Auch
Naturheilmittel versagen bei der Behandlung der Wechseljahresbeschwerden.
von
Dr. med. Jochen Kubitschek
Immer
mehr Frauen suchen zur Linderung der typischen Beschwerden
der Wechseljahre nach einer Alternative zu der mittlerweile
als gefährlich eingestuften Hormonersatztherapie
(HET).
Dabei
verwenden sie in erster Linie Produkte, die sog. Isoflavone
enthalten - beispielsweise Extrakte aus Rotklee.
Nun
belegt eine im Journal of the American Medical Association
(JAMA) publizierte wissenschaftliche Studie, dass diese
als Nahrungsmittelzusätze vermarkteten Medikamente
die lästigen Hitzewallungen nicht besser unterdrücken
als ein wirkungsloses Scheinmedikament (Placebo).
Phytoestrogen
Supplements for the Treatment of Hot Flashes: The Isoflavone
Clover Extract (ICE) Study
A
Randomized Controlled Trial
Jeffrey
A. Tice, MD; Bruce Ettinger, MD; Kris Ensrud, MD, MPH;
Robert Wallace, MD; Terri Blackwell, PhD; Steven R. Cummings,
MD, MPH
JAMA.
2003;290:207-214.
Context
Clinical trials demonstrating increased risk of cardiovascular
disease and breast cancer among women randomized to hormone
replacement therapy have increased interest in other therapies
for menopausal symptoms. Dietary supplements containing
isoflavones are widely used as alternatives to hormonal
therapies for hot flashes, but there is a paucity of data
supporting their efficacy.
Objective
To compare the efficacy and safety of 2 dietary supplements
derived from red clover with placebo in symptomatic menopausal
women.
Design,
Setting, and Participants Randomized, double-blind, placebo-controlled
trial of menopausal women, aged 45 to 60 years, who were
experiencing at least 35 hot flashes per week. The study
was conducted between November 1999 and March 2001 at
3 US medical centers and included women who were recently
postmenopausal (mean [SD], 3.3 [4.5] years since menopause)
experiencing 8.1 hot flashes per day. Women were exluded
if they were vegetarians, consumed soy products more than
once per week, or took medications affecting isoflavone
absorption.
Intervention
After a 2-week placebo run-in, 252 participants were randomly
assigned to Promensil (82 mg of total isoflavones per
day), Rimostil (57 mg of total isoflavones per day), or
an identical placebo, and followed-up for 12 weeks.
Main
Outcome Measure The primary outcome measure was the change
in frequency of hot flashes measured by participant daily
diaries. Secondary outcome measures included changes in
quality of life and adverse events.
Results
Of 252 participants, 246 (98%) completed the 12-week protocol.
The reductions 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, participants in the Promensil group (41%; 95% confidence
interval [CI], 29%-51%; P = .03), but not in the Rimostil
group (34%; 95% CI, 22%-46%; P = .74) reduced hot flashes
more rapidly. Quality-of-life improvements and adverse
events were comparable in the 3 groups.
Conclusion
Although the study provides some evidence for a biological
effect of Promensil, neither supplement had a clinically
important effect on hot flashes or other symptoms of menopause.
Author
Affiliations: Division of General Internal Medicine (Dr
Tice), Prevention Sciences Group (Drs Blackwell and Cummings),
Department of Medicine (Drs Tice, Blackwell, and Cummings),
University of California, San Francisco; Division of Epidemiology,
School of Public Health, University of Minnesota and Division
of General Internal Medicine, and Department of Medicine,
Veterans Affairs Medical Center, Minneapolis (Dr Ensrud);
Division of Research, Kaiser Permanente Medical Care Program,
Oakland, Calif (Dr Ettinger); Preventive Intervention
Center, Department of Epidemiology, University of Iowa,
Iowa City (Dr Wallace).
RELATED
ARTICLES IN JAMA
This
Week in JAMA
JAMA. 2003;290:157.
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