- 作者：Dr Rilana FF Cima ; MSc
- 刊名：The Lancet
- 出版年：2012
- 期刊代码：182_01406736
- 类别：med
- 出版时间：26 May-1 June, 2012
- 卷：379
- 期：9830
- 页码：1951-1959
- 文件大小：164 K
Summary
Background
Up to 21%of adults will develop tinnitus, which is one of the most distressing and debilitating audiological problems. The absence of medical cures and standardised practice can lead to costly and prolonged treatment. We aimed to assess effectiveness of a stepped-care approach, based on cognitive behaviour therapy, compared with usual care in patients with varying tinnitus severity.Methods
In this randomised controlled trial, undertaken at the Adelante Department of Audiology and Communication (Hoensbroek, Netherlands), we enrolled previously untreated Dutch speakers (aged >18 years) who had a primary complaint of tinnitus but no health issues precluding participation. An independent research assistant randomly allocated patients by use of a computer-generated allocation sequence in a 1:1 ratio, stratified by tinnitus severity and hearing ability, in block sizes of four to receive specialised care of cognitive behaviour therapy with sound-focused tinnitus retraining therapy or usual care. Patients and assessors were masked to treatment assignment. Primary outcomes were health-related quality of life (assessed by the health utilities index score), tinnitus severity (tinnitus questionnaire score), and tinnitus impairment (tinnitus handicap inventory score), which were assessed before treatment and at 3 months, 8 months, and 12 months after randomisation. We used multilevel mixed regression analyses to assess outcomes in the intention-to-treat population. This study is registered with , number .
Findings
Between September, 2007 and January, 2011, we enrolled and treated 492 (66%) of 741 screened patients. Compared with 247 patients assigned to usual care, 245 patients assigned to specialised care improved in health-related quality of life during a period of 12 months (between-group difference 0路059, 95%CI 0路025 to 0路094; effect size of Cohen's d=0路24; p=0路0009), and had decreased tinnitus severity (鈭?路062, 鈭?0路829 to 鈭?路295; d=0路43; p<0路0001) and tinnitus impairment (鈭?路506, 鈭?0路661 to 鈭?路352; d=0路45; p<0路0001). Treatment seemed effective irrespective of initial tinnitus severity, and we noted no adverse events in this trial.
Interpretation
Specialised treatment of tinnitus based on cognitive behaviour therapy could be suitable for widespread implementation for patients with tinnitus of varying severity.
Funding
Netherlands Organisation for Health Research and Development (ZonMW).