Bochen Pan, Yasuhito Kato, Kazuo Sengoku, Naoyuki Takuma, Noriyasu Niizeki, Mutsuo Ishikawa
Treatment of climacteric symptoms with herbal formulas of traditional Chinese medicine.
Gynecol Obstet Invest. 2004;57(3):144-8. doi: 10.1159/000076003. Epub 2003 Dec 30.
Abstract/Text
Hormone replacement therapy (HRT) is not successful or is contraindicated for the treatment of climacteric symptoms in some patients. To investigate whether certain herbal formulas of traditional Chinese medicine (Kampo in Japanese) could be used as an alternative treatment, a longitudinal 'before and after' comparative study was carried out in 18 Japanese women, and the results were compared with those of 16 women who underwent HRT. Kampo improved all the climacteric symptoms. In contrast, improvement of cold limbs, sleeping disorders, shoulder stiffness/lumbago, and fatigue in the HRT group was either not significant or of limited extent. In addition, the serum level of estradiol in postmenopausal women was raised by the combined use of two Kampo formulas. These results suggest that Kampo may be considered an alternative to HRT for the treatment of climacteric symptoms, but vigorous monitoring for potential side effects of increased estrogen levels in some postmenopausal patients is needed.
Copyright 2004 S. Karger AG, Basel
Takao Hidaka, Rika Yonezawa, Shigeru Saito
Kami-shoyo-san, Kampo (Japanese traditional medicine), is effective for climacteric syndrome, especially in hormone-replacement-therapy-resistant patients who strongly complain of psychological symptoms.
J Obstet Gynaecol Res. 2013 Jan;39(1):223-8. doi: 10.1111/j.1447-0756.2012.01936.x. Epub 2012 Jul 6.
Abstract/Text
AIM: Hormone replacement therapy (HRT) for climacteric symptoms is effective for vasomotor symptoms, such as hot flushes and sweating, but not for various psychological symptoms, such as anxiety, depression, and irritability. In such cases, prescribing Kampo, traditional herbal medicine, is sometimes considered. However, the effectiveness of Kampo has not been clearly shown. We examined the clinical effect of Kami-shoyo-san, a herbal formula commonly prescribed for climacteric symptoms in a Japanese Kampo clinic.
METHODS: There were 180 patients who initially consulted our Kampo Outpatient Clinic due to the absence of a response to HRT or unsatisfactory improvement. Out of 180 patients, 45 patients received a Kami-shoyo-san extract for 4 weeks based on patient-centered Kampo diagnosis. We evaluated the severity of climacteric symptoms based on the visual analogue scale (VAS) score before and after 4 weeks of Kami-shoyo-san administration. Furthermore, the severity of each symptom before treatment was compared between the responders and non-responders.
RESULTS: Kami-shoyo-san was effective in 33 (73.3%) of the 45 patients. After treatment, on the whole, the VAS score significantly decreased (P < 0.0001). Concerning vasomotor symptoms and psychological symptoms, each VAS score significantly decreased (P<0.0001). When comparing the severity of pretreatment symptoms between responders and non-responders, symptoms, such as 'insomnia', 'depression', and 'vertigo' were significantly more marked in the responders (P<0.05).
CONCLUSION: The results of this study suggest that Kami-shoyo-san relieved both vasomotor and psychological symptoms, and especially in patients with marked psychological symptoms, it exhibited potent effects.
© 2012 The Authors. Journal of Obstetrics and Gynaecology Research © 2012 Japan Society of Obstetrics and Gynecology.
Kiyoshi Takamatsu, Mariko Ogawa, Satoshi Obayashi, Takashi Takeda, Masakazu Terauchi, Tsuyoshi Higuchi, Kiyoko Kato, Toshiro Kubota
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Effects of Kamishoyosan, a Traditional Japanese Medicine, on Menopausal Symptoms: The KOSMOS Study.
Evid Based Complement Alternat Med. 2021;2021:8856149. doi: 10.1155/2021/8856149. Epub 2021 Feb 26.
Abstract/Text
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.
Copyright © 2021 Kiyoshi Takamatsu et al.
Masakazu Terauchi, Shiro Hiramitsu, Mihoko Akiyoshi, Yoko Owa, Kiyoko Kato, Satoshi Obayashi, Eisuke Matsushima, Toshiro Kubota
Effects of three Kampo formulae: Tokishakuyakusan (TJ-23), Kamishoyosan (TJ-24), and Keishibukuryogan (TJ-25) on Japanese peri- and postmenopausal women with sleep disturbances.
Arch Gynecol Obstet. 2011 Oct;284(4):913-21. doi: 10.1007/s00404-010-1779-4. Epub 2010 Dec 1.
Abstract/Text
PURPOSE: To assess the effects of Kampo, a traditional Japanese adaptation of Chinese herbal medicine, on peri- and postmenopausal women with sleep disturbances.
METHODS: Among the records of 1,523 peri- and postmenopausal women who are enrolled in the Health and Nutrition Education Program at the Tokyo Medical and Dental University, Menopause Clinic, during 1995-2009, about 151 women suffering from moderate to severe sleep disturbances were retrospectively analyzed. These women had received only health/nutrition education (control; n = 77) or received treatment with one of the three major Kampo formulae: Tokishakuyakusan (TJ-23; n = 42), Kamishoyosan (TJ-24; n = 16), or Keishibukuryogan (TJ-25; n = 16) according to their "Sho" or symptom patterns. Subjective sleep parameters, menopausal symptoms, health-related quality of life, body composition, blood pressure, and pulse rate were compared before and after the intervention.
RESULTS: The TJ-25 group had significantly higher body weight, body mass index, body fat, lean body mass, resting energy expenditure, and relatively high blood pressure and heart rate at baseline than the other groups. After ~5-month follow up, TJ-23 reduced the sleep disruption frequency, increased lean body mass, and decreased diastolic pressure. TJ-24 alleviated subjective sleep disturbances; improved difficulties in initiating sleep, disrupted sleep, and non-restorative sleep; and relieved headache/dizziness. TJ-25 improved subjective sleep disturbances, alleviated perspiration, and reduced systolic/diastolic pressure and heart rate.
CONCLUSIONS: Each of the Kampo formulae effectively alleviated sleep disturbances in Japanese peri- and postmenopausal women. Middle-aged female patients having sleeping disorder could successfully be treated using Kampo medicines.
Takahisa Ushiroyama, Atsushi Ikeda, Kou Sakuma, Minoru Ueki
Comparing the effects of estrogen and an herbal medicine on peripheral blood flow in post-menopausal women with hot flashes: hormone replacement therapy and gui-zhi-fu-ling-wan, a Kampo medicine.
Am J Chin Med. 2005;33(2):259-67. doi: 10.1142/S0192415X05002813.
Abstract/Text
We investigated the association between blood flow in the extremities and hot flashes, and compared change in blood flow following hormone replacement therapy (HRT) and Gui-zhi-fu-ling-wan (Keishi-bukuryo-gan), a herbal therapy in post-menopausal women with hot flashes. Three hundred and fifty-two post-menopausal women aged 46-58 years (mean: 53.4 +/- 3.6 years) with climacteric complaints participated in the study. One hundred and thirty-one patients with hot flashes were treated with HRT (64 cases) or herbal therapy (67 cases). Blood flow was measured with laser doppler fluxmetry under the jaw, in the middle finger and in the third toe. Post-menopausal women with hot flashes (129 cases) showed significantly higher blood flow under the jaw (13.6 +/- 4.13) than women without hot flashes (166 cases) (5.48 +/- 0.84) (p < 0.0001). Blood flow at this site decreased significantly with either therapy (p < 0.0001). On the other hand, the administration of Gui-zhi-fu-lingwan significantly increased (p = 0.002) the blood flow in the lower extremities, whereas HRT decreased the blood flow. Thus, we have demonstrated that Gui-zhi-fu-ling-wan did not affect the activity of vasodilator neuropeptides on sensory neurons of systemic peripheral vessels uniformly. Therefore, Gui-zhi-fu-ling-wan, rather than HRT, is suggested as an appropriate therapy for treatment of hot flashes in the face and upper body with concomitant coldness in the lower body, which is one of the symptoms of menopause.
Toshiaki Kogure, Katsuhiko Ito, Hiroko Sato, Tomoyuki Ito, Yuko Oku, Jun Horiguchi, Izumi Takeyoshi, Takeshi Tatsumi
Efficacy of Nyoshinsan/TJ-67, a traditional herbal medicine, for menopausal symtoms following surgery and adjuvant chemotherapy for premenopausal breast cancer.
Int J Clin Oncol. 2008 Apr;13(2):185-9. doi: 10.1007/s10147-007-0718-2. Epub 2008 May 8.
Abstract/Text
We report a 39-year-old woman with premenopausal breast cancer who developed estrogen-deficiency symptoms associated with chemotherapy-related amenorrhea, and was successfully treated with Nyoshinsan/TJ-67, a Japanese traditional herbal medicine (Kampo). Six other breast cancer survivors with menopausal symptoms were also treated with Nyoshinsan/TJ-67, and five of the six patients showed noticeable improvement without adverse effects. Managing estrogen-deficiency symptoms in breast cancer survivors is still problematic, and Nyoshinsan/TJ-67 may be a useful and safe agent for such symptoms in these patients.
Kazuo Yamada, Shigenobu Kanba
Effectiveness of kamishoyosan for premenstrual dysphoric disorder: open-labeled pilot study.
Psychiatry Clin Neurosci. 2007 Jun;61(3):323-5. doi: 10.1111/j.1440-1819.2007.01649.x.
Abstract/Text
The purpose of the present paper was to investigate the efficacy of kamishoyosan (TJ-24), a traditional Japanese herbal formula (kampo), for outpatients with premenstrual dysphoric disorder (PMDD) as an alternative treatment. Thirty patients with PMDD were treated with TJ-24 for six menstrual cycles. Nineteen patients (63.3%) had >50% improvement in the total score of the Hamilton Depression Rating Scale (HAM-D) Scale (17 items) in the late luteal phase. Fourteen patients (46.7%) went into remission (total HAM-D score <7). In the present study many patients with PMDD were successfully treated with TJ-24.
Kazuo Yamada, Gohei Yagi, Shigenobu Kanba
Effectiveness of Gorei-san (TJ-17) for treatment of SSRI-induced nausea and dyspepsia: preliminary observations.
Clin Neuropharmacol. 2003 May-Jun;26(3):112-4.
Abstract/Text
Selective serotonin reuptake inhibitors (SSRIs) are apt to cause gastrointestinal adverse events such as nausea and dyspepsia. Gorei-san (TJ-17), which is composed of five herbs (Alismatis rhizoma, Atractylodis lanceae rhizoma, Polyporus, Hoelen, and Cinnamomi cortex), is a Japanese herbal medicine that has been used to treat nausea, dry mouth, edema, headache, and dizziness. The authors investigated the efficacy of TJ-17 for patients who experienced nausea or dyspepsia induced by SSRIs. Twenty outpatients who experienced nausea or dyspepsia induced by SSRIs were recruited for the study. Seventeen patients were female, three were male, and patient age ranged from 21 to 74 years (49.8 +/- 17.0 years). TJ-17 was added to the previous regimen. Nausea and dyspepsia disappeared completely in nine patients, decreased in four patients, decreased slightly in two patients, and did not change in five patients. No adverse events were associated with the addition of TJ-17 in any patient.
T Tanaka
Effects of herbal medicines on menopausal symptoms induced by gonadotropin-releasing hormone agonist therapy.
Clin Exp Obstet Gynecol. 2001;28(1):20-3.
Abstract/Text
The therapeutic effects of certain Japanese herbal medicines on menopausal symptoms induced by gonadotropin-releasing hormone agonist therapy were examined in Japanese women with endometriosis, adenomyosis, or leiomyoma. Menopausal symptoms occurred in 17 of the 22 patients. Toki-shakuyaku-san, Shakuyaku-kanzo-to, Keishi-bukuryo-gan, Kami-shoyo-san, Tokaku-joki-to, or Keishi-to was administered to 13 of the 17 patients with menopausal symptoms, and efficacy was observed in all 13. Eleven patients with hot flashes were treated with Toki-shakuyaku-san, and all II patients experienced some relief; four experienced total relief. Three patients complaining of severe shoulder stiffness were treated with Shakuyaku-kanzo-to and were completely relieved of symptoms. There was no significant change in serum estradiol levels after treatment with the Japanese herbal medicines. Our results indicate that Japanese herbal medicines can be recommended for menopausal symptoms induced by gonadotropin-releasing hormone agonists without a negative effect on serum estradiol levels.
