Women taking a Chinese herbal formula experienced less than half the number of menopausal hot flashes they had before the treatment, according to a new study from Hong Kong.

Among women taking an herbal mix called Er-xian decoction (EXD), the frequency of daily hot flashes dropped by 62 percent, compared to a 52-percent drop seen among women taking a placebo.
“It’s a modest effect, but not a zero effect,” said Katherine Newton, a researcher who has studied herbal menopause therapies at the Group Health Research Institute in Seattle.

Newton, who was not involved in the research, said she’d want to see more, long-term studies demonstrating that these herbs are safe before she would recommend them to women, but that the current study makes EXD look promising as an alternative menopause treatment.

Hormone replacement therapy is considered the most effective therapy for menopause-related symptoms, but potential health risks from hormones have women looking for alternatives, said Yao Tong, a professor at the University of Hong Kong and one of the authors of the new study.

Er-xian decoction (EXD) contains compounds extracted from the roots, stems or leaves of six Chinese herbs, processed into granules then packaged in sachets to be made into a tea.

Although previous studies have found that EXD can help reduce hot flashes, they were not high quality experiments, the researchers write in the medical journal Menopause: The Journal of The North American Menopause Society.

To get a more reliable assessment of how well EXD works, they asked 101 women in their 40s and 50s, who were at or near menopause and experiencing symptoms, to drink an herbal formula twice a day for 12 weeks.

Half of the women drank a 15 gram dose of EXD, while the other half drank a fake remedy that consisted of tea, caramel and an herbal compound called gardenin.

For two weeks prior to the treatment, the women logged their hot flashes.

Those in the EXD group reported an average of 5.8 hot flashes each day, and those in the other group experienced five daily.

After the treatment, the number of hot flashes dropped to 2.2 in the EXD group and 2.5 in the other group.

Three months after the treatment ended, hot flashes stayed put at 2.2 a day for women who had drank EXD, while they went up slightly to 2.9 a day for women who had drank the placebo.

“Menopausal flushing is notoriously responsive to fluctuations and placebo responses in clinical trials, yet they have rigorously demonstrated an improvement in favor of active treatment” with Er-xian decoction, said Dr. Alan Bensoussan, the director of the Centre for Complementary Medicine Research at the University of Western Sydney, in an email to Reuters Health.

The severity of the hot flashes also declined to a greater degree in the EXD group, from a three out of four at the beginning of the study to a 1.6 at the end.

Among women who drank the fake remedy, hot flash severity went from three to 2.3 on a four-point scale.

The trend continued three months later, with hot flash severity returning to baseline for women who drank the placebo, but only rising slightly to a 2.1 for women who drank EXD.

“It’s a small effect, but a measurable effect,” said Newton, who was not part of the research.

The researchers did not compare EXD to other menopause treatments, so it’s unclear how it would perform compared to them.

But Newton told Reuters Health that the results put EXD “in the ball park of other studies of non-hormonal therapies that aren’t as effective as hormones but do show some promise.”

Tong and her colleagues write in their report that traditional Chinese medicine views menopause symptoms as related to deficiencies in kidney yin and yang, which regulate the function of the body.

“The composition of EXD includes herbs for enhancing both kidney yin and kidney yang to treat menopausal symptoms,” they write.

Tong also said in an email to Reuters Health that her earlier research has shown EXD increases hormonal and anti-oxidant functions in the body.

Er Xian preparations are available online, costing about $30 for 42, 2-gram packets.

The problem, Bensoussan pointed out, is that the chemical composition can change from batch to batch and from supplier to supplier.

Tong said a company has shown interest in developing the formulation she and her colleagues used in the study.

However, Bensoussan, who was not involved in the research, noted, “The researchers have not reported accurate chemical profiling (definition) of the formula based on key putative bioactives or selected chemical markers in the formula. This is important for its reproducibility and for long term use in the marketplace.”

SOURCE: Menopause: The Journal of The North American Menopause Society, online February 25, 2013.

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A randomized, double-blind, controlled trial of a Chinese herbal formula (Er-Xian decoction) for menopausal symptoms in Hong Kong perimenopausal women

Results: Among 108 participants, 101 participants finished the study. EXD significantly reduced the mean (SD) frequency of hot flushes from 5.8 (5.0) to 2.2 (3.0) in the treatment group and from 5.0 (3.8) to 2.4 (2.5) in the placebo group (P = 0.04). The mean (SD) hot flush score was also reduced from 19.6 (6.6) to 4.9 (7.8) in the treatment group and from 16.6 (5.4) to 7.0 (6.4) in the placebo group (P = 0.02). The superiority of EXD to placebo was also observed with greater improvement in the total scores for the MRS (P = 0.03) and the Menopause-Specific Quality of Life questionnaire (P

< 0.01). There were no differences in serum hormone levels between the EXD group and the placebo group. There were no serious adverse events, and the safety indices of whole blood counts, renal function, and liver function were within the normal range before and after treatment.

Conclusions: The Chinese herbal formula EXD is superior to placebo in reducing the frequency and severity of hot flushes and in improving menopausal symptoms in Hong Kong perimenopausal women. It is well tolerated, with no serious adverse events noted during the study period.
Zhong, Linda L.D. PhD; Tong, Yao PhD; Tang, Grace W.K. MD; Zhang, Zhang Jin PhD; Choi, Wai Ki RN; Cheng, Kin Lok BSc; Sze, Stephen C.W. PhD; Wai, Kun MSc; Liu, Qing PhD; Yu, Ben X.B. PhD