Context: Gastrointestinal ailments are some of the common conditions treated in homeopathy; yet only a few trials have explored the effects of individualized homeopathic medicines (IHMs) for irritable bowel syndrome (IBS).
Objective: To explore the efficacy of IHMs in treatment of IBS.
Design: Double-blind, randomized, placebo-controlled trial.
Setting: Outpatient departments of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, India.
Patients: Sixty patients suffering from IBS; randomized to receive either IHMs (n = 30) or identical-looking placebo (n = 30).
Interventions: IHMs or placebo in the mutual context of concomitant care in terms of dietary advice, yoga, meditation and exercises.
Main outcome measures: Primary - IBS quality of life (IBS-QOL) questionnaire; secondary -IBS severity scoring system (IBS-SSS) and EQ-5D-5L scores; all measured at baseline and every month, up to 3 months.
Results: Group differences and effect sizes (Cohen's d) were calculated on intention-to-treat (ITT) sample. Groups were comparable at baseline. Recruitment, retention and attrition rates were 64.5%, 91.7% and 8.3% respectively. Group differences in IBS-QOL total scores, IBS-SSS, EQ-5D-5L scores favored IHMs against placebo overall and at all the time points (all P < 0.001). Pulsatilla nigricans (n = 4, 6.7%) and Thuja occidentalis (n = 4, 6.7%) were the most frequently prescribed medicines. Barring some minor events unrelated to interventions, no harms or serious adverse events were recorded in either of the groups. Thus, IHMs acted significantly better than placebos in the treatment of IBS. Independent replications are warranted. [Trial registration: CTRI/2019/10/021632].
Keywords: Homeopathy; Irritable bowel syndrome; Placebo; Quality of life; Randomized controlled trial.
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