Barbaric Jelena, Abbott Rachel, Posadzki Pawel, Car Mate, Gunn Laura H, Layton Alison M, Majeed Azeem, Car Josip
Andrija Stampar School of Public Health, School of Medicine, University of Zagreb, Rockefellerova 4, Zagreb, Croatia, 10000.
Cochrane Database Syst Rev. 2016 Sep 27;9(9):CD007917. doi: 10.1002/14651858.CD007917.pub2.
Acne vulgaris is a very common skin problem that presents with blackheads, whiteheads, and inflamed spots. It frequently results in physical scarring and may cause psychological distress. The use of oral and topical treatments can be limited in some people due to ineffectiveness, inconvenience, poor tolerability or side-effects. Some studies have suggested promising results for light therapies.
To explore the effects of light treatment of different wavelengths for acne.
We searched the following databases up to September 2015: the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase and LILACS. We searched ISI Web of Science and Dissertation Abstracts International (from inception). We also searched five trials registers, and grey literature sources. We checked the reference lists of studies and reviews and consulted study authors and other experts in the field to identify further references to relevant randomised controlled trials (RCTs). We updated these searches in July 2016 but these results have not yet been incorporated into the review.
We included RCTs of light for treatment of acne vulgaris, regardless of language or publication status.
We used standard methodological procedures expected by Cochrane.
We included 71 studies, randomising a total of 4211 participants.Most studies were small (median 31 participants) and included participants with mild to moderate acne of both sexes and with a mean age of 20 to 30 years. Light interventions differed greatly in wavelength, dose, active substances used in photodynamic therapy (PDT), and comparator interventions (most commonly no treatment, placebo, another light intervention, or various topical treatments). Numbers of light sessions varied from one to 112 (most commonly two to four). Frequency of application varied from twice daily to once monthly.Selection and performance bias were unclear in the majority of studies. Detection bias was unclear for participant-assessed outcomes and low for investigator-assessed outcomes in the majority of studies. Attrition and reporting bias were low in over half of the studies and unclear or high in the rest. Two thirds of studies were industry-sponsored; study authors either reported conflict of interest, or such information was not declared, so we judged the risk of bias as unclear.Comparisons of most interventions for our first primary outcome 'Participant's global assessment of improvement' were not possible due to the variation in the interventions and the way the studies' outcomes were measured. We did not combine the effect estimates but rated the quality of the evidence as very low for the comparison of light therapies, including PDT to placebo, no treatment, topical treatment or other comparators for this outcome. One study which included 266 participants with moderate to severe acne showed little or no difference in effectiveness for this outcome between 20% aminolevulinic acid (ALA)-PDT (activated by blue light) versus vehicle plus blue light (risk ratio (RR) 0.87, 95% confidence interval (CI) 0.72 to 1.04, low-quality evidence). A study (n = 180) of a comparison of ALA-PDT (activated by red light) concentrations showed 20% ALA was no more effective than 15% (RR 1.05, 95% CI 0.96 to 1.15) but better than 10% ALA (RR 1.22, 95% CI 1.05 to 1.42) and 5% ALA (RR 1.47, 95% CI 1.19 to 1.81). The number needed to treat for an additional beneficial outcome (NNTB) was 6 (95% CI 3 to 19) and 4 (95% CI 2 to 6) for the comparison of 20% ALA with 10% and 5% ALA, respectively.For our second primary outcome 'Investigator-assessed changes in lesion counts', we combined three RCTs, with 360 participants with moderate to severe acne and found methyl aminolevulinate (MAL) PDT (activated by red light) was no different to placebo cream plus red light with regard to change in inflamed lesions (ILs) (mean difference (MD) -2.85, 95% CI -7.51 to 1.81), percentage change in ILs (MD -10.09, 95% CI -20.25 to 0.06), change in non-inflamed lesions (NILs) (MD -2.01, 95% CI -7.07 to 3.05), or in percentage change in NILs (MD -8.09, 95% CI -21.51 to 5.32). We assessed the evidence as moderate quality for these outcomes meaning that there is little or no clinical difference between these two interventions for lesion counts.Studies comparing the effects of other interventions were inconsistent or had small samples and high risk of bias. We performed only narrative synthesis for the results of the remaining trials, due to great variation in many aspects of the studies, poor reporting, and failure to obtain necessary data. Several studies compared yellow light to placebo or no treatment, infrared light to no treatment, gold microparticle suspension to vehicle, and clindamycin/benzoyl peroxide combined with pulsed dye laser to clindamycin/benzoyl peroxide alone. There were also several other studies comparing MAL-PDT to light-only treatment, to adapalene and in combination with long-pulsed dye laser to long-pulsed dye laser alone. None of these showed any clinically significant effects.Our third primary outcome was 'Investigator-assessed severe adverse effects'. Most studies reported adverse effects, but not adequately with scarring reported as absent, and blistering reported only in studies on intense pulsed light, infrared light and photodynamic therapies. We rated the quality of the evidence as very low, meaning we were uncertain of the adverse effects of the light therapies.Although our primary endpoint was long-term outcomes, less than half of the studies performed assessments later than eight weeks after final treatment. Only a few studies assessed outcomes at more than three months after final treatment, and longer-term assessments are mostly not covered in this review.
AUTHORS' CONCLUSIONS: High-quality evidence on the use of light therapies for people with acne is lacking. There is low certainty of the usefulness of MAL-PDT (red light) or ALA-PDT (blue light) as standard therapies for people with moderate to severe acne.Carefully planned studies, using standardised outcome measures, comparing the effectiveness of common acne treatments with light therapies would be welcomed, together with adherence to the Consolidated Standards of Reporting Trials (CONSORT) guidelines.
寻常痤疮是一种非常常见的皮肤问题,表现为黑头、白头和炎性丘疹。它常导致身体留疤,并可能引起心理困扰。由于疗效不佳、不便、耐受性差或副作用,口服和外用治疗在某些人身上的应用可能受到限制。一些研究表明光疗有不错的效果。
探讨不同波长的光治疗痤疮的效果。
我们检索了截至2015年9月的以下数据库:Cochrane皮肤专科注册库、Cochrane系统评价数据库、医学期刊数据库、荷兰医学文摘数据库和拉丁美洲及加勒比地区卫生科学数据库。我们检索了科学引文索引网络版和国际学位论文摘要数据库(自创建以来)。我们还检索了五个试验注册库和灰色文献来源。我们检查了研究和综述的参考文献列表,并咨询了研究作者和该领域的其他专家,以确定相关随机对照试验(RCT)的更多参考文献。我们在2016年7月更新了这些检索,但这些结果尚未纳入综述。
我们纳入了光治疗寻常痤疮的随机对照试验,无论语言或发表状态如何。
我们采用了Cochrane预期的标准方法程序。
我们纳入了71项研究,共随机分配了4211名参与者。大多数研究规模较小(中位数为31名参与者),纳入了年龄在20至30岁之间、患有轻至中度痤疮的男女参与者。光干预在波长、剂量、光动力疗法(PDT)中使用的活性物质以及对照干预(最常见的是不治疗、安慰剂、另一种光干预或各种外用治疗)方面差异很大。光疗疗程数量从1次到112次不等(最常见的是2至4次)。应用频率从每天两次到每月一次不等。大多数研究中选择和实施偏倚不明确。大多数研究中,参与者评估的结果检测偏倚不明确,研究者评估的结果检测偏倚较低。超过一半的研究中失访和报告偏倚较低,其余研究中不明确或较高。三分之二的研究由行业资助;研究作者要么报告了利益冲突,要么未声明此类信息,因此我们将偏倚风险判断为不明确。由于干预措施的差异以及研究结果的测量方式,我们无法对第一个主要结局“参与者对改善情况的总体评估”的大多数干预措施进行比较。我们没有合并效应估计值,但将光疗比较的证据质量评为极低,包括PDT与安慰剂、不治疗、外用治疗或其他对照的比较。一项纳入266名中重度痤疮患者的研究表明,20%氨基乙酰丙酸(ALA)-PDT(蓝光激活)与赋形剂加蓝光在该结局的有效性上几乎没有差异(风险比(RR)0.87,95%置信区间(CI)0.72至1.04,低质量证据)。一项比较ALA-PDT(红光激活)浓度的研究(n = 180)表明,20% ALA并不比15%更有效(RR 1.05,95% CI 0.96至1.15),但优于10% ALA(RR 1.22,95% CI 1.05至1.42)和5% ALA(RR 1.47,95% CI 1.19至1.81)。20% ALA与10%和5% ALA比较时,额外有益结局的所需治疗人数(NNTB)分别为6(95% CI 3至19)和4(95% CI 2至6)。对于第二个主要结局“研究者评估的皮损计数变化”,我们合并了三项随机对照试验,共360名中重度痤疮患者,发现甲基氨基乙酰丙酸(MAL)-PDT(红光激活)与安慰剂乳膏加红光在炎性皮损(ILs)变化方面无差异(平均差(MD)-2.85,95% CI -7.51至1.81)、ILs百分比变化(MD -10.09,95% CI -20.25至0.06)、非炎性皮损(NILs)变化(MD -2.01,95% CI -7.至3.05)或NILs百分比变化(MD -8.09,95% CI -21.51至5.32)。我们将这些结局的证据质量评估为中等质量,这意味着这两种干预措施在皮损计数方面几乎没有临床差异。比较其他干预措施效果的研究结果不一致,或样本量小且偏倚风险高。由于研究的许多方面差异很大、报告不佳以及未能获取必要数据,我们仅对其余试验的结果进行了叙述性综合分析。几项研究比较了黄光与安慰剂或不治疗、红外光与不治疗、金微粒悬浮液与赋形剂,以及克林霉素/过氧化苯甲酰联合脉冲染料激光与单独的克林霉素/过氧化苯甲酰。还有几项其他研究比较了MAL-PDT与单纯光疗、阿达帕林以及与长脉冲染料激光联合与单独的长脉冲染料激光。这些研究均未显示出任何临床显著效果。我们的第三个主要结局是“研究者评估的严重不良反应”。大多数研究报告了不良反应,但报告不充分,瘢痕形成报告为无,水疱形成仅在强脉冲光、红外光和光动力疗法的研究中报告。我们将证据质量评为极低,这意味着我们不确定光疗的不良反应。尽管我们的主要终点是长期结局,但不到一半的研究在最终治疗后八周后进行评估。只有少数研究在最终治疗后三个月以上评估结局,本综述大多未涵盖长期评估。
缺乏关于光疗用于痤疮患者的高质量证据。对于中重度痤疮患者,MAL-PDT(红光)或ALA-PDT(蓝光)作为标准疗法的有效性存在低确定性。精心设计的研究,采用标准化结局测量,比较常见痤疮治疗与光疗的有效性,同时遵循报告试验的统一标准(CONSORT)指南,将受到欢迎。