Randomized Controlled Trial of Medical Therapies for Chronic Post- Traumatic Headaches.

摘要

A randomized, double-blinded, placebo-controlled clinical trial was conducted to evaluate the effectiveness of propranolol, topiramate, and amitriptyline as treatments for chronic post-traumatic headaches secondary to combat-related mild head injury. The study has completed the third of three years. 305 soldiers with chronic PTH were screened and 64 were enrolled, falling well short of the enrollment target of 240 subjects. 39 (61%) had evaluable data after drug titration and 34 (53%) completed the 3-month treatment period. Discontinuation rates ranged from 39% for topiramate to 53% for amitriptyline but were not significantly different between treatment arms. Monthly headache days decreased from 12.2 at baseline to 7.9 during the final month in all subjects (-36%, p=0.0001), 16.7 to 8.7 in the placebo arm (-48%, p=0.012), 11.7 to 6.1 in the amitriptyline arm (-41%, p=0.0005), 14.0 to 8.3 in the propranolol arm (-41%, p=0.10), and 9.3 to 8.8 in the topiramate arm (-5%, p=0.80). Mean MIDAS scores decreased from 71 at baseline to 31 at the final visit among all subjects (p=0.0001) and significantly declined in the placebo, topiramate, and propranolol arms. PTSD symptom checklist scores significantly declined in the topiramate arm. This study is limited by the small number of subjects and better than expected response in the placebo arm. The study is closed.