Health Technology Assessment 2005; Vol 9: number 33
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C Price,1* N Arden,2 L Coglan3 and P Rogers4
1 Pain Clinic, Royal South Hants Hospital, Southampton, UK
2 MRC Rheumatology Unit, Southampton General Hospital, UK
3 Department of Health Economics, Economics and Business Faculty, University of Portsmouth, UK
4 Pain Clinic, St Marys Hospital, Portsmouth, UK
* Corresponding author
Sciatica is a common cause of pain and disability. Epidural injections of corticosteroids (ESIs) commonly are used to treat sciatica. In 2002/03 there were 45,948 ESIs performed within the NHS. A systematic review and meta-analysis of previous trials found that there was weak benefit from ESIs, but most trials were underpowered. Safety and cost-effectiveness have not been evaluated.
The objectives of this study were:
A pragmatic, prospective, multicentre, double-blind, randomised, placebo-controlled trial with 12-month follow-up was performed. The study included 228 patients listed for ESI with clinically diagnosed unilateral sciatica, aged between 18 and 70 years, who had a duration of symptoms between 4 weeks and 18 months. Patients were stratified according to acute (<4 months since onset) versus chronic (418 months) presentation. All analyses were performed on an intention-to-treat basis with last observation carried forward used to impute missing data. Data were collected from dropouts, cross-overs and withdrawals at 52 weeks to give as much information as possible on long-term follow-up.
The study took place in rheumatology, orthopaedic and pain clinics in four participating centres: three district hospitals and one teaching hospital in the south of England.
Patients received up to three injections of epidural steroid and local anaesthetic (active), or an injection of normal saline into the interspinous ligament (placebo).
The primary outcome measure was the Oswestry Disability Questionnaire (ODQ); measures of pain relief and psychological and physical function were collected. Health economic data on return to work, analgesia use and other interventions were also measured. Quality-adjusted life-years (QALYs) were calculated using the SF-6D, calculated from the Short Form (SF-36). Costs per patient were derived from figures supplied by Trust finance departments and a costings exercise performed as part of the study. A costutility analysis was performed using the SF-36 to calculate costs per QALY.
ESI led to a transient benefit in ODQ and pain relief, compared with placebo at 3 weeks (p = 0.017, number needed to treat = 11.4). There was no benefit over placebo between weeks 6 and 52. Using incremental QALYs, this equates to an additional 2.2 days of full health. Acute sciatica seemed to respond no differently to chronic sciatica. There were no significant differences in any other indices, including objective tests of function, return to work or need for surgery at any time-points. There were no clinical predictors of response, although the trial lacked sufficient power to be confident of this. Adverse events were uncommon, with no difference between groups.
Costs per QALY to providers under the trial protocol were £44,701. Costs to the purchaser per QALY were £354,171. If only one ESI was provided then costs per QALY fell to £25,745 to the provider and £167,145 to the purchaser. ESIs thus fail the QALY threshold recommended by the National Institute for Health and Clinical Excellence (NICE).
Although ESIs are relatively safe, it was found that they confer only transient benefit in symptoms and self-reported function in a small group of patients with sciatica at substantial costs. ESIs do not provide good value for money to the NHS as determined by NICE guidelines.
The results of this study suggest the following.
There are a number of areas that would benefit from additional research:
Price C, Arden N, Coglan L, Rogers P. Cost-effectiveness and safety of epidural steroids in the management of sciatica. Health Technol Assess 2005;9(33).
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