Loprinzi, C.L., Sloan, J., Stearns, V., Slack, R., Iyengar, M., Diekmann, B., … Novotny, P. (2009). Newer antidepressants and gabapentin for hot flashes: An individual patient pooled analysis. Journal of Clinical Oncology, 27, 2831–2837.

Efficacy and side-effects of three relatively low gabapentin doses in comparison to placebo.

Randomized to:

• Placebo for 28 days, or
• Gabapentin 300 mg at bedtime for 28 days, or
• Gabapentin 300 mg at bedtime for 7 days then 300 mg twice a day for 7 days then 300 mg three times a day for 14 days

• Men undergoing androgen deprivation therapy for prostate cancer with at least 14 hot flashes per week.
• N = 223; 214 completed the study.
• Mean age: 70 years old
• Inclusion: Men with a history of prostate cancer on a program of androgen ablation hormone therapy four weeks prior study and planning continuation of therapy during study; bothersome hot flashes of at least 14 times per week with hot flashes present at least 1 month prior study entry; Antidepressant use at least one month prior study with continuation during study trial.
• Exclusion: Renal insufficiency; concurrent therapies, including antineoplastic chemotherapy, androgens, estrogens, or progestational agents; previous therapy with gabapentin

Outpatient oncology centers

Double-blind, placebo-controlled.

Hot flash frequencies and severities were recorded daily for a baseline week and for four weeks while taking the study medication; symptom experience diaries were completed weekly for five weeks; 30-item Profile of Mood States–Brief was completed at the end of the baseline week and the end of four weeks of treatment.

By the fourth treatment week, mean hot flash scores decreased from baseline in the placebo group by 4.1 units. They also decreased in the three increasing dose gabapentin groups by 3.2, 4.6, and 7.0 units. No significant difference was reported in the three combined gabapentin arms versus placebo: Wilcoxon rank-sum p values for change in hot flash scores and frequencies after four weeks of treatment were 0.10 and 0.02 comparing the highest dose gabapentin arm to the placebo arm, respectively.

Short follow-up period