Clinical study to evaluate efficacy and safety of topical balms for headache: a randomized trial

Background: Topical balms containing natural ingredients are commonly used in complementary therapies for headache. There is a need to evaluate the clinical efficacy and safety of these balms. Objectives were to assess the efficacy and safety of commercial balms in patients diagnosed with tension type headache as per the ICHD II criteria. Methods: A randomised, single blind, multi-centre clinical trials were conducted for headache. Adult participants were enrolled at three sites in India (IND [n=31], [n=30] and [n=30]) to study the efficacy of three commercial balms (CT64, CT46 and CT17) by assessing percentage of subjects with meaningful headache relief and pain intensity after application on verbal rating scale (VRS). Effect on headache on a 100-point visual analog score (VAS), use of rescue medications, onset, intensity and duration of action of balm, quality of sleep, quality of pain relief, global assessment of overall effect by physician and patient and global assessment of tolerability of drug were also assessed. Results: The CT64, CT46 and CT17 groups responded with 93.33%, 90.32% and 86.66% of total meaningful headache relief respectively. There is a significant decrease in headache intensity in CT64 followed by CT46 group on VAS scale. The VRS rating also demonstrated significant reduction in headache within two hours. The balms also demonstrated safe to use on the basis of adverse drug reaction study. Conclusions: The commercial balms containing 10-15% menthol and 10-25% methyl salicylate can provide significant relief from headache and are safe to use.