Efficacy of a Biobehavioral Intervention for Hot Flashes: a Randomized Controlled Pilot Study

Overview

Journal Menopause

Specialty Gynecology & Obstetrics

Date 2017 Mar 8

PMID 28266949

Citations 5

Authors

Debra L Barton

Kelliann C Fee Schroeder

Tanima Banerjee

Sherry Wolf

Timothy Z Keith

Gary Elkins

Affiliations

Soon will be listed here.

Abstract

Objective: The need for effective nonhormonal treatments for hot flash management without unwanted side effects continues. The primary aim of this pilot study was to evaluate the effect of combining a nonhormonal pharmacologic agent with a behavioral treatment for hot flash reduction.

Methods: Seventy-one postmenopausal women were randomized to one of four groups: venlafaxine 75 mg + hypnosis (VH) versus venlafaxine 75 mg + sham hypnosis (VSH) versus a placebo pill + hypnosis (PH) versus placebo pill + sham hypnosis (PSH). Women recorded hot flash severity and frequency in a daily diary, in real time. The intrapatient difference in hot flash score (frequency × severity) at 8 weeks was analyzed using a General Estimating Equation model, using VSH as the referent arm, controlling for baseline hot flashes.

Results: The active arms including PH or VH were not statistically significantly different than VSH (P = 0.34, P = 0.05, respectively). Women in each active arm reported hot flash reductions of about 50%, with the PSH group reporting a 25% reduction. Women receiving the PSH reported statistically significantly smaller reductions in hot flash score than women in the referent VSH arm (P = 0.001). There were no significant negative side effects during the course of the study.

Conclusions: Hypnosis alone reduced hot flashes equal to venlafaxine alone, but the combination of hypnosis and venlafaxine did not reduce hot flashes more than either treatment alone. More research is needed to clarify whether combining hypnosis with a different antidepressant would provide synergistic benefits.

Citing Articles

Management of menopausal hot flushes. Recommendations from the Spanish Menopause Society.

Fasero M, Sanchez M, Baquedano L, Gippini I, Fuentes D, Navarro C Eur J Obstet Gynecol Reprod Biol X. 2025; 25:100366.

PMID: 39944633 PMC: 11814524. DOI: 10.1016/j.eurox.2025.100366.

Clinical Hypnosis and Cognitive Behavioral Therapy for Hot Flashes: A Scoping Review.

Muniz V, Padilla V, Alldredge C, Elkins G Womens Health Rep (New Rochelle). 2025; 6(1):1-20.

PMID: 39882144 PMC: 11773179. DOI: 10.1089/whr.2024.0144.

Best Practice Recommendations for Conducting and Reporting Controlled Trials in Clinical Hypnosis Research.

Kekecs Z, Moss D, Whorwell P, Varga K, Terhune D, Shenefelt P J Evid Based Integr Med. 2024; 29:2515690X241274538.

PMID: 39403729 PMC: 11483803. DOI: 10.1177/2515690X241274538.

Hypnosis Intervention for Sleep Disturbances in Individuals with Mild Cognitive Impairment: A Randomized Pilot Study.

Elkins G, Padilla V, Otte J, Sanford K, Benge J, Stevens A Int J Clin Exp Hypn. 2023; 72(1):16-28.

PMID: 38100554 PMC: 10841837. DOI: 10.1080/00207144.2023.2279672.

Oncology Advanced Practitioners and Breast Cancer Prevention.

Vogel W, Pace H, Brignola M J Adv Pract Oncol. 2021; 11(8):863-870.

PMID: 33489426 PMC: 7810267. DOI: 10.6004/jadpro.2020.11.8.6.

References

Morales L, Neven P, Timmerman D, Christiaens M, Vergote I, Van Limbergen E . Acute effects of tamoxifen and third-generation aromatase inhibitors on menopausal symptoms of breast cancer patients. Anticancer Drugs. 2004; 15(8):753-60. DOI: 10.1097/00001813-200409000-00003. View

Hilditch J, Lewis J, Peter A, van Maris B, Ross A, Franssen E . A menopause-specific quality of life questionnaire: development and psychometric properties. Maturitas. 1996; 24(3):161-75. DOI: 10.1016/s0378-5122(96)82006-8. View

Freeman E, Guthrie K, Caan B, Sternfeld B, Cohen L, Joffe H . Efficacy of escitalopram for hot flashes in healthy menopausal women: a randomized controlled trial. JAMA. 2011; 305(3):267-74. PMC: 3129746. DOI: 10.1001/jama.2010.2016. View

Mao J, Chung A, Benton A, Hill S, Ungar L, Leonard C . Online discussion of drug side effects and discontinuation among breast cancer survivors. Pharmacoepidemiol Drug Saf. 2013; 22(3):256-62. PMC: 4380018. DOI: 10.1002/pds.3365. View

Barton D, Lavasseur B, Sloan J, Stawis A, Flynn K, Dyar M . Phase III, placebo-controlled trial of three doses of citalopram for the treatment of hot flashes: NCCTG trial N05C9. J Clin Oncol. 2010; 28(20):3278-83. PMC: 2903326. DOI: 10.1200/JCO.2009.26.6379. View

Manson J, Kaunitz A . Menopause Management--Getting Clinical Care Back on Track. N Engl J Med. 2016; 374(9):803-6. DOI: 10.1056/NEJMp1514242. View

Loprinzi C, Sloan J, Stearns V, Slack R, Iyengar M, Diekmann B . Newer antidepressants and gabapentin for hot flashes: an individual patient pooled analysis. J Clin Oncol. 2009; 27(17):2831-7. PMC: 2698018. DOI: 10.1200/JCO.2008.19.6253. View

Elkins G, Marcus J, Stearns V, Perfect M, Rajab M, Ruud C . Randomized trial of a hypnosis intervention for treatment of hot flashes among breast cancer survivors. J Clin Oncol. 2008; 26(31):5022-6. PMC: 2652097. DOI: 10.1200/JCO.2008.16.6389. View

Loprinzi C, Sloan J, Perez E, Quella S, Stella P, Mailliard J . Phase III evaluation of fluoxetine for treatment of hot flashes. J Clin Oncol. 2002; 20(6):1578-83. DOI: 10.1200/JCO.2002.20.6.1578. View

10.

Pandya K, Morrow G, Roscoe J, Zhao H, Hickok J, Pajon E . Gabapentin for hot flashes in 420 women with breast cancer: a randomised double-blind placebo-controlled trial. Lancet. 2005; 366(9488):818-24. PMC: 1627210. DOI: 10.1016/S0140-6736(05)67215-7. View

11.

Carpenter J, Gilchrist J, Chen K, Gautam S, Freedman R . Hot flashes, core body temperature, and metabolic parameters in breast cancer survivors. Menopause. 2004; 11(4):375-81. DOI: 10.1097/01.gme.0000113848.74835.1a. View

12.

Marino J, Saunders C, Emery L, Green H, Doherty D, Hickey M . Nature and severity of menopausal symptoms and their impact on quality of life and sexual function in cancer survivors compared with women without a cancer history. Menopause. 2013; 21(3):267-74. DOI: 10.1097/GME.0b013e3182976f46. View

13.

Gracia C, Freeman E . Acute consequences of the menopausal transition: the rise of common menopausal symptoms. Endocrinol Metab Clin North Am. 2004; 33(4):675-89. DOI: 10.1016/j.ecl.2004.07.003. View

14.

Goss P, Ingle J, Pritchard K, Robert N, Muss H, Gralow J . Extending Aromatase-Inhibitor Adjuvant Therapy to 10 Years. N Engl J Med. 2016; 375(3):209-19. PMC: 5024713. DOI: 10.1056/NEJMoa1604700. View

15.

Mahon S, Kaplan M . Placebo effect in hot flush research. Lancet Oncol. 2012; 13(5):e188. DOI: 10.1016/S1470-2045(12)70197-3. View

16.

MacLaughlan David S, Salzillo S, Bowe P, Scuncio S, Malit B, Raker C . Randomised controlled trial comparing hypnotherapy versus gabapentin for the treatment of hot flashes in breast cancer survivors: a pilot study. BMJ Open. 2013; 3(9):e003138. PMC: 3773636. DOI: 10.1136/bmjopen-2013-003138. View

17.

Stearns V, Ullmer L, Lopez J, Smith Y, Isaacs C, Hayes D . Hot flushes. Lancet. 2002; 360(9348):1851-61. DOI: 10.1016/s0140-6736(02)11774-0. View

18.

Greendale G, Reboussin B, Hogan P, Barnabei V, Shumaker S, Johnson S . Symptom relief and side effects of postmenopausal hormones: results from the Postmenopausal Estrogen/Progestin Interventions Trial. Obstet Gynecol. 1998; 92(6):982-8. DOI: 10.1016/s0029-7844(98)00305-6. View

19.

Ayers B, Smith M, Hellier J, Mann E, Hunter M . Effectiveness of group and self-help cognitive behavior therapy in reducing problematic menopausal hot flushes and night sweats (MENOS 2): a randomized controlled trial. Menopause. 2012; 19(7):749-59. DOI: 10.1097/gme.0b013e31823fe835. View

20.

Carpenter J, Johnson D, Wagner L, Andrykowski M . Hot flashes and related outcomes in breast cancer survivors and matched comparison women. Oncol Nurs Forum. 2002; 29(3):E16-25. DOI: 10.1188/02.ONF.E16-E25. View