Treatment of Menstrual Irregularities with Individualized Homeopathy

Irregular menstrual cycle is a common complaint. Recent research suggested that homeopathy is one of the most popular choices for women with various gynecological disorders. This randomised, double-blind, placebo-controlled trial was aimed at differentiating individualized homeopathic medicinal products (IHMPs) from identical-looking placebos in the treatment of menstrual irregularities in early reproductive women.

Group verum (n = 46) received IHMPs plus concomitant care. The control group (n = 46) received placebos plus concomitant care. The proportion patients in whom menstrual irregularities were corrected for consecutive three cycles was the primary outcome measure. The secondary outcome measure was the Menstrual Distress Questionnaire (MDQ) total score. Both endpoints were measured at baseline and then monthly for up to 4 months.

The intention-to-treat sample (n = 92) was analyzed. Group differences were examined by chi-squared tests with categorical outcomes, two-way repeated measure analysis of variance accounting for the time–effect interactions, and unpaired t-tests comparing the mean estimates obtained individually every month. The level of significance was set at p < 0.05 two-tailed.

• After 4 months of intervention, the group difference in the primary outcome was nonsignificant—IHMPs: 22/46 v/s placebo: 24/46, chi-square (Yates corrected) = 0.043, p = 0.835.
• The improvement observed in the MDQ total score (F₁,₉₀ = 0.054, p = 0.816) and subscales scores were also not significant in most of the occasions, except for the behavioral change subscale (F₁,₉₀ = 0.029, p < 0.001).
• Pulsatilla nigricans was the most frequently prescribed medicine.
• Kent’s Repertory and Zandvoort’s Complete Repertory were the most frequently used repertories.
• No harm or serious adverse events were reported from either group.

The authors concluded that the analysis failed to demonstrate clearly that IHMPs were effective beyond placebos in all but one of the outcomes. More appropriate outcome measures may be sought for future trials.

I have just four short comments:

1. I’d like to congratulate the authors for their courage in reporting a squarely negative result.
2. I should nevertheless correct their conclusion regarding the statement “in all but one of the outcomes”; according to their own admission, the subscale of the MDQ was not even a secondary outcome measure.
3. The sentence “More appropriate outcome measures may be sought for future trials”  seems to imply that the negative result was due to having chosen the wrong endpoints for this study. This would be mistaken: the negative result was due to the ineffectiveness of homeopathy.
4. And because of the ineffectiveness of homeopathy, the entire concept of the study was a mistake and arguably not even ethical. To put it bluntly, this trial should have never been conducted in the first place.