title: Phase III trial of gabapentin alone or in conjunction with an antidepressant in the management of hot flashes in women who have inadequate control with an antidepressant alone: NCCTG N03C5.
abstract: OBJECTIVE
  Despite the utility of newer antidepressants for alleviating hot flashes, antidepressants do not work adequately enough in many patients. Gabapentin is a nonhormonal agent that also can reduce hot flashes. No data have been available to address whether the combination of both agents would more effectively alleviate hot flashes, compared with gabapentin alone, in patients with inadequate hot flash control with an antidepressant alone.
  
  
  METHODS
  This was a randomized trial in which 118 patients with inadequate hot flash control on an antidepressant were randomly assigned to receive both an antidepressant and gabapentin versus being weaned off the antidepressant and receiving gabapentin alone. Patients were observed for 5 weeks (including a baseline week in which patients continued on their current antidepressant without gabapentin) during which time they completed validated daily hot flash diaries.
  
  
  RESULTS
  Ninety-one patients provided complete data at the 5-week assessment. Regardless of whether or not the antidepressant was continued when gabapentin was started, there was an approximately 50% median reduction in hot flash frequencies (54%; 95% CI, 34% to 70% for combined treatment v 49%; 95% CI, 26% to 58% for gabapentin alone) and scores (56%; 95% CI, 26% to 71% for combined treatment v 60%; 95% CI, 33% to 73% for gabapentin alone).
  
  
  CONCLUSIONS
  Gabapentin seems to decrease hot flashes by approximately 50% in women with inadequate hot flash control who were using an antidepressant. This study saw no significant additional hot flash reduction from continuation of the antidepressant.
authors.affiliation: Mayo Clinic, Rochester, MN 55905, USA. cloprinzi@mayo.edu
authors.forename: Charles L
authors.initials: CL
authors.lastname: Loprinzi
authors.forename: John W
authors.initials: JW
authors.lastname: Kugler
authors.forename: Debra L
authors.initials: DL
authors.lastname: Barton
authors.forename: Amylou C
authors.initials: AC
authors.lastname: Dueck
authors.forename: Loren K
authors.initials: LK
authors.lastname: Tschetter
authors.forename: Robert A
authors.initials: RA
authors.lastname: Nelimark
authors.forename: Ernie Porteza
authors.initials: EP
authors.lastname: Balcueva
authors.forename: Kelli N
authors.initials: KN
authors.lastname: Burger
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Novotny
authors.forename: Mark D
authors.initials: MD
authors.lastname: Carlson
authors.forename: Steven Fletcher
authors.initials: SF
authors.lastname: Duane
authors.forename: Steven W
authors.initials: SW
authors.lastname: Corso
authors.forename: David B
authors.initials: DB
authors.lastname: Johnson
authors.forename: Anthony J
authors.initials: AJ
authors.lastname: Jaslowski
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000588:Amines / Q000627:therapeutic use*; D000927:Anticonvulsants / Q000627:therapeutic use*; D000928:Antidepressive Agents / Q000627:therapeutic use*; D003509:Cyclohexanecarboxylic Acids / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D000077206:Gabapentin; D019584:Hot Flashes / Q000188:drug therapy*; D006801:Humans; D008875:Middle Aged; D016896:Treatment Outcome; D005680:gamma-Aminobutyric Acid / Q000627:therapeutic use*
chemical_list: D000588:Amines; D000927:Anticonvulsants; D000928:Antidepressive Agents; D003509:Cyclohexanecarboxylic Acids; D005680:gamma-Aminobutyric Acid; D000077206:Gabapentin