THC:CBD Spray Improved MS Spasticity in Real-World Italian Clinics at Lower Doses Than Clinical Trials

Prospective observational study (MOVE 2 Italy) using web-based real-time data collection and patient diaries across more than 30 Italian MS centers. Outcomes included the patient-based 0-10 numerical rating scale for spasticity and physician-rated modified Ashworth scale. Interim analysis performed after 300 patient enrollment threshold.

Real-world data often tells a different story than clinical trials. In this case, the story is more positive: patients achieved good results with lower doses and fewer side effects than expected from trial data. This suggests that the clinical trial setting may have led to higher dosing than necessary, and that in practice, lower doses are both effective and better tolerated.

This study bridges the gap between controlled trial evidence and clinical practice for cannabinoid-based MS treatment. The finding that lower doses work in practice suggests that the "start low, go slow" approach to cannabinoid dosing is not just safer but may be equally effective.

Observational design without a control group means improvements could reflect placebo effects or natural disease fluctuation. Interim analysis rather than final results. Selection bias may be present if centers or patients with better outcomes were more likely to be captured. No randomization or blinding.