A Placebo-Controlled Double-Blind Randomized Trial with Individualized Homeopathic Treatment Using a Symptom Cluster Approach in Women with Premenstrual SyndromeFunding This research was part of the Ph.D. research project of Michal Yakir at the Hadassa Medical School, Jerusalem.
10. Januar 2019
08. April 2019
21. August 2019 (eFirst)
Background In a double-blind placebo-controlled randomized trial with parallel groups, the efficacy of individually prescribed homeopathic medicines was evaluated in women with premenstrual syndrome (PMS).
Methods In an outpatient department of a university clinic in Jerusalem, Israel (1996–1999), women with PMS, aged 18 to 50 years, entered a 2-month screening phase with prospective daily recording of premenstrual symptoms by the Menstrual Distress Questionnaire (MDQ). They were included after being diagnosed with PMS. A reproducible treatment protocol was used: women received a homeopathic prescription based on symptom clusters identified in a questionnaire. The symptoms were verified during a complementary, structured, interview. Only women whose symptoms matched the symptom profile of one of 14 pre-selected homeopathic medicines were included. Each participant was administered active medicine or placebo via random allocation. Primary outcome measures were differences in changes in mean daily premenstrual symptom (PM) scores by the MDQ. Analysis was by intention-to-treat.
Results A total of 105 women were included: 49 were randomized to active medicine and 56 to placebo. Forty-three women in the active medicine group and 53 in the placebo group received the allocated intervention with at least one follow-up measurement and their data were analyzed. Significantly greater improvement of mean PM scores was measured in the active medicine group (0.443 [standard deviation, SD, 0.32] to 0.287 [SD, 0.20]) compared to placebo (0.426 [SD, 0.34] to 0.340 [SD, 0.39]); p = 0.043.
Conclusions Individually prescribed homeopathic medicines were associated with significantly greater improvement of PM scores in women with PMS, compared to placebo. Replication, with larger sample size and other refinements, is recommended to confirm the efficacy of this treatment in other settings.
Keywordspremenstrual syndrome - randomized - double-blind - placebo-controlled trial - homeopathy - individualized - symptom cluster
• Homeopathic medicines proved superior to placebo in women with premenstrual syndrome.
• The use of active homeopathic medicines (compared to placebo) was also associated with more reduction in sick days and less use of other medication.
• A novel method called “the symptom cluster approach” was used for individualized homeopathic medicine selection for all women.
• This design with 14 homeopathic medicines enables replication of the treatment for future research or practice.
Michal Yakir (M.Y.) designed the study, was the principal investigator, drafted the initial protocol, looked after the participants, collected the data, analyzed and interpreted the results, and wrote the draft of the original report. George Vithoulkas (G.V.) proposed the questions for the homeopathic questionnaire. Zvi Bentwich supervised the study, assisted in writing the initial manuscript, was responsible (with G.V.) for generating grant support and (with M.Y.) for conceptualizing and designing the study. Shulamith Kreitler was responsible for the psychological tests and for some of the statistical analyses. Amnon Brzezinski was in charge of the gynecological clinic, provided the logistical support for the study, and gave expert gynecological advice. G.V. and M.O. served as homeopathic consultants. CKL revised and updated the draft manuscript in 2015-2017. All authors gave final approval of the article.
* Previously, Hebrew University Hadassah Medical School, Jerusalem, Israel.
** Previously, Department of Psychology (now called: School of Psychological Sciences), Tel Aviv University, Tel Aviv, Israel.
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