Biglia, N., Torta, R., Roagna, R., Maggiorotto, F., Cacciari, F., Ponzone, R., … Sismondi, P. (2005). Evaluation of low-dose venlafaxine hydrochloride for the therapy of hot flushes in breast cancer survivors. Maturitas, 52, 78–85.

DOI Link

Study Purpose

  • Evaluation of low-dose venlafaxine hydrochloride for the therapy of hot flashes in breast cancer survivors
  • Evaluate the efficacy and tolerability of a longer treatment (eight weeks) at a lower dose of venlafaxine (37.5 mg/day)

Sample Characteristics

  • N = 40
  • Patients attending the outpatient clinic for menopausal symptoms 
  • All witha history of breast cancer without evidence of recurrence and no requirement of fulfilling menopausal status
  • Anti-estrogen therapy was allowed provided that it had been started at least four months before study entry and continued the next three months

Setting

Outpatient

Study Design

Open label study

Measurement Instruments/Methods

Measures included:

  • Hot flash diary and computation of daily hot flash scores
  • Weekly documentation in diariesof side effects experienced  
  • Beck Depression Inventory (BDI) as completed at baseline and at week 8 
  • At weeks 4 and 8,a clinical visit to monitor blood pressure, assess side effects, and hot flash frequency
    • Patient was excluded from study if blood pressure found diastolic above 95 or systolic above 160, or if important side effect occurred

Results

Thirty patients completed the first 4 weeks of treatment with reduction of hot flash frequency of 39% compared to baseline. After eight weeks of treatment, a further significant reduction in hot flashes by 53% and a hot flash score by 59% was observed. Very few side effects were reported, mainly nausea during first the two weeks and mouth dryness. Only 23 women completed the BDI at week 8 with a reduction of 23% reported. No patient was withdrawn for blood pressure increase or major toxicity.

Conclusions

Low-dose venlafaxine hydrochloride can be effective in reducing frequency and severity of hot flashes in patients with breast cancer.

Limitations

  • Not blinded or placebo-controlled