This phase II RCT evaluated an oral Cannabis sativa extract (CBD 96 mg/ml + THC 2.1 mg/ml; final daily dose ~43.9 mg CBD / 0.96 mg THC) vs. placebo over 9 weeks in 101 PD patients with chronic pain, with the primary outcome being the PD-Pain Classification System (PD-PCS) score at final visit.
No significant between-group difference in PD-PCS scores (P = 0.757) or any other non-motor scale; 87/101 participants completed the study and no serious adverse events were reported.
- Small phase II sample (n=101) may be underpowered to detect modest effects. - Single formulation with a low THC dose (0.96 mg/day); results may not generalize to higher-dose or different cannabinoid ratios. - 9-week duration limits conclusions about longer-term use.
This CBD/THC oral oil formulation did not relieve pain or other non-motor symptoms in PD compared to placebo, so it should not be recommended for this indication based on current evidence. Clinicians should continue prioritizing established NMS treatments while awaiting larger trials.
