title: Phase II evaluation of S-adenosyl-L-methionine (SAMe) for the treatment of hot flashes.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  The use of SAMe does not appear to significantly reduce hot flashes more than would be expected with a placebo.
authors.affiliation: Division of Hematology and Medical Oncology, University of Michigan, Ann Arbor, USA. kkadakia@umich.edu.
authors.forename: Kunal C
authors.initials: KC
authors.lastname: Kadakia
authors.affiliation: Division of Medical Oncology, Mayo Clinic, Rochester, USA. cloprinzi@mayo.edu.
authors.forename: Charles L
authors.initials: CL
authors.lastname: Loprinzi
authors.affiliation: Division of Medical Oncology, Mayo Clinic, Rochester, USA. atherton.pamela@mayo.edu.
authors.forename: Pamela J
authors.initials: PJ
authors.lastname: Atherton
authors.affiliation: Division of Medical Oncology, Mayo Clinic, Rochester, USA. feeschroeder.kelliann@mayo.edu.
authors.forename: Kelliann C
authors.initials: KC
authors.lastname: Fee-Schroeder
authors.affiliation: Division of General Internal Medicine, Mayo Clinic, Rochester, USA. Sood.Amit@mayo.edu.
authors.forename: Amit
authors.initials: A
authors.lastname: Sood
authors.affiliation: School of Nursing, University of Michigan, 400 N. Ingalls, Room 2153, Ann Arbor, MI, 48109, USA. debbartn@umich.edu.
authors.forename: Debra L
authors.initials: DL
authors.lastname: Barton
mesh_terms: D005260:Female; D019584:Hot Flashes / Q000188:drug therapy*; D006801:Humans; D011788:Quality of Life; D012436:S-Adenosylmethionine / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D012436:S-Adenosylmethionine
keywords: Clinical trials; Hot flashes; Quality of life; S-Adenosyl-L-methionine; SAMe