Homeopathy for Irritable Bowel Syndrome (HIBS)

ISRCTN	ISRCTN90651143
DOI	https://doi.org/10.1186/ISRCTN90651143
Secondary identifying numbers	HIBS_ protocol_final_v3_ 19_07_11

Submission date: 03/10/2011
Registration date: 14/11/2011
Last edited: 17/07/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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.

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

Contact information

Dr Kapil Kapur
Scientific

Barnsley Hospital NHS Foundation Trust
Gawber Road
Barnsley
S75 2EP
United Kingdom

Study information

Study design	Cohort multiple randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	HIBS
Study objectives	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
Ethics approval(s)	Leeds (East) Research Ethics Committee, 09/12/2010, ref: 10/H1306/73
Health condition(s) or problem(s) studied	Irritable bowel syndrome
Intervention	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
Intervention type	Other
Primary outcome measure	Irritable bowel syndrome symptom severity scale
Secondary outcome measures	1. Hospital Anxiety and Depression Scale (HADS) 2. EQ-5D
Overall study start date	14/01/2011
Completion date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	198
Key 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
Key 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
Date of first enrolment	14/01/2011
Date of final enrolment	14/01/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Barnsley Hospital NHS Foundation Trust

Barnsley
S75 2EP
United Kingdom

Sponsor information

Barnsley Hospital NHS Foundation Trust (UK)
Hospital/treatment centre

c/o Mr Michael Bramall
Gawber Road
Barnsley
S75 2EP
England
United Kingdom

Website	http://www.barnsleyhospital.nhs.uk/
"ROR"	https://ror.org/00yx91b22

Funders

Funder type

Hospital/treatment centre

Barnsley Hospital - Small Grants Fund (UK)

No information available

Friends of Barnsley Hospital (UK)

No information available

Homeopathy Research Institute (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	06/11/2012		Yes	No
Results article	results	01/07/2014		Yes	No