Abstract

Irritable bowel syndrome (IBS) is a common GI functional disorder, which presents with a wide range of symptoms such as chronic abdominal discomfort, bloating and altered bowel habits. The variety of symptoms has led to a difficult therapeutic challenge and no specific treatment for relieving all IBS symptoms has been suggested yet. The purpose of this study was to evaluate the impact of Chamomile extract on IBS symptoms. In a randomized trial, 45 patients who fulfilled the ROOM III criteria and had no organic disease enrolled in this study and were asked to take Chamomile 20 drops daily for four weeks. They were asked to fill in IBS-associated symptoms questionnaire to specify abdominal pain intensity, bloating, nausea, stool consistency and altered bowel habits. The questionnaire was filled out during 5visits: at the first day, at the second and fourth weeks after starting the treatment and also the second and fourth weeks after the end of intervention. IBS symptoms were significantly reduced at the second and fourth weeks after beginning of the herbal therapy (p<0.001). Symptom relief continued up to 2 weeks after the end of intervention and started to decrease in 4 weeks after beginning of the herbal therapy. Considering the improving effects of Chamomile on all IBS symptoms, it may have a positive effect on the syndrome pathogenesis as well. Trial registration: Current Controlled TrialsIRCT201106206842N1.
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Chamomile efficacy in patients of the irritable bowel syndrome
Shahram Agah
1
, Amirmahdi Taleb
2
, Reyhaneh Moeini
3
, Narjes Gorji
3
, Hajar Nikbakht
4
and Mojtaba Soltani-Kermanshahi*
4
1
Department of Gastroentrology, Colorectal Research Center, Rasool-Akram Hospital, Iran University of Medical
Sciences , Tehran, Iran
2
Department of Pharmacogenesis, Member of Educational Board of Iranian Traditional Medicine, Pharmacy
Faculty, Tehran University of Medical Sciences , Tehran, Iran
3
Department of Traditional Medicine, Medical Faculty, Tehran University of Medical Sciences, Tehran, Iran
4
Colorectal Research Center, Rasool-Akram Hospital, Iran University of Medical Sciences, Tehran, Iran
_____________________________________________________________________________________________
ABSTRACT
Irritable bowel syndrome (IBS) is a common GI functional disorder, which presents with a wide range of symptoms
such as chronic abdominal discomfort, bloating and altered bowel habits. The variety of symptoms has led to a
difficult therapeutic challenge and no specific treatment for relieving all IBS symptoms has been suggested yet. The
purpose of this study was to evaluate the impact of Chamomile extract on IBS symptoms. In a randomized trial, 45
patients who fulfilled the ROOM III criteria and had no organic disease enrolled in this study and were asked to
take Chamomile 20 drops daily for four weeks. They were asked to fill in IBS-associated symptoms questionnaire to
specify abdominal pain intensity, bloating, nausea, stool consistency and altered bowel habits. The questionnaire
was filled out during 5visits: at the first day, at the second and fourth weeks after starting the treatment and also the
second and fourth weeks after the end of intervention. IBS symptoms were significantly reduced at the second and
fourth weeks after beginning of the herbal therapy (p<0.001). Symptom relief continued up to 2 weeks after the end
of intervention and started to decrease in 4 weeks after beginning of the herbal therapy. Considering the improving
effects of Chamomile on all IBS symptoms, it may have a positive effect on the syndrome pathogenesis as well.
Trial registration: Current Controlled TrialsIRCT201106206842N1.
Keywords: Irritable bowel syndrome, Chamomile Matricaria L., Phytomedicine
_____________________________________________________________________________________________
INTRODUCTION
Irritable bowel syndrome (IBS) is the most frequent functional gastrointestinal disorder with a prevalence of 5-11%
in most countries[1]. The workload generated by IBS is considerable and constitutes approximately one-third of all
visits to gastroenterologist IBS Diagnosis is based on the identification of symptoms according to Manning, Rome
III criteria and exclusion of alarm indicators[2]. The pathophysiology of IBS is considered to be multi factorial,
involving disturbances of the brain-gut-axis. IBS has been associated with abnormal gastrointestinal motor
functions, visceral hypersensitivity, psychosocial factors, autonomic dysfunction and mucosal inflammation[3].
IBS affects females more often than males for unexplained pathophysiologic reasons[4].The clinical approach is
based on the treatment of common symptoms. When pain predominates, antispasmodics are the first choice. In case
of diarrhea, loperamide is useful for reducing bowel frequency. Soluble fiber represents the first option in subjects
with IBS and constipation or mixed IBS. Dietary integrators (composed of probiotics and serotonin precursors) are a
promising therapeutic option[5].
Unfortunately, none of the currently available drugs (e.g. antispasmodics, antidiarrheals, osmotic, bulking agents and
Mojtaba Soltani-Kermanshahi et al Der Pharma Chemica, 2015, 7 (4):41-45 _____________________________________________________________________________
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sedatives) are globally effective in treating all IBS symptoms[6].
Health related quality of life is impaired in all subgroups of IBS sufferes[7]. Many patients and doctors are
dissatisfied with the level of improvement in symptoms that can be achieved with standard medical care, forcing
them to seek alternatives for care. In such situations, an important question is whether herbal medicines are effective
and safe for IBS patients[8].
Irritable bowel sufferers commonly have recourse to the use of complementary and alternative medical remedies and
practices. Foremost among such approaches have been various dietary manipulations including exclusion diets, and
a variety of dietary supplements[7].
One of the most common herbs used for medicinal purposes is chamomile whose standardized tea and herbal
extracts are prepared from dried flowers of Matricaria species. Chamomile is one of the eldest , most widely used
and well documented medicinal plants in the world[9].
Medicinal ingredients are normally extracted from the dry flowers of chamomile by using water, ethanol or
methanol as solvents and corresponding extracts are known as aqueous, ethanolic (alcoholic) and/or methanolic
extracts. Optimum chamomile extracts contain about 50 percent alcohol. Normally standardized extracts contain
1.2% of apigenin which is one of the most effective bioactive agents. Aqueous extracts, such as in the form of tea,
contain quite low concentrations of free apigenin but include high levels of apigenin-7-O-glucoside[10].
Chamomile is used traditionally for numerous gastrointestinal conditions, including digestive disorders, "spasm" or
colic, upset stomach, flatulence (gas), ulcers, and gastrointestinal irritation[11].
Chamomile is used internally for inflammatory diseases of the gastrointestinal tract associated with gastrointestinal
spasms, irritation of the oral pharyngeal mucous membrane and upper respiratory tract. Externally, the drug is used
for skin and mucous membrane inflammations, pulpitis, gingivitis, respiratory catarrh, and anogenitalinflammation
Chamomile should not be taken by anyone with a known allergy to its components or to other members of the
Compositae family (e.g., arnica, yarrow, feverfew, tansy, artemesia), or if they have a history of atopic hay fever or
asthma[12].
The purpose of this study was to evaluate the impact of Chamomile extract on IBS symptoms.
MATERIALS AND METHODS
This is a prospective pre-post study in an academic GI clinic performed in 2009-2010.Chamomile drop (produced by
SohaJissa Company Tehran, Iran) that contained bizabulol and camazolen (69.47 mg/100cc) was prescribed for
patients. Study was approved by institutional ethics committee. Informed consent was obtained from patients and all
patients were allowed to refuse to participate in study when they desired.
Patients who had diagnosis of IBS (with diarrhea or constipation dominancy), no history of sensitivity to milk and
its products, age between 10 to 50 years, willingness to participate, no other active illness (specially asthma), no
drug consumption (specially anticoagulants), no psychiatric illness, not having pregnancy or doing breast feeding,
no history of hyper sensitivity, no current therapy for IBS, and no abnormal lab data (CBC/ ESR/ CRP/ TSH)
depending on the ROME III criteria were included in our study.
Our exclusion criteria were any complication, exacerbation of symptoms or if the patient refuses to continue. After 2
weeks stopping any other drugs symptom control, patients were visited and IBS-associated symptoms including
abdominal pain, nausea, painful defection, presence of mucosa in stool, changes in stool consistency and defecation
frequency were recorded in a questionnaire which was gathered by the clinicians based on different studies and
references. Chamomile drop was administered in a similar way for all patients (two times a day,10 drops at morning
and 10 drops at night in a glass of warm water ,15 minutes after meal with a minimum of 12 hours’ time interval
,this time mention is to eliminate the effects of confounding factors like the time of drug use, time intervals between
drug intake and time between last meal and drug intake.) A telephone follow up was considered for patients 2 and 4
weeks after beginning Chamomile drop administration and 2 and 4 weeks after stopping it and any changes in
symptoms were recorded again by the same questionnaire used before Chamomile administration.
The total of 70 patients who were diagnosed and finally, 45 of them were included in the study due to our inclusion
criteria.This study has Irct ID: IRCT201106206842N1.
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Descriptive statistics were presented as minimum, maximum, mean and standard deviation. (the proportions of two-
by- two contingency tables were compared by the chi-square test, and t-test was used for continuous variables. We
considered p<0.05 as significant. All analyses were performed with SPSS, version 18 (SPSS, Inc., Chicago, IL).
RESULTS
All 45 patients completed the study and no complication was reported.the results are shown in table 1.
Overall, all IBS symptoms (bloating, abdominal pain, stool consistency and defecation difficulties) were decreased
significantly after 2 weeks of treatment. This relief was persistant until 2 weeks after the end of the intervention but
4 weeks after the end of treatment, almost all symptoms had been exacerbated but were continuously decreased in
comparison with the first visit.
Frequency of defecation was significantly decreased after 4 weeks of treatment in the patients with diarrhea
dominancy (3.4 vs 1.3, (p<0.001)). In follow up, the decrease was 1.9 after two weeks (p<0.001) and 2.4 four weeks
after the end of the intervention (p<0.001).
At the first visit 32 patients (71%) experienced severe bloating and 13 cases (28.9%) reported intermediate intensity
of bloating. After 4 weeks of treatment, 5 patients (11%) reported intermediate and 40 cases (88.9%) reported severe
bloating. At 4 weeks after intervention the severity was increased to 8 patients (17.8%) severe, intermediate in 36
patients (80%) and mild bloating in 1 patient (2.2%) (p<0.001).
Nausea at the beginning had intermediate severity in 1 patient (2.2%) and mild in 10 patients, which was decreased
to just 1 patient (2.2%) with mild severity at 4 weeks of treatment (p=0.000). A 4 weeks after the end of the
intervention, it was increased to 1 patient (2.2%) with intermediate and 4 patients (8.9%) with mild nausea.
Abdominal pain at the first visit was reported in 28 patients (62.2%) as severe and in 17 patients (37.8%) as
intermediate, which was decreased to 5 (11.1%) intermediate and 37 (82.2%) mild cases after the end of treatment
((p<0.001)). Four weeks after intervention, the abdominal pain increase to 5 (11.1%) severe, 38 (84.4%)
intermediate and 2 (4.4%) mild cases was reported, but it showed continuously significant decrease in comparison
with the beginning of the study (p<0.001).
In the patients with diarrhea dominancy, stool consistency was changed from 18 patients (78%) with watery diarrhea
and 5 patients (21%) with loose stool at the beginning of the study into 1 patient (4.3%) with loose stool and 22
patients (95%) with normal defecation after the treatment (p<0.001). A 4 weeks after the end of treatment, 3 patients
(13%) reported watery diarrhea, 18 patients (78%) loose stool and 2 patients had normal defecation. These rate were
significantly different from those of the first visit (p<0.001).
In patients with constipation dominancy, stool consistency was changed from 22 patients (100%) with constipation
into 22 patients with normal defecation after 4 weeks of treatment (p<0.001). 2 weeks after the intervention was
stopped, constipation reported into 4 patients (20%) and 18 patients (80%) had normal defecation (p<0.001). At four
weeks follow up, 19 patients (87%) had constipation and 3 (13%) had normal defecation which was not significantly
different from those of the first visit (p=0.08).
The sensitivity of incomplete defecation was reported by 43 patients (95%) at the first visit but it was reported only
in 4 patients (8.9%) 4 weeks after the treatment (p<0.001), which was increased to 36 patients (80%) during the
follow up 4 weeks after intervention (p=0.008).
Defecation urgency was reported by 40 patients (88%) at the beginning of the study, all of which experienced
recovery but it was relapsed in 29 cases relapsed at 4 weeks after treatment (p=0.002).
Mucous defecation was also cured in 37 patients (82.2%), which was relapsed in 6 patients (13%) 2 weeks after the
treatment, and continuously kept a decreasing pace since the first visit (p<0.001). At 4 weeks after the intervention,
mucous defecation was reported in 30 cases (66.7%) with significant difference to the beginning (p=0.016).
Painful defecation was present in 18 patients (81.8%) with constipation at the first visit, which was decreased to 1
case (4.5%) after intervention and was reported in 2 patients (9%) at 2 weeks after intervention, both of which were
significantly decreased comparing to the first visit (p<0.001). A 4 weeks after the treatment, it was reported in 16
cases (72%), which was not different from the baseline (p=0.50).
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Table1: Frequency of IBS-associated symptoms in patients during the study course
stool form D Abdominal pain bloating Daily defecation number
Visit n# after intervention N L w no m mo s m mo s C D 0 5 18 0 0 17 28 0 13 32 0.09 3.4 1st visit
22 1
0
P=0.000
3 37 5
0
P=0.000
40
5
P=0.000
0
P=0.000
1.7
P=0.000
1.3
P=0.000
2rd visit
16 7 0 0 31 37 1 27 18
0
P=0.000
1.1
P=0.000
1.9
P=0.000
3th visit
2 18
3
P=0.000
0 2 38
5
P=0.000
1 36
8
P=0.000
0.5
P=0.000
2.7
P=0.000
4th visit
Table1: Continued
Pain full defecation Mocuse defecation Emergency defecation Incomplete defecation stool formC
Visit n# after intervention No yes no yes no yes no yes N H 4 18 8 37 5 40 2 43 0 22 1st visit
21
1
P=0.000
45
0
P=0.000
45
0
P=0.000
41
4
P=0.000
22
0
P=0.000
2rdvisit
20 2 39 6 38 7 32 13 18 4 3th visit
6
16
P=0.5
15
30
P=0.016
16
29
P=0.002
9
36
P=0.008
3
19
P=0.08
4th visit
D: diarrhea, C: constipation, S: sever, Mo: moderate, M: mild, No: not, W: watery, L: loose, N: normal, H: hard
DISCUSSION
The recent results from the controlled clinical trial on chamomile extract for GAD suggests that it may have modest
anxiolytic activity in patients with mild to moderate GAD[13] our study showed that Chamomile drop (Matricaria
recutita L.) has a significant effect on IBS symptoms, which is more when the consumption is longer. This effect is
persisted until 2 weeks after intervention and then the symptoms relapse. So, many of the patients wanted to
continue the consumption of Chamomile drop even after the completion of the study.
There are different therapies for IBS patients such as antispasmodics, anti-diarrhea, antidepressants, behavioral
therapy, psychotherapy, etc, which are used based on the severity and types of the symptoms, and the treatment is
chosen for the predominant symptoms.
Current therapies are not satisfactory and efficient, or early relapse is very prevalent. These facts and complications
of the current treatments have caused the patients to seek alternative medicine. For example, a study on 1012
patients in 2008 showed that 35% of IBS patients used complementary and alternative medicine and believed on its
efficiency. Many studies have been done on different types of alternative medicine specially phetotherapy[14].The
effect of Spearmint oil has been proven in several studies[13-16].
Chamomile has satisfactory effects on gastrointestinal spasms and ulcers and is a relaxant and antiseptic[16].
we included IBS patients, who had no history of hypersensitivity or allergy were. We also considered more inclusion
criteria such as absence of any other diseases to limit their possible affects of these variables and to attain exact and
confident results.
In the present study, most patients with more severe symptoms were eligible to be included into the study, so the
results are useful for IBS patients with severe symptoms.In this study, the time for both treatment and follow up was
longer by two weeks in comparison with other studies[13,14,16].
Unfortunately, we were not able to produce and use placebo, which is a negative point of our study.Most of the
patients in this study had a history of different therapies for a mean time of 43 months, which had not been
satisfactory or caused some complications and a lot of costs for them.
CONCLUSION
According to the effectiveness of Chamomile (shown in this study), we guess that it is effective on both the
symptoms and pathogenesis of IBS. Chamomile is easily available and is not expensive, so is better than other
current therapies.
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... 54,55 These same claims cannot be made of Rona's herbal treatment due to the individualised nature of the formula, however, research does suggest potential clinical value for each individual herb specific to Rona's case. [56][57][58][59][60][61][62][63][64][65][66][67] While minimal evidence establishes the effectiveness of some commercial formulas for IBS treatment, research utilizing specific commercial preparations, exclusively for FGID, appears unexplored. Notwithstanding, the personalisation of individualised treatments, as prescribed in both cases, fosters opportunities to enhance understandings of real-world health implications. ...
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Background: Functional gastrointestinal disorders (FGID) affect more than one-third of the general population and contribute a considerable burden on the health and wellbeing of the community and the economy. This study aims to examine the treatment approaches and outcomes of naturopathic management of individuals presenting with a non-specific FGID. Methods: We report a comparison of two clinical case studies of patients being treated by a naturopath for a functional gastrointestinal disorder. The care was provided by two different student practitioners under the supervision of an industry qualified mentor within a multidisciplinary academic clinic at the Endeavour College of Natural Health. A student practitioner and student observer conduct consultations under the supervision of an industry qualified mentor. The outcomes of care were measured by the Gastrointestinal Symptom Rating Scale. Results: Clinical notations partially correlate to Jane's outcomes measured by gastrointestinal rating scale scores, which remain stable. Significant changes in Rona's gastrointestinal rating scale scores equate to only generalizable minimal clinical notations. Conclusions: The holistic and individualised approach core to naturopathic medicine practice is also informed by traditional methods, research evidence and the pragmatic needs of the patient. The emphasis within naturopathic treatment approaches on dietary changes and lifestyle prescription alongside other ingestive therapies such as herbal and nutritional medicine underscores the need for clinical research designs which support evaluation of complex interventions in real-world settings.
... Os resultados estão relacionados com estudos envolvendo a atividade da camomila frente a doenças crônicas, tendo por exemplo o controle glicêmico e perfil lipídico sérico em paciente com diabetes Mellitus tipo 2 (RAFRAF et al., 2014) e distúrbios do sono e ansiedade, levando em consideração a fundamentação baseada na medicina popular (MAO et al., 2016;ADIB, MOUSAVI, 2017;ZENI et al., 2017;KEEFE et al., 2018) e identificação do teor de aminoácidos livres presentes nas flores de camomila como, alanina, prolina, leucina e outros, utilizando o método cromatográfico muitos estudos vem mostrando a eficiência da camomila sobre infestações parasitárias como a helmintíase e amebíase (HAJAJI et al., 2017;HAJAJI et al., 2018), Da mesma forma, utilizando o descritor "chamomile", a busca revelou 2515 publicações entre 1914 e 2018 (Figura 1). No que se refere aos artigos científicos envolvendo o temo "chamomile", estudos demonstraram sua eficácia quando utilizada como antidepressivo, antialérgico e anti-osteoporose, além de melhorar desordens no trato gastrointestinal AMSTERDAM et al., 2012;SOHGAURA et al., 2012;AGAH et al., 2015), sendo que muitos dos artigos encontrados também eram vistos nos outros bancos de dados, já que o Scopus faz parte de um grande grupo editorial de revistas científicas (Elsevier). ...
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A Matricaria recutita L. (camomila) é uma planta pertencente à família Asteraceae que é bastante utilizada na medicina popular devido às suas várias aplicações biológicas como, por exemplo, atividade antidiarreica, anti-inflamatória, antioxidante, gastroprotetora, antibacteriana, entre outras. O objetivo do presente estudo foi realizar uma prospecção científica e tecnológica da planta Matricaria recutita conhecida popularmente como camomila. A prospecção científica foi realizada pesquisando todos os artigos científicos publicados até junho de 2015 nas bases de dados do Pubmed, Web of ScienceTM, Scopus e Scielo utilizando separadamente no descritor o nome científico e o nome popular da planta, e observando o ano da publicação. Já a prospecção tecnológica foi realizada nos bancos de dados USPTO, EPO, WIPO e INPI selecionando as patentes que possuíam o nome científico ou o nome popular da planta no título e/ou resumo, observando a classificação, o ano e os países de depósitos. Desse modo, verificou-se que nas bases de dados de artigos científicos e nos bancos de depósitos de patentes, os trabalhos publicados envolvem principalmente o nome popular da espécie quando comparado ao nome científico, esses resultados podem ser explicados pelo fato da planta ser conhecida mundialmente como camomila. Além disso, a referida prospecção teve como resultados a utilização da planta em diversas finalidades, tais como: formulações farmacêuticas, produtos alimentícios e aplicações industriais na área cosmética. Dessa forma, a planta possui grande relevância para as áreas de ciência e tecnologia. Palavras-chave: Prospecção tecnológica; camomila; Matricaria recutita.
... Os resultados estão relacionados com estudos envolvendo a atividade da camomila frente a doenças crônicas, tendo por exemplo o controle glicêmico e perfil lipídico sérico em paciente com diabetes Mellitus tipo 2 (RAFRAF et al., 2014) e distúrbios do sono e ansiedade, levando em consideração a fundamentação baseada na medicina popular (MAO et al., 2016;ADIB, MOUSAVI, 2017;ZENI et al., 2017;KEEFE et al., 2018) e identificação do teor de aminoácidos livres presentes nas flores de camomila como, alanina, prolina, leucina e outros, utilizando o método cromatográfico muitos estudos vem mostrando a eficiência da camomila sobre infestações parasitárias como a helmintíase e amebíase (HAJAJI et al., 2017;HAJAJI et al., 2018), Da mesma forma, utilizando o descritor "chamomile", a busca revelou 2515 publicações entre 1914 e 2018 (Figura 1). No que se refere aos artigos científicos envolvendo o temo "chamomile", estudos demonstraram sua eficácia quando utilizada como antidepressivo, antialérgico e anti-osteoporose, além de melhorar desordens no trato gastrointestinal AMSTERDAM et al., 2012;SOHGAURA et al., 2012;AGAH et al., 2015), sendo que muitos dos artigos encontrados também eram vistos nos outros bancos de dados, já que o Scopus faz parte de um grande grupo editorial de revistas científicas (Elsevier). ...
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Background: This is an update of the original Cochrane review, last published in 2009 (Huertas-Ceballos 2009). Recurrent abdominal pain (RAP), including children with irritable bowel syndrome, is a common problem affecting between 4% and 25% of school-aged children. For the majority of such children, no organic cause for their pain can be found on physical examination or investigation. Many dietary inventions have been suggested to improve the symptoms of RAP. These may involve either excluding ingredients from the diet or adding supplements such as fibre or probiotics. Objectives: To examine the effectiveness of dietary interventions in improving pain in children of school age with RAP. Search methods: We searched CENTRAL, Ovid MEDLINE, Embase, eight other databases, and two trials registers, together with reference checking, citation searching and contact with study authors, in June 2016. Selection criteria: Randomised controlled trials (RCTs) comparing dietary interventions with placebo or no treatment in children aged five to 18 years with RAP or an abdominal pain-related, functional gastrointestinal disorder, as defined by the Rome III criteria (Rasquin 2006). Data collection and analysis: We used standard methodological procedures expected by Cochrane. We grouped dietary interventions together by category for analysis. We contacted study authors to ask for missing information and clarification, when needed. We assessed the quality of the evidence for each outcome using the GRADE approach. Main results: We included 19 RCTs, reported in 27 papers with a total of 1453 participants. Fifteen of these studies were not included in the previous review. All 19 RCTs had follow-up ranging from one to five months. Participants were aged between four and 18 years from eight different countries and were recruited largely from paediatric gastroenterology clinics. The mean age at recruitment ranged from 6.3 years to 13.1 years. Girls outnumbered boys in most trials. Fourteen trials recruited children with a diagnosis under the broad umbrella of RAP or functional gastrointestinal disorders; five trials specifically recruited only children with irritable bowel syndrome. The studies fell into four categories: trials of probiotic-based interventions (13 studies), trials of fibre-based interventions (four studies), trials of low FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides and polyols) diets (one study), and trials of fructose-restricted diets (one study).We found that children treated with probiotics reported a greater reduction in pain frequency at zero to three months postintervention than those given placebo (standardised mean difference (SMD) -0.55, 95% confidence interval (CI) -0.98 to -0.12; 6 trials; 523 children). There was also a decrease in pain intensity in the intervention group at the same time point (SMD -0.50, 95% CI -0.85 to -0.15; 7 studies; 575 children). However, we judged the evidence for these outcomes to be of low quality using GRADE due to an unclear risk of bias from incomplete outcome data and significant heterogeneity.We found that children treated with probiotics were more likely to experience improvement in pain at zero to three months postintervention than those given placebo (odds ratio (OR) 1.63, 95% CI 1.07 to 2.47; 7 studies; 722 children). The estimated number needed to treat for an additional beneficial outcome (NNTB) was eight, meaning that eight children would need to receive probiotics for one to experience improvement in pain in this timescale. We judged the evidence for this outcome to be of moderate quality due to significant heterogeneity.Children with a symptom profile defined as irritable bowel syndrome treated with probiotics were more likely to experience improvement in pain at zero to three months postintervention than those given placebo (OR 3.01, 95% CI 1.77 to 5.13; 4 studies; 344 children). Children treated with probiotics were more likely to experience improvement in pain at three to six months postintervention compared to those receiving placebo (OR 1.94, 95% CI 1.10 to 3.43; 2 studies; 224 children). We judged the evidence for these two outcomes to be of moderate quality due to small numbers of participants included in the studies.We found that children treated with fibre-based interventions were not more likely to experience an improvement in pain at zero to three months postintervention than children given placebo (OR 1.83, 95% CI 0.92 to 3.65; 2 studies; 136 children). There was also no reduction in pain intensity compared to placebo at the same time point (SMD -1.24, 95% CI -3.41 to 0.94; 2 studies; 135 children). We judged the evidence for these outcomes to be of low quality due to an unclear risk of bias, imprecision, and significant heterogeneity.We found only one study of low FODMAP diets and only one trial of fructose-restricted diets, meaning no pooled analyses were possible.We were unable to perform any meta-analyses for the secondary outcomes of school performance, social or psychological functioning, or quality of daily life, as not enough studies included these outcomes or used comparable measures to assess them.With the exception of one study, all studies reported monitoring children for adverse events; no major adverse events were reported. Authors' conclusions: Overall, we found moderate- to low-quality evidence suggesting that probiotics may be effective in improving pain in children with RAP. Clinicians may therefore consider probiotic interventions as part of a holistic management strategy. However, further trials are needed to examine longer-term outcomes and to improve confidence in estimating the size of the effect, as well as to determine the optimal strain and dosage. Future research should also explore the effectiveness of probiotics in children with different symptom profiles, such as those with irritable bowel syndrome.We found only a small number of trials of fibre-based interventions, with overall low-quality evidence for the outcomes. There was therefore no convincing evidence that fibre-based interventions improve pain in children with RAP. Further high-quality RCTs of fibre supplements involving larger numbers of participants are required. Future trials of low FODMAP diets and other dietary interventions are also required to facilitate evidence-based recommendations.
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