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J Ethnopharmacol. 2018 Apr 24;216:162-174. doi: 10.1016/j.jep.2018.01.028. Epub 2018 Feb 6.

Efficacy and safety of Pueraria candollei var. mirifica (Airy Shaw & Suvat.) Niyomdham for menopausal women: A systematic review of clinical trials and the way forward.

Author information

1
Centre for Safety and Quality in Health, Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand; Research Department of Practice and Policy, School of Pharmacy, University College London, UK. Electronic address: chuenjid@googlemail.com.
2
Centre for Safety and Quality in Health, Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand. Electronic address: normans@nu.ac.th.
3
Centre for Safety and Quality in Health, Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand. Electronic address: teerapond@nu.ac.th.
4
Center of Pharmaceutical Outcomes Research, Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand. Electronic address: piyamethd@gmail.com.
5
School of Pharmacy, Monash University Malaysia, Kuala Lumpur, Malaysia; Center of Pharmaceutical Outcomes Research, Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand; Center of Health Outcomes Research and Therapeutic Safety (Cohorts), School of Pharmaceutical Sciences, University of Phayao, Phayao, Thailand. Electronic address: saokaew@gmail.com.
6
School of Pharmacy, Monash University Malaysia, Kuala Lumpur, Malaysia; Center of Pharmaceutical Outcomes Research, Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand; Asian Centre for Evidence Synthesis in Population, Implementation and Clinical Outcomes (PICO), Health and Well-being Cluster, Global Asia in the 21st Century (GA21) Platform, Monash University Malaysia, Bandar Sunway, Selangor, Malaysia; School of Pharmacy, University of Wisconsin-Madison, Madison, WI, USA. Electronic address: nathorn.chaiyakunapruk@monash.edu.

Abstract

ETHNOPHARMACOLOGICAL RELEVANCE:

Pueraria candollei var. mirifica (Airy Shaw & Suvat.) Niyomdham (commonly termed P. mirifica, PM) growing in upland Thailand has a long history as a postmenopausal rejuvenant therapy for indigenants. Its amelioration of menopause symptoms in clinical trials was assessed.

MATERIALS AND METHODS:

International and Thai databases were searched from inception to February 2017. Clinical trials investigating effects of PM menopausal or postmenopausal women were included. Outcomes were self-reported menopausal symptoms, serum reproductive hormones, urino-genital tract function, and bone surrogates. Methodological quality was assessed by Cochrane risk-of-bias v2.0, and a 22-parameter quality score based on the CONSORT checklist for herbal medicines.

RESULTS:

Eight studies (9 articles) used data from 309 menopausal patients. Five-studies demonstrated that PM was associated with climacteric scores reduced by ~50% compared to baseline. Other PM studies using limited numbers of placebo participants suggested improved vaginal and other urogenital tract symptoms. Bone alkaline phosphatase halved (suggesting lowered bone turnover). Variable serum reproductive hormone levels suggested menopausal status differed between studies. PM active ingredients and sources were not defined. Adverse event rates (mastodynia, vaginal spotting, dizziness) were similar in all groups (PM, conjugated equine estrogen, and placebos) but serum C-reactive protein doubled. These studies had design and reporting deficiencies, high risks of biases, and low quality scores.

CONCLUSIONS:

The efficacy of PM on menopausal symptoms remains inconclusive because of methodological short-comings especially placebo effects inherent in self-assessment/recall questionnaires and no PM standardization. PM efficacy and safety need a fundamental re-appraisal by: (i) cohort (retro- and prospective) studies on current users to define its traditional use for rejuvenation; (ii) tightly coupling long-term efficacy to safety of well-defined PM and multiple end-points; (iii) using study design related to current understanding of menopause progression and estrogen pharmacology (iv) robust pharmacovigilance.

KEYWORDS:

Clinical trials; Menopause; Phytoestrogens; Postmenopausal; Pueraria candollei var. mirifica (Airy Shaw & Suvat.) Niyomdham; Pueraria mirifica

PMID:
29409850
DOI:
10.1016/j.jep.2018.01.028
[Indexed for MEDLINE]

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