Current medical research and opinion
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Randomized Controlled Trial Multicenter Study
Efficacy and safety of budesonide/formoterol via a dry powder inhaler in Chinese patients with chronic obstructive pulmonary disease.
To evaluate the efficacy and safety of budesonide (BUD)/formoterol (FORM) compared with BUD, both administered by way of a dry powder inhaler (Turbuhaler * ). * Turbuhaler is a registered trade name of AstraZeneca, Södertälje, Sweden. ⋯ In Chinese patients with moderate to very severe COPD, fixed combination treatment with BUD/FORM resulted in clinically meaningful improvements in lung function, health-related quality-of-life, COPD symptoms and a reduction in reliever use, compared with BUD alone and both treatments were well tolerated. Treatment of BUD/FORM for milder patients with COPD and head to head comparison of Chinese and Caucasians in future studies will be helpful to expand upon the findings of the current clinical trial.
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Randomized Controlled Trial
Efficacy and safety of oral strontium ranelate for the treatment of knee osteoarthritis: rationale and design of randomised, double-blind, placebo-controlled trial.
The osteoporosis drug strontium ranelate dissociates bone remodelling processes. It also inhibits subchondral bone resorption and stimulates cartilage matrix formation in vitro. Exploratory studies in the osteoporosis trials report that strontium ranelate reduces biomarkers of cartilage degradation, and attenuates the progression and clinical symptoms of spinal osteoarthritis, suggesting symptom- and structure-modifying activity in osteoarthritis. We describe the rationale and design of a randomised trial evaluating the efficacy and safety of strontium ranelate in knee osteoarthritis. ⋯ This randomised, double blind, placebo-controlled study will establish the potential of strontium ranelate in improving structure and symptoms in patients with knee osteoarthritis.
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Despite limited empirical support, chronic pain has traditionally been defined mainly on the basis of its duration, which takes no account of the causative mechanisms or its clinical significance. ⋯ The implementation of a prognostic definition and wider adoption of integrated care could bring significant advantages. However, these measures require improved training in pain management and structural revision of specialist facilities, for which political support is essential.
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Placebo effects are well-known phenomena in medicine and biology. In fact, placebos are used as control conditions in randomized cross-over clinical trials to validate new treatments. ⋯ Frighteningly, this bias is always in the same direction, namely to increase the risk of rejecting potentially valid treatments. New models for clinical trials should be encouraged if we wish to market new and truly valid treatments.
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Previous studies have shown that long-term outcomes are more favorable for patients newly diagnosed with chronic myeloid leukemia (CML) if a complete cytogenetic response is achieved within ≤12 months of diagnosis. Because continuous and adequate dosing is important to achieve this outcome, it is important to understand treatment adherence as part of managing long-term CML therapy. While studies regarding imatinib suggest that adherence varies widely, data addressing adherence to newer breakpoint cluster region-Abelson (BCR-ABL) inhibitors (dasatinib and nilotinib) are sparse. This study evaluates real-world adherence in patients diagnosed with CML receiving dasatinib or nilotinib as second-line therapy. ⋯ While this study is limited by use of claims data to identify CML and adherence, claims based data have been widely used to evaluate the association between treatment use and clinical outcomes. When stratified by dose, patients receiving second-line nilotinib were almost two times more likely to have poor adherence compared with patients receiving second-line dasatinib at the current approved dose of 100 mg once daily.