Table 6.
Summary of Naltrexone (NTX) Efficacy and Safety in Adult Trials for Pruritis
| Reference | Sample Size (Study Design) | Disease: Dosing and Duration | Outcomes |
|---|---|---|---|
| Wolfhagen163 | 16 (PCT) | Chronic cholestatic pruritis – NTX: 50 mg/day for 4 wk | Day itching (VAS): NTX: −54% (range, <5–55); PLB: −8% Night itching (VAS): NTX: −44% (range, <5–50); PLB: −7% SAE: none |
| Mansour-Ghanaei164 | 34 (PCT) | Cholestatic pruritis – NTX: 50 mg/day for 1 wk | Day pruritis (VAS): NTX: 7.54 (CV = 52%); PLB: 4.91 Night pruritis (VAS): NTX: 8.29 (CV = 45%); PLB: 5.54 SAE: none |
| Peer165 | 15 (PCT with crossover) | Uremic hemodialysis patients – NTX: 50 mg/day for 7 days | Pruritis (VAS): Baseline: 9.9; NTX: 2.1 (IQR: 1.5–2.15) SAE: none |
| Pauli-Magnus166 | 23 (PCT with crossover) | Uremic hemodialysis and peritoneal dialysis – NTX: 50 mg/day for 4 wk | Pruritis (VAS): NTX: −29.2% (95% CI: 18.7–39.6); PLB: −16.9% SAE: none |
| Malekzad167 | 38 (PCT) | Atopic dermatitis – NTX: 50 mg/day for 2 wk | Pruritis (VAS): NTX: 1.3 (CV = 107%); PLB: 4.5 Remission: NTX: n = 6; PLB: n = 0 SAE: none |
| Legroux-Crespel168 | 52 (RCT) | Uremic hemodialysis – NTX: 50 mg/day for 2 wk; LOR: 10 mg/day for 2 wk | Pruritis score: NTX: 27% of NTX patients had reduction with >3 VAS points SAE: none |
| Terg169 | 20 (PCT with crossover) | Cholestatic pruritis – NTX: 50 mg/day for 2 wk | Day pruritis (VAS): NTX: −56% (CV = 67%) Night pruritis: NTX: −40% (CV = 68%) Pruritus score: 45% of patients had >50% decrease SAE: none |
| Ajayi170 | 12 (RCT) | Chloroquine-induced pruritis – NTX: 50 mg pretreatment for 1 dose; PMZ: 25 mg pretreatment for 1 dose | Parasitic pruritogenic index: NTX: 9.1 (CV = 69%), PMZ: 12.1 SAE: none |
CV, coefficient of variation; LOR, loratadine; PCB, placebo; PCT, placebo-controlled trial; PMZ, promethazine; RCT, randomized controlled trial; SAE, serious adverse event; VAS, visual analog scale