Vasomotor symptom relief by soy isoflavone extract tablets in postmenopausal women: A multicenter, double-blind, randomized, placebo-controlled study
ABSTRACT To determine the safety and efficacy of an oral soy isoflavone extract for relief of menopausal hot flushes.
This was a double-blind, randomized, parallel group, outpatient, multicenter (15 sites) study. A total of 177 postmenopausal women (mean age = 55 years) who were experiencing five or more hot flushes per day were randomized to receive either soy isoflavone extract (total of 50 mg genistin and daidzin per day) or placebo. Physical examinations and endometrial and biochemical evaluations were performed upon admission and completion. Body weight, symptoms, and safety were evaluated at all visits.
Relief of vasomotor symptoms was observed in both groups. Decreases in the incidence and severity of hot flushes occurred as soon as 2 weeks in the soy group, whereas the placebo group experienced no relief for the first 4 weeks. Differences between evaluable subjects in both groups were statistically significant over 6 weeks (p = 0.03). Over 12 weeks, between-group differences approached significance (p = 0.08). Endometrial thickness evaluated by ultrasound, lipoproteins, bone markers, sex hormone-binding globulin and follicle-stimulating hormone, and vaginal cytology did not change in either group.
Soy isoflavone extract was effective in reducing frequency and severity of flushes and did not stimulate the endometrium. Soy isoflavone extracts provide an attractive addition to the choices available for relief of hot flushes.
- SourceAvailable from: Juergen Drewe
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- "); (Saadati et al. 2013) #3447 (Agarwal et al. 2014; Pinkerton et al. 2014); SSRIs: (Simon et al. 2013; Aedo et al. 2011; Suvanto-Luukkonen et al. 2005; Oktem et al. 2007), venlafaxine (Evans et al. 2005; Boekhout et al. 2011; Vitolins et al. 2013), desvenlafaxine (Speroff et al. 2008; Archer et al. 2009a; Archer et al. 2009b; Cheng et al. 2013; Bouchard et al. 2012; Pinkerton et al. 2013), isoflavones (Albertazzi et al. 1998; Han et al. 2002; van de Weijer & Barentsen 2002; Jeri 2002; Sammartino et al. 2003; Nahas et al. 2004; Nahas et al. 2007; Khaodhiar et al. 2008; Cheng et al. 2007; Radhakrishnan et al. 2009; Ye et al. 2012; Aso et al. 2012; Mainini et al. 2013; D'Anna et al. 2007; D'Anna et al. 2009; Ferrari 2009; Evans et al. 2011; Murkies et al. 1995; Crisafulli et al. 2004; Labos et al. 2013; Upmalis et al. 2000; Faure et al. 2002); hops (Heyerick et al. 2006); red clover (Hidalgo et al. 2005; Lipovac et al. 2012), flaxseed (Colli et al. 2012), St. John's wort (Uebelhack et al. 2006; Briese et al. 2007), French maritime pine bark (Yang et al. 2007; Kohama & Negami 2013), Sibiric Rhubarb (Heger et al. 2006; Kaszkin-Bettag et al. 2007; Kaszkin-Bettag et al. 2009; Hasper et al. 2009), and CREs (Drewe et al. 2013; Lopatka et al. 2007; Vermes et al. 2005; Liske et al. 2002; Frei-Kleiner et al. 2005; Schellenberg et al. 2012; Osmers et al. 2005; Ross 2012; Newton et al. 2006; Geller et al. 2009; Stoll 1987; Wuttke et al. 2003; Nappi et al. 2005; Bai et al. 2007; Uebelhack et al. 2006; Briese et al. 2007; Oktem et al. 2007; Hernández Munoz & Pluchino 2003; Rostock et al. 2011). "
ABSTRACT: The cardinal climacteric symptoms of hot flushes and night sweats affect 24-93% of all women during the physiological transition from reproductive to post-reproductive life. Though efficacious, hormonal therapy and partial oestrogenic compounds are linked to a significant increase in breast cancer. Non-hormonal treatments are thus greatly appreciated. This systematic review of published hormonal and non-hormonal treatments for climacteric, and breast and prostate cancer-associated hot flushes, examines clinical efficacy and therapy-related cancer risk modulation. A PubMed search included literature up to June 19, 2014 without limits for initial dates or language, with the search terms, (hot flush* OR hot flash*) AND (clinical trial* OR clinical stud*) AND (randomi* OR observational) NOT review). Retrieved references identified further papers. The focus was on hot flushes; other symptoms (night sweats, irritability, etc.) were not specifically screened. Included were some 610 clinical studies where a measured effect of the intervention, intensity and severity were documented, and where patients received treatment of pharmaceutical quality. Only 147 of these references described studies with alternative non-hormonal treatments in post-menopausal women and in breast and prostate cancer survivors; these results are presented in Additional file 1. The most effective hot flush treatment is oestrogenic hormones, or a combination of oestrogen and progestins, though benefits are partially outweighed by a significantly increased risk for breast cancer development. This review illustrates that certain non-hormonal treatments, including selective serotonin reuptake inhibitors, gabapentin/pregabalin, and Cimicifuga racemosa extracts, show a positive risk-benefit ratio. Key pointsSeveral non-hormonal alternatives to hormonal therapy have been established and registered for the treatment of vasomotor climacteric symptoms in peri- and post-menopausal women.There are indications that non-hormonal treatments are useful alternatives in patients with a history of breast and prostate cancer. However, confirmation by larger clinical trials is required.SpringerPlus 12/2015; 4(1). DOI:10.1186/s40064-015-0808-y
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- "Vaginal atrophy is associated with a clustering of symptoms, including dryness, itching, burning/soreness, discharge, irritation and painful intercourse (Nahas et al. 2007; Pastore et al. 2004). Vaginal atrophy occurs in 25–47% of postmenopausal women (Tedeschi and Benvenuti 2012; Upmalis et al. 2000). Although most menopausal symptoms are relieved or disappeared overtime (such as hot flashes), vaginal symptoms are progressive and frequently need treatment (Sturdee and MacLennan 2006). "
ABSTRACT: Current systematic review evaluated the efficacy of topical isoflavones to relieve vaginal symptoms in menopausal women. MEDLINE (1966 to January 2014), Scopus (1990 to January 2014), and the Cochrane Central Register of Controlled Trials (The Cochrane Library issue 1, 2013) were searched using keywords ‘isoflavone and vagina’. Relevant studies were reviewed by two independent reviewers. Only randomised controlled trials (RCTs) were included in the systematic review. Out of 115 potentially relevant publications, four studies met the inclusion criteria. Topical isoflavones showed beneficial effects on dyspareunia, vaginal dryness and maturation value. Based on only one trial, the result of conjugated equine oestrogen cream (0.3 mg/day) was similar to use of isoflavone vaginal gel and superior to that of placebo gel. However, drawing any definite conclusion was difficult because of the limited number of RCTs, the small sample sizes, weak methodology and considerable heterogeneity of the included studies.Journal of Obstetrics and Gynaecology 02/2015; DOI:10.3109/01443615.2015.1011104 · 0.60 Impact Factor
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- "Numerous extracts and compounds isolated from natural products are included in drugs and healthcare supplements. For instance, a supplement of red clover isoflavones and a tablet of soy isoflavones were used to reduce hot flushes in women [1,2], and extracts of valerian, hops, and passion flower were blended into a sleep aid tablet to improve sleep . "
ABSTRACT: Extracts and compounds of natural products have potential as alternatives to current Western medicines. However, these products may not be patentable under the statutory requirements because of their naturally-occurring nature. This article analyzes the current patenting practices for natural products in the United States, particularly in light of the recent Supreme Court ruling in Myriad, and suggests an advantageous strategy for patenting these products. Briefly, isolated natural products per se are not patentable in the United States. Therefore, patenting focus should be placed on the modification, formulation, manufacture, and application of natural products. A detailed description of each invention is highly recommended for stronger support and broader coverage of the claims.Chinese Medicine 07/2014; 9:17. DOI:10.1186/1749-8546-9-17 · 2.34 Impact Factor