Effectiveness and Safety of East Asian Herbal Medicine for Menopausal Insomnia: a Systematic Review and Meta-analysis

Overview

Journal Front Pharmacol

Date 2024 Aug 23

PMID 39175534

Authors

Chan-Young Kwon

Boram Lee

Ji-Yeon Lee

Affiliations

Soon will be listed here.

Abstract

Menopausal insomnia significantly impacts the quality of life in women. East Asian herbal medicines (EAHMs) have been traditionally used in Asian countries, but their efficacy and safety require systematic evaluation. This systematic review and meta-analysis aimed to evaluate the effectiveness and safety of EAHM for treating menopausal insomnia. A comprehensive literature search was conducted across 10 electronic databases from inception until 19 July 2023. Randomized controlled trials (RCTs) investigating EAHM for menopausal insomnia were included. Two reviewers independently screened studies, extracted data, and assessed the risk of bias using the Cochrane risk of bias tool. The primary outcome was sleep quality, insomnia severity, and sleep architecture. Secondary outcomes included total effective rate (TER), menopausal symptoms, and adverse effects. Meta-analysis was conducted using a random-effects model, and the results were calculated as mean differences (MDs) or risk ratios (RRs) and their 95% confidence intervals (CIs). Also, the certainty of evidence was assessed using the GRADE approach. A total of 70 RCTs involving 6,035 participants met the inclusion criteria. The most frequently used EAHMs were modified Suan Zao Ren Tang, and the most frequently used herbal component was Zizyphus jujuba Miller var. spinosa Hu ex H. F. Chou [Rhamnaceae; Zizyphi Semen]. Compared with sedative-hypnotics, EAHM significantly improved sleep quality, as measured by the Pittsburgh Sleep Quality Index (PSQI) (MD -2.18, 95% CI -2.56 to -1.80), and reduced menopausal symptoms, as assessed by the Kupperman Index (MD -4.92, 95% CI -6.03 to -3.80). Similar results were seen when EAHM was added to sedative-hypnotics. When EAHM was additionally used in sedative-hypnotics, similar benefits were shown for PSQI (MD -2.46, 95% CI -3.09 to -1.82) and the Kupperman Index (MD -4.64, 95% CI -5.07 to -4.21). EAHM was generally safer than sedative-hypnotics, with significantly fewer adverse reactions (RR 0.15, 95% CI 0.07-0.34). However, the certainty of evidence was moderate to low. EAHMs, alone or with sedative-hypnotics, may be effective and safe for improving sleep quality and managing menopausal symptoms. Future studies should include diverse populations, rigorous methodologies, and explore mechanisms of action to confirm these findings. Systematic Review Registration: [https://www.crd.york.ac.uk/prospero/display_record.php?], identifier [CRD42023446708].

References

Gao J, Wang Q, Huang Y, Tang K, Yang X, Cao Z . Study of Anti-Insomnia Mechanism for Suanzaoren Prescription. Front Pharmacol. 2019; 10:925. PMC: 6713715. DOI: 10.3389/fphar.2019.00925. View

Li X, Chen W, Simal-Gandara J, Georgiev M, Li H, Hu H . West meets east: open up a dialogue on phytomedicine. Chin Med. 2021; 16(1):57. PMC: 8287783. DOI: 10.1186/s13020-021-00467-6. View

Jia Y, Huang D, Wen J, Wang Y, Rosman L, Chen Q . Assessment of Language and Indexing Biases Among Chinese-Sponsored Randomized Clinical Trials. JAMA Netw Open. 2020; 3(5):e205894. PMC: 7256669. DOI: 10.1001/jamanetworkopen.2020.5894. View

Desmawati D, Sulastri D . Phytoestrogens and Their Health Effect. Open Access Maced J Med Sci. 2019; 7(3):495-499. PMC: 6390141. DOI: 10.3889/oamjms.2019.044. View

Tsai Y, Lai J, Wu C, Lin S . Concurrent Use in Taiwan of Chinese Herbal Medicine Therapies among Hormone Users Aged 55 Years to 79 Years and Its Association with Breast Cancer Risk: A Population-Based Study. Evid Based Complement Alternat Med. 2014; 2014:683570. PMC: 4058844. DOI: 10.1155/2014/683570. View

Salari N, Hasheminezhad R, Hosseinian-Far A, Rasoulpoor S, Assefi M, Nankali S . Global prevalence of sleep disorders during menopause: a meta-analysis. Sleep Breath. 2023; 27(5):1883-1897. PMC: 9996569. DOI: 10.1007/s11325-023-02793-5. View

Cho S, Park J, Pae A, Han D, Kim D, Cho N . Hypnotic effects and GABAergic mechanism of licorice (Glycyrrhiza glabra) ethanol extract and its major flavonoid constituent glabrol. Bioorg Med Chem. 2012; 20(11):3493-501. DOI: 10.1016/j.bmc.2012.04.011. View

Wu T, Li Y, Bian Z, Liu G, Moher D . Randomized trials published in some Chinese journals: how many are randomized?. Trials. 2009; 10:46. PMC: 2716312. DOI: 10.1186/1745-6215-10-46. View

Hajirahimkhan A, Dietz B, Bolton J . Botanical modulation of menopausal symptoms: mechanisms of action?. Planta Med. 2013; 79(7):538-53. PMC: 3800090. DOI: 10.1055/s-0032-1328187. View

10.

Hajirahimkhan A, Simmler C, Yuan Y, Anderson J, Chen S, Nikolic D . Evaluation of estrogenic activity of licorice species in comparison with hops used in botanicals for menopausal symptoms. PLoS One. 2013; 8(7):e67947. PMC: 3709979. DOI: 10.1371/journal.pone.0067947. View

11.

Ciano C, King T, Wright R, Perlis M, Sawyer A . Longitudinal Study of Insomnia Symptoms Among Women During Perimenopause. J Obstet Gynecol Neonatal Nurs. 2017; 46(6):804-813. PMC: 5776689. DOI: 10.1016/j.jogn.2017.07.011. View

12.

Mahmoudi R, Ansari S, Haghighizadeh M, Maram N, Montazeri S . Investigation the effect of jujube seed capsule on sleep quality of postmenopausal women: A double-blind randomized clinical trial. Biomedicine (Taipei). 2021; 10(4):42-48. PMC: 7735973. DOI: 10.37796/2211-8039.1038. View

13.

Coyle M, Liu J, Yang H, Wang K, Zhang A, Guo X . Licorice (Glycyrrhiza spp.) and jujube (Ziziphus jujuba Mill.) formula for menopausal symptoms: Classical records, clinical evidence and experimental data. Complement Ther Clin Pract. 2021; 44:101432. DOI: 10.1016/j.ctcp.2021.101432. View

14.

Balshem H, Helfand M, Schunemann H, Oxman A, Kunz R, Brozek J . GRADE guidelines: 3. Rating the quality of evidence. J Clin Epidemiol. 2011; 64(4):401-6. DOI: 10.1016/j.jclinepi.2010.07.015. View

15.

Kim D, Shih C, Cheng H, Kwon S, Kim H, Lim B . A comparative study of the traditional medicine systems of South Korea and Taiwan: Focus on administration, education and license. Integr Med Res. 2021; 10(3):100685. PMC: 7903058. DOI: 10.1016/j.imr.2020.100685. View

16.

Zhu X, Tao M, Hu H, Gao J, Chen J, Lu T . The Efficacy and Safety of Zaoren Anshen Capsule in Combination with Zolpidem for Insomnia: A Multicentre, Randomized, Double-Blinded, Placebo-Controlled Trial. Evid Based Complement Alternat Med. 2022; 2022:5867523. PMC: 9711951. DOI: 10.1155/2022/5867523. View

17.

Buysse D, Reynolds 3rd C, Monk T, BERMAN S, Kupfer D . The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989; 28(2):193-213. DOI: 10.1016/0165-1781(89)90047-4. View

18.

Li M, Hung A, Lenon G, Yang A . Chinese herbal formulae for the treatment of menopausal hot flushes: A systematic review and meta-analysis. PLoS One. 2019; 14(9):e0222383. PMC: 6752783. DOI: 10.1371/journal.pone.0222383. View

19.

Kravitz H, Joffe H . Sleep during the perimenopause: a SWAN story. Obstet Gynecol Clin North Am. 2011; 38(3):567-86. PMC: 3185248. DOI: 10.1016/j.ogc.2011.06.002. View

20.

Bruni O, Ferini-Strambi L, Giacomoni E, Pellegrino P . Herbal Remedies and Their Possible Effect on the GABAergic System and Sleep. Nutrients. 2021; 13(2). PMC: 7914492. DOI: 10.3390/nu13020530. View