A multicenter, randomized, double-blind, placebo-controlled, parallel design study on the efficacy and safety of gabapentin, an anticonvulsant drug in the treatment of postherpetic neuralgia
10.3760/cma.j.issn.0412-4030.2009.07.003
- VernacularTitle:加巴喷丁胶囊治疗疱疹后神经痛的多中心临床观察
- Author:
Julin GU
;
Hai WEN
;
Xunquan LIU
;
Zhizhong ZHENG
;
Jun GU
;
Hao YU
- Publication Type:Journal Article
- Keywords:
Neuralgia,postherpetic;
Gabapentin;
Randomized controlled trials
- From:
Chinese Journal of Dermatology
2009;42(7):451-454
- CountryChina
- Language:Chinese
-
Abstract:
Objective To observe the clinical efficacy and safety of gahapentin in the treatment of postherpetic neuralgia. Methods A multicenter, randomized, double-blind, placebo-controlled, parallel design, 6-week study was performed. Patients with postherpetic neuralgia were recruited into this study and randomly divided into two groups to receive gabapentin or placebo 1800 mg daily in three divided doses with a forced titration schedule, respectively. The primary efficacy measure was change in the pain score based on a visual analogue scale from baseline to the final week of therapy, and secondary measure was the improvement in sleep quality scored on a 5-point severity scale. Efficacy and safety evaluation was performed at baseline, and 1, 3, and 6 weeks atter the treatment. Results One hundred and forty-one patients were recruited in four clinical centers, and 125 patients completed the trial, of whom 66 were in the treatment group and 59 in the control group. An improvement was observed in both pain scores and sleep scores on week 1, 3 and 6 in both two groups, and the improvement was greater in gabapentin-treated group than that in the control group. The response rate was 29.58% and 57.75%, respectively in gabapentin-treated group on week 1 and 3, com-pared to 13.04% and 40.58%, respectively, in the control group (t = 5.94, 4.12, respectively, both P ＜0.05).Gabapentin was well tolerated, and the most common adverse events were dizziness, vertigo, somnolence and transient abnormality of hepatic function. Conclusion Gabapentin could markedly reduce pain intensity and improve sleep quality with a low incidence of adverse events in patients with postherpetic neuralgia.
