Kanjanarangsichai Auempa, Mitarnun Witoon, Mitarnun Wenika, Pangwong Wilasinee, Laoharattanahirun Nutchaya, Kajornrith Warut, Junlaor Panomporn, Nonghan Pawarin, Witthayapirote Wannisa, Sangkarom Gorawan
Department of Social Medicine, Buriram Hospital, Buriram, Thailand.
Department of Medicine, Buriram Hospital, Buriram, Thailand.
J Neurosci Rural Pract. 2022 Oct-Dec;13(4):663-668. doi: 10.25259/JNRP-2022-6-19. Epub 2022 Oct 22.
The objective of this study was to assess cannabidiol-enriched cannabis extraction product (CBDEP) efficacy in patients with Parkinson's disease (PD).
Forty patients with PD were randomly assigned to the sublingual CBDEP ( = 20) or placebo ( = 20) group. All patients were prescribed a low initial dose with gradual titration within 2 weeks based on individual response - including side effects - followed by 6 weeks of stable dosing. The primary outcome was the Unified Parkinson's Disease Rating Scale (UPDRS) score. The secondary outcomes were as follows: Quality of life (QOL) evaluated by the EQ-5D-5L, timed up and go (TUG) test, 5 times sit to stand (FTSTS) test, gait velocity, hospital anxiety and depression scale (HADS), renal and liver function indices, and adverse events. All outcomes were measured at baseline and at 8 weeks. The generalized estimating equation adjusted for baseline scores was used to compare the values at baseline and at 8 weeks, and between the groups.
Four patients were lost to follow-up (CBDEP group, = 1; placebo group, = 3) and 36 were included in the analysis (CBDEP group, = 19; placebo group, = 17). The CBDEP group received mean cannabidiol and tetrahydrocannabinol dosages of 15.59 ± 5.04 mg/day and 0.61 ± 0.19 mg/day, respectively. No significant differences were found between the groups in terms of the UPDRS, TUG test, FTSTS test, gait velocity, HADS-anxiety, and HADS-depression. The placebo group had significantly improved EQ-5D-5L scores for QOL ( = 0.004). The CBDEP group showed significantly improved blood urea nitrogen (BUN), serum albumin, serum globulin levels, and albumin/globulin ratio ( = 0.037, < 0.001, = 0.011, and = 0.002, respectively) compared with the placebo group. Neither group had serious side effects.
No evidence was found that CBDEP can reduce disease severity or improve functional performance, anxiety, or depression in PD. However, CBDEP is safe and can improve the levels of BUN, serum albumin, serum globulin, and albumin/globulin ratio in patients with PD.
Thai Clinical Trials Registry (registration number: TCTR 20210303005).
本研究的目的是评估富含大麻二酚的大麻提取物产品（CBDEP）对帕金森病（PD）患者的疗效。
40例PD患者被随机分为舌下含服CBDEP组（n = 20）或安慰剂组（n = 20）。所有患者均给予低初始剂量，并根据个体反应（包括副作用）在2周内逐渐滴定，随后进行6周的稳定给药。主要结局是统一帕金森病评定量表（UPDRS）评分。次要结局如下：通过EQ-5D-5L评估的生活质量（QOL）、计时起立行走（TUG）测试、5次坐立（FTSTS）测试、步态速度、医院焦虑抑郁量表（HADS）、肾功能和肝功能指标以及不良事件。所有结局均在基线和8周时测量。使用针对基线评分进行调整的广义估计方程来比较基线和8周时以及组间的值。
4例患者失访（CBDEP组，n = 1；安慰剂组，n = 3），36例纳入分析（CBDEP组，n = 19；安慰剂组，n = 17）。CBDEP组大麻二酚和四氢大麻酚的平均剂量分别为15.59±5.04毫克/天和0.61±0.19毫克/天。两组在UPDRS、TUG测试、FTSTS测试、步态速度、HADS焦虑和HADS抑郁方面无显著差异。安慰剂组的QOL的EQ-5D-5L评分有显著改善（P = 0.004）。与安慰剂组相比，CBDEP组的血尿素氮（BUN）、血清白蛋白、血清球蛋白水平及白蛋白/球蛋白比值显著改善（分别为P = 0.037、P < 0.001、P = 0.011和P = 0.002）。两组均无严重副作用。
未发现证据表明CBDEP可降低PD的疾病严重程度或改善功能表现、焦虑或抑郁。然而，CBDEP是安全的，并且可以改善PD患者的BUN、血清白蛋白、血清球蛋白水平及白蛋白/球蛋白比值。
泰国临床试验注册中心（注册号：TCTR 20210303005）。
