Irani, J., Salomon, L., Oba, R., Bouchard, P., & Mottet, N. (2010). Efficacy of venlafaxine, medroxyprogesterone acetate, and cyproterone acetate for the treatment of vasomotor hot flushes in men taking gonadotropin-releasing hormone analogues for prostate cancer: a double-blind, randomised trial. Lancet Oncology, 11(2), 147-154.

Compare the efficacy of 3 drugs in preventing hot flashes in men receiving  hormone treatment for prostate cancer

Patients were randomly assigned to receive wither venlafaxine delayed release 75 mg/day, medroxyprogesterone 20 mg/day or cyproterone acetate 100 mg/day in addition to leuprorelin injections.  Patients were followed up at 4, 8 and 12 weeks.  Patients completed daily hot flush diaries and categorised hot flush severity

• N  309 AGE   Not reported
• MALES (%) 100%         FEMALES (%)
• KEY DISEASE CHARACTERISTICS All had prostate cancer treated with hormonal therapy for at least 6 months.  All had experienced 14 or more hot flushes in the week before study entry

 Double blind randomized controlled trial

• Daily hot flush diary
• European Organization for Research and Treatment of Cancer Quality of life questionnaire ( EORTC-QLC 30)
   

Patients in the medroxyprogesterone group had higher hot flash scores at baseline.  The reduction in daily hot flush scores at 4 weeks was significantly lower for all 3 groups (p<.0001).  Improvements were significantly lower in the venlafaxine group than either of the other 2 groups ( p = .0006), and patients ratings of efficacy of treatment showed that significantly fewer patients in the venlafaxine group rated the treatment as good ( p<.0001) compared to the other 2 groups. Adverse events related to the study drugs were not significantly different between groups, though cyproterone led to a non significantly higher number of vascular adverse events.  The most frequent adverse events were gastrointestinal, including pain, constipation, diarrhea and nausea.  GI events were more frequent with venlafaxine.

Men with significant hot flushes during androgen suppression for prostate cancer appeared to respond better to cyproterone acetate and medroxyprogesterone acetate than to venlafaxine

• Baseline sample/group differences of import
• Risk of bias (no control group)
• Other limitations/*explanation  No control or placebo group precluded observation of placebo effect.  The sample was limited to patients who sought treatment for hot flashes.  This was a short follow up period - longer term efficacy is not known. Effects of hormonal treatment for hot flashes on prostate cancer are not known.

It appears that hormonal treatment is more effective in than venlafaxine for management of hot flashes in patients who are receiving androgen suppression for prostate cancer.  Results also showed that many men did not seek treatment for this problem, suggesting that nurses may need to directly assess these patients for problems with hot flash symptoms.  Effects of steroidal anti androgens on prostate cancer are not clear, and patients receiving both androgen suppression and cyproterone or medroxyprogesterone could have increases in prostate specific antigen concentrations.