Tizanidine and Ibuprofen in Acute Low-Back Pain: Results of a Double-Blind Multicentre Study in General Practice

Abstract

This study reports on 105 patients with acute low-back pain given tizanidine (4 mg three times daily) plus ibuprofen (400 mg three times daily) or placebo plus ibuprofen (400 mg three times daily). Patients assessed their pain using visual analogue scales in a daily diary and the doctor assessed their condition at baseline and on days 3 and 7. Both groups were treated effectively, but earlier improvement occurred in patients given tizanidine/ibuprofen, particularly regarding pain at night and at rest. Doctors assessed the helpfulness of treatment: tizanidine/ibuprofen was significantly better than placebo/ibuprofen at day 3 (P = 0.05). Significant differences between treatments in favour of tizanidine/ibuprofen occurred in patients with moderate and severe pain at night (P less than 0.05), at rest (P less than 0.05) and those with moderate or severe sciatica (P less than 0.05). Significantly more patients given placebo/ibuprofen had gastro-intestinal side-effects compared with tizanidine/ibuprofen (P = 0.002). This supports previous work in animals showing that tizanidine mediates gastric mucosal protection against anti-inflammatory drugs. More patients given tizanidine/ibuprofen suffered drowsiness and other central nervous system effects (P = 0.025). In patients with severe acute low-back pain, however, some sedation and bed rest is advantageous. This study shows that tizanidine/ibuprofen is more effective in the treatment of moderate or severe acute low-back pain than placebo and ibuprofen alone.

Aceclofenac–tizanidine in the treatment of acute low back pain: a double-blind, double-dummy, randomized, multicentric, comparative study against aceclofenac alone

“…Frequently, however, the patient presents with muscle spasm causing the condition to be more painful and produce functional impairment. In such cases, the use of muscle relaxant drugs may be useful [2].…”

“…Also, tizanidine as a single agent has similar effect as that of diazepam [10] and chlormezanone [2]. Studies comparing the efficacy of tizanidine with diazepam and chlormezanone found tizanidine to be as effective as other agents in reducing spasticity.…”

“…It is indicated for the symptomatic treatment of painful muscle spasms due to musculo-skeletal disorders and of spasticity of various origins at higher dose levels. In combination with NSAID, it is superior to NSAID alone [2]. Besides pain relief, addition of tizanidine reduces the consumption of NSAID and tranquillizer, thereby reducing the side effects potential.…”

“…Studies comparing the efficacy of tizanidine with diazepam and chlormezanone found tizanidine to be as effective as other agents in reducing spasticity. Whilst there is much controversy about the role of muscle spasm in acute back injury [2], there is no doubt that when the condition is extremely painful, a muscle relaxing drug in combination with an analgesic may be a useful way of managing the situation.…”

The results of the multicenter pharmaco-epidemiological observational project on the use of mydocalm in the treatment of pain syndromes with the muscle spasm

“…В ряде систематических обзоров [6][7][8] были вы-явлены убедительные доказательства того, что прием мио релаксантов вызывает уменьшение болевого синдро-ма, и что различные типы миорелаксантов имеют одина-ковую эффективность. Кроме того, во многих исследова-ниях было установлено [9][10][11][12][13], что при острой неспеци-фической боли в нижней части спины комбинация мио-релаксантов с нестероидными противовоспалительными средствами (НПВС) более эффективна, чем монотерапия НПВС.…”