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A Placebo-Controlled Double-Blind Randomized Trial with Individualized Homeopathic Treatment Using a Symptom Cluster Approach in Women with Premenstrual Syndrome.

Abstract

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.

Authors+Show Affiliations

Israeli Association for Classical Homeopathy, Tel Aviv, Israel.Louis Bolk Institute, Health and Nutrition, Bunnik, The Netherlands.Psycho-oncology Research Center, Sheba Medical Center, Tel HaShomer, Israel.Hadassah University Hospital, Jerusalem, Israel.The Center for Integrative Complementary Medicine, Shaare Zedek Medical Center, Jerusalem, Israel.International Homeopathic Academy, Allonisos, Greece.Rosetta Genomics, Rehovot, Israel.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31434111

Citation

Yakir, Michal, et al. "A Placebo-Controlled Double-Blind Randomized Trial With Individualized Homeopathic Treatment Using a Symptom Cluster Approach in Women With Premenstrual Syndrome." Homeopathy : the Journal of the Faculty of Homeopathy, 2019.
Yakir M, Klein-Laansma CT, Kreitler S, et al. A Placebo-Controlled Double-Blind Randomized Trial with Individualized Homeopathic Treatment Using a Symptom Cluster Approach in Women with Premenstrual Syndrome. Homeopathy. 2019.
Yakir, M., Klein-Laansma, C. T., Kreitler, S., Brzezinski, A., Oberbaum, M., Vithoulkas, G., & Bentwich, Z. (2019). A Placebo-Controlled Double-Blind Randomized Trial with Individualized Homeopathic Treatment Using a Symptom Cluster Approach in Women with Premenstrual Syndrome. Homeopathy : the Journal of the Faculty of Homeopathy, doi:10.1055/s-0039-1691834.
Yakir M, et al. A Placebo-Controlled Double-Blind Randomized Trial With Individualized Homeopathic Treatment Using a Symptom Cluster Approach in Women With Premenstrual Syndrome. Homeopathy. 2019 Aug 21; PubMed PMID: 31434111.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A Placebo-Controlled Double-Blind Randomized Trial with Individualized Homeopathic Treatment Using a Symptom Cluster Approach in Women with Premenstrual Syndrome. AU - Yakir,Michal, AU - Klein-Laansma,Christien T, AU - Kreitler,Shulamith, AU - Brzezinski,Amnon, AU - Oberbaum,Menachem, AU - Vithoulkas,George, AU - Bentwich,Zvi, Y1 - 2019/08/21/ PY - 2019/8/22/entrez JF - Homeopathy : the journal of the Faculty of Homeopathy JO - Homeopathy N2 - 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. SN - 1476-4245 UR - https://www.unboundmedicine.com/medline/citation/31434111/A_Placebo-Controlled_Double-Blind_Randomized_Trial_with_Individualized_Homeopathic_Treatment_Using_a_Symptom_Cluster_Approach_in_Women_with_Premenstrual_Syndrome L2 - http://www.thieme-connect.com/DOI/DOI?10.1055/s-0039-1691834 DB - PRIME DP - Unbound Medicine ER -