Clinical Hypnosis in the Treatment of Postmenopausal Hot Flashes: A Randomized Controlled Trial

Gary R. Elkins, PhD; William I. Fisher, MA; Aimee K. Johnson, MA; Janet S. Carpenter, PhD, RN, FAAN; Timothy Z. Keith, PhD

Disclosures

Menopause. 2013;20(3):291-298. 

In This Article

Results

From December 2008 to April 2012, 538 women were screened to determine eligibility upon entrance in the study. Of these, 88 women did not meet the minimal hot flash inclusionary criteria, 50 were not classified as postmenopausal, 55 were receiving other simultaneous treatments of hot flashes, 10 were excluded for prohibitive medical/psychiatric diagnoses, 2 were non-English speaking, and 146 were successfully screened but failed to arrive for their baseline measurements (Figure 1). The remaining 187 women, who were eligible, provided a written informed consent form and were randomized at their baseline appointment. 

Figure 1.

Participant flow chart.

Groups were matched for age, race, marital status, education, onset of symptoms, and symptoms severity ( Table 1 ). The participants ranged in age from 39 to 75 years, with a mean age of 54.61 years. The sample was largely white (68.8% vs 78.7%), followed by African Americans (21.5% vs 11.7%) and Hispanics (6.5% vs 6.4%). Most of them were married (61.3% vs 69.1%), with educational level being normally distributed. There were no statistically significant between-groups differences in onset of amenorrhea, menopausal symptoms, hot flashes, hot flash frequencies, and hot flash scores at baseline. Missing data accounted for less than 2% of the data analyzed and were prorated for incomplete diaries.

Change in Frequency of Hot Flashes

Reductions in subjectively reported mean hot flash frequency from baseline to week 6 in the hypnosis intervention showed a mean reduction of 48.07 (63.87%) hot flashes from baseline as compared with a 6.95 (9.24%) reduction in controls ( Table 2 ). The mean difference in hot flash frequency between conditions was significant (P < 0.001; 95% CI, 38.84-47.85). Mean reductions continued into week 12, with follow-up reports of hot flash frequency showing a mean reduction of 55.82 (74.16%) hot flashes from baseline as compared with a 12.89 (17.13%) hot flash reduction for participants in the structured-attention condition. The mean difference in hot flash frequency at 12-week follow-up was significant (P < 0.001; 95% CI, 36.15-49.67).

Change in Hot Flash Scores

Mean reductions in hot flash score (a product of hot flash frequency x hot flash severity) were 16.72 (71.36%) for the hypnosis group on week 6 from baseline as compared with 1.91 (8.32%) in controls ( P < 0.001; 95% CI, 38.84-47.85; Figure 2). At 12-week follow-up, participants in the hypnosis intervention reported a continuing reduction of 18.83 (80.32%) from baseline as compared with 3.53 (15.38%) in controls. Mean differences in hot flash scores at 12-week follow-up were significant between conditions (P < 0.001; 95% CI, 12.60-17.54).

Figure 2.

Change in weekly composite hot flash scores.

Physiologically Recorded Hot Flashes

There was a 4.26 (40.92%) mean reduction in physiologically monitored hot flashes at 6 weeks compared with baseline for the hypnosis intervention. Conversely, the structured attention control condition showed a mean increase of 0.63 (+7%) monitored hot flashes. The mean difference was significant (P < 0.001; 95% CI, 2.30-5.91). At 12-week follow-up, the hypnosis intervention reported a further reduction of 5.92 (56.86%) physiologically monitored hot flashes from baseline compared with a 0.88 (9.94%) decrease from baseline in the control condition. The mean difference between the two conditions in the number of physiologically monitored hot flashes was significant (P < 5.46; Figure 3).

Figure 3.

Physiologically verified hot flashes via skin conductance monitoring.

Hot Flash-related Daily Interference

Hot flash-related daily interference was assessed using the Hot Flash Related Daily Interference Scale. In the clinical hypnosis intervention, there was a mean score reduction of 4.02 (69.02%) from baseline at 6 weeks, compared with a mean score reduction of 1.04 (18.08%) from baseline in the structured-attention control condition. The mean difference between groups was significant (P < 0.001; 95% CI, 2.37-3.47). At 12-week follow-up, the clinical hypnosis participants continued to improve, showing a mean score reduction of 4.82 (82.11%) from baseline as compared with the mean score reduction of 1.32 (22.96%) from baseline in the structured-attention control. The mean difference between the participants in the clinical hypnosis condition and controls was significant (P < 0.001; 95% CI, 2.74-4.02; Table 2 ). This suggests that participants who received clinical hypnosis had substantially reduced levels of hot flash-related daily interference after treatment, with levels continuing to fall at 12-week follow-up, as compared with the control condition, which showed modest improvement.

Sleep Quality

To evaluate the quality of participants’ sleep after the intervention, we evaluated the PSQI global score. In the clinical hypnosis intervention, participants reported a global score reduction of 5.59 (43.49%) on week 6 of the intervention, compared with a 1.04 (8.75%) reduction in the structured-attention control condition. The difference between the global scores of the two groups was significant (P < 0.001; 95% CI, 3.65-5.84; Table 2 ). On follow-up, the clinical hypnosis participants continued to improve, showing a reduction in global score of 6.27 (53.63%) from baseline as compared with a 1.23 (10.34%) reduction in the control condition. This suggests that, for participants in the clinical hypnosis intervention, there was substantial improvement in the quality of sleep after intervention, as compared with the structured-attention control, which showed very modest improvement.

Adverse Events

Adverse events were assessed at each session by participant self-reports. Adverse events for this study consisted solely of 25 participants reporting mild skin irritation from the skin conductance monitor electrode adhesive, which required no medical intervention to resolve. There were no other reported adverse events, adverse effects, or unintended effects from the clinical hypnosis or the structured-attention control.

Participant Satisfaction

Treatment satisfaction in this study was assessed via a rating scale of 0 to 10 (0 ="highly dissatisfied to 10 ="highly satisfied"). Generally, participants in both arms found the treatment pleasant. Treatment satisfaction was assessed at 12-week follow-up. The clinical hypnosis intervention group showed a high degree of treatment satisfaction (mean [SD], 9.33 [0.99]). Satisfaction with structured attention was also positive (mean [SD], 7.09 [3.06]). Participants in the clinical hypnosis intervention reported significantly greater levels of satisfaction (P < 0.001; 95% CI, 7.79-8.59).

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