Behaviour therapy for obesity treatment considering approved drug therapy, HTA

Hintergrund: Adipositas und Übergewicht sind Risikofaktoren für viele Erkrankungen, die für einen hohen Kostenanteil im Gesundheitswesen verantwortlich sind. Verhaltenstherapie, unter Umständen auch mit zusätzlicher medikamentöser Behandlung, die bei Patienten mit Übergewicht oder Adipositas eingesetzt wird, kann eine langfristige Änderung der Ernährungs- und Bewegungsgewohnheiten erreichen und somit adipositasassoziierten Erkrankungen vorbeugen.Um die Effektivität der Verhaltenstherapie bei Adipositas zu bewerten, wurde im Jahr 2008 ein Health Technology Assessment (HTA) im Auftrag des Deutschen Instituts für medizinische Dokumentation und Information durchgeführt. Die vorliegende Arbeit bewertet die aktuelle Studienlage. Methode: Nach Durchführung einer systematischen Literaturrecherche wurden die identifizierten Literaturstellen gemäß vorab definierten Einschlusskriterien ausgewählt und nach anerkannten methodischen Standards der evidenzbasierten Medizin und Gesundheitsökonomie beurteilt. Ergebnisse: Es wurden neun randomisierte kontrollierte Studien und zwei Studien zur Kosteneffektivität bewertet. Alle Studien hatten zum Ziel, die Wirksamkeit von Verhaltenstherapie gegenüber keiner oder geringfügiger Intervention (Empfehlungen) zur untersuchen, allerdings mit unterschiedlichen Methoden. Eingesetzt wurden face-to face Interventionen oder Interventionen mittels Medien (Telefon, Internetplattformen oder Monitoring-Armband). Im Vergleich von Interventions- und Kontrollgruppen konnte eine moderate Reduktion des Gewichts zwischen 1,1 kg (Monat 4) und 6,6 kg (Monat 9) mit statistisch signifikanten Unterschieden nachgewiesen werden. Langzeituntersuchungen (Monat 12 bis 24) ergaben dagegen keine belegbare Überlegenheit der Verhaltenstherapie. Die aktuelle Studienlage zeigt im Vergleich zu den Ergebnissen des HTA aus 2008 eine geringere Effektivität von Verhaltenstherapie bei Adipositas und Übergewicht. , allerdings konnten im Update aufgrund der Veränderungen der Arzneimittelzulassungen in dieser Indikation keine Studien mehr identifiziert werden, die eine zusätzliche medikamentöse Behandlung bewerten. Die Kosteneffektivität wird durch die nun identifizierten Studien zwar belegt, die Ergebnisse sind jedoch in ihrer Aussagekraft durch eine hohe Drop-out Rate stark limitiert. Zusammenfassung: Verhaltenstherapie zeigt unter Berücksichtigung der aktuellen Studienlage eine moderate Effektivität bezüglich der Gewichtsreduktion, allerdings nicht in Langzeituntersuchungen

Systematic review on inhaled corticosteroid monotherapy and its efficacy and safety in longterm treatment of patients with chronic obstructive pulmonary disease (COPD)

--chronic obstructive pulmonary disease,COPD,corticosteroids,systematic review,chronisch obstruktive Lungenerkrankung,COPD,Kortikosteroid,systematischer Review

Antioxidative vitamines for prevention of cardiovascular disease for patients after renal transplantation and patients with chronic renal failure

Introduction: The mortality from cardiovascular disease in patients with chronic renal failure is much higher than in the general population. In particular, patients with chronic renal failure with replacement therapies (dialysis patients and patients with renal transplantation) show both increased traditional risk factors and risk factors due to the dysfunction of the renal system. In combination with necessary medication for renal insufficiency oxidative stress is elevated. Progression of atherosclerosis is promoted due to increased oxidation of lipids and endothelium damage. This link between lipid oxidation and artherogenesis provides the rationale for the supposed beneficial effect of supplementation with antioxidative vitamins (vitamin A, C and E). Such an effect could not be demonstrated for patients with a history of cardiovascular disease and without kidney diseases. However, in high risk patients with chronic renal failure and renal replacement therapies this could be different. Objectives: The objective of this systematic literature review was to assess the clinical effectiveness and cost-effectiveness of supplementation with antioxidative vitamins A, C or E to reduce cardiovascular events in patients with chronic kidney diseases, dialysis-requiring patients and patients after a renal transplantation with or without cardiovascular diseases. Methods: A systematic literature review was conducted with documented search and selection of the literature, using a priori defined inclusion and exclusion criteria as well as a documented extraction and assessment of the literature according to the methods of evidence-based medicine. Results: 21 publications met the inclusion criteria for the evaluation of clinical effectiveness. No study could be identified for the economic evaluation. Two studies (four publications) analysed the effect of oral supplementation on the secondary prevention of clinical cardiovascular endpoints. Studies analysing the effect on patients without a history of cardiovascular disease could not be identified. 17 studies analysed the effect of oral supplementation or infusion with antioxidative vitamins or the supplementation with dialysis membranes coated with vitamin E on intermediate outcomes like oxidative stress or vessel parameters. The two randomized clinical trials analysing the effect of orally supplemented vitamin E on clinical endpoints in patients with mild-to-moderate renal insufficiency and for haemodialysis patients respectively reported different results. After 4.5 years supplementation with a daily dose of 400 IU vitamin E renal insufficiency patients showed neither a beneficial nor a harmful effect on a combined event rate of myocardial infarction, stroke or death by cardiovascular causes. The second study reported a 50% risk reduction (RR=0.46, 95%-KI: 0.27-0.78, p=0.014) on the combined event rate of fatal myocardial infarction, nonfatal myocardial infarction, stroke, peripheral vascular disease or unstable angina pectoris in the study arm with vitamin E-Supplementation of 800 IU daily. In 16 of 17 studies with intermediate endpoints the supplementation with vitamins was associated with a change of one or several of the examined endpoints in the expected direction. This means that the concentrations of the markers for oxidative stress decreased in the Vitamin E-group, the progression of aortic calcification (only one study) was reduced, the intima media thickness decreased and the lipid profile improved. No studies regarding costs or cost-effectiveness were identified. Discussion: A possible explanation for the different results in the two studies with clinical endpoints may be due to the different study populations with different risk profiles, to different dosage during the intervention or to variation by chance. Due to the absence of clinically meaningful endpoints, the relevance of studies analysing the effect of antioxidative vitamins on intermediate endpoints like oxidative stress markers is basically limited to show single intermediate steps of the postulated biological effect mechanisms by which a potentially preventive effect could possibly be mediated. The mainly unsatisfactory planning and reporting quality of the 17 identified studies and a possible "publication bias" are further limitations. Conclusion: The available evidence is not sufficient to support or to reject an effect of antioxidative vitamins on secondary prevention for cardiovascular disease for patients with chronic renal insufficiency or renal replacement therapy. There is a lack of randomized, placebo-controlled studies with a sufficient number of cases and clinical endpoints of cardiovascular disease, on the effect of antioxidative vitamins either orally applied or given by vitamin E-modified dialysers.No data are available about supplementation with antioxidative vitamins for primary prevention of cardiovascular disease. Therefore the current evidence does not allow to draw conclusions concerning this subject either. As opposed to patients with a history of cardiovascular disease without kidney diseases where there is enough evidence to exclude a beneficial effect on secondary prevention of cardiovascular disease for patients with chronic renal insufficiency and renal replacement therapy this question remains unanswered. Conclusions about costs and cost-effectiveness also cannot be drawn