Taylor Jennifer, Glenny Anne-Marie, Walsh Tanya, Brocklehurst Paul, Riley Philip, Gorodkin Rachel, Pemberton Michael N
Department of Oral Medicine, The University of Manchester, Dental Hospital, Higher Cambridge Street, Manchester, UK, M15 6FH.
Cochrane Database Syst Rev. 2014 Sep 25;2014(9):CD011018. doi: 10.1002/14651858.CD011018.pub2.
Behçet's disease is a chronic inflammatory vasculitis that can affect multiple systems. Mucocutaneous involvement is common, as is the involvement of many other systems such as the central nervous system and skin. Behç̧et's disease can cause significant morbidity, such as loss of sight, and can be life threatening. The frequency of oral ulceration in Behçet's disease is thought to be 97% to 100%. The presence of mouth ulcers can cause difficulties in eating, drinking, and speaking leading to a reduction in quality of life. There is no cure for Behçet's disease and therefore treatment of the oral ulcers that are associated with Behçet's disease is palliative.
To determine the clinical effectiveness and safety of interventions on the pain, episode duration, and episode frequency of oral ulcers and on quality of life for patients with recurrent aphthous stomatitis (RAS)-type ulceration associated with Behçet's disease.
We undertook electronic searches of the Cochrane Oral Health Group Trials Register (to 4 October 2013); the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 9); MEDLINE via Ovid (1946 to 4 October 2013); EMBASE via Ovid (1980 to 4 October 2013); CINAHL via EBSCO (1980 to 4 October 2013); and AMED via Ovid (1985 to 4 October 2013). We searched the US National Institutes of Health trials register (http://clinicaltrials.gov) and the World Health Organization (WHO) Clinical Trials Registry Platform for ongoing trials. There were no restrictions on language or date of publication in the searches of the electronic databases. We contacted authors when necessary to obtain additional information.
We included randomised controlled trials (RCTs) that looked at pre-specified oral outcome measures to assess the efficacy of interventions for mouth ulcers in Behçet's disease. The oral outcome measures included pain, episode duration, episode frequency, safety, and quality of life. Trials were not restricted by outcomes alone.
All studies meeting the inclusion criteria underwent data extraction and an assessment of risk of bias, independently by two review authors and using a pre-standardised data extraction form. We used standard methodological procedures expected by The Cochrane Collaboration.
A total of 15 trials (n = 888 randomised participants) were included, 13 were placebo controlled and three were head to head (two trials had more than two treatment arms). Eleven of the trials were conducted in Turkey, two in Japan, one in Iran and one in the UK. Most trials used the International Study Group criteria for Behçet's disease. Eleven different interventions were assessed. The interventions were grouped into two categories, topical and systemic. Only one study was assessed as being at low risk of bias. It was not possible to carry out a meta-analysis. The quality of the evidence ranged from moderate to very low and there was insufficient evidence to support or refute the use of any included intervention with regard to pain, episode duration, or episode frequency associated with oral ulcers, or safety of the interventions.
AUTHORS' CONCLUSIONS: Due to the heterogeneity of trials including trial design, choice of intervention, choice and timing of outcome measures, it was not possible to carry out a meta-analysis. Several interventions show promise and future trials should be planned and reported according to the CONSORT guidelines. Whilst the primary aim of many trials for Behç̧et's disease is not necessarily reduction of oral ulceration, reporting of oral ulcers in these studies should be standardised and pre-specified in the methodology. The use of a core outcome set for oral ulcer trials would be beneficial.
白塞病是一种可累及多个系统的慢性炎症性血管炎。黏膜皮肤受累很常见，中枢神经系统和皮肤等许多其他系统也会受累。白塞病可导致严重的发病情况，如失明，甚至可能危及生命。白塞病中口腔溃疡的发生率据认为在97%至100%。口腔溃疡的存在会导致进食、饮水和说话困难，从而降低生活质量。白塞病无法治愈，因此与白塞病相关的口腔溃疡的治疗是姑息性的。
确定干预措施对白塞病相关复发性阿弗他口炎（RAS）型溃疡患者口腔溃疡的疼痛、发作持续时间、发作频率以及生活质量的临床疗效和安全性。
我们对Cochrane口腔健康组试验注册库（截至2013年10月4日）、Cochrane对照试验中央注册库（CENTRAL）（《Cochrane图书馆》2013年第9期）、通过Ovid检索的MEDLINE（1946年至2013年10月4日）、通过Ovid检索的EMBASE（1980年至2013年10月4日）、通过EBSCO检索的CINAHL（1980年至2013年10月4日）以及通过Ovid检索的AMED（1985年至2013年10月4日）进行了电子检索。我们检索了美国国立卫生研究院试验注册库（http://clinicaltrials.gov）和世界卫生组织（WHO）临床试验注册平台以查找正在进行的试验。在电子数据库检索中对语言或出版日期没有限制。必要时我们联系作者以获取更多信息。
我们纳入了随机对照试验（RCT），这些试验观察预先指定的口腔结局指标以评估白塞病口腔溃疡干预措施的疗效。口腔结局指标包括疼痛、发作持续时间、发作频率、安全性和生活质量。试验不受限于仅这些结局指标。
所有符合纳入标准的研究由两位综述作者独立进行数据提取和偏倚风险评估，并使用预先标准化的数据提取表。我们采用了Cochrane协作网期望的标准方法程序。
共纳入15项试验（n = 888名随机参与者），13项为安慰剂对照试验，3项为直接比较试验（两项试验有两个以上治疗组）。其中11项试验在土耳其进行，两项在日本，一项在伊朗，一项在英国。大多数试验采用国际研究组的白塞病标准。评估了11种不同的干预措施。这些干预措施分为两类，局部用药和全身用药。只有一项研究被评估为低偏倚风险。无法进行荟萃分析。证据质量从中等到非常低不等，没有足够证据支持或反驳任何纳入的干预措施在与口腔溃疡相关的疼痛、发作持续时间或发作频率方面的使用，或干预措施的安全性。
由于试验的异质性，包括试验设计、干预措施选择、结局指标选择和时间安排，无法进行荟萃分析。几种干预措施显示出前景，未来的试验应根据CONSORT指南进行规划和报告。虽然许多白塞病试验的主要目的不一定是减少口腔溃疡，但这些研究中口腔溃疡的报告应标准化并在方法中预先指定。使用口腔溃疡试验的核心结局指标集将是有益的。
