McMillan Roddy, Forssell Heli, Buchanan John Ag, Glenny Anne-Marie, Weldon Jo C, Zakrzewska Joanna M
Department of Oral Medicine and Facial Pain, Eastman Dental Hospital, 256 Gray's Inn Road, London, UK, WC1X 8LD.
Cochrane Database Syst Rev. 2016 Nov 18;11(11):CD002779. doi: 10.1002/14651858.CD002779.pub3.
Burning mouth syndrome (BMS) is a term used for oral mucosal pain (burning pain or discomfort in the tongue, lips or entire oral cavity) without identifiable cause. General population prevalence varies from 0.1% to 3.9%. Many BMS patients indicate anxiety, depression, personality disorders and impaired quality of life (QoL). This review updates the previous versions published in 2000 and 2005.
To determine the effectiveness and safety of any intervention versus placebo for symptom relief and changes in QoL, taste, and feeling of dryness in people with BMS.
Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 31 December 2015), the Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 11) in the Cochrane Library (searched 31 December 2015), MEDLINE Ovid (1946 to 31 December 2015), and Embase Ovid (1980 to 31 December 2015). We searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform for ongoing trials. We placed no restrictions on the language or date of publication when searching the electronic databases SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing any treatment against placebo in people with BMS. The primary outcomes were symptom relief (pain/burning) and change in QoL. Secondary outcomes included change in taste, feeling of dryness, and adverse effects.
We used standard methodological procedures expected by Cochrane. Outcome data were analysed as short-term (up to three months) or long-term (three to six months).
We included 23 RCTs (1121 analysed participants; 83% female). Interventions were categorised as: antidepressants and antipsychotics, anticonvulsants, benzodiazepines, cholinergics, dietary supplements, electromagnetic radiation, physical barriers, psychological therapies, and topical treatments.Only one RCT was assessed at low risk of bias overall, four RCTs' risk of bias was unclear, and 18 studies were at high risk of bias. Overall quality of the evidence for effectiveness was very low for all interventions and all outcomes.Twenty-one RCTs assessed short-term symptom relief. There is very low-quality evidence of benefit from electromagnetic radiation (one RCT, 58 participants), topical benzodiazepines (two RCTs, 111 participants), physical barriers (one RCT, 50 participants), and anticonvulsants (one RCT, 100 participants). We found insufficient/contradictory evidence regarding the effectiveness of antidepressants, cholinergics, systemic benzodiazepines, dietary supplements or topical treatments. No RCT assessing psychological therapies evaluated short-term symptom relief.Four studies assessed long-term symptom relief. There is very low-quality evidence of a benefit from psychological therapies (one RCT, 30 participants), capsaicin oral rinse (topical treatment) (one RCT, 18 participants), and topical benzodiazepines (one RCT, 66 participants). We found no evidence of a difference for dietary supplements or lactoperoxidase oral rinse. No studies assessing antidepressants, anticonvulsants, cholinergics, electromagnetic radiation or physical barriers evaluated long-term symptom relief.Short-term change in QoL was assessed by seven studies (none long-term).The quality of evidence was very low. A benefit was found for electromagnetic radiation (one RCT, 58 participants), however findings were inconclusive for antidepressants, benzodiazepines, dietary supplements and physical barriers.Secondary outcomes (change in taste and feeling of dryness) were only assessed short-term, and the findings for both were also inconclusive.With regard to adverse effects, there is very low-quality evidence that antidepressants increase dizziness and drowsiness (one RCT, 37 participants), and that alpha lipoic acid increased headache (two RCTs, 118 participants) and gastrointestinal complaints (3 RCTs, 138 participants). We found insufficient/contradictory evidence regarding adverse events for anticonvulsants or benzodiazepines. Adverse events were poorly reported or unreported for cholinergics, electromagnetic radiation, and psychological therapies. No adverse events occurred from physical barriers or topical therapy use.
AUTHORS' CONCLUSIONS: Given BMS' potentially disabling nature, the need to identify effective modes of treatment for sufferers is vital. Due to the limited number of clinical trials at low risk of bias, there is insufficient evidence to support or refute the use of any interventions in managing BMS. Further clinical trials, with improved methodology and standardised outcome sets are required in order to establish which treatments are effective. Future studies are encouraged to assess the role of treatments used in other neuropathic pain conditions and psychological therapies in the treatment of BMS.
灼口综合征(BMS)是指口腔黏膜疼痛(舌、唇或整个口腔内的灼痛或不适)且无明确病因。普通人群患病率在0.1%至3.9%之间。许多BMS患者存在焦虑、抑郁、人格障碍及生活质量(QoL)受损的情况。本综述更新了2000年和2005年发表的 previous versions。
确定与安慰剂相比,任何干预措施在缓解BMS患者症状以及改善生活质量、味觉和口干感觉方面的有效性和安全性。
Cochrane口腔健康信息专家检索了以下数据库:Cochrane口腔健康试验注册库(截至2015年12月31日)、Cochrane图书馆中的Cochrane对照试验中央注册库(CENTRAL;2015年第11期,检索于2015年12月31日)、MEDLINE Ovid(1946年至2015年12月31日)以及Embase Ovid(1980年至2015年12月31日)。我们检索了ClinicalTrials.gov和世界卫生组织国际临床试验注册平台以查找正在进行的试验。在检索电子数据库时,我们对语言或出版日期没有限制。
比较BMS患者中任何治疗与安慰剂的随机对照试验(RCT)。主要结局为症状缓解(疼痛/灼痛)和生活质量变化。次要结局包括味觉变化、口干感觉及不良反应。
我们采用了Cochrane期望的标准方法程序。结局数据按短期(至多三个月)或长期(三至六个月)进行分析。
我们纳入了23项RCT(1121名分析参与者;83%为女性)。干预措施分为:抗抑郁药和抗精神病药、抗惊厥药、苯二氮䓬类药物、胆碱能药物、膳食补充剂、电磁辐射、物理屏障、心理治疗和局部治疗。总体而言,只有1项RCT被评估为低偏倚风险,4项RCT的偏倚风险尚不清楚,18项研究存在高偏倚风险。所有干预措施和所有结局的有效性证据总体质量都非常低。
21项RCT评估了短期症状缓解情况。关于电磁辐射(1项RCT,58名参与者)、局部苯二氮䓬类药物(2项RCT,111名参与者)、物理屏障(1项RCT,50名参与者)和抗惊厥药(1项RCT,100名参与者),有非常低质量的证据表明有益。我们发现关于抗抑郁药、胆碱能药物、全身性苯二氮䓬类药物、膳食补充剂或局部治疗的有效性,证据不足/相互矛盾。没有评估心理治疗的RCT评估短期症状缓解情况。
4项研究评估了长期症状缓解情况。关于心理治疗(1项RCT,30名参与者)、辣椒素口腔冲洗(局部治疗)(1项RCT,18名参与者)和局部苯二氮䓬类药物(1项RCT,66名参与者),有非常低质量的证据表明有益。我们没有发现膳食补充剂或乳过氧化物酶口腔冲洗有差异的证据。没有评估抗抑郁药、抗惊厥药、胆碱能药物、电磁辐射或物理屏障的研究评估长期症状缓解情况。
7项研究(均非长期研究)评估了生活质量的短期变化。证据质量非常低。发现电磁辐射(1项RCT,58名参与者)有益,但抗抑郁药、苯二氮䓬类药物、膳食补充剂和物理屏障的研究结果尚无定论。
次要结局(味觉变化和口干感觉)仅进行了短期评估,两者的研究结果也尚无定论。
关于不良反应,有非常低质量的证据表明抗抑郁药会增加头晕和嗜睡(1项RCT,37名参与者),α硫辛酸会增加头痛(2项RCT,118名参与者)和胃肠道不适(3项RCT,138名参与者)。我们发现关于抗惊厥药或苯二氮䓬类药物的不良事件,证据不足/相互矛盾。胆碱能药物、电磁辐射和心理治疗的不良事件报告不佳或未报告。物理屏障或局部治疗使用未发生不良事件。
鉴于BMS可能导致残疾的性质,为患者确定有效的治疗方式至关重要。由于低偏倚风险的临床试验数量有限,没有足够的证据支持或反驳在管理BMS中使用任何干预措施。需要进行方法改进和结局指标标准化的进一步临床试验,以确定哪些治疗方法有效。鼓励未来的研究评估用于其他神经性疼痛疾病的治疗方法和心理治疗在BMS治疗中的作用。