naturopathydigest.com -- Will the HALT Study Hurt or Help Naturopathic Medicine?

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Will the HALT Study Hurt or Help Naturopathic Medicine?

As a naturopathic physician, what do you do when research suggests a supplement isn't effective for treating a particular condition?

By Kathryn Feather, Associate Editor

It seems to be the hot topic on every television news show and in the pages of the most influential newspapers these days - supplements.

Lately, the discussion seems to center around the topic of research. As a naturopathic physician, do your clinical practice protocols change if research shows that a supplement does not, in fact, do what it was previously thought to do? And what do you tell your patients if they ask about the effectiveness of such a supplement, or tell you they have been using it and have experienced excellent results?
There's no doubt that an increasing number of people use supplements and believe they are effective. A recent poll taken by CBS News surveyed 993 adults by telephone and found that nearly four in 10 Americans have used herbal supplements, including echinacea, St. John's wort and saw palmetto, to try to help a medical problem or as part of their regular diet. And most who have tried these supplements think they generally are effective. When asked the question, "Have you taken herbal supplements?" 31 percent of men and 45 percent of women answered yes. Forty-four percent of all respondents agreed that herbal supplements are generally helpful. Fifty-five percent of Americans said they have at least heard something about herbal supplements; and women are more likely than men to have heard a lot of information. Most men say they've heard little or nothing. Younger people (under age 30) are the most likely to have not heard much about supplements.
With the public embracing herbal and nutritional supplements, it's important that all health care providers give patients an accurate picture of the efficacy and safety of those supplements. While your clinical/experiential evidence might lead you to recommend a particular supplement, what happens when research shows otherwise?
Case in point: The Herbal Alternatives for Menopause Study (HALT), which found that black cohosh, whether used alone or with other botanical supplements, did not relieve hot flashes in postmenopausal women or those approaching menopause. The study was funded by the National Institute on Aging (NIA) and the National Center for Complementary and Alternative Medicine (NCCAM), both components of the National Institutes of Health (NIH). Katherine M. Newton, PhD, of the Group Health Center for Health Studies in Seattle and the University of Washington, led the investigation. The 12-month randomized, double-blind, placebo-controlled trial compared several herbal regimens and menopausal hormone therapy (estrogen with or without progesterone) to placebo in 351 women ages 45 to 55.
"In recent years, scientific studies have raised questions about the safety of certain types of menopausal hormone therapy in some women. Interest has grown in alternatives to hormones, including herbal supplements, for controlling hot flashes and other symptoms of menopause," said NIA Director Richard J. Hodes, MD. "Testing the safety and efficacy of various treatments in randomized clinical trials such as HALT is critically important in helping women in mid-life and their doctors to make informed choices."
Each study participant was experiencing at least two hot flashes and/or night sweats daily at the start of the study. The women were approaching menopause, having missed at least one menstrual cycle in the preceding 12 months, or were postmenopausal, having had no menstrual cycle in at least 12 months. Researchers included women who were perimenopausal, or in menopause transition, because most previous studies looked only at postmenopausal women, who tend to have fewer symptoms than women going through menopause. Women were randomly assigned to receive one of five therapies:

black cohosh;
a multibotanical supplement, including black cohosh, alfalfa, boron, chaste tree, dong quai, false unicorn, licorice, oats, pomegranate and Siberian ginseng;
a multibotanical supplement plus diet counseling to increase consumption of foods containing soy;
menopausal hormone therapy, consisting of estrogen with or without progestin; and
a placebo, containing no drug or supplement.

Participants met with clinic staff three, six and 12 months after the beginning of the study and also received monthly telephone calls from study nurses. Women were recruited into the study from May 2001 through August 2003. Interestingly, it was during this same time frame that reports from the Women's Health Initiative (WHI) raised concerns about the safety of menopausal hormone therapy. Researchers informed all of the women in the HALT study about those findings and offered them the opportunity to take part in a study without a menopausal hormone therapy group. Most women consented to continue participation in the trial. All of the participants were informed about subsequent WHI publications and later recruits were enrolled in the trial without the option of a menopausal hormone therapy group.
The study found no significant difference between the number of daily hot flashes and/or night sweats in any of the herbal supplement groups when compared to the placebo group. At the end of one year, the average difference was less than 0.6 symptoms per day. However, the average difference at one year in symptoms between the menopausal hormone therapy and placebo group was significant, with 4.06 fewer symptoms per day among women receiving hormone replacement therapy. Women using menopausal hormone therapy, however, did receive significant relief from their hot flashes and night sweats.
According to the 2000 census, approximately 2 million women turn 50 every year. Fifty-one is the average age at which women experience menopause. Many of these women experience menopausal symptoms with varying degrees of intensity. In the study, Newton noted that alternatives to menopausal hormone therapy, including over-the-counter supplements and phytoestrogens, "are sometimes assumed to be safer than ET/EPT (i.e., menopausal hormone therapy), though few have been evaluated in randomized trials."
"While this study found that black cohosh alone or with other herbs did not reduce menopausal hot flashes," said NCCAM Acting Director, Ruth L. Kirschstein, MD, "it highlights the importance of studying herbs using well-designed research to find out what works and what does not. With this information, women and their physicians can have a meaningful discussion of complementary and alternative medicine approaches to menopause."
Research has shown that far too many patients don't tell their medical doctor what supplements they are taking, and don't tell their other health care professionals, including naturopathic doctors, what prescription medications they are taking. Naturopathic physicians can position themselves as authorities on herbal and other supplements - in the eyes of the public and the health care community - by sharing the most current findings regarding supplement research, whether such research suggests a particular supplement is effective or ineffective for treating a particular condition.