PDF(Pubmed)
Abstract：
BACKGROUND: Age-related macular degeneration (AMD) is a leading cause of vision loss. Photobiomodulation (PBM) offers a controversial approach for managing dry AMD, aiming to halt or reverse progression through mitochondrial activity modulation. However, the efficacy and clinical relevance of PBM as a potential approach for managing dry AMD remain debated.
METHODS: We systematically searched PubMed, Embase, and Cochrane databases for randomized controlled trials (RCTs) comparing PBM versus a sham in patients with dry AMD. We performed trial sequential analysis (TSA) and minimal clinically important difference (MCID) calculations to assess statistical and clinical significance applying a random-effects model with 95% confidence intervals (CI).
RESULTS: We included three RCTs comprising 247 eyes. The pooled analysis showed that PBM significant improved BCVA (MD 1.76 letters; 95% CI: 0.04 to 3.48) and drusen volume (MD -0.12 mm³; 95% CI: -0.22 to -0.02) as compared with a sham control. However, the TSA indicated that the current sample sizes were insufficient for reliable conclusions. No significant differences were observed in GA area. The MCID analysis suggested that the statistically significant results did not translate into clinically significant benefits. In the quality assessment, all studies were deemed to have a high risk of bias.
CONCLUSIONS: This meta-analysis points limitations in the current evidence base for PBM in dry AMD treatment, with issues around small sample sizes. Statistically significant improvements do not translate into clinical benefits. The research underscores need for larger RCTs to validate PBM\'s therapeutic potential for dry AMD.
METHODS: We systematically searched PubMed, Embase, and Cochrane databases for randomized controlled trials (RCTs) comparing PBM versus a sham in patients with dry AMD. We performed trial sequential analysis (TSA) and minimal clinically important difference (MCID) calculations to assess statistical and clinical significance applying a random-effects model with 95% confidence intervals (CI).
RESULTS: We included three RCTs comprising 247 eyes. The pooled analysis showed that PBM significant improved BCVA (MD 1.76 letters; 95% CI: 0.04 to 3.48) and drusen volume (MD -0.12 mm³; 95% CI: -0.22 to -0.02) as compared with a sham control. However, the TSA indicated that the current sample sizes were insufficient for reliable conclusions. No significant differences were observed in GA area. The MCID analysis suggested that the statistically significant results did not translate into clinically significant benefits. In the quality assessment, all studies were deemed to have a high risk of bias.
CONCLUSIONS: This meta-analysis points limitations in the current evidence base for PBM in dry AMD treatment, with issues around small sample sizes. Statistically significant improvements do not translate into clinical benefits. The research underscores need for larger RCTs to validate PBM\'s therapeutic potential for dry AMD.
摘要：
背景：年龄相关性黄斑变性（AMD）是视力丧失的主要原因。光生物调节（PBM）提供了一个有争议的方法来管理干性AMD，旨在通过线粒体活性调节停止或逆转进展。然而,PBM作为治疗干性AMD的潜在方法的有效性和临床意义仍存在争议.
方法：我们系统地搜索了PubMed，Embase,和Cochrane数据库的随机对照试验（RCTs），比较了PBM和假手术在干性AMD患者中的应用。我们进行了试验序贯分析（TSA）和最小临床重要差异（MCID）计算，以使用具有95％置信区间（CI）的随机效应模型评估统计学和临床意义。
结果：我们纳入了三个RCT，包括247只眼。汇总分析显示，与假对照相比，PBM显着改善了BCVA（MD1.76字母；95％CI：0.04至3.48）和玻璃疣体积（MD-0.12mmpa；95％CI：-0.22至-0.02）。然而,TSA表明,目前的样本量不足以得出可靠的结论.在GA面积中没有观察到显著差异。MCID分析表明，统计学上的显着结果并未转化为临床上的显着益处。在质量评估中，所有研究均被认为存在高偏倚风险.
结论：本荟萃分析指出了目前关于PBM治疗干性AMD的证据基础的局限性，围绕小样本量的问题。统计学上显著的改善不能转化为临床益处。该研究强调需要更大的随机对照试验来验证PBM对干性AMD的治疗潜力。
方法：我们系统地搜索了PubMed，Embase,和Cochrane数据库的随机对照试验（RCTs），比较了PBM和假手术在干性AMD患者中的应用。我们进行了试验序贯分析（TSA）和最小临床重要差异（MCID）计算，以使用具有95％置信区间（CI）的随机效应模型评估统计学和临床意义。
结果：我们纳入了三个RCT，包括247只眼。汇总分析显示，与假对照相比，PBM显着改善了BCVA（MD1.76字母；95％CI：0.04至3.48）和玻璃疣体积（MD-0.12mmpa；95％CI：-0.22至-0.02）。然而,TSA表明,目前的样本量不足以得出可靠的结论.在GA面积中没有观察到显著差异。MCID分析表明，统计学上的显着结果并未转化为临床上的显着益处。在质量评估中，所有研究均被认为存在高偏倚风险.
结论：本荟萃分析指出了目前关于PBM治疗干性AMD的证据基础的局限性，围绕小样本量的问题。统计学上显著的改善不能转化为临床益处。该研究强调需要更大的随机对照试验来验证PBM对干性AMD的治疗潜力。
