@article{fdi:010049527, title = {{M}ethodology of clinical studies dealing with the treatment of envenomation}, author = {{C}hippaux, {J}ean-{P}hilippe and {S}tock, {R}. {P}. and {M}assougbodji, {A}.}, editor = {}, language = {{ENG}}, abstract = {{A} total of 142 clinical studies have been devoted to the treatment of envenomations, of which 115 address snake bites, 20 scorpion stings, and 8 other animals (one addresses both snake and spider envenomation). {A}ntivenom use was studied in 118, of which 82 addressed efficacy, 43 evaluated safety, 23 studied dosage and 8 explored other issues. {B}esides anecdotal clinical reports, three classes of clinical studies are distinguished: (a) observational clinical studies (55 of the total) which analyze series of cases, (b) comparative clinical studies (36) which compare therapeutic products or treatment regimens without a gold standard for comparison and (c) randomized clinical trials ({RCT}, 51). {T}he goals, methods and constraints of design of {RCT} are determined by whether explanatory (analytical) or pragmatic considerations are prioritized. {E}xplanation-oriented {RCT} rely on strict group comparability before and during treatment, in order to ensure the internal validity of the study. {T}he pragmatically-oriented {RCT} aims at establishing the superiority of a treatment over another, the goal being to maximize the external validity of the trial (that is, its application in current practice). {W}e found that all clinical studies of treatment of envenomation lean markedly toward the explanatory end and suggest that, given some particularities of envenomation as a medical condition, a more pragmatic approach may be of value, particularly under the conditions prevalent for clinical studies in developing nations.}, keywords = {{E}nvenomations ; {T}reatment ; {C}linical studies ; {C}linical trial ; {M}ethodology}, booktitle = {}, journal = {{T}oxicon}, volume = {55}, numero = {7}, pages = {1195--1212}, ISSN = {0041-0101}, year = {2010}, DOI = {10.1016/j.toxicon.2010.02.022}, URL = {https://www.documentation.ird.fr/hor/fdi:010049527}, }