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Placebo Combined With Pre-Exisiting Therapy Found Effective in IBS Patients

January 4, 2011

“The placebo effect” occurs when a simulated medical intervention produces a perceived or actual improvement in symptoms. Placebos are commonplace across all medical specialties, but they are of particular importance in clinical trials.

Irritable bowel syndrome (IBS) is a functional bowel disorder treated with pharmacotherapy, psychotherapy, and dietary adjustments. Whitehead and colleagues(1) found that 94% of IBS suffers also had a comorbid psychiatric disorder. IBS has been found to be comorbid with depression, fibromyalgia, anxiety disorders, and chronic fatigue syndrome.

Ted Kaptchuk, ODM, and colleagues(2) conducted an open-label, randomized, controlled trial of 80 patients with IBS. These patients met Rome III criteria for IBS, and also scored >150 on the IBS Symptom Severity Scale (IBS-SSS). At end point, the patients were assessed with the IBS-SSS, the IBS Global Improvement Scale (IBS-GIS), IBS Adequate Relief (IBS-AR), and the IBS Quality of Life (IBS-QOL).

Patients already receiving active pharmacotherapy for IBS were divided into two groups. The open placebo group (N=37) received placebo pills BID, and patients were informed that they were receiving an inactive placebo. The no treatment group (N=43) only had the same interaction with healthcare providers that the patients in the open placebo group had. Patients in both groups, however, were able to continue taking their IBS medications as long as they were on a stable dose of these medications for at least 30 days prior to joining the study. In that case, they were not permitted to discontinue the medication once this study began.

The patients met their respective provider at baseline, midpoint (day 11), and endpoint (day 21), meeting the same provider on each visit. During these visits, patients in the placebo group were able to ask questions, were given a brief physical exam, and were given questionnaires. The no treatment group only received thanks and encouragement for being a part of the study.

Kaptchuk and colleagues found that the patients in the open placebo group showed greater improvement at study midpoint and endpoint on the IBS-GIS, the IBS-SSS, the IBS-AR, and the IBS-QOL compared to the patients in the no treatment group. At endpoint, patients in the open placebo arm had a 5.0+1.5 global improvement on the IBS-GIS, a 59% placebo response for the IBS-AR, a 92+99 symptom severity reduction in the IBS-SSS, and an 11.4+16.6 point reduction in the IBS-QOL. Meanwhile, patients in the no treatment arm had a 5.2+1.0 global improvement on the IBS-GIS, a 49% placebo response for the IBS-AR, a 75+87 symptom severity reduction in the IBS-SSS, and an 8.3+11.6 point reduction in the IBS-QOL.

Overall, the researchers believe that placebos administered without deception and with a plausible rationale can produce significant improvements in symptom severity and are a possibly effective treatment for IBS. They believe that further research is needed, in IBS and other conditions, where placebos are used as treatment options.

Kaptchuk’s study was partially supported by grant K24 AT004095, R01 AT00402-01 and R01AT004662 from National Center for Complementary and Alternative Medicine-NIH and in part from a gift from The Bernard Osher Foundation. —Christopher Naccari

REFERENCES

1. Whitehead WE, Palsson O, Jones KR. Systematic review of the comorbidity of irritable bowel syndrome with other disorders: what are the causes and implications?”. Gastroenterology. 2002;122:1140–1156.

2. Kaptchuk TJ, Friedlander E, Kelley JM, et al. Placebos without deception: a randomized controlled trial in irritable bowel syndrome. PLoS ONE. 2010;5(12):e15591. doi:10.1371/journal.pone.001559.

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From → Pharmacotherapy

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