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KMID : 0911820120130010001
Korean Journal of Headache
2012 Volume.13 No. 1 p.1 ~ p.6
Efficacy and Safety of Gynostemma Pentaphyllum Extract in Complementary Prophylaxis of Chronic Migraine: A Double-blind, Randomized, Placebo-controlled Study
Jeong Myeong-Ja

Kim Jae-Moon
Park Mi-Sook
Lee Myung-Koo
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¡¾2.3 before treatment to 2.8¡¾2.6 after 6 week of GP-EX treatment (vs. placebo: from 5.4¡¾1.9 to 3.9¡¾2.8 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¡¾10.8 (mean¡¾SD) to 43.7¡¾10.7 in patient with GP-EX, p=0.017 vs. from 48.3¡¾12.9 to 45.8¡¾10.2 in patients with placebo, p>0.05; STAI-T=from 48.8¡¾11.5 to 43.2¡¾11.6 in patient with GP-EX, p=0.017 vs. from 48.4¡¾11.2 to 44.8¡¾11.5 in patients with placebo, p>0.05; ASI =from 32.4¡¾14.3 to 26.3¡¾16.2 in patient with GP-EX, p=0.017 vs. from 30.2¡¾14.2 to 25.4¡¾13.8 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.
KEYWORD
Gynostemma pentaphyllum , Visual analogue scale, Anxiety, Chronic migraine
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