Comparison of diclofenac gel, ibuprofen gel, and ibuprofen gel with levomenthol for the topical treatment of pain associated with musculoskeletal injuries

Alan G Wade, Gordon M Crawford, David Young, Stephen Corson, Colin Brown, Alan G Wade, Gordon M Crawford, David Young, Stephen Corson, Colin Brown

Abstract

Objective: To determine whether 3% w/w levomenthol added to ibuprofen gel (5% w/w) improves its efficacy compared with ibuprofen gel alone or diclofenac gel (1.16%) for the treatment of soft-tissue injuries.

Methods: A total of 182 patients with acute soft-tissue injuries participated in a randomised, single-blind, single-dose study to assess the efficacy and safety of three topical analgesic gels. Efficacy was assessed as the score change in a numeric rating scale for pain.

Results: The median time to significant pain relief was 20 minutes for the ibuprofen/levomenthol and diclofenac gels but 25 minutes for ibuprofen gel. At 2 hours, significantly more patients treated with ibuprofen/levomenthol gel reported a cooling sensation (45.8%) compared with diclofenac (16.4%) or ibuprofen (14.7%) gels, and both ibuprofen/levomenthol and diclofenac gels provided significantly more effective global pain relief compared with ibuprofen gel. Few adverse events and no serious adverse events related to study medication were recorded.

Conclusions: Although all gels effectively relieved pain, both ibuprofen/levomenthol and diclofenac gels provided superior global pain relief compared with ibuprofen gel, with a shorter median time to significant pain relief. Only ibuprofen/levomenthol gel provided cooling for up to 2 hours. None of the gels were associated with serious safety concerns. EudraCT No 2015-005240-33 EU Clinical Trials Register URL: https://www.clinicaltrialsregister.eu/ctr-search/search

Keywords: Analgesic; diclofenac; ibuprofen; levomenthol; menthol; pain relief; topical.

Figures

Figure 1.
Figure 1.
Survival analysis showing the proportion of patients yet to report significant pain relief (2-point reduction in pain score from baseline) at successive time points.
Figure 2.
Figure 2.
Proportion of patients achieving significant pain relief at each time point.
Figure 3.
Figure 3.
Association of ibuprofen/levomenthol gel with prolonged cooling.
Figure 4.
Figure 4.
Between-group comparison of global pain relief at 2 hours.

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