title: Ineffectiveness of sertraline for treatment of menopausal hot flushes: a randomized controlled trial.
abstract: OBJECTIVE
  To estimate the effect of the selective serotonin reuptake inhibitor sertraline on hot flush frequency and severity in perimenopausal and postmenopausal women.
  
  
  METHODS
  We performed a randomized, blinded, placebo-controlled trial in women aged 40 to 60 years with 14 or more hot flushes per week (N=99). Women were randomly assigned initially to daily oral sertraline (50 mg) or identical placebo for 2 weeks. If no substantial side effects were noted, the dose was increased to two tablets daily (100 mg sertraline or placebo) and continued for an additional 4 weeks. Hot flush frequency and severity were recorded on a daily diary. Hot flush score was calculated as frequency multiplied by severity. Participants also completed questionnaires addressing quality of life, menopausal symptoms, sleep quality, sexual function, mood, and side effects.
  
  
  RESULTS
  After 6 weeks of treatment, hot flush frequency decreased similarly in both the placebo (38%) and sertraline (39%) groups (P=.94). Mean hot flush scores also decreased similarly in both groups (41% and 42%, respectively, P=.86). Compared with placebo, women in the sertraline group were more likely to report gastrointestinal complaints, dry mouth, and dizziness. Treatment with sertraline also resulted in greater worsening of scores on the Medical Outcomes Study (MOS) Short Form 36 standardized physical component and the global Female Sexual Function Index. Results were similar in women at least 80% adherent to study medication.
  
  
  CONCLUSIONS
  Treatment with sertraline did not improve hot flush frequency or severity in generally healthy perimenopausal and postmenopausal women, but was associated with bothersome side effects.
  
  
  BACKGROUND
  ClinicalTrials.gov, www.clinicaltrials.gov, NCT00283192
  
  
  METHODS
  I.
authors.affiliation: University of California, San Francisco, and San Francisco VA Medical Center, San Francisco, California 94115, USA. Deborah.Grady@ucsf.edu
authors.forename: Deborah
authors.initials: D
authors.lastname: Grady
authors.forename: Beth
authors.initials: B
authors.lastname: Cohen
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Tice
authors.forename: Margaret
authors.initials: M
authors.lastname: Kristof
authors.forename: Azin
authors.initials: A
authors.lastname: Olyaie
authors.forename: George F
authors.initials: GF
authors.lastname: Sawaya
mesh_terms: D004311:Double-Blind Method; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy*; D006801:Humans; D008593:Menopause / Q000187:drug effects*; D008875:Middle Aged; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D020280:Sertraline / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index
chemical_list: D017367:Selective Serotonin Reuptake Inhibitors; D020280:Sertraline