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Evaluation of green light exposure on headache frequency and quality of life in migraine patients: A preliminary one-way cross-over clinical trial.
Cephalalgia ( IF 4.9 ) Pub Date : 2020-09-09 , DOI: 10.1177/0333102420956711
Laurent F Martin 1, 2 , Amol M Patwardhan 1, 2, 3, 4 , Sejal V Jain 5 , Michelle M Salloum 1 , Julia Freeman 1 , Rajesh Khanna 1, 2, 4 , Pooja Gannala 1 , Vasudha Goel 6 , Felesia N Jones-MacFarland 5 , William Ds Killgore 7 , Frank Porreca 1, 2 , Mohab M Ibrahim 1, 2, 3, 4
Affiliation  

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.



中文翻译:

绿光照射对偏头痛患者头痛频率和生活质量的评估:一项初步的单向交叉临床试验。

背景

偏头痛的药物治疗对某些患者可能无效。我们之前证明,在啮齿动物疼痛模型中,暴露于绿光会导致镇痛和逆转热和机械超敏反应。鉴于绿光发光二极管的安全性,我们评估了绿光作为治疗发作性或慢性偏头痛患者的潜在疗法。

材料与方法

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 1-2 小时暴露于白色发光二极管 10 周,然后是 2 周的清洗期,然后每天暴露于绿色发光二极管 1-2 小时10周。允许患者继续当前的治疗并按照医生的指示开始新的治疗。结果包括患者报告的调查。主要结果测量是每月头痛的天数。次要结果测量包括患者报告的两周内头痛强度和频率的变化,以及其他生活质量测量,包括入睡和保持睡眠的能力以及执行工作的能力。

结果

当将 7 名发作性偏头痛和 22 名慢性偏头痛患者作为单独的队列进行分析时,无论是发作性偏头痛患者还是慢性偏头痛患者,白光发光二极管对头痛天数均没有显着变化。结合发作性偏头痛组和慢性偏头痛组的数据显示,白光发光二极管使头痛天数从(天数 ± SEM)18.2 ± 1.8 天减少到 16.5 ± 2.01 天,但具有统计学意义。绿光发光二极管导致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 到 2.4 ± 1.1 和从 22.3 ± 1.2 到 9.4 ± 1.6 显着减少。虽然使用白光发光二极管观察到次要结果有所改善,使用绿色发光二极管观察到更多次要结果,包括生活质量评估、简式 McGill 疼痛问卷、头痛影响测试 6 和 EuroQol 五维调查的五级版本,没有报告副作用. 不可能得出关于通过绿光发光二极管暴露减少止痛药的结论。没有报告光疗法的副作用。研究中的患者均未报告开始使用新疗法。没有报告光疗法的副作用。研究中的患者均未报告开始使用新疗法。没有报告光疗法的副作用。研究中的患者均未报告开始使用新疗法。

讨论

绿色发光二极管显着减少了发作性偏头痛或慢性偏头痛患者的头痛天数。此外,绿色发光二极管显着改善了多项次要结果指标,包括生活质量以及头痛发作的强度和持续时间。由于没有报告任何不良事件,绿光发光二极管可能为那些喜欢非药物治疗的患者提供一种治疗选择,或者可以考虑补充其他治疗策略。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,以确定绿色发光二极管治疗的可能效果。

该研究已在临床试验.gov 注册,编号为 NCT03677206。

更新日期:2020-09-10
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