DIalysis Symptom COntrol-Pruritus Outcome Trial (DISCO-POT): A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Crossover Trial
Bibliographic record
Abstract
Background: Uremic pruritus affects 50% of patients with kidney failure and negatively impacts quality of life. Itch often persists despite effective pharmacologic treatments. Cannabinoids may reduce pruritus. We evaluated nabilone, a synthetic cannabinoid, to treat uremic pruritus. Methods: Eligible participants were adults age>25 years receiving in-center or home hemodialysis at least 2x weekly or peritoneal dialysis daily for at least 90 days and at least moderate itch defined by a mean worst visual analogue scale (VAS) >40mm during a 1-week screening period. Participants were randomly allocated to oral nabilone 0.5mg daily x 1 week then nabilone 0.5mg twice a day x 3 weeks or an identical placebo regimen. Then, after a 2-week washout, participants received an identical regimen of nabilone or placebo, whichever they did not receive in the first treatment period. The primary outcome was the difference in worst VAS over the last 24 hours over each 4 week crossover period. Results: Of 14 participants randomized, the mean (SD) age was 60.5 (12.7) years, 4 (28.6%) were female sex, 8 (57.1%) had diabetes, and all were on hemodialysis for a mean (SD) of 3.29 (0.73) sessions per week for a mean (SD) 4.04 (0.50) hours/treatment. The mean (SD) worst VAS was 69mm (25). Baseline co-interventions included topical emollients in 12 (85.7%) and alpha 2 delta ligands in 7 (50%). Self-reported and pill count adherence was >90%. Nabilone did not reduce the worst VAS to a greater extent than placebo (Figure 1). The worst VAS was 4.79 (95% CI -3.95 to 13.5, p=0.28) higher with nabilone compared to placebo, indicating worse itch. Nabilone also had no effect on other measures of itch, sleep, quality of life or adverse events. Conclusion: This small trial detected no effect of nabilone on uremic pruritus compared to placebo. (ClinicalTrials.gov NCT05180968) Funding: Government Support - Non-U.S.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.009 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".