Invited editorial presents an accurate summary of the results of two randomised placebo-controlled trials of vertebroplasty.
نویسندگان
چکیده
Our recent editorial in the Journal presents an accurate summary of our two randomised trials of vertebroplasty, which found no benefit of vertebroplasty over placebo. Participants in both trials are representative of patients seen in clinical practice and who would qualify for government-subsidised funding of vertebroplasty in Australia. Clinical experience and previous published literature are likely to have overestimated the treatment benefit of vertebroplasty for many reasons. This is why randomised placebo-controlled trials are required to determine the efficacy of treatment interventions, particularly when the condition being treated is self-limiting and the primary end point is improvement of symptoms. Based on the best evidence currently available, the routine use of vertebroplasty outside of the research setting for painful osteoporotic vertebral fractures appears unjustified.
منابع مشابه
Effectiveness of vertebroplasty using individual patient data from two randomised placebo controlled trials: meta-analysis
OBJECTIVE To determine whether vertebroplasty is more effective than placebo for patients with pain of recent onset (≤ 6 weeks) or severe pain (score ≥ 8 on 0-10 numerical rating scale). DESIGN Meta-analysis of combined individual patient level data. SETTING Two multicentred randomised controlled trials of vertebroplasty; one based in Australia, the other in the United States. PARTICIPANT...
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Two randomised placebo-controlled trials show the importance of establishing the efficacy of procedures before adopting them into clinical practice.
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SUMMARY Ethical considerations in standard medical care and clinical research are underpinnings to quality medicine. Similarly, the placebo-controlled double-blind randomised clinical trial is the gold standard for medical research and fundamental to the development of evidence-based medicine. Researchers and clinicians are challenged by ethical concerns in the informed consent with a need to m...
متن کاملPercutaneous vertebroplasty does not reduce pain and disability from osteoporotic vertebral compression fracture.
Context Vertebroplasty is a frequently performed procedure stabilising predominantly osteoporotic vertebral fractures through injection of polymethylmethacrylate (PMMA). Recent placebo-controlled (sham) investigations have assessed the efficacy of vertebroplasty. This Cochrane review provides information about the available randomised controlled trials (RCTs) current to November 2014 and is int...
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ورودعنوان ژورنال:
- The Medical journal of Australia
دوره 192 6 شماره
صفحات -
تاریخ انتشار 2010