The Netherlands journal of medicine
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Randomized Controlled Trial
Fendrix® compared to Engerix® in HIV-infected patients nonresponding to initial- and re-vaccination schedule.
In HIV-infected patients, the immunogenicity of hepatitis B vaccines is impaired. In this randomised controlled study (RCT), we investigated the effect of Fendrix® versus double-dose Engerix® vaccination in previously non-responsive HIV-infected subjects. ⋯ These results together, suggest that continuing HBV vaccination in non-responders to a first course of single-dose vaccine and a double-dose revaccination scheme is worth the effort. No superiority of one of the investigated hepatitis B vaccines was shown in this cohort but an appropriate number of patients needed to achieve reliable answers was not achieved.
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Randomized Controlled Trial
A cost-controlling treatment strategy of adding liraglutide to insulin in type 2 diabetes.
Addition of the GLP-1 receptor agonist liraglutide to insulin can reverse insulin-associated weight gain, improve HbA1c and decrease the need for insulin, but is expensive. From a cost perspective, such treatment should be discontinued when it is clear that treatment targets will not be achieved. Our aim was to find the best cost-controlling treatment strategy: the shortest possible trial period needed to discriminate successfully treated patients from those failing to achieve predefined targets of treatment success. ⋯ An 8-week trial period of adding liraglutide to insulin in patients with insulin-associated weight gain is an effective cost-controlling treatment strategy if the liraglutide is discontinued in patients not showing an early response regarding weight loss or insulin reduction.
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Randomized Controlled Trial Multicenter Study
Antibiotic treatment of moderate-severe community-acquired pneumonia: design and rationale of a multicentre cluster-randomised cross-over trial.
For the empirical treatment of community-acquired pneumonia requiring admission to a non-ICU ward, the Dutch guidelines recommend either beta-lactam monotherapy, beta-lactam and macrolide combination therapy, or fluoroquinolone monotherapy. The lack of convincing evidence to preferentially recommend any of the three empiric regimens results from intrinsic limitations of current studies, such as bias by indication and residual confounding in observational studies, and the unknown effects of pre-randomisation antibiotic use in randomised controlled trials. In this paper we discuss the methodological drawbacks of observational cohorts and randomised controlled trials in antibiotic therapy. Next, we explain why we designed a multicentre cluster-randomised cross-over study to evaluate the effectiveness of three antibiotic treatment strategies, consisting of a preferred treatment regimen of beta-lactam monotherapy, beta-lactam and macrolide combination therapy or fluoroquinolone monotherapy, in adult patients admitted to a non-ICU ward with a clinical diagnosis of community-acquired pneumonia. Furthermore we outline different aspects of this design that deserve thorough consideration. ⋯ We discuss different aspects of a cluster-randomised cross-over trial that is designed to determine the effects of three recommended regimens of antibiotic treatment of CAP.
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Randomized Controlled Trial Multicenter Study
Maintenance treatment with budesonide 6 mg versus 9 mg once daily in patients with Crohn's disease in remission.
In previous trials, budesonide 6 mg/day was able to prolong the time to relapse in patients with quiescent Crohn's disease and budesonide 9 mg/day was effective in active disease with limited side effects. The aim of this study was to compare the effectiveness of budesonide 9 mg vs 6 mg once daily on the maintenance of remission and occurrence of adverse events. ⋯ The one-year relapse rates were low and not significantly different between the group of patients treated with budesonide 6 mg vs 9 mg/day. Also, time to relapse and the number of adverse events were similar in both treatment groups.
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Letter Randomized Controlled Trial Clinical Trial
Diuretic therapy in Afrocaribbeans with uncomplicated essential hypertension.