- 만성편두통에서 돌외추출물의 효과와 안정성: 무작위, 이중맹검, 위약대조법을 이용한 연구
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Seong-Hae Jeong, Jae-Moon Kim, Mi Sook Park, Myung Koo Lee
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Korean J Headache. 2012;13(1):1-6. Published online June 30, 2012
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Abstract
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- 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.
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