“Warmi” and the menopause: synthesis of the evidence after 10 years of commercialization

Abstract

Background: Warmi®, a natural supplement containing glucosinolates, beta-sitosterol and flavonoid citrus, is used for the treatment of menopausal symptoms. In this report we synthesize the accumulated evidence from preclinical and clinical studies regarding its efficacy and safety. Methods: We carried out a systematic review in PubMed/Medline, EMBASE, WOS, CENTRAL and gray literature sources. Results: We found six studies of which three were published as conference abstracts. Two preclinical(PCS)and four clinical studies(CS). PCS1 was conducted in a murine menopausal model finding beneficial effects for Warmi®compared to placebo in preventing body and uterine weight gain, and decreasing triglyceride and total cholesterol levels. PCS2 was performed in MCF-7 cell lines and found that Warmi®had a non-proliferative effect with weak estrogenic activity. CS1 was a phase1, double-blinded, placebo-controlled, randomized clinical trial(RCT)that found that the daily consumption of Warmi®was safe and tolerable in healthy adult women. Moreover, there was no effect on menstrual cycles, serum hormonal profile (estradiol, LH, FSH and progesterone), body mass index and blood pressure values. CS2 was a phase2, single blinded, three-armed controlled RCT including hormone therapy (HT). This study found that the decrease of baseline menopausal symptoms (MENQOL)after three-month of treatment was significant in all three groups (two doses of Warmi®and HT)without difference between groups. CS3 and CS4 were phase2, double-blinded RCTs. One compared Warmi®against tibolone and placebo and other compared against tibolone and isoflavones. Both consistently found that oral administration of Warmi®for six months significantly improved levels of total blood cholesterol(decrease), LDLdecrease), HDL(increase), estradiol, and IL-6. In addition, the RCT which compared Warmi®against tibolone and placebo found significant improvements in the LDL/HDL ratio and levels of osteocalcin and IL-8; as well as the alleviation of all common menopausal (Green Climacteric Scale)and sexual symptoms(McCoy Scale). Despite this, we could not assess the risk of bias, because full reports of the mentioned studies were not founded. Conclusions: There is no in-extenso published study regarding Warmi®. Promising results of Warmi®are available only in congress summaries and gray literature. There is a need to have the available information published as original articles in peer-reviewed journals.