Westerberg B D, Roberson J B, Stach B A
California Ear Institute, Stanford University Medical Center, Palo Alto 94304, USA.
Am J Otol. 1996 Nov;17(6):896-903.
To determine the effectiveness of baclofen in ameliorating tinnitus in adult patients.
Randomized double-blind placebo-controlled trial.
California Ear Institute at Stanford, California, a tertiary otology/neurotology referral center.
Restricted to adults receiving otologic evaluation at the California Ear Institute at Stanford. Some patients had a primary complaint of tinnitus, whereas others with tinnitus were recruited during treatment for another condition. The study population was felt to be representative of the general population with tinnitus.
Three weeks of baclofen (10 mg orally twice daily for 1 week, 20 mg orally twice daily for the second week, and 30 mg orally twice daily for the third week) or placebo designed to mimic baclofen capsules in route, schedule, appearance, and taste were given to patients.
Tinnitus handicap inventory, pitch and loudness matching, and maskability of tinnitus.
Subjective and objective evaluation failed to demonstrate any clinical or statistical advantage of baclofen over placebo. Reports of subjective improvement occurred in only 9.7% of the baclofen versus 3.4% of the placebo groups, a nonsignificant difference. Withdrawal from the baclofen arm of the study occurred in 26% due to side effects, which could be attributed to the medication.
Baclofen is no more effective than placebo in ameliorating tinnitus in adult patients.
确定巴氯芬改善成年患者耳鸣的有效性。
随机双盲安慰剂对照试验。
加利福尼亚州斯坦福市的加利福尼亚耳科研究所，一家三级耳科/神经耳科学转诊中心。
限于在加利福尼亚州斯坦福市的加利福尼亚耳科研究所接受耳科评估的成年人。一些患者主要抱怨耳鸣，而其他耳鸣患者是在治疗其他疾病期间招募的。研究人群被认为是耳鸣普通人群的代表。
给予患者为期三周的巴氯芬（第1周口服10毫克，每日两次；第2周口服20毫克，每日两次；第3周口服30毫克，每日两次）或设计成在给药途径、给药时间表、外观和味道上模仿巴氯芬胶囊的安慰剂。
耳鸣障碍量表、音高和响度匹配以及耳鸣的掩蔽性。
主观和客观评估均未显示巴氯芬比安慰剂有任何临床或统计学优势。巴氯芬组仅有9.7%的患者报告主观症状改善，而安慰剂组为3.4%，差异无统计学意义。由于副作用，26%的患者退出了巴氯芬组的研究，这些副作用可归因于药物。
在改善成年患者耳鸣方面，巴氯芬并不比安慰剂更有效。
