Cannabis-Containing Cream for CKD-Associated Pruritus: A Double-Blind, Placebo Controlled Trial

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 χ² 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

Plain Language Summary

Chronic kidney disease (CKD)-associated pruritus presents a significant burden to hemodialysis patients, with current medications often falling short in alleviating symptoms. Cannabinoids, with their anti-inflammatory, antioxidative, and peripheral nerve activation reduction properties, hold promise in treating CKD-associated pruritus. Especially when applied topically, cannabinoids could provide moisturized skin along with their other effects. We analyzed the efficacy of cannabis cream compared to a placebo, demonstrating that the cannabis cream could improve the severity of itch, as reported by the WI-NRS score at the end of the fourth week of treatment. This innovative therapeutic approach has the potential to pave the way for new drugs aimed at effectively treating CKD-associated pruritus, ultimately reducing symptom severity, and potentially enhancing patients’ quality of life.