Loprinzi, C. L., Kugler, J. W., Barton, D. L., Dueck, A. C., Tschetter, L. K., Nelimark, R. A., . . . Jaslowski, A. J. (2007). 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. Journal of Clinical Oncology, 25, 308-312.

To determine the effectiveness of Gabapentin in combination with an antidepressant for the treatment of hot flashes.

Women must have been on a stable dose of antidepressant for the tx of hot flashes. In week one, patients completed a hot flash diary. In the second week, patients took 300 mg gabapentin at bedtime for 3 days, then twice daily for 3 days, then 3 times a day for 22 days. In one arm of the study patients remained on their previous dose of antidepressant and in the other arm patients weaned off antidepressants over 7-10 days and physician discretion was allowed. Patients completed a daily hot flash diary for 4 week and a weekly symptom assessment.

SITE  Single site    SETTING TYPE  Outpatient    LOCATION USA

PHASE OF CARE Late effects and survivorship

RCT

Both groups experienced a reduction in hot flashes: gabapentin = 60% reduction (95% CI, 33%-73%) and gabapentin plus antidepressant = 56% reduction (95% CI, 26%-71%)No difference between groups in hot flash scores or frequency from baseline to 4 weeks in either arm. No difference in toxicities reported by either arm. No difference in QOL in either arm.

This trial failed to demonstrate that the combination of gabapentin with antidepressants is more effective to reduce the number of hot flashes experienced by breast cancer survivors.

Risk of bias (no control group)

Risk of bias (no blinding)

Risk of bias(sample characteristics)

Other limitations/*explanation  All breast cancer patients, no placebo arm

The combination of gabapentin plus antidepressant does not appear to be an effective regimen to decrease hot flashes in breast cancer survivors