Infantile colic is a widespread clinical condition affecting between 5% and 28% of infants in the first 3-4 months of life. It refers to paroxysms of excessive, high-pitched, inconsolable crying frequently accompanied by flushing of the face, tensing of the abdomen, clenching of the fists, drawing up of the legs, and passing of gas in an otherwise healthy infant.
In this chapter, the physiology of gastrointestinal gas is outlined, the clinical manifestations of excessive gastrointestinal gas are discussed, and infantile colic is reviewed.
In the 1990s we published Ethnoveterinary Medicine (EVM) research in veterinary journals for the first time. Many of the plants used were either considered weeds or were not considered at all. The lack of scientific research on the plants being published resulted in Dr. Duke’s Ethnobotanical database being utilised to fill in the scientific gaps. This chapter reports on the plants used for urinary and other problems in pets. Cushings /hyperadrenocorticism was treated with ginkgo leaf (Ginkgo biloba). Benign prostatic hyperplasia in dogs was treated with saw palmetto (Serenoa repens) fruit. Aphanes arvensis, Hydrangea arborescens and Urtica dioica were used as kidney tonics. The understudied plants parsley-piert (Aphanes arvensis) and Hydrangea arborescens were evaluated using Dr. Duke’s ethnobotanical database.
Infantile colic is a common disturbance occurring in the first three months of life. It is a benign condition and one of the main causes of pediatric consultation in the early part of life because of its great impact on family life. Some pediatricians are prone to undervalue this issue and there is no consensus concerning management and treatment. In literature are growing evidences about the effectiveness of dietary, pharmacological, complementary and behavioral therapies as options for the management of infantile colic. Dietary approach is based on the avoidance of cow’s milk proteins in breast-feeding mothers and bottle-fed infants. Currently pharmacological agents over the counter or by prescription are not recommended because of reported side effects. There is limited evidence supporting the use of complementary and alternative treatments (herbal supplements, manipulative approach and acupuncture) or behavioral modification interventions. Recent studies have partially clarified the pathogenesis of this disturb and so new treatments, such as probiotics, have been proposed. Further investigations are needed in order to provide evidence-based guidelines.
As part of an emerging movement in complementary therapy, the practice of infant foot reflexology and abdominal massage is gaining widespread acceptance as a therapeutic approach to the relief of infantile colic. The objective of the current research is to offer an evaluation of knowledge, attitudes and practice amongst new mothers in relation to infant massage and reflexology. Specifically, the intention is to apply any insights gained to the establishment of appropriate educational programmes in line with the requirements of new mothers. This is to be achieved through the appraisal of any perceived improvements in the knowledge, attitudes and practices of new mothers following the completion of any programme. A quasi-experimental design is adopted in this research and applied in the setting of the outpatient clinic at the University Hospital in Najran, Saudi Arabia. A convenience sample, comprising sixty-two new mothers, all of whom have infants ranging in age from one month to four months. All the infants experience colic. The first instrument employed in this research comprises a structured interview wherein interviewees are presented with a two-part sheet. Section one is devoted to the obtaining of socio-demographic data regarding the mothers and the infants, whilst section two consists of a questionnaire devoted to gauging the level of knowledge of new mothers. The second research instrument is an observation checklist aimed at evaluating the practical skills of new mothers, whereas the third research tool employed in this study is a Likert scale which judges the attitudes of new mothers toward foot reflexology and abdominal massage. The findings of the research reveal that most new mothers demonstrated improvements to their attitudes, knowledge, and practice following the programme. Specifically, there was found to be statistically significant correlation between the age, educational level, and work experience of new mothers and their scores for attitudes, knowledge, and practices. Hence, it was possible to conclude that educational programmes for new mothers can augment their knowledge, refine their practices and improve their attitudes in respect of abdominal massage and foot reflexology as a means of treating colic in infants. Thus, the authors recommend that educational programmes constitute a significant means by which abdominal massage and foot reflexology can be promoted as a therapy for the treatment of colic.
The presence of benzodiazepine-like substances in dried flower heads of Matricaria chamomilla was investigated. After extraction and HPLC purification we tested several fractions for their ability to displace in vitro [3H]Flunitrazepam bound to its receptors in rat cerebellar membranes, [3H]Muscimol linked to GABA receptors in rat cortical membrane preparations and [3H]RO 5-4864 specifically bound to the so-called 'peripheral' benzodiazepine binding sites present in membrane preparations from rat adrenal glands. Few of these fractions displaced both central and peripheral benzodiazepine binding sites and GABA receptors, too. As regards this last activity, by further HPLC analysis we identified GABA as the main agent responsible for the displacing effect. Some of the extracted fractions, not containing GABA, were intracerebronventricularly injected in rats and produced a statistically significant reduction of the locomotor activity. Ongoing experiment by mass spectrometric technique will help in the identification of the benzodiazepine-like compounds present in the extract of Matricaria chamomilla responsible for its sedative effect.
A two-part population-based study investigating the occurrence of infantile colic was undertaken, in which 92% of mothers with newborn healthy infants were reached. In the prospective part 152 mothers ("diary group") registered crying and fussing in their infants during 12 weeks. In the retrospective part 224 mothers ("interview group") were contacted by telephone at an infant age of 5-7 months. The colic occurrence was determined according to four different definitions; the rate varied from 3.3 to 17.1%. The classical "Wessel-type" colic was present in 9.3%. Colic defined as "crying seen as a problem by parent" was present in 12.1% of the "interview group", but in only 3.3% of the "diary group". Some earlier studies may have overestimated colic occurrence. Another possibility is an actual decline. The contributive part of preventive measures is discussed.
To evaluate the effectiveness of diets, drug treatment, and behavioural interventions on infantile colic in trials with crying or the presence of colic as the primary outcome measure.
Controlled clinical trials identified by a highly sensitive search strategy in Medline (1966-96), Embase (1986-95), and the Cochrane Controlled Trials Register, in combination with reference checking for further relevant publications. Keywords were crying and colic.
Two independent assessors selected controlled trials with interventions lasting at least 3 days that included infants younger than 6 months who cried excessively.
Methodological quality was assessed by two assessors independently with a quality assessment scale (range 0-5). Effect sizes were calculated as percentage success. Effect sizes of trials using identical interventions were pooled using a random effects model.
27 controlled trials were identified. Elimination of cows' milk protein was effective when substituted by hypoallergenic formula milks (effect size 0.22 (95% confidence interval 0.09 to 0.34)). The effectiveness of substitution by soy formula milks was unclear when only trials of good methodological quality were considered. The benefit of eliminating cows' milk protein was not restricted to highly selected populations. Dicyclomine was effective (effect size 0.46 (0.33 to 0.60)), but serious side effects have been reported. The advice to reduce stimulation was beneficial (effect size 0.48 (0.23 to 0.74)), whereas the advice to increase carrying and holding seemed not to reduce crying. No benefit was shown for simethicone. Uncertainty remained about the effectiveness of low lactose formula milks.
Infantile colic should preferably be treated by advising carers to reduce stimulation and with a one week trial of a hypoallergenic formula milk.
Despite its benign, natural course, colic is a significant problem in infants and imparts a psychological, emotional, and physical burden to parents. Dicyclomine hydrochloride is the only pharmacological treatment for infantile colic that has been consistently effective. Unfortunately, 5% of infants treated with dicyclomine hydrochloride develop serious side effects, including death. Fennel seed oil has been shown to reduce intestinal spasms and increase motility of the small intestine. However, there have not been any clinical studies of its effectiveness.
To determine the effectiveness of fennel seed oil emulsion in infantile colic.
Randomized placebo-controlled trial.
Two large multi-specialty clinics.
125 infants, 2 to 12 weeks of age, who met definition of colic.
Fennel seed oil emulsion compared with placebo.
Relief of colic symptoms, which was defined as decrease of cumulative crying to less than 9 hours per week.
The use of fennel oil emulsion eliminated colic, according to the Wessel criteria, in 65% (40/62) of infants in the treatment group, which was significantly better than 23.7% (14/59) of infants in the control group (P < 0.01). There was a significant improvement of colic in the treatment group compared with the control group [Absolute Risk Reduction (ARR) = 41% (95% CI 25 to 57), Number Needed to Treat (NNT) = 2 (95% CI 2 to 4)]. Side effects were not reported for infants in either group during the trial.
Our study suggests that fennel seed oil emulsion is superior to placebo in decreasing intensity of infantile colic.
Objective. To determine the efficacy of simethicone in the treatment of infant colic.
Design. Randomized, double blind, placebo-controlled.
Setting. Three general pediatric practices in distinct geographic regions.
Patients. Eighty-three infants between 2 and 8 weeks of age with infant colic.
Interventions. Treatment with simethicone and placebo in double blind crossover fashion.
Results. A total of 166 treatment periods, ranging from 3 to 10 days, were evaluated in the 83 infants. Compared to baseline, improvement in symptoms was reported for 54% of the treatment periods, worsening was reported for 22%, and, for 24%, there was no change. The likelihood of the treatment period being rated as showing improvement, worsening, or no change was the same whether the infant was receiving placebo or simethicone. Twenty-eight percent of he infants responded only to simethicone, 37% only to placebo, and 20% responded to both. No statistically significant differences were noted among these three groups of responders. No difference could be shown even when infants with "gas-related symptoms" (by parental report) were separated out as a group.
Conclusion. Although both produced perceived improvements in symptoms, simethicone is no more effective than placebo in the treatment of infantile colic.
Biological activity studies of Melissa officinalis L. (S.I.P.F.) on C.N.S. and on isolated duodenum of rat, permit us to demonstrate on animal by in vivo tests the sedative, hypnotic and analgesic effects and in vitro an antispasmodic effect. The sedative and hypnotic properties were investigated by the observation of motility and exploration of mice exposed in particular contraint (staircase test) or non contraint (two compartment test) situations and also by the estimation of induction and barbituric sleep potentialization. The only one peripheric analgesic obviousness effect is probably due to inhibitory effect of the extract on intestinal peristaltism. On the opposite any anticholinergic and spasmolytic effects are not observed on the isolated duodenum.
Objective: To evaluate the effectiveness of diets, medication and behavioral interventions on infantile colic in trials with crying or the presence of colic as primary outcome measure. Data sources: Controlled clinical trials identified by a highly sensitive search strategy in Medline (1966-1996), Embase (1986-1995), and the Cochrane Controlled Trials Register, in combination with checking references for further relevant publications. Keywords: 'crying' and 'colic'. Study selection: Two independent assessors selected controlled trials with interventions of at least 3 days duration that included infants younger than 6 months who cried excessively. Data synthesis: Methodological quality was assessed by two assessors independently with a quality assessment scale (range: 0-5). Effects were calculated as percentage success. Effects of trials using identical interventions were statistically pooled using a random effects model. Results: 27 controlled trials were identified. Elimination of cow's milk protein is effective when substituted by hypoallergenic formulas (effect = 0.22, 95% CI 0.09-0.34). The effectiveness of substitution by soy formulas remains unclear when only trials of good methodological quality are considered. The benefit of cow's milk protein elimination is not restricted to highly selected populations. Dicyclomine is effective (effect = 0.46, 95% CI 0.33-0.60); however, serious side effects have been reported. The advice to reduce stimulation is beneficial (effect = 0.48, 95% CI 0.23- 0.74), whereas the advice to increase carrying and holding seems not to reduce crying. No benefit is shown of simethicone. Uncertainty remains about the effectiveness of low lactose formulas. Conclusions: Infantile colic should preferably be treated with the advice to reduce stimulation and a trial of a hypoallergenic formula.
The term 'three months' colic' is reserved for a clinical entity in which the baby, in the first three months of life, has rhythmical screaming attacks in the evenings, which are not stopped when he is picked up, and for which there is no obvious explanation, such as hunger. The great ease with which crying can be ascribed to colic when in fact it is due to some readily correctable cause such as hunger is emphasized. Severe forms, however, are felt to be so characteristic that they cannot be confused with anything else. The literature on the subject is reviewed. A controlled investigation of colic was carried out, 50 babies with colic being compared with 50 who had no colic. It is shown that the mothers of these two groups of babies differed in no way as regards their age, parity or pregnancy history. The babies differed in no way as regards their sex, birth weight, feeding history, family history of allergy, signs of allergy, incidence of posseting, number of stools, or weight gain. They appeared to be well, normal babies apart from their attacks of pain in the evenings, and when followed up they continued to be normal. In 33 out of 49 babies the colic began in hospital. In 44 of the babies it began in the first 15 days. In 47 of the 50 babies it began at 5 p.m. or later in the evening. The average age at which the colic disappeared was 91/2 weeks. Fifty-four per cent had lost it by the end of two months, 85 % by the end of three months, and all by the end of four months. The cause of colic, in the light of the above findings, is discussed. It is felt that it is not due to underfeeding, overfeeding, or other errors of feeding technique. It is not due to mismanagement or spoiling, to allergy, hypertonia, swallowed air or to foods taken by the mother. X-ray studies taken during an attack of colic did not show an excess of gas in the bowel. The most likely explanation of colic is thought to be the local obstruction to the passage of gas in the colon by local spasm or kinking of uncertain cause.
To determine the relationship between infantile colic and cow's milk protein intolerance (CMPI) in formula-fed infants, 70 infants (38 male, 32 female) were selected, with mean age 30.2 +/- 21.4 days, with severe colic (duration of crying >4 h per day for 5 days per week). In 50 of the infants in the study group (71.4%) there was a remission of symptoms when cow's milk protein (CMP) was eliminated from the diet. Two successive challenges caused the return of symptoms in all these 50 infants. There was a positive anamnesis for atopy in 9 of 50 of the patients with CMP-related colic and in 1 of 20 of those with non-CMP-related colic (p > 0.05). A follow-up period of 18 months' mean duration showed that 22 of 50 (44%) of the infants with CMP-related colic and 1 of 20 (5%) of those with non-CMP-related colic developed an overt alimentary intolerance (p < 0.02). We conclude that a considerable percentage of the infants with severe colic also have CMPI and that in these cases, dietetic treatment should be the first therapeutic approach
To find out whether intestinal microflora in colicky infants is different from that in noncolicky controls, stool samples were collected from colicky infants during colic (n = 55) and at the age of 3 months (n = 46) and compared with samples from age-matched controls (n = 49 and n = 45, respectively). The samples were cultured on several selective and unselective aerobic and anaerobic culture agars, and gas-liquid chromatography of bacterial cellular fatty acids was used to produce fatty-acid profiles of the stool samples. In quantitative bacterial cultures, no differences were found between the colicky and control groups in the amounts of each bacterium. The colicky infants were more frequently colonized with Clostridium difficile during the time of colic than were the age-matched controls. This difference disappeared by age 3 months. The fatty-acid profiles did not differ between the colicky and control groups as a whole at the time of colicky symptoms. At age 3 months, a difference in fatty-acid profiles was found between the colicky infants who had suffered from severe colic and the control infants. The fatty-acid profiles were also influenced by the age of the infant, the mode of delivery, antimicrobial drugs taken by the mother during delivery, and breast-feeding and type of feeding. In conclusion, no difference in intestinal microflora was found between the colicky infants at the time of colic and the controls. However, a difference in bacterial cellular fatty-acid profiles at the age of 3 months was found that correlated with severe infantile colic. This difference may contribute to the cause(s) of colic, or it may be secondary to the colic, which may influence the microbial environment of the intestine.
Background:
Infantile colics are a common problem in the first months of life. During this period, a process of intestinal colonization rapidly occurs. A difference in the gut microflora could play an important role in the pathogenesis of colics, changing the metabolism of carbohydrates and fatty acids. Actually, in the literature, only few data have been collected about this topic. In this study, we evaluated intestinal microflora in breastfed colicky and non-colicky infants.
Methods:
Seventy-one breastfed infants, aged 3.2 +/- 0.6 wk, free from episodes of gastroenteritis and without previous assumption of antibiotic and probiotic drugs, were enrolled in the study. They were divided into two groups: colicky (42 cases) and non-colicky (29 cases), according to Wessel's criteria. Stool samples were collected, diluted and cultured on several selective media to detect lactobacilli, clostridia, gram-negative anaerobes and Enterobacteriaceae. Statistical analysis was performed using Student's t-test, chi2 test and a non-parametric test (Mann-Whitney U-test).
Results:
Differences in gut microflora were found among colicky and non-colicky infants: colicky infants were less frequently colonized by Lactobacillus spp., and more frequently by anaerobic gram-negative bacteria.
Conclusion:
Our study indicates that colicky infants have different patterns of gut microflora. Further studies are required to understand whether gut microflora is the primary cause of colics or its consequence.
The ethanol extract of the dried ripe fruit of Foeniculum vulgare (500 mg/kg) was tested for diuretic, analgesic, antipyretic, antimicrobial, cytotoxic activities and its effect on bile secretion in rats. Also, the acute toxicity after 0.5, 1 and 3 g/kg was investigated in mice. The extract showed diuretic, analgesic, antipyretic activities and it enhanced bile secretion. As an antimicrobial agent, the extract inhibited the growth of Staphylococcus aureus and Bacillus subtilis and showed a marked mitodepressive effect. At a dose of 3 g/kg, it caused piloerection and it depressed locomotor activity but caused no deaths when administered acutely to mice.
Efficacy and tolerance of Lomatol® drops (a preparation with extracts of the fruits of Carum carvi [caraway], fruits of Foeniculum vulgare [fennel], leaves of Menta piperita [peppermint] and the herb of Artemisia absinthium [wormwood] in the treatment of upper abdominal complaints was compared with the efficacy and tolerance of metoclopramide drops in a controlled, randomized, double-blind study. Their impact on the symptoms of pain, nausea, heartburn, retching and gastrospasms were assessed on a 5-point rating scale. During the two weeks of treatment and observation the phytodrug demonstrated statistically significant better results than the synthetic preparation in relieving all the symptoms. These findings were confirmed by subjective assessment of the general condition by the patient. Moreover, Lomatol® caused significantly fewer adverse drug reactions than metoclopramide and was statistically significantly better tolerated. Thus, this plant combination can be recommended for upper abdominal complaints without any restrictions. The same is also true for similarly composed Lomatol® coated tablets.
Efficacy and tolerance of Lomatol® drops (a preparation with extracts of the fruits of Carum carvi [caraway], fruits of Foeniculum vulgare [fennel], leaves of Menta piperita [peppermint] and the herb of Artemisia absinthium [wormwood] in the treatment of upper abdominal complaints was compared with the efficacy and tolerance of metoclopramide drops in a controlled, randomized, double-blind study. Their impact on the symptoms of pain, nausea, heartburn, retching and gastrospasms were assessed on a 5-point rating scale. During the two weeks of treatment and observation the phytodrug demonstrated statistically significant better results than the synthetic preparation in relieving all the symptoms. These findings were confirmed by subjective assessment of the general condition by the patient. Moreover, Lomatol® caused significantly fewer adverse drug reactions than metoclopramide and was statistically significantly better tolerated. Thus, this plant combination can be recommended for upper abdominal complaints without any restrictions. The same is also true for similarly composed Lomatol® coated tablets.
The literature on "infantile colic" or "paroxysmal fussing" is reviewed.
The frequent occurrence of a regular evening fussy period in two groups of infants is reported as indicative that this is a normal physiological event of the first few weeks of life.
The longitudinal records of 98 infants who were study subjects of the Yale Rooming-In Project were analyzed with respect to incidence, duration, and severity of "paroxysmal fussing." Forty-eight of the infants were classified as "fussy" and 50 as "contented."
The "fussy" babies typically began to have their paroxysms in the second week of life and ceased to have them at about eight weeks. Almost all of them were more fussy in the evening hours than in the morning. The rationale of various methods of treatment is discussed.
The "fussy" group was similar to the "contented" group as regards details of feeding, birth weight, weight gain, sex, educational level of the mother, and family history of allergy.
Of the 48 "fussy" infants, family tension was judged to be an important contributing cause in 22 cases, allergy in six cases; both allergy and family tension together in nine cases; in 11 cases there was no apparent cause.
"Paroxysmal fussing" or "infantile colic" is possibly one of the earliest somatic responses to the presence of tension in the environment. The particular degree to which any infant reacts is probably determined by constitutional factors.
A double-blind crossover trial was carried out in 25 babies with infant colic to compare the symptomatic relief provided by dicyclomine hydrochloride (5mg4-times daily) or placebo. Patients received each treatment, in random order, for 1 week. A scoring system was used to measure the total symptom complex as well as the individual parameters of post-prandial crying, post-prandial vomiting, and sleep disturbance. Dicyclomine hydrochloride syrup was found to be superior to placebo in relieving the total symptom complex (p < 0.025) and in reducing sleep disturbance (p < 0.05). Side-effects with both therapies were minimal.
No doubt can remain that the flavonoids have profound effects on the function of immune and inflammatory cells as determined by a large number and variety of in vitro and some in vivo observations. That these ubiquitous dietary chemicals may have significant in vivo effects on homeostasis within the immune system and on the behavior of secondary cell systems comprising the inflammatory response seems highly likely but more work is required to strengthen this hypothesis. Ample evidence indicates that selected flavonoids, depending on structure, can affect (usually inhibit) secretory processes, mitogenesis, and cell-cell interactions including possible effects on adhesion molecule expression and function. The possible action of flavonoids on the function of cytoskeletal elements is suggested by their effects on secretory processes. Moreover, evidence indicates that certain flavonoids may affect gene expression and the elaboration and effects of cytokines and cytokine receptors. How all of these effects are mediated is not yet clear but one important mechanism may be the capacity of flavonoids to stimulate or inhibit protein phosphorylation and thereby regulate cell function. Perhaps the counterbalancing effect of cellular protein tyrosine phosphatases will also be found to be affected by flavonoids. Some flavonoid effects can certainly be attributed to their recognized antioxidant and radical scavenging properties. A potential mechanism of action that requires scrutiny, particularly in relation to enzyme inhibition, is the redox activity of appropriately configured flavonoids. Finally, in a number of cell systems it seems that resting cells are not affected significantly by flavonoids but once a cell becomes activated by a physiological stimulus a flavonoid-sensitive substance is generated and interaction of flavonoids with that substance dramatically alters the outcome of the activation process.
A lyophilised hydroalcoholic extract of Melissa officinalis L. (Lamiaceae) has been evaluated for behavioral effects in mice. According to the traditional use of M. officinalis, sedative properties have been confirmed for low doses by the decrease of behavioral parameters measured in a non-familiar environment test (staircase test) and in a familiar environment test (two compartment test). With high doses, a peripheral analgesic activity was obtained by reducing the acetic acid-induced pain (writhing test); moreover, the plant extract induced the sleep in mice after treatment with an infrahypnotic dose of pentobarbital and potentialised the sleep induced by a hypnotic dose of pentobarbital.
Previous studies have suggested that an unidentified cow's milk protein, other than beta-lactoglobulin and casein, might play a pathogenetic role in infant colic. Therefore, a radioimmunoassay was used to analyze human breast milk and infant formula samples for the presence of bovine IgG. Milk samples from 88 of the 97 mothers tested contained greater than 0.1 micrograms/mL of bovine IgG. In a study group of 59 mothers with infants in the colic-prone 2- to 17-week age group, the 29 mothers of colicky infants had higher levels of bovine IgG in their breast milk (median 0.42 micrograms/mL) than the 30 mothers of noncolicky infants (median 0.32 micrograms/mL) (P less than .02). The highest concentrations of bovine IgG observed in human milk were 8.5 and 8.2 micrograms/mL. Most cow's milk-based infant formulas contained 0.6 to 6.4 micrograms/mL of bovine IgG, a concentration comparable with levels found in many human milk samples. The results suggest that appreciable quantities of bovine IgG are commonly present in human milk, that significantly higher levels are present in milk from mothers of colicky infants, and that bovine IgG may possibly be involved in the pathogenesis of infant colic.
Eight infants with histories of apnea and cyanosis were referred to the Southwest SIDS Research Institute for evaluation of apparent life threatening events (ALTE). All of the infants had been treated for colic with a 1:1 concentration of dimenhydrinate (Dramamine) and phenobarbital, hyoscyamine sulfate, atropine sulfate and scopolamine hydrobromide (Donnatal). The medication was pre-mixed by local pharmacists. A comprehensive work-up failed to reveal a cause for the ALTE in any infant. The Dramamine/Donnatal mixture was withdrawn and polygraphic evaluation was conducted. Cardiorespiratory abnormalities were identified in all eight infants and significant gastroesophageal reflux (GER) was documented in four. The possibility that colic medication contributes to cardiorespiratory instability and GER in vulnerable infants requires serious consideration and further evaluation.
To determine the relationship between infantile colic and cow's milk protein intolerance (CMPI) in formula-fed infants, 70 infants (38 male, 32 female) were selected, with mean age 30.2 +/- 21.4 days, with severe colic (duration of crying greater than 4 h per day for 5 days per week). In 50 of the infants in the study group (71.4%) there was a remission of symptoms when cow's milk protein (CMP) was eliminated from the diet. Two successive challenges caused the return of symptoms in all these 50 infants. There was a positive anamnesis for atopy in 9 of 50 of the patients with CMP-related colic and in 1 of 20 of those with non-CMP-related colic (p greater than 0.05). A follow-up period of 18 months' mean duration showed that 22 of 50 (44%) of the infants with CMP-related colic and 1 of 20 (5%) of those with non-CMP-related colic developed an overt alimentary intolerance (p less than 0.02). We conclude that a considerable percentage of the infants with severe colic also have CMPI and that in these cases, dietetic treatment should be the first therapeutic approach.
There are several causes of infantile colic. The aim of this study was to evaluate, under controlled conditions, whether bovine whey proteins can elicit symptoms of infantile colic in colicky formula-fed infants. The mean age for entering the study was 6.4 weeks and the mean age for colic debut was 3.7 weeks. In 24 of 27 infants with severe colic, the symptoms disappeared when they were given a cow's milk-free diet (Nutramigen). These 24 infants were entered into a double-blind crossover study. The infants (receiving cow's milk-free diet) were given the contents of identical capsules with each meal during day 6. The same procedure was repeated on day 10. The capsules contained either whey protein powder (with Nutramigen added) or human albumin powder (with Nutramigen added). Eighteen infants receiving the whey protein-containing capsules reacted with colic, two infants receiving placebo reacted with colic (P less than .001), and four infants did not react at all. Crying hours per day for the 24 infants were 5.6 hours for formula-fed infants and 0.7 hour for cow's milk-free diet-fed infants (P less than .001). Crying hours per day were 3.2 hours for the infants receiving whey protein capsules and 1.0 hour for those receiving placebo (P less than .001). In conclusion, bovine whey protein can elicit symptoms of infantile colic in colicky formula-fed infants.
The literature regarding infant colic is critically reviewed. Although there have been a number of theories proposed as to etiology of colic, the literature is characterized by difficulties in definition, methodologic problems, and numerous claims as to both etiology and management that are anecdotal. Infant colic is best conceptualized as the end result of a complex transaction between the infant and his environment, with multiple factors responsible for the crying and distress of an infant. The most important factors in appropriate intervention are a physician's receptivity and sensitivity toward the stressed mother, together with an interested and practical approach to providing adequate support while delineating the individual stresses acting on both mother and baby. Future research is needed to delineate markers for those subgroups of infants who may present with crying as a manifestation of specific clinical situations.
• During early infancy, problems of crying, colic, spitting, and feeding difficulties often provoke anxiety and lack of self-confidence in parents. We studied prospectively what proportion of mothers felt that their infants had problems of this type and determined risk factors for perceived problems identified in the early postnatal period. The mothers of 189 breast-fed and 184 formula-fed infants completed questionnaires post partum and responded to a follow-up interview at four months. Thirty-five percent of mothers in each group reported that their infants had moderate or severe problems of feeding or crying behavior. Risk factors for perceived problems were identified using stepwise logistic regression analyses. Inquiry about, and early attention to, risk factors may alleviate the parents' concerns and possibly affect the development of these problems.
(AJDC 1985;139:269-272)
The effects of volatile oils of 22 plants from 11 different families and of some of their constituents on tracheal and ileal smooth muscles were investigated. The results were compared with the relaxant effects of catecholamines and phosphodiesterase inhibitors. All of the oils had relaxant effects on the tracheal smooth muscle, the most potent were angelica root, clove, elecampane root, basil and balm leaves oil. 16 oils inhibited the phasic contractions of the ileal myenteric plexus-longitudinal muscle preparation, the most potent were elecampane root, clove, thyme, balm leaves and angelica root oil. 2 oils (anise and fennel) increased the phasic contractions, and 4 oils (bitter orange, caraway, mace, pepper) produced a marked increase in resting force (i.e. contracture). In regard to the relaxant effects, most of the 16 oils were more potent on the ileal than on the tracheal muscle. However, a small group of 4 oils (angelica root, clove, basil, black caraway) had a higher relaxant effect on the tracheal than on the ileal muscle. This was also found to be the case with eugenol, eugenol acetate and cinnamic aldehyde as well as with isoprenaline and phosphodiesterase inhibitors.
We performed a prospective, randomized, double-blind, placebo-controlled clinical trial of dicyclomine hydrochloride using specific diagnostic criteria for infantile colic: spells of unexplained irritability, agitation, fussiness or crying lasting greater than or equal to 3 hours/day, occurring greater than or equal to 3 days/week, and continuing for greater than or equal to 3 weeks. Dicyclomine eliminated colic in 15 of 24 (63%) infants, whereas placebo was effective in six of 24 (25%) (corrected X2 = 5.42, P = 0.02). The study also addressed the hypothesis that parental distress caused by infantile colic affects subsequent temperament and sleep patterns. The data fail to document easier temperaments or longer sleep durations at 4 months in infants whose colic ceased during treatment.
Sixty-six mothers of 66 breast-fed infants with infantile colic were put on a diet free from cow's milk. The colic disappeared in 35 infants; it reappeared on at least two challenges (cow's milk to mother) in 23 infants (35%). A double-blind crossover trial with cow's milk whey protein was performed in 16 of these 23 mothers and infants. Six infants had to be taken out of the study for various reasons; of the remaining ten infants, nine reacted with colic after their mothers' intake of whey protein-containing capsules. Sequential analysis showed a high correlation between infantile colic in breast-fed infants and their mothers' consumption of cow's milk protein. A diet free of cow's milk is suggested for the mothers as a first trial of treatment of infantile colic in breast-fed infants.
Colic affected 16% of 843 infants. It was not related to breast or cows' milk feeding. Increased prevalence was noted if cereals or solids had been introduced during the first 3 months of life and in infants from professional or skilled social groupings.
The antispasmodic activity of 2.5 and 10.0 ml/l of alcoholic extracts of Melissa officinalis, Rosmarinus officinalis, Mentha piperita, Matricaria chamomilla, Foeniculum vulgare, Carum carvi and Citrus aurantium prepared from 1 part of the plant and 3.5 parts of ethanol (31 % w/w) was tested employing the guinea pig ileum and using acetylcholine and histamine as spasmogens. Most of the extracts shifted the dose response curves of acetylcholine and histamine to the right in a dose dependent manner. Extracts from Carum carvi, Mentha piperita, Citrus aurantium and Matricaria chamomilla showed a significant rise of the DE50 of cetylcholine-induced contractions and a significant decrease of the maximal possible contractility. In histamine-induced contractions, all plant extracts except Extractum Melissae exhibited a significant increase of the DE50, and all extracts used here decreased the maximal possible contractility produced by histamine. The alcoholic extract of Mentha piperita was most effective when tested with acetylcholine and the extract of Citrus auran-tium was most active when tested with histamine. Melissa officinalis did not show significant antispasmodic activity. When the antispasmodic activities of the most effective plant extracts were compared with the activity of atropine, it was evident that their effects were less than that of the usual therapeutic dosage of atropine in man. The most pronounced effects with 10 ml/l Extractum Citrus aurantii and 10 ml/l Extractum Menthae piperitae correspond to the effect of 0.07 resp. 0.13 mg atropine.
To find out whether intestinal microflora in colicky infants is different from that in noncolicky controls, stool samples were collected from colicky infants during colic (n = 55) and at the age of 3 months (n = 46) and compared with samples from age-matched controls (n = 49 and n = 45, respectively). The samples were cultured on several selective and unselective aerobic and anaerobic culture agars, and gas-liquid chromatography of bacterial cellular fatty acids was used to produce fatty-acid profiles of the stool samples. In quantitative bacterial cultures, no differences were found between the colicky and control groups in the amounts of each bacterium. The colicky infants were more frequently colonized with Clostridium difficile during the time of colic than were the age-matched controls. This difference disappeared by age 3 months. The fatty-acid profiles did not differ between the colicky and control groups as a whole at the time of colicky symptoms. At age 3 months, a difference in fatty-acid profiles was found between the colicky infants who had suffered from severe colic and the control infants. The fatty-acid profiles were also influenced by the age of the infant, the mode of delivery, antimicrobial drugs taken by the mother during delivery, and breast-feeding and type of feeding. In conclusion, no difference in intestinal microflora was found between the colicky infants at the time of colic and the controls. However, a difference in bacterial cellular fatty-acid profiles at the age of 3 months was found that correlated with severe infantile colic. This difference may contribute to the cause(s) of colic, or it may be secondary to the colic, which may influence the microbial environment of the intestine.
To determine the efficacy of simethicone in the treatment of infant colic.
Randomized, double blind, placebo-controlled.
Three general pediatric practices in distinct geographic regions.
Eighty-three infants between 2 and 8 weeks of age with infant colic.
Treatment with simethicone and placebo in double blind crossover fashion.
A total of 166 treatment periods, ranging from 3 to 10 days, were evaluated in the 83 infants. Compared to baseline, improvement in symptoms was reported for 54% of the treatment periods, worsening was reported for 22%, and, for 24%, there was no change. The likelihood of the treatment period being rated as showing improvement, worsening, or no change was the same whether the infant was receiving placebo or simethicone. Twenty-eight percent of he infants responded only to simethicone, 37% only to placebo, and 20% responded to both. No statistically significant differences were noted among these three groups of responders. No difference could be shown even when infants with "gas-related symptoms" (by parental report) were separated out as a group.
Although both produced perceived improvements in symptoms, simethicone is no more effective than placebo in the treatment of infantile colic.
We evaluated the effect of an herbal tea preparation on infantile colic in a prospective double-blind study. The use of tea eliminated the colic in 19 (57%) of 33 infants, whereas placebo was helpful in only 9 (26%) of 35 (p < 0.01). The mean colic score was significantly improved in tea-treated infants. No significant differences were noted between groups regarding number of night wakings.
b
Ample evidence is available on the impact of health care practices and hospital routines and procedures on breastfeeding. Good practices enhance successful initiation and establishment of breastfeeding and contribute to increased duration, just as inappropriate practices, and failure to support and encourage mothers, have the opposite effect. In 1991 the World Health Organization (WHO) and the United Nations Children's Fund (UNICEF) jointly launched the Baby‐Friendly Hospital Initiative, which aims to give every baby the best start in life by ensuring a health care environment where breastfeeding is the norm. The initiative is based on the principles summarized in a joint statement issued by the two organizations in 1989 on the role of maternity services in protecting, promoting, and supporting breastfeeding. To become truly baby‐friendly, hospitals and maternity wards around the world are giving practical effect to the principles described in the joint WHO/UNICEF statement that have been synthesized into Ten Steps To Successful Breastfeeding. This summary of the rationale and scientific basis for the Ten Steps is presented in the light of cumulative experience demonstrating the crucial importance of these principles for the successful initiation and establishment of breastfeeding.
The pharmacological activity of nine commercial essential oils was studied on the rat isolated phrenic nerve diaphragm preparation and compared with activity on field-stimulated guinea-pig ileum preparations. The essential oils at final bath concentrations of 2 x 10(-5) and 2 x 10(-4) g/ml produced four different effects on skeletal muscle, whilst only a contracture with or without a decrease in response to field stimulation in smooth muscle. The first type of effect on skeletal muscle involved a contracture and inhibition of the twitch response to nerve stimulation shown by a sample of clary sage, dill, fennel, frankincense and nutmeg; a second, shown by thyme produced a contracture without a change in the twitch response; a third, shown by lavender reduced the twitch response alone and the fourth, shown by camphor, increased the size of the twitch response. Angelica root oil at the highest concentration studied showed no response on skeletal muscle.
The flavonoids are a large group of naturally occurring phenylchromones found in fruits, vegetables, grains, bark, roots, stems, flowers, tea, and wine. Up to several hundred milligrams are consumed daily in the average Western diet. Only limited information is available on the absorption, distribution, metabolism, and excretion of these compounds in man. Some compounds are absorbed, however, and measurable plasma concentrations are achieved which could have pharmacological relevance. A variety of in vitro and in vivo experiments have shown that selected flavonoids possess antiallergic, antiinflammatory, antiviral and antioxidant activities. Moreover, acting by several different mechanisms, particular flavonoids can exert significant anticancer activity including anticarcinogenic properties and even a prodifferentiative activity, amongst other modes of action. Certain flavonoids possess potent inhibitory activity against a wide array of enzymes, but of particular note is their inhibitory effects on several enzyme systems intimately connected to cell activation processes such as protein kinase C, protein tyrosine kinases, phospholipase A2, and others. Evidence suggests that only activated cells are susceptible to the modulating effects of flavonoids, i.e. cells which are responding to a stimulus. The stimulated activities of numerous cell types, including mast cells, basophils, neutrophils, eosinophils, T & B lymphocytes, macrophages, platelets, smooth muscle, hepatocytes, and others, can be influenced by particular flavonoids. On balance, a considerable body of evidence suggests that plant flavonoids may be health-promoting, disease-preventing dietary compounds.
Persistent infant crying and "colic" have been linked in some studies to feeding, but this association has not been tested in a planned longitudinal study comparing breast- with formula fed babies. We used validated maternal diaries of infant behaviours, kept for three days at both two and six weeks of infant age, in a comparative study of 97 breast- or formula fed babies. The total duration of overall crying rose significantly between 2 and 6 weeks in breast-fed infants and fell in those fed formula. At 6 weeks, breast-fed infants cried an average of almost 40 minutes more per day than formula fed infants; and 31% cried for more than three hours per day, compared with only 12% of the formula fed group. At six weeks, breast-fed infants also slept almost 80 minutes less per day than the formula fed babies. While six weeks is the established peak age for infant crying, those fed formula peaked much earlier and at 2 weeks intense crying/colic behaviour occurred in 43% of formula fed babies and just 16% of those fed by breast. These findings link the timing of the infant crying peak to the mode of feeding. Our data indicate that any regimen designed to reduce crying should commence in the neonatal period in formula fed infants.
In this article, some aspects of the phenomenon of infantile colic or fussing and crying behavior in early infancy are reviewed. The major points addressed are as follows: 1) evidence that infants with colic differ significantly in their pattern of distressed behavior from noncolicky infants; 2) the evidence of colic in children with known food allergy; 3) the incidence of food allergy in children with colic; 4) the outcome of trials focusing on the dietary management of colic; 5) the outcome of studies involving behavior modification in colic; 6) the outcome of a preliminary trial of modification of maternal diet in very young infants with colic; and 7) findings of a systematic review of different treatments for colic.
Infant colic, a common disorder of infancy, is characterized by excessive crying and fussing. In this preliminary study we examined whether Neocate, an amino acid-based formula, would be accepted by formula-fed infants with colic, 3-7 wk of age, and whether Neocate would improve their symptoms. Six infants with colic were studied using Barr-type infant behavior diaries for 3-6 d on their current formula and then for 5-17 d on Neocate exclusively. All infants tolerated Neocate well and all improved, usually within 1-2 d. The total time spent crying and fussing was reduced by an average of 45%, representing a decrease of 1.0 to 5.2 h daily. After colic symptoms improved, infants were challenged with oral doses of 75 mg of bovine IgG at a 1 mg/ml concentration in order to assess its potential role in colic. Bovine IgG challenges resulted in increased crying and fussing behavior, suggesting that this protein may be etiologically important.
Dried flowers of Matricaria chamomilla L. are largely used to provide sedative as well as spasmolytic effects. In the present study, we examined in particular the pharmacological property of a fraction isolated from a methanolic extract of M. chamomilla, which was identified by HPLC-MS-MS analysis as apigenin. By radioreceptor binding assays, we demonstrated the ability of the flavone to displace a specific radioligand, [(3)H]Ro 15-1788, from the central benzodiazepine binding site. Electrophysiological studies performed on cultured cerebellar granule cells showed that apigenin reduced GABA (gamma-aminobutyric acid)-activated Cl(-) currents in a dose-dependent fashion. The effect was blocked by co-application of Ro 15-1788, a specific benzodiazepine receptor antagonist. Accordingly, apigenin reduced the latency in the onset of picrotoxin-induced convulsions. Moreover, apigenin injected i.p. in rats reduced locomotor activity, but did not demonstrate anxiolytic, myorelaxant, or anticonvulsant activities. The present results seem to suggest that the inhibitory activity of apigenin on locomotor behaviour in rats cannot be ascribed to an interaction with GABA(A)-benzodiazepine receptor but to other neurotransmission systems, since it is not blocked by Ro 15-1788.
It has been shown that altering hospital policies in a way to avoid interference of routine prescriptions with initiation of breast feeding and to provide active encouragement to mothers and personnel can result in significant benefit for later breast feeding success. It is less clear, however, which of the elements of a promotional programme such as UNICEF/WHO’s “ten steps to successful breast feeding” are absolutely essential and which can be adapted to local cultural habits.
We performed an open randomized multicenter study in Switzerland to evaluate, whether restriction of supplementary fluids for breast fed infants in the first week of life and strict avoidance of artificial teats and pacifiers affects later breast feeding success. Follow up to 6 months was ensured by mailed questionnaires.
602 mother infant pairs were enrolled. Of 294 infants in the intervention group 39% were excluded from the final analysis because of protocol violations, mainly maternal request for the use of pacifiers or bottles. Though the number of dextrin maltose supplements during the first two days (1.7 vs. 2.2 on day 1, 2.2 vs. 2.6 on day 2) and the percentage of infants receiving any supplement (85% vs. 96.6%) was significantly smaller in the intervention group, the difference was disappointingly small. The prevalence of breast feeding was 100% vs. 99% at day 5, 88% vs. 88% at 2 months, 75% vs. 71% at 4 months and 57% vs. 55% at 6 months, none of the differences being significant. We conclude that rigorous adherence to all of the ten steps may encounter obstinate resistance from cultural habits even in a population highly favourable to breast feeding. An improvement in adherence does not necessarily lead to better breast feeding success. The results of the few comparable studies in the literature show also that cultural practices during the first months of life may influence profoundly the long term effects of interventions during the first days of life.
The authors review the major scientific milestones and the legislative framework that have made possible the spectacular successes of many modern therapies that trace their origins to plants. They emphasize that drugs used in mainstream medicine, in contrast to most of those used in alternative medicine, are required to meet stringent federal requirements for purity, safety, and efficacy before they can be distributed to the public, and that the necessary testing requires much time and effort. Yet alternative medicines based on plant substances are extremely popular, even though their safety and efficacy have not been scientifically proven. Reasons for this are reviewed and numerous examples and case histories are cited illustrating both successes in the scientific development of drugs from plants and the dangers of unregulated drugs. Such drugs are more easily available because of the deregulating effect of the 1994 Dietary Supplement Health and Education Act (DSHEA), which has substantially weakened the authority of the Food and Drug Administration to ensure the safety of dietary supplements. The authors describe the rigorous scientific investigations of curcumin, from the ginger family, and of sulforaphane, from crucifers, to illustrate the long and demanding scientific process that is required to establish the safety and effectiveness of potential drugs from plants. They re-emphasize the necessity for strict scientific review of all drugs. They also recommend that all providers of care be required to question patients about their intakes of dietary supplements. The authors close by saying that the DSHEA is "a disaster waiting to happen," but warn that any attempts to strengthen current legislation will be opposed by special interests.
Treatment of infantile colic remains an open issue. In Italy, cimetropium bromide is used extensively to treat infantile colic. The aim of this randomized, double-blind, placebo-controlled clinical trial was to investigate the effectiveness and side effects of cimetropium bromide in the treatment of infants with colic crisis.
Ninety-seven infants with colic were enrolled. The diagnosis of infantile colic in healthy infants with regular growth, aged 15 to 60 days was made according to the criteria of Wessel. The infants were divided into two groups, one treated with cimetropium bromide (1.2 mg/kg) and the other treated with placebo at onset of each crisis for 3 days. Duration of crying and side effects were recorded daily in a structured diary for the 3 days of therapy. Statistical analysis was performed using the chi-square and t tests.
Eighty-six infants completed the trial. The average duration of crying for each crisis was 17.3 +/- 12.6 minutes in the cimetropium bromide group and 47.5 +/- 28.5 minutes in the placebo group (P < 0.005). Response to cimetropium bromide was 74%. Response to placebo was 33% (P < 0.05). Side effects did not differ significantly between the two groups, except sleepiness, which increased in the infants treated with cimetropium bromide.
Cimetropium bromide was more effective than placebo in reducing the duration of crying in children with infantile colic. The use of the anticholinergic drugs, aside from the dicyclomine because of its dangerous side effects, should be revaluated for treating infantile colic.
Infantile colics are a common problem in the first months of life. During this period, a process of intestinal colonization rapidly occurs. A difference in the gut microflora could play an important role in the pathogenesis of colics, changing the metabolism of carbohydrates and fatty acids. Actually, in the literature, only few data have been collected about this topic. In this study, we evaluated intestinal microflora in breastfed colicky and