A Randomized, Controlled Pilot Study of Acupuncture Treatment for Menopausal Hot Flashes

Nancy E. Avis, PhD; Claudine Legault, PhD; Remy R. Coeytaux, MD, PhD; May Pian-Smith, MD; Jan L. Shifren, MD; Wunian Chen, MD, LAc; Peter Valaskatgis, MAc

Disclosures

Menopause. 2008;15(6):1070-1078. 

In This Article

Results

Participant data are shown in Figure 2. Of the 246 women screened, 141 (57%) were ineligible. Primary reasons for ineligibility at the time of screening were not enough hot flashes and taking antidepressants. Of the 105 eligible women, 41 women declined participation. Of the 64 women seen for baseline visits, eight did not have enough hot flashes after the diary completion. Fifty-six women were entered into the study and randomized. Overall, we found that 39% (97) of women who were reached in response to the advertisements were eligible and that 58% (56/97) of these eligible women were enrolled in the study. Study retention was excellent with all women remaining in the study. However, not all women completed all study procedures. Eight (42%) of the women in the TA group and 10 (56%) in the SA group completed at least 80% of the 16 treatments. Furthermore, two women in the UC group did not complete any follow-up diaries, one in the SA group, and three in the TA group.

CONSORT figure.

Sample Characteristics

Sample characteristics by group assignment are shown in Table 2 . Thirty-six percent of women had an average of four to six hot flashes per day, whereas 64% had an average of more than seven hot flashes per day. Fourteen percent of the women were perimenopausal, 48% were naturally postmenopausal, and 38% had undergone surgical menopause. There were no significant differences by group. The majority of women had a TCM diagnosis of kidney deficiency (n = 14) or kidney and heart not harmonized (n = 10).

At baseline, the mean frequency of hot flashes was between 7.4 in the UC group and 8.5 in the SA and TA groups. These differences were not statistically significant (P = 0.63). Differences in the mean index scores were also not statistically significant (P = 0.80): UC, 16.3, SA, 18.1 and TA, 15.7.

Hot Flash Change

The percentages of change in hot flash frequency (including daytime and nighttime) are shown in Figure 3. There was a significant week effect (P = 0.01) with hot flash frequency declining over time for all three groups. There were no significant differences in hot flash frequency between the treatment groups (P = 0.15). However, when the two acupuncture groups were combined, there was a significant difference between acupuncture and UC (P < 0.05), with both acupuncture groups showing greater decline than the UC group. By the third week of treatment, women in both acupuncture groups were reporting a decrease of approximately 40% in hot flash frequency. The UC group showed a decrease of approximately 10% until week 7, when hot flash frequency decreased more. One participant in the UC group had a particularly greater decrease at weeks 7 and 8, which is reflected in the figure, but the significance of the results is similar with and without this participant. When daytime frequency and nighttime frequency were looked at separately, these effects were only seen for daytime frequency (data not shown).

Percentage of change in hot flash frequency in the daytime and nighttime. UC, usual care; SA, sham acupuncture; TA, Traditional Chinese Medicine.

Figure 4 shows the results using the hot flash index, which takes into account both frequency and severity. This figure follows a pattern similar to that for frequency alone, although neither the week effect (P = 0.08) nor treatment effect (P = 0.07) was significant. There was a significant decrease (P = 0.02) over time in both of the acupuncture groups compared with the UC group, with no difference between the acupuncture groups. Both acupuncture groups decreased to approximately 40% to 50% of their index score by week 3.

Percentage of change in hot flash severity index in the daytime and nighttime. UC, usual care; SA, sham acupuncture; TA, Traditional Chinese Medicine.

Other Outcomes

We did not find any significant results in hot flash interference, sleep, mood, or health-related quality of life. Although this small pilot study was not powered to find statistical significance, these variables did not show any consistent trends. However, women in the two acupuncture groups reported that their vasomotor symptoms were less bothersome than women in the UC group reported (P < 0.02).

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