Kiyoshi Takamatsu1, Mariko Ogawa1, Satoshi Obayashi2, Takashi Takeda3, Masakazu Terauchi4, Tsuyoshi Higuchi5, Kiyoko Kato6, Toshiro Kubota7. 1. Department of Obstetrics and Gynecology, Tokyo Dental College Ichikawa General Hospital, Chiba, Japan. 2. Department of Obstetrics and Gynecology, Dokkyo Medical University, Tochigi, Japan. 3. Division of Women's Health, Research Institute of Traditional Asian Medicine, Kindai University, Osaka, Japan. 4. Department of Women's Health, Tokyo Medical and Dental University, Tokyo, Japan. 5. Department of Nursing Science, Hirosaki University Graduate School of Health Sciences, Aomori, Japan. 6. Department of Obstetrics and Gynecology, Graduate School of Medicine, Kyushu University, Fukuoka, Japan. 7. Department of Gynecology, Tokyo Kyosai Hospital, Tokyo, Japan.
Abstract
OBJECTIVE: The KOSMOS study, a multicenter, randomized, double-blind, placebo-controlled trial, investigated the effects and safety of kamishoyosan (TJ-24), a traditional Japanese medicine, in the treatment of climacteric disorder. METHODS: Japanese women with climacteric disorder were administered a placebo during a 4-week run-in period, after which they were classified as placebo responders (R group) if their score on the modified Questionnaire for the Assessment of Climacteric Symptoms in Japanese Women (m-QACS) with excitability and irritability as the primary outcome improved by ≥ 3 points and as placebo nonresponders (NR group) otherwise. Members of the NR group were randomly allocated to receive either TJ-24 or placebo. After 12 weeks, their m-QACS scores, anxiety and depression, sleep, and overall quality of life (QOL) were compared. RESULTS: The TJ-24 and placebo arms in the NR group included 20 patients each. The change in the m-QACS scores of members of the NR group for excitability and irritability at 12 weeks versus baseline was -3.1 ± 1.7 in the TJ-24 arm, a significant decrease, but compared with -2.7 ± 2.2 in the placebo arm, no significant difference was between two arms. However, the proportion of participants whose score improved by ≥3 points was significantly higher in the TJ-24 arm. In the subgroup analysis of premenopausal women, the changes in the score for excitability and irritability were significantly larger in the TJ-24 arm. The incidence of adverse drug reactions or adverse events did not differ between the two arms, and no serious events were reported. CONCLUSION: Although no significant difference was identified for the primary outcome, a significantly higher proportion of patients who received TJ-24 displayed improvement. Its high level of safety and effects on excitability and irritability in premenopausal women suggest that TJ-24 may be a useful treatment.
OBJECTIVE: The KOSMOS study, a multicenter, randomized, double-blind, placebo-controlled trial, investigated the effects and safety of kamishoyosan (TJ-24), a traditional Japanese medicine, in the treatment of climacteric disorder. METHODS: Japanese women with climacteric disorder were administered a placebo during a 4-week run-in period, after which they were classified as placebo responders (R group) if their score on the modified Questionnaire for the Assessment of Climacteric Symptoms in Japanese Women (m-QACS) with excitability and irritability as the primary outcome improved by ≥ 3 points and as placebo nonresponders (NR group) otherwise. Members of the NR group were randomly allocated to receive either TJ-24 or placebo. After 12 weeks, their m-QACS scores, anxiety and depression, sleep, and overall quality of life (QOL) were compared. RESULTS: The TJ-24 and placebo arms in the NR group included 20 patients each. The change in the m-QACS scores of members of the NR group for excitability and irritability at 12 weeks versus baseline was -3.1 ± 1.7 in the TJ-24 arm, a significant decrease, but compared with -2.7 ± 2.2 in the placebo arm, no significant difference was between two arms. However, the proportion of participants whose score improved by ≥3 points was significantly higher in the TJ-24 arm. In the subgroup analysis of premenopausal women, the changes in the score for excitability and irritability were significantly larger in the TJ-24 arm. The incidence of adverse drug reactions or adverse events did not differ between the two arms, and no serious events were reported. CONCLUSION: Although no significant difference was identified for the primary outcome, a significantly higher proportion of patients who received TJ-24 displayed improvement. Its high level of safety and effects on excitability and irritability in premenopausal women suggest that TJ-24 may be a useful treatment.
Authors: Gregory A Plotnikoff; Kenji Watanabe; Carolyn Torkelson; June La Valleur; David M Radosevich Journal: Menopause Date: 2011-08 Impact factor: 2.953
Authors: Siobán D Harlow; Michael R Elliott; Irina Bondarenko; Rebecca C Thurston; Elizabeth A Jackson Journal: Menopause Date: 2020-01 Impact factor: 2.953
Authors: Siobán D Harlow; Carrie Karvonen-Gutierrez; Michael R Elliott; Irina Bondarenko; Nancy E Avis; Joyce T Bromberger; Maria Mori Brooks; Janis M Miller; Barbara D Reed Journal: Womens Midlife Health Date: 2017-07-27