Efficacy and tolerability of DHEP-heparin plaster in reducing pain in mild-to-moderate muscle contusions: a double-blind, randomized trial.

Abstract

OBJECTIVES:

To investigate if the 180-mg diclofenac epolamine and heparin sodium 5600 IU medicated plaster (DHEP-heparin) is more effective for pain reduction in mild-to-moderate contusions than the reference diclofenac epolamine 180 mg plaster (DHEP).

RESEARCH DESIGN AND METHODS:

This multicenter, multinational, prospective, double-blind versus reference comparator and versus placebo, controlled trial had balanced random assignment in three parallel treatment groups. The DHEP-heparin medicated plaster was compared to the DHEP medicated plaster and a placebo medicated plaster. A total of 331 outpatients, aged ≥18 and ≤65 years, with unilateral mild-to-moderate muscle contusion, pain on standardized movement of ≥50 mm, and superficial hematoma of ≤10 × 14 cm(2) completed the study. Plasters were applied each morning, for ≥20 hours daily for 14 consecutive days. Outcomes were assessed in three visits, over 14 days, plus patients' daily self-assessment.

CLINICAL TRIAL REGISTRATION:

05DCz/FHp11 - Eudra CT n: 2005-003829-31

MAIN OUTCOME MEASURES:

Primary efficacy endpoint was mean change from baseline in pain on movement after 3 days of treatment, compared between groups. Secondary efficacy endpoints included mean daily change from baseline in pain on movement during treatment, pain level as assessed at control visits after 7 and 14 days, time (days) to hematoma disappearance based on patients' daily evaluations, rescue medication use, and overall treatment efficacy as judged by both patients and investigators.

RESULTS:

Pain progressively declined in all groups, more rapidly in DHEP-heparin recipients, compared to DHEP, and in both active treatment groups compared to placebo. Adverse events were recorded in 24 of the 355 (6.7%) exposed patients, and generally resolved without need to interrupt treatment.

CONCLUSION:

The DHEP-heparin plaster is superior to the reference DHEP plaster in reducing pain associated with mild-to-moderate muscle contusion. Both active treatments were significantly more effective than placebo, and each showed a comparably favorable, placebo-like safety profile.

• Authors: Peter Hoffmann, Pavel Kopačka, Barbara Gugliotta, Stefano Rovati
• Journal: Current medical research and opinion (Curr Med Res Opin) Vol. 28 Issue 8 Pg. 1313-21 (Aug 2012) ISSN: 1473-4877 [Electronic] England
• PMID: 22762346 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Inflammatory Agents, Non-Steroidal
• Antifibrinolytic Agents
• Placebos
• diclofenac hydroxyethylpyrrolidine
• Diclofenac
• Heparin

Topics

• Administration, Topical
• Adolescent
• Adult
• Aged
• Algorithms
• Anti-Inflammatory Agents, Non-Steroidal (administration & dosage, adverse effects)
• Antifibrinolytic Agents (administration & dosage, adverse effects)
• Casts, Surgical
• Contusions (complications, drug therapy)
• Diclofenac (administration & dosage, adverse effects, analogs & derivatives)
• Double-Blind Method
• Female
• Heparin (administration & dosage, adverse effects)
• Humans
• Male
• Middle Aged
• Muscular Diseases (complications, drug therapy)
• Pain (drug therapy, etiology)
• Placebos
• Severity of Illness Index
• Treatment Outcome
• Young Adult