title: Traumeel vs. diclofenac for reducing pain and improving ankle mobility after acute ankle sprain: a multicentre, randomised, blinded, controlled and non-inferiority trial.
abstract: BACKGROUND
  Acute ankle sprains are common and activity limiting injuries, and topical diclofenac gel has proven efficacy in alleviating pain and restoring function. This trial aimed to compare a topical natural agent, Traumeel with topical diclofenac gel (1%) in the management of acute ankle sprain.
  
  
  METHODS
  This prospective, multicentre, randomised, blinded, active-control and non-inferiority study involved 449 physically active adults sustaining unilateral grade 1 or 2 ankle sprain within the past 24 h. Participants were randomised to receive 2 g of Traumeel ointment (T-O) (n = 152) or Traumeel gel (T-G) (n = 150) or diclofenac gel (D-G) (n = 147), administered topically to the ankle three times a day for 14 days, with 6-weeks follow up.
  
  
  RESULTS
  Day 7 median percentage reductions in Visual Analogue Scale pain score were 60.6%, 71.1% and 68.9% for the T-O, T-G and D-G groups, respectively. Total pain relief was reported by 12 (8.5%), 7 (5.0%) and 8 (5.9%) participants in each group, respectively. Median improvements in Foot and Ankle Ability Measure Activities of Daily Living subscale score were 26.2, 26.2 and 25.0 points for T-O, T-G and D-G groups, respectively. Mann-Whitney effect sizes and lower bound confidence intervals demonstrated non-inferiority of Traumeel vs. diclofenac for reducing pain and functional improvement. At 6 weeks, participants reported total pain relief and normal functioning. Adverse events (n = 43) were reported by 31/447 participants (6.9%). Treatments were equally well tolerated.
  
  
  CONCLUSIONS
  T-O and T-G decreased pain and improved joint function to the same extent as D-G in acute ankle sprain, and were well tolerated.
authors.affiliation: MEDYR Clinic, Sports Medicine & Rehabilitation, Madrid, Spain.
authors.forename: C
authors.initials: C
authors.lastname: González de Vega
authors.forename: C
authors.initials: C
authors.lastname: Speed
authors.forename: B
authors.initials: B
authors.lastname: Wolfarth
authors.forename: J
authors.initials: J
authors.lastname: González
mesh_terms: D000208:Acute Disease; D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000700:Analgesics / Q000008:administration & dosage* / Q000009:adverse effects; D016512:Ankle Injuries / Q000188:drug therapy* / Q000503:physiopathology; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D018771:Arthralgia / Q000517:prevention & control*; D004008:Diclofenac / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D008903:Minerals / Q000008:administration & dosage* / Q000009:adverse effects; D009824:Ointments; D010147:Pain Measurement; D010936:Plant Extracts / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D016059:Range of Motion, Articular / Q000187:drug effects; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000700:Analgesics; D000894:Anti-Inflammatory Agents, Non-Steroidal; D005782:Gels; D008903:Minerals; D009824:Ointments; D010936:Plant Extracts; C433370:Traumeel S; D004008:Diclofenac
references.citation: Pain. 2009 Jun;143(3):238-245
references.pmid: 19380203
references.citation: Fortschr Med. 1988 Feb 20;106(5):96-100
references.pmid: 3283007
references.citation: Expert Opin Pharmacother. 2008 Nov;9(16):2921-9
references.pmid: 18937623
references.citation: Curr Med Res Opin. 2011 Mar;27(3):605-22
references.pmid: 21231861
references.citation: Am Fam Physician. 2006 Nov 15;74(10):1714-20
references.pmid: 17137000
references.citation: Sports Med. 2007;37(1):73-94
references.pmid: 17190537
references.citation: Explore (NY). 2005 Nov;1(6):446-52
references.pmid: 16781589
references.citation: Int J Technol Assess Health Care. 1988;4(4):637-42
references.pmid: 10291102
references.citation: Complement Ther Med. 1999 Dec;7(4):225-30
references.pmid: 10709306
references.citation: Am Fam Physician. 2001 Jan 1;63(1):93-104
references.pmid: 11195774
references.citation: Br J Sports Med. 2003 Jun;37(3):233-8
references.pmid: 12782548
references.citation: J Altern Complement Med. 2004 Aug;10(4):627-32
references.pmid: 15353018
references.citation: Complement Ther Med. 2008 Feb;16(1):22-7
references.pmid: 18346625
references.citation: Foot Ankle Int. 2005 Nov;26(11):968-83
references.pmid: 16309613
references.citation: Am Fam Physician. 1998 Feb 1;57(3):474-80
references.pmid: 9475896
references.citation: J Orthop Sports Phys Ther. 1979;1(1):51-2
references.pmid: 18810189
references.citation: Int J Gen Med. 2011 Mar 25;4:225-34
references.pmid: 21556350
references.citation: Arch Intern Med. 1992 Mar;152(3):507-12
references.pmid: 1546913
references.citation: Cochrane Database Syst Rev. 2010 Jun 16;(6):CD007402
references.pmid: 20556778
references.citation: Biometrics. 1994 Dec;50(4):1029-41
references.pmid: 7786985
references.citation: Biom J. 2006 Aug;48(4):623-34
references.pmid: 16972714
references.citation: Curr Med Res Opin. 2008 Apr;24(4):925-50
references.pmid: 18279583