ObjectivesTo compare the efficacy of hypnotherapy versus gabapentin for the treatment of hot flashes in breast cancer survivors, and to evaluate the feasibility of conducting a clinical trial comparing a drug with a complementary or alternative method (CAM).DesignProspective randomised trial.SettingBreast health centre of a tertiary care centre.Participants15 women with a personal history of breast cancer or an increased risk of breast cancer who reported at least one daily hot flash.InterventionsGabapentin 900 mg daily in three divided doses (control) compared with standardised hypnotherapy. Participation lasted 8 weeks.Outcome measuresThe primary endpoints were the number of daily hot flashes and hot flash severity score (HFSS). The secondary endpoint was the Hot Flash Related Daily Interference Scale (HFRDIS).Results27 women were randomised and 15 (56%) were considered evaluable for the primary endpoint (n=8 gabapentin, n=7 hypnotherapy). The median number of daily hot flashes at enrolment was 4.5 in the gabapentin arm and 5 in the hypnotherapy arm. HFSS scores were 7.5 in the gabapentin arm and 10 in the hypnotherapy arm. After 8 weeks, the median number of daily hot flashes was reduced by 33.3% in the gabapentin arm and by 80% in the hypnotherapy arm. The median HFSS was reduced by 33.3% in the gabapentin arm and by 85% in the hypnotherapy arm. HFRDIS scores improved by 51.6% in the gabapentin group and by 55.2% in the hypnotherapy group. There were no statistically significant differences between groups.ConclusionsHypnotherapy and gabapentin demonstrate efficacy in improving hot flashes. A definitive trial evaluating traditional interventions against CAM methods is feasible, but not without challenges. Further studies aimed at defining evidence-based recommendations for CAM are necessary.Trial registrationclinicaltrials.gov (NCT00711529).
168 Background: The purpose of this study is to compare the efficacy of hypnotherapy versus gabapentin for the treatment of hot flashes in women with an increased risk or personal history of breast cancer. Methods: In a prospective trial, eligible women were randomized to receive gabapentin (control arm) or hypnotherapy (experimental arm). Eligibility was defined by a personal history of breast cancer or an increased risk of developing breast cancer in women who reported at least one daily hot flash. The duration of participation was eight weeks, and women were asked to keep a daily journal of the number and severity of their hot flashes. The primary endpoints were number of daily hot flashes and hot flash severity score (HFSS). The secondary endpoint was quality of life, measured using the Hot Flash Related Daily Interference Score (HFRDIS). Results: Twenty-seven women were enrolled (n=14 gabapentin, n=13 hypnotherapy) and 15 (56%) were considered evaluable for the primary endpoint (n=8 gabapentin, n=7 hypnotherapy). The median number of daily hot flashes at enrollment was 4.5 in the gabapentin arm, and 5 in the hypnotherapy arm. HFSS scores were 7.5 in the gabapentin arm and 10 in the hypnotherapy arm. After eight weeks, the median number of daily hot flashes was reduced by 33.3% among women in the gabapentin arm, and 80% in the hypnotherapy arm. The median HFSS was reduced by 33.3% in the gabapentin arm, and 85% in the hypnotherapy arm. HFRDIS scores improved by 51.6% in the gabapentin group and 55.2% in the hypnotherapy group. Conclusions: Hypnotherapy and gabapentin both demonstrate efficacy in improving hot flashes in women with an increased risk or personal history of breast cancer. Complementary and alternative medicine (CAM) therapies are preferable to many women over hormone therapy due to the perceived risk of breast cancer, but objective data have been lacking comparing its use to conventional therapies. This pilot study provides evidence supporting the use of hypnotherapy for the treatment of hot flashes and emphasizes the need to perform further studies aimed at defining evidence-based recommendations for CAM.
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