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

1988 ◽  
Vol 16 (2) ◽  
pp. 83-91 ◽  
Author(s):  
H. Berry ◽  
D. R. Hutchinson

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<0.05), at rest ( P<0.05) and those with moderate or severe sciatica ( P<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.

1988 ◽  
Vol 16 (2) ◽  
pp. 75-82 ◽  
Author(s):  
H. Berry ◽  
D. R. Hutchinson

Patients (112) with acute low-back pain of recent onset were recruited to this double-blind, randomized, placebo-controlled parallel group study in general practice to evaluate the efficacy and tolerability of the muscle relaxant, tizanidine. They were treated for 7 days with tizanidine (4 mg three times daily) or matching placebo. Aspirin tablets (300 mg) were taken as required as ‘rescue’ medication. Symptoms were assessed by the patient and doctor before treatment, and after 3 and 7 days. Patients recorded pain and aspirin consumption in a daily diary. Both treatments were effective. In patients who had taken no medication prior to entry, aspirin consumption was almost halved in the first 3 days of taking tizanidine compared with placebo ( P = 0.037). Results for pain at rest, pain at night, restriction of movement and pain on movement suggest that tizanidine may give greater improvement, earlier. No serious drug-related adverse events or abnormal biochemistry or haematology were observed in either group. Drowsiness occurred in 22% of patients taking tizanidine although, in patients with severe acute low-back pain, sedation, analgesia and bed rest might be beneficial and desired. Considerably more patients given aspirin/placebo had gastro-intestinal side-effects ( P = 0.018). In conclusion, tizanidine may reduce the need for analgesics and be useful in the treatment of acute low-back pain.


Author(s):  
Kåre Birger Hagen ◽  
Gunvor Hilde ◽  
Gro Jamtvedt ◽  
Michael Winnem

2001 ◽  
Vol 90 (01) ◽  
pp. 21-28 ◽  
Author(s):  
C Stam ◽  
MS Bonnet ◽  
RA van Haselen

AbstractAcute low back pain is a very common condition in Western industrialised countries. In most cases analgesics or topical medications are prescribed at first encounter with the general practitioner (GP).The aim of this study was to investigate whether the homeopathic gel Spiroflor SRL® gel (SRL) is equally effective and better tolerated than Cremor Capsici Compositus FNA (CCC) in patients with acute low back pain.A multi-centre, randomised, double-blind, controlled clinical trial was conducted in the practices of 19 GPs in the districts of Bristol and Manchester, UK. One hundred and sixty-one subjects suffering from acute low back pain were treated for one week either with SRL or with CCC. Pain was scored on a 100 mm visual analogue scale (VAS). Main efficacy parameter VAS reduction was compared between treatments. Evaluation of safety was primarily based on the number of subjects with adverse events (AEs), withdrawals due to an AE and adverse drug reactions (ADRs).The mean difference between the VAS reduction in the SRL group and the CCC group adjusted for VAS at baseline and age was −0.6 mm (90%CI=−6.5–5.3 mm). Fewer subjects in the SRL group (11%) experienced an AE than in the CCC group (26%). The same applies to the number of subjects with an ADR (3/81=4% vs 18/74=24%) and the number of subjects withdrawn due to an ADR (0/81=0% vs 8/74=11%).In conclusion, SRL and CCC are equally effective in the treatment of acute low back pain, however, SRL has a better safety profile. Spiroflor SRL® gel is preferable to Capsicum-based products for the topical treatment of low back pain, because of the lower risk of adverse effects.


1986 ◽  
Vol 315 (17) ◽  
pp. 1064-1070 ◽  
Author(s):  
Richard A. Deyo ◽  
Andrew K. Diehl ◽  
Marc Rosenthal

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