Efficacy of Manasamitra Vataka (Ayurveda Preparation) Over Clonazepam to Establish Normal Sleep Architecture in Patients with Generalized Anxiety Disorder and Co Morbid Generalized Social Phobia - Abstract
The efficacy of anxiolytic drugs on sleep organization in Generalized Anxiety Disorder (GAD) is poorly studied although sleep disturbances are common manifestations of the disorder. In the present study, we compared the efficacy of Manasamitravataka (Ayurveda preparation) or Clonazepam on macro sleep architecture in patients diagnosed with GAD with co morbid generalized social phobia(SP) using an open label, randomized controlled, parallel group study with 72 GAD patients ( of either sex, aged between 20-55 years ).Patients were randomly divided into three treatment groups: Group I (n=24) received
Manasamitravataka (100mg twice daily for 30 days); Group II, in addition to Manasamitravataka (100mg twice daily for 30 days),received Shirodhara (therapy involving dripping of medicated oil over forehead) treatment for first 7 days; and Group III (n=24) received Clonazepam (0.25 mg in morning and 0.50 mg at night for 30 days). Whole night polysomnographic evaluation of sleep architecture was carried out before and after treatment. Patients from all three groups reported having had good sleep following treatment but showed distinct changes in sleep architecture. Groups I & II showed sleep architecture with proper slow wave sleep and REM sleep states. Additionally, the ayurveda treatment helped to reduce NREM S1 sleep (p=0.001) and nocturnal intermittent awakenings (p=0.005). Whereas, patients treated with Clonazepam showed increase in lighter sleep states such as NREM S2 (p<0.001) but significantly reduced slow wave sleep states(p<0.001).The study demonstrated the effectiveness of Ayurveda treatment over Clonazepamin preserving the restorative sleep though both drugs and Manasamitra vataka and Clonazepam were found to have anxiolytic properties.