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Acupuncture beats gabapentin for hot flashes.

SAN ANTONIO -- Electroacupuncture proved significantly more effective than gabapentin for hot flashes in breast cancer survivors in a randomized, placebo-controlled clinical trial.

Acupuncture was far better tolerated as well.

The rate of treatment-related adverse events was higher in patients randomized to gabapentin than to women assigned to electroacupuncture, sham acupuncture, or placebo, Dr. Jun J. Mao reported at the San Antonio Breast Cancer Symposium.

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The study included 120 women who had completed primary treatment for breast cancer and were having hot flashes at least twice daily. They were randomized to 8 weeks of electroacupuncture, sham acupuncture, gabapentin at 300 mg t.i.d., or placebo. The primary endpoint was change from baseline to week 8 in hot flash composite score as gleaned from participants' diaries. The secondary endpoint was durability of response based on hot flash composite score at week 24, 4 months after patients went off treatment, said Dr. Mao, a family physician and licensed acupuncturist at the University of Pennsylvania, Philadelphia.

From a baseline mean hot flash score of 14.3, scores dropped by a mean of 7.4 points by week 8 in the electroacupuncture recipients. This was a significantly greater treatment effect compared with the reductions of 5.9 points (sham acupuncture), 5.2 points (gabapentin), and 3.4 points (placebo).

Only acupuncture showed a durable treatment benefit at 24 weeks. The magnitude of the reduction in hot flash scores 4 months after the final acupuncture session was even greater than at 8 weeks, both for electroacupuncture and sham acupuncture. The mean reduction in hot flash score at 24 weeks was 8.5 points in the electroacupuncture group, compared with 7.4 points at week 8. Sham acupuncture showed a mean 6.1-point decrease in the hot flash score at week 24, gabapentin a 4.6-point reduction, and placebo a 2.8-point drop.

No serious adverse events were noted, but 48% of gabapentin-treated patients reported treatment-related adverse events, compared with 29% on placebo, 19% who got electroacupuncture, and 3% with sham acupuncture. The acupuncture adherence rate was 90%, versus 75% with gabapentin.

Discussant Dr. Michelle E. Melisko noted that this is one of the largest randomized trials of acupuncture for hot flashes, and it included women of widely varied ages and a substantial African American population. It's the first study she's aware of to compare acupuncture to a nonhormonal medication.

Hot flashes tend to be more debilitating in breast cancer survivors than in the general population, she said. Gabapentin (Neurontin) and venlafaxine (Effexor) are the two most widely prescribed centrally acting drugs for treatment of hot flashes in breast cancer survivors. Gabapentin "can make people sleepy, so if patients are having hot flashes and night sweats it's nice to give them an agent they can take at bedtime that might have the dual effects of reducing hot flashes as well as improving their sleep," said Dr. Melisko, an oncologist at the University of California, San Francisco.

She noted that in a systematic review of gabapentin for hot flashes in 901 patients in seven clinical trials, including four studies in breast cancer survivors, the drug resulted in 20%-30% reductions in hot flash frequency and severity, but with a dropout rate twice that for placebo (Clin. Therapeutics 2009;31:221-35).

But many breast cancer survivors say they don't want to take an additional side effect-laden medication to treat a different set of treatment-induced side effects, Dr. Melisko said. They're interested in complementary and alternative medicine. And while a Cochrane review showed that acupuncture resulted in a significant reduction in hot flash severity but not frequency (Cochrane Database Syst. Rev. 2013 July 30;7:CD007410), Dr. Melisko noted that many of the trials included in that analysis may have been too brief to give acupuncture a fair shake.

Dr. Mao agreed.

"By 4 weeks in our trial you see only about onehalf of the eventual effect of electro acupuncture. So if you design a short trial you may not get to the full therapeutic dose," he said. "With acupuncture, it's a slow start but eventual substantial effect. I tell patients you need to give acupuncture a therapeutic trial of at least six treatments."

In acupuncture trials across the board, whether in the setting of cancer, chronic pain, or other conditions, roughly one-third of patients are non-responders, said Dr. Mao.

His study was funded by the NIH's National Center for Complementary and Alternative Medicine. He reported having no financial conflicts.

BY BRUCE JANCIN

AT SABCS 2014

bjancin@frontlinemedcom.com
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Title Annotation:WOMEN'S HEALTH
Author:Jancin, Bruce
Publication:Family Practice News
Date:Jan 1, 2015
Words:752
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