title: Management of hot flashes in patients who have breast cancer with venlafaxine and clonidine: a randomized, double-blind, placebo-controlled trial.
abstract: OBJECTIVE
  Therapies for breast cancer may induce hot flashes that can affect quality of life. We undertook a double-blind, placebo-controlled trial with the primary objective of comparing the average daily hot flash scores in the twelfth week among patients treated with venlafaxine, clonidine, and placebo. Additional analyses of the hot flash score over the full 12 weeks of treatment were performed.
  
  
  METHODS
  In all, 102 patients with a history of breast cancer were randomly assigned (2:2:1) to venlafaxine 75 mg, clonidine 0.1 mg, or placebo daily for 12 weeks. Questionnaires at baseline and during treatment assessed daily hot flash scores, sexual function, sleep quality, anxiety, and depression.
  
  
  RESULTS
  After 12 weeks, a total of 80 patients were evaluable for the primary end point. During week 12, hot flash scores were significantly lower in the clonidine group versus placebo (P = .03); for venlafaxine versus placebo, the difference was borderline not significant (P = .07). However, hot flash scores were equal in the clonidine and venlafaxine groups. Over the course of 12 weeks, the differences between both treatments and placebo were significant (P <.001 for venlafaxine v placebo; P = .045 for clonidine v placebo). Frequencies of treatment-related adverse effects of nausea (P = .02), constipation (P = .04), and severe appetite loss were higher in the venlafaxine group.
  
  
  CONCLUSIONS
  Venlafaxine and clonidine are effective treatments in the management of hot flashes in patients with breast cancer. Venlafaxine resulted in a more immediate reduction of hot flash scores when compared with clonidine; however, hot flash scores at week 12 were lower in the clonidine group than in the venlafaxine group.
authors.affiliation: The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Division of Clinical Pharmacology, Amsterdam, The Netherlands.
authors.forename: Annelies H
authors.initials: AH
authors.lastname: Boekhout
authors.forename: Andrew D
authors.initials: AD
authors.lastname: Vincent
authors.forename: Otilia B
authors.initials: OB
authors.lastname: Dalesio
authors.forename: Joan
authors.initials: J
authors.lastname: van den Bosch
authors.forename: Joke H
authors.initials: JH
authors.lastname: Foekema-Töns
authors.forename: Sandra
authors.initials: S
authors.lastname: Adriaansz
authors.forename: Sylvia
authors.initials: S
authors.lastname: Sprangers
authors.forename: Bastiaan
authors.initials: B
authors.lastname: Nuijen
authors.forename: Jos H
authors.initials: JH
authors.lastname: Beijnen
authors.forename: Jan H M
authors.initials: JH
authors.lastname: Schellens
mesh_terms: D000328:Adult; D000368:Aged; D000700:Analgesics / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000150:complications* / Q000188:drug therapy; D003000:Clonidine / Q000627:therapeutic use*; D003511:Cyclohexanols / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D019584:Hot Flashes / Q000139:chemically induced / Q000188:drug therapy* / Q000209:etiology*; D006801:Humans; D008875:Middle Aged; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use; D016896:Treatment Outcome; D000069470:Venlafaxine Hydrochloride
chemical_list: D000700:Analgesics; D003000:Clonidine; D003511:Cyclohexanols; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors; D000069470:Venlafaxine Hydrochloride