Effects of Gut-directed Hypnotherapy on IBS in Different Clinical Settings

Results From Two Randomized, Controlled Trials

Perjohan Lindfors MD; Peter Unge MD; PhD; Patrik Arvidsson PhD; Henry Nyhlin MD; PhD; Einar Björnsson MD; PhD; Hasse Abrahamsson MD; PhD; Magnus Simrén MD; PhD

Disclosures

Am J Gastroenterol. 2012;107(2):276-285. 

In This Article

Methods

Study Design

Two separate randomized, controlled trials were conducted. Study 1 was performed at Sahlgrenska University Hospital, Gothenburg, Sweden, where the patients were recruited in a highly specialized unit for functional GI disorders, but the hypnotherapy sessions took place in psychology private practices outside the hospital. The second study (study 2) was conducted at Gävle Hospital, a medium-sized county hospital with a small gastroenterology department with two gastroenterologists, serving ~100,000 inhabitants.

Patients with IBS refractory to standard management were invited to participate in the studies. The participants should meet the Rome II criteria for IBS.[1] All patients underwent appropriate GI diagnostic tests in order to rule out organic GI disorders before inclusion, as judged by the treating physician. Patients with other GI conditions explaining their symptoms, or with another severe co-existing disease, were not included. The patients were consecutively included among patients referred to the gastroenterology departments at the two units for IBS symptoms refractory to standard dietary and pharmacological therapies. Before randomization, all patients had a run-in period for at least 2 weeks where the severity of symptoms was recorded (see below). In both studies, patients were randomized to receive gut-directed hypnotherapy, or to serve as a control subject. All subjects provided written informed consent before inclusion and the studies were approved by the ethics committee of the University of Gothenburg and the local ethics committee at the County Council of Gävle/Dalarna. If the patients were on a stable dose of symptom modifying drugs for IBS, such as antidiarrheals, bulking agents, or spasmolytics, they were allowed to continue with their medication during the study, provided they could continue on a stable dose of the medication during the study. The use of psychotropic drugs or antidepressants was not allowed.

Gut-directed Hypnotherapy

The intervention method used in these studies was based on the gut-directed hypnotherapy described by the Manchester group.[18] It was based on muscular and mental relaxation, and general hypnotic suggestions were used either to focus on the symptoms or to distract from them. After feedback from the subject, individual adapted suggestions were used to develop the ability of the subject to bring forward a deeper feeling of being able to control the symptoms. Specifically, suggestions toward normalizing the GI function were used, such as a river floating smoothly or a blocked river cleared by the patient. The main strategy was to let the subject experience that they had an ability to control external stimuli such as sounds, lights, and pressure from the surface of the chair, and to gain control of inner physiological phenomenon such as breathing and finally the IBS symptoms. All patients who participated in the studies were treated individually during 12 sessions, each session lasting 60 min, once a week. The patients were told to practice their hypnotic skills at home between the sessions on a regular basis. Audiotapes were used in study 2 but not in study 1. The psychologists had limited previous experience in gut-directed hypnotherapy, but had received formal training from gut-directed hypnotherapists, and had all conducted hypnotherapy for other medical conditions for several years.

Study 1

We invited IBS patients according to the Rome II criteria[1] to participate in the study performed at Sahlgrenska University Hospital. These were randomized by a study nurse in blocks of four using numbered containers to receive gut-directed hypnotherapy 1 h per week for 12 weeks, or to serve as controls. The study nurse was otherwise not involved in the analysis or interpretation of data generated in the study, and the investigators (M.S., H.A., and E.B.) were not at all involved in the randomization process, ensuring treatment allocation concealment. Three experienced clinical psychologists in private practices, specially trained in hypnotherapy (>10 years experience of general hypnotherapy), conducted the treatment. The treatment was given outside the hospital at the private practices of the psychologists. The patients randomized to the control group were provided with supportive therapy to control for attention. They met with a dietician once for 1 h to receive general dietary advice with emphasis on good or bad food items for IBS, and with a physiotherapist for 1 h, who provided general information about relaxation training. Furthermore, a gastroenterologist with a special interest in functional GI disorders (M.S., H.A., or E.B.) met the patients for 1 h and informed them about GI physiology in general and the pathophysiology of IBS in particular. Moreover, the study nurse telephoned the subjects in the control group regularly during the treatment period for extra support. The subjects in the control group were also informed that they would receive gut-directed hypnotherapy after 6 months, which was recommended by the local ethics committee.

The effectiveness of the treatment was evaluated with questionnaires (for detailed information see below) assessing QOL (IBS-QOL), anxiety and depression (Hospital anxiety and depression (HAD) scale), and GI symptoms (GI-symptom questionnaire). All patients completed the questionnaires before the randomization and directly after the treatment, that is, at 3 months, and the presence of adverse events were assessed verbally by the psychologist using an open question at the end of the sessions. The patients in the hypnotherapy group were also evaluated concerning GI symptoms and QOL 1 year after the gut-directed hypnotherapy treatment using the GI-symptom questionnaire and IBS-QOL.

Study 2

We invited patients with IBS according to the Rome II criteria[1] to participate in the study at Gävle Hospital. These were randomized by a statistician at the local research unit at the hospital, otherwise not involved in the study, to receive gut-directed hypnotherapy 1 h per week for 12 weeks or to serve as control group. A randomization list using a computer program was used for this purpose. The patients in the control group were informed that they would receive gut-directed hypnotherapy after 1 year, but after the randomization they did not receive any extra support, but served as waiting list controls. Before the start of the study, all patients received a thorough explanation about IBS in general by a gastroenterologist (P.L.), who informed and reassured them about the benign, but troublesome nature of the condition. They were given general advice about lifestyle changes to improve symptoms, factors known to trigger symptoms, and general information about IBS. The hypnotherapy was given by one experienced clinical psychologist, specially trained in hypnotherapy (P.A.) (1 year experience). The treatment was given at the gastroenterology outpatient clinic of the hospital.

The effectiveness of the treatment was measured with validated questionnaires (for detailed information see below) assessing QOL (Short Form 36 (SF-36), anxiety and depression (HAD scale), and GI symptoms (Gastrointestinal Symptom Rating Scale IBS version (GSRS-IBS). All patients completed the questionnaires before the randomization and directly after the treatment period, that is, at 3 months, and the presence of adverse events were assessed verbally by the psychologist using an open question at the end of the sessions. The patients in the gut-directed hypnotherapy group were also evaluated concerning the severity of GI symptoms 1 year after the treatment using the GSRS-IBS, and QOL using SF-36.

Primary Outcome Measures

GI-symptom Questionnaires

  • GI-symptom questionnaire used in study 1. This questionnaire evaluates the perceived severity of symptoms related to IBS during the past week, and was created specifically for this study.[27] It uses a seven-graded Likert scale ranging from no symptoms (=1) to very severe symptoms (=7). The higher the score, the more severe are the symptoms. The symptoms included are bloating, gas, pain, loose stools, urgency, hard stools, and incomplete evacuation. The scores of the individual symptoms were then summarized into a total symptom severity score ranging from 7 to 49 and two different domains: sensory symptoms score (pain, bloating, and gas) and bowel habit score (loose stools, urgency, hard stools, and incomplete evacuation).

  • GSRS-IBS used in study 2. The GSRS-IBS is an IBS-specific questionnaire assessing the pattern and severity of IBS-related GI symptoms during the past week using a seven-graded Likert scale (1, no discomfort; 2, minor discomfort; 3, mild discomfort; 4, moderate discomfort; 5, moderately severe discomfort; 6, severe discomfort; and 7, very severe discomfort).[28] The GSRS-IBS consists of 13 questions, divided into five domains or syndromes: pain, bloating, constipation, diarrhea, and satiety. The higher the score the more severe are the symptoms.

Secondary Outcome Measures

QOL Questionnaires

  • IBS-QOL used in study 1. This disease-specific health-related QOL instrument includes 30 items measuring nine dimensions of health: emotional functioning, mental health, sleep, energy, physical functioning, diet, social role, physical role, and sexual relations.[29] Raw scores are transformed into a scale of 0–100, with 100 representing the best possible QOL score.

  • SF-36 used in study 2. This is a widely used generic health-related QOL measure with eight multi-item subscales (36 items), including physical functioning, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.[30] Raw scores are transformed into a scale ranging from 0 (worst possible health state) to 100 (best possible health state) on each of the eight subscales. A physical component score and a mental component score can be calculated and used as summary scores, and these were used in this study.

Questionnaire Assessing Anxiety and Depression

  • The HAD scale used in studies 1 and 2. This scale was developed for non-psychiatric medical patients to detect anxiety and depression.[31] It consists of 14 items, with 7 items relating to anxiety and 7 items related to depression. A four-graded Likert scale is used (0–3), and the higher the score, the more pronounced are the symptoms. The HAD scale is a reliable instrument, with cutoff scores, for screening for clinically significant anxiety and depression in patients attending a general medical clinic and has also been shown to be a valid measure of the severity of these disorders of mood.

Data Analysis and Statistics

Patient data and results from questionnaires were entered into a database by persons otherwise not involved in the conduct of the studies. All analyses were performed on an intention-to-treat basis, including all patients who were randomized and completed baseline questionnaires. For dropouts, we used the principle of last observation carried forward technique and the data missing post-treatment were imputed from baseline assessments and included in the final analyses. The analyses of the results from the questionnaires were made with parametric methods, that is, t-tests for paired and independent samples, respectively. The change in GI-symptom severity at 3 months relative to baseline (GI-symptom questionnaire in study 1 and GSRS-IBS in study 2) was compared between the hypnotherapy and control group in the two studies separately, and constituted our primary end point (demonstrated as mean difference and 95% confidence interval of the difference). We also performed within-group comparisons for these questionnaires, comparing results at 3 months with baseline for both groups, and results from the 1-year follow-up evaluation relative to baseline in the hypnotherapy groups. In an attempt to demonstrate the response to the treatment more clearly, we defined a responder as a subject with reduction of the total symptom score ≥25% on the GI-symptom questionnaire (study 1) or on GSRS-IBS (study 2) at follow-up (3 months). The proportion of responders in the hypnotherapy group vs. the control group was compared using χ2 test. Within- and between-group comparisons for the QOL evaluations (IBS-QOL and SF-36), and anxiety and depression (HAD) were secondary outcome variables. No formal power calculation was made to determine the number of patients to be included, but these decisions were made based on the number of patients in previous studies,[32] and resources available at the two sites, with the aim to end up with 90 evaluable patients in study 1 and 45 patients in study 2. The scores from the questionnaires are displayed as mean±s.d., unless otherwise stated. Statistical significance was accepted at the 5% level. No adjustments for multiple comparisons were made.

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