RESUMO
In the age of evidence-based medicine, results from prospective controlled interventional studies are awarded the highest priority for determining the efficacy of a therapeutic measure. In contract, the role of non-controlled therapy-related observations is very low. This conception is due to the fact that in the absence of a control group it is impossible to assess a causal relationship between an administered therapy and the subsequent clinical outcome.Nevertheless, non-controlled therapeutic observations may be clinically relevant. Four domains may be distinguished : besides their importance for learning and teaching, such observations can contribute to evaluate which benefits results gained in controlled studies have in daily practice. On the other hand, they may point to hitherto unknown phenomena, such as the detection of new indications or unexpected therapeutic side effects. Finally, they may act as an important source for the generation of hypotheses about therapeutic measures, thus fostering further research.
Assuntos
Ensaios Clínicos como Assunto , Grupos Controle , Ensaios Clínicos Controlados como Assunto , HumanosRESUMO
BACKGROUND: Stringy, tenacious tracheal secretions may prevent extubation in patients weaned from the respirator. This prospective, randomized, double-blind, placebo-controlled study with parallel assignment was performed to assess the influence of sublingually administered potassium dichromate C30 on the amount of tenacious, stringy tracheal secretions in critically ill patients with a history of tobacco use and COPD. METHODS: In this study, 50 patients breathing spontaneously with continuous positive airway pressure were receiving either potassium dichromate C30 globules (group 1) [Deutsche Homoopathie-Union, Pharmaceutical Company; Karlsruhe, Germany] or placebo (group 2). Five globules were administered twice daily at intervals of 12 h. The amount of tracheal secretions on day 2 after the start of the study as well as the time for successful extubation and length of stay in the ICU were recorded. RESULTS: The amount of tracheal secretions was reduced significantly in group 1 (p < 0.0001). Extubation could be performed significantly earlier in group 1 (p < 0.0001). Similarly, length of stay was significantly shorter in group 1 (4.20 +/- 1.61 days vs 7.68 +/- 3.60 days, p < 0.0001 [mean +/- SD]). CONCLUSION: These data suggest that potentized (diluted and vigorously shaken) potassium dichromate may help to decrease the amount of stringy tracheal secretions in COPD patients.
