La eficacia y los efectos de la tizanidina gastroprotectores más diclofenaco versus placebo más diclofenaco en pacientes con espasmos musculares dolorosos

The efficacy and gastroprotective effects of tizanidine plus diclofenac were compared with placebo plus diclofenac in patients with acute local pain syndromes such as low-back pain. This multicenter, double-masked, placebo-controlled, parallel-group study included patients in the Asia-Pacific region who experienced local pain syndromes of recent onset and clinically discernible muscle spasms. Patients received either tizanidine 2 mg twice daily (BID) with diclofenac 50 mg BID or placebo BID with diclofenac 50 mg BID for 7 days. Efficacy variables (pain at rest, at night, on palpation, and during movement; hardness of muscles on palpation; restriction of body movement and disability due to pain; sleep quality; duration of daytime bed rest) and tolerability (including a questionnaire for gastrointestinal adverse effects) were assessed at baseline, and on days 4 and 8. Overall efficacy and tolerability were assessed and a test for occult blood in the stool was performed on day 8. A total of 405 patients were entered into the study in 12 centers in 6 countries; 361 were assessable. Results revealed that the combination of tizanidine with diclofenac was significantly more effective than diclofenac with placebo for most variables. Overall tolerability was better in patients who received tizanidine with diclofenac, although the difference between groups did not reach statistical significance. However, the frequency of gastrointestinal adverse effects was significantly less in patients who received tizanidine plus diclofenac (12%) compared with patients who received placebo plus diclofenac (32%). The frequency of positive test results for occult blood in the stool was 5% in the former group and 11% in the latter group. The combination of tizanidine with diclofenac was more effective and better tolerated than diclofenac alone in patients with local pain syndromes. This study confirms and extends the results of previous studies suggesting increased efficacy and gastroprotective effects of tizanidine when combined with nonsteroidal anti-inflammatory drugs.