Li Chunjie, Wu Fanglong, Zhang Qi, Gao Qinghong, Shi Zongdao, Li Longjiang
Department of Head and Neck Oncology, West China Hospital of Stomatology, Sichuan University, State Key Laboratory of Oral Diseases, No. 14, Section Three, Ren Min Nan Road, Chengdu, Sichuan, China, 610041.
Cochrane Database Syst Rev. 2015 Mar 17;2015(3):CD009959. doi: 10.1002/14651858.CD009959.pub2.
Frey's syndrome is a rare disorder, the symptoms of which include sweating, flushing and warming over the preauricular and temporal areas following a gustatory stimulus. It often occurs in patients who have undergone parotidectomy, submandibular gland surgery, radical neck dissection, infection and traumatic injury in the parotid region, and is caused by the aberrant regrowth of facial autonomic nerve fibres. Currently there are several options used to treat patients with Frey's syndrome; for example, the topical application of anticholinergics and antiperspirants, and the intradermal injection of botulinum toxin. It is uncertain which treatment is most effective and safe.
To assess the efficacy and safety of different interventions for the treatment of Frey's syndrome.
We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; CINAHL; Web of Science; ICTRP and additional sources for published and unpublished trials. The date of the search was 28 April 2014.
We included randomised or quasi-randomised controlled trials (RCTs) in participants diagnosed with Frey's syndrome using a clinical standard such as Minor's starch-iodine test. We planned to include trials in which participants received any intervention versus no treatment (observation) or an alternative intervention, with or without a second active treatment. Our primary outcome measures were success rate (as assessed clinically by Minor's starch-iodine test, the iodine-sublimated paper histogram method, blotting paper technique or another method) and adverse events. Our secondary outcome measure was success rate as assessed by patients (disappearance or improvement of symptoms).
We used the standard methodological procedures expected by The Cochrane Collaboration.
We identified no RCTs or quasi-RCTs that fulfilled the inclusion criteria. Our searches retrieved eight potentially relevant studies, but after assessment of the full-text reports we excluded all of them due to the absence of randomisation or because the patients did not have Frey's syndrome. We excluded one randomised controlled trial that compared two different doses of botulinum toxin in patients with Frey's syndrome because the comparator was not an alternative treatment.
AUTHORS' CONCLUSIONS: We are unable to establish the efficacy and safety of the different methods used for the treatment of Frey's syndrome.RCTs are urgently needed to assess the effectiveness of interventions for the treatment of Frey's syndrome. Future RCTs should include patients with Frey's syndrome of different ranges of severity and report these patients separately. Studies should investigate all possibly effective treatments (such as anticholinergics, antiperspirants and botulinum toxin) compared to control groups using different treatments or placebo. Subjective assessment of Frey's syndrome should be considered as one of the outcome measures.
弗雷综合征是一种罕见疾病,其症状包括在味觉刺激后耳前和颞部区域出汗、潮红和发热。它常发生于接受过腮腺切除术、下颌下腺手术、根治性颈清扫术、腮腺区域感染和创伤性损伤的患者,由面部自主神经纤维的异常再生引起。目前有多种用于治疗弗雷综合征患者的方法;例如,局部应用抗胆碱能药物和止汗剂,以及皮内注射肉毒杆菌毒素。尚不确定哪种治疗最有效和安全。
评估不同干预措施治疗弗雷综合征的疗效和安全性。
我们检索了Cochrane耳、鼻和咽喉疾病组试验注册库;Cochrane对照试验中央注册库(CENTRAL);PubMed;EMBASE;CINAHL;科学引文索引;国际临床试验注册平台及其他已发表和未发表试验的来源。检索日期为2014年4月28日。
我们纳入了使用诸如米诺淀粉碘试验等临床标准诊断为弗雷综合征的参与者的随机或半随机对照试验(RCT)。我们计划纳入参与者接受任何干预与不治疗(观察)或替代干预对比的试验,有或没有第二种积极治疗。我们的主要结局指标是成功率(通过米诺淀粉碘试验、碘升华纸直方图法、吸水纸技术或其他方法进行临床评估)和不良事件。我们的次要结局指标是患者评估的成功率(症状消失或改善)。
我们采用了Cochrane协作网期望的标准方法程序。
我们未识别出符合纳入标准的RCT或半RCT。我们的检索找到了8项潜在相关研究,但在评估全文报告后,由于缺乏随机分组或患者没有弗雷综合征,我们将它们全部排除。我们排除了一项比较弗雷综合征患者两种不同剂量肉毒杆菌毒素的随机对照试验,因为对照不是替代治疗。
我们无法确定用于治疗弗雷综合征的不同方法的疗效和安全性。迫切需要进行RCT来评估治疗弗雷综合征干预措施的有效性。未来的RCT应纳入不同严重程度范围的弗雷综合征患者,并分别报告这些患者。研究应调查与使用不同治疗或安慰剂的对照组相比的所有可能有效的治疗方法(如抗胆碱能药物、止汗剂和肉毒杆菌毒素)。弗雷综合征的主观评估应被视为结局指标之一。