Background: Upper respiratory tract infections (URTI) are very common and associated with considerable healthcare costs. We evaluated the clinical benefit of a homeopathic add-on therapy. Patients and Methods: In this randomized controlled multinational clinical trial, patients (age range 1-65 years) with feverish URTI received either on-demand symptomatic standard treatment (ST group: paracetamol, ambroxol, and/or oxymetazoline), or homeopathic medication (IFC group: Influcid®) for 7 days plus the same on-demand standard treatment. URTI symptoms were assessed using the Wisconsin Upper Respiratory Symptom Survey-21. Response at day 4, defined as absence of fever and absence or very mild degree of URTI symptoms, was the primary outcome measure. Results: 523 patients (265 IFC group, 258 ST group) were randomized in 12 Ukrainian and 10 German centers. The responder rate on day 4 was 15.4% in the IFC group and 6.7% in the ST group (ΔIFC-ST = 8.7%, 95% confidence interval 2.9-14.5%). The IFC group used less symptomatic medication, and symptoms were alleviated 1-2 days earlier. 3 and 8 adverse events (AEs) in the IFC and ST group, respectively, were assessed as possibly treatment-related; 2 out of the 3 AEs in the IFC group were possibly related to symptomatic therapy, 1 (vomiting) to IFC treatment. Conclusion: The homeopathic treatment shortened URTI duration, reduced the use of symptomatic medication, and was well tolerated.
The course of type 1 diabetes in children can be complicated by cardiovascular disorders in the form of life-threatening arrhythmias, especially in patients with congenital long QT syndrome (LQTS). It remains relevant to determine the risk groups for developing such complications, to search for convenient diagnostic algorithms and subsequent management tactics for children with type 1 diabetes mellitus (T1DM) who have acquired and congenital long LQTS. Study purpose is to determine the risk groups for the development of cardiovascular complications of type 1 diabetes mellitus in children, by the QT and corrected (QTc) interval ranges. Materials and methods. The examination involved 53 children with type 1 diabetes, who were divided into 2 groups depending on the duration of the disease. To determine the parameters relevant for the study, the bioelectrical activity of the heart was assessed by ECG and Holter ECG monitoring. For additional assessment of the patients' condition over a long period of time, they were offered to keep a diary with monitoring of parameters important for the study. Statistical processing of the research results was carried out with the SPSS 22.0 program. Results and conclusions. Changes in the duration of the QTc interval and its variance have been proved depending on the duration of the disease and influence of the glycemia level plus insulin therapy on the value of these indicators. For children with newly diagnosed type 1 diabetes, an algorithm has been developed to identify risk groups for the development of cardiovascular complications associated with LQTS, which makes it possible to determine three risk groups and the tactics of their further management. According to the authors, the main goal of reducing the risk of developing cardiovascular complications in the form of ventricular arrhythmias (which can lead to sudden death syndrome) is the timely diagnosis of long QT interval syndrome. Recognition of congenital LQTS is important, since unstable glycemic levels and the appointment of insulin therapy can significantly worsen the child's condition. For children with newly diagnosed type 1 diabetes mellitus before the appointment of insulin therapy, the authors propose their own algorithm for identifying risk groups for the development of cardiovascular complications associated with long QT interval syndrome and tactics for their further management. The research was carried out in accordance with the principles of the Helsinki Declaration. The study protocol was approved by the Local Ethics Committee of these Institutes. The informed consent of the patient was obtained for conducting the studies. No conflict of interest was declared by the authors. Key words: type 1 diabetes, long QT syndrome, patient management algorithm.
Background : Complex homeopathic medications are an opportunity to introduce homeopathy in countries without homeopathic tradition and in cases where daily routine doesn't allow homeopathic repertorisation for an individual therapy. We set out a clinical trial to investigate the effectiveness and safety of the complex homeopathic medication Influcid? as add-on therapy to usual care in patients suffering from upper respiratory tract infections (URTI), the most frequently occurring illness in the world with great impact on health economics in terms of missing days at work. Methods : Between Nov 2010 and Apr 2011 we conducted a randomised, controlled clinical trial in Germany and Ukraine. Patients aged 1?65 years with URTI were included. To all patients standard symptomatic medication (Paracetamol, Ambroxol and/or Oxymetazoline) was offered on demand depending on their symptoms. The test group received additionally Influcid (active ingredients: Aconitum D3, Bryonia D2, Eupatorium perfoliatum D1, Gelsemium D3, Ipecacuanha D3, Phosphorus D5) for seven days. The Wisconsin Upper Respiratory Symptom Survey (WURSS-21) was used to assess URTI symptoms. Primary outcome measure was the response at day 4, defined as the absence of fever and the absence or very mild degree of URTI-symptoms. Results : 523 patients (265 test and 258 control group) were randomised in 22 centres. Response at day 4 differed highly significantly in favour of the Influcid-group (15.4% vs. 6.7%, ? 8.7%; 95%-CI: 2.9?14.5%; p = 0.0018; Chi2-Test). Dosage and duration of symptomatic treatment was significantly lower and symptoms alleviated 1?2 days earlier in the Influcid group. Eleven adverse events were classified as probably or possibly treatment related: one adverse event was possibly related to Influcid (vomiting) and ten to the symptomatic therapy. Conclusion : The study data suggest Influcid as a therapeutic option in the treatment of URTI as it effectively reduced URTI symptoms and the need for conventional symptomatic treatment and was well tolerated.
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