For physicians who see a lot of menopausal women, the annual meeting of the North American Menopause Society (NAMS) is a cornucopia of interesting research. I have attended several NAMS conferences now, and it is a unique opportunity to hear principal investigators of the major studies on hormone replacement, osteoporosis, heart disease, breast cancer, exercise, sexual function and more.

Amidst the mostly conventional practitioners, I’m pretty certain I was the only Naturopathic Physician this year. Occasionally there have been others. I have come to know many of the attendees and speakers, and despite the overall conservative medical viewpoint, there are enough scientific controversies to make NAMS interesting for and inclusive of those of us with a more alternative perspective.

There are usually a few presentations on soy and botanicals, and when pressed about bio-identical hormones versus non bio-identical hormones, even some of the most prestigious menopause researchers admit to using natural hormones, if only for medicolegal rather than scientific reasons. They figure that if the Women’s Health Initiative impugned Premarin and Provera, then using estradiol and progesterone might provide some legal safe haven.

Here are a few of the abstracts, highlights, observations and tidbits from this year’s NAMS meeting, held in San Diego in September.

Estrogen, Estrogen/Progestin May Not Increase Breast Cancer Recurrence

According to an open-label Swedish study of 378 post-menopausal women, estrogen-containing regimens do not appear to increase risk of breast cancer recurrence, as an earlier trial suggested. The women in this study had undergone breast cancer surgery, and received estradiol valerate with or without medroxyprogesterone acetate or no hormone therapy. The primary end point was recurrence-free survival.

Investigators stopped this trial after 4 years, following a report of increased risk of breast cancer from the Hormonal Replacement Therapy After Breast Cancer—Is It Safe? (HABITS) trial. Though the trial designs were different, the Stockholm researchers felt they were similar enough to warrant concern.

When they analyzed data gathered up to the point of study cessation, the Stockholm researchers found 11 women in the hormone group had cancer recurrences, compared with 13 in the non-hormone group (Von Schoultz E, Rutqvist L, for the Stockholm Breast Cancer Study Group. J Natl Cancer Inst. 2005; 97: 533–535). Overall, there was an 18% decrease in relative risk of recurrence in the hormone group compared with the untreated women. This is in direct contrast to HABITS data showing a significant 3.3-fold increased relative hazard associated with hormone therapy.

One of the key differences between the two studies was that the proportion of women with lymph-node-positive tumors was smaller in the Stockholm trial than in HABITS (16% vs. 26%, respectively), and more women received Tamoxifen (52% vs. 21%). Also, 73% used either estrogen only or a regimen with continuous estrogen and 14 days of progestogen every 3 months. The Stockholm study is in line with other studies suggesting that short-term hormone use after breast cancer probably does not raise risk of breast cancer recurrence, especially in patients with node-negative cancers and who are on Tamoxifen.

Herbal Alternatives for Menopause (HALT) Study Humbles Cohosh

This trial set out to test 2 herbal regimens for menopause symptoms compared with placebo and conventional hormone therapy. Women were given either: 1) a standardized black cohosh extract, 160 mg daily (PureWorld Botanicals); 2) a combination herbal product containing black cohosh, alfalfa, chaste tree, dong quai, false unicorn, licorice, oats, pomegranate, Siberian ginseng, and boron, 4 capsules daily (Progena); 3) conjugated equine estrogen, 0.625 mg per day, plus 2.5 mg medroxyprogesterone acetate; or 4) placebo.

Participants were 351 perimenopausal and menopausal women, aged 45–55, with 2 or more vasomotor symptom episodes daily. At 3 months the mean number of night sweats was 12% lower in the black cohosh group and 83% lower with hormone therapy, compared with placebo. Overall Wiklund score (an instrument validated to measure menopausal and perimenopausal complaints) was 22% lower among those on cohosh. Mean vasomotor symptoms score was 22% lower with black cohosh compared with placebo (Newton K, et al. Maturitas. 2005; 52: 134–146). There was no effect of the multibotanical formula on any of the study outcomes.

After one year, however, there was no difference in frequency or intensity of vasomotor symptoms between the herb groups and the placebo, and at no point in the trial did either herbal formula show better symptom reduction than conventional hormone therapy.

What happened? There have been seven published randomized trials of black cohosh for treatment of menopause symptoms. Five show a decrease in hot flashes/night sweats or reduced scores on the Kupperman index. However, the difficulties with these studies have included lack of placebo controls, small sample sizes, and relatively short treatment durations of 12 weeks.

In reviewing the current study, we could scrutinize the statistics. We could note differences between in-office practice and mailed questionnaires (which his how the HALT data were obtained). We could point out that the multi-herb formula used in the study has some less-than-ideal ingredients. For example, I would not consider chaste tree an effective menopausal herb except for perimenopausal bleeding. I would also not consider oats, boron, Siberian ginseng, false unicorn or pomegranate to be useful for menopause symptoms.

We could cite the flaw of expecting dietary compliance with soy foods. (Each study group had soy subjects and non-soy subjects. The soy subjects were instructed to increase soy intake to at least 12–20 mg of soy protein daily, with dietitian phone calls to monitor compliance.) We could note the problematic issue of studying perimenopausal women with inconsistent symptoms compared with postmenopausal women. Perhaps a better multi-herb formulation could have been chosen: the three herbs with the strongest prior data for reducing hot flashes are black cohosh, red clover, and kava.

In the end, though, it is impossible to dismiss the HALT findings. What can we say? It was a disappointing result for black cohosh. However, one negative study will not change my prescribing habits. Now with eight randomized trials, we’ve still got five showing a decrease in symptoms, and three showing no effect. I will still be using black cohosh in my practice.

Go FSHing for First Sign of Menopause

Among the many vendors at NAMS was a company marketing the first and only in-office, FDA-approved, rapid diagnostic test for qualitative detection of elevated follicle stimulating hormone (FSH). MENOCHECK-PRO is a one-step urine test. It is CLIA waived, takes 3 minutes, is inexpensive, and can be used for the evaluation of the onset of menopause.

In a study of 20 women, the rapid urine test accurately predicted FSH levels when compared with serum FSH levels and menses. Findings for 19 of 20 women were consistent between the rapid urine test and commercial reference laboratory serum FSH tests (Ferroni J, Thompson F, Lourenco M, Sgro J. The Gynecology and Menopause Center, Malvern, PA).

An in-office urine FSH test offers the ability to assess the cause of presenting symptoms, and may be useful in cases that lack clarity. For example, are a woman’s symptoms due to menopause or hypothyroid? MENOCHECK-PRO could provide insight. More information can be found at www.menocheckpro.com.

C No Evil: Keeping Tabs on Vaginal pH

Another new product, TODAY vaginal vitamin C tablets for restoring normal vaginal pH, definitely caught my attention for its simplicity and potential clinical importance. Maintaining vaginal pH is fundamental for restoring normal vaginal micro-ecology, and preventing bacterial vaginosis and candidal vaginitis.

TODAY tablets contain 250 mg buffered vitamin C, to be administered intravaginally. TODAY comes in 6- or 12-tablet packages. The 6-pack is, according to the label, “Ideal for use during: pregnancy, bacterial vaginosis, hormonal birth control, HRT, IUD use.” The 12-tablet package is “for use after: bacterial vaginosis, menstruation, douching, treatment for a yeast infection, systemic antibiotics, sexual intercourse, use of barrier contraceptives.”

The product literature reports on 39 women with elevated vaginal pH, who used the product at night prior to bed for 6 nights. They checked their vaginal pH each day. Within 12 hours of use, vaginal pH was &60;4.5, which would be considered normal and conducive to a predominance of lactobacilli, the normal healthy bacterial species in the vagina (normal vaginal pH = 3.8 to 4.5).

I look forward to incorporating vitamin C tablets into my clinical practice and will consider it as an option in normalizing pH, especially post-yeast or bacterial vaginosis treatment to prevent recurrence. This product is available over the counter. For more information, email: questions@todayswomencare.com. This is the same company that brings us the TODAY contraceptive sponge.

A Treasure-Trove of Tidbits

A few days at NAMS yields a host of interesting clinical pearls. Here are a few:

• Check vaginal pH to assess estrogen status. If pH is less than 4.5, then the patient is estrogenizing adequately.
• HRT does not cause weight gain.
• Women who have low serum triglycerides lose more weight on a low fat diet, while women who have high serum triglycerides lose more weight on a low carbohydrate diet.
• Women with insulin resistance lose more weight on a moderate carbohydrate restriction diet.
• Those women who are not insulin resistant do best on a low fat diet.
• Eating a solid food pre-meal snack leads to 70% decrease in caloric intake at the meal.

MenoNotes and Other NAMS Goodies

For a small fee, healthcare providers can download what are called MenoNotes from the NAMS website (www.menopause.org). These one- or two-page handouts can be given to women to reinforce counseling given during the office visit. Although I do not agree with all information given, I do use some of these selectively. I encourage menopause practitioners to become NAMS members. Two excellent publications come with membership: Menopause Journal and Menopause Management. NAMS also provides some great e-news research updates. Call 440-442-7550.