CARE - A Retrospective, Dual-Cohort, 24-Week Real-World Study from the German Pain e-Registry on the Effectiveness and Safety of CBD-Dominant Oral Cannabis Extracts versus THC/Dronabinol in Older Patients with Chronic Pain.

BACKGROUND

Pharmacological treatment of chronic pain in older adults presents a therapeutic challenge. The severity of symptoms contrasts with the risk-benefit ratio of available drugs, especially in the presence of comorbidities and polypharmacy. This underlines the need to evaluate alternative therapies such as cannabis-based medicines (CBM).

OBJECTIVE

To assess the safety, tolerability and effectiveness of cannabidiol (CBD)-dominant full-spectrum extracts (CBD > tetrahydrocannabinol [THC]) versus pure THC/dronabinol (THC/DRO) in patients aged ≥65 years with chronic or refractory pain.

METHODS

Retrospective, longitudinal, exploratory analysis of anonymized data from the German Pain e-Registry. Two propensity-score-matched cohorts of 484 patients each were evaluated over ≥24 weeks. The primary composite endpoint required no discontinuation due to an adverse drug reaction (ADR) AND a clinically relevant improvement (≥20 mm VAS or ≥50% from baseline) in average 24-h pain intensity (PIX), pain-related disability (mPDI), or nighttime sleep (mPDI subitem #6). Secondary analyses covered pain intensities, daily-life functioning, quality of life, well-being and affective distress. Safety analyses included ADR frequency, spectrum, and concomitant analgesic use.

RESULTS

Both treatments were associated with symptom relief. Greater improvements were observed with CBD > THC across all domains (all p < 0.001). ADRs were less frequent with CBD > THC (104 vs 342 events), with fewer patients affected (15.5% vs 35.7%) and lower discontinuation rates (5.6% vs 19.2%; all p < 0.001). The composite endpoint was achieved by 85.7% (CBD > THC) vs 21.9% (THC/DRO; p < 0.001; OR 21.5; RR 3.9; effect size 0.640; NNT 2).

CONCLUSION

In this real-world cohort of older adults with chronic pain, CBD-dominant extracts were associated with more favorable multidimensional outcomes and better tolerability than THC/DRO. Findings are exploratory and warrant confirmation in randomized controlled trials.

TRIAL REGISTRATION: HMA-EMA Catalogues of Real-World Data Sources and Studies. http://www. https://encepp.europa.eu/index_en, EU PAS number EUPAS1000000490.