Hydromorphone extended release for neuropathic and non-neuropathic/nociceptive chronic low back pain: A post hoc analysis of data from a randomized, multicenter, double-blind, placebo-controlled clinical trial

2014 ◽  
Vol 10 (5) ◽  
pp. 311 ◽  
Author(s):  
Srinivas Nalamachu, MD ◽  
Martin Hale, MD ◽  
Arif Khan, MD
Keyword(s):  
Clinical Trial ◽  
Low Back Pain ◽  
Extended Release ◽  
Controlled Clinical Trial ◽  
Low Back ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Post Hoc Analysis ◽  
Titration Phase ◽  
Post Hoc

Objective: The aim of this study was to determine the efficacy and tolerability of hydromorphone extended release (ER) in patients with chronic low back pain (LBP) with or without a neuropathic component.Design: This was a post hoc analysis of data from a multicenter, double-blind, placebo-controlled clinical trial using a randomized withdrawal design, performed in patients with moderate to severe chronic LBP. Patients achieving stable doses of hydromorphone ER during a 2- to 4-week conversion and titration phase were randomized to continue treatment with hydromorphone ER or taper-down to placebo during a 12-week double-blind phase. The primary efficacy outcome was the mean change in 11-point Numeric Rating Scale (NRS) pain intensity score from randomization to the final visit of the double-blind phase. Tolerability was assessed by recording adverse events (AEs). Data were analyzed separately for patients with non-neuropathic and neuropathic LBP.Results: A total of 173 patients with non-neuropathic/nociceptive LBP and 94 with neuropathic LBP were randomized into the double-blind phase. During the conversion and titration phase, mean (SD) NRS scores decreased significantly from 6.5 (1.87) and 6.4 (1.99) at screening to 3.3 (0.98) and 3.2 (1.05), respectively. For both LBP subgroups, patients randomized to hydromorphone ER maintained this improvement over the double-blind treatment period, whereas those randomized to placebo reported significant increase in NRS scores. Across subgroups, the incidence of 1 or more AE was 54 percent to 57 percent in the conversion and titration phase and 47 percent to 55 percent in the double-blind phase.Conclusions: The results of this study indicate that hydromorphone ER is efficacious and generally well tolerated in the management of patients with non-neuropathic and neuropathic chronic LBP.

The efficacy and safety of a homeopathic gel in the treatment of acute low back pain: a multi-centre, randomised, double-blind comparative clinical trial

2001 ◽  
Vol 90 (01) ◽  
pp. 21-28 ◽  
Author(s):  
C Stam ◽  
MS Bonnet ◽  
RA van Haselen
Keyword(s):  
Clinical Trial ◽  
Low Back Pain ◽  
Back Pain ◽  
Controlled Clinical Trial ◽  
Low Back ◽  
Double Blind ◽  
Acute Low Back Pain ◽  
Efficacy Parameter ◽  
Industrialised Countries ◽  
Topical Medications

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.

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