Welcome
Support Centre
20 August 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
Homeopathy for Irritable Bowel Syndrome (HIBS)
ISRCTN ISRCTN90651143
DOI 10.1186/ISRCTN90651143
ClinicalTrials.gov identifier
EudraCT number
Public title Homeopathy for Irritable Bowel Syndrome (HIBS)
Scientific title A randomised controlled trial to evaluate the clinical and cost effectiveness of two adjunctive treatments for patients with irritable bowel syndrome (IBS) compared to usual care alone: A - Homeopathic treatment (consultation + homeopathic medicine) and B - Supportive listening
Acronym HIBS
Serial number at source HIBS_ protocol_final_v3_ 19_07_11
Study hypothesis This study is designed to test three different hypotheses.
1. Homeopathic consultation + a “medication that may help” (homeopathic medicine) + usual care will improve the outcomes of patients with IBS in comparison to usual care alone
2. Homeopathic consultation + a ‘medication that may help’ (homeopathic medicine) + usual care will result in significantly more benefit than supportive listening + usual care
3. Supportive listening + usual care will improve the outcomes of patients with IBS in comparison to usual care alone
Lay summary Background and study aims
Irritable Bowel Syndrome (IBS) is a common chronic disorder estimated to be present in about 10% of the population. IBS is characterised by abdominal pain or discomfort, bloating, nausea, vomiting, constipation, or diarrhoea. Patients’ quality of life can be affected leading to tiredness, poor sleep and depression. The reasons for the symptoms in IBS are not well understood and treatment is aimed at controlling symptoms rather than curing them. Usual care for IBS generally includes advice on diet, exercise and reducing stress sometimes combined with medication. There are a number of different medicines used to help treat IBS: antispasmodic medicines, which help to reduce abdominal pain and cramping; laxatives, which help to treat the symptoms of constipation; antimotility medicines, which help to treat the symptoms of diarrhoea, and tricyclic antidepressants (TCAs), which were originally designed to treat depression, but also help to reduce the feeling of abdominal pain and cramping.
It is not clear which treatments are acceptable, safe and work well. One promising treatment for IBS is homeopathic treatment. This is available on the NHS in some parts of the UK and is used worldwide but the treatment remains controversial in the UK.
The aim of this study is to measure whether homeopathy is useful to treat patients with IBS.

Who can take part?
People who have been diagnosed with irritable bowl syndrome (IBS) or are taking medication associated with IBS e.g. mebeverine, loperamide or peppermint oil can take part in this trial.
To take part you need to be:
1. Aged 18 years or older
2. Have a good understanding of English language
Patients with mental dysfunction or severe psychiatric disorder or who are pregnant or breastfeeding and patients with who have had gastrointestinal surgery or seen a homeopath in he last six months can not participate in the study.
Patients will be recruited through GPs and hospital databases. GPs will send questionnaires to patients on their databases who have either been diagnosed with IBS or are taking medication associated with IBS. Patients who wish to take part in this study then need to return the questionnaire. The questionnaire includes questions from the ROME III criteria (a questionnaire developed to diagnose IBS by asking questions about the persons bowel habit) and the IBS symptom severity scale. On completion of the questionnaire, participants will be eligible if they meet the following criteria:
1. ROME III criteria for IBS
2. Score over 100 on the IBS symptom severity score

What does the study involve?
Participants in the trial will be randomly allocated to usual care, supportive listening or homeopathic treatment on a 4:1:1 ratio (meaning that for every four participants allocated to usual care one participant will be allocated to supportive listening and one will be allocated to homeopathic treatment). All three groups will receive medical treatment as usual.
Homeopathic treatment involves a consultation with a homeopath who will ask for a detailed description of symptoms the patient is experiencing. After the consultation a homeopathic remedy will be prescribed.
Supportive listening is based on the theories and counselling techniques of Carl Rogers with the use of active listening skills (minimal encouraging, empathising reflecting and summarising and paraphrasing) being used. Supportive listening will provide the patient with the opportunity to feel heard and with the opportunity to express themselves in a non judgemental environment.

What are the possible benefits and risks of participating?
Participants allocated to the homeopathic treatment will be offered up to five sessions with a homeopath and those allocated to the supportive listening treatment will be offered up to five sessions with a counsellor. A possible advantage to participants allocated to one of these treatments is an improvement in IBS, but this cannot be guaranteed.
There are no known risks to participants.

Where is the study run from?
The study is taking place at Barnsley Hospital, UK and will start in January 2011. Approximately 6 GP practices and secondary care gastroenterology departments will be involved in the database search and mail out.

When is the study starting and how long is it expected to run for?
It is expected to run for two years, with participant recruitment taking place between January 2011 and January 2012.

Who is funding the study?
The study is funded by Barnsley Hospital Small Grants Fund, Friends of Barnsley Hospital and the Homeopathy Research Institute (UK).

Who is the main contact?
Dr Kapil Kapur
kapil.kapur@nhs.net
Ethics approval Leeds (East) Research Ethics Committee approved on 9 December 2010, ref: 10/H1306/73
Study design Cohort multiple randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Irritable bowel syndrome
Participants - inclusion criteria 1. Diagnosis of Irritable bowel syndrome (according to ROME III diagnostic criteria for IBS)
2. Aged 18 and over
3. Consent to fill in and return further postal questionnaires to the researchers
4. Score of more than 100 on the IBS Symptom Severity Score (Francis et al., 1997), this score if often taken as the cut off for symptomatic IBS
5. Fluent in English
Participants - exclusion criteria 1. Pregnant or breast feeding
2. Unstable medical or psychiatric illness
3. Currently receiving treatment from a homeopath or taking homeopathic medicines
4. Current diagnosis of haemophilia or cancer, or major gastrointestinal surgery in previous 6 months
Anticipated start date 14/01/2011
Anticipated end date 31/12/2012
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 198
Interventions Three armed trial using the ‘cohort multiple RCT’ design (Relton 2010). The three arms will be:
1. Homeopathic treatment + usual care
2. Supportive listening + usual care
3. Usual care alone
Primary outcome measure(s) Irritable bowel syndrome symptom severity scale
Secondary outcome measure(s) 1. Hospital Anxiety and Depression Scale (HADS)
2. EQ-5D
Sources of funding 1. Barnsley Hospital - Small Grants Fund (UK)
2. Friends of Barnsley Hospital (UK)
3. Homeopathy Research Institute (UK)
Trial website
Publications 1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23131064
Contact name Dr  Kapil  Kapur
  Address Barnsley Hospital NHS Foundation Trust
Gawber Road
  City/town Barnsley
  Zip/Postcode S75 2EP
  Country United Kingdom
Sponsor Barnsley Hospital NHS Foundation Trust (UK)
  Address c/o Mr Michael Bramall
Gawber Road
  City/town Barnsley
  Zip/Postcode S75 2EP
  Country United Kingdom
  Sponsor website: http://www.barnsleyhospital.nhs.uk/
Date applied 03/10/2011
Last edited 08/11/2012
Date ISRCTN assigned 14/11/2011
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.