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Phytoestrogen Supplements for the Treatment of Hot Flashes: the Isoflavone Clover Extract (ICE) Study a Randomized Controlled Trial

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Phytoestrogen Supplements for the Treatment of Hot Flashes: the Isoflavone Clover Extract (ICE) Study a Randomized Controlled Trial ORIGINAL CONTRIBUTION Phytoestrogen Supplements for the Treatment of Hot Flashes: The Isoflavone Clover Extract (ICE) Study A Randomized Controlled Trial Jeffrey A. Tice, MD Context Clinical trials demonstrating increased risk of cardiovascular disease and breast Bruce Ettinger, MD cancer among women randomized to hormone replacement therapy have increased Kris Ensrud, MD, MPH interest in other therapies for menopausal symptoms. Dietary supplements contain- ing isoflavones are widely used as alternatives to hormonal therapies for hot flashes, Robert Wallace, MD but there is a paucity of data supporting their efficacy. Terri Blackwell, PhD Objective To compare the efficacy and safety of 2 dietary supplements derived from Steven R. Cummings, MD, MPH red clover with placebo in symptomatic menopausal women. Design, Setting, and Participants Randomized, double-blind, placebo- OT FLASHES ARE THE PRIMARY controlled trial of menopausal women, aged 45 to 60 years, who were experiencing reason that women seek at least 35 hot flashes per week. The study was conducted between November medical attention for meno- 1999 and March 2001 at 3 US medical centers and included women who were pausal symptoms. The re- recently postmenopausal (mean [SD], 3.3 [4.5] years since menopause) experienc- Hcent results from the Women’s Health ing 8.1 hot flashes per day. Women were exluded if they were vegetarians, con- sumed soy products more than once per week, or took medications affecting isofla- Initiative1 and long-term follow-up from vone absorption. the Heart and Estrogen/progestin Re- placement Study2,3 demonstrating an in- Intervention After a 2-week placebo run-in, 252 participants were randomly as- creased risk of cardiovascular disease and signed to Promensil (82 mg of total isoflavones per day), Rimostil (57 mg of total iso- flavones per day), or an identical placebo, and followed-up for 12 weeks. breast cancer among women random- ized to hormone therapy are likely to re- Main Outcome Measure The primary outcome measure was the change in fre- duce the use of hormones for relief of quency of hot flashes measured by participant daily diaries. Secondary outcome mea- sures included changes in quality of life and adverse events. menopausal symptoms. Dietary supple- ments containing isoflavones derived Results Of 252 participants, 246 (98%) completed the 12-week protocol. The re- from soy or red clover are heavily mar- ductions in mean daily hot flash count at 12 weeks were similar for the Promensil (5.1), Rimostil (5.4), and placebo (5.0) groups. In comparison with the placebo group, par- keted as alternative treatments for meno- ticipants in the Promensil group (41%; 95% confidence interval [CI], 29%-51%; P=.03), pausal symptoms. In Asia, only 10% to but not in the Rimostil group (34%; 95% CI, 22%-46%; P=.74) reduced hot flashes 20% of women experience hot flashes more rapidly. Quality-of-life improvements and adverse events were comparable in compared with 70% to 80% of women the 3 groups. 4-7 in Western countries. A popular hy- Conclusion Although the study provides some evidence for a biological effect of pothesis to explain this difference is that Promensil, neither supplement had a clinically important effect on hot flashes or other isoflavones found in soy, a staple in the symptoms of menopause. traditional Asian diet, influence the JAMA. 2003;290:207-214 www.jama.com body’s response to the changing hor- monal levels of menopause.8 Isofla- Author Affiliations: Division of General Internal Medi- Permanente Medical Care Program, Oakland, Calif (Dr vones are polyphenol compounds struc- cine (Dr Tice), Prevention Sciences Group (Drs Black- Ettinger); Preventive Intervention Center, Depart- turally related to estrogens that have well and Cummings), Department of Medicine (Drs ment of Epidemiology, University of Iowa, Iowa City Tice, Blackwell, and Cummings), University of Cali- (Dr Wallace). been shown to bind to estrogen recep- fornia, San Francisco; Division of Epidemiology, School Corresponding Author and Reprints: Jeffrey A. Tice, tors9 and appear to act as partial ago- of Public Health, University of Minnesota and Divi- MD, Division of General Internal Medicine, Univer- sion of General Internal Medicine, and Department sity of California, 1701 Divisadero St, Suite 554, San nists in some tissues and antagonists in of Medicine, Veterans Affairs Medical Center, Min- Francisco, CA 94143 (e-mail: [email protected] others. They have a higher binding af- neapolis (Dr Ensrud); Division of Research, Kaiser .edu). ©2003 American Medical Association. All rights reserved. (Reprinted) JAMA, July 9, 2003—Vol 290, No. 2 207 Downloaded from www.jama.com at Medical Library of the PLA, on August 16, 2007 PHYTOESTROGENS FOR TREATMENT OF HOT FLASHES finity for estrogen-receptor ␤ than for es- flashes per week, and had a follicle- ceived numbered containers and trogen-receptor ␣.10-12 stimulating hormone (FSH) level of 30 distributed them sequentially at ran- Dietary supplements containing iso- mIU/mL. Eligible women had either domization. The clinical center prin- flavones from soy or red clover are documented bilateral oophorectomy or cipal investigators, their staff, the par- widely marketed for menopausal symp- at least 2 consecutive months of amen- ticipants, and the coordinating center toms and are increasingly being used orrhea prior to enrollment with at least principal investigator and staff were all by women in the United States as an al- 6 months of amenorrhea in the year blinded to treatment allocation until the ternative to estrogen.13-16 Most pub- prior to entry. Women were excluded last participant completed her close- lished studies of isoflavones for relief from the study if they were vegetar- out visit and the data clean-up was of menopausal symptoms have inves- ian, consumed soy products more than finished. tigated the effectiveness of soy prod- once per week, took medications af- ucts.17-28 Dietary supplements derived fecting isoflavone absorption (antibi- Measurements from red clover contain additional iso- otics, antacids) or hormonal prepara- Staff from each of the clinical sites at- flavones (biochanin A, formononetin) tions during the 3 months prior to tended a training session organized by not found in soy, which may have ad- enrollment, had significant gastroin- the coordinating center to ensure stan- ditional biological activity. On the other testinal disease, drank more than 2 al- dard administration of the study proto- hand, red clover lacks components of coholic beverages per day, were aller- col and to certify staff on measurement soy that may contribute to soy’s bio- gic to red clover, were regular users of techniques. Participant eligibility, ac- logical effects. There are few pub- dietary supplements containing isofla- cording to the selection criteria previ- lished data29-33 and no published large vones, or consumed less than 80% of ously described, was assessed at an ini- clinical trials on the effects of these com- the expected study tablets during the tial screening telephone call and 2 clinic pounds on menopausal symptoms and 2-week placebo run-in period. visits. At the first clinic visit, weight, quality of life. Furthermore, many cli- height, pulse, and blood pressure were nicians and the public have expressed Study Supplements measured according to a standard pro- concern about the safety of dietary and Randomization tocol. Body mass index (BMI) was cal- supplements. The 2 study supplements, Promensil culated as weight in kilograms divided We initiated the Isoflavone Clover and Rimostil, and identical placebo by the square of height in meters. De- Extract study to investigate whether 2 were prepared by the manufacturer mographics, reproductive history, smok- dietary supplements derived from red (Novogen Ltd, Sydney, Australia) and ing, and alcohol consumption were as- clover were safe and more effective than sent to a central research pharmacy for sessed by participant self-report. A placebo at reducing hot flashes and im- packaging and labeling. The central supply of placebo tablets was distrib- proving menopausal quality of life in pharmacy was not involved in the study uted for a 2-week run-in phase. The par- symptomatic postmenopausal women. design or participant monitoring. Pro- ticipants were informed that the run-in mensil contains a higher proportion of tablets were placebos and were the same METHODS biochanin A and genistein. Rimostil as those that were to be used in the main Participants contains a higher proportion of for- study. At the end of the run-in phase, Women were recruited at 3 academic mononetin and daidzein. An indepen- baseline questionnaires and physical ex- clinical research sites located in Oak- dent laboratory (Sigma Pharmaceuti- amination were completed. A 24-hour land, Calif; Minneapolis, Minn; and cals, South Croydon, Australia) verified urine sample was collected and willing Iowa City, Iowa. The study was admin- the contents of the study tablets. Pla- participants, who were at least 80% com- istered through a coordinating center cebo tablets contained less than 0.04 mg pliant with the run-in regimen, were ran- at the University of California, San of total isoflavones per tablet; Promen- domized to receive a dietary supple- Francisco. The institutional review sil tablets contained an average of 41.0 ment or placebo. boards at each clinical site and at the mg of total isoflavones (range, 37.0- Participants were contacted by tele- coordinating center approved the study 43.0 mg); and
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