International journal of clinical practice
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Int. J. Clin. Pract. · Sep 2008
Randomized Controlled Trial Multicenter Study Comparative StudyPostprandial blood glucose response to a standard test meal in insulin-requiring patients with diabetes treated with insulin lispro mix 50 or human insulin mix 50.
To compare the 2-h postprandial blood glucose (PPBG) excursion following a standard test meal in insulin-requiring patients with diabetes treated twice daily with human insulin mix 50 vs. insulin lispro mix 50 (LM50). ⋯ Insulin lispro mix 50 provided better postprandial glycaemic control compared with human insulin mix 50 while providing the convenience of injecting immediately before meals. Both treatments were generally well tolerated by all randomly assigned patients.
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Int. J. Clin. Pract. · Aug 2008
Randomized Controlled Trial Multicenter StudyPatient assessment of a novel therapeutic approach for the treatment of severe, chronic pain.
Opioid-induced constipation can have a major negative impact on patients' quality of life. This randomised clinical trial evaluated patient assessment of the efficacy and tolerability of oral prolonged-release (PR) oxycodone when co-administered with oral naloxone PR. ⋯ The co-administration of oral naloxone PR with oxycodone PR improves patient assessment of analgesic opioid therapy for severe chronic pain, in terms of both efficacy and tolerability.
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Int. J. Clin. Pract. · Aug 2008
Randomized Controlled TrialThe impact of analytic method on interpretation of outcomes in longitudinal clinical trials.
Various analytical strategies for addressing missing data in clinical trials are utilised in reporting study results. The most commonly used analytical methods include the last observation carried forward (LOCF), observed case (OC) and the mixed model for repeated measures (MMRM). Each method requires certain assumptions regarding the characteristics of the missing data. If the assumptions for any particular method are not valid, results from that method can be biased. Results based on these different analytical methods can, therefore, be inconsistent, thereby making interpretation of clinical study results confusing. In this investigation, we compare results from MMRM, LOCF and OC in order to illustrate the potential biases and problems in interpretation. ⋯ Inferences are based on between-group comparisons. Therefore, whether or not underestimating (overestimating) within-group changes was conservative or anticonservative depended on the relative magnitude of the bias in each treatment and on whether within-group changes represented improvement or worsening. Preference should be given in analytic plans to methods whose assumptions are more likely to be valid rather than relying on a method based on the hope that its results, if biased, will be conservative.
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Int. J. Clin. Pract. · Jun 2008
Randomized Controlled Trial Comparative StudyHead-to-head comparison of risedronate vs. teriparatide on bone turnover markers in women with postmenopausal osteoporosis: a randomised trial.
We aimed to compare the effect of risedronate (RIS) and teriparatide (TPTD) (recombinant human parathyroid hormone 1-34) on bone turnover markers in women with postmenopausal osteoporosis. ⋯ Our data suggest that both serum P1NP and CTx are reliable markers of RIS and TPTD action in women with postmenopausal osteoporosis. In a similar way, serum total ALP can be used as an alternative marker for monitoring both RIS and TPTD action, while iPTH can be used only for TPTD-treated women. The increase in P1NP and CTx after 3 months of treatment with RIS or TPTD can predict the increase in BMD after 12 months of treatment.
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Int. J. Clin. Pract. · May 2008
Randomized Controlled Trial Comparative StudyPatient-controlled sedation vs. anaesthetic nurse-controlled sedation for cataract surgery in elderly patients.
Patient-controlled sedation (PCS) with propofol has been used successfully in various conditions, but controversies exist about its use in sedation of elderly patients for cataract surgery. This study evaluates the efficacy of anaesthetic nurse-controlled sedation (ACS) compared with PCS using the same device and the drug. ⋯ Both ACS and PCS using propofol provided reduced anxiety compared with control, but patient's satisfaction was higher in the PCS group compared with ACS group.