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

Abstract

Tizanidine and aceclofenac individually have shown efficacy in the treatment of low back pain. The efficacy and tolerability of the combination have not yet been established. The objective of the study was to evaluate the efficacy and safety of aceclofenac-tizanidine fixed dose combination against aceclofenac alone in patients with acute low back pain. This double-blind, doubledummy, randomized, comparative, multicentric, parallel group study enrolled 197 patients of either sex in the age range of 18-70 years with acute low back pain. The patients were randomized to receive either aceclofenac (100 mg)-tizanidine (2 mg) b.i.d or aceclofenac (100 mg) alone b.i.d for 7 days. The primary efficacy outcomes were pain intensity (on movement, at rest and at night; on VAS scale) and pain relief (on a 5-point verbal rating scale). The secondary efficacy outcomes measures included functional impairment (modified Schober's test and lateral body bending test) and patient's and investigator's global efficacy assessment. aceclofenac-tizanidine was significantly superior to aceclofenac for pain intensity (on movement, at rest and at night; P \ 0.05) and pain relief (P = 0.00) on days 3 and 7. There was significant increase in spinal flexion in both the groups from baseline on days 3 and 7 with significant difference in favour of the combination group (P \ 0.05). There were significantly more number of patients with excellent to good response for the aceclofenac-tizanidine treatment as compared to aceclofenac alone (P = 0.00). Both the treatments were well tolerated. In this study, aceclofenac-tizanidine combination was more effective than aceclofenac alone and had a favourable safety profile in the treatment of acute low back pain.

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.…”

“…ЖУРНАЛ НЕВРОЛОГИИ И ПСИХИАТРИИ, 12,2015 ЛЕЧЕНИЕ НЕРВНЫХ И ПСИХИЧЕСКИХ ЗАБОЛЕВАНИЙ патологически усиленную импульсацию из ретикулярной формации ствола мозга [17,18]. Препарат селективно ос-лабляет патологический мышечный спазм и в терапевти-ческих дозах не оказывает влияния на нормальные сен-сорные и двигательные функции ЦНС (мышечный тонус, произвольные движения, координация движений) и не вызывает седативного эффекта, мышечной слабости и атаксии.…”

Pharmacotherapy for lumbago

“…Наиболее крупное исследование эффективности ком-бинации тизанидина и НПВП при острой БНЧС было про-ведено учеными 6 азиатских стран в ходе 8-дневного много-центрового РКИ (n=361) [43]. Больные получали диклофе-нак 50 мг и тизанидин 2 мг 2 раза/сут или только диклофенак 50 мг 2 раза/сут.…”

Comparison of naproxen with cyclobenzaprine, oxycodone-acetaminophen, and placebo for the treatment of acute low back pain

“…Despite the common use of these medications, the evidence for opioids in the treatment of acute low back pain is very limited 3 . Additionally, existing data comparing the combination of NSAIDs plus muscle relaxants with NSAIDS plus placebo has been conflicting [4][5][6][7][8] .…”