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Treatment of refractory obsessive–compulsive disorder with nutraceuticals (TRON): a 20-week, open label pilot study
CNS Spectrums ( IF 3.3 ) Pub Date : 2021-06-21 , DOI: 10.1017/s1092852921000638
Jerome Sarris 1, 2 , Gerard J Byrne 3, 4 , Georgina Oliver 2 , Lachlan Cribb 2 , Scott Blair-West 2 , David Castle 5 , Olivia M Dean 6 , David A Camfield 6 , Vlasios Brakoulias 7, 8 , Chad Bousman 9, 10, 11 , Nathan Dowling 2 , Carolyn Ee 1 , Jenifer Murphy 2 , Ranjit Menon 2 , Michael Berk 6, 12, 13 , Suneel Chamoli 3 , Mark Boschen 14 , Chee H Ng 2
Affiliation  

Background

Obsessive–compulsive disorder (OCD) is often challenging to treat and resistant to psychological interventions and prescribed medications. The adjunctive use of nutraceuticals with potential neuromodulatory effects on underpinning pathways such as the glutamatergic and serotonergic systems is one novel approach.

Objective

To assess the effectiveness and safety of a purpose-formulated combination of nutraceuticals in treating OCD: N-acetyl cysteine, L-theanine, zinc, magnesium, pyridoxal-5′ phosphate, and selenium.

Methods

A 20-week open label proof-of-concept study was undertaken involving 28 participants with treatment-resistant DSM-5-diagnosed OCD, during 2017 to 2020. The primary outcome measure was the Yale-Brown Obsessive–Compulsive Scale (YBOCS), administered every 4 weeks.

Results

An intention-to-treat analysis revealed an estimated mean reduction across time (baseline to week-20) on the YBOCS total score of −7.13 (95% confidence interval = −9.24, −5.01), with a mean reduction of −1.21 points per post-baseline visit (P ≤ .001). At 20-weeks, 23% of the participants were considered “responders” (YBOCS ≥35% reduction and “very much” or “much improved” on the Clinical Global Impression-Improvement scale). Statistically significant improvements were also revealed on all secondary outcomes (eg, mood, anxiety, and quality of life). Notably, treatment response on OCD outcome scales (eg, YBOCS) was greatest in those with lower baseline symptom levels, while response was limited in those with relatively more severe OCD.

Conclusions

While this pilot study lacks placebo-control, the significant time effect in this treatment-resistant OCD population is encouraging and suggests potential utility especially for those with lower symptom levels. Our findings need to be confirmed or refuted via a follow-up placebo-controlled study.



中文翻译:

用营养品 (TRON) 治疗难治性强迫症:一项为期 20 周的开放标签试点研究

背景

强迫症 (OCD) 通常很难治疗,并且对心理干预和处方药有抵抗力。辅助使用对谷氨酸能和血清素能系统等基础通路具有潜在神经调节作用的营养保健品是一种新方法。

客观的

评估专门配制的营养保健品组合在治疗强迫症方面的有效性和安全性:N-乙酰半胱氨酸、L-茶氨酸、锌、镁、5'磷酸吡哆醛和硒。

方法

在 2017 年至 2020 年期间,进行了一项为期 20 周的开放标签概念验证研究,涉及 28 名患有治疗耐药性 DSM-5 诊断的强迫症的参与者。主要结果测量是耶鲁-布朗强迫症量表 (YBOCS),每 4 周给药一次。

结果

一项意向性治疗分析显示,YBOCS 总分随时间(基线至第 20 周)的估计平均降低为 -7.13(95% 置信区间 = -9.24,-5.01),平均降低 -1.21 分每次基线后访问 ( P  ≤ .001)。在 20 周时,23% 的参与者被认为是“反应者”(YBOCS 减少≥35% 并且在临床整体印象-改善量表上“非常”或“大大改善”)。所有次要结果(例如,情绪、焦虑和生活质量)也显示出统计学上的显着改善。值得注意的是,OCD 结果量表(例如,YBOCS)的治疗反应在基线症状水平较低的患者中最大,而在 OCD 相对较严重的患者中反应有限。

结论

虽然这项初步研究缺乏安慰剂对照,但在这种治疗抵抗性强迫症人群中的显着时间效应令人鼓舞,并表明其潜在效用,尤其是对于症状水平较低的人群。我们的发现需要通过后续的安慰剂对照研究来证实或反驳。

更新日期:2021-06-21
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