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Phase II evaluation of S-adenosyl-L-methionine (SAMe) for the treatment of hot flashes.

ABSTRACT: Hot flashes are a significant source of symptom burden that negatively impacts quality of life (QOL). For women who have contraindications to, or are unwilling to consider, estrogens or antidepressants for bothersome hot flashes, there are limited effective pharmacologic or complementary and alternative medicines.This single-arm phase II trial studied the efficacy of S-adenosyl-L-methionine (SAMe) for the treatment of hot flashes. Eligible women were required to have reported ?14 hot flashes per week for ?1 month. The patients were treated with SAMe at a dose of 400 mg twice daily to evaluate whether a reduction in hot flash score appeared to be better than the historical placebo response of approximately 25%. The women kept a daily hot flash diary during a baseline week and then daily during weeks 2-7. The primary endpoint was the change from baseline to week 7 in hot flash score and hot flash frequency. Secondary endpoints included toxicity analyses and the effect of SAMe on QOL.From October 28, 2010 to January 30, 2012, 43 women were treated with SAMe. The decrease in mean percent of baseline hot flash score and frequency was 35.4 and 32.6%, respectively. When compared to the historical placebo response of 25%, the effect of SAMe on hot flash score was not statistically significant (p?=?0.09). Treatment was well tolerated with expected grade 1/2 gastrointestinal toxicity and no negative effect on QOL.The use of SAMe does not appear to significantly reduce hot flashes more than would be expected with a placebo.

SUBMITTER: Kadakia KC

PROVIDER: S-EPMC4973573 | biostudies-literature | 2016 Mar

REPOSITORIES: biostudies-literature

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Phase II evaluation of S-adenosyl-L-methionine (SAMe) for the treatment of hot flashes.

Kadakia Kunal C KC Loprinzi Charles L CL Atherton Pamela J PJ Fee-Schroeder Kelliann C KC Sood Amit A Barton Debra L DL

Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer 20150808 3

<h4>Purpose</h4>Hot flashes are a significant source of symptom burden that negatively impacts quality of life (QOL). For women who have contraindications to, or are unwilling to consider, estrogens or antidepressants for bothersome hot flashes, there are limited effective pharmacologic or complementary and alternative medicines.<h4>Methods</h4>This single-arm phase II trial studied the efficacy of S-adenosyl-L-methionine (SAMe) for the treatment of hot flashes. Eligible women were required to h ...[more]

PMID: 26248653

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Project description:BackgroundEvidence on the impact of expectancy on acupuncture treatment response is conflicting.ObjectivesThis secondary analysis of a randomized sham-controlled trial on acupuncture for menopausal hot flashes investigated whether treatment expectancy score was associated with hot flash score at end-of-treatment. Secondary analyses investigated whether there were associations between other pre-specified factors and hot flash score.Study designWomen experiencing moderately-severe hot flashes were randomized to receive 10 sessions of real or sham acupuncture over eight weeks. Hot flash score was collected using a seven-day hot flash diary, and expectancy using the modified Credibility and Expectancy Questionnaire immediately after the first treatment. Linear mixed-effects models with random intercepts were used to identify associations between expectancy score and hot flash score at end-of-treatment. Regression was also used to identify associations between pre-specified factors of interest and hot flash score. Because there was no difference between real and sham acupuncture for the primary outcome of hot flash score, both arms were combined in the analysis.Results285 women returned the Credibility and Expectancy Questionnaire, and 283 women completed both expectancy measures. We found no evidence for an association between expectancy and hot flash score at end-of-treatment for individual cases in either acupuncture or sham group. Hot flash scores at end-of-treatment were 8.1 (95%CI, 3.0 to 13.2; P = 0.002) points lower in regular smokers compared to those who had never smoked, equivalent to four fewer moderate hot flashes a day.ConclusionIn our study of acupuncture for menopausal hot flashes, higher expectancy after the first treatment did not predict better treatment outcomes. Future research may focus on other determinants of outcomes in acupuncture such as therapist attention. The relationship between smoking and hot flashes is poorly understood and needs further exploration.

Dataset Information

Phase II evaluation of S-adenosyl-L-methionine (SAMe) for the treatment of hot flashes.

Publications

Phase II evaluation of S-adenosyl-L-methionine (SAMe) for the treatment of hot flashes.

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