Centre for ALS and other motor neuron disorders, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.
Ambulanzpartner Soziotechnologie APST GmbH, Westhafenstr. 1, 13353, Berlin, Germany.
BMC Neurol. 2019 Sep 7;19(1):222. doi: 10.1186/s12883-019-1443-y.
Treatment of spasticity poses a major challenge in amyotrophic lateral sclerosis (ALS) patient management. Delta-9-tetrahydrocannabinol (THC):cannabidiol (CBD) oromucosal spray (THC:CBD), approved for the treatment of spasticity in multiple sclerosis, serves as a complementary off-label treatment option in ALS-related spasticity. However, few structured data are available on THC:CBD in the treatment of spasticity in ALS.
A retrospective mono-centric cohort study was realised in 32 patients that meet the following criteria: 1) diagnosis of ALS, 2) ALS-related spasticity; 3) treatment with THC:CBD. Spasticity was rated using the Numeric Rating Scale (NRS). Patient's experience with THC:CBD was assessed using the net promoter score (NPS) and treatment satisfaction questionnaire for medication (TSMQ-9) as captured through telephone survey or online assessment.
The mean dose THC:CBD were 5.5 daily actuations (range < 1 to 20). Three subgroups of patients were identified: 1) high-dose daily use (≥ 7 daily actuations, 34%, n = 11), 2) low-dose daily use (< 7 daily actuations, 50%, n = 16), 3) infrequent use (< 1 daily actuation, 16%, n = 5). Overall NPS was + 4.9 (values above 0 express a positive recommendation to fellow patients). Remarkably, patients with moderate to severe spasticity (NRS ≥ 4) reported a high recommendation rate (NPS: + 29) in contrast to patients with mild spasticity (NRS < 4; NPS: - 44). For the three main domains of TSQM-9 high mean satisfaction levels were found (maximum value 100): effectiveness 70.5 (±22.3), convenience 76.6 (±23.3) and global satisfaction 75.0 (±24.7).
THC:CBD is used in a wide dose range suggesting that the drug was applied on the basis of individual patients' needs and preferences. Contributing to this notion, moderate to severe spasticity was associated with an elevated number of daily THC:CBD actuations and stronger recommendation rate (NPS) as compared to patients with mild spasticity. Overall, treatment satisfaction (TSQM-9) was high. The results suggest that THC:CBD may serve as a valuable addition in the spectrum of symptomatic therapy in ALS. However, prospective studies and head-to-head comparisons to other spasticity medications are of interest to further explore the effectiveness of THC:CBD in the management of spasticity, and other ALS-related symptoms.
痉挛的治疗是肌萎缩侧索硬化症（ALS）患者管理中的一个主要挑战。Δ-9-四氢大麻酚（THC）：大麻二酚（CBD）口腔喷雾剂（THC：CBD）已被批准用于多发性硬化症的痉挛治疗，作为 ALS 相关痉挛的补充标签外治疗选择。然而，关于 THC：CBD 在 ALS 痉挛治疗中的应用，几乎没有结构化数据。
对符合以下标准的 32 名患者进行了回顾性单中心队列研究：1）ALS 诊断，2）ALS 相关痉挛，3）THC：CBD 治疗。使用数字评分量表（NRS）评估痉挛程度。通过电话调查或在线评估，使用净推荐值（NPS）和药物治疗满意度问卷（TSMQ-9）评估患者对 THC：CBD 的体验。
THC：CBD 的平均剂量为每日 5.5 次喷雾（范围<1 至 20 次）。发现了三组患者：1）高剂量每日使用（≥7 次喷雾，34%，n=11），2）低剂量每日使用（<7 次喷雾，50%，n=16），3）低频率使用（<1 次喷雾，16%，n=5）。总体 NPS 为+4.9（数值大于 0 表示向其他患者推荐）。值得注意的是，中重度痉挛患者（NRS≥4）的推荐率较高（NPS：+29），而轻度痉挛患者（NRS<4；NPS：-44）则较低。在 TSQM-9 的三个主要领域中，均发现了较高的满意度水平（最高值为 100）：有效性 70.5（±22.3），便利性 76.6（±23.3）和整体满意度 75.0（±24.7）。
THC：CBD 的使用剂量范围广泛，表明该药物是根据患者的个体需求和偏好应用的。中度至重度痉挛与每日 THC：CBD 喷雾次数增加和更高的推荐率（NPS）相关，而与轻度痉挛患者相比，这一现象更为明显。总体而言，治疗满意度（TSQM-9）较高。结果表明，THC：CBD 可能是 ALS 症状治疗谱中一种有价值的附加治疗药物。然而，需要进一步探索 THC：CBD 在痉挛管理和其他 ALS 相关症状中的有效性，这需要开展前瞻性研究和与其他痉挛治疗药物的头对头比较。
