Abstract and Introduction
Abstract
Objective. The use of estrogen and progesterone to manage vasomotor symptoms (ie, hot flashes and night sweats) has declined because of concerns about their risks, and there is an increased interest in alternate, effective, and low-risk treatments. This study reports the results of a randomized controlled trial of clinical hypnosis for treating vasomotor symptoms among postmenopausal women.
Methods. This is a randomized, single-blind, controlled, clinical trial involving 187 postmenopausal women reporting a minimum of seven hot flashes per day (or at least 50 hot flashes a week) at baseline between December 2008 and April 2012. Eligible participants received five weekly sessions of either clinical hypnosis or structured-attention control. Primary outcomes were hot flash frequency (subjectively and physiologically recorded) and hot flash score assessed by daily diaries on weeks 2 to 6 and week 12. Secondary outcomes included measures of hot flash-related daily interference, sleep quality, and treatment satisfaction.
Results. In a modified intent-to-treat analysis that included all randomized participants who provided data, reported subjective hot flash frequency from baseline to week 12 showed a mean reduction of 55.82 (74.16%) hot flashes for the clinical hypnosis intervention versus a mean reduction of 12.89 (17.13%) hot flashes for controls (P < 0.001; 95% CI, 36.15-49.67). The mean reduction in hot flash score was 18.83 (80.32%) for the clinical hypnosis intervention as compared with 3.53 (15.38%) for controls (P < 0.001; 95% CI, 12.60-17.54). At 12-week follow-up, the mean reduction in physiologically monitored hot flashes was 5.92 (56.86%) for clinical hypnosis and 0.88 (9.94%) for controls (P < 0.001; 95% CI, 2.00-5.46). Secondary outcomes were significantly improved compared with controls at 12-week follow-up: hot flash-related interference (P < 0.001; 95% CI, 2.74-4.02), sleep quality (P < 0.001; 95% CI, 3.65-5.84), and treatment satisfaction (P < 0.001; 95% CI, 7.79-8.59).
Conclusions. Compared with structured-attention control, clinical hypnosis results in significant reductions in self-reported and physiologically measured hot flashes and hot flash scores in postmenopausal women.
Introduction
Several meta-analyses and a Cochrane review indicate that additional clinical trials are needed to guide clinical practice decisions around the use of nonhormonal therapies for vasomotor symptoms (ie, hot flashes and night sweats). Trials are needed to generate a sufficient evidence base to guide clinical treatment decisions concerning the use of nonhormonal therapies for vasomotor symptoms. As many as 80% of women experience vasomotor symptoms, and nearly 20% find them intolerable. Sudden rushes of heat and sweating are often accompanied by increased heart rate, chills, shivering, clamminess, anxiety, feelings of nausea, a "headache"-like sensation, visible reddening and blotching of face and neck, increase in core body temperature, increased metabolism, and interrupted sleep. Symptoms generally wane 5 to 7 years after menopause but can persist in some women for more than 20 years, with a median symptom duration of approximately 4 years. Alternate nonhormonal pharmacotherapy, such as clonidine, gabapentin, and paroxetine, seems promising, but adverse effects and cost can diminish long-term compliance.
Clinical hypnosis, a mind-body therapy designed to facilitate a hypnotic state, coolness, and control of symptoms, seems promising; however, no large-scale, randomized controlled trials have yet been published. Pilot data showed that breast cancer survivors who received five weekly sessions of clinical hypnosis experienced a 69% reduction in hot flashes relative to baseline. These results are comparable to or greater than the results of open-label studies with paroxetine and venlafaxine. Thus, the purpose of this randomized controlled trial was to evaluate clinical hypnosis against structured-attention control for the treatment of hot flashes in postmenopausal women. Primary outcomes were hot flash frequency (perceived and physiologically measured) and hot flash score (diary frequency x severity). Secondary outcomes were hot flash interference, sleep quality, and treatment satisfaction.