Treatment of Hemorrhoids with Individualized Homeopathic Medicinal Products: A Double-Blind, Randomized, Placebo-Controlled Trial

CONTEXT: Anecdotal reports and preliminary clinical observations suggest potential benefits of homeopathic medicines in hemorrhoids, but high-quality evidence remains limited. OBJECTIVE: To evaluate whether individualized homeopathic medicinal products (IHMPs) are superior to placebo in reducing anorectal symptom severity and improving quality of life over 3 months in adults with hemorrhoids, and to assess their safety and tolerability. DESIGN: Three-month, double-blind, randomized (1:1), placebo-controlled trial. SETTING: Surgery, PG3, and research outpatients of a tertiary homeopathic medical college hospital in West Bengal, India. PATIENTS: One hundred and thirty-four adults with grade I-III hemorrhoids. INTERVENTION: = 67) both administered alongside standard concomitant care including sitz baths, pelvic floor exercises, and dietary advice. MAIN OUTCOME MEASURES: The primary outcome was the change in the Anorectal Symptom Severity and Quality-of-Life (ARSSQoL) total score over 3 months. Secondary outcomes included ARSSQoL subscales, numeric rating scales (NRSs), and EQ-5D-5L questionnaire and visual analog scale. Outcomes were assessed monthly for up to 3 months. The primary analysis compared model-based estimates of change over time between groups using repeated measures analysis of variance; the secondary analyses comprised multivariate linear mixed models, Bayesian hierarchical modeling, and sensitivity analyses under intention-to-treat and per-protocol frameworks. RESULTS: emerged as the most effective remedy. No treatment-related serious adverse events were observed. CONCLUSION: In this randomized, double-blind trial, IHMPs were associated with greater reductions in the ARSSQoL improvements in quality of life compared with placebo over 3 months. Although the magnitude and consistency of effects across multiple analytic approaches suggest potential clinical relevance, the absence of a validated minimal clinically important difference for the ARSSQoL warrants cautious interpretation. Further independent replications and methodological refinement of outcome thresholds are needed.