Globules against cycle disorders: study shows limited effect

Globules against cycle disorders: study shows limited effect

The research examined whether homeopathic remedies (called IHMPs) are more effective than placebos in women with irregular menstrual cycles. A placebo is a dummy medication that contains no active ingredients. The study was conducted as a double-blind trial, meaning that neither the participants nor the researchers knew who was receiving the homeopathic remedy and who was receiving the placebo, so as not to influence the results.

In the study, 92 women were randomly divided into two groups: one group received the homeopathic remedies along with usual care, the other group received a placebo along with the same care. The main focus was whether the irregular menstrual cycle can be regulated over three consecutive cycles. Another aspect was the detection of other symptoms using a special questionnaire (Menstrual Distress Questionnaire - MDQ) that measures women's well-being during their period.

After four months, the results were analyzed. It turned out that there was little difference in the regular menstrual cycle between the homeopathy group and the placebo group. For the other symptoms assessed by the questionnaire, the homeopathy group showed improvements in some areas, but these were generally not statistically significant, with the exception of one category involving behavioral changes.

Interestingly, the research resulted in no harm or serious side effects in the participants, whether they took the homeopathic remedies or placebos.

In summary, this particular study did not demonstrate that homeopathic remedies are more effective than placebos for menstrual irregularities. In the future, other methods or measuring instruments could be used to potentially achieve different or more accurate results.

Basic terms and concepts

• Homöopathie: Eine alternative Heilmethode, die auf dem Prinzip basiert, dass „Ähnliches durch Ähnliches geheilt werden kann“.
• Placebo: Ein Scheinmedikament ohne pharmakologisch wirksame Stoffe, das in klinischen Studien zur Kontrolle der Ergebnisse verwendet wird.
• Doppelblindstudie: Eine Studiendesign, bei dem weder die Teilnehmer noch die Forscher wissen, wer welches Präparat erhält, um keine voreingenommenen Ergebnisse zu erzeugen.
• Menstrual Distress Questionnaire (MDQ): Ein Fragebogen, der entwickelt wurde, um psychologische und körperliche Symptome während der Menstruation zu bewerten.
• Intention-to-treat Analyse: Eine analytische Methode, bei der alle Probanden in der ursprünglichen Gruppe analysiert werden, auch wenn sie die Behandlung nicht abschließen.

Abbreviations

• IHMPs: Individuelle homöopathische Heilmittel (Individualized Homeopathic Medicinal Products)
• MDQ: Menstrual Distress Questionnaire

Homeopathy versus placebo for menstrual irregularities: A double-blind, randomized trial

The present study examines the effectiveness of individualized homeopathic medicines (IHMPs) compared to placebo in the treatment of menstrual irregularities. The research is based on a double-blind, randomized and placebo-controlled study with two parallel groups. This was carried out at the D.N. De Homoeopathic Medical College & Hospital, Kolkata, India. The aim was to assess the effect of homeopathic preparations over three consecutive menstrual cycles.

methodology

The study enrolled 92 women with menstrual irregularities, divided into two groups: the verum group (46 patients who received IHMPs and concomitant care) and the control group (46 patients who received placebos and the same care). The main results were evaluated over a period of four months, with the primary endpoint being the correction of menstrual irregularities over three consecutive cycles.

Primary and secondary outcomes

The primary analysis focused on the proportion of women who achieved correction of menstrual irregularities. Additionally, the Menstrual Distress Questionnaire (MDQ) was used to measure secondary outcomes. Chi-square tests for categorical data as well as two-way repeated measures analyzes of variance were performed to assess time-effect interactions.

Conclusions and implications

The study found no statistically significant difference between the effectiveness of IHMPs and placebos in most outcomes. An exception was the behavior change subscale of the MDQ, which showed a significant improvement in the verum group, but without adding clinical relevance. The most common active ingredient wasLachesis muta, and the most commonly used repertories were Kent's Repertory and Zandvoort's Complete Repertory. No serious adverse event or harm was reported in either group.

The researchers concluded that more appropriate outcome measures are needed for future studies to more clearly demonstrate the effectiveness of IHMPs. Full details of the study can be found at the following source: https://pubmed.ncbi.nlm.nih.gov/39084625.