School of Medical Sciences, University of Sydney, Camperdown, Australia.
Governance and Research Department, Sydney Adventist Hospital, Wahroonga, Australia.
BMC Neurol. 2021 Jul 2;21(1):256. doi: 10.1186/s12883-021-02248-y.
Parkinson's disease (PD) is a progressive neurodegenerative disease with no cure and few treatment options. Its incidence is increasing due to aging populations, longer disease duration and potentially as a COVID-19 sequela. Photobiomodulation (PBM) has been successfully used in animal models to reduce the signs of PD and to protect dopaminergic neurons.
To assess the effectiveness of PBM to mitigate clinical signs of PD in a prospective proof-of-concept study, using a combination of transcranial and remote treatment, in order to inform on best practice for a larger randomized placebo-controlled trial (RCT).
Twelve participants with idiopathic PD were recruited. Six were randomly chosen to begin 12 weeks of transcranial, intranasal, neck and abdominal PBM. The remaining 6 were waitlisted for 14 weeks before commencing the same treatment. After the 12-week treatment period, all participants were supplied with PBM devices to continue home treatment. Participants were assessed for mobility, fine motor skills, balance and cognition before treatment began, after 4 weeks of treatment, after 12 weeks of treatment and the end of the home treatment period. A Wilcoxon Signed Ranks test was used to assess treatment effectiveness at a significance level of 5%.
Measures of mobility, cognition, dynamic balance and fine motor skill were significantly improved (p < 0.05) with PBM treatment for 12 weeks and up to one year. Many individual improvements were above the minimal clinically important difference, the threshold judged to be meaningful for participants. Individual improvements varied but many continued for up to one year with sustained home treatment. There was a demonstrable Hawthorne Effect that was below the treatment effect. No side effects of the treatment were observed.
PBM was shown to be a safe and potentially effective treatment for a range of clinical signs and symptoms of PD. Improvements were maintained for as long as treatment continued, for up to one year in a neurodegenerative disease where decline is typically expected. Home treatment of PD by the person themselves or with the help of a carer might be an effective therapy option. The results of this study indicate that a large RCT is warranted.
Australian New Zealand Clinical Trials Registry, registration number: ACTRN12618000038291p , registered on 12/01/2018.
帕金森病(PD)是一种进行性神经退行性疾病,目前尚无治愈方法,治疗选择也有限。由于人口老龄化、疾病持续时间延长以及可能作为 COVID-19 的后遗症,其发病率正在上升。光生物调节(PBM)已成功用于动物模型,以减轻 PD 的体征并保护多巴胺能神经元。
在一项使用经颅和远程治疗相结合的前瞻性概念验证研究中,评估 PBM 减轻特发性 PD 临床体征的有效性,以便为更大规模的随机安慰剂对照试验(RCT)提供最佳实践信息。
招募了 12 名特发性 PD 患者。其中 6 名随机选择开始进行 12 周的经颅、鼻内、颈部和腹部 PBM 治疗。其余 6 名等待 14 周后再开始相同的治疗。12 周治疗期结束后,所有参与者都获得了 PBM 设备以继续家庭治疗。在治疗开始前、治疗 4 周后、治疗 12 周后和家庭治疗结束时,对参与者进行移动性、精细运动技能、平衡和认知能力评估。使用 Wilcoxon 符号秩检验在 5%的显著性水平上评估治疗效果。
PBM 治疗 12 周和长达一年后,移动性、认知、动态平衡和精细运动技能等方面的测量均有显著改善(p<0.05)。许多个体的改善超过了最小临床重要差异的阈值,这是参与者认为有意义的阈值。个体的改善有所不同,但许多人在持续的家庭治疗下持续了一年。存在明显的霍桑效应,但低于治疗效果。未观察到治疗的副作用。
PBM 被证明是一种安全且潜在有效的治疗方法,可用于治疗 PD 的一系列临床体征和症状。只要治疗持续,改善就会持续,在退行性疾病中,预计会持续一年。PD 患者本人或在护理人员的帮助下进行家庭治疗可能是一种有效的治疗选择。这项研究的结果表明,需要进行一项大型 RCT。
澳大利亚新西兰临床试验注册处,注册号:ACTRN12618000038291p,于 2018 年 1 月 12 日注册。