Randomised clinical trial: the efficacy of gut-directed hypnotherapy is similar to that of the low FODMAP diet for the treatment of irritable bowel syndrome
Peters S.L, Yao K, Philpott G, et al
Alimentary Pharmacology & Therapeutics 2016 ; 44 : 447-459
The low FODMAP diet is increasingly applied by health professionals in patients with IBS as a first or second-line dietary therapy. There is strong evidence to support this approach, consisting of randomised controlled trials, comparative and observational studies.
Alimentary Pharmacology & Therapeutics 2016 ; 44 : 447-459
The low FODMAP diet is increasingly applied by health professionals in patients with IBS as a first or second-line dietary therapy. There is strong evidence to support this approach, consisting of randomised controlled trials, comparative and observational studies.
Another promising option for managing this patient group is gut-directed hypnotherapy, where several controlled trials and observational studies have reported an associated reduction in symptoms. However, the nature of psychological studies (where it is typically not possible to provide a no-treatment control arm) has hindered the possibility of obtaining more robust evidence for efficacy in relation to gut-directed hypnotherapy. As an alternative, the authors of this study sought to compare a hypnotherapy treatment model for IBS with an active control group with proven efficacy (the low FODMAP diet). The aims of the study where to perform a randomised clinical trial in patients with IBS, naïve to dietary or psychological therapies, to compare the effect of gut-directed hypnotherapy with the low FODMAP diet, alone or in combination on symptoms and psychological health over both a short (6 week) and long term (6 month) period.
Seventy four participants were randomised to receive gut-directed hypnotherapy (6 x weekly 1 hour sessions over 6 weeks) – based on the ‘Manchester model’ (n=25); low FODMAP education (n=24) via an experienced gastro-specialist dietitian (1 hour education session at the beginning of week 1 and review at week 6 with reintroduction advice); or a combination of both (n=25). Validated questionnaires were used to evaluate gastrointestinal symptoms and psychological indices concerning anxiety, depression and quality of life. Questionnaires were completed at base-line, after treatment (week 6) and after 6 months, at which point, long-term dietary adherence data was also recorded. The study was not blinded. Subjects that underwent hypnotherapy were provided with a recorded disc of their first session to listen to every day for the 6 week intervention period. Patients receiving low FODMAP advice were provided with written information including food lists, recipes and food labelling advice. Weekly telephone contact was provided to aid compliance.
Adherence to the low FODMAP diet was achieved in 88% of the low FODMAP group and 76% of the combined treatment group. Adherence to gut-directed hypnotherapy (daily listening to CD) was achieved in 72% of subjects in the hypnotherapy group and 80% in the combined treatment group. There were significant and equivalent improvements in overall gastro symptoms from baseline for all groups at both week 6 (p=0.001) and at 6 months (p=0.001), with no significant differences across treatment groups. No significant change in state anxiety or depression was observed in any of the treatment groups at week 6 or after 6 months. No change in trait anxiety or depression was observed in either of the groups that involved low FODMAP treatment, however, these parameters were significantly improved (in addition to the gut symptoms improvement noted above) in those who received just hypnotherapy after 6 months (p=0.0001).
The authors of this study concluded that the effects of gut-directed hypnotherapy are similar to those of the low FODMAP diet in terms of relief of gastrointestinal symptoms, but that hypnotherapy has an additional, sustained benefit of improvement in psychological indices and should be regarded as a viable option for the primary therapy of patients with IBS.
There is no evidence for an additive effect when treatments are combined, and a variety of possible explanations for this observation are offered by the authors: 1) Efficacy may have been driven by a placebo effect in all three study arms; 2) The use of a visual analogue scale may have prevented the detection of an enhanced effect of combined treatment owing to the ‘ceiling effect’; 3) The two treatment models may have been targeting the same pathophysiology; 4) The two treatments may have adversely affected each other since patients may not have adhered to either one as strictly as they would have, had they only felt they were receiving a single intervention (however no evidence for this was detected when adherence to dietary therapy was assessed). Despite the success of the hypnotherapy intervention, a lack of skilled gut-directed hypnotherapists, the financial burden of therapy and the time commitment required for this type of treatment may prevent it’s usage in clinical practice. However, the low FODMAP diet is also not without disadvantages, including possible negative effects on nutritional adequacy and the gut microbiome.
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Seventy four participants were randomised to receive gut-directed hypnotherapy (6 x weekly 1 hour sessions over 6 weeks) – based on the ‘Manchester model’ (n=25); low FODMAP education (n=24) via an experienced gastro-specialist dietitian (1 hour education session at the beginning of week 1 and review at week 6 with reintroduction advice); or a combination of both (n=25). Validated questionnaires were used to evaluate gastrointestinal symptoms and psychological indices concerning anxiety, depression and quality of life. Questionnaires were completed at base-line, after treatment (week 6) and after 6 months, at which point, long-term dietary adherence data was also recorded. The study was not blinded. Subjects that underwent hypnotherapy were provided with a recorded disc of their first session to listen to every day for the 6 week intervention period. Patients receiving low FODMAP advice were provided with written information including food lists, recipes and food labelling advice. Weekly telephone contact was provided to aid compliance.
Adherence to the low FODMAP diet was achieved in 88% of the low FODMAP group and 76% of the combined treatment group. Adherence to gut-directed hypnotherapy (daily listening to CD) was achieved in 72% of subjects in the hypnotherapy group and 80% in the combined treatment group. There were significant and equivalent improvements in overall gastro symptoms from baseline for all groups at both week 6 (p=0.001) and at 6 months (p=0.001), with no significant differences across treatment groups. No significant change in state anxiety or depression was observed in any of the treatment groups at week 6 or after 6 months. No change in trait anxiety or depression was observed in either of the groups that involved low FODMAP treatment, however, these parameters were significantly improved (in addition to the gut symptoms improvement noted above) in those who received just hypnotherapy after 6 months (p=0.0001).
The authors of this study concluded that the effects of gut-directed hypnotherapy are similar to those of the low FODMAP diet in terms of relief of gastrointestinal symptoms, but that hypnotherapy has an additional, sustained benefit of improvement in psychological indices and should be regarded as a viable option for the primary therapy of patients with IBS.
There is no evidence for an additive effect when treatments are combined, and a variety of possible explanations for this observation are offered by the authors: 1) Efficacy may have been driven by a placebo effect in all three study arms; 2) The use of a visual analogue scale may have prevented the detection of an enhanced effect of combined treatment owing to the ‘ceiling effect’; 3) The two treatment models may have been targeting the same pathophysiology; 4) The two treatments may have adversely affected each other since patients may not have adhered to either one as strictly as they would have, had they only felt they were receiving a single intervention (however no evidence for this was detected when adherence to dietary therapy was assessed). Despite the success of the hypnotherapy intervention, a lack of skilled gut-directed hypnotherapists, the financial burden of therapy and the time commitment required for this type of treatment may prevent it’s usage in clinical practice. However, the low FODMAP diet is also not without disadvantages, including possible negative effects on nutritional adequacy and the gut microbiome.
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