Purpose: To access frequency and severity of adverse effects (AE) of non-hormonal drugs (NHD) for hot flashes in breast cancer survivors compared to controls and analyze adverse-effect risk by reviewing published randomized trials.
Methods: Cochrane Central Register for Controlled Trials, Embase, Medline, PsycINFO and PubMed databases were searched. Trials were included where participants were survivors of breast cancer suffering from hot flashes, treatment included self-administered venlafaxine, gabapentin or clonidine, and AE were reported. AE frequency and severity were graded. A meta-analysis of ten trials with sub-group analyses was conducted.
Results: Forty-nine studies were identified, and 12 were included. A total of 1467 participants experienced 772 adverse effects, 81 % (n = 627) in the treatment group and 19 % (n = 145) in the control group. Sixty-seven percent of AE was graded as mild and 33 % as moderate. The frequency of AE for NHD was overall significant compared to placebo. Sub-group analysis indicated that AE frequency and severity increased at higher doses of venlafaxine and gabapentin compared to placebo.
Conclusion: The odds for experiencing AE was significantly higher in patients randomized to high-dose NHD than those randomized to controls, including placebo, low-dose medication and acupuncture. These therapies should be considered as a potential treatment alternative.
Keywords: Adverse effects; Breast cancer; Hot flashes; Non-hormonal drugs.