Acupuncture for irritable bowel syndrome an exploratory randomised controlled trial

Area of Science:

• Gastroenterology
• Complementary Medicine
• Clinical Trials

Background:

• Evidence on acupuncture for irritable bowel syndrome (IBS) is inconclusive.
• Many IBS patients self-refer for acupuncture, necessitating efficacy research.
• This study aimed to assess feasibility and determine sample size for a full-scale trial.

Purpose of the Study:

• To establish variability in the primary outcome measure for sample size calculation.
• To explore feasibility and design criteria for a full-scale trial.
• To investigate the effectiveness of acupuncture for IBS symptom management.

Main Methods:

• A pragmatic randomized controlled trial comparing acupuncture plus usual GP care versus usual GP care alone.
• Thirty IBS patients were recruited and randomized 1:2 to acupuncture or usual care.
• The primary outcome was the IBS Symptom Severity Score (SSS) at three months, analyzed by intention-to-treat with multiple imputation.

Main Results:

• A statistically and clinically significant difference in IBS SSS favoring acupuncture was observed (138 points, P=0.001).
• A sample size of 108 patients per arm is estimated for a full-scale trial.
• The pilot study successfully recruited patients and established feasibility.

Conclusions:

• A full-scale trial for acupuncture in IBS is feasible and merited.
• Pilot results suggest acupuncture may be effective for IBS symptom reduction.
• A pragmatic trial design is suitable for determining cost-effectiveness, though it cannot differentiate specific from placebo effects.