Law Simon K, Wang Lin, Li Tianjing
University of California, Los Angeles, Jules Stein Eye Institute, 100 Stein Plaza 2-235, Los Angeles, California, USA, 90095.
Johns Hopkins Bloomberg School of Public Health, Department of Epidemiology, Baltimore, Maryland, USA.
Cochrane Database Syst Rev. 2020 Feb 7;2(2):CD006030. doi: 10.1002/14651858.CD006030.pub4.
Glaucoma is a multi-factorial optic neuropathy characterized by an acquired loss of retinal ganglion cells at levels beyond normal age-related loss and corresponding atrophy of the optic nerve. Although many treatments are available to manage glaucoma, patients may seek complementary or alternative medicine approaches such as acupuncture to supplement their regular treatment. The underlying plausibility of acupuncture is that disorders related to the flow of Chi (traditional Chinese concept of vital force or energy) can be managed by stimulating relevant points on the body surface.
To assess the effectiveness and safety of acupuncture compared with other treatments, no treatment, or placebo in patients with glaucoma.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), which contains the Cochrane Eyes and Vision Trials Register (2018, Issue 11); Ovid MEDLINE; Embase.com; the Cumulative Index to Nursing and Allied Health Literature (CINAHL); the Allied and Complementary Medicine Database (AMED); PubMed; Latin American and Caribbean Literature on Health Sciences (LILACS); ZETOC; the metaRegister of Controlled Trials (mRCT); ClinicalTrials.gov; the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP); and the National Center for Complementary and Alternative Medicine (NCCAM) website. We did not use any language or date restrictions in the search for trials. We last searched electronic databases on November 16, 2018, with the exception of NCCAM, which we last searched on July 14, 2010, and the metaRegister of Controlled Trials (mRCT), which we last searched on January 8, 2013. We handsearched Chinese medical journals at Peking Union Medical College Library in April 2007. We searched the Chinese Acupuncture Trials Register, the Traditional Chinese Medical Literature Analysis and Retrieval System (TCMLARS), the Chinese Biological Database (CBM), and the China National Knowledge Infrastructure (CNKI). We last searched Chinese electronic databases on November 19, 2018.
We included randomized controlled trials (RCTs) in which one arm involved acupuncture treatment.
Two review authors independently screened results, then extracted the data and assessed risk of bias for eligible trials.
We included three completed trials and one ongoing trial in the 2019 update of this review. The three completed trials, conducted in Taiwan and the United States, included participants with glaucoma or intraocular hypertension. The interventions investigated varied across trials. One trial compared auricular acupressure-a non-standard acupuncture technique-with the sham procedure in 33 patients. Another trial compared transcutaneous electrical nerve stimulation (TENS) with a sham procedure in 82 patients. The third trial compared 12 sessions of acupuncture on eye-points versus on non-eye-points in 22 patients. All three trials were rated at high risk of bias for at least one domain. The certainty of evidence across all outcomes was very low due to high risk of bias in at least one contributing study; substantial clinical heterogeneity and methodological heterogeneity; and imprecision of results. One trial reported change in the visual field from baseline without any between-group comparison. Because of the quantity of missing data (50%), we did not calculate a between-group comparison, as the quantitative results are difficult to interpret. All three trials reported data for estimation of reduction of intraocular pressure (IOP). However, time points of IOP measurement varied. For the trial comparing acupressure to a sham procedure, the difference in IOP reduction (measured in mm Hg) is estimated to be -3.70 (95% confidence interval [CI] -7.11 to -0.29) for the right eye and -4.90 (95% CI -8.08 to -1.72) for the left eye at four weeks, and -1.30 mm Hg (95% CI -4.78 to 2.18) for the right eye and -2.30 mm Hg (95% CI -5.73 to 1.13) for the left eye at eight weeks. For the trial comparing TENS to sham treatment, the difference reduction is estimated to be -2.81 (95% CI -3.8 to -1.84) for the right eye and -2.58 (95% CI -3.36 to -1.80) for the left eye immediately after treatment, -2.93 (95% CI -3.72 to -2.13) for the right eye and -3.56 (95% CI -4.35 to 2.78) for the left eye 30 minutes after treatment, and finally -3.61 (95% CI -4.47 to -2.75) for the right eye and -3.61 (95% -4.47 to -2.74) for the left eye. For the trial that compared acupuncture on eye-points versus non-eye-points, 11 out of 22 (50%) participants did not complete the treatment. One trial reported data for estimation of visual acuity. When acupressure is compared to sham treatment, the difference in uncorrected visual acuity (UCVA, measured in logMAR) is estimated to be -0.01 (95% CI -0.24 to 0.22) for the right eye and -0.04 (95% CI -0.27 to 0.19) for the left eye at four months, and -0.03 logMAR (95% CI -0.27 to 0.21) for the right eye and -0.16 logMAR (95% CI -0.43 to 0.11) for the left eye at eight months. The difference in best corrected visual acuity (BCVA) is estimated to be 0.10 (95% CI -0.06 to 0.26) for the right eye and 0 (95% CI -0.14 to 0.14) for the left eye at four months, and -0.04 logMAR (95% CI -0.09 to 0.17) for the right eye and -0.04 logMAR (95% CI -0.18 to 0.10) for the left eye at eight months. One trial reported progression of optic disc damage or nerve fiber layer loss without any between-group comparison. Because of the quantity of missing data (50%), we did not calculate a between-group comparison, as the quantitative results are difficult to interpret. One trial reported adverse events in two patients (out of 22) who experienced needle sensitivity. However, the study did not report between-group comparisons. Because of the quantity of missing data (50%), we did not calculate a between-group comparison, as the quantitative results are difficult to interpret.
AUTHORS' CONCLUSIONS: At this time, it is impossible to draw reliable conclusions from available data to support the use of acupuncture for treatment of patients with glaucoma. Because of ethical considerations, RCTs comparing acupuncture alone with standard glaucoma treatment or placebo are unlikely to be justified in countries where the standard of care has already been established.
青光眼是一种多因素导致的视神经病变,其特征是视网膜神经节细胞出现后天性丢失,且超出正常与年龄相关的丢失水平,并伴有相应的视神经萎缩。尽管有多种治疗方法可用于控制青光眼,但患者可能会寻求补充或替代医学方法,如针灸,以辅助其常规治疗。针灸的潜在合理性在于,与气(中医概念中的生命力或能量)的流动相关的疾病可通过刺激身体表面的相关穴位来治疗。
评估与其他治疗、不治疗或安慰剂相比,针灸治疗青光眼患者的有效性和安全性。
我们检索了Cochrane对照试验中心注册库(CENTRAL),其中包含Cochrane眼科和视力试验注册库(2018年第11期);Ovid MEDLINE;Embase.com;护理学与健康相关文献累积索引(CINAHL);补充与替代医学数据库(AMED);PubMed;拉丁美洲和加勒比地区健康科学文献数据库(LILACS);ZETOC;对照试验元注册库(mRCT);ClinicalTrials.gov;世界卫生组织(WHO)国际临床试验注册平台(ICTRP);以及美国国立补充与替代医学中心(NCCAM)网站。我们在检索试验时未设置任何语言或日期限制。我们最近一次检索电子数据库的时间是2018年11月16日,NCCAM除外,我们最后一次检索该数据库的时间是2010年7月14日,对照试验元注册库(mRCT)除外,我们最后一次检索该数据库的时间是2013年1月8日。我们于2007年4月在北京协和医学院图书馆手工检索了中文医学期刊。我们检索了中国针灸试验注册库、中医文献分析与检索系统(TCMLARS)、中国生物医学数据库(CBM)和中国知网。我们最近一次检索中文电子数据库的时间是2018年11月19日。
我们纳入了随机对照试验(RCT),其中一个组采用针灸治疗。
两位综述作者独立筛选结果,然后提取数据并评估符合条件试验的偏倚风险。
在本综述2019年的更新中,我们纳入了三项已完成的试验和一项正在进行的试验。这三项已完成的试验分别在台湾和美国进行,纳入对象为青光眼或高眼压症患者。各试验所研究的干预措施各不相同。一项试验在33例患者中比较了耳穴按压(一种非标准针灸技术)与假手术。另一项试验在82例患者中比较了经皮电刺激神经疗法(TENS)与假手术。第三项试验在22例患者中比较了针对眼部穴位进行12次针灸与针对非眼部穴位进行12次针灸的效果。所有三项试验在至少一个领域的偏倚风险被评为高风险。由于至少一项纳入研究存在高偏倚风险、大量临床异质性和方法学异质性以及结果不精确,所有结局的证据确定性都非常低。一项试验报告了视野相对于基线的变化,但未进行任何组间比较。由于缺失数据量(50%),我们未计算组间比较结果,因为定量结果难以解释。所有三项试验均报告了眼压降低情况的数据。然而,眼压测量的时间点各不相同。对于比较耳穴按压与假手术的试验,四周时右眼眼压降低差值(以毫米汞柱为单位)估计为-3.70(95%置信区间[CI]-7.11至-0.29),左眼为-4.90(95%CI-8.08至-1.72);八周时右眼为-1.30毫米汞柱(95%CI-4.78至2.18),左眼为-2.30毫米汞柱(95%CI-5.73至1.13)。对于比较TENS与假治疗的试验,治疗后即刻右眼眼压降低差值估计为-2.81(95%CI-3.8至-1.84),左眼为-2.58(95%CI-3.36至-1.80);治疗后30分钟右眼为-2.93(95%CI-3.72至-2.13),左眼为-3.56(95%CI-4.35至2.78);最后右眼为-3.61(95%CI-4.47至-2.75),左眼为-3.61(95%-4.47至-2.74)。对于比较眼部穴位针灸与非眼部穴位针灸的试验,22例(50%)参与者中有11例未完成治疗。一项试验报告了视力评估的数据。当比较耳穴按压与假治疗时,四个月时右眼未矫正视力(UCVA,以logMAR为单位)差值估计为-0.01(95%CI-0.24至0.22),左眼为-0.04(95%CI-0.27至0.19);八个月时右眼为-0.03 logMAR(95%CI-0.27至0.21),左眼为-0.16 logMAR(95%CI-0.43至0.11)。最佳矫正视力(BCVA)差值在四个月时右眼估计为0.10(95%CI-0.06至0.26),左眼为0(95%CI-0.14至0.14);八个月时右眼为-0.04 logMAR(95%CI-0.09至0.17),左眼为-0.04 logMAR(95%CI-0.18至0.10)。一项试验报告了视神经盘损伤或神经纤维层丢失的进展情况,但未进行任何组间比较。由于缺失数据量(50%),我们未计算组间比较结果,因为定量结果难以解释。一项试验报告了2例(共22例)患者出现针刺敏感的不良事件。然而,该研究未报告组间比较情况。由于缺失数据量(50%),我们未计算组间比较结果,因为定量结果难以解释。
目前,无法从现有数据得出可靠结论来支持使用针灸治疗青光眼患者。出于伦理考虑,在已经确立治疗标准的国家,比较单独使用针灸与标准青光眼治疗或安慰剂的随机对照试验不太可能是合理的。