Naltrexone does not relieve uremic pruritus: Results of a randomized, double-blind, placebo-controlled crossover study

Improvement of uremic pruritus was reported under short-term administration of the mu-receptor antagonists naltrexone and naloxone. The aim of the pre sent study was to confirm the efficacy and safety of the oral mu-receptor a ntagonist naltrexone during a 4-wk treatment period in patients on hemodial ysis and peritoneal dialysis. A placebo-controlled, double-blind crossover study of uremic patients with persistent, treatment-resistant pruritus was performed. Of 422 patients screened between December 1997 and June 1998, 93 suffered from pruritus and 23 were eligible for the study. Patients were s tarted either with a 4-wk naltrexone sequence (50 mg/d) or matched placebo. This was followed by a 7-d washout, and patients continued with a 4-wk seq uence of the alternate medication. Pruritus intensity was scored daily by a visual analogue scale (VAS) and weekly by a detailed score assessing scrat ching activity, distribution of pruritus, and frequency of pruritus-related sleep disturbance. Sixteen of 23 patients completed the study. During the naltrexone period, pruritus decreased by 29.2% (95% confidence interval [CI ], 18.7 to 39.6) on the VAS and by 17.6% (95% CI, 4.2 to 31.1) on the detai led score. In comparison, pruritus decreased by 16.9% (95% CI, 6.8 to 26.9) on the VAS and by 22.3% (95% CI, 9.3 to 35.2) on the detailed score during the placebo period. The difference between the naltrexone and the placebo treatment period was not statistically significant. Nine of 23 patients com plained of gastrointestinal disturbances during the naltrexone period compa red with only one of 23 patients during the placebo period (P < 0.05). Thes e results show that treatment of uremic pruritus with naltrexone is ineffec tive. In addition, a high incidence of adverse effects was observed during treatment with naltrexone.