While Warmi is a new, promising approach for menopause relief, natural options for menopause have always been popular. Published studies on botanicals for menopause date back to the 1980s. More recently, the National Institutes of Health (NIH) of the US government has funded controlled research on certain menopause botanicals. Some studies have found that menopausal women taking the most popular types of supplements had no better relief of symptoms than those taking a placebo “sugar” pill. Below is a review of research for menopause by the type of natural ingredient.
This summary is not based on a complete review of menopausal clinical research and is presented in non-technical form. It is largely based on recent menopausal symptom review articles and clinical research published in leading medical journals. Except for the studies involving Warmi, unpublished studies or reports were not considered. Experts may have selected other studies, reports or review articles for this summary and may have provided a different analysis of the research selected. This information is best used for general reference.
Warmi is new, comprised of vegetable and fruit extracts. Its ingredient sources have been studied in published clinical research. However, the combination of extracts in Warmi have been used in three preliminary, clinical trials, involving 229 women. These trials have been prepared for scientific journal publication.
Activity: A study of 122 women experiencing moderate to intense menopausal symptoms found that Warmi significantly improved changes in mood (2 different measures), vasomotor (hot flashes/night sweats) symptoms and sexuality compared to baseline values. Sexual improvement included sexual fantasy, arousal, satisfaction, intercourse discomfort, orgasm frequency and vaginal dryness. Compared to baseline, Warmi also improved somatic (sleep) measures at months 1 and 3 and quality of life measures (physical health, psychological, social relationships, general) at 6 months. Finally, cardiovascular, bone resorption and other hormonal balance markers saw statistically significant improvement over baseline at 6 months in that study.1
A study of 54 women experiencing severe menopausal symptoms found that the vegetable extract in Warmi significantly improved the following menopausal symptoms (overall, vasomotor, physical, psychosocial and sexual). Cardiovascular and hormonal balance markers also improved statistically, at 3 months.2
More Effective than placebo? Yes (based on 1 study) Statistically significant improvement versus placebo was seen starting at 3 months. Improved menopausal symptoms included mood, vasomotor (hot flashes/night sweats) and sexual ( based on the Greene Climacteric Scale).1
Safety: Two studies involving 53 women 18 to 40 years old and 54 post menopausal women found Warmi to be safe, even at double the recommended intake for 3 months.. Reported side effects included drowsiness (15%) and increased appetite (10%).2,3
Response Time: Significant improvement baseline for several symptoms was noted at the first measurement period (1 month) and generally improved thereafter. Improvement to placebo was noted at 3 months and generally improved thereafter.
Black cohosh has been widely studied for menopausal symptoms, albeit in different forms and potencies. The herb is recommended by certain health professionals and organizations.
Activity: An independent review article in 2005, identified five key menopause studies with black cohosh. Those studies found that black cohosh reduced some menopause symptoms. Hot flash improvement was significant versus placebo in some studies but not in others.5 A 2006 independent review article identified six key menopause studies with black cohosh. These studies did not demonstrate a consistent benefit of black cohosh for menopausal symptoms compared to a placebo or control group.7 Two 2006 clinical trials of 132 and 351 menopausal women found no difference in vasomotor (hot flash/night sweats) symptoms between placebo and black cohosh.4,8 Similarly, 2009 study of 89 menopausal women found that black cohosh did reduce vasomotor symptoms compared to baseline, but not placebo, after 12 months.6
More effective than placebo? Inconclusive (based on 14 studies) Certain menopausal symptoms improved in some studies but not in others. Recent studies saw no vasomotor symptom benefit over placebo.
Safety: No serious events have been reported in any of the published studies and two safety reviews found black cohosh is well tolerated for up to 6 months.5,6,8
Soy Extracts (Isoflavones)
Soy intake has been attributed to the lower incidence of hot flashes reported by Asian women. Soy extracts are popular and have been widely studied for menopause symptom relief.
Activity: Six studies involving soy extracts for menopause symptoms were evaluated in an independent 2005 review article.5 According to the author, the six studies “produced equivocal results.” One study found that soy reduced the severity of hot flashes but not the frequency compared to placebo. One found no difference to placebo on any menopausal symptom measure. In contrast, a 6 week study found a significant benefit to placebo among soy extract users for vasomotor symptoms. Other studies showed impressive results but had potential design or high drop-out problems.
More effective than placebo? Inconclusive (based on 6 studies) The review article author concludes: “The results from clinical studies are contradictory and difficult to evaluate…At this time, the scientific evidence cannot support the recommendation of soy isoflavones extracts for the relief of menopausal symptoms." 5
Safety: Few if any serious adverse events were reported in the six studies analyzed. A separate independent review by Munro concluded that soy isoflavones are safe, although others have questioned its long-term safety (approximately 5 years).5,9
In traditional Chinese medicine, Don Quai is used to treat a number of conditions, although menopause is not typically one of them. Only one published menopause study with Don Quai was found by an independent researcher.
Activity: A double blind study of 71 postmenopausal women found Don Quai had no benefit for menopausal symptoms, compared to a placebo after 24 weeks.5
More effective than placebo? No (based on 1 study)
Safety: No significant adverse events were reported among general studies. No change was noted in serum hormone levels in the menopause study using Dong Qual.5
Evening Primrose Oil
Evening primrose oil ( EPO) is a rich source of linoleic acid and y-linolenic acid, from the seeds of the wild evening primrose plant.
Activity: An independent review article of menopausal dietary supplements found only one published study involving EPO suitable for inclusion in its analysis. Fifty-six women reporting four or more hot flashes in a day found no significant benefit of EPO over placebo for vasomotor symptoms, hot flash and sweating frequency at 24 weeks.5
More effective than placebo? No (based on 1 study) This is far from definitive. The study was small and had a 37% drop-out rate.
Safety: EPO is generally well tolerated. Mild nausea, diarrhea, flatulence or bloating was reported by some patients.5
The World Health Organization (WHO) endorses the use of Panax ginseng, an herbal root, for fatigue or mental exhaustion. While popular as a supplement, ginseng has been involved in only limited research for menopause symptoms.
Activity: An independent review article of menopausal dietary supplements found only one published study with ginseng suitable for inclusion in its analysis. A study of 284 women concluded that ginseng did improve mood, well-being and general health, but not vasomotor (hot flash) symptoms compared to placebo after 16 weeks.5
More effective than placebo? No (based on 1 study) While ginseng did help quality of life measures, vasomotor symptom changes among ginseng users were no better than those taking a placebo.
Safety: Ginseng is not generally associated with serious adverse events or drug interactions. Complaints were similar to those taking a placebo (headache, sleep or stomach discomfort).5
Red Clover Extracts (Isoflavones)
Extracts of the red clover leaf are rich in isoflavones, which researchers believe provide estrogen-like effects. Red clover extract is a popular menopause remedy and the subject of recent research.
Activity: Five red clover isoflavone studies were independently evaluated, with conflicting outcomes. A large study of 252 postmenopausal women found no significant improvement of red clover or placebo for hot flash frequency symptom score after 12 weeks. Studies of 51 and 37 menopausal women also found no difference among red clover patients versus placebo for hot flashes, flushing or other physiological measures. However, two smaller studies of 30 women each noted that red clover users reported a significant improvement in hot flashes to placebo after 12-16 weeks.5 A 2009 study of 88 women found that red clover did not relieve vasomotor symptoms better than placebo.6
More effective than placebo? Inconclusive (based on 6 studies) More red clover studies show no benefit over placebo than do show a benefit.
Safety: No serious adverse events were reported in clinical trials. Red clover appears safe but may not be appropriate for those trying to avoid isoflavones.5,6
- Maradiegue E, Rojas P A, Cabrera S, Rechkemmer A, Rojas J, Salvador J. Timoteo O, Galloso M. Caparó C. Warmi®´s effect on postmenopausal women: A multicentric, double-blind and randomized clinical trial. ≠
- Nacha G, Curse R, Rojas PA, Villar M. Safety and tolerance of Warmi® in healthy adult women. ≠
- Osorio J, Osorio A, Fernandez J, Cruz W, Moya E, Rojas PA, Brinkmann JA, Villar M. Estrogenic and hypolipidemic effects of Warmi® on menopausal women. ≠
- Pokaj BA: et al. Phase III double blind,randomized placebo-controlled crossover trial on black cohosh in the management of hot flashes NCCTG Trial N01CC1 J Clin Oncol 2006 June 20 (18) 2836-41
- Low Dog T. Menopause: a review of botanical dietary supplements, American Jrl Medicine 2005 Vol 118 985-1085.
- Geller SE, et al. Safety and efficacy of black cohosh and red clover for management of vasomotor symptoms: a randomized controlled trial. Menopause 2009 Nov-Dec 16 156-66
- Borrelli F.et al. Black cohosh for menopausal symptoms: a systemic review of its efficacy Pharmacol Res 2008Jul 58 8-14.
- Newton KM et al. Treatment of vasomotor symptoms of menopause with black cohosh, multibotanicals, soy, hormone therapy or placebo: a randomized trial Ann Intern Med 2006 Dec 19 896-79
- Munro I et al. Soy Isoflavones: A Safety Review Nutr Rev 2003 Vol 61, 1, 1-33
≠ Articles not yet published
Menopause Supplement Considerations
- Human clinical evidence
- Consistent results
- Breadth of relief
- Safety data
- Estrogen vs. non-estrogen-like effect
- Ease of use and price
- Quality (USP, GMP, USDA)
- Doctor recommendations