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

Abstract

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:

IHMPs (verum; n = 67) or identical-looking placebos (control; n = 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:

After 3 months, IHMPs demonstrated significantly greater improvement than placebo in ARSSQoL total (mean group difference −6.5, 95% confidence interval −8.7, −4.2; p < 0.001), with large effect sizes. Most ARSSQoL subscales, NRSs, and EQ-5D-5L scores favored IHMPs. Multivariate and Bayesian analyses confirmed consistent intervention-by-time effects, with a high probability of directional superiority for IHMPs in symptom reduction and self-rated health, while sensitivity analyses showed the findings to be robust to protocol deviations. Kent’s repertory was the most frequently used in remedy selection. Nitricum acidum 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.