Efficacy of Huadananshenmistura on insomnia: a randomized, double-blind, placebo-controlled, and multi-center clinical trial

The medicine Huadananshenmistura consists of Dan Shen (Salviaemiltiorrhizae Radix) and the twigs and leaves of the peanut plant (which opens and closes its leaves in the morning and evening and may contain sleep-promoting substances), and is an approved hypnotic medicine in China. In this trial 244 patients with insomnia were randomly allocated to a placebo group, a low dose (10ml/day) medicine group or a high dose medicine (20ml/day) group. Efficacy was assessed using the Sleep Dysfunction Rating (SDR) score and the Clinical Global Impression Improvement (CGII) score. The total SDR scores decreased in all three groups, with significant differences between the placebo and the low- and high-dose medicine groups. The CGII scores in both medicine groups also significantly improved compared to the placebo group. Overall, the efficacy of both medicine groups was significantly better than the placebo group, with no significant difference between the low- and high-dose groups. [Aug 2013]