Osteoarthritis: clinical evaluation of diclofenac combined with the B complex vitamins / Osteoartrite: avaliação clínica da ação do diclofenaco com as vitaminas do complexo B
RBM rev. bras. med
;
66(7): 206-212, jul. 2009. graf, tab
Article
in English
| LILACS
| ID: lil-524580
ABSTRACT
A double-blind, placebo controlled evaluation was performed on parallel groups of patients presenting osteoarthritis of the knee, hip or hand. The study aimed to evaluate the use of a combination of sustained-release diclofenac and vitamins B1, B6 and B12 in the treatment of the signs and symptoms of osteoarthritis. After screening and informed consent, randomized subjects underwent a 7-day treatment period with twice-daily oral therapy. Osteoarthritis pain, mobility and satisfaction assessments by both the subjects and the investigating physician were performed at each of the three visits to the study center before, during and at the end of the treatment period, along with physical examinations, laboratory evaluations and monitoring of adverse events and concomitant medications. Results were compared between the active and placebo treated groups (Group A and Group B, respectively).The active treatment was found to be superior to placebo in all of the pain, mobility and satisfaction assessments. Patients treated with the active substance were more willing to continue treatment at the end of the study. No significant difference was observed between the treatment groups in the physical examinations and laboratory evaluations performed.Based on the results observed in this double-blind clinical evaluation, we conclude that the combination of sustained-release diclofenac and vitamins B1, B6 and B12 is both well-tolerated and superior to placebo in the treatment of the signs and symptoms of OA in the study population evaluated.
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Index:
LILACS (Americas)
Type of study:
Controlled clinical trial
Language:
English
Journal:
RBM rev. bras. med
Journal subject:
Medicine
Year:
2009
Type:
Article
Affiliation country:
Brazil
/
Canada
/
United States
Institution/Affiliation country:
American College of Physicians/US
/
Federal University of Serra dos Orgãos/BR
/
Fluminense Federal University/BR
/
Sunnybrook Health Science Center/CA
/
Weill Medical College of Cornell University/US
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