Effect of Combining Therapy with Traditional Chinese Medicine-Based Psychotherapy and Herbal Medicines in Women with Menopausal Syndrome: A Randomized Controlled Clinical Trial

Abstract

This multicenter, randomized, controlled clinical study was designed to address the effectiveness of combined traditional-Chinese-medicine- (TCM-) based psychotherapy and Chinese herbal medicine (CHM) in the treatment of menopausal syndrome. Altogether 424 eligible women diagnosed as menopausal syndrome and categorized as Kidney-Yin/Kidney-Yang deficiency pattern in TCM were randomly assigned into 4 groups and accepted TCM-based psychotherapy (PSY), CHM, PSY + CHM, or placebo therapies, respectively, for 12 weeks, and another 12 weeks were taken as the followup. Kupperman Index (KI) and the Menopause-Specific Quality of Life (MENQOL) with its four subscales (vasomotor, physical, psychosocial, and sexual) were employed for efficacy assessment. Results showed that 400 participants completed 12-week treatment, of which 380 finished the record of KI and MENQOF at week 24. The average adjusted number of KI score decreased between baseline and 12 weeks in all groups. Statistically significant differences were detected in the average adjusted change between the PSY + CHM group and placebo at overall time points (P < 0.05). No severe adverse events occurred in each group and no significant differences were indicated between any of the three groups and placebo in adverse event proportion. We concluded that TCM psychotherapy combined with CHM has a favorable outcome in treating menopausal syndrome.

Astragalin, a Flavonoid from Morus alba (Mulberry) Increases Endogenous Estrogen and Progesterone by Inhibiting Ovarian Granulosa Cell Apoptosis in an Aged Rat Model of Menopause

“…In an attempt to identify the active chemical constituents of the MPG formula that may be responsible for these effects on granulosa cells, we have investigated some of the primary chemical compounds present in M. alba fruits. The main flavonoid glycosides include quercetin, astragalin, isoquercetin and rutin [16,17,18]. In this work, we demonstrate that purified astragalin (kaempferol-3- O -glucoside; Figure 1), a flavonoid glycoside that isolated from M. alba (white mulberry fruit) one of the herbal constituents of the TCM formula for menopause reduces ovarian GC apoptosis in vitro and in vivo and reverses ovarian failure in an aged female rat model of menopause.…”

“…Since 2008 we have been investigating a TCM herbal formula Menoprogen (MPG) [14,15,16,17,18,19], which has been shown to reduce menopausal symptoms and the Kupperman index in Chinese women [15]. This formula contains five medicinal and food plants, and has been used in China for centuries to treat menopausal symptoms [14,15,16,17,18,19]. In our previous work, we have shown that the mechanism of MPG is very novel in that it does not act as a phytoestrogen, but works indirectly by reducing GC apoptosis via a mechanism involving IGF-1.…”

“…Converting the clinically equivalent dose for a 70-kg adult to that for a 200-g rat by body surface area ratio, the dose of Progynova for rats is 0.18 mg/kg/day. Menoprogen (MPG) contains five semi-purified plant extracts, including M. alba [14,15,16,17,18,19]. The polyphenol content of M. alba is approximately 32 mg/g, of which ~9.5 mg/g is astragalin [35,36].…”

“…MPG contains five herbal extracts of which 20% is M. alba [14,19]. MPG is administered at a dose of 0.4 g/capsule, with 2 to 4 capsules per day [14,15,16,17,18,19,20]. The flavonoid content of MPG is approximately 20% per capsule, of which ~80 mg is AST.…”

“…Herbal medicines, including traditional Chinese medicines (TCM), are used in most countries worldwide for the management of menopausal symptoms [13,14,15,16,17,18,19]. In a pilot observational clinical trial, we have demonstrated that treatment of menopausal Chinese women with a TCM formula named Menoprogen (MPG) that contains five medicinal herbs, including Morus alba L .…”