Traditional Chinese Medicine for Perimenopause

Traditional Chinese Medicine (TCM) has garnered increasing attention as a potential complementary or alternative therapy for perimenopause, a transitional period marked by fluctuating hormone levels and a range of associated symptoms. Several randomized controlled trials (RCTs) have investigated the efficacy and safety of various TCM interventions, such as herbal formulas and acupuncture, in managing these perimenopausal symptoms. Understanding the findings of these trials is crucial for evaluating the potential role of TCM in improving the well-being of women during this life stage.

Protocols Studied in Research

[1] Real and sham acupuncture for comorbid perimenopausal depression and insomnia. (Cited by: 8) (pmid: 36815166)

• Protocol: A patient-assessor-blinded, randomized, sham-controlled trial with 70 women. Participants received 17 acupuncture sessions over 8 weeks. Outcomes were assessed using HAM-D(17) and PSQI scores at baseline, post-treatment, 8 weeks, and 16 weeks.
• Outcome: Acupuncture showed significant short-term improvement in sleep quality (PSQI), but the improvement in mood (HAM-D) wasn't significantly different from sham. No long-term benefits were observed at 16 weeks. The treatment was safe and well-tolerated.

[2] Bushen Tiaogan formula (BSTG) plus Traditional Chinese Medicine-based psychotherapy (TBP) for perimenopausal depression (PMD). (Cited by: 6) (pmid: 31513088)

• Protocol: A randomized, placebo-controlled trial in 307 Chinese women with PMD. Participants received either BSTG + TBP or placebo + TBP for 8 weeks, followed by 4 weeks of follow-up.
• Outcome: BSTG plus TBP was significantly more effective than placebo plus TBP in reducing PMD symptoms (GCS, SDS, SAS scores), improving certain lipid and hormone levels (FSH, triglycerides, HDL), and had no serious adverse effects.

[3] Acupuncture for peri-menopausal insomnia (PMI). (Cited by: 37) (pmid: 29029258)

• Protocol: A randomized, placebo-controlled trial with 76 peri-menopausal women with insomnia. Participants received 10 acupuncture sessions (or placebo acupuncture) over 3 weeks targeting specific acupoints. Sleep quality was assessed using PSQI, ISI, and polysomnography.
• Outcome: Acupuncture significantly improved sleep quality (PSQI, ISI) and sleep parameters (sleep efficiency, total sleep time) compared to placebo acupuncture, suggesting short-term clinical benefit for PMI.

[4] Electroacupuncture (EA) for mild-to-moderate depression in perimenopausal women. (Cited by: 17) (pmid: 30003102)

• Protocol: A multicenter, randomized, controlled trial compared 36 sessions of EA to escitalopram in 242 perimenopausal women with mild-to-moderate depression. Outcomes included HAMD-17, MENQOL, and serum hormone levels.
• Outcome: Both EA and escitalopram improved depression symptoms (HAMD-17) and quality of life (MENQOL) at 24-week follow-up, with no significant difference between groups. EA was deemed safe and effective.

[5] Jiawei Qing'e Fang (JQF), a Chinese herbal medicine, for hot flashes and quality of life in perimenopausal women. (Cited by: 11) (pmid: 22089177)

• Protocol: A 12-week randomized, double-blind, placebo-controlled trial involving 72 perimenopausal women with frequent hot flashes. Participants received JQF or placebo for 8 weeks, with a 4-week follow-up.
• Outcome: JQF was significantly better than placebo at reducing hot flashes and improving vasomotor and physical aspects of menopausal quality of life. JQF also showed potential benefit in reducing triglyceride levels. No serious adverse events were reported.

[6] Gua sha therapy for perimenopausal syndrome. (Cited by: 8) (pmid: 27760084)

• Protocol: A randomized controlled trial of 80 women with perimenopausal syndrome. The intervention group received 15-minute Gua sha sessions weekly for 8 weeks, in addition to conventional treatment; the control group received conventional treatment only.
• Outcome: Gua sha therapy significantly reduced perimenopausal symptoms and improved quality of life compared to the control group, with no significant changes in serum hormone levels. The therapy is suggested as a safe and effective non-drug treatment option.

[7] Tianwang Buxin Granules (TWBXG) for perimenopausal insomnia (PI). (Cited by: 13) (pmid: 34825005)

• Protocol: A study of 13 perimenopausal women with insomnia and their non-insomniac spouses. Participants received TWBXG for 4 weeks; gut microbiota was analyzed via metagenomic sequencing before and after treatment, and insomnia severity was measured using the PSQI scale.
• Outcome: TWBXG improved insomnia symptoms (reduced PSQI scores). The treatment altered the gut microbiota composition, suggesting a potential mechanism of action through modulation of specific bacterial genera. However, complete normalization of gut flora wasn't achieved.

[8] Xiaoyao pill for functional dyspepsia (FD) in perimenopausal women with depression. (Cited by: 21) (pmid: 25469046)

• Protocol: A double-blind, randomized, controlled trial with 180 participants. Patients received either Xiaoyao pill or placebo for 8 weeks, followed by 6 months of follow-up. Depression, gastric function (motilin, gastrin levels, gastric emptying), were assessed.
• Outcome: Xiaoyao pill significantly improved FD symptoms and depression scores compared to placebo. Improvements in gastric function were also observed, supporting the pill's efficacy and safety for this patient population.

[9] Combined Chinese medicine therapy (Kunbao Pill and Modified Xiaoyao Pill) and psychological intervention for peri-menopausal syndrome with hyperlipidemia. (Cited by: 7) (pmid: 20473737)

• Protocol: A randomized controlled trial with 185 women assigned to three groups: Chinese medicine only, psychological intervention only, or combined therapy. Treatment lasted six months, with a one-year follow-up.
• Outcome: Combined therapy significantly improved clinical symptoms, lipid profiles, and sex hormone levels compared to either intervention alone. The combined approach showed superior efficacy and no adverse effects.

[10] Auricular point seed burying combined with fire dragon pot moxibustion for perimenopausal insomnia. (Cited by: 1) (pmid: 35508300)

• Protocol: A randomized controlled trial of 70 perimenopausal women with insomnia. The control group received auricular seed burying; the observation group received this plus fire dragon pot moxibustion. Outcomes were measured after 10 weeks using PSQI, SAS, and SDS scores.
• Outcome: Combined auricular seed burying and moxibustion was significantly more effective than seed burying alone in improving sleep quality, reducing anxiety and depression scores, and shortening sleep onset latency in perimenopausal women with insomnia.

[11] Acupuncture treatment for menopausal vasomotor symptoms (VMS). (Cited by: 7) (pmid: 27676631)

• Protocol: A randomized controlled trial of 209 perimenopausal and postmenopausal women (45-60 years old) with frequent VMS. Participants received up to 20 acupuncture treatments over 6 months or were waitlisted. VMS frequency was tracked weekly.
• Outcome: Acupuncture led to four distinct trajectories of VMS change. While ~50% experienced a reduction in VMS frequency, predicting individual response to acupuncture remained difficult. A substantial portion showed minimal improvement.

[12] Menoprogen (herbal remedy) for menopausal symptoms in Chinese women. (Cited by: 3) (pmid: 19769480)

• Protocol: A multicenter prospective observational study in China involving perimenopausal and postmenopausal women seeking alternatives to HRT. Participants received two Menoprogen capsules twice daily.
• Outcome: Menoprogen significantly reduced Kupperman Menopausal Index scores, increased estrogen and progesterone levels, and showed no significant endometrial hyperplasia. Results suggest a rationale for a randomized controlled trial.

[13] He's fire needle therapy combined with walnut-shell moxibustion for perimenopausal dry eye disease. (Cited by: 0) (pmid: 39681489)

• Protocol: A randomized controlled trial (RCT) of 60 perimenopausal women with dry eye disease. The intervention group received fire needle therapy and walnut-shell moxibustion; the control group received hyaluronic acid eye drops. Treatment lasted 4 weeks.
• Outcome: The combined fire needle and moxibustion therapy showed significantly better improvement in dry eye symptoms (tear secretion, tear film break-up time, and symptom scores) compared to hyaluronic acid eye drops.

[14] Bushen Huoxue Anshen Fang (TCM) and acupuncture for perimenopausal sleep disorder with kidney deficiency and blood stasis. (Cited by: 1) (pmid: 30989965)

• Protocol: A randomized controlled trial comparing TCM and acupuncture in 67 women. Both interventions were administered for three 30-day courses. Outcomes included PSQI, Kupperman scores, TCM syndromes, and hormone levels.
• Outcome: Both TCM and acupuncture showed similar efficacy in improving sleep quality and related symptoms. TCM was superior for improving Kupperman scores, while acupuncture showed better effects on PT and TT (coagulation parameters). Both were considered safe and effective.

Research Interpretation: Summary and Conclusion

Multiple randomized controlled trials (RCTs) and one observational study investigated various Traditional Chinese Medicine (TCM) interventions for perimenopausal symptoms, employing diverse protocols including acupuncture, herbal remedies (BSTG+TBP, JQF, Xiaoyao pill, TWBXG, Menoprogen), Gua sha, and moxibustion, often compared to placebo or conventional treatments. Consistent findings across several studies demonstrated short-to-medium-term efficacy of certain TCM interventions for improving sleep quality (PSQI scores), reducing hot flashes, and alleviating depression symptoms (HAM-D scores). Some studies also showed benefits in improving lipid profiles and certain hormone levels. However, the effectiveness varied across different TCM modalities and specific symptoms, with some interventions showing greater impact on certain symptoms than others. While many studies reported safety and tolerability, the long-term benefits remain less clear, with some showing no sustained effects beyond the treatment period. Future research should focus on larger, longer-term studies to confirm these findings and explore potential mechanisms of action, as well as identifying predictors of individual response to specific TCM treatments.

Publications

[1] Zhao FY; Zheng Z; Fu QQ; Conduit R; Xu H; Wang HR; Huang YL; Jiang T; Zhang WJ; Kennedy GA (2023). Acupuncture for comorbid depression and insomnia in perimenopause: A feasibility patient-assessor-blinded, randomized, and sham-controlled clinical trial Frontiers in public health 11 :1120567.

[2] Cao XJ; Huang XC; Wang X (2019). Effectiveness of Chinese herbal medicine granules and traditional Chinese medicine-based psychotherapy for perimenopausal depression in Chinese women: a randomized controlled trial Menopause (New York, N.Y.) 26 (10) :1193-1203.

[3] Fu C; Zhao N; Liu Z; Yuan LH; Xie C; Yang WJ; Yu XT; Yu H; Chen YF (2017). Acupuncture Improves Peri-menopausal Insomnia: A Randomized Controlled Trial Sleep 40 (11).

[4] Li S; Li ZF; Wu Q; Guo XC; Xu ZH; Li XB; Chen R; Zhou DY; Wang C; Duan Q; Sun J; Luo D; Li MY; Wang JL; Xie H; Xuan LH; Su SY; Huang DM; Liu ZS; Fu WB (2018). A Multicenter, Randomized, Controlled Trial of Electroacupuncture for Perimenopause Women with Mild-Moderate Depression BioMed research international 2018 :5351210.

[5] Xia Y; Zhao Y; Ren M; Zhang J; Wang Y; Chang Y; Fu S; Fan G; Zhu Y; Huang Y; Gao X (2012). A randomized double-blind placebo-controlled trial of a Chinese herbal medicine preparation (Jiawei Qing'e Fang) for hot flashes and quality of life in perimenopausal women Menopause (New York, N.Y.) 19 (2) :234-44.

[6] Meng F; Duan PB; Zhu J; Lou QQ; Fang ZH; An HL; Liu LY; Hu Y; Hu Q (2017). Effect of Gua sha therapy on perimenopausal syndrome: a randomized controlled trial Menopause (New York, N.Y.) 24 (3) :299-307.

[7] Yang X; Xiao H; Zeng Y; Huang L; Ji K; Deng D; Yang W; Liu L (2021). Tianwang Buxin Granules Influence the Intestinal Flora in Perimenopausal Insomnia BioMed research international 2021 :9979511.

[8] Du HG; Ming L; Chen SJ; Li CD (2014). Xiaoyao pill for treatment of functional dyspepsia in perimenopausal women with depression World journal of gastroenterology 20 (44) :16739-44.

[9] Qian LQ; Wang B; Niu JY; Gao S; Zhao DY (2010). Assessment of the clinical effect of Chinese medicine therapy combined with psychological intervention for treatment of patients of peri-menopausal syndrome complicated with hyperlipidemia Chinese journal of integrative medicine 16 (2) :124-30.

[10] Feng H; Pan A; Zheng G; Yu W (2022). Clinical study of auricular point seed burying combined with fire dragon pot moxibustion in perimenopausal women with insomnia The journal of obstetrics and gynaecology research 48 (7) :1938-1944.

[11] Avis NE; Coeytaux RR; Levine B; Isom S; Morgan T (2017). Trajectories of response to acupuncture for menopausal vasomotor symptoms: the Acupuncture in Menopause study Menopause (New York, N.Y.) 24 (2) :171-179.

[12] Liu D; Lu Y; Ma H; Wei RC; Li J; Fang J; Mahady GB (2009). A pilot observational study to assess the safety and efficacy of Menoprogen for the management of menopausal symptoms in Chinese women Journal of alternative and complementary medicine (New York, N.Y.) 15 (1) :79-85.

[13] Zeng Q; Hong QY; Yao J; Liu XJ; Liu NG (2024). [Observation on the clinical effect of He's fire needle therapy combined with walnut-shell moxibustion on perimenopausal dry eye disease] Zhen ci yan jiu = Acupuncture research 49 (12) :1303-1309.

[14] Ma K; Chen YX; Dong ML (2019). [Clinical efficacy of Bushen Huoxue Anshen therapy in treating perimenopausal sleep disorder with kidney deficiency and blood stasis] Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica 44 (6) :1069-1074.