JBM  Vol.7 No.4 , April 2019
The Efficacy and Safety of Modified Xiaoyao San for Perimenopausal Syndrome (PMS): A Systematic Review and Meta-Analysis
Abstract: Objectives: To assess the efficacy and safety of modified Xiaoyao San (XYS) for treating Perimenopausal syndrome (PMS). Methods: Literature searches were carried out on PubMed, Cochrane Library, CNKI Database, Chinese Biomedical Literature Database, Wan Fang Database, and VIP Database up to December 2018. Hand search for further references was conducted. Study selection, data extraction, quality assessment, and data analyses were performed as request of the Cochrane standards. Results: Nine publications in total were suitable for inclusion. There was evidence that modified XYS was tested to be more effective in improving overall symptoms compared with HRT (odds ratio 3.50, 95% CI 2.56 to 4.78). Whereas HRT was more sensitive and direct in decreasing FSH (WMD 6.69, 95% CI 5.60 to 9.52) and LH (WMD 7.00, 95% CI, 5.75 to 8.25) in comparison with XYS group. It was also strongly supported that XYS had less adverse effect than HRT (odds ratio 0.07, 95% CI 0.05 to 0.10). Conclusion: Modified XYS might be more effective and safer in treatment of perimenopausal syndrome. However, due to poor methodological quality in the majority of included studies, the potential benefit and safety about XYS need to be confirmed in rigorously designed, multi-centre, and large-scale trials.
Cite this paper: Hao, W. , Gong, L. and Xue, F. (2019) The Efficacy and Safety of Modified Xiaoyao San for Perimenopausal Syndrome (PMS): A Systematic Review and Meta-Analysis. Journal of Biosciences and Medicines, 7, 60-72. doi: 10.4236/jbm.2019.74007.

[1]   Jaspers, L., van Dijk, G.M., Roeters van Lennep, J.E., Franco, O.H., Kavousi, M., et al. (2015) Health in Middle-Aged and Elderly Women: A Conceptual Framework for Healthy Menopause. Maturitas, 81, 93-98.

[2]   Hulka, B.S. and Meirik, O. (1996) Research on the Menopause. Maturitas, 23, 109-112.

[3]   Hartlage, S.A., Freels, S., Gotman, N., et al. (2012) Criteria for Premenstrual Dysphoric Disorder: Secondary Analyses of Relevant Data Sets. Archives of General Psychiatry, 69, 300-305.

[4]   El Shafie, K., Al Farsi, Y., Al Zadjali, N., et al. (2011) Menopausal Symptoms among Healthy, Middle-Aged Omani Women as Assessed with the Menopause Rating Scale. Menopause, 18, 1113-1119.

[5]   Campbell, E.M., Peterkin, D., O’Grady, K. and Sanson-Fisher, R. (1997) Premenstrual Symptoms in General Practice Patients. Prevalence and Treatment. The Journal of Reproductive Medicine, 42, 637-646.

[6]   Borenstein, J., Chiou, C.F., Dean, B., et al. (2005) Estimating Direct and Indirect Costs of Premenstrual Syndrome. Journal of Occupational and Environmental Medicine, 47, 26-33.

[7]   Halbreich, U., Borenstein, J., Pearlstein, T., et al. (2003) The Prevalence, Impairment, Impact, and Burden of Premenstrual Dysphoric Disorder (PMS/PMDD) Psychoneuroendocrinology, 28, 1-23.

[8]   Goldbacher, E.M., Bromberger, J. and Matthews, K.A. (2009) Lifetime History of Major Depression Predicts the Development of the Metabolic Syndrome in Middle-Aged Women. Psychosomatic Medicine, 71, 266-272.

[9]   Genazzani, A.R. and Genazzani, A.D. (2015) Polycystic Ovary Syndrome: From Contraception to Hormone Replacement Therapy. In: Fauser, B.C.J.M. and Genazzani, A.R., Eds., Frontiers in Gynecological Endocrinology, ISGE Series, Springer, Cham, Switzerland, 25-31.

[10]   Panay, N., Hamoda, H. and Arya, R. (2013) The 2013 British Menopause Society& Women’s Health Concern Recommendations on Hormone Replacement Therapy. Menopause International, 19, 59-68.

[11]   Li, C.C., Wang, J.J., Chen, C., et al. (2013) Treating Menopause Syndrome by Kuntai Capsuale and Hormone Replacement Therapy: A Meta-Analysis of Efficacy and Safety Comparison. Chinese Journal of Integrated Traditional Chinese and Western Medicine, 33, 1183-1190.

[12]   Lundqvist, A., Andersson, E., Ahlberg, I., et al. (2016) Socio-Economic Inequalities in Breast Cancer Incidence and Mortality in Europe: A Systematic Review and Meta-Analysis. European Journal of Public Health, 26, 804-813.

[13]   Li, K., Hüsing, A., Fortner, R.T., et al. (2015) An Epidemiologic Risk Prediction Model for Ovarian Cancer in Europe: The EPIC Study. British Journal of Cancer, 112, 1257-1265.

[14]   Boardman, H.M., Hartley, L., Eisinga, A., et al. (2015) Hormone Therapy for Preventing Cardiovascular Disease in Both Healthy Post-Menopausal Women and Post-Menopausal Women with Pre-Existing Cardiovascular Disease. Cochrane Database of Systematic Reviews, No. 3, CD002229.

[15]   Marjoribanks, J., Brown, J., O’Brien, P.M., et al. (2013) Selective Serotonin Reuptake Inhibitors for Premenstrual Syndrome. Cochrane Database of Systematic Reviews, No. 3, CD001396.

[16]   Hu, X.H., Bull, S.A., Hunkeler, E.M., et al. (2004) Incidence and Duration of Side Effects and Those Rated as Bothersome with Selective Serotonin Reuptake Inhibitor Treatment for Depression: Patient Report versus Physician Estimate. Journal of Clinical Psychiatry, 65, 959-965.

[17]   O’Brien, P.M. (1993) Helping Women with Premenstrual Syndrome. BMJ, 307, 1471-1475.

[18]   DeMonico, S.O., Brown, C.S. and Ling, F.W. (1994) Premenstrual Syndrome. Current Opinion in Obstetrics and Gynecology, 6, 499-502.

[19]   Kim, S.Y., Park, H.J. and Lee, H. (2011) Acupuncture for Premenstrual Syndrome: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. BJOG: An International Journal of Obstetrics & Gynaecology, 118, 899-915.

[20]   Hsing, Y., Chen, B.-S., Huang, Y., et al. (2014) Identifying Chinese Herbal Medicine for Premenstrual Syndrome: Implications from a Nationwide Database. BMC Complementary and Alternative Medicine, 14, 206.

[21]   Huang, Z.-J. (2013) The Clinical Observation of the Treatment of Pre-menstrual Syndrome with Xiaoyao Wan. Practical Journal of traditional Chinese Medicine, 29, 86-86.

[22]   Tang, B.-P. and Long, C.-X. (2005) Treatment of 322 Cases of Perimenopausal Syndrome with Xiaoyao Pill. Hunan Journal of Traditional Chinese Medicine, 21, 54.

[23]   Zhang, W.-G. (2014) Clinical Observation on Treatment of Climacteric Syndrome with Xiaoyao Pill. China Practical Medicine, 9, 193.

[24]   Hu, K.-J. (2009) The Treatment on 84 Cases Perimenopausal Syndrome with Danzhi Xiaoyao San. Modern Distance Education of Chinese Medicine, 7, 27-28.

[25]   Yun, Q. and Fu, Y. (2015) The Treatment on Perimenopausal Syndrome with Danzhi Xiaoyao San. Jilin Journal of Traditional Chinese Medicine, 35, 495-497.

[26]   Liu, X.-Y. (2008) Clinical Observation on Treatment of 64 Cases Perimenopausal Syndrome with Danzhi Xiaoyao San. Guiding Journal of Traditional Chinese Medicine, 14, 47-48.

[27]   Zhou, R.-Q. (1997) Clinical Research on Treatment of Spleen Deficient and Liver Depression Type Menopausal Syndrome with Danzhi Xiaoyao Powder in the Treatment of Accumulate Heat. Guangming Journal of traditional Chinese Medicine, 4, 48-50.

[28]   Wang, X.-Y. and Yu, J.-W. (2016) To Explore the Clinical Effect of Modified Xiaoyao Pill in the Treatment of Climacteric Syndrome. Guide of China Medicine, 14, 13-14.

[29]   Zhang, H. (2011) Application of Modified Xiaoyao Pill in the Treatment of Climacteric Syndrome. Guiding Journal of Traditional Chinese Medicine, 08, 92.

[30]   State Administration of Traditional Chinese Medicine (1994) Diagnostic Criteria of TCM Symptoms. Nanjing University Press, Nanjing, 6.

[31]   Li, J. (2004) Concealment Methods of Clinical Random Allocation. Chinese Evidence-Based Medicine, 4, 714-715

[32]   Li, R.-X., Ma, M. and Xiao, X.-R. (2016) Perimenopausal Syndrome and Mood Disorders in Perimenopause: Prevalence, Severity, Relationships, and Risk Factors. Medicine (Baltimore), 95, e4466.

[33]   Kwon, S., Lee, B., Kim, M., et al. (2010) Antidepressant-Like Effect of the Methanolic Extract from Bupleurum Falcatum in the Tail Suspension Test. Progress in Neuro-Psychopharmacology and Biological Psychiatry, 34, 265-270.

[34]   Zhang, X.-J., Zhu, C.-C. and Hu, L. (2002) The Immune Activity of Angelica Sinensis Polysaccharide and Its Effect on Hematopoietic Function. Pharmacology and Clinics of Chinese Materia Medica, 18, 24-25.

[35]   Han, S.B., Kim, Y.H., Lee, C.W., et al. (1998) Characteristic Immunostimulation by Angelan Isolated from Angelica Gigas Nakai. Immunopharmacology, 40, 39-48.

[36]   Mao, Q.-Q., Huang, Z., Ip, S.-P., Xian, Y.-F. and Che, C.-T. (2012) Peony Glycosides Reverse the Effects of Corticosterone on Behavior and Brain BDNF Expression in Rats. Behavioural Brain Research, 227, 305-309.

[37]   Qiu, F.-M., Zhong, X.-M., Mao, Q.-Q. and Huang, Z. (2013) Antidepressant-Like Effects of Paeoniflorin on the Behavioural, Biochemical, and Neurochemical Patterns of Rats Exposed to Chronic Unpredictable Stress. Neuroscience Letters, 541, 209-213.

[38]   Zhang, C.-Y., Tang, Y.-X., Zeng, N., et al. (2009) Xiaoyao Powder and Its Formula for the Effect of Behavioral Depression Model Rats. Journal of Chengdu University of Traditional Chinese Medicine, 32, 51-53.

[39]   Chou, P.B., Morse, C.A. and Xu, H. (2008) A Controlled Trial of Chinese Herbal Medicine for Premenstrual Syndrome. Journal of Psychosomatic Obstetrics & Gynecology, 29,185-192.

[40]   Shen, X., Zhao, Z.-Y., Luo, X., Wang, H., Hu, B.-X. and Guo, Z.-H. (2016) Systems Pharmacology Based Study of the Molecular Mechanism of SiNiSan Formula for Application in Nervous and Mental Diseases. Evidence-Based Complementary and Alternative Medicine, 2016, Article ID: 9146378.