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Traumeel vs. diclofenac for reducing pain and improving ankle mobility after acute ankle sprain: a multicentre, randomised, blinded, controlled and non-inferiority trial.

González de Vega C, Speed C, Wolfarth B, González J - Int. J. Clin. Pract. (2013)

Bottom Line: Mann-Whitney effect sizes and lower bound confidence intervals demonstrated non-inferiority of Traumeel vs. diclofenac for reducing pain and functional improvement.Treatments were equally well tolerated.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.

View Article: PubMed Central - PubMed

Affiliation: MEDYR Clinic, Sports Medicine & Rehabilitation, Madrid, Spain.

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Related in: MedlinePlus

TAASS trial flowchart of study population with ankle sprain randomised and followed up in study monitoring efficacy. Exclusions, all circumstances leading to exclusion from Safety or Intent-To-Treat or Per Protocol populations; In/Ex criteria, inclusion/exclusion criteria; time first application, first time of first application of study drug; date of day 7, date of Visit 3 (day 7); premature discont., premature discontinuation (not efficacy related); administrative reasons including ‘lost to follow up’; * ‘severe’ violation of the VAS pain inclusion criterion (VAS <30 mm); † a participant may have had more than one reason for exclusion; ‡ includes the participant in the Traumeel ointment group who discontinued the study prematurely on day 8 because of worsening of the injury.
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fig01: TAASS trial flowchart of study population with ankle sprain randomised and followed up in study monitoring efficacy. Exclusions, all circumstances leading to exclusion from Safety or Intent-To-Treat or Per Protocol populations; In/Ex criteria, inclusion/exclusion criteria; time first application, first time of first application of study drug; date of day 7, date of Visit 3 (day 7); premature discont., premature discontinuation (not efficacy related); administrative reasons including ‘lost to follow up’; * ‘severe’ violation of the VAS pain inclusion criterion (VAS <30 mm); † a participant may have had more than one reason for exclusion; ‡ includes the participant in the Traumeel ointment group who discontinued the study prematurely on day 8 because of worsening of the injury.

Mentions: Of the 449 individuals enrolled into the study (i.e. 299 participants in Stage I and 150 in Stage II), all were randomised to treatment (Figure1). Two participants in the T-G group did not receive treatment; they withdrew their consent for participation in the trial after randomisation and before receiving the first medication dose. Stages I and II participants in each treatment group were combined for the analyses.


Traumeel vs. diclofenac for reducing pain and improving ankle mobility after acute ankle sprain: a multicentre, randomised, blinded, controlled and non-inferiority trial.

González de Vega C, Speed C, Wolfarth B, González J - Int. J. Clin. Pract. (2013)

TAASS trial flowchart of study population with ankle sprain randomised and followed up in study monitoring efficacy. Exclusions, all circumstances leading to exclusion from Safety or Intent-To-Treat or Per Protocol populations; In/Ex criteria, inclusion/exclusion criteria; time first application, first time of first application of study drug; date of day 7, date of Visit 3 (day 7); premature discont., premature discontinuation (not efficacy related); administrative reasons including ‘lost to follow up’; * ‘severe’ violation of the VAS pain inclusion criterion (VAS <30 mm); † a participant may have had more than one reason for exclusion; ‡ includes the participant in the Traumeel ointment group who discontinued the study prematurely on day 8 because of worsening of the injury.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4231442&req=5

fig01: TAASS trial flowchart of study population with ankle sprain randomised and followed up in study monitoring efficacy. Exclusions, all circumstances leading to exclusion from Safety or Intent-To-Treat or Per Protocol populations; In/Ex criteria, inclusion/exclusion criteria; time first application, first time of first application of study drug; date of day 7, date of Visit 3 (day 7); premature discont., premature discontinuation (not efficacy related); administrative reasons including ‘lost to follow up’; * ‘severe’ violation of the VAS pain inclusion criterion (VAS <30 mm); † a participant may have had more than one reason for exclusion; ‡ includes the participant in the Traumeel ointment group who discontinued the study prematurely on day 8 because of worsening of the injury.
Mentions: Of the 449 individuals enrolled into the study (i.e. 299 participants in Stage I and 150 in Stage II), all were randomised to treatment (Figure1). Two participants in the T-G group did not receive treatment; they withdrew their consent for participation in the trial after randomisation and before receiving the first medication dose. Stages I and II participants in each treatment group were combined for the analyses.

Bottom Line: Mann-Whitney effect sizes and lower bound confidence intervals demonstrated non-inferiority of Traumeel vs. diclofenac for reducing pain and functional improvement.Treatments were equally well tolerated.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.

View Article: PubMed Central - PubMed

Affiliation: MEDYR Clinic, Sports Medicine & Rehabilitation, Madrid, Spain.

Show MeSH
Related in: MedlinePlus