1. From this randomized, partially-blinded, sham-controlled trial, Chinese medicine acupuncture was not superior to sham (i.e., non-insertive) acupuncture to treat menopausal hot flashes in women with kidney yin deficiency.
2. Patients in both the treatment and sham arms of the study experienced a decrease in hot flash symptoms at the end of treatment and for up to six months afterwards.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Hot flashes, which are a major symptom of menopause, affect up to 75% of women. While drug-based therapy effectively reduces symptoms for many women, it is also associated with potentially severe side effects. Although acupuncture has been suggested as a potential treatment, it is unclear whether it would be superior to placebo acupuncture. This study enrolled patients with menopausal hot flashes who met criteria for kidney yin deficiency (a Chinese medicine classification). Patients were randomized to receive either standardized acupuncture designed to treat kidney yin deficiency or “sham” acupuncture, in which a blunt needle was pressed against the skin to give the sensation of insertion, but not actually inserted into the skin. Patients were not told whether they received true or sham acupuncture. Sham needling points were specifically chosen to be different from true acupuncture points. Overall, there was no significant difference in frequency or severity of hot flashes between patients receiving true or sham therapy. Interestingly, patients experienced a decrease in symptoms after receiving either therapy. Although needle insertion points were determined after review of both Chinese medicine principles and previous trials, the study is limited in that there are no scientifically validated, mechanistic understanding of acupuncture’s effects exist to guide needle (or sham needle) placement or manipulation, nor for the classification of kidney yin deficiency. Overall, acupuncture is likely not effective in the treatment of menopausal hot flashes, and any reduction in symptoms is likely due to the placebo effect.
In-Depth [partially-blinded, randomized, sham-controlled trial]: This trial compared 327 women who were randomly assigned to receive either acupuncture tailored according to Chinese medicine principles to treat kidney yin deficiency, or sham, non-insertive acupuncture. All patients experienced hot flashes and were post-menopausal or in late menopausal transition. Patients and assessors were blinded to randomization, but acupuncturists were not. Patients received 10 treatment episodes over eight weeks. Overall, true acupuncture was not superior to sham acupuncture in terms of frequency (end-of-therapy acupuncture vs. sham difference in mean hot flash instances per day: -0.19 instances, 95%CI -1.32 to – 0.94, p = 0.74) or in a combined “hot flashes score” (end-of-therapy acupuncture vs. sham difference in mean score: 0.33, 95%CI: -1.87 to 2.52, p = 0.77). There was a slight decrease in symptom severity among patients receiving sham acupuncture compared to true acupuncture at the end of therapy, according to a four-point qualitative scale (acupuncture vs. sham difference in mean score: 0.12, 95%CI 0.01 to 0.24, p = 0.035), although this difference did not persist at three and six months of follow-up. Both groups experienced an approximately 40% decrease in hot flashes score between baseline and the end of therapy.
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