The Irritable Bowel Syndrome Outcome Study (IBSOS): Rationale and design of a randomized, placebo-controlled trial with 12month follow up of self- versus clinician-administered CBT for moderate to severe irritable bowel syndrome

Background A recent randomised controlled trial (RCT) of acupuncture as a treatment for irritable bowel syndrome (IBS) demonstrated sustained benefits over a period of 12 months post-randomisation. Aim To extend the trial follow-up to evaluate the effects of acupuncture at 24 months post-randomisation. Methods Patients in primary care with ongoing IBS were recruited to a two-arm pragmatic RCT of acupuncture for IBS. Participants were randomised to the offer of up to 10 weekly sessions of acupuncture plus usual care (n=116 patients) or to continue with usual care alone (n=117). The primary outcome was the self-reported IBS symptom severity score (IBS SSS) measured at 24 months post-randomisation. Analysis was by intention-to-treat using an unstructured multivariate linear model incorporating all repeated measures. Results The overall response rate was 61%. The adjusted difference in mean IBS SSS at 24 months was −18.28 (95% CI −40.95 to 4.40) in favour of the acupuncture arm. Differences at earlier time points estimated from the multivariate model were: −27.27 (−47.69 to −6.86) at 3 months; −23.69 (−45.17 to −2.21) at 6 months; −24.09 (−45.59 to −2.59) at 9 months; and −23.06 (−44.52 to −1.59) at 12 months. Conclusions There were no statistically significant differences between the acupuncture and usual care groups in IBS SSS at 24 months post-randomisation, and the point estimate for the mean difference was approximately 80% of the size of the statistically significant results seen at 6, 9 and 12 months. Trial registration number ISRCTN08827905.

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Protocol for a pilot randomised, double-blind, placebo-controlled trial for assessing the feasibility and efficacy of faecal microbiota transplantation in adolescents with refractory irritable bowel syndrome: FAIS Trial

BMJ Paediatrics Open ◽

10.1136/bmjpo-2020-000689 ◽

2020 ◽

Vol 4 (1) ◽

pp. e000689

Author(s):

Judith Zeevenhooven ◽

Clara Marieke Andrea de Bruijn ◽

Arine Vlieger ◽

Max Nieuwdorp ◽

Marc Alexander Benninga

Keyword(s):

Irritable Bowel Syndrome ◽

Medical Condition ◽

Controlled Trial ◽

Incidence Rates ◽

Chronic Medical Condition ◽

Faecal Microbiota ◽

Double Blind ◽

Faecal Microbiota Transplantation ◽

Irritable Bowel

BackgroundIrritable bowel syndrome (IBS) is a common chronic medical condition, in both children and adults. Despite the availability of effective (non)pharmacological treatments, symptoms persist in a significant amount of patients with IBS. Faecal microbiota transplantation (FMT) may be an effective alternative treatment in adolescents with refractory IBS through manipulation of the intestinal microbiota.Methods and analysisThis randomised, placebo-controlled single-centre pilot study will assess feasibility and efficacy of FMT in 30 adolescents (16–21 years) with refractory IBS. Patients will be randomly allocated (1:1) to receive two allogeneic (healthy donor) or two autologous (own) faecal infusions at baseline and after 6 weeks. Primary outcomes will assess feasibility, including patient and donor recruitment, adherence and incidence rates of adverse events. To evaluate clinical efficacy, secondary outcomes will include the proportion of patients with at least >50% reduction of their abdominal pain intensity and frequency 12 weeks after the first FMT, and after 6-month and 12-month follow-up. Other outcomes comprise changes in faecal gut microbiota composition, quality of life, depression and anxiety, school or work absenteeism and adequate relief, measured directly after FMTs and after 6 and 12 months of follow-up.DiscussionThis randomised controlled trial will investigate the feasibility and effectiveness of repetitive FMTs in adolescents with refractory IBS.Ethics and disseminationThe study is approved by the Medical Research Ethics Committees AMC (MEC-AMC) in the Netherlands.Trial registration numberNCT03074227.

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715 Mindfulness Meditation Has Long-Term Therapeutic Benefits in Women With Irritable Bowel Syndrome (IBS): Follow-Up Results From a Randomized Controlled Trial

Gastroenterology ◽

10.1016/s0016-5085(14)60447-9 ◽

2014 ◽

Vol 146 (5) ◽

pp. S-124 ◽

Cited By ~ 2

Author(s):

Keturah (Kim) R. Faurot ◽

Susan Gaylord ◽

Olafur S. Palsson ◽

Eric L. Garland ◽

John D. Mann ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Irritable Bowel Syndrome ◽

Mindfulness Meditation ◽

Controlled Trial ◽

Randomized Controlled ◽

Therapeutic Benefits ◽

Irritable Bowel

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A Randomised Controlled Trial of Psychotherapy in Patients with Refractory Irritable Bowel Syndrome

The British Journal of Psychiatry ◽

10.1192/bjp.163.3.315 ◽

1993 ◽

Vol 163 (3) ◽

pp. 315-321 ◽

Cited By ~ 91

Author(s):

Elspeth Guthrie ◽

Francis Creed ◽

David Dawson ◽

Barbara Tomenson

Keyword(s):

Irritable Bowel Syndrome ◽

Randomised Controlled Trial ◽

Psychological Symptoms ◽

Controlled Trial ◽

Control Group ◽

Psychological Assessments ◽

Irritable Bowel ◽

One Year ◽

Randomised Controlled

Patients with chronic, refractory irritable bowel syndrome (n =102) were entered into a randomised controlled trial of psychotherapy versus supportive listening. Independent physical and psychological assessments were carried out at the beginning and end of the 12-week trial. For women, psychotherapy was found to be superior to supportive listening, in terms of an improvement in both physical and psychological symptoms. There was a similar trend for men, but this did not reach significance. Following completion of the trial, patients in the control group were offered psychotherapy; 33 accepted and following treatment experienced a marked improvement in their symptoms; ten declined. At follow-up one year later, those patients who had received psychotherapy remained well, patients who had dropped out of the trial were unwell with severe symptoms, and most of the controls who declined psychotherapy had relapsed. This study shows that psychotherapy is feasible and effective in the majority of irritable bowel syndrome patients with chronic symptoms unresponsive to medical treatment.

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