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.
METHODS: This was a retrospective study on women attending a tertiary urogynecological unit. The assessment included an interview, POPQ assessment, Modified Oxford Scale (MOS) score, and 4D translabial ultrasound (US) on PFM contraction (PMFC). Hormonal status and details on hormone replacement therapy (HRT) were recorded. Corrected menopausal age was defined as the duration of systemic estrogen deprivation. Offline analysis of stored US volumes was performed to measure the reduction in anteroposterior hiatal diameter and bladder neck elevation on PFMC at a later date.
RESULTS: Seven hundred thirty-nine women were seen during the study period. Fifty-three were excluded for missing data, leaving 686. Mean age was 56 (17-89, SD 13.3) years; average BMI was 29 (16-66, SD 6.6) kg/m²; 60.6% (n = 416) were menopausal at a mean duration of 16 (1-56, SD 10.2) years. Forty-nine (7.1%) were currently on systemic HRT, while 104 (15.2%) had used it previously. Mean corrected menopausal age (menopausal age - systemic HRT duration) was 7.4 (0-56, SD 10.0) years. Current local estrogen use ≥ 3 months was reported by 31 (4.5%). Mean PFM contractility measured by MOS was 2 (0-5, SD 1.1,). On multivariate analysis there was no association between menopausal age and PFM contractility.
CONCLUSIONS: Estrogen deprivation may not be an independent predictor of pelvic floor muscle contractility.