DOI: 10.4103/ijra.ijra_15_26 ISSN: 3117-4051

A Randomized, Double-blind, Placebo-controlled Trial of Individualized Homeopathic Medicines in Menorrhagia from Uterine Fibroids in Fertile Women

Suman Singh, Ompriya Mishra, Rumsha Tamkeen, Umesh Kumar, Shruti Rai, Satarupa Sadhukhan, Srijana Panda, Munmun Koley, Subhranil Saha
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Introduction:

Uterine fibroids are the most common benign tumours in fertile women and frequently present with menorrhagia, leading to impaired quality of life and repeated therapeutic interventions. Effective noninvasive treatment options remain limited.

Aim:

This study aimed to evaluate the efficacy of individualized homeopathic medicines (IHMs) compared with placebo in fertile women with fibroid-associated menorrhagia.

Methods:

This randomized, double-blind, placebo-controlled, parallel-group study included a sample size of 68 participants allocated in a 1:1 ratio to receive either IHMs ( n = 34) or indistinguishable placebo ( n = 34) for 12 weeks, along with dietary advice. The primary outcome was menstrual blood loss assessed using the pictorial blood loss assessment chart. The secondary outcomes included fibroid volume and number assessed by transvaginal ultrasonography and symptom-related quality of life measured using the uterine fibroid symptom and health-related quality of life (HRQOL) questionnaire. Analyses were conducted on an intention-to-treat basis using conventional comparisons and longitudinal mixed-effects modelling.

Results:

Between-group differences favored IHMs for pictorial blood loss assessment chart (PBAC) scores (mean difference − 77.3; 95% Confidence intervals −115.9 to −38.7; effect size d = 0.969; P < 0.001) over the 12-week period, indicating a greater reduction in the treatment group. Mixed-effects modeling demonstrated a significant intervention × time interaction ( P < 0.001), indicating greater reductions in menstrual blood loss. Secondary outcomes also revealed some benefits of IHMs over placebo. Bayesian estimations indicated a high probability of benefit across outcomes (PBAC: 93.1%–96.6%; fibroid volume: 88.1%; uterine fibroid symptom and HRQOL: 99.2%), and sensitivity analyses confirmed the robustness of the findings.

Conclusion:

Individualized homeopathic treatment was associated with greater reductions in menstrual blood loss and fibroid volume compared with placebo over 3 months.

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