9/30/2013 Conflict of Interest Statement Behavioral Interventions for Hot 2 Flashes. The author of this presentation has no financial or commercial conflicts of interest pertinent to this 1 presentation within the last 12 months. GARY R. ELKI NS, P H .D., ABP P D I R E C T O R , M I N D - B O D Y M E D I C I N E R E S E A R C H , L A B O R A T O R Y D E P A R T M E N T O F P S Y C H O L O G Y & N E U R O S C I E N C E B A Y L O R U N I V E R S I T Y Overview Behavioral interventions for hot flashes 3 4 Behavioral Interventions for Hot � Paced Respiration Flashes. � Mindfulness-Based Stress Reduction Review of clinical trials � Cognitive- Behavioral Therapy Next Steps � Yoga � Clinical Hypnosis Advantages of Behavioral Treatments Behavioral interventions for hot flashes 5 6 � Generally considered safe � There is a need for a safe and effective treatment alternatives for women suffer from hot flashes and � Many are skill-based insomnia. � Hormone therapy may be contraindicated for Hormone therapy may be contraindicated for � No side effects N id ff some women. � Many women seek options for the treatment of hot � May have side benefits (stress) flashes due to concerns over risks and potential side-effects of pharmaceutical therapies. � But are they effective in reducing hot flashes… ? 1
9/30/2013 Paced Respiration The Placebo Effect & Hot Flash Clinical Trials 7 8 � Placebo effect can be � Slow measured breathing quite remarkable in hot intervention, often paired with flash trials (>30%-40%). progressive muscle relaxation or relaxation response training. � The reason for the size of this placebo effect is not � Paced Respiration “protocol”: fully understood. � 8 hours, biweekly, laboratory-based, one- on-one instruction � Practice, 15 min, 2X day � Establishing clinical � Application at each HF (slow deep significance (>50%) breathing at each HF onset) Paced Respiration Paced Respiration 9 10 � Initially combined with progressive muscle � Subsequently, an early study examining the biochemical relaxation in a study of 14 healthy midlife women and thermoregulatory effects of paced respiration versus (Germaine & Freedman, 1984) alpha-EEG biofeedback (used as control), found (~50% � Reduced diary-recorded HF after 6 weeks & 6 months. reduction in HF frequency in paced respiration. (Freedman, Woodward, Brown, Javiad, & Pandey, 1995) � Follow-up comparative study of paced respiration ll i d f d i i ( n =11), progressive muscle relaxation ( n =11), and � However, a recent study investigating ‘dose’ compared attention control ( n= 11). two paced-breathing programs to usual breathing found (Freedman & Woodward, 1992) hot flash reduction during the 9 weeks, 52% for paced � Only paced respiration showed significant reductions in breathing twice a day, 4 2% for paced breathing once a objectively measured hot flashes after 8 weeks. day, and 4 6% for usual breathing. (Sood et al., 2013). � 50% reduction in hot flash frequency by diary and objective measure. Paced Respiration… Further Study… Mindfulness-Based Stress Reduction 11 12 � A 16-week, 3 group, partially blinded, controlled trial � Learning to recognize and discriminate more (2:2:1 randomization and stratification: breast accurately between the components of experience cancer/ no cancer), 218 women received either paced respiration, a breathing control group, or usual care. such as thoughts, feelings, and sensations, and (Carpenter et al., 2013). developing a non-reactive awareness of these. � Results of this study showed no significant group differences for HF frequency, severity, and bother at 8 or 16 weeks post-randomization. � The authors concluded the paced respiration is unlikely to provide clinical benefit for menopausal symptoms in breast cancer survivors or menopausal women without cancer. Small benefits in mood and sleep disturbance. 2
9/30/2013 Mindfulness-Based Stress Reduction Mindfulness-Based Stress Reduction 13 14 � Pilot study for hot flashes in 2006. � MBSR training teaches mindfulness through (Carmody, Crawford, & Churchill, 2006). breathing, body awareness exercises, sitting and walking meditation as well as gentle yoga. � 15 symptomatic women completed an 8-week MBSR program, keeping daily diaries of hot flashes and completing hot flash related quality of life instruments at completing hot flash related quality of life instruments at � Shifting emphasis from focus (inward thinking) to baseline and follow-up. awareness (outward, “seeing the scenery). � Significant improvements on quality of life measures and hot flash severity decreased by 40%. � HF frequency reduced 39%. Mindfulness-Based Stress Reduction Cognitive-Behavioral Therapy 15 16 � A randomized controlled study of mindfulness training � Cognitive behavior therapy (CBT) is a type of for coping with hot flashes was published in 2011. 110 psychotherapeutic treatment that helps patients women were randomized to MBSR or wait list control. (Carmody, Crawford, Salmoirago-Blotcher, Leung, Churchill & Olendzki, 2011) understand the relationship between thoughts and feelings and develop coping behaviors. � Primary outcome was degree of bother from hot flashes. y g Secondary outcomes were hot flash intensity, quality of life, insomnia, anxiety & perceived stress. � Initial case reports showed substantial improvements in hot flash frequency, quality of life, � Results showed within-woman changes in bother from depression and anxiety with improvements hot flashes differed significantly by treatment arm, HF bother decreased by 14.7% in MBSR vs. 6.8% in WLC. At maintained 6 months post-treatment . 20 weeks, total reduction in bother was 21.6% in MBSR (Allen, Dobkia, Boohar & Woolfolk, 2006) vs 10.5% in WLC. There were no differences in HF intensity. Cognitive-Behavioral Therapy Yoga 17 18 � Pilot study of hatha yoga for hot flashes published in 2007. � MENOS 2: Randomized, no-treatment control study of (Booth-LaForce, Thurston & Taylor, 2007) group cognitive behavioral therapy and guided self-help CBT in 140 symptomatic women. � Prospective within-group design. Participants were 12 peri- and post- (Ayers, Smith, Hellier, Mann & Hunter, 2012) menopausal women experiencing at least 4 menopausal hot flashes per day, at least 4 days per week. Assessments were administered before and after completion of a 10-week yoga program p y g p g � Group and self-help CBT reduced hot flashes and night � Group and self-help CBT reduced hot flashes and night sweat frequency at 6 and 26 weeks. � The authors found significant pre- to post-treatment improvements in � Combined HF/ NS reductions at 26 weeks: 4 0 % for group CBT, the severity of questionnaire-rated total menopausal symptoms, hot- 36 % for self-help CBT, 23% for control. flash daily interference, and sleep efficiency, disturbances, and quality. � Mood, indices of quality of life, indices of emotional � Neither 24 -h physiological m onitoring nor accom panying functioning, and physical functioning showed significant diaries yielded significant changes in hot flashes. improvements for group CBT at 26 weeks. 3
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