Gevorgyan Artur, Segboer Christine, Gorissen Rob, van Drunen Cornelis M, Fokkens Wytske
Department of Otorhinolaryngology, Academic Medical Centre, Meibergdreef 9, A2-234, 1105 Az, Amsterdam, Netherlands.
Cochrane Database Syst Rev. 2015 Jul 14;2015(7):CD010591. doi: 10.1002/14651858.CD010591.pub2.
There are many forms of rhinitis. Patients are diagnosed with non-allergic rhinitis when anatomic, infectious and allergic aetiologies have been excluded. The symptoms, including nasal congestion, blockage or obstruction, clear rhinorrhoea, sneezing and, less frequently, nasal itching, can range from mild to debilitating. It affects between 25% and 50% of patients with rhinitis. Several medications are widely used in the treatment of non-allergic rhinitis, including oral and topical nasal antihistamines, intranasal and (rarely) systemic corticosteroids, and anticholinergics. Capsaicin, the active component of chili peppers, delivered intranasally, is considered a treatment option for non-allergic rhinitis.
To assess the effectiveness of capsaicin in the management of non-allergic rhinitis compared with no therapy, placebo or other topical or systemic medications, or two or more of the above therapies in combination, or different capsaicin regimens.
We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL 2015, Issue 5); PubMed; EMBASE; CINAHL; Web of Science; Cambridge Scientific Abstracts; ICTRP and additional sources for published and unpublished trials. The date of the search was 24 June 2015.
Randomised controlled trials in adult patients with non-allergic rhinitis comparing intranasal capsaicin with no therapy, placebo or other topical or systemic medications, or their combinations.
We used the standard methodological procedures expected by The Cochrane Collaboration.
We included four studies (five publications) involving 302 participants with idiopathic non-allergic rhinitis. All the included studies described patients with moderately severe, idiopathic non-allergic rhinitis who were between the ages of 16 and 65. Studies had follow-up periods ranging from four to 38 weeks. The overall risk of bias in the studies was either high or unclear (two studies had overall high risk of bias, while two others had low to unclear risk of bias). Using the GRADE system we assessed the evidence as being of low to moderate quality. A meta-analysis was not possible, given lack of similarity of the reported outcomes.Two studies compared capsaicin with placebo. One study reported that capsaicin resulted in an improvement of overall nasal symptoms (a primary outcome) measured on a visual analogue scale (VAS) of 0 to 10. There was a mean difference (MD) of -3.34 (95% confidence interval (CI) -5.24 to -1.44), MD -3.73 (95% CI -5.45 to -2.01) and MD -3.52 (95% CI -5.55 to -1.48) at two, 12 and 36 weeks post-treatment, respectively. Another study reported that, compared to placebo, capsaicin (at 4 µg/puff) was more likely to produce overall symptom resolution (reduction in nasal blockage, sneezing/itching/coughing and nasal secretion measured with a daily record chart) at four weeks post-treatment (a primary outcome). The risk ratio (RR) was 3.17 (95% CI 1.38 to 7.29).One study compared capsaicin to budesonide (an intranasal corticosteroid). This study found that patients treated with capsaicin had a better overall symptom score compared to those treated with budesonide (MD 2.50, 95% CI 1.06 to 3.94, VAS of 0 to 10). However, there were no differences in the individual symptom scores for headache, postnasal drip, rhinorrhoea, nasal blockage, sneezing and sore throat assessed during the last three days of a four-week treatment.One study compared two different regimens of capsaicin administration: five treatments in one day versus five treatments given every two to three days during two weeks. Using daily record charts, the study reported significant improvement of individual symptom scores for rhinorrhoea in patients treated five times per day, however numerical data were not presented. There were no improvements in the other outcomes: rhinorrhoea, nasal obstruction, sneezing and overall nasal symptoms, measured on a VAS.Finally, one of these studies also compared three doses of capsaicin (to placebo). Patients treated with a 1 µg versus 4 µg per puff dose of capsaicin had a worse daily record chart overall symptom score resolution (RR 0.63, 95% CI 0.34 to 1.16).Only one study attempted to measure adverse effects (a primary outcome), however due to methodological issues with the assessment we are unable to draw any conclusions.We sought to include other secondary outcomes (e.g. quality of life measures, treatment dropouts, endoscopic scores, turbinate or mucosal size, cost of therapy), but none of these were measured or reported in the included studies.
AUTHORS' CONCLUSIONS: Capsaicin may be an option in the treatment of idiopathic non-allergic rhinitis. It is given in the form of brief treatments, usually during the same day. It appears to have beneficial effects on overall nasal symptoms up to 36 weeks after treatment, based on a few, small studies (low-quality evidence). Well-conducted randomised controlled trials are required to further advance our understanding of the effectiveness of capsaicin in non-allergic rhinitis, especially in patients with non-allergic rhinitis of different types and severity, and using different methods of capsaicin application.
鼻炎有多种形式。当解剖学、感染性和过敏性病因被排除后,患者被诊断为非过敏性鼻炎。其症状包括鼻塞、堵塞或梗阻、清涕、打喷嚏,较少见的还有鼻痒,症状程度从轻到严重不等。它影响25%至50%的鼻炎患者。几种药物被广泛用于治疗非过敏性鼻炎,包括口服和局部鼻用抗组胺药、鼻内和(很少)全身用皮质类固醇以及抗胆碱能药物。辣椒中的活性成分辣椒素经鼻内给药,被认为是治疗非过敏性鼻炎的一种选择。
评估与不治疗、安慰剂或其他局部或全身药物,或上述两种或更多疗法联合使用,或不同辣椒素治疗方案相比,辣椒素治疗非过敏性鼻炎的有效性。
我们检索了Cochrane耳鼻喉疾病组试验注册库;Cochrane对照试验中央注册库(CENTRAL 2015年第5期);PubMed;EMBASE;CINAHL;科学引文索引;剑桥科学文摘;ICTRP以及其他已发表和未发表试验的来源。检索日期为2015年6月24日。
针对成年非过敏性鼻炎患者的随机对照试验,比较鼻内辣椒素与不治疗、安慰剂或其他局部或全身药物,或它们的联合使用。
我们采用了Cochrane协作网期望的标准方法程序。
我们纳入了四项研究(五篇出版物),涉及302名特发性非过敏性鼻炎患者。所有纳入研究均描述了年龄在16至65岁之间、患有中度严重特发性非过敏性鼻炎的患者。研究的随访期为4至38周。这些研究中的总体偏倚风险较高或不明确(两项研究总体偏倚风险高,另外两项研究偏倚风险低至不明确)。使用GRADE系统,我们将证据评估为低至中等质量。由于报告结果缺乏相似性,无法进行荟萃分析。两项研究将辣椒素与安慰剂进行了比较。一项研究报告称,辣椒素使通过0至10视觉模拟量表(VAS)测量的总体鼻部症状(主要结局)得到改善。治疗后第2周、12周和36周的平均差值(MD)分别为-3.34(95%置信区间(CI)-5.24至-1.44)、MD -3.73(95%CI -5.45至-2.01)和MD -3.52(95%CI -5.55至-1.48)。另一项研究报告称,与安慰剂相比,辣椒素(4μg/喷)在治疗后4周更有可能使总体症状缓解(通过每日记录表测量鼻堵塞、打喷嚏/瘙痒/咳嗽和鼻分泌物减少)(主要结局)。风险比(RR)为3.17(95%CI 1.38至7.29)。一项研究将辣椒素与布地奈德(一种鼻内皮质类固醇)进行了比较。该研究发现,与接受布地奈德治疗的患者相比,接受辣椒素治疗的患者总体症状评分更好(MD 2.50,95%CI 1.06至3.94,VAS为0至10)。然而,在为期4周治疗的最后三天评估的头痛、鼻后滴漏、流涕、鼻塞、打喷嚏和喉咙痛的个体症状评分没有差异。一项研究比较了两种不同的辣椒素给药方案:一天五次治疗与在两周内每两至三天进行五次治疗。该研究使用每日记录表报告称,每天治疗五次的患者流涕的个体症状评分有显著改善,但未提供数值数据。在通过VAS测量的其他结局(流涕、鼻阻塞、打喷嚏和总体鼻部症状)方面没有改善。最后,这些研究中的一项还比较了三种剂量的辣椒素(与安慰剂相比)。每喷1μg与4μg剂量辣椒素治疗的患者在每日记录表总体症状评分缓解方面较差(RR 0.63,95%CI 0.34至1.16)。只有一项研究试图测量不良反应(主要结局),然而由于评估方法存在问题,我们无法得出任何结论。我们试图纳入其他次要结局(如生活质量测量、治疗退出、内镜评分、鼻甲或黏膜大小、治疗费用),但纳入研究中均未测量或报告这些内容。
辣椒素可能是治疗特发性非过敏性鼻炎的一种选择。它以简短治疗的形式给药,通常在同一天。基于少数小型研究(低质量证据),治疗后长达36周,它似乎对总体鼻部症状有有益影响。需要进行设计良好的随机对照试验,以进一步增进我们对辣椒素治疗非过敏性鼻炎有效性的理解,特别是在不同类型和严重程度的非过敏性鼻炎患者中,以及使用不同辣椒素应用方法的情况下。