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Iberis amara L. and Iberogast®—Results of a Systematic Review Concerning Functional Dyspepsia

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Abstract

A systematic review referring to efficacy and tolerability of the herbal combination Iberogast (Iberis amara planta totalis, Chelidonii herba, Cardui mariae fructus, Melissae folium, Carvi fructus, Liquiritiae radix, Angelicae radix, Matricariae flos, Menthae piperitae folium) was performed in patients with functional dyspepsia. Three placebo-controlled trials and a reference-controlled trial showed a statistical significant and therapeutical relevant reduction of the gastrointestinal symptom-scores in 595 patients. The therapeutic efficacy was also found in one observational study (2267 patients). In accordance with the available evidence Iberogast seems to be an effective phytotherapeutic preparation to reduce the symptoms of dyspepsia yet, without central nervous side effects.
... Future studies should consider investigating drugs presented in Table 1, herbal products and food supplements, which showed potential effectiveness to reduce symptoms in adults and children with FD. These herbal products and food supplements include motilitone, cyproheptadine, STW 5 (Iberogast), peppermint oil, modified xiaoyao san, Rikkunshito, Chinese Herbal Medicine, and probiotics [6,21,22,32,33,[36][37][38]42,69,92,93]. However, again, we stress that evidence on efficacy in adults cannot be directly translated to children. ...
Article
Introduction: Chronic idiopathic nausea (CIN) and functional dyspepsia (FD) cause considerable strain on many children’s lives and their families. Areas Covered: This study aims to systematically assess the evidence on efficacy and safety of pharmacological treatments for CIN or FD in children. CENTRAL, EMBASE and Medline were searched for Randomized Controlled Trials (RCTs) investigating pharmacological treatments of CIN and FD in children (4-18 years). Cochrane risk of bias tool was used to assess methodological quality of the included articles. Expert Commentary: Three RCTs (256 children with FD, 2-16 years) were included. No studies were found for CIN. All studies showed considerable risk of bias, therefore results should be interpreted with caution. Compared to baseline, successful relief of dyspeptic symptoms was found for omeprazole (53.8%), famotidine (44.4%), ranitidine (43.2%) and cimetidine (21.6%) (p=0.024). Compared with placebo, famotidine showed benefit in global symptom improvement (OR 11.0; 95% CI 1.6-75.5; p=0.02). Compared to baseline, mosapride versus pantoprazole reduced global symptoms (p=0.011; p=0.009). One study reported no occurrence of adverse events. This systematic review found no evidence to support the use of pharmacological drugs to treat CIN or FD in children. More high quality clinical trials are needed.
... Soweit Übelkeit und Erbrechen hauptsächlich auf gastrointestinalen Beeinträchtigungen beruhen, können sich Zubereitungen aus bzw. mit Bitterstoffen [49] und vor allem geprüfte antidyspeptische Fertigarzneimittel [7,32] als günstig erweisen (Tabelle 4). Auch Zubereitungen aus Ingwerwurzel [2,5,9,59], Pfefferminzblättern sowie Pfefferminzöl [24,56] können nützlich sein. ...
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Numerous herbal preparations and herbal medicinal products may be effective in the palliative and supportive treatment of the gastrointestinal symptoms suffered by cancer patients (halitosis, nausea, vomiting, dyspepsia, irritable bowel symptoms, constipation, diarrhoea). This use is based on empirical findings, scientific data and clinical studies, although only a few trials have been performed with cancer patients. A variety of herbal drugs, herbal preparations and combinations are available: volatile oils (e.g. peppermint, sage, Australian tea tree), preparations with bitter principles (e.g. wormwood, enzian, artichoke, candytuft), teas and tinctures (e.g. camomile, bramble, alchemilla, yellow enzian, tormentil, uzara, szygium, bilberry, black tea), laxatives (e.g. rhubarb, alder buckthorn, senna, aloe, linseed, psyllium) and finished drug products (e.g. Padmed Laxan and Iberogast). Current experience and results of clinical studies clearly indicate the possible advantages, the rarity of side effects, but also the limitations of phytotherapy. On balance, it appears that the potential has been underestimated for the treatment with herbal medicines of gastrointestinal symptoms in cancer patients.
... Soweit Übelkeit und Erbrechen hauptsächlich auf gastrointestinalen Beeinträchtigungen beruhen, können sich Zubereitungen aus bzw. mit Bitterstoffen [49] und vor allem geprüfte antidyspeptische Fertigarzneimittel [7,32] als günstig erweisen (Tabelle 4). Auch Zubereitungen aus Ingwerwurzel [2,5,9,59], Pfefferminzblättern sowie Pfefferminzöl [24,56] können nützlich sein. ...
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Zusammenfassung Eine Reihe von pflanzlichen Arzneimitteln lassen sich bei den verschiedenen gastrointestinalen Beschwerden und Symptomen von tumorkranken Menschen (Halitosis, Übelkeit, Erbrechen, dyspeptische Beschwerden, Reizdarmsymptome, Obstipation, Diarrhoe) sinnvoll einsetzen als palliative und supportive Behandlung. Die Basis für die Anwendung bilden einerseits therapeutische Empirie und andererseits wissenschaftlich erhobene Daten und klinische Studien, wobei derzeit nur ein kleinerer Teil mit Tumorpatienten durchgeführt wurde. Unter diesen Gesichtspunkten stehen vielfältige Arzneidrogen, phytotherapeutische Zubereitungen und Kombinationen zur Verfügung: ätherische Öle (z.B. Pfefferminze, Salbei, australischer Teebaum), Bitterstoff-Drogen (z.B. Wermut, Enzian, Artischocke, Iberis), Teezubereitungen und Tinkturen (z.B. Kamille, Brombeere, Frauenmantel, Gänsefinger, Tormentill, Uzara, Szygium, Heidelbeere, Schwarztee), Laxanzien (z.B. Rhabarber, Faulbaum, Senna, Aloe, Leinsamen, Flohsamen) und Fertigarzneimittel wie z.B. Padmed Laxan und Iberogast. Die vorhandenen Erfahrungen und die bisherigen klinischen Studien lassen die möglichen Vorteile, die geringe Häufigkeit unerwünschter Wirkungen, aber auch die Einschränkungen der phytotherapeutischen Therapien deutlich hervortreten. Insgesamt scheint es, dass das Potential der symptomorientierten Therapie mit pflanzlichen Arzneimitteln in der Behandlung gastrointestinaler Beschwerden bei Patienten mit Tumorerkrankungen unterschätzt wird.
... Additionally, most patients continue to self-treat with over-the-counter medication. Some herbal products have been shown to be helpful in treating gastrointestinal problems [11], and some of these studies have been conducted in comparison with standard prokinetic drugs [12]. For many other over-the-counter medications, research about use, benefit, and risk is lacking. ...
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Aim. To investigate efficacy and tolerability of Silicea Gastrointestinal Gel in patients with gastrointestinal disorders. Methods. Open, prospective pivotal phase IV study with oral Silicea Gastrointestinal Gel over 6 weeks. Symptom score was part 1 of the Nepean Dyspepsia Index: 15 questions addressing intensity, frequency and impact of upper abdominal symptoms. 10 lower abdominal symptoms were asked analogously. A responder showed reduction of score of >50%. Results. 62 of 90 patients were evaluated per protocol. Upper and lower abdomen sum scores decreased already in the first three weeks (P < 0.001), which continued the following three weeks (P < 0.01). Mean symptom score for upper abdomen decreased from 52.2 ± 31.0 to 33.7 ± 28.7 (or by 35.4%; responder rate 37%); for lower from 39.6 ± 24.7 to 22.6 ± 21.7 (by 42.9%; responder rate 46%). Subgroups with diarrhea, IBS and GERD presented highest responder rates. 6% of patients reported adverse reactions with probable or possible relationship to the test product. Conclusions. Silicea Gastrointestinal Gel seems suitable beyond infectious acute gastrointestinal disorders. Responses are relevant for chronic functional disorders, but it remains unclear, how much of that might be placebo-effect. Controlled studies are recommended in gastrointestinal syndromes like IBS or GERD.
... The findings showed a substantial improvement of symptoms with Iberogast but varying superiority to placebo pertinent to dyspepsiaspecific gastrointestinal symptom score [36]. A systematic review on efficacy and tolerability of Iberogast by Melzer et al. also validated the therapeutically related decrease of gastrointestinal symptom-scores in patients with functional dyspepsia [37]. Patients' assessments of global efficacy as measured by the proportion of patients without symptoms or with marked improvements have shown the superiority of Gut- Gard treatment (56%) over placebo (0%) and have been found to be in accordance with the changes in the severity of total symptoms. ...
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A randomized, double-blind, placebo-controlled study was conducted to evaluate the efficacy of GutGard, an extract of Glycyrrhiza glabra, in patients with functional dyspepsia. The primary outcome variables of the study were the change in the severity symptoms and the global assessment of efficacy. The quality of life was evaluated as a secondary outcome measure. The patients received either placebo or GutGard (75 mg twice daily) for 30 days. Efficacy was evaluated in terms of change in the severity of symptoms (as measured by 7-point Likert scale), the global assessment of efficacy, and the assessment of quality of life using the short-form Nepean Dyspepsia Index. In comparison with placebo, GutGard showed a significant decrease (P ≤ .05) in total symptom scores on day 15 and day 30, respectively. Similarly, GutGard showed marked improvement in the global assessment of efficacy in comparison to the placebo. The GutGard group also showed a significant decrease (P ≤ .05) in the Nepean dyspepsia index on day 15 and 30, respectively, when compared to placebo. GutGard was generally found to be safe and well-tolerated by all patients. GutGard has shown significant efficacy in the management of functional dyspepsia.
... As for alosetron, whose use is restricted in some countries due to side effects it has shown benefit in functional dyspepsia (Talley et al., 2001). As treatment of functional dyspepsia with conventional medication remains unsatisfactory, herbal remedies such as iberogast (Melzer et al., 2004a,b; Von Arnim et al., 2007), and artichoke leaf extract (Holtmann et al., 2003; Meier and Brignoli, 2005) have been tried in small studies for the treatment of this condition. The results have been promising and results from bigger trials are awaited. ...
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Herbal remedies are increasingly popular for the treatment of functional dyspepsia. Chios mastic gum is a resinous exudate from the stem of Pistacia lentiscus var. chia. It is a traditional natural remedy used throughout the eastern Mediterranean. The aim of this study was to assess the efficacy of Chios mastic gum in patients with functional dyspepsia. One hundred and forty eight patients fulfilling Rome II criteria for functional dyspepsia were randomly assigned to receive either Chios mastic gum 350 mg three times daily or placebo. After 3 weeks of treatment the change from baseline in the severity of symptoms of functional dyspepsia was assessed using the Hong Kong index of dyspepsia. Patients' global assessment of efficacy was also evaluated. The symptom score after treatment was significantly lower in the Chios mastic gum than in the placebo group ((14.78+/-1.78) vs (19.96+/-1.83)) (p<0.05). There was a marked improvement of symptoms in 40% of patients receiving placebo and in 77% of patients receiving Chios mastic gum (p<0.02). Individual symptoms that showed significant improvement with Chios mastic gum were: stomach pain in general, stomach pain when anxious, dull ache in the upper abdomen and heartburn (<0.05 for all four symptoms). Chios mastic gum significantly improves symptoms in patients with functional dyspepsia compared to placebo.
... Traditionally, it was used in the treatment of arthritis, gout, enlarged heart, and asthma. The seeds, stems, roots, and leaves have all been used medicinally (Melzer et al., 2005). ...
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A correlation between the levels of secondary and primary plant metabolites and food coefficient parameters with the population density of infested broccoli plants was studied. Cucurbitacins and glucosinolates compounds were good signs of resistance in bitter candytuft plants. On the other hand, lower values or the absence of these markers rendered broccoli susceptible to the pests under study, not during all stages of growth but whenever these values were much lower throughout growth stages. The major cucurbitacins were isolated and purified from bitter candytuft and identified by spectroscopic techniques. Glucosinolates content in bitter candytuft was also studied. The development of cabbage aphid treated with various bitter candytuft extracts as well as isolated cucurbitacins was also evaluated. A field study showed a remarkable reduction (88.9 %) of cabbage aphid induced by spraying the broccoli plants with 4 % water extract after autolysis of bitter candytuft.
Article
Die Diagnostik der funktionellen Dyspepsie ist zunächst eine Ausschlussdiagnostik, um andere Erkrankungen die dyspeptische Beschwerden verursachen können zu entdecken. Sind diese durch Anamnese, Basisuntersuchungen und Routinediagnostik hinreichend sicher ausgeschlossen, kann beim Fehlen von Alarmsymptomen als nächster Schritt eine probatorische Therapie erfolgen. Nur bei atypischer Anamnese oder unklaren Symptomen sollte eine weiterführende Diagnostik angestrebt werden. Die Therapieansätze bieten neben dem Einsatz von Phytotherapeutika die Möglichkeit, bei Helicobacter-pylori-Positivität einen Eradikationsversuch zu unternehmen oder eine Säureblockade mit H2-Blockern oder Protonenpumpeninhibitoren durchzuführen. Für diese Ansatzpunkte ist ein positiver Wirknachweis erbracht. Andere Therapieansätze sind entweder noch in der Zulassungsphase oder es gibt für sie bisher noch keine stabilen therapeutischen Ergebnisse.
Article
Die Diagnostik der funktionellen Dyspepsie ist zunächst eine Ausschlussdiagnostik, um andere Erkrankungen die dyspeptische Beschwerden verursachen können zu entdecken. Sind diese durch Anamnese, Basisuntersuchungen und Routinediagnostik hinreichend sicher ausgeschlossen, kann beim Fehlen von Alarmsymptomen als nächster Schritt eine probatorische Therapie erfolgen. Nur bei atypischer Anamnese oder unklaren Symptomen sollte eine weiterführende Diagnostik angestrebt werden. Die Therapieansätze bieten neben dem Einsatz von Phytotherapeutika die Möglichkeit, bei Helicobacter-pylori-Positivität einen Eradikationsversuch zu unternehmen oder eine Säureblockade mit H2-Blockern oder Protonenpumpeninhibitoren durchzuführen. Für diese Ansatzpunkte ist ein positiver Wirknachweis erbracht. Andere Therapieansätze sind entweder noch in der Zulassungsphase oder es gibt für sie bisher noch keine stabilen therapeutischen Ergebnisse.
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Summary Iberogast(r): A Modern Phytotherapeutic Combined Herbal Drug for the Treatment of Functional Disorders of the Gastrointestinal Tract (Dyspepsia, Irritable Bowel Syndrome) – from Phytomedicine to ‘Evidence Based Phytotherapy’. A Systematic Review Iberogast is a complex herbal preparation. As a fixed drug combination (9 constituents) it is composed of a fresh plant extract of Iberis amara and of extracts of 8 other dried herbal drugs ( Chelidonii herba, Cardui mariae fructus, Melissae folium, Carvi fructus, Liquiritiae radix, Angelicae radix, Matricariae flos, Menthae piperitae folium). The pharmacological effects as well as the therapeutic effectiveness, tolerability, and toxicity of Iberogast were experimentally and clinically recorded and documented using modern investigation tools. Both the experimental as well as the clinical studies indicated a regulatory influence of Iberogast on the whole gastrointestinal tract by a special dual action. While the included extracts of the dried herbal drugs have mainly spasmolytic properties, the fresh plant extract of Iberis amara has a tonic effect on the gastrointestinal tract. Depending on the predistension of the gastric or intestinal wall, the tonic or the spasmolytic effects of Iberogast prevail. Both the fresh plant extract of Iberis amara and the combined preparation of Iberogast were found to be toxicologically safe in therapeutically effective doses. For the estimation of the clinical effectiveness a systematic review was performed (data research: January 1970 to September 2002). As shown in controlled (according GCP standard) as well as supportive and uncontrolled clinical studies, the symptoms of functional dyspepsia and of irritable bowel syndrome (one controlled study and one observational study) could be significantly reduced by these herbal preparation in comparison to placebo. Two trials comparing Iberogast with the prokinetics metoclopramide and cisapride demonstrated a comparable therapeutic effectiveness of the herbal preparation and the prokinetics in the treatment of dyspepsia. Adverse events were rare and, with respect to frequency and spectrum, partly the same as found with placebo. Another advantage of Iberogast is that it targets only the gastrointestinal tract and the enteral nervous system, but not the central nervous system. Because of its special dual action, its clinically proven effectiveness, and its good tolerability, Iberogast may be a drug of first choice in the treatment of functional gastrointestinal diseases and their corresponding symptoms.
Article
Background Right upper abdominal pain may often be caused by biliary dyskinesia. Choleretica and cholekinetica are widely used for medical treatment of complaints due to biliary dyskinesia despite of a lack of randomized clinical trials which may prove their efficacy and potency. □ Patients and Methods The present prospective multicenter pilot study analyzes the effects of Cholagogum F Nattermann® (dried extracts from Schöllkraut and Curcuma) in comparison with placebo in patients with dumpy or colicky abdominal pain in the right upper quadrant due to biliary dyskinesia. Cholagogum was given in 39 patients and placebo in 37 patients for 3 weeks, respectively. □ Results The reduction of dumpy and colicky pain was more rapid during the first treatment week in patients who received Cholagogum F when compared to those who received placebo. The reduction of other complaints (feeling of being filled up, food intolerance, nausea, vomiting, meteorism) secondary variables) was similar in patients who received Cholagogum F versus placebo during the whole treatment period. The were no side-effects in patients who received Cholagogum. □ Conclusions The study presents the first solid indication that extracts from Schöllkraut/Curcuma (Cholagogum F Nattermann®) which have widely been used in daily practice for many decades have beneficial effects on pain due to biliary dyskinesia.
Article
Ziel: In der vorliegenden plazebokontrollierten, multizentrischen, doppelblinden, randomisierten Phase-II-Studie wurden bei 60 Patienten (Mittelwert 46,8 Jahre, Altersrange 25-70, Anzahl Frauen 38) mit funktioneller Dyspepsie (FD) Wirksamkeit und Verträglichkeit eines im Handel befindlichen Phytotherapeutikums (Iberogast®, STW-5*) und eines Forschungspräparates (STW-5-S) gegen Plazebo untersucht. Patienten und Methoden: Nach einer 7-tägigen Wash-out-Periode erhielten 60 Patienten in randomisierter Reihenfolge über 28 Tage entweder einen Mischextrakt aus 8 Drogen und dem Frischpflanzenauszug Iberis amara (STW-5) (n = 20), das Forschungspräparat STW-5-S (ohne den Frischpflanzenauszug Iberis amara) (n = 20) oder Plazebo (n = 20) (jeweils 3 × 20 Tropfen täglich). Untersuchungszeitpunkte waren Tag minus 7, Tag 0, Tag 14 und Tag 28. Als Hauptzielparameter wurde die Veränderung des gastrointestinalen Symptomenprofils (GIS) bewertet, einem Summenscore aus 10 Einzelsymptomen. Der Schweregrad der Einzelsymptome wurde anhand der validierten Likert-Skala bewertet. Ergebnisse: Der plazebokontrollierte Vergleich beider Phytotherapeutika zeigte nach 14- und 28-tägiger Therapie eine statistisch signifikante Beschwerdebesserung, gemessen anhand der Veränderung des GIS (p < 0,001). Im Vergleich der beiden Vera untereinander zeigten sich keine statistisch signifikanten Unterschiede in der Beeinflussung des GIS (p > 0,05). Für STW-5 wurde jedoch eine frühere stabile Beschwerdebesserung erzielt als mit dem Forschungspräparat STW-5-S (p = 0,023). Diskussion: Die vorliegende plazebokontrollierte Studie belegt die Wirksamkeit des Phytotherapeutikums STW-5 und seiner Modifikation STW-5-S bei der funktionellen Dyspepsie. Beide Rezepturen waren statistisch in ihrer Wirksamkeit auf das GIS nicht unterschiedlich. Der Vergleich beider Vera untereinander deutet jedoch auf eine additive Wirkung des Frischpflanzenauszuges Iberis amara zur Linderung der dyspeptischen Beschwerden hin. Commercially available herbal preparation and its modified dispense in patients with functional dyspepsia. Results of a double-blind, placebo-controlled, randomized multicenter trial Aims: To assess the efficacy and safety of the commercially available herbal preparation (Iberogast®, STW-5*) containing extracts from bitter candy tuft, chamomile flower, peppermint leaves, caraway fruit, licorice root, lemon balm leaves, angelica root, celandine herbs, milk thistle fruit and its research preparation STW-5-S (without bitter candy tuft) in patients with functional dyspepsia. Patients and methods: After a standardized diagnostic work-up and at least 7 days free of medication, 60 patients, diagnosed with functional dyspepsia, were recruited in a multicenter trial and randomly assigned to one of 3 treatment groups (STW-5, STW-5-S or placebo). Each patient received the treatment for 4 weeks. The main outcome variables were the improvement of a gastrointestinal symptom score (GIS), a sumscore consisted of 10 dyspeptic symptoms rated on a Likert scale. Dyspeptic symptoms were assessed at baseline, 2 and 4 weeks after treatment. Results: 60 patients completed the trial (mean age 46.8 years, range 25-70, female 38 patients). Compared with placebo-group both herbal preparations STW-5 and STW-5-S showed a clinically significant improvement of GIS after 2 and 4 weeks of treatment (p < 0.001). No statistically significant difference could be observed between the efficacy of STW-5 and STW-5 S (p > 0.05), but a solid improvement of gastrointestinal symptoms could be achieved earlier with STW-5 than with its research preparation STW-5-S without bitter candy tuft (p = 0,023). Conclusions: In patients with functional dyspepsia, the commercially available herbal preparation STW-5 and its modified dispense STW-5-S tested improved dyspeptic symptoms significantly better than placebo. The extract bitter candy tuft appeared to have an additive effect on dyspeptic symptoms.
Article
Background : Non-ulcer dyspepsia is predominantly a self-managed condition, although it accounts for a significant number of general practitioner consultations and hospital referrals. Herbal medicinal products are often used for the relief of dyspeptic symptoms. Aims : To critically assess the evidence for and against herbal medicinal products for the treatment of non-ulcer dyspepsia. Methods : Systematic searches were performed in six electronic databases and the reference lists located were checked for further relevant publications. No language restrictions were imposed. Experts in the field and manufacturers of identified herbal extracts were also contacted. All randomized clinical trials of herbal medicinal products administered as supplements to human subjects were included. Results : Seventeen randomized clinical trials were identified, nine of which involved peppermint and caraway as constituents of combination preparations. Symptoms were reduced by all treatments (60–95% of patients reported improvements in symptoms). The mechanism of any anti-dyspeptic action is difficult to define, as the causes of non-ulcer dyspepsia are unclear. There appear to be few adverse effects associated with these remedies, although, in many cases, comprehensive safety data were not available. Conclusions : There are several herbal medicinal products with anti-dyspeptic activity and encouraging safety profiles. Further research is warranted to establish their therapeutic value in the treatment of non-ulcer dyspepsia.
Article
The efficacy and safety of the standardized herbal combination preparation of Enteroplant, consisting of peppermint oil (90 mg) and caraway (50 mg) in an enteric coated capsule, have been studied in a double-blind, placebo-controlled multicentre trial in patients with non-ulcer dyspepsia. A total of 45 patients were included in the trial after thorough physical and gastro-enterological examination. The primary outcome variables were the change in the intensity of pain and the global clinical impression (Clinical Global Impression [CGI], Item 2), which were evaluated for 39 patients (test preparation: 19, placebo: 20). After four weeks of treatment both target parameters were significantly improved for the group of patients treated with the peppermint oil/caraway oil combination compared to the placebo group (p = 0.015 and 0.008, respectively). Before the start of treatment all patients in the test preparation group reported moderate to severe pain, while by the end of the study 63.2% of these patients were free of pain. The pain symptoms had improved in a total of 89.5% of the patients in the active treatment group. After 4 weeks the Clinical Global Impressions were improved for 94.5% of the patients treated with the peppermint oil/caraway oil combination. The trial medication was also superior to placebo with respect to pain frequency, medical prognosis, the severity of the disorder and the efficacy index (CGI, Items 1 and 3), which were adopted as secondary end-points for evaluation of efficacy. There were similarly favourable findings for the herbal combination, compared with placebo, with respect to the reduction of other gastrointestinal symptoms. The combination preparation was found to be excellently tolerated. There was a total of 7 adverse events (test preparation: 4, placebo: 3), with a causal association with the treatment being ascribed in one case for the test preparation group and one case for the placebo group.
Article
Functional dyspepsia and the irritable bowel syndrome (IBS) are amongst the most widely recognised functional gastrointestinal disorders. Symptom based diagnostic criteria have been developed and refined for the syndromes (the Rome criteria) and these are now widely applied in clinical research. Both functional dyspepsia and IBS are remarkably prevalent in the general population, affecting approximately 20% and 10% of persons, respectively. The prevalence is stable from year to year because the onset of these disorders is balanced by their disappearance in the population. Clinically useful predictors of the course of these disorders have not been identified. Approximately one third of persons with functional dyspepsia concurrently have IBS. In most studies from Western countries, it has been shown that only a minority with functional dyspepsia and IBS present for medical care; the factors that explain consultation behaviour remain inadequately defined although fear of serious disease and psychological distress may be important. The majority of patients diagnosed as having functional dyspepsia or IBS continue to have symptoms long term with a significant impact on quality of life. The indirect costs of the functional gastrointestinal disorders greatly outweigh the direct costs but overall these conditions are responsible for a major proportion of health care consumption. Rational management of the functional gastrointestinal disorders will only follow a better understanding of the natural history of these conditions.
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Herbs have been used as food and for medicinal purposes for centuries. Research interest has focused on various herbs that possess hypolipidemic, antiplatelet, antitumor, or immune-stimulating properties that may be useful adjuncts in helping reduce the risk of cardiovascular disease and cancer. In different herbs, a wide variety of active phytochemicals, including the flavonoids, terpenoids, lignans, sulfides, polyphenolics, carotenoids, coumarins, saponins, plant sterols, curcumins, and phthalides have been identified. Several of these phytochemicals either inhibit nitrosation or the formation of DNA adducts or stimulate the activity of protective enzymes such as the Phase II enzyme glutathione transferase (EC 2.5.1.18). Research has centered around the biochemical activity of the Allium sp. and the Labiatae, Umbelliferae, and Zingiberaceae families, as well as flaxseed, licorice root, and green tea. Many of these herbs contain potent antioxidant compounds that provide significant protection against chronic diseases. These compounds may protect LDL cholesterol from oxidation, inhibit cyclooxygenase and lipoxygenase enzymes, inhibit lipid peroxidation, or have antiviral or antitumor activity. The volatile essential oils of commonly used culinary herbs, spices, and herbal teas inhibit mevalonate synthesis and thereby suppress cholesterol synthesis and tumor growth.
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Right upper abdominal pain may often be caused by biliary dyskinesia. Choleretica and cholekinetica are widely used for medical treatment of complaints due to biliary dyskinesia despite of a lack of randomized clinical trials which may prove their efficacy and potency. The present prospective multicenter pilot study analyzes the effects of Cholagogum F Nattermann (dried extracts from Schöllkraut and Curcuma) in comparison with placebo in patients with dumpy or colicky abdominal pain in the right upper quadrant due to biliary dyskinesia. Cholagogum was given in 39 patients and placebo in 37 patients for 3 weeks, respectively. The reduction of dumpy and colicky pain was more rapid during the first treatment week in patients who received Cholagogum F when compared to those who received placebo. The reduction of other complaints (feeling of being filled up, food intolerance, nausea, vomiting, meteorism) (secondary variables) was similar in patients who received Cholagogum F versus placebo during the whole treatment period. The were no side-effects in patients who received Cholagogum. The study presents the first solid indication that extracts from Schöllkraut/Curcuma (Cholagogum F Nattermann) which have widely been used in daily practice for many decades have beneficial effects on pain due to biliary dyskinesia.
Article
To assess the efficacy and safety of enteric coated capsules containing a fixed combination of 90 mg peppermint oil and 50 mg caraway oil (PCC; Enteroplant) in patients with functional dyspepsia. A total of 96 out-patients received one capsule twice daily of PCC or placebo for 28 days. Primary efficacy variables were the intra-individual change in (i) pain intensity and (ii) sensation of pressure, heaviness and fullness between days 1 and 29, and the investigators' rating of (iii) global improvement (Clinical Global Impressions [CGI] item 2) on day 29. A global type I error of alpha=0.05 was controlled by a priori ordering of hypotheses. All patients were evaluable for efficacy and safety. On day 29, the average intensity of pain was reduced by 40% vs. baseline in the PCC group and by 22% in the placebo group. With regards to pressure, heaviness and fullness, a 43% reduction was observed for PCC vs. 22% for placebo. In CGI item 2, 67% (PCC) vs. 21% (placebo) of the patients were described as much or very much improved. In all three target parameters, the superiority of PCC over placebo was statistically significant. Six patients (PCC: 5; placebo: 1) reported adverse events, either unrelated to the trial, or attributable to an aggravation of the disease under investigation. Eructation with peppermint taste did not occur. These results demonstrate the good tolerability and the favourable risk-benefit ratio of PCC for the treatment of functional dyspepsia.