Differences between the real and the desired worlds in the results of clinical trials

OBJECTIVE:We refer to the effectiveness (known as pragmatic or real world) and efficacy (known as explanatory or desired or ideal world) of interventions. However, these terms seem to be randomly chosen by investigators who design clinical trials and do not always reflect the true purpose of the study. A pragmatic-explanatory continuum indicator summary tool was thus developed with the aim of identifying the characteristics of clinical trials that distinguish between effectiveness and efficacy issues. We verified whether clinical trials used the criteria proposed by the indicator summary tool, and we categorized these clinical trials according to a new classification.METHOD:A systematic survey of randomized clinical trials was performed. We added a score ranging from 0 (more efficacious) to 10 (more effective) to each domain of the indicator summary tool and proposed the following classifications: high efficacy

More resistant tendons obtained from the association of Heteropterys aphrodisiaca and endurance training

<p>Abstract</p> <p>Background</p> <p>Popular Brazilian medicine uses <it>Heteropterys aphrodisiaca </it>infusion as a tonic or stimulant, for the treatment of nervous debility and breakdown and for muscle and bone weakness. This study investigated the effects of <it>Heteropterys aphrodisiaca </it>infusion on the tendon properties and extracellular matrix of rats under endurance training.</p> <p>Methods</p> <p>Wistar rats were grouped as follows: CS- control sedentary, HS- <it>H. aphrodisiaca </it>sedentary, CT-control trained, HT- <it>H. aphrodisiaca </it>trained. The training protocol consisted in running on a motorized treadmill, five times a week, with weekly increase in treadmill speed and duration. Control groups received water while the HS and HT groups received <it>H. aphrodisiaca </it>infusion, daily, by gavage for the 8 weeks of training. Achilles tendons were frozen for biochemical and biomechanical analysis or preserved in Karnovsky's fixative, then processed for histomorphological analysis with light microscopy.</p> <p>Results</p> <p>Biomechanical analysis showed significant increase in maximum load, maximum stress, modulus of elasticity and stiffness of the HT animals' tendons. The metalloproteinase-2 activity was reduced in the HT group. The compression region of HT animals' tendons had a stronger and more intense metachromasy, which suggests an increase in glycosaminoglycan concentration in this region of the tendon. The most intense birefringence was observed in both compression and tension regions of HT animals' tendons, which may indicate a higher organizational level of collagen bundles. The hydroxyproline content increased in the HT group.</p> <p>Conclusions</p> <p>The association of endurance training with <it>H. aphrodisiaca </it>resulted in more organized collagen bundles and more resistant tendons to support higher loads from intense muscle contraction. Despite the clear anabolic effects of <it>Heteropterys aphrodisiaca </it>and the endurance exercise association, no side effects were observed, such as those found for synthetic anabolic androgenic steroids.</p