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Peony-Glycyrrhiza Decoction for Antipsychotic-Related Hyperprolactinemia in Women With Schizophrenia: A Randomized Controlled Trial

Man, Sui Cheung BS; Li, Xian-Bin MD; Wang, Huai-Hai MD; Yuan, Hai-Ning MS; Wang, Hua-Ning MD; Zhang, Rui-Guo MD; Tan, Qing-Rong MD; Wong, Hei Kiu MS; McAlonan, Grainne M. MD, PhD; Wang, Chuan-Yue MD; Zhang, Zhang-Jin MD, PhD

Journal of Clinical Psychopharmacology: December 2016 - Volume 36 - Issue 6 - p 572–579
doi: 10.1097/JCP.0000000000000607
Original Contributions
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Objectives An herbal preparation called peony-glycyrrhiza decoction (PGD) may have the potential in reducing antipsychotic-related hyperprolactinemia (hyperPRL). This double-blind, randomized placebo-controlled study aimed to reevaluate the efficacy of PGD against antipsychotic-related hyperPRL.

Methods Ninety-nine schizophrenic women who were under antipsychotic therapy and had symptomatic hyperPRL were randomly assigned to additional treatment with placebo (n = 50) or PGD (n = 49, 45 g/d) for 16 weeks. The severity of hyperPRL, psychosis, and abnormal involuntary movements was assessed at baseline and weeks 8 and 16 using standard instruments including the Prolactin Related Adverse Event Questionnaire. Blood levels of prolactin (PRL) and related pituitary and sex hormones were measured at the same time points.

Results Peony-glycyrrhiza decoction treatment produced a significantly greater reduction of the Prolactin Related Adverse Event Questionnaire score at weeks 8 and 16 and a greater improvement on abnormal involuntary movements at end point compared with placebo, without altering the severity of psychosis. The group treated with PGD showed significantly higher proportion of having overall improvement on hyperPRL symptoms (χ2 = 4.010, P = 0.045) and menstrual resumption (χ2 = 4.549, P = 0.033) at week 8 than placebo. Serum PRL levels were similar in the 2 groups.

Conclusions Peony-glycyrrhiza decoction is effective in reducing antipsychotic-related hyperPRL and abnormal involuntary movement symptoms, but no reduction in blood PRL concentrations was observed. The underlying mechanisms of PGD's effects need further investigation (trial registration of NCT01852331 at www.clinicaltrials.gov).

From the *School of Chinese Medicine, LKS Faculty of Medicine, the University of Hong Kong, Hong Kong; †Department of Psychiatry, Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital, and ‡Center of Schizophrenia, Beijing Institute for Brain Disorders, Capital Medical University, Beijing; and §Department of Psychiatry, Xijing Hospital, the Fourth Military Medical University, Shaanxi, China; and ∥Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.

Received December 21, 2015; accepted after revision September 8, 2016.

Reprints: Chuan-Yue Wang, MD, PhD, Beijing Anding Hospital, Capital Medical University, 5 Ankang Lane, Deshengmenwai Ave, Xicheng District, Beijing 100088, China (e-mail: wang.cy@163.net); and Zhang-Jin Zhang, MD, PhD, School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Rd, Pokfulam, Hong Kong, China (e-mail: zhangzj@hku.hk).

S.C.M., X.-B.L., and H.-H.W. are joint first authors.

This study was supported in part by the Health and Medical Research Fund (09101141, Z.J.Z.) of the Food and Health Bureau of Hong Kong and the National Natural Science Fund of China (81071083, C.Y.W.).

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