Efficacy of methylprednisolone on pain, fatigue, and appetite loss in patients with advanced cancer using opioids: A randomized, placebo-controlled, double-blind trial

摘要

Results: A total of 592 patients were screened; 50 were randomly assigned, and 47 were analyzed. Baseline opioid level was 269.9 mg in the MP arm and 160.4 mg in the PL arm. At day-7 evaluation, there was no difference between the groups in pain intensity (MP, 3.60 v PL, 3.68; P =.88) or relative analgesic consumption (MP, 1.19 vPL, 1.20; P=.95). Clinically and statistically significant improvements were found in fatigue (-17 v 3 points; P.003), appetite loss (-24 v2 points; P=.003), and patient satisfaction (5.4 v2.0 points; P=.001) in favor of the MP compared with the PL group, respectively. There were no differences in adverse effects between the groups.Conclusion: MP 32 mg daily did not provide additional analgesia in patients with cancer receiving opioids, but it improved fatigue, appetite loss, and patient satisfaction. Clinical benefit beyond a short-term effect must be examined in a future study.Purpose: Corticosteroids are frequently used in cancer pain management despite limited evidence. This study compares the analgesic efficacy of corticosteroid therapy with placebo.Patients and Methods: Adult patients with cancer receiving opioids with average pain intensity ≥ 4 (numeric rating scale [NRS], 0 to 10) in the last 24 hours were eligible. Patients were randomly assigned to methylprednisolone (MP) 16 mg twice daily or placebo (PL) for 7 days. Primary outcome was average pain ntensity measured at day 7 (NRS, 0 to 10); secondary outcomes were analgesic consumption (ora morphine equivalents), fatigue and appetite loss (European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire C30, 0 to 100), and patient satisfaction (NRS, 0 to 10)