Extracorporeal shockwave therapy for refractory tennis elbow

According to the results of this double-blind, randomised equivalence trial, oral prednisolone and naproxen are equally effective in the initial treatment of gout arthritis over 4 days. Equivalence trials are similar to non-inferiority studies and are conducted to show that there is no clinically significant difference between a standard and an experimental treatment. In the trial, 120 primary-care patients in the Netherlands who had confirmed gout (presence of monosodium urate crystals) were randomised to treatment with either prednisolone (35 mg once a day; n=60) or naproxen (500 mg twice a day; n=60), for 5 days. The primary outcome was pain measured on a 100 mm visual analogue scale and the margin for equivalence set at 10%. Analyses were done per protocol and by intention to treat, although the per-protocol analysis results are given in the report as the researcher’s note that the results of the intention-to-treat analyses agree with those of the per-protocol analyses. Data were incomplete for one patient in each treatment group, so per-protocol analyses included 59 patients in each group. The results of the study found:

• After 90 hours the reduction in the pain score was 44.7 mm and 46.0 mm for prednisolone and naproxen, respectively (difference 1.3 mm; 95% CI -9•8 to 7•1), suggesting equivalence.
• The difference in the size of change in pain was 1.57 mm (95% CI -8.65 to 11.78).
• Adverse effects were similar between groups, minor, and resolved by 3 week follow-up.

In a related Comment article, researchers from Hong Kong note some limitations to the trial and say that these results may need to be repeated in larger trials to convince physicians to change existing clinical practice. They conclude:

“Although well designed, Janssens’ study is fairly small and was done in one centre. The general clinician might not be convinced that studies with only 120 patients should change long-established practice. Clearly this study needs to be repeated in other locales with different incidences of gastrointestinal disease. Second, changes in clinical practice often need strong marketing forces, which might not be forthcoming unless drug companies stand to benefit from newer and more expensive drugs. Nevertheless Janssens’ trial will go some way to satisfy both rheumatological purists and front-line pragmatists that short-term oral corticosteroids are as equally effective as NSAIDs in the initial treatment of acute gout and gout-like syndrome.”

Written by: NLH RSS Search results for 'Musculoskeletal Diseases'

Original Article: http://www.library.nhs.uk/rss/

Long-term phenytoin treatment may reduce bone density

Published in June 4th, 2010

Posted by NLH RSS Search results for 'Musculoskeletal Diseases' in Musculoskeletal Disorders

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A comparative study involving premenopausal women with epilepsy found that use of phenytoin, but not other anti-epileptic drugs (AED), was associated with reductions in bone mineral density (BMD) over the course of a year.

There is evidence that use of AED may be associated with reductions in bone density, however most studies have been cross-sectional and have not investigated the effects of individual drugs. This study aimed to follow a group of young women taking different AED for a sufficient time to be able to demonstrate an effect on bone. Participants were pre-menopausal women (age 18 to 40) with epilepsy and taking one AED for at least six months before enrolment. Each completed a baseline food intake and activity questionnaire, had spine and femoral BMD measurement, and measurement of a range of relevant biochemical markers. They were followed-up for 12 months at which point all measurements were repeated. Outcomes included BMD and measures of bone turnover.

A total of 147 women was enrolled, of whom 93 completed the study (main reasons for discontinuation were loss to follow-up, and change of AED). The 93 subjects for whom 12-month data were available were taking carbamazepine (n=43), lamotrigine (n=23), phenytoin (n=15), and valproate (n=14); their average age was 32. All had long-term epilepsy, with an average duration of treatment of 9 years. Those in the phenytoin group showed a 2.6% loss of BMD at the hip but not at other sites; those in the other groups showed stable BMD at all sites measured. Most markers of bone turnover were not significantly different between the groups, and measures of calcium and vitamin D metabolism were similar. Within the phenytoin group, 25-hydroxyvitamin D concentrations varied significantly, with a picture suggesting secondary hyperparathyroidism.

The authors conclude that in this study group of young women with epilepsy, those taking phenytoin had significant loss in BMD at the femoral neck. They discuss possible mechanisms for the effect, and suggest that alterations in vitamin D metabolism related to effects on the cytochrome P450 enzyme system may be responsible.

Written by: NLH RSS Search results for 'Musculoskeletal Diseases'

Original Article: http://www.library.nhs.uk/rss/

NICE ACD recommends against sequential use of TNF-alpha inhibitors in rheumatoid arthritis

Published in June 4th, 2010

Posted by NLH RSS Search results for 'Musculoskeletal Diseases' in Musculoskeletal Disorders

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NICE is conducting a multiple technology appraisal of adalimumab, etanercept and infliximab for the treatment of rheumatoid arthritis (RA) after the failure of a TNF-alpha inhibitor, for use in the NHS in England and Wales. The Appraisal Committee has now published its preliminary recommendations in an Appraisal Consultation Document (ACD), which are as follows:

• Adalimumab, etanercept and infliximab, within their licensed indications, are not recommended for the treatment of rheumatoid arthritis after the failure of a TNF-alpha inhibitor.

• People with rheumatoid arthritis currently receiving adalimumab, etanercept or infliximab after the failure of a TNF-alpha inhibitor should have the option to continue therapy until they and their clinicians consider it appropriate to stop.

This guidance should be read in conjunction with ‘Adalimumab, etanercept and infliximab for the treatment of rheumatoid arthritis’ (NICE TA 130; see link above).

The consultation period will run until 20th May 2008 and the second Appraisal Committee meeting will be held on 3rd June 2008.

Written by: NLH RSS Search results for 'Musculoskeletal Diseases'

Original Article: http://www.library.nhs.uk/rss/

Rituximab fails to meet endpoints in SLE study

Published in June 4th, 2010

Posted by NLH RSS Search results for 'Musculoskeletal Diseases' in Musculoskeletal Disorders

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According to BioSpace, a Phase II/III study of rituximab for systemic lupus erythematosus (SLE) did not meet its primary endpoint of major clinical response (MCR) or partial clinical response (PCR) compared to placebo at 52 weeks, nor any of its secondary endpoints. For details of the study design please see the link above.

Genentech and Biogen Idec will continue to analyse the study results for presentation at a medical meeting, and a Phase III trial of rituximab in the treatment of lupus nephritis (LUNAR) will continue.

Written by: NLH RSS Search results for 'Musculoskeletal Diseases'

Original Article: http://www.library.nhs.uk/rss/

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