Peckham Et Al-2019-Cochrane Database of Systematic Reviews

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Homeopathy for treatment of irritable bowel syndrome (Review)
Peckham EJ, Cooper K, Roberts ER, Agrawal A, Brabyn S, Tew G
Peckham EJ, Cooper K, Roberts ER, Agrawal A, Brabyn S, Tew G.

Homeopathy for treatment of irritable bowel syndrome.
Cochrane Database of Systematic Reviews 2019, Issue 9. Art. No.: CD009710.
DOI: 10.1002/14651858.CD009710.pub3.
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Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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TABLE OF CONTENTS
HEADER......................................................................................................................................................................................................... 1
ABSTRACT..................................................................................................................................................................................................... 1
PLAIN LANGUAGE SUMMARY....................................................................................................................................................................... 2
SUMMARY OF FINDINGS.............................................................................................................................................................................. 4
BACKGROUND.............................................................................................................................................................................................. 9
OBJECTIVES.................................................................................................................................................................................................. 10
METHODS..................................................................................................................................................................................................... 10
RESULTS........................................................................................................................................................................................................ 11
Figure 1.................................................................................................................................................................................................. 13
Figure 2.................................................................................................................................................................................................. 15
DISCUSSION.................................................................................................................................................................................................. 17
AUTHORS' CONCLUSIONS........................................................................................................................................................................... 18
ACKNOWLEDGEMENTS................................................................................................................................................................................ 19
REFERENCES................................................................................................................................................................................................ 20
CHARACTERISTICS OF STUDIES.................................................................................................................................................................. 23
DATA AND ANALYSES.................................................................................................................................................................................... 29
Analysis 1.1. Comparison 1 Homeopathy versus placebo, Outcome 1 Homeopathy versus placebo.............................................. 29
Analysis 2.1. Comparison 2 Homeopathy versus usual care, Outcome 1 Global improvement (feeling unwell)............................. 30
Analysis 3.1. Comparison 3 Homeopathy plus usual care versus usual care, Outcome 1 Global improvement (IBS-SSS).............. 30
Analysis 3.2. Comparison 3 Homeopathy plus usual care versus usual care, Outcome 2 Quality of life......................................... 30
Analysis 4.1. Comparison 4 Homeopathy plus usual care versus supportive listening plus usual care, Outcome 1 Global 31
improvement (IBS-SSS)........................................................................................................................................................................
Analysis 4.2. Comparison 4 Homeopathy plus usual care versus supportive listening plus usual care, Outcome 2 Quality of life.... 31
APPENDICES................................................................................................................................................................................................. 31
WHAT'S NEW................................................................................................................................................................................................. 33
HISTORY........................................................................................................................................................................................................ 33
CONTRIBUTIONS OF AUTHORS................................................................................................................................................................... 34
DECLARATIONS OF INTEREST..................................................................................................................................................................... 34
SOURCES OF SUPPORT............................................................................................................................................................................... 34
INDEX TERMS............................................................................................................................................................................................... 34
Homeopathy for treatment of irritable bowel syndrome (Review) i

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[Intervention Review]
Homeopathy for treatment of irritable bowel syndrome
Emily J Peckham1, Katy Cooper2, E Rachel Roberts3, Anurag Agrawal4, Sally Brabyn1, Garry Tew5
1Department of Health Sciences, University of York, York, UK. 2School of Health and Related Research (ScHARR), University of Sheffield,
Sheffield, UK. 3Homeopathy Research Institute, London, UK. 4Department of Gastroenterology and Medicine, Doncaster Royal Infirmary,
Doncaster, UK. 5Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle Upon Tyne, UK
Contact address: Emily J Peckham, Department of Health Sciences, University of York, Heslington, York, - None -, Y010 5DD, UK.
emily.peckham@york.ac.uk.
Editorial group: Cochrane IBD Group.

Publication status and date: Edited (no change to conclusions), published in Issue 10, 2019.
Citation: Peckham EJ, Cooper K, Roberts ER, Agrawal A, Brabyn S, Tew G. Homeopathy for treatment of irritable bowel syndrome.
Cochrane Database of Systematic Reviews 2019, Issue 9. Art. No.: CD009710. DOI: 10.1002/14651858.CD009710.pub3.
ABSTRACT
Background
Irritable bowel syndrome (IBS) is a common, chronic disorder that leads to decreased health-related quality of life and work productivity.
A previous version of this review was not able to draw firm conclusions about the effectiveness of homeopathic treatment for IBS and
recommended that further high quality RCTs were conducted to explore the clinical and cost effectiveness of homeopathic treatment for
IBS. Two types of homeopathic treatment were evaluated in this systematic review: 1. Clinical homeopathy where a specific remedy is
prescribed for a specific condition; 2. Individualised homeopathic treatment, where a homeopathic remedy based on a person's individual
symptoms is prescribed after a detailed consultation.
Objectives
To assess the effectiveness and safety of homeopathic treatment for IBS.
Search methods
For this update we searched MEDLINE, CENTRAL, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Allied and
Complementary Medicine Database (AMED), the Cochrane IBD Group Specialised Register and trials registers from inception to 31 August
2018.
Selection criteria
Randomised controlled trials (RCTs), cohort and case-control studies that compared homeopathic treatment with placebo, other control
treatments, or usual care, in adults with IBS were considered for inclusion.
Data collection and analysis

Two authors independently assessed the risk of bias and extracted data. The primary outcome was global improvement in IBS as measured
by an IBS symptom severity score. Secondary outcomes included quality of life, abdominal pain, stool frequency, stool consistency, and
adverse events. The overall certainty of the evidence supporting the primary and secondary outcomes was assessed using the GRADE
criteria. We used the Cochrane risk of bias tool to assess risk of bias. We calculated the mean difference (MD) and 95% confidence interval
(CI) for continuous outcomes and the risk ratio (RR) and 95% CI for dichotomous outcomes.
Main results
Four RCTs (307 participants) were included. Two studies compared clinical homeopathy (homeopathic remedy, asafoetida or asafoetida
plus nux vomica) to placebo for IBS with constipation (IBS-C). One study compared individualised homeopathic treatment (consultation
plus remedy) to usual care for the treatment of IBS in female patients. One study was a three armed RCT comparing individualised
Homeopathy for treatment of irritable bowel syndrome (Review) 1
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homeopathic treatment to supportive listening or usual care. The risk of bias in three studies (the two studies assessing clinical
homeopathy and the study comparing individualised homeopathic treatment to usual care) was unclear on most criteria and high for
selective reporting in one of the clinical homeopathy studies. The three armed study comparing individualised homeopathic treatment
to usual care and supportive listening was at low risk of bias in four of the domains and high risk of bias in two (performance bias and
detection bias).
A meta-analysis of the studies assessing clinical homeopathy, (171 participants with IBS-C) was conducted. At short-term follow-up of
two weeks, global improvement in symptoms was experienced by 73% (46/63) of asafoetida participants compared to 45% (30/66) of
placebo participants (RR 1.61, 95% CI 1.18 to 2.18; 2 studies, very low certainty evidence). In the other clinical homeopathy study at two
weeks, 68% (13/19) of those in the asafoetida plus nux vomica arm and 52% (12/23) of those in the placebo arm experienced a global
improvement in symptoms (RR 1.31, 95% CI 0.80 to 2.15; very low certainty evidence). In the study comparing individualised homeopathic
treatment to usual care (N = 20), the mean global improvement score (feeling unwell) at 12 weeks was 1.44 + 4.55 (n = 9) in the individualised
homeopathic treatment arm compared to 1.41 + 1.97 (n=11) in the usual care arm (MD 0.03; 95% CI -3.16 to 3.22; very low certainty
evidence).
In the study comparing individualised homeopathic treatment to usual care, the mean IBS symptom severity score at 6 months was 210.44
+ 112.4 (n = 16) in the individualised homeopathic treatment arm compared to 237.3 + 110.22 (n = 60) in the usual care arm (MD -26.86, 95%
CI -88.59 to 34.87; low certainty evidence). The mean quality of life score (EQ-5D) at 6 months in homeopathy participants was 69.07 (SD
17.35) compared to 63.41 (SD 23.31) in usual care participants (MD 5.66, 95% CI -4.69 to 16.01; low certainty evidence).
For In the study comparing individualised homeopathic treatment to supportive listening, the mean IBS symptom severity score at 6
months was 210.44 + 112.4 (n = 16) in the individualised homeopathic treatment arm compared to 262 + 120.72 (n = 18) in the supportive
listening arm (MD -51.56, 95% CI -129.94 to 26.82; very low certainty evidence). The mean quality of life score at 6 months in homeopathy
participants was 69.07 (SD 17.35) compared to 63.09 (SD 24.38) in supportive listening participants (MD 5.98, 95% CI -8.13 to 20.09; very
low certainty evidence).
None of the included studies reported on abdominal pain, stool frequency, stool consistency, or adverse events.
Authors' conclusions
The results for the outcomes assessed in this review are uncertain. Thus no firm conclusions regarding the effectiveness and safety of
homeopathy for the treatment of IBS can be drawn. Further high quality, adequately powered RCTs are required to assess the efficacy and
safety of clinical and individualised homeopathy for IBS compared to placebo or usual care.
PLAIN LANGUAGE SUMMARY
Homeopathy for treatment of irritable bowel syndrome
What is irritable bowel syndrome?
Irritable bowel syndrome (IBS) is a common chronic disorder where a person experiences the following symptoms: abdominal pain,
discomfort, bloating, constipation or diarrhoea or both. It is difficult to treat because different people experience different symptoms.
Some people experience constipation as the main symptom, this form of IBS is known as IBS-C, while others experience diarrhoea as the
main symptom. This form of IBS is known as IBS-D. Others experience both constipation and diarrhoea, this form of IBS is known as IBS-
M where the M stands for mixed. Currently there is no agreement on the best form of treatment for IBS.This means that it is important to
evaluate the effectiveness and safety of treatments, including homeopathic treatment, which some IBS sufferers use.
What is homeopathy?
There are different types of homeopathy. Clinical homeopathy matches a 'remedy' to a specific condition, such as IBS and everybody
who has that condition would be given the same remedy. Individualised homeopathy involves a series of in-depth consultations to assess
symptoms and other issues that may affect the patient. Following an in-depth consultation the homeopath will select the most appropriate
remedy based on the persons' individual symptoms. Individualised homeopathy includes both a consultation and a remedy, whereas
clinical homeopathy consists of a remedy without the in-depth consultation.
What did the researchers investigate?
The researchers investigated whether homeopathic treatment led to the improvement of the symptoms of IBS in people with IBS.
What did the researchers find?
Four randomised controlled trials (RCTs) with 307 participants with IBS were included. Two RCTs (129 participants) compared a
homeopathic remedy (asafoetida and asafoetida plus nux vomica) to a placebo remedy for the treatment of people with IBS-C. One study
(23 participants) compared individualised homeopathic treatment to usual care in female patients diagnosed with IBS. One study (94

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participants) was a three armed study comparing individualised homeopathic treatment plus usual care, supportive listening plus usual
care and usual care.
The four trials tested the effects of homeopathic treatment on the severity of IBS symptoms. No conclusions can be drawn from the RCT
comparing individualised homeopathic treatment to usual care due to the small number of participants and the low quality of reporting
in this trial. This study was carried out in 1990 and usual care for IBS may have changed since then making the results difficult to compare
to current treatments.
No conclusions can be drawn from the three armed study comparing individualised homeopathic treatment plus usual care, supportive
listening plus usual care and usual care due to the small number of participants in the homeopathic treatment arm (n=16).
The results of two small studies were combined (129 participants) and this suggested that there may be a possible benefit for clinical
homeopathy, using the remedy asafoetida, over placebo for patients with IBS-C at a short-term follow-up of two weeks. However both of
the studies were carried out in the 1970s when the reporting of trials was not as comprehensive as it is now and we are very uncertain
about these results and cannot suggest a possible benefit for clinical homeopathy.
Conclusions
The results for the outcomes assessed in this review are uncertain. Thus no firm conclusions regarding the effectiveness and safety of
homeopathy for the treatment of IBS can be drawn. Further high quality RCTs enrolling larger numbers of patients are required to assess
the effectiveness and safety of clinical and individualised homeopathy for IBS.

SUMMARY OF FINDINGS

Summary of findings for the main comparison. Homeopathy versus placebo
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Homeopathy versus placebo for the treatment of irritable bowel syndrome
Patient or population: patients with irritable bowel syndrome

Settings: outpatients
Intervention: homeopathy
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Outcomes Illustrative comparative Relative ef- No of Par- Quality of Comments
risks* (95% CI) fect ticipants the evi-
(95% CI) (studies) dence
Risk with Risk with (GRADE)
placebo homeopathy
Global improvement (Asafoetida 455 per 732 per 1000 RR 1.61 129 ⊕⊝⊝⊝ Global improvement defined as self improvement on
subgroup) 1000 (536 to 991) (1.18 to (2 studies) very a 3 point Likert scale
2.18) low1,2,3
Follow-up: 2 weeks
Global improvement (Asafoetida + 522 per 683 per 1000 RR 1.31 42 ⊕⊝⊝⊝ Global improvement defined as self improvement on
nux vom subgroup) 1000 (417 to 1000) (0.8 to 2.15) (1 study) very a 3 point Likert scale
low1,3,4
Follow-up: 2 weeks
Quality of life Not reported This outcome was not reported
Abdominal pain Not reported This outcome was not reported
Stool frequency Not reported This outcome was not reported

Stool consistency Not reported This outcome was not reported
Adverse events Not reported This outcome was not reported
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is
based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio;
GRADE Working Group grades of evidence

High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
4

Very low quality: We are very uncertain about the estimate.
1 Downgraded one level due to high risk of bias
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2 Downgraded one level due to sparse data (76 events)
3 Downgraded one level due to the endpoint time (2 weeks). Given the long term nature of IBS it is not clear how useful a two week outcome is for patients' and clinicians'
decision making.
4 Downgraded two levels due to very sparse data ( 25 events)

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Summary of findings 2. Homeopathy versus usual care
Homeopathy versus usual care for the treatment of irritable bowel syndrome

Outcomes Illustrative comparative risks* (95% CI) Relative No of Qual- Comments

effect Partici- ity of
Assumed risk Corresponding risk (95% pants the evi-
CI) (stud- dence
Usual care Homeopathy ies) (GRADE)
Global improvement The mean global The mean global improve- - 20 ⊕⊝⊝⊝ Global improvement defined as a self reported
(Feeling unwell) improvement score ment score was 1.44 (SD = (1 study) very improvement of symptoms. Scale from: 0 to 5
was 1.41 (SD = 1.97) 4.55) low1,2
Follow-up: 12 weeks Higher scores indicate greater improvement
MD 0.03 higher (3.16 lower to
3.22 higher)

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2 Downgraded two levels due to very sparse data (20 participants)

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Summary of findings 3. Homeopathy plus usual care versus usual care
Homeopathy plus usual care versus usual care for the treatment of irritable bowel syndrome

Outcomes Illustrative comparative risks* (95% CI) Relative No of Qual- Comments

effect Partici- ity of
Assumed risk Corresponding risk (95% pants the evi-
CI) (stud- dence
Control Homeopathy ies) (GRADE)
Global improvement The mean global im- The mean global improvement score - 76 ⊕⊕⊝⊝ IBS-SSS. Scale from: 0 to 400
(IBS-SSS) provement score was was 210.44 (SD = 112.4) (1 study) low1,2
Follow-up: 6 months 237.3 (SD = 110.27) Lower scores indicate less severe dis-
MD 26.86 lower (88.59 lower to 34.87 ease
higher)
Quality of life The mean quality of life The mean quality of life score was - 76 ⊕⊕⊝⊝ EQ-5D
score was 63.41 (SD = 69.07 (SD = 17.35) (1 study) low1,2

Follow-up 6 months 23.31) Higher scores indicate better quality of
MD 5.66 higher (4.69 lower to 16.01 life
higher)

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1 Downgraded one level due to sparse data (76 participants)

Summary of findings 4. Homeopathy plus usual care versus supportive listening plus usual care
Homeopathy plus usual care versus supportive listening plus usual care for treatment of irritable bowel syndrome

Intervention: Homeopathy
Outcomes Illustrative comparative risks* (95% CI) Relative No of Quality Comments

effect Partici- of the evi-
Assumed risk Corresponding risk (95% pants dence
CI) (stud- (GRADE)
Control Homeopathy ies)
Global improvement The mean global im- The mean global improvement score - 34 ⊕⊝⊝⊝ IBS-SSS. Scale from: 0 to 400
(IBS-SSS) provement score was was 210.44 (SD = 112.4) (1 study) very
Follow-up: 6 months 262 (SD = 120.72) low1,2 Lower scores indicate less severe
MD 51.56 lower (129.94 lower to 26.82 disease

higher)
Quality of life The mean quality of The mean quality of life score was 69.07 - 34 ⊕⊝⊝⊝ EQ-5D
life score was 63.09 (SD (SD = 17.35) (1 study) very
Follow-up: 6 months = 24.38) low1,2 Higher scores indicate better quali-
MD 5.98 higher (8.13 lower to 20.09 high- ty of life
er)

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1 Downgraded two levels due to very sparse data (34 participants)



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BACKGROUND developed by Samuel Hahnemann in the eighteenth century in

Germany and works on the principle of “like cures like” whereby a
Description of the condition substance that would cause symptoms in a healthy person cures
those same symptoms in illness.
Irritable bowel syndrome (IBS) is a common, chronic disorder
that affects 10 to 22% of the population in the UK (Williams Homeopathic treatment varies among different practitioners and
2007). The economic costs of IBS in primary care in the UK four main types can be identified (Linde 1997):
are estimated to be over GBP 200 million per year (Akehurst
2002). It is difficult to treat because no single cause has been • Individualised (or classical) homeopathy, the type most
identified. Treatment is directed at controlling symptoms, using commonly practised in the UK, involves a consultation followed
pharmacological and non-pharmacological approaches (Ruepert by the prescription of a homeopathic medicine individualised to
2011; Spiller 2007; Zijdenbos 2009). the patient;
• Clinical homeopathy, where the same homeopathic medicine is
IBS is characterised by recurrent symptoms (i.e. abdominal pain
used for a group of patients all presenting with the same clinical
or discomfort, bloating, constipation, or diarrhoea) that indicate a
condition (e.g. lycopodium for IBS, arnica for bruising);
dysfunctional gastrointestinal tract rather than an organic change
or specific diagnosis. It has an uncertain prognosis for recovery • Complex homeopathy, where a number of different
(Mearin 2006). Such patients have a plethora of non-colonic homeopathic medicines are given either in a fixed combination
symptoms such as back pain, urinary frequency, and chronic or concurrently; and
fatigue which can lead to the patient being referred to the • Isopathy, where the homeopathic medicine is based on the
wrong specialty and having inappropriate investigations and even substance which has led to the problem (e.g. grass pollen for hay
surgery. This can lower quality of life (Agrawal 2006; Longstreth fever).
2007). In addition, sleep disturbance and depressed mood are
common in IBS patients. Homeopathic medicines when prescribed by trained professionals
are generally regarded as safe (Dantas 2000).
Diagnosis of IBS can be made using the Rome IV criteria (Drossman
2016), although this is largely a research tool used to allow common How the intervention might work
reporting standards of symptoms in trials and other research Homeopathy is based on the ‘law of similars’ i.e. a substance which
populations. In clinical practice the diagnosis of IBS is largely based causes symptoms in a healthy individual can be used to treat
on symptoms and should be positive rather than by exclusion, similar symptoms in a diseased person (Vithoulkas 1980).There is
although the presence of alarm symptoms (e.g. blood in stool, significant debate regarding the scientific basis for homeopathy
weight loss or family history) should prompt further investigations amongst healthcare practitioners, scientists, politicians and policy
(Spiller 2007). IBS can be characterised into the following subtypes: makers and the mechanism by which homeopathic remedies may
IBS with constipation, IBS with diarrhoea, IBS with mixed bowel work is not completely understood.
habits and unspecified.
The manufacture of homeopathic medicines involves serial
Usual care for IBS commonly includes advice on lifestyle, including dilution alternating with violent agitation (i.e. ‘succussion’).
diet and stress reduction, possibly combined with medication. The combination of these two processes is referred to as
There are a number of different medications used to help treat ‘potentisation’ or ‘sequential kinetic activation’ (Gariboldi 2009).
IBS: antispasmodic medicines, which help to reduce abdominal Many homeopathic medicines are diluted beyond Avogadro’s
pain and cramping; laxatives, which help to treat the symptoms number and therefore fall under the classification of ultra-high
of constipation; anti-motility medicines, which help to treat the dilutions (UHDs). Avogadro's number is the number of molecules in
symptoms of diarrhoea, and neuropathic modulators such as a mole of a substance, approximately 6.0225 × 1023, which means
tricyclic antidepressants, which were originally designed to treat that a sample diluted beyond 1024 would have reached a stage
depression, but also help to reduce the feeling of abdominal where it is very unlikely that there is even a single molecule of the
pain and cramping. Alternative treatments such as hypnotherapy, original substance present. The biological efficacy of UHDs may be
psychotherapy and acupuncture have been tried and have a place dependent on sequential kinetic activation (Gariboldi 2009), but
in selected patients (Agrawal 2006,McPherson 2012). However the mechanism by which sequential kinetic activation enables a
these treatments have limited availability and are expensive and UHD to be biologically active is unknown. A common theory is that
labour intensive. Despite much research into both psychological it involves stable water structures, created by interactions between
and pharmacological treatments for irritable bowel syndrome no molecules of the biological material and the water it is dissolved
consensus exists on its optimal treatment (Ruepert 2011; Zijdenbos in, allowing the water to retain information about the biological
2009). material (Montagnier 2009).
Description of the intervention Why it is important to do this review
Homeopathy is a popular, albeit controversial form of This review is an update of a previously published Cochrane review
complementary and alternative medicine. A UK survey has shown on homeopathy for irritable bowel syndrome (Peckham 2012).
that 1.9% of the population consulted a homeopath in the 12 The original review marked a small step forward in establishing
months prior to the survey and 8.6% had bought an over-the- whether or not homeopathy is an effective treatment for IBS;
counter homeopathic remedy (Thomas 2001). Homeopathy is however due to the small number of studies, age of the studies
based on treating patients with remedies prepared from substances and methodological limitations the original review provided only
that have been highly diluted and succussed (shaken). It was first limited information. This updated review is timely not only because

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of the passage of time but also given the continued lack of effective Secondary outcomes
treatments for IBS and the sustained interest in homeopathy as a
Secondary outcomes included:
potential treatment option. Lower gastrointestinal tract disorders
account for one in 20 of all general practice consultations in • Quality of life as measured by validated quality of life measure
the UK (Thompson 2000). In addition, gastroenterology problems e.g. EQ5D, SF36, IBS Quality of Life Measure, IBS Quality of
are the fourth most common referral to National Health Service Life Questionnaire, Functional Digestive Disorder Quality of Life
(NHS) homeopathic hospitals (Spence 2005) and one of the eight Questionnaire, IBS Health Related Quality of Life Questionnaire;
most common conditions treated by NHS homeopaths in general
• Abdominal pain, discomfort and distension;
practice (Mathie 2006). The frequency with which people with IBS
consult homeopaths may be some indication of the value which • Stool frequency, bowel transit time;
they place on the homeopathic approach. Homeopathic treatment • Stool consistency; and
may offer a treatment strategy for patients with IBS, but at present • Adverse events.
it is not clear if it offers any benefit.
Search methods for identification of studies
OBJECTIVES
Electronic searches
The objective of this systematic review is to assess the effectiveness The following electronic databases were searched from inception
and safety of homeopathic treatment for IBS. to 31 August 2018:
METHODS The Cochrane Central Register of Controlled Trials (CENTRAL) on
the Cochrane Library, Ovid MEDLINE, EMBASE, the Cumulative
Criteria for considering studies for this review Index to Nursing and Allied Health Literature (CINAHL) and
Types of studies the Allied and Complementary Medicine Database (AMED). The
Cochrane IBD/FBD Group Specialised Register, Clinical trials.gov
Randomised controlled trials (RCTs) comparing homeopathic and the WHO International Clinical Trials Registry Platform (ICTRP)
treatment with placebo or active comparators were considered http://www.who.int/ictrp/en/ were also searched.
for inclusion regardless of blinding method, publication status
and language of publication. Quasi randomised studies were also Searching other resources
considered for inclusion, where allocation was achieved by 'quasi-
1. Reference searching
random' methods such as alternation between treatment arms,
year of birth, month entered into study. Cohort and case-control The reference lists for all identified studies were inspected for
studies were also considered for inclusion. additional studies.
Types of participants 2. Personal contact
All trials of patients with a diagnosis of IBS were eligible for
inclusion in this review regardless of age, gender, race, educational The first author of each included study was contacted for
status or duration of IBS. Trials which included IBS patients information regarding unpublished trials.
in whom 10% or more had unstable psychiatric disorders,
Data collection and analysis
ulcerative colitis, Crohn's disease, bowel cancer and pregnant and
breastfeeding women were excluded from this review. Selection of studies
Types of interventions Two authors (EJP and SB) independently reviewed the titles and
abstracts of the studies identified by the literature search. Included
Trials were included if one of the groups in the trial received studies were assessed against the predefined inclusion criteria.
any type of homeopathic treatment involving the delivery of
a homeopathic remedy (either by a homeopath following a Data extraction and management
consultation or studies where a homeopathic remedy was
Two authors (EP and SB) independently extracted data from the
delivered without a consultation) and the other received placebo,
included studies. Authors were contacted to clarify any unclear
an active comparator treatment, or no treatment.
data. EP who is an author of one of the included studies was not
Types of outcome measures involved in the data extraction or assessment of the risk of bias for
the study that she was involved in the conduct of, GT extracted the
All trials that included any one of the following outcome measures data for this study.
were included in the review.
Assessment of risk of bias in included studies
Primary outcomes
Two authors (SB and GT) independently assessed the
The primary outcome was global improvement of symptoms methodological quality of included randomised trials using the
(patient-reported or clinician-evaluated or both) as measured Cochrane risk of bias tool (Higgins 2011). The following items were
by a global IBS symptom score (e.g. IBS Severity Scoring assessed:
System (IBS-SSS), Adequate Relief Measure, GI Symptom Rating
Scale, Functional Bowel Disorder Severity Index or IBS Symptom • sequence generation (i.e. was allocation sequence adequately
Questionnaire). generated?);

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• allocation sequence concealment (i.e. was allocation Dealing with missing data
adequately concealed?);
We intended to analyse data using the intention to treat (ITT)
• blinding (i.e. was knowledge of the allocated interventions principle and sensitivity analyses were to be undertaken as
adequately prevented during the study?); appropriate (e.g. ITT versus available case, and study quality).
• incomplete outcome data (i.e. were incomplete outcome data However, data were analysed on an available case basis as the
adequately addressed?); included studies did not provide enough detail to allow for an ITT
• selective outcome reporting (i.e. are reports of the study free of analysis.
suggestion of selective outcome reporting?); and
Assessment of heterogeneity
• other potential sources of bias (i.e. was the study apparently
free of other problems that could lead to a high risk of bias e.g. Statistical heterogeneity was assessed using the Chi2 test and the I2
baseline imbalances, evidence of carry-over in cross-over trials, statistic. If heterogeneity existed between studies (I2 ≥ 50%) for the
comparability of groups in cluster trials). primary outcome, reasons for the heterogeneity would be explored.
Clinical heterogeneity would be assessed through the description
It was intended that, based on these criteria the studies would be of the setting and homeopathic approach used in each study.
subdivided into three categories:
Assessment of reporting biases
1. Low risk of bias i.e. all quality criteria met;
In the protocol we noted that if more than 10 studies were identified
2. Medium risk of bias i.e. one or more of the quality criteria partly for inclusion in this review, funnel plots would be used to assess
met; and publication biases.
3. High risk of bias i.e. one or more of the quality criteria not met. Data synthesis
It was intended that the quality of quasi-randomised trials, non- Data from individual trials were combined by meta-analysis if
randomised trials, cohort and case control studies would be the interventions, outcomes and patient groups were sufficiently
assessed using a quality instrument designed for assessing the similar (determined by consensus). For continuous data the MD
quality of non-randomised studies (Downs 1998). with 95% CI was calculated where the same scales have been used.
Where studies were deemed sufficiently similar but different scales
Using the GRADE (Grading of Recommendations Assessment, have been used the standardised mean difference (SMD) would be
Development and Evaluation) approach (Atkins 2004, Schünemann used to combine data. For dichotomous outcomes the pooled RR
2011), we will assess the overall quality of the evidence supporting and 95% CI were calculated.
the following outcomes: global improvement of symptoms, quality
of life, improvement in abdominal pain, stool frequency, stool In the protocol we specified that data would not be pooled for meta-
consistency and adverse events. The summary of the evidence will analysis if a high degree of heterogeneity (I2 > 75%) was detected.
be presented in a 'Summary of findings’ table, which will provide A fixed-effect model would be used to pool data in the absence
key information about the best estimate of the magnitude of the of heterogeneity. An I2 ≥ 50% is considered to represent moderate
effect for each relevant comparison, and the rating of the overall heterogeneity and in such cases (I2 50 to 75%) a random-effects
confidence in effect estimates for each outcome. The GRADEpro model would be used for pooling the data.
Guideline Development Tool will be used to create the 'Summary
Subgroup analysis and investigation of heterogeneity
of findings’ table.
Subgroup analysis was planned between studies that prospectively
Measures of treatment effect identified IBS patients using ROME III criteria versus studies that did
Review Manager (RevMan 5.3.5) was used to analyse the data. not use ROME III criteria to prospectively identify IBS patients. In
For continuous outcomes the mean difference (MD) with 95% the protocol we also noted that if data were reported separately for
confidence interval (95% CI) was calculated. For each dichotomous the different forms of IBS then a subgroup analysis comparing the
outcome the risk ratio (RR) with 95% CI was calculated. different forms would be carried out. A subgroup analysis was also
planned for quasi and true randomisation, different comparators
Unit of analysis issues (e.g. no treatment, usual care, placebo, or other active treatment)
and different homeopathy interventions (e.g. individualised or
We did not anticipate any unit of analysis issues arising from cluster
clinical homeopathy).
randomisation. In the case of multiple intervention groups each
intervention group was analysed separately against the control Sensitivity analysis
group and the sample size for the control group was divided
proportionately across each intervention group. We noted that if In the protocol we noted that if a sufficient number of trials were
the results were reported at multiple time points in the studies, identified a sensitivity analysis would be carried out by study
each outcome would be analysed at pre-defined periods of follow- quality to determine if the results of the primary analysis change
up in separate meta-analyses. Time points would be grouped as according to which trials are incorporated into the analysis.
follows: less than three months, three months to one year, longer
than one year. These time points were chosen as representing time RESULTS
frames in which a difference in the likelihood of responding could
be expected.
Description of studies
See Characteristics of included studies and Characteristics of
excluded studies and Characteristics of ongoing studies.
Informed decisions.

Results of the search table) and four studies plus two secondary publications from two
included studies were included in the review (Owen 1990; Peckham
Figure 1 shows details of the search and selection process.
2014; Rahlfs 1976; Rahlfs 1979). Two studies were included in
From citations initially identified, full text sources were examined
quantitative synthesis (Rahlfs 1976; Rahlfs 1979). No cohort or case-
(after removal of duplicates and assessment of abstract), studies
control studies were identified.
were excluded for various reasons (listed in the excluded studies


Informed decisions.

Figure 1. Study flow diagram.

Informed decisions.

Included studies details of the symptoms patients chose were not reported are not
given, hence this outcome measure was not included in this review.
Four studies with a total of 307 participants were included (Owen
1990; Peckham 2014; Rahlfs 1976; Rahlfs 1979). See Characteristics Peckham 2014 was a three armed trial that compared
of included studies. Owen 1990 and Peckham 2014 were conducted individualised homeopathic treatment plus usual care to
in the UK and published in English. Rahlfs 1976 and Rahlfs 1979 supportive listening plus usual care to usual care alone.
were conducted in the former Federal Republic of Germany and Unequal randomisation was used in Peckham 2014 with 16
published in German and were translated from German into participants allocated to individualised homeopathic treatment,
English. Rahlfs 1976, was a three arm trial comparing asafoetida 18 to supportive listening and 60 to usual care. Individualised
against asafoetida + nux vomica, against placebo, whereas Rahlfs homeopathic treatment involved a homeopathic consultation and
1979 compared asafoetida versus placebo (the participants in an individualised homeopathic remedy. Supportive listening aimed
the two trials are independent). The authors noted that Rahlfs to control for the time and attention given to the patient in the
1976 failed to recruit its target number of participants, hence the individualised homeopathic treatment arm and consisted of the
(simplified) trial being re-run. There were 23 participants in Owen same number of sessions of the same duration as the homeopathic
1990, 72 participants in Rahlfs 1976, 119 participants in Rahlfs 1979 consultation. In both the individualised homeopathic treatment
and 94 participants in Peckham 2014. All included studies were and supportive listening arms patients were offered five one hour
published as full articles. sessions with a homeopath or counsellor respectively. The primary
outcome measure in Peckham 2014 was change in IBS-SSS at 6
Owen 1990 compared individualised homeopathic treatment,
months.
which involved a homeopathic consultation and an individualised
homeopathic remedy, to usual care which consisted of high doses None of the included studies reported on adverse events as an
of dicyclomine hydrochloride, faecal bulking agents and diet outcome.
sheets asking the patient to take a high fibre diet. This study
differs from other pragmatic trials of individualised homeopathic Excluded studies
treatment, where the more common approach has been to
The Characteristics of excluded studies table, describes the
compare individualised homeopathic treatment plus usual care to
characteristics of the 32 excluded studies along with the reason for
usual care alone. In Owen 1990 participants were asked to rate
their exclusion.
how unwell they felt before and after treatment, exact details of
how this was scored are not given. Although Owen 1990 did not Ongoing studies
include a global measurement of IBS as one of the outcomes, we
considered the rating of how unwell patients felt to provide a global No ongoing studies were identified.
measurement of the patients' health. The other outcome measures
in Owen 1990 involved the patients choosing their own top four Risk of bias in included studies
worst symptoms and grading these on a visual analogue scale, it The risk of bias in the included studies for each domain are
was not specified that these symptoms had to be related to IBS, and discussed below. See results of the risk of bias analysis are
summarized in Figure 2.


Informed decisions.

Figure 2. Methodological quality summary: review authors' judgments about each methodological quality item for
each included study.

Allocation containers and were rated as low risk for allocation concealment.
Owen 1990 did not describe the procedure used for allocation
Owen 1990, Rahlfs 1976, Rahlfs 1979 and Peckham 2014 were
concealment and was rated as unclear for this item.
described as RCTs. Owen 1990 reported that the participants
were stratified and randomised into one of two treatment groups. Blinding
However, no details were given about the stratification or how
randomisation sequence was generated. Rahlfs 1976 reported that Participants and physicians were not blinded to treatment
a chance code was used for randomisation, although what this allocation in the Owen 1990 and Peckham 2014 studies as it was
entailed and how it was implemented was not described. Rahlfs not possible to design a study where participants were not aware
1979 did not report any information regarding the method of of their receiving an individualised homeopathic consultation,
generation of the randomisation code. Peckham 2014 reported supportive listening or usual care. Owen 1990 did not report
that the random sequence was generated by shuffling of sealed whether other key study personnel were blinded, or whether
opaque envelopes containing the allocation and was reported as outcome assessment was carried out blind. In Peckham 2014
being of low risk of bias for allocation concealment. Rahlfs 1976 and outcomes were participant reported and due to participants being
Rahlfs 1979 provided medication in sequentially numbered drug aware of their allocation outcomes were at high risk of bias. In
Rahlfs 1976 and Rahlfs 1979 the study participants and the doctors
Informed decisions.

who recruited the participants were blinded to allocation by the use not or negligibly improved, more than half improved or free of
of an identical placebo. In Rahlfs 1979, the participant blinding was symptoms. Participants in the Rahlfs 1979 study were asked to rate
well described. Rahlfs 1976 and Rahlfs 1979 did not report whether whether they were worse, not or negligibly improved, more than
other key study personnel were blinded, or if outcome assessment half improved or free of symptoms. For the purposes of this review,
was carried out blind. we dichotomised these scales into two categories: those who had
improved (more than half improved or free of symptoms) versus
Incomplete outcome data those who had not improved (those who were worse, or not or
The number of patient withdrawals was reported for Owen 1990, negligibly improved).
Rahlfs 1976, Rahlfs 1979 and Peckham 2014. Although Owen 1990
At short term follow up of two weeks, a pooled analysis (129
reported the number of withdrawals and the arm from which the
participants) indicated that there may be a benefit of the
patients withdrew, the reasons for withdrawal were not reported.
homeopathic treatment asafoetida over placebo. At short-term
In Peckham 2014 the reasons for withdrawal were reported and a
follow up of two weeks, the RR for global improvement in
comparison of baseline data was made between those who had
symptoms for asafoetida versus placebo was 1.61 (95% CI 1.18
missing data and those who did not, this indicated that there
to 2.18; very low certainty evidence). Little heterogeneity was
was a relationship between age, employment status and missing
detected for this comparison (I2 = 18%). For the study that
data, hence employment status and age were included in the
compared homeopathic remedy (asafoetida plus nux vomica) to
ANCOVA model for the primary outcome. Rahlfs 1976 did not report
placebo the RR was 1.31 (95% CI 0.80 to 2.15; very low certainty
which arms that patients withdrew from and therefore it was not
evidence).
clear whether there may be attrition bias in this trial. Rahlfs 1979
reported the number of withdrawals from each treatment group Homeopathic treatment versus usual care
and the reasons for withdrawal. Whilst dropouts appear to be
comparable in terms of number and reason for withdrawal across In Owen 1990 participants (N = 20) were asked to rate how
both arms of this study (Rahlfs 1979), it should be remembered unwell they felt before and after treatment. The effect of
that any dropout threatens group comparability at baseline as individualised homeopathic treatment was uncertain. The mean
random allocation seeks to distribute both known and unknown global improvement score (i.e. how unwell the participants felt -
characteristics across groups, and dropouts may differ for unknown a lower score indicates feeling more unwell) in the individualised
characteristics that cannot be measured. homeopathic treatment arm was 1.44 (SD 4.55) compared to 1.41
(SD 1.97) in the usual care arm (MD 0.03, 95% CI -3.16 to 3.22; very
Selective reporting low certainty evidence).
Due to insufficient reporting in Owen 1990 and Rahlfs 1976 both
Homeopathic treatment plus usual care versus usual care
studies were rated as unclear for the item on selective reporting.
Rahlfs 1979 was deemed to be at a high risk of bias due to In Peckham 2014 participants were asked to complete the IBS-
selective reporting because of evidence of selective choice of SSS at baseline and at 6 months. The effect of individualised
data for an outcome. Some participants were excluded from the homeopathic treatment at 6 months was uncertain. In the
outcome analyses for not meeting the inclusion criteria while other individualised homeopathic treatment plus usual care arm the
participants who did not meet the inclusion criteria in terms of age mean IBS-SSS score was 210.44 (SD 112.4) compared to 237.30 (SD
were included in the analyses. Peckham 2014 was deemed to be at 110.22) in the usual care arm (MD -26.86, 95% CI -88.59 to 34.87;
low risk of bias for selective reporting due to all the outcomes being low certainty evidence). A lower score indicates less severity of
reported in the protocol paper being presented in the main paper. symptoms.
Other potential sources of bias Homeopathic treatment plus usual care versus supportive
Due to the low quality of reporting in Owen 1990, Rahlfs 1976 and listening plus usual care
Rahlfs 1979, the potential for other sources of bias in these studies
In Peckham 2014 participants were asked to complete the IBS-SSS
could not be assessed. No other potential sources of bias were
at baseline and at 6 months. The effect of homeopathic treatment
identified in Peckham 2014, however it cannot be certain that there
compared to supportive listening was uncertain. At six months the
were no other sources of bias so this has been marked as unclear.
mean IBS-SSS score in the homeopathic treatment plus usual care
Effects of interventions arm was 210.44 (SD 112.4) compared to 262.00 (SD 120.72) in the
supportive listening plus usual care arm (MD -51.56, 95% CI -129.94
See: Summary of findings for the main comparison Homeopathy to 26.82; very low certainty evidence). A lower score indicates less
versus placebo; Summary of findings 2 Homeopathy versus usual severity of symptoms.
care; Summary of findings 3 Homeopathy plus usual care versus
usual care; Summary of findings 4 Homeopathy plus usual care Secondary outcome measures
versus supportive listening plus usual care
The secondary outcomes quality of life, abdominal pain, stool
Clinical homeopathic remedy versus placebo remedy frequency, stool consistency and adverse events were not reported
on in Rahlfs 1976, Rahlfs 1979 or Owen 1990. Quality of life
Rahlfs 1976 and Rahlfs 1979 assessed global improvement in IBS using the EQ-5D was reported on in Peckham 2014. The effect
at two weeks as an outcome measure. For this outcome patients of individualised homeopathic treatment on quality of life was
were asked to measure their improvement on a three-point scale uncertain. In the homeopathic treatment arm the mean EQ-5D
(Rahlfs 1976) and a four-point scale (Rahlfs 1979). For the Rahlfs visual analogue score (VAS) at six months was 69.07 (SD 17.35)
1976 study participants were asked to rate whether they were compared to 63.41 (SD 23.31) in the usual care arm (MD 5.66,
Informed decisions.

95% CI -4.69 to 16.01; low certainty evidence). In the homeopathic Therefore this review does not provide information on the
treatment arm the mean EQ-5D score at six months was 69.07 (SD effectiveness of clinical homeopathy for the treatment of IBS in
17.35) compared to 63.09 (SD 24.38) in the supportive listening arm general, or diarrhoea-predominant, or mixed typology IBS. Both
(MD 5.98, 95% CI -8.13 to 20.09; very low certainty evidence). A lower Rahlfs 1976 and Rahlfs 1979 reported outcomes at two weeks. Given
score indicates a worse quality of life. the long term nature of IBS it is not clear how useful a two-week
outcome is for patients', clinicians' and policy makers' decision
Pooling of results making. As people live with IBS for years, an evaluation of impact
at two weeks fails to take into account possible rebound effects or
Outcome data from the Owen 1990 study was not pooled
longer term benefits or adverse events that would be important for
with the data from Rahlfs 1976 and Rahlfs 1979 because of
patients and practitioners to know about when they consider the
heterogeneity between the studies. The three studies investigated
potential benefits and harms associated with this intervention.
two different types of homeopathy. For the same reason outcome
data from Peckham 2014 was not pooled with outcome data Two studies that assessed the effectiveness of individualised
from Rahlfs 1976 and Rahlfs 1979. Owen 1990 and Peckham homeopathic treatment were identified in this review (Owen
2014 investigated the effectiveness of individualised (classical) 1990; Peckham 2014). The number of participants in both these
homeopathic treatment, whilst Rahlfs 1976 and Rahlfs 1979 studies were small (N = 23 and N = 94 respectively). Owen 1990
investigated clinical homeopathy. The type of IBS investigated was conducted over 25 years ago. It is likely that there have
was also potentially different. In the Owen 1990 and Peckham been changes in usual care for IBS since this time, therefore
2014 studies participants were diagnosed with IBS and no further Owen 1990 may not provide a full picture of the effectiveness of
information on type was given, whilst the participants in Rahlfs individualised homeopathic treatment compared to usual care.
1976 and Rahlfs 1979 had constipation-predominant IBS. In Peckham 2014 was conducted more recently and is likely to
addition, the studies measured outcomes at different time points. compare individualised homeopathic treatment to current usual
Peckham 2014 measured outcomes at 26 weeks and Owen 1990 care however given the small size of this study and the fact that it is
measured outcomes at 12 weeks, whilst Rahlfs 1976 and Rahlfs underpowered makes it difficult to draw any firm conclusions from
1979 measured outcomes at 2 weeks. The primary outcome for the the study.
Owen 1990 study was not a global improvement measure and was
not comparable with the other three studies. Although it may be Quality of the evidence
tempting to combine studies in a meta-analysis when it is likely to
yield a statistically significant result, it is important not to combine The results from the pooled analysis indicate a possible
studies where there is significant clinical heterogeneity, because benefit for homeopathic treatment using clinical homeopathy
these results would not be meaningful due to the large degree of (non-individualised homeopathic remedies) over placebo for
differences between the studies. For these reasons the outcomes constipation-predominant IBS. However, this result needs to be
from Owen 1990, Peckham 2014, Rahlfs 1976 and Rahlfs 1979 were interpreted with caution. The two studies included in the pooled
not combined. analysis (Rahlfs 1976 and Rahlfs 1979) were carried out in the 1970s
before the introduction of the CONSORT statement (Begg 1996),
DISCUSSION and the quality of reporting in these studies does not meet currently
expected standards (Schultz 2010). The low quality of the reporting
Summary of main results means that it is not possible to determine whether or not these
studies were carried out in a rigorous manner and thus how likely
Two RCTs compared a clinical homeopathic remedy (asafoetida it is that these results are a true reflection of the treatment effect.
and asafoetida plus nux vomica) with placebo for treating IBS-C Both studies were determined to have an unknown risk of bias for
(Rahlfs 1976; Rahlfs 1979). In a meta-analysis of these studies, the most assessed items and Rahlfs 1979 was at a high risk of reporting
homeopathic remedy found that there may be a benefit of the bias. The quality of the evidence supporting the primary outcome
remedy over placebo for improvement in global IBS symptoms at a (i.e. global improvement) was very low due to the low quality of
short-term follow-up of two weeks. However, this result should be reporting in the included studies, high or unknown risk of bias,
interpreted with caution due to the low quality of the reporting in sparse data and short-term follow-up.
these studies, a high or unknown risk of bias associated with the
trials in this pooled analysis, short-term follow-up, and sparse data. Participants in the Rahlfs 1976 and Rahlfs 1979 studies were
recruited through general practice as having suspected IBS. It is not
Two RCTs (Owen 1990; Peckham 2014) compared individualised clear whether diseases such as Crohn's disease or ulcerative colitis
homeopathic treatment with usual care. In Owen 1990 were ruled out in these participants and it is possible that some
individualised homeopathic treatment was compared to usual care participants had diseases such as Crohn's or ulcerative colitis rather
(dicyclomine hydrochloride, faecal bulking agents, and diet sheets than IBS.
advising a high fibre diet). No conclusions can be drawn from this
study due to the small number of participants, the low quality of The quality of the reporting in the Owen 1990 study was low, and
reporting in this trial and a high risk of bias. Although Peckham this study does not meet the current expected standards (Schultz
2014 has a low risk of bias and the quality of the reporting is good 2010). No conclusions can be drawn from this study due to the small
it is difficult to draw conclusions from this study due to the small number of participants and risk of bias. Owen 1990 was rated as
number of participants. high risk of bias for blinding of participants and personnel. The
study was rated as unknown risk of bias for the other assessed
Overall completeness and applicability of evidence items. The exact details of the medication prescribed in the usual
Rahlfs 1976 and Rahlfs 1979 assessed the effectiveness of clinical care arm, in terms of dosage and frequency were not reported.
homeopathy for the treatment of constipation-predominant IBS.
Informed decisions.

The quality of the reporting in the Peckham 2014 was good effects, chance or bias. Furthermore, the low quality of reporting
and combined with the published protocol it meets the current practice means that it is difficult to assess whether the results
expected standards (Schultz 2010). Peckham 2014 was rated as would be replicated in everyday practice, that is, whether the
being at low risk of bias for selection bias, attrition bias and results are externally valid or generalisable. We are therefore very
reporting bias and at high risk of bias for performance bias and uncertain about these results and cannot suggest a possible benefit
detection bias. However the small number of participants in this for clinical homeopathy.
study (n = 16 homeopathic treatment, n = 18 supportive listening
and n = 60 usual care) and the fact that it was underpowered It is of note that Rahlfs 1976 and Rahlfs 1979 reported outcomes at
mean no firm conclusions can be drawn from this study. The two weeks. Given the long term nature of IBS, it is not clear how
quality of the evidence supporting the primary outcome (i.e. global useful a two-week outcome is for decision making. It is essential
improvement) ranged from very low to low due to sparse data and that trials have a follow-up period that is clinically meaningful.
high risk of bias. As people live with IBS for years, an evaluation of impact at two
weeks fails to take into account any possible rebound effects, or
Potential biases in the review process longer term benefits or adverse events that would be important for
patients and practitioners to know about when they consider the
To avoid potential biases in the review process data extraction was potential benefits and harms associated with this intervention.
carried out independently by two assessors. In addition, efforts
were made to identify all studies that were potentially eligible The results from Owen 1990 are uncertain and no conclusions can
for this review (see Search methods for identification of studies). be drawn from this study. Owen 1990 compared individualised
However, It is possible that not all potentially eligible studies homeopathic treatment and usual care consisting of dicyclomine
were identified. This could be because potentially eligible studies hydrochloride and faecal bulking agents. The results from Peckham
have been carried out and then have not been published, or 2014 are uncertain and no conclusions can be drawn from
that studies have been published but not in places where they this study. Peckham 2014 compared individualised homeopathic
could be accessed, possibly because they were published in little treatment plus usual care, supportive listening plus usual care
known non-indexed journals or they could have been published in and usual care. Individualised homeopathy is the most common
places where they should have been found, but were not found. form of homeopathy practised in the UK. However due to the
One of the review authors (EJP) was a trialist for an included poor quality of reporting in Owen 1990 study and the small
study (Peckham 2014). For this study, the assessment of risk of number of participants in both Owen 1990 and Peckham 2014, no
bias and data extraction was performed by other authors. Cohort conclusions can be made regarding the usefulness of individualised
and case-control studies were considered for inclusion but none homeopathic treatment for the treatment of IBS.
were identified by the literature search. In retrospect the inclusion
of case-control studies was not appropriate given that the main None of the included studies reported on adverse events therefore
reason for including case-control studies in a review is when an no conclusions can be drawn on the safety of homeopathic
event is very rare and thus it is unlikely that any RCTs have been treatment for IBS.
carried out (Reeves 2011).
Implications for research
Agreements and disagreements with other studies or
Further high quality, adequately powered RCTs are required
reviews to assess the efficacy and safety of clinical and individualised
No other systematic reviews of homeopathic treatment for IBS were homeopathy for IBS compared to placebo or usual care.
identified. However non-condition specific systematic reviews of
homeopathic treatment that included the Rahlfs 1976 and Rahlfs Rahlfs 1976 and Rahlfs 1979 evaluated clinical homeopathy
1979 studies have been published (Linde 1997; Shang 2005). involving pre-specified homeopathic remedies for the treatment
Neither of these systematic reviews carried out any analyses on of IBS-C and were therefore designed to assess the effectiveness
homeopathy for the treatment of IBS or specifically commented on of non-individualised homeopathic remedies. However due to the
homeopathy for IBS. high risk of reporting bias in one of these studies and unclear
reporting in both of these studies it is recommended that these
AUTHORS' CONCLUSIONS trials are repeated using current reporting guidelines (Schultz
2010), to determine whether or not there is any benefit associated
Implications for practice with homeopathy for IBS. Future high quality studies should enrol
larger numbers of patients and assess longer term efficacy and
The results for the outcomes assessed in this review are uncertain. safety outcomes.
Thus no firm conclusions regarding the effectiveness and safety of
homeopathy for the treatment of IBS can be drawn. Owen 1990 assessed the effectiveness of individualised
homeopathic treatment compared to usual care and Peckham
In this review of homeopathic treatment for IBS, two of the included 2014 assessed the effectiveness of individualised homeopathic
studies used clinical (non-individualised) homeopathic remedies treatment plus usual care to usual care. Due to the low quality
to treat patients with constipation-predominant IBS (Rahlfs 1976; reporting in Owen 1990 and the likelihood that usual care for
Rahlfs 1979). A meta-analysis of these two studies found a possible IBS has changed since this study was conducted, and the fact
benefit favouring the homeopathic remedy over placebo. However, that Peckham 2014 was underpowered to detect a significant
these results should be interpreted with caution due to the low difference, it is recommended that the effectiveness and safety
quality of reporting in these studies, a high or unknown risk of of individualised homeopathic treatment be evaluated in a well-
bias and sparse data. Thus it is not possible to be certain whether designed, adequately powered trial.
or not the trials were able to distinguish between true treatment
Informed decisions.

ACKNOWLEDGEMENTS
Funding for the Cochrane IBD Group (May 1, 2017 - April 30, 2022)
has been provided by Crohn's and Colitis Canada (CCC).

Informed decisions.

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Agrawal 2006
Jones 1996 {published data only}
Agrawal A, Whorwell PJ. Irritable bowel syndrome: diagnosis
Jones A. Homoeopathic case studies: irritable bowel syndrome.
and management. BMJ 2006;332(7536):280-3.
Positive Health 1996;16:30.
Akehurst 2002
Jones 1997 {published data only}
Akehurst RL, Brazier JE, Mathers N, O'Keefe C, Kaltenthaler E,
Jones A. Irritable bowel syndrome. Homoeopathy
Morgan A, et al. Health-related quality of life and cost impact
1997;47(5):101-2.
of irritable bowel syndrome in a UK primary care setting.
Jones 1999 {published data only} Pharmacoeconomics 2002;20(7):455-62.
Jones A. Homeopathic case studies: Nux Vomica for bowel Atkins 2004
symptoms. Positive Health 1999;37:25.
Atkins D, Best D, Briss PA, Eccles M, Falck-Ytter Y, Flottorp S, et al.
Krishendu 2010 {published data only} Grading quality of evidence and strength of recommendations.
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Krishendu. Irritable bowel syndrome - a homeopathic
perspective. Homoeopathic Heritage International Begg 1996
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Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, et al.
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The CONSORT statement. JAMA 1996;276(8):637-9.
Lobo A. IBS: a constitutional approach. National Journal of
Homoeopathy 2000;2(4):262a-d. Dantas 2000
Master 2008 {published data only} Dantas F, Rampes H. Do homeopathic medicines provoke
adverse effects? A systematic review. British Homoeopathic
Master FJ. From the editor's desk. Homoeopatic approaches to
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irritable bowel syndrome. Homoeopathic Heritage International
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Mohan 2006 {published data only} Downs SH, Black N. The feasibility of creating a checklist
for the assessment of the methodological quality both of
Mohan G, Kishore KC, Ratna SA. Irritable bowel syndrome:
randomised and non-randomised studies of health care
"A challenge in medical practice". National Journal of
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Homoeopathy 2006;8(2):131-3.
1998;52(6):377-84.
Pawar 2015 {published data only}
Drossman 2016
Pawar D. Management of irritable bowel syndrome with
Drossman DA, Hasler WL. Rome IV-functional GI disorders:
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disorders of gut-brain interaction. Gastroenterology
2015;17(7):12-13.
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Gariboldi 2009
Pinto G. Case studies - Marylebone health centre action
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Diagnostics and therapy [Reizdarmsyndrom - Diagnostik und Higgins 2011
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Higgins JPT, Altman DG, Sterne JAC (editors). Chapter 8:
Assessing risk of bias in included studies. In: Higgins JPT,

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Green S editor(s). Cochrane Handbook for Systematic Reviews Schünemann 2011

of Interventions Version 5.1.0 [updated March 2011]. The Schünemann HJ, Oxman AD, Vist GE, Higgins JPT, Deeks JJ,
Cochrane Collaboration, 2011. Available from www.cochrane- Glasziou P, et al. Chapter 12: Interpreting results and drawing
handbook.org. conclusions. In: Higgins JPT, Green S editor(s). Cochrane
Handbook for Systematic Reviews of Interventions. 2011. Vol.
Linde 1997
5.1.0, The Cochrane Collaboration, 2011.
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effects? A meta-analysis of placebo controlled trials. Lancet Shang AJ, Huwiler-Muntene MD, Narety C, Juni P, Dorig S,
1997;350(9081):834-43. Sterne JA, et al. Are the clinical effects of homoeopathy placebo
effects? Comparative study of placebo-controlled trials of
Longstreth 2007
homoeopathy and allopathy. Lancet 2005;366(9487):726-32.
Longstreth GF. Avoiding unnecessary surgery in irritable bowel
syndrome. Gut 2007;56(5):608-10. Spence 2005
Spence DS, Thompson EA, Barron SJ. Homeopathic treatment
Mathie 2006
for chronic disease: a 6 year, university-hospital outpatient
Mathie RT, Robinson TW. Outcomes from homeopathic observational study. Journal of Alternative and Complementary
prescribing in medical practice: A prospective, research- Medicine 2005;11(5):793-8.
targeted, pilot study. Homeopathy 2006;95(4):199-205.
Spiller 2007
McPherson 2012
Spiller R, Aziz Q, Creed F, Emmanuel A, Houghton L, Hungin P,
MacPherson H, Tilbrook H, Bland JM, Bloor K, Brabyn S, Cox H, et al. Guidelines on the irritable bowel syndrome: mechanisms
et al. Acupuncture for irritable bowel syndrome: primary and practical management. Gut 2007;56(12):1770-98.
care based pragmatic randomised controlled trial. BMC
Gastroenterology 2012;12:150. Thomas 2001
Thomas KJ, Nicholl JP, Coleman P. Use and expenditure on
Mearin 2006
complementary medicine in England: a population based
Mearin F, Badía X, Balboa A, Benavent J, Caballero AM, survey. Complementary Therapies in Medicine 2001;9(1):2-11.
Domínguez-Muñoz E, et al. Predictive factors of irritable bowel
syndrome improvement: 1-year prospective evaluation of Thompson 2000
400 patients. Alimentary Pharmacology and Therapeutics Thompson WG, Heaton KW, Smyth GT, Smyth C. Irritable bowel
2006;23(6):815-26. syndrome in general practice: prevalence, characteristics, and
referral. Gut 2000;46(1):78-82.
Montagnier 2009
Montagnier L, Aïssa J, Ferris S, Montagnier JL, Lavallée C. Vithoulkas 1980
Electromagnetic signals are produced by aqueous Vithoulkas G. The Science of Homeopathy. New York: Grove
nanostructures derived from bacterial DNA sequences. Press, 1980.
Interdisciplinary Sciences, Computational Life Sciences
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Williams JG, Roberts SE, Ali MF, Cheung WY, Cohen DR,
Reeves 2011
Demery G, et al. Gastroenterology services in the UK. The
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Including non-randomized studies. In: Higgins JPT, Green for gastrointestinal and liver disorders: a review of the evidence.
S editor(s). Cochrane Handbook for Systematic Reviews Gut 2007;56 Suppl 1:1-113.
of Interventions Version 5.1.0 [updated March 2011]. The
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Quartero AO. Psychological treatments for the management
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Schulz KF, Altman DG, Moher D, CONSORT Group. CONSORT Agrawal A. Homeopathy for treatment of irritable bowel
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2010;63(8):834-40.


Informed decisions.

* Indicates the major publication for the study

CHARACTERISTICS OF STUDIES
Characteristics of included studies [ordered by study ID]

Owen 1990
Methods RCT, unblinded, parallel study, 12 weeks duration
Participants Setting; county hospital, UK
Number of participants; 23 patients were allocated into one of the treatment groups, 20 patients in-
cluded in analysis
Recruitment methods; female patients attending the out-patient department at a county hospital in
whom a diagnosis of IBS was made
Diagnosis of IBS; clinical diagnosis by a consultant gastroenterologist and consultant gynaecologist
Age range of patients; 20-69 years
Gender (of treated patients); 100% female
Duration of symptoms > 3 months
Interventions 1. Individualised homeopathic treatment
2. High doses of Dicyclomine hydrocholoride (exact dose not stated), faecal bulking agents and diet
sheets advising a high fibre diet
Outcomes Patients were asked to grade: their four worst symptoms on a visual analogue scale, dysmenorrhoea,
dyspareunia, and feeling unwell at baseline, 2, 6 and 12 weeks
Notes Detailed information is given on the homeopathic treatment the participants received in terms of; rem-
edy chosen, potency and dosage, whilst no information is given on the strength and dosage of the dicy-
clomine hydrocholoride and faecal bulking agents prescribed in the usual care arm
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence genera- Unclear risk Although it is stated that this is a randomised trial no details were given as to
tion (selection bias) how randomisation was achieved
Allocation concealment Unclear risk Not described

(selection bias)
Incomplete outcome data Unclear risk Insufficient reporting of attrition, whilst possible reasons for attrition were dis-
(attrition bias) cussed for one patient, the reasons for the other two patients leaving the study
All outcomes were not reported
Selective reporting (re- Unclear risk Insufficient information is provided to be able to judge whether the study is at
porting bias) risk from selective reporting
Other bias Unclear risk Due to the low quality of the reporting in this study it is unclear whether the
study is at risk from any other forms of bias
Blinding of participants High risk Participants and doctors were not blinded to allocation, however it is not stat-
and personnel (perfor- ed whether other key study personnel were blinded
mance bias)

Informed decisions.

Owen 1990 (Continued)
All outcomes
Blinding of outcome as- Unclear risk It is not reported whether or not the outcome assessment was carried out
sessment (detection bias) blind
All outcomes

Peckham 2014
Methods Three arm, parallel group non-blinded randomised controlled trial 26 weeks in duration
Participants Setting: Hospital outpatient, UK
Number of participants; 94 patients were allocated into one of the treatment groups in a 4:1:1 ratio, 60
patients were allocated to usual care, 16 were offered homeopathic treatment plus usual care and 18
were offered supportive listening plus usual care
Recruitment methods; GP database recruitment, consultant gastroenterologist in secondary care
Diagnosis of IBS; diagnosed according to the Rome III criteria, potentially eligible participants were
asked to complete a questionnaire which included the Rome III criteria for IBS. Participants had to
score a minimum of 100 on the IBS-SSS to be eligible to take part in the trial
Mean age range of participants; 49 years
Gender; 83% female
Duration of symptoms > 3 months
Interventions 1. Individualised homeopathic treatment plus usual care
2. Supportive listening plus usual care
3. Usual care
Outcomes IBS-SSS, EQ-5D, HADS
Notes This study employed a Trials Within Cohorts design which recruited a cohort of people with IBS. From
this cohort people were randomly selected to receive the offer of a treatment.
Risk of bias
Random sequence genera- Low risk Random sequence generated by shuffling of sealed opaque envelopes con-
tion (selection bias) taining the allocation (protocol paper)
Allocation concealment Low risk Questionnaires from participants consenting and meeting the eligibility crite-
(selection bias) ria are taken one at a time, at the same time a sealed opaque envelope con-
taining the allocation is taken from the top of the shuffled pack and opened
and the allocation noted. This is carried out by an independent administrator
at the University of Sheffield, in the presence of another independent adminis-
trator. (protocol paper).
Incomplete outcome data Low risk The proportion of patients who dropped out of the usual care and supportive
(attrition bias) listening arms was similar and the reasons for dropping out were the same in
All outcomes both groups.
9/60 (15%) participants in the usual care arm did not return the follow-up
questionnaire
Informed decisions.

Peckham 2014 (Continued)
All 16 participants in the homeopathy arm were included in the analysis
3/18 (17%) participants in the supportive listening arm did not return the
questionnaire
Selective reporting (re- Low risk Outcome data presented for those outcome measures stated in the protocol.
porting bias)
Other bias Low risk The quality of reporting in this study was good and did not indicate that there
were likely to be other forms of bias.
Blinding of participants High risk Neither the nature of the interventions in this study nor the study design al-
and personnel (perfor- lows for the masking of the therapists or the participants.
mance bias)
All outcomes
Blinding of outcome as- High risk Outcomes were patient-reported outcomes (i.e. the patient was the outcome
sessment (detection bias) assessor). As the patients were aware of the group allocation, this domain was
All outcomes judged as high risk of bias.

Rahlfs 1976
Methods RCT, double blind, parallel study, 2 weeks duration
Participants Setting; general practice, Germany
Number of participants; 71 patients treated (number of patients randomised not clearly stated), 63 pa-
tients included in analysis
Recruitment methods; patients presenting in general practice with suspected IBS
Diagnosis of IBS; Clinical diagnosis plus completion of detailed questionnaire
Mean age (of treated patients); 43.8 years
Gender (of treated patients); 50.8% female
Duration of symptoms > 14 days
Interventions 1. 0.1% asafoetida alcohol solution, 6 x 5 drops daily
2. 0.1% asafoetida alcohol solution + 0.01% nux vomica alcohol solution, 6 x 5 drops daily
3. placebo, 45% alcohol solution, 6 x 5 drops daily
Outcomes Self assessment on a 3 point scale; no or negligible improvement, more than half improved, free of
symptoms measured on day 8 and day 15 of the study
Time to recovery assessed by the patient reporting the day they felt considerable improvement
Freiburg Personality Inventory
Notes Analysed participant data were fairly well described, but a lot of pre-randomisation and pre-analysis
data were missing
Risk of bias

Informed decisions.

Rahlfs 1976 (Continued)
Random sequence genera- Unclear risk A chance code was used for the randomisation, the exact nature of which was
tion (selection bias) not reported
Therefore the risk of bias cannot be determined
Allocation concealment Low risk Medication was provided in sequentially numbered drug containers
(selection bias)
Incomplete outcome data Unclear risk Insufficient reporting of attrition, some reasons for attrition are given, details
(attrition bias) of allocation are not always given
All outcomes
Selective reporting (re- Unclear risk Insufficient information was provided to be able to judge whether the study
porting bias) was at risk from selective reporting
Other bias Unclear risk Insufficient information was provided to assess whether the study was at risk
from any other bias
Blinding of participants Low risk Study participants and recruiting doctors were blinded
and personnel (perfor-
mance bias)
All outcomes
Blinding of outcome as- Unclear risk It was not reported whether outcome assessment was carried out blind
sessment (detection bias)
All outcomes

Rahlfs 1979
Methods RCT, double blind, parallel study, 2 weeks duration
Participants Setting; general practice, Germany
Number of participants; 119 patients treated (number of participants randomised not clearly stated),
89 patients included in analysis
Recruitment methods; patients presenting in general practice with suspected IBS
Diagnosis of IBS; Clinical diagnosis plus completion of detailed questionnaire
Mean age (of patients included in analysis, ages of those not included not stated); 42.5 years
Gender (of those included in analysis, gender of those not included not stated); 68.5% female
Duration of symptoms > 14 days
Interventions 1. 0.1% asafoetida alcohol solution, 6 x 5 drops daily
2. placebo, 45% alcohol solution, 6 x 5 drops daily
Outcomes Self assessment on a 4 point scale; worsening of symptoms, no or negligible improvement, more than
half improved, free of symptoms, measured on day 8 and day 15 of the study
Time to recovery assessed by the patient reporting the day they felt considerable improvement
Notes Analysed participant data were fairly well described, but a lot of pre-randomisation and pre-analysis
data were missing

Informed decisions.

Rahlfs 1979 (Continued)
Risk of bias
Random sequence genera- Unclear risk Although it was reported that this was a randomised trial no details were given
tion (selection bias) as to how randomisation was achieved
Allocation concealment Low risk Medication was provided in sequentially numbered drug containers
(selection bias)
Incomplete outcome data Unclear risk Incomplete outcome data, reasons for missing data, and how incomplete out-
(attrition bias) come data were addressed was not clearly described
All outcomes
Selective reporting (re- High risk The inclusion and exclusion criteria were applied in a variable manner, some
porting bias) people that were subsequently found not to meet the exclusion and inclusion
criteria were removed from the analysis
However people who did not meet the inclusion criteria for age, being too old
were still included in the analysis
This leaves the study at risk of bias due to selective reporting
Other bias Unclear risk Due to the low quality of the reporting it was unclear whether the study was at
risk from any other forms of bias
Blinding of participants Low risk Participants and doctors were blinded to allocation
and personnel (perfor-
mance bias)
All outcomes
Blinding of outcome as- Unclear risk It was not reported whether outcome assessment was carried out blind to
sessment (detection bias) treatment allocation
All outcomes

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion
Aleem 2000 Discussion piece and not a randomised controlled trial, cohort or case-control study
Anonymous 2005 An initial reading of this Italian article revealed it to be discussing a meta analysis by Shang 2005
Therefore a full translation was not conducted
Anonymous 2009 Discussion piece and not a randomised controlled trial, cohort or case-control study
Bauer 2014 Case studies on the treatment of IBS and not a randomised controlled trial, cohort or case-control
study
Bhagat 2010 Case report (n = 1) of homeopathic treatment for IBS
Bhattacharjee 2010 The article was a discussion on the different homeopathic remedies used for the treatment of IBS

Informed decisions.

Chen 2015 A discussion on the use of complementary therapies for the treatment of functional gastrointesti-
nal disorders
Cherniack 2013 Not on IBS
Chimthanawala 2004 Case report (n = 2) of homeopathic treatment for IBS
Diamond 2005 A discussion on the use of complementary therapies for the treatment of gastroenterological prob-
lems
Elio 2014 Report on a series of patients attending a clinic. Not specific to IBS and not an RCT or case series
Feldhaus 2000 This was a discussion piece on the treatment of IBS
Gamble 2007 Discussion of a potentially new way of assessing and treating IBS, from a homeopathic perspective,
using two cases as an example
Gebhardt 1988 Discussion on homeopathic treatment for IBS, not a randomised controlled trial, cohort or case-
control study
Gray 1998 This study was a case series of 25 patients with no comparator group
Greeson 2008 Non-randomised observational study of outcomes for patients attending a integrative medical cen-
tre where homeopathy was only one of the treatments offered
Grundmann 2014 Review of treatments for IBS does not include homeopathy
Innes 2000 This study was a case series (n = 20) with no comparator group
Jagose 2004 Case report (n = 1) of homeopathic treatment for IBS
Jones 1996 A discussion of the homeopathic treatment of IBS, illustrated by three cases
Jones 1997 Discussion piece on homeopathic treatment of IBS
Jones 1999 Case report study of a woman with IBS treated with homeopathy
Krishendu 2010 A discussion of the different homeopathic remedies used for the treatment of IBS
Lobo 2000 Case report (n = 1) on homeopathic treatment of IBS
Master 2008 Discussion piece on homeopathy for IBS
Mohan 2006 Case report (n = 2) of IBS treated with homeopathy
Pawar 2015 A discussion on homeopathic remedies
Pinto 1999 A selection of case reports on homeopathic treatment for a variety of conditions
Pohl 2013 An overview of treatments for irritable bowel syndrome which does not include homeopathy
Slade 2003 Case report (n = 1) of homeopathic treatment of ulcerative colitis
Turner 2008 Discussion of homeopathic treatment of IBS, illustrated by eight case histories

Informed decisions.

White 1999 Discussion of homeopathic treatment for IBS, not a randomised controlled trial, cohort or case-
control study

DATA AND ANALYSES

Comparison 1. Homeopathy versus placebo
Outcome or subgroup title No. of No. of Statistical method Effect size

studies partici-
pants
1 Homeopathy versus placebo 2 Risk Ratio (M-H, Fixed, 95% CI) Subtotals only
1.1 Global improvement (Asafoetida only) 2 129 Risk Ratio (M-H, Fixed, 95% CI) 1.61 [1.18, 2.18]
1.2 Global improvement (Asafoetida + nux 1 42 Risk Ratio (M-H, Fixed, 95% CI) 1.31 [0.80, 2.15]
vom)

Analysis 1.1. Comparison 1 Homeopathy versus placebo, Outcome 1 Homeopathy versus placebo.
Study or subgroup Homeopathy Placebo Risk Ratio Weight Risk Ratio
n/N n/N M-H, Fixed, 95% CI M-H, Fixed, 95% CI
1.1.1 Global improvement (Asafoetida only)
Rahlfs 1976 14/21 12/23 39.17% 1.28[0.78,2.1]
Rahlfs 1979 32/42 18/43 60.83% 1.82[1.23,2.69]
Subtotal (95% CI) 63 66 100% 1.61[1.18,2.18]
Total events: 46 (Homeopathy), 30 (Placebo)
Heterogeneity: Tau2=0; Chi2=1.22, df=1(P=0.27); I2=17.77%
Test for overall effect: Z=3.04(P=0)

1.1.2 Global improvement (Asafoetida + nux vom)
Rahlfs 1976 13/19 12/23 100% 1.31[0.8,2.15]
Subtotal (95% CI) 19 23 100% 1.31[0.8,2.15]
Total events: 13 (Homeopathy), 12 (Placebo)
Heterogeneity: Not applicable
Test for overall effect: Z=1.07(P=0.28)
Test for subgroup differences: Chi2=0.47, df=1 (P=0.49), I2=0%
Favours placebo 0.01 0.1 1 10 100 Favours homeopathy

Comparison 2. Homeopathy versus usual care
Outcome or subgroup title No. of No. of par- Statistical method Effect size
studies ticipants
1 Global improvement (feeling unwell) 1 Mean Difference (IV, Fixed, 95% CI) Totals not selected

Informed decisions.


Analysis 2.1. Comparison 2 Homeopathy versus usual care, Outcome 1 Global improvement (feeling unwell).
Study or subgroup Homeopathy Usual care Mean Difference Mean Difference
N Mean(SD) N Mean(SD) Fixed, 95% CI Fixed, 95% CI
Owen 1990 9 1.4 (4.6) 11 1.4 (2) 0.03[-3.16,3.22]
Favours usual care -4 -2 0 2 4 Favours homeopathy

Comparison 3. Homeopathy plus usual care versus usual care

studies partici-
pants
1 Global improvement (IBS-SSS) 1 Mean Difference (IV, Fixed, 95% CI) Totals not selected
2 Quality of life 1 Mean Difference (IV, Fixed, 95% CI) Totals not selected

Analysis 3.1. Comparison 3 Homeopathy plus usual care
versus usual care, Outcome 1 Global improvement (IBS-SSS).
Peckham 2014 16 210.4 (112.4) 60 237.3 (110.2) -26.86[-88.59,34.87]
Favours homeopathy -100 -50 0 50 100 Favours usual care

Analysis 3.2. Comparison 3 Homeopathy plus usual care versus usual care, Outcome 2 Quality of life.
Peckham 2014 16 69.1 (17.4) 60 63.4 (23.3) 5.66[-4.69,16.01]
Favours usual care -100 -50 0 50 100 Favours homeopathy

Comparison 4. Homeopathy plus usual care versus supportive listening plus usual care

studies partici-
pants
1 Global improvement (IBS-SSS) 1 Mean Difference (IV, Fixed, 95% CI) Totals not selected
2 Quality of life 1 Mean Difference (IV, Fixed, 95% CI) Totals not selected


Informed decisions.

Analysis 4.1. Comparison 4 Homeopathy plus usual care versus supportive

listening plus usual care, Outcome 1 Global improvement (IBS-SSS).
Study or subgroup Homeopathy Supportive listening Mean Difference Mean Difference
Peckham 2014 16 210.4 (112.4) 18 262 (120.7) -51.56[-129.94,26.82]
Favours homeopathy -100 -50 0 50 100 Favours control

Analysis 4.2. Comparison 4 Homeopathy plus usual care versus
supportive listening plus usual care, Outcome 2 Quality of life.
Study or subgroup Homeopathy Supportive listening Mean Difference Mean Difference
Peckham 2014 16 69.1 (17.4) 18 63.1 (24.4) 5.98[-8.13,20.09]
Favours control -100 -50 0 50 100 Favours homeopathy

APPENDICES
Appendix 1. Search Strategies

Medline
1. Colonic disease*.mp
2. irritable bowel syndrome/
3. colonic diseases, functional/
4. irritable bowel/
5. irritable colon/
6. spastic colon/
7. functional bowel disease*.mp.
8. functional colonic disease*.mp.
9. or/1-8
10. homeopathy/
11. homeopath*.mp.
12. homoeopath*.mp.
13. alternative medicine*.mp.
14. or/10-13
15. 9 and 14
EMBASE

Informed decisions.

4. irritable bowel/
5. irritable colon/
6. spastic colon/
9. or/1-8
10. homeopathy/
11. homeopath*.mp.
12. homoeopath*.mp.
14. or/10-13
15. 9 and 14
CENTRAL
#1 MeSH: [Irritable bowel syndrome] explode all trees
#2 Colonic disease*
#3 irritable bowel syndrome
#4 colonic diseases, functional
#5 irritable bowel
#6 irritable colon
#7 spastic colon
#8 functional bowel disease*
#9 functional colonic disease*
#10 #1 or #2 or #3 or #4 or #5 or #6 or #7 or #8 or #9
#11 homeopathy
#12 homeopath*
#13 homoeopath*
#14 alternative medicine*
#15 #11 or #12 or #13 or #14
#16 #10 and #15
Cumulative Index to Nursing and Allied Health Literature (CINAHL)
1. (TI homeopathy or AB homeopathy) OR (TI homeopath* or AB homeopath*) OR (TI homoeopath* or AB homoeopath*) OR (TI alternative
medicine* of AB alternative medicine*)
2. (TI Irritable bowel syndrome or AB Irritable bowel syndrome) OR (TI Colonic disease* or AB Colonic disease*) OR (TI irritable colon or AB
irritable colon) OR (TI spastic colon or AB spastic colon) OR (TI functional bowel disease* or AB functional bowel disease*) OR (TI functional
colonic disease* or AB functional colonic disease*)

Informed decisions.

Allied and Complementary Medicine Database (AMED)
4. irritable bowel/
5. irritable colon/
6. spastic colon/
9. or/1-8
10. homeopathy/
11. homeopath*.mp.
12. homoeopath*.mp.
14. or/10-13
15. 9 and 14
Clinical trials. Gov
1. Homeopathy and Irritable bowel syndrome
IBD specialized register
1. Irritable bowel syndrome and homeopath
2. Colonic diseases and homeopath
3. Functional bowel and homeopath
WHAT'S NEW

Date Event Description
15 October 2019 Amended Minor typographical error in plain language summary correct-
ed. There is no impact on the data, review findings, or interpreta-
tion.

HISTORY
Protocol first published: Issue 3, 2012
Review first published: Issue 11, 2013

31 August 2018 New citation required but conclusions Updated review, no new conclusions
have not changed

Informed decisions.

31 August 2018 New search has been performed New search and one new study added

CONTRIBUTIONS OF AUTHORS
EJP initiated, designed the study and drafted the protocol. EP, SB and GT, extracted the data and conducted the quality assessment. AA
and KC arbitrated. KC provided advice on meta analysis. KC, SB, GT and AA all commented on the review.
DECLARATIONS OF INTEREST
EJP has contributed to the design and management of one of the included RCTs. EJP is a homeopath.
GT: None known.
SB: None known.
KC: None known.
AA: None known.
SOURCES OF SUPPORT
Internal sources
• University of Leeds, UK.
• Homeopathy Research Institute, UK.
• ScHARR, UK.
External sources
• No sources of support supplied
INDEX TERMS
Medical Subject Headings (MeSH)

Constipation [etiology] [therapy]; Dietary Fiber [therapeutic use]; Homeopathy [*methods]; Irritable Bowel Syndrome [*therapy];
Phytotherapy [*methods]; Quality of Life; Randomized Controlled Trials as Topic
MeSH check words

Female; Humans; Male


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Peckham EJ, Cooper K, Roberts ER, Agrawal A, Brabyn S, Tew G

Peckham EJ, Cooper K, Roberts ER, Agrawal A, Brabyn S, Tew G.

Homeopathy for treatment of irritable bowel syndrome (Review) i

Homeopathy for treatment of irritable bowel syndrome

Editorial group: Cochrane IBD Group.

Data collection and analysis

Homeopathy for treatment of irritable bowel syndrome

What is irritable bowel syndrome?

What did the researchers investigate?

What did the researchers find?

Homeopathy for treatment of irritable bowel syndrome (Review) 2

Homeopathy for treatment of irritable bowel syndrome (Review) 3

Patient or population: patients with irritable bowel syndrome

Quality of life Not reported This outcome was not reported

Abdominal pain Not reported This outcome was not reported

Stool frequency Not reported This outcome was not reported

Cochrane Database of Systematic Reviews

Adverse events Not reported This outcome was not reported

GRADE Working Group grades of evidence

1 Downgraded one level due to high risk of bias

Patient or population: patients with irritable bowel syndrome

Outcomes Illustrative comparative risks* (95% CI) Relative No of Qual- Comments

Quality of life Not reported This outcome was not reported

Cochrane Database of Systematic Reviews

Stool frequency Not reported This outcome was not reported

Stool consistency Not reported This outcome was not reported

Adverse events Not reported This outcome was not reported

1 Downgraded one level due to high risk of bias

Patient or population: patients with irritable bowel syndrome

Outcomes Illustrative comparative risks* (95% CI) Relative No of Qual- Comments

Cochrane Database of Systematic Reviews

Abdominal pain Not reported This outcome was not reported

Stool frequency Not reported This outcome was not reported

Stool consistency Not reported This outcome was not reported

Adverse events Not reported This outcome was not reported

Patient or population: patients with irritable bowel syndrome

Outcomes Illustrative comparative risks* (95% CI) Relative No of Quality Comments

Cochrane Database of Systematic Reviews

Quality of life Not reported This outcome was not reported

Abdominal pain Not reported This outcome was not reported

Stool consistency Not reported This outcome was not reported

1 Downgraded two levels due to very sparse data (34 participants)

Cochrane Database of Systematic Reviews

BACKGROUND developed by Samuel Hahnemann in the eighteenth century in

Homeopathy for treatment of irritable bowel syndrome (Review) 9

Homeopathy for treatment of irritable bowel syndrome (Review) 10

Homeopathy for treatment of irritable bowel syndrome (Review) 12

Figure 1. Study flow diagram.

Homeopathy for treatment of irritable bowel syndrome (Review) 13

Homeopathy for treatment of irritable bowel syndrome (Review) 14

Homeopathy for treatment of irritable bowel syndrome (Review) 19

Homeopathy for treatment of irritable bowel syndrome (Review) 20

Homeopathy for treatment of irritable bowel syndrome (Review) 21

Green S editor(s). Cochrane Handbook for Systematic Reviews Schünemann 2011

Homeopathy for treatment of irritable bowel syndrome (Review) 22

* Indicates the major publication for the study

Characteristics of included studies [ordered by study ID]

Participants Setting; county hospital, UK

Diagnosis of IBS; clinical diagnosis by a consultant gastroenterologist and consultant gynaecologist