Abstract
RATIONALE & OBJECTIVE: This study aims to compare the efficacy of a cannabis cream and a placebo in the treatment of chronic kidney disease (CKD)-associated pruritus. STUDY DESIGN: A double-blind randomized controlled study. SETTING & PARTICIPANTS: Sixty hemodialysis patients with the worst itching intensity numerical rating scale (WI-NRS) ≥3. EXPOSURE: Patients received cannabis cream or placebo. OUTCOMES: The primary endpoint was the WI-NRS score at week 4. The secondary endpoints included the WI-NRS at week 2, the Skindex-10 score at weeks 2 and 4, and the mean difference score between baseline and week 4 for the WI-NRS and the Skindex-10 score. ANALYTICAL APPROACH: We used unpaired t tests or Mann Whitney U tests, along with χ(2) or Fisher exact tests as appropriate. The adjusted mean differences were determined using ANCOVA, adjusting for baseline scores. RESULTS: Among 60 participants, the mean age was 61.6 ± 14.4 years and the mean baseline WI-NRS was 6.7 ± 1.7. The placebo and cannabis cream groups were similar at baseline, although more individuals in the placebo group had diabetes. At 4 weeks, the WI-NRS dropped to 2.6 in the cannabis group and 3.6 in the placebo group (the mean difference after adjustment for baseline scores:-1.1, 95% CI, -2.1 to -0.2; P = 0.02). Skindex-10 scores at week 4 were also lower in the cannabis group, but after adjustment for baseline scores, statistical significance was not maintained. No side effects were observed in either group. LIMITATIONS: A single study with a small sample size restricts its generalizability. Variances in participants' diabetes statuses might have affected the itch outcomes. The absence of cannabinoid level assessment in blood prevents conclusive determination of the potential systemic impacts. A 4-week follow-up period inadequately captures long-term effect. CONCLUSIONS: In CKD-associated pruritus, the topical cream containing cannabis significantly reduced the severity of itching symptoms compared to the placebo. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT06159686.