Comparison of the Efficiency and Safety of Oral Phenyramidol and Phenyramidol+Diclofenac Treatment in Muscle Spasms with Spinal Pain – Open-Label Study

Abstract

Muscle relaxants (MR) and nonsteroidal anti-inflammatory drugs (NSAID) are frequently used in the treatment of spasms and are effective combined or alone in muscle spasms. In this study, 30 patients aged 32-82 years, male and female, with moderate to severe acute spinal pain-muscle spasms due to trauma, sprain, or injury history were evaluated. Group 1 received phenyramidol 400 mg orally 3 times a day for 7 days. In the second group, phenyramidol (400 mg) three times a day + diclofenac (75 mg) once a day was given orally for 7 days. Patients were evaluated on the 0th and 7th days in terms of muscle spasm level, pain intensity, and side effects. Side effects were noted for clinical safety. Evaluation was performed at the start of treatment and after treatment. Compared with the adverse drug reactions that occurred during the study, Group 1 treated with phenyramidol alone showed a statistically significantly better safety profile than Group 2 treated with the combination of phenyramidol and diclofenac (p<0.001). As a result, it was observed that oral phenyramidol treatment alone and oral phenyramidol+diclofenac combination treatment did not have any difference in terms of efficacy, but when compared in terms of side effects, the use of phenyramidol alone showed a higher safety profile.
 Keywords: phenyramidol, diclofenac, muscle spasm, spinal pain