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评估偏头痛患者头痛发作频率和生活质量的绿光暴露:初步单盲交叉临床试验。

Evaluation of green light exposure on headache frequency and quality of life in migraine patients: A preliminary one-way cross-over clinical trial.

机构信息

Department of Anesthesiology, College of Medicine, University of Arizona, Tucson, AZ, USA.

Department of Pharmacology, College of Medicine, University of Arizona, Tucson, AZ, USA.

出版信息

Cephalalgia. 2021 Feb;41(2):135-147. doi: 10.1177/0333102420956711. Epub 2020 Sep 9.

Abstract

BACKGROUND

Pharmacological management of migraine can be ineffective for some patients. We previously demonstrated that exposure to green light resulted in antinociception and reversal of thermal and mechanical hypersensitivity in rodent pain models. Given the safety of green light emitting diodes, we evaluated green light as a potential therapy in patients with episodic or chronic migraine.

MATERIAL AND METHODS

We recruited (29 total) patients, of whom seven had episodic migraine and 22 had chronic migraine. We used a one-way cross-over design consisting of exposure for 1-2 hours daily to white light emitting diodes for 10 weeks, followed by a 2-week washout period followed by exposure for 1-2 hours daily to green light emitting diodes for 10 weeks. Patients were allowed to continue current therapies and to initiate new treatments as directed by their physicians. Outcomes consisted of patient-reported surveys. The primary outcome measure was the number of headache days per month. Secondary outcome measures included patient-reported changes in the intensity and frequency of the headaches over a two-week period and other quality of life measures including ability to fall and stay asleep, and ability to perform work. Changes in pain medications were obtained to assess potential reduction.

RESULTS

When seven episodic migraine and 22 chronic migraine patients were analyzed as separate cohorts, white light emitting diodes produced no significant change in headache days in either episodic migraine or chronic migraine patients. Combining data from the episodic migraine and chronic migraine groups showed that white light emitting diodes produced a small, but statistically significant reduction in headache days from (days ± SEM) 18.2 ± 1.8 to 16.5 ± 2.01 days. Green light emitting diodes resulted in a significant decrease in headache days from 7.9 ± 1.6 to 2.4 ± 1.1 and from 22.3 ± 1.2 to 9.4 ± 1.6 in episodic migraine and chronic migraine patients, respectively. While some improvement in secondary outcomes was observed with white light emitting diodes, more secondary outcomes with significantly greater magnitude including assessments of quality of life, Short-Form McGill Pain Questionnaire, Headache Impact Test-6, and Five-level version of the EuroQol five-dimensional survey without reported side effects were observed with green light emitting diodes. Conclusions regarding pain medications reduction with green light emitting diode exposure were not possible. No side effects of light therapy were reported. None of the patients in the study reported initiation of new therapies.

DISCUSSION

Green light emitting diodes significantly reduced the number of headache days in people with episodic migraine or chronic migraine. Additionally, green light emitting diodes significantly improved multiple secondary outcome measures including quality of life and intensity and duration of the headache attacks. As no adverse events were reported, green light emitting diodes may provide a treatment option for those patients who prefer non-pharmacological therapies or may be considered in complementing other treatment strategies. Limitations of this study are the small number of patients evaluated. The positive data obtained support implementation of larger clinical trials to determine possible effects of green light emitting diode therapy.This study is registered with clinicaltrials.gov under NCT03677206.

摘要

背景

偏头痛的药物治疗对一些患者可能无效。我们之前证明,暴露在绿光下会导致啮齿动物疼痛模型中的镇痛作用,并逆转热和机械性超敏反应。鉴于绿光发光二极管的安全性,我们评估了绿光作为发作性或慢性偏头痛患者的潜在治疗方法。

材料和方法

我们招募了(共 29 名)患者,其中 7 名患有发作性偏头痛,22 名患有慢性偏头痛。我们使用单向交叉设计,包括每天暴露于白光发光二极管 1-2 小时,持续 10 周,然后进行为期 2 周的洗脱期,随后每天暴露于绿光发光二极管 1-2 小时,持续 10 周。患者可以继续接受当前的治疗,并根据医生的指示开始新的治疗。结果包括患者报告的调查。主要结局指标是每月头痛天数。次要结局指标包括两周内头痛强度和频率的患者报告变化,以及其他生活质量指标,包括入睡和保持睡眠的能力,以及进行工作的能力。为了评估潜在的减少,获得了疼痛药物的变化。

结果

当分别分析 7 名发作性偏头痛和 22 名慢性偏头痛患者时,白光发光二极管在发作性偏头痛或慢性偏头痛患者中均未显著改变头痛天数。将发作性偏头痛和慢性偏头痛组的数据合并显示,白光发光二极管可使头痛天数从(天±SEM)18.2±1.8 减少至 16.5±2.01 天,这虽小但具有统计学意义。绿光发光二极管可使发作性偏头痛和慢性偏头痛患者的头痛天数分别从 7.9±1.6 天减少至 2.4±1.1 天和从 22.3±1.2 天减少至 9.4±1.6 天,这具有显著意义。虽然在使用白光发光二极管时观察到一些次要结局的改善,但使用绿光发光二极管观察到更多具有更大幅度的次要结局,包括生活质量评估、简明麦吉尔疼痛问卷、头痛影响测试-6 和欧洲五维健康量表的五级版本,没有报告副作用。关于绿光发光二极管暴露时疼痛药物减少的结论是不可能的。没有报告光疗的副作用。研究中没有患者报告开始新的治疗。

讨论

绿光发光二极管可显著减少发作性偏头痛或慢性偏头痛患者的头痛天数。此外,绿光发光二极管可显著改善多项次要结局指标,包括生活质量以及头痛发作的强度和持续时间。由于没有报告不良事件,绿光发光二极管可能为那些更喜欢非药物治疗的患者提供一种治疗选择,或者可被视为补充其他治疗策略。本研究的局限性在于评估的患者数量较少。获得的积极数据支持实施更大规模的临床试验,以确定绿光发光二极管疗法的可能效果。本研究在 clinicaltrials.gov 上注册,编号为 NCT03677206。

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