Francis Gengo1. 1. DENT Neurological Institute at Millard Fillmore Hospital, Buffalo, New York 14226, USA. fgengo@buffalo.edu
Abstract
BACKGROUND: Although some literature has suggested that NSAIDs may affect sleep physiology, this observation is not consistent with clinical use of these drugs and has not been verified using standard sleep-research methodologies. OBJECTIVE: This study was undertaken to determine whether ibuprofen 400 mg administered at 3, 7, and 11 pm (total daily dose, 1200 mg) produced any significant alterations in the character and quality of night-time sleep as measured by standard sleep laboratory polysomnography (PSG) and subjective measures. METHODS: This 4-day, multiple-dose, double-blind, randomized, placebo-controlled trial was conducted in a hospital-based, sleep laboratory in the United States (DENT Neurological Institute at Millard Fillmore Hospital, Buffalo, New York). Healthy subjects aged > or = 18 years spent 3 consecutive nights in a sleep laboratory. Day 1/night 1 was for acclimation; day 2/night 2, for baseline PSG and subjective sleep assessments; and day 3/night 3, for treatment effects on sleep character and quality. All subjects received placebo on days 1 and 2. On day 3, subjects received ibuprofen 400 mg or placebo TID. RESULTS:All 30 subjects (15 per group) completed the study (18 men, 12 women; all white). The mean age (SD) was 28.6 years and mean body weight was 71.4 kg. In both groups, mean values for sleep efficiency and quality of sleep were significantly higher on night 3 compared with baseline; the mean (SD) changes from baseline were not significantly different between the ibuprofen and control groups (sleep efficiency, 0.4 [6.3] and 0.3 [6.2]; quality of sleep, 8.6 [26.8] and 3.3 [21.3]). Mean night-3 sleep efficiency in the ibuprofen group was 88.6%--substantially higher than the minimally acceptable sleep efficiency of 75% stated in the protocol. Three mild adverse events were reported in 2 subjects. CONCLUSION: This study found that in these subjects a total daily dose of 1200 mg ibuprofen did not produce any clinically or statistically significant alterations in the character and quality of nighttime sleep as measured using standard sleep laboratory PSF and subjective measures.
RCT Entities:
BACKGROUND: Although some literature has suggested that NSAIDs may affect sleep physiology, this observation is not consistent with clinical use of these drugs and has not been verified using standard sleep-research methodologies. OBJECTIVE: This study was undertaken to determine whether ibuprofen 400 mg administered at 3, 7, and 11 pm (total daily dose, 1200 mg) produced any significant alterations in the character and quality of night-time sleep as measured by standard sleep laboratory polysomnography (PSG) and subjective measures. METHODS: This 4-day, multiple-dose, double-blind, randomized, placebo-controlled trial was conducted in a hospital-based, sleep laboratory in the United States (DENT Neurological Institute at Millard Fillmore Hospital, Buffalo, New York). Healthy subjects aged > or = 18 years spent 3 consecutive nights in a sleep laboratory. Day 1/night 1 was for acclimation; day 2/night 2, for baseline PSG and subjective sleep assessments; and day 3/night 3, for treatment effects on sleep character and quality. All subjects received placebo on days 1 and 2. On day 3, subjects received ibuprofen 400 mg or placebo TID. RESULTS: All 30 subjects (15 per group) completed the study (18 men, 12 women; all white). The mean age (SD) was 28.6 years and mean body weight was 71.4 kg. In both groups, mean values for sleep efficiency and quality of sleep were significantly higher on night 3 compared with baseline; the mean (SD) changes from baseline were not significantly different between the ibuprofen and control groups (sleep efficiency, 0.4 [6.3] and 0.3 [6.2]; quality of sleep, 8.6 [26.8] and 3.3 [21.3]). Mean night-3 sleep efficiency in the ibuprofen group was 88.6%--substantially higher than the minimally acceptable sleep efficiency of 75% stated in the protocol. Three mild adverse events were reported in 2 subjects. CONCLUSION: This study found that in these subjects a total daily dose of 1200 mg ibuprofen did not produce any clinically or statistically significant alterations in the character and quality of nighttime sleep as measured using standard sleep laboratory PSF and subjective measures.
Authors: Piedad Morillas-Arques; Carmen Ma Rodriguez-Lopez; Rocio Molina-Barea; Fernando Rico-Villademoros; Elena P Calandre Journal: BMC Musculoskelet Disord Date: 2010-09-10 Impact factor: 2.362