The STAF pilot study showed no differences between the two treatment strategies in all end points except hospitalizations. These data suggest that there was no benefit in attempting rhythm-control in these patients with a high risk of arrhythmia recurrence. It remains unclear whether the results in the rhythm-control group would have been better if sinus rhythm had been maintained in a higher proportion of patients, as all but one end point occurred during AF.
Acupuncture has gained increasing attention in the treatment of chronic pain. The lack of a satisfying placebo method has made it impossible to show whether needling is an important part of the method or whether the improvement felt by the patient is due to the therapeutic setting and psychological phenomena. Also, the effectiveness of acupuncture has not been demonstrated sufficiently. We treated 52 sportsmen with rotator cuff tendinitis in a randomised single-blind clinical trial using a new placebo-needle as control. Patients were treated for 4 weeks. The primary endpoint of the trial was the change in the modified Constant-Murley-score from the baseline. Assessment of the treatment outcome was made by experienced orthopaedists not informed of the treatment allocation. Acupuncture with penetration of the skin was shown to be more effective than a similar therapeutic setting with placebo needling in the treatment of pain. The acupuncture-group improved 19.2 Constant-Murley-score points (SD 16.1, range from -13 to 50), the control-group improved 8.37 points (SD 14.56, range from -20 to 41), (P=0.014; C.I. 2.3;19.4). This study showed that needling is an important part of the acupuncture effect in the treatment of chronic shoulder pain in athletes. No conclusions can be derived from this study concerning the importance of choosing points and the rules of Traditional Chinese Medicine. Using the new placebo method as control for other ailments could improve the evidence of specific acupuncture effects beyond pain treatment.
Since it came up in the 1960s, the principle of intention-to-treat (ITT) has become widely accepted for the analysis of controlled clinical trials. In this context the question of how to perform such an analysis in the presence of missing information about the main endpoint is of major importance. Uncritical use of several ad hoc strategies for dealing with missing values is common in the practice of clinical trials. On the other hand, little is known about possible dangers and problems of applying these strategies. We therefore performed a detailed investigation of different methods for dealing with missing values in order to develop recommendations for their practical use. A simulation study was performed investigating possible consequences on type I error and power of applying different methods for dealing with missing values. The simulations were based on a clinical trial of osteoporosis, a progressively deteriorating disease. The strategies examined can be roughly classified into numerical imputation strategies (last observation carried forward, mean and regression based methods) and non-parametric strategies (rank and dichotomization based methods). Different drop-out mechanisms and different types of progression of disease are considered. The type I error increases drastically for the different strategies, especially if the courses of disease vary between treatment groups. The loss in power can be substantial. There is no strategy which is adequate for all different combinations of drop-out mechanisms, drop-out rates and courses of disease over time. For drop-out rates less than 20 per cent and similar courses of disease in the treatment groups, missing values might be replaced by the mean of the other group, or counted as treatment failures after dichotomization of the endpoint. For larger drop-out rates or less similar courses of disease, no adequate recommendations can be given. Because of the drastic consequences of increasing drop-out rates, it has to be a primary goal in clinical trials to keep missing values to a minimum. Unobserved information cannot be reliably regained by any methodological resources. As there are no strategies for universal use, reasons for the choice of a certain method have to be provided when designing and analysing clinical trials.
Aims-To compare treatment regimens of two widely used natural surfactant preparations Curosurf and Survanta in respiratory distress syndrome (RDS). Methods-The effects of the two treatment regimens on gas exchange, ventilatory requirements, and 28 day outcome in infants with RDS were compared. Seventy five preterm infants (birth weight 700-1500 g) with RDS requiring artificial ventilation with an FIO2 of :0 4, were randomly selected at 1-24 hours of age. One group received an initial dose of Curosurf (200 mg/kg); the other group Survanta (100 mg/kg). Patients who remained dependent on artificial ventilation with an FIO2 of B0*3 received up to two additional doses of Curosurf (each of 100 mg/g) after 12 and 24 hours or up to three additional doses of Survanta (each of 100 mg/kg) between six and 48 hours after the initial dose. Results-There was a rapid improvement in oxygenation and ventilatory requirements were reduced in both groups. However, infants treated with Curosurf had a higher arterial:alveolar oxygen tension ratio and required a lower peak inspiratory pressure and mean airway pressure at several time points within 24 hours of randomisation (p<0.05-0.001).The incidences of pneumothorax in the Curosurf and Survanta groups were 6% and 12-5%S respectively; the corresponding figures for grades 3-4 intracerebral haemorrhage were 30/0 and 12/5%o respectively. Mortality was 30/0 in the Curosurf group and 12-5% in the Survanta group. However, these differences did not reach significance.Conclusion-The Curosurf treatment regimen resulted in a more rapid improvement in oxygenation than Survanta and reduced ventilatory requirements up to 24 hours after start of treatment. This was associated with a trend towards reduced incidence of serious pulmonary and nonpulmonary complications. (Arch Dis Child 1995; 72: F8-F13)
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