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A randomized, placebo- and active-controlled, multi-country, multi-center parallel group trial to evaluate the efficacy and safety of a fixed-dose combination of 400 mg ibuprofen and 100 mg caffeine compared with ibuprofen 400 mg and placebo in patients with acute lower back or neck pain.

ABSTRACT: Background:Ibuprofen is a well-established analgesic for acute pain symptoms. In several acute pain models, caffeine has demonstrated an analgesic adjuvant effect. This randomized trial (NCT03003000) was designed to compare the efficacy of a fixed-dose combination of ibuprofen and caffeine with ibuprofen or placebo for the treatment of acute lower back/neck pain. Methods:Patients with acute lower back/neck pain resulting in pain on movement (POM) ?5 on a 10-point numerical rating scale were randomized 2:2:1 to receive orally, three times daily for 6 days, 400 mg ibuprofen+100 mg caffeine, 400 mg ibuprofen or placebo, respectively. The primary endpoint was change in POMWP (POM triggering highest pain score at baseline [worst procedure]) between baseline and the morning of day 2. Key secondary endpoints included POMWP area under curve (AUC) between baseline and the morning of day 4 (POMWPAUC72h) and day 6 (POMWPAUC120h). Results:In total, 635 patients were randomized (256 ibuprofen + caffeine: 253 ibuprofen: 126 placebo). Active treatments exhibited similar reductions in POMWP, with an adjusted mean reduction of 1.998 (standard error [SE]: 0.1042) between baseline and day 2 for ibuprofen, 1.869 (SE: 0.1030) for ibuprofen + caffeine and 1.712 (SE: 0.1422) for placebo. Similar results were observed for POMWPAUC72h and POMWPAUC120h. Safety and tolerability was as expected. Conclusion:A decrease in lower back/neck pain, indicated by reduced POMWP, was shown in all active treatment arms; however, treatment effects were small versus placebo. Ibuprofen plus caffeine was not superior to ibuprofen alone or placebo for the treatment of acute lower back/neck pain in this setting.

SUBMITTER: Predel HG

PROVIDER: S-EPMC6765100 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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A randomized, placebo- and active-controlled, multi-country, multi-center parallel group trial to evaluate the efficacy and safety of a fixed-dose combination of 400 mg ibuprofen and 100 mg caffeine compared with ibuprofen 400 mg and placebo in patients with acute lower back or neck pain.

Predel Hans-Georg HG Ebel-Bitoun Caty C Lange Robert R Weiser Thomas T

Journal of pain research 20190923

<h4>Background</h4>Ibuprofen is a well-established analgesic for acute pain symptoms. In several acute pain models, caffeine has demonstrated an analgesic adjuvant effect. This randomized trial (NCT03003000) was designed to compare the efficacy of a fixed-dose combination of ibuprofen and caffeine with ibuprofen or placebo for the treatment of acute lower back/neck pain.<h4>Methods</h4>Patients with acute lower back/neck pain resulting in pain on movement (POM) ≥5 on a 10-point numerical rating ...[more]

PMID: 31576162

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Project description:BACKGROUND:Thermogenic fitness drink formulas (TFD) have been shown to increase energy expenditure and markers of lipid metabolism. The purpose of the current study was to compare TFD formulas containing different caffeine concentrations versus a placebo drink on energy expenditure and lipid metabolism at rest and during exercise. METHODS:Thirty-two recreationally active participants (22.9?±?0.7 y, 167.1?±?1.4?cm, 68.8?±?2.0?kg, 24.0?±?1.2% fat) who were regular caffeine consumers, participated in this randomized, double-blind, crossover design study. Participants reported to the laboratory on three occasions, each of which required consumption of either a TFD containing 140?mg or 100?mg of caffeine or a placebo. Baseline measurements of resting energy expenditure (REE) and resting fat oxidation (RFO) were assessed using indirect calorimetry as well as measurements of serum glycerol concentration. Measurements were repeated at 30, 60, 90?min post-ingestion. Following resting measures, participants completed a graded exercise test to determine maximal oxygen uptake (V?O2max), maximal fat oxidation (MFO) and the exercise intensity that elicits MFO (Fatmax), and total energy expenditure (EE). RESULTS:A significant interaction was shown for REE (p <?0.01) and RFO (p <?0.01). Area under the curve analysis showed an increased REE for the 140?mg compared to the 100?mg formula (p =?0.02) and placebo (p <?0.01) and an increased REE for the 100?mg formula compared to placebo (p =?0.02). RFO significantly decreased for caffeinated formulas at 30?min post ingestion compared to placebo and baseline (p <?0.01) and significantly increased for the 140?mg formula at 60?min post-ingestion (p =?0.03). A main effect was shown for serum glycerol concentrations over time (p <?0.01). No significant differences were shown for V?O2max (p =?0.12), Fatmax (p =?0.22), and MFO (p =?0.05), and EE (p =?0.08) across drinks. CONCLUSIONS:Our results suggest that TFD formulas containing 100 and 140?mg of caffeine are effective in increasing REE and that a 40?mg of caffeine difference between the tested formulas may impact REE and RFO in healthy individuals within 60?min of ingestion.

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Dataset Information

A randomized, placebo- and active-controlled, multi-country, multi-center parallel group trial to evaluate the efficacy and safety of a fixed-dose combination of 400 mg ibuprofen and 100 mg caffeine compared with ibuprofen 400 mg and placebo in patients with acute lower back or neck pain.

Publications

A randomized, placebo- and active-controlled, multi-country, multi-center parallel group trial to evaluate the efficacy and safety of a fixed-dose combination of 400 mg ibuprofen and 100 mg caffeine compared with ibuprofen 400 mg and placebo in patients with acute lower back or neck pain.

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