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2015, Number 2

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Rev Cubana Farm 2015; 49 (2)

Multicentered, randomized, double-blind and controlled study for the evaluation of efficacy of a set combination of thiocolchicoside plus potasium diclofenac in spams

Guayasamín LI, Pacheco VO, Moreno OJ, Ballesteros PC, Vacas SJ, Mantilla GE, García BG

Language: Spanish
References: 32
Page: 271-290
PDF size: 317.30 Kb.


ABSTRACT

Objective: to determine the efficacy and tolerability of a combination at a set dose in a single tablet of thiocolchicoside 4 mg plus potassium diclofenac 50 mg in the reduction of painful acute muscle spasm compared with the placebo and the use of 500 mg paracetamol as rescue medication.
Methods: ninety seven patients from two Ecuador cities, named Quito and Guayaquil, were recruited in three research centers, both public and private. They suffered cervical pain, low back pain and dorsal pain, mainly of functional cause. The patients were randomly assigned in two groups 1) active medication group with 50 patients treated with thiocolchicoside plus potassium diclofenac and 2) placebo group with 47 patients. The efficacy of both groups was evaluated by the reduction of muscle spams observed in checking, palpation and pain reduction measured in an analogue visual scale after 5 days of treatment.
Results: the progress of the muscle spasm degree in the active medication group according to visual evaluation went from 100 % with visible spasm with or without fixed antialgic activity to 96 % with no visible signs of spasm; from 82 % of moderate spasm to severe with or without evoked pain by palpation to 74 % of mild spasm without pain and 26 % of spasm-free muscle. The pain average according to the visual scale decreased from 6.66 cm before treatment to 0,86 cm after the 5th day. The adverse effects were mild in t he treated group.
Conclusions: the fixed combination of thiocolchicoside 4mg plus potassium diclofenac 50 mg in a single tablet, administered two times a day is efficacious in the painful acute muscle spasm of diverse etiology in a statistically significant way, well-tolerated and with no alteration of the psychomotor performance.


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