Abstract

Objective: To evaluate the clinical efficacy and safety of a standardized special ethanol extract from Gynostemma pentaphyllum (GP-EX) as a management of chronic migraine.
Methods
This is a two-arm, parallel-group, randomized trial comparing GP-EX 20 mg bid or placebo bid in 64 patients with chronic migraine. Eligible patients were those who meet the broader concept of chronic migraine. The main outcome measure was the decrease in visual analogue scale (VAS) of general pain including headache and anxiety scale from baseline over a 6 weeks treatment period.
Results
The VAS decreased from 4.6±2.3 before treatment to 2.8±2.6 after 6 week of GP-EX treatment (vs. placebo: from 5.4±1.9 to 3.9±2.8 p=0.017). In all questionnaires using in this study, the anxiety in group with GP-EX was decreased significantly than one in patients with placebo (STAI-S=from 47.6±10.8 (mean±SD) to 43.7±10.7 in patient with GP-EX, p=0.017 vs. from 48.3±12.9 to 45.8±10.2 in patients with placebo, p>0.05; STAI-T=from 48.8±11.5 to 43.2±11.6 in patient with GP-EX, p=0.017 vs. from 48.4±11.2 to 44.8±11.5 in patients with placebo, p>0.05; ASI =from 32.4±14.3 to 26.3±16.2 in patient with GP-EX, p=0.017 vs. from 30.2±14.2 to 25.4±13.8 in patients with placebo, p>0.05). The most frequent adverse reactions considered possibly related to treatment were mild gastrointestinal events.
Conclusions
GP-EX 20 mg bid treatment might be effective in reducing general pain and anxiety in chronic migraine patients.