PMID- 31434111 OWN - NLM STAT- MEDLINE DCOM- 20200608 LR - 20200608 IS - 1476-4245 (Electronic) IS - 1475-4916 (Linking) VI - 108 IP - 4 DP - 2019 Nov TI - A Placebo-Controlled Double-Blind Randomized Trial with Individualized Homeopathic Treatment Using a Symptom Cluster Approach in Women with Premenstrual Syndrome. PG - 256-269 LID - 10.1055/s-0039-1691834 [doi] AB - 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. CI - The Faculty of Homeopathy. FAU - Yakir, Michal AU - Yakir M AD - Israeli Association for Classical Homeopathy, Tel Aviv, Israel. FAU - Klein-Laansma, Christien T AU - Klein-Laansma CT AD - Louis Bolk Institute, Health and Nutrition, Bunnik, The Netherlands. FAU - Kreitler, Shulamith AU - Kreitler S AD - Psycho-oncology Research Center, Sheba Medical Center, Tel HaShomer, Israel. FAU - Brzezinski, Amnon AU - Brzezinski A AD - Hadassah University Hospital, Jerusalem, Israel. FAU - Oberbaum, Menachem AU - Oberbaum M AD - The Center for Integrative Complementary Medicine, Shaare Zedek Medical Center, Jerusalem, Israel. FAU - Vithoulkas, George AU - Vithoulkas G AD - International Homeopathic Academy, Allonisos, Greece. FAU - Bentwich, Zvi AU - Bentwich Z AD - Rosetta Genomics, Rehovot, Israel. LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20190821 PL - Germany TA - Homeopathy JT - Homeopathy : the journal of the Faculty of Homeopathy JID - 101140517 SB - IM MH - Adult MH - Double-Blind Method MH - Female MH - Homeopathy/*methods MH - Humans MH - Middle Aged MH - Precision Medicine/*methods MH - Premenstrual Syndrome/*therapy MH - Surveys and Questionnaires MH - Young Adult COIS- The authors declare that no competing financial interests exist. Dr. Klein-Laansma reports personal fees from Deutsche Homoopathische-Union (DHU), Karlsruhe, Germany, outside the submitted work. EDAT- 2019/08/23 06:00 MHDA- 2020/06/09 06:00 CRDT- 2019/08/22 06:00 PHST- 2019/08/23 06:00 [pubmed] PHST- 2020/06/09 06:00 [medline] PHST- 2019/08/22 06:00 [entrez] AID - 10.1055/s-0039-1691834 [doi] PST - ppublish SO - Homeopathy. 2019 Nov;108(4):256-269. doi: 10.1055/s-0039-1691834. Epub 2019 Aug 21.