Irritable Bowel Syndrome (IBS) is a common, chronic disorder that affects approximately 10% - 22% of the population
]. It is characterised by abdominal pain or discomfort and altered bowel habits, and may also be accompanied by bloating, nausea and vomiting and early satiety. IBS is a functional gastrointestinal disorder. Functional gastrointestinal disorders are difficult to treat because no single aetiology is known and thus treatment is directed at controlling symptoms, using pharmacological and non-pharmacological approaches. There are an estimated 240,000 primary care consultations per year in the UK of new cases of IBS
] and the economic costs of IBS in primary care are estimated to be over £200 million
]. IBS is diagnosed using the Rome criteria, the most recent being Rome III
], or on the basis of clinical symptoms with the absence of alarm signs (signs that indicate the potential presence of a serious disease). There are four subtypes: IBS-C constipation predominant, IBS-D diarrhoea predominant, IBS-M mixed and IBS-unspecified.
The prognosis for recovery with IBS is poor. A one year prospective evaluation found that although 50% of patients improved over the year, improvement was minor in terms of IBS symptoms such as pain, constipation and diarrhoea
]. This could lead to the patients’ quality of life being adversely affected resulting in depressed mood, sleep disturbance and fatigue
]. IBS is associated with high healthcare utilisation costs and loss of productivity
]. Despite much research into both psychological and pharmacological treatments there is no consensus as to its optimal treatment
A significant proportion of patients with gastrointestinal disorders use complementary or alternative medicine, between 11% and 43% according to one systematic review
]. Gastroenterology problems are the fourth most common referral to NHS homeopathic hospitals
] and one of the eight most common conditions treated by NHS homeopaths in general practice
], with irritable bowel syndrome being the tenth most common condition seen by NHS homeopathic hospitals
]. There is currently a degree of scepticism regarding homeopathic treatment with claims that it is a placebo treatment and therefore unethical
]. Much of the criticism focuses on the opinion that the homeopathic medicine is no more than a placebo
] and it is the long consultation time with an empathetic practitioner that leads to any perceived effectiveness of homeopathic treatment
A literature search for trials of homeopathic treatment for IBS using the search terms ‘irritable bowel syndrome’, or ‘irritable colon’ and ‘homeopathy’ identified many case reports e.g. a clinical audit
], one consecutive case series
] and three randomised controlled trials
]. Two randomised controlled trials (RCTs) assessing the effectiveness of one specific homeopathic medicine (asafoetida) reported positive results associated with homeopathic medicine compared to placebo
] and one found no difference between homeopathic treatment and usual care
]. In the consecutive case series
], twenty out of twenty five patients reported an improvement in the intensity and frequency of their symptoms. In spite of its popularity in the treatment of gastroenterology disorders there is a lack of robust evidence as to the effectiveness of homeopathic treatment for IBS and thus there is a need for further research into the clinical effectiveness of homeopathic treatment for patients with IBS.
The majority of previous trials of homeopathic treatment focus on the homeopathic medicine as the key ingredient and as such compare changes in health of subjects having a homeopathic consultation plus a homeopathic medicine with changes in health in subjects having a homeopathic consultation plus a placebo medicine, Figure
shows a schematic of the standard RCT for homeopathic treatment. Studies using the design depicted in Figure
are only able to assess the effect of the homeopathic medicine and are not able to assess the effect of homeopathic treatment as a package, (the homeopathic consultation plus the homeopathic medicine). There has been much debate as to whether or not this is an appropriate design to determine the efficacy of homeopathic treatment
], in part because the traditional homeopathic medicine versus placebo medicine design fails to take into account any aspects specific to the homeopathic consultation. Furthermore the homeopathic approach is best understood as a complex intervention with component parts (consultation and medicine) consequently the design of an appropriate control is less straightforward than would be the case if a drug therapy alone were being evaluated. Pragmatic trials comparing homeopathic treatment (as a package of consultation plus homeopathic medicine) to usual care provide a means of assessing the effect of homeopathic treatment as a package. However the lack of a comparison intervention in the homeopathic treatment plus usual care versus usual care design leads to the question as to whether any observed effectiveness of homeopathic treatment is due to non-specific effects of spending time with an empathetic practitioner. A possible solution to this problem is to compare homeopathic treatment to an “attention control” designed to control for the time and attention that the patient spends with/receives from the homeopath. Whilst other studies have been conducted to assess the effect of the homeopathic consultation,
] as yet no studies have attempted to compare the whole package of homeopathic treatment to a control intervention as a means of assessing the effects of homeopathic treatment.
Standard RCT for homeopathic treatment.
For this study supportive listening was chosen as the “attention control”. Supportive listening is a non-specific treatment that has been used in previous trials of psychological therapies for IBS
]. It has in the past been used to control for the non-specific aspects of therapy including the time that the patient spends with the practitioner, empathy and positive regard
]. Supportive listening is not formal counselling per se
], and although based on the theories of Carl Rogers and utilising the skills of active listening, it does not include the more advanced Rogerian skills such as challenging, problem clarification and accurate understanding
]. Including supportive listening as one of the arms in a RCT of homeopathic treatment allows homeopathic treatment to be compared to spending time with a caring and empathetic practitioner. Supportive listening was chosen as an “attention control” because it contains the non-specific factors of homeopathic treatment such as the opportunity for disclosure and empathy without containing the specific effects such as the homeopathic medicine and the in-depth enquiry into bodily complaints. A supportive listening arm will be included in this trial to test the feasibility of supportive listening as an attention control for homeopathic treatment, in the treatment of IBS. In addition, a usual care arm is included in the trial, this is to put the results into context and allow an assessment to be made as to whether homeopathic treatment in addition to usual care offers any benefits over usual care alone.
Therefore, in this study we are attempting to assess whether homeopathic treatment (consultation plus homeopathic medicine) is more effective than usual care alone and whether homeopathic treatment is any more effective than spending time with an empathetic and caring practitioner as assessed by change in IBS symptom severity score (IBS-SSS) between baseline and 26 weeks. This study aims to test the whole intervention of “homeopathic treatment”. It is not aiming to, and nor is it designed to, give new insights into the question as to the effects of homeopathic medicines per se. Results of this study will report the clinical effectiveness of homeopathic treatment plus usual care compared to usual care alone, and provide information on the feasibility of including a supportive listening arm as an attention control for homeopathic treatment, for patients with IBS. Additionally the supportive listening arm will provide information on effect size and variation, information which will enable future investigators to more accurately estimate the sample size required for a full scale trial comparing homeopathic treatment to supportive listening.
The aims of this study are:
to evaluate the clinical effectiveness of homeopathic treatment plus usual care as compared to usual care alone for patients with IBS.
to test whether supportive listening is a feasible attention control for homeopathic treatment.