Does Melatonin Improve Subjective Sleep Quality after Total Knee Arthroplasty? A Randomized, Placebo-Controlled Trial
Abstract
INTRODUCTION
Sleep disturbance is a common problem following total knee arthroplasty (TKA). The objective of this study was to determine if exogenous melatonin improves sleep quality following primary TKA.
METHODS
A randomized, double-blind, placebo-controlled trial was conducted. A total of 172 patients undergoing unilateral TKA for primary knee osteoarthritis were randomized to receive either 5 mg melatonin (n=86) or 125 mg vitamin C placebo (n=86) nightly for 6 weeks. The primary outcome was the Pittsburgh Sleep Quality Index (PSQI) at 6 weeks and 90 days postoperatively. Secondary outcomes included 6-week and 90-day patient-reported outcome measures (PROMs), morphine milligram equivalents (MMEs) prescribed, medication compliance, adverse events, and 90-day readmissions.
RESULTS
Mean PSQI scores worsened at 6 weeks before returning to the preoperative baseline at 90 days in both groups. There were no differences in PSQI scores between melatonin and placebo groups at 6 weeks (10.2±4.2 versus 10.5±4.4, P=0.66) or 90 days (8.1±4.1 versus 7.5±4.0, P=0.43). Melatonin did not improve the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS-JR), Lower Extremity Activity Scale (LEAS), Visual Analog Scale (VAS) for pain, or Veterans Rand 12 (VR-12) Physical Component Score (PCS) or Mental Component Score (MCS) at 6 weeks or 90 days. Poor sleep quality was associated with worse PROMs at 6 weeks and 90 days on univariate and multivariable analyses, but melatonin…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 172 participants or records.
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