[Infusion therapy in sudden deafness. Reducing the risk of pruritus after hydroxyethyl starch and maintaining therapeutic success--a prospective randomized study].

A Prospective Randomized Study: The aim of the study was to demonstrate the effectiveness of two different treatment schemes with hydroxyethyl starch (HES) and the incidence of pruritus as a side effect in a population of patients with sudden sensorineural hearing loss and hematocrit values above 44% and/or hemoglobin values above 14 g/dl. Under these circumstances we found a significant hearing improvement with infusions of 500 ml 10% HES 200/0.5 compared to saline infusions in a previous double-blind placebo-controlled study. Two groups are compared in a prospective randomized study. Group 1 was treated with infusions of 250 ml 10% HES 200/0.5 and group 2 with 500 ml of the same substance (n = 200). No difference in hearing improvement was detected between the two groups. The results were significantly better than with saline infusions. Eleven percent of the patients in group 1 developed pruritus and 38% in group 2. The incidence of pruritus correlated with the cumulative dosage of HES given. A correlation between allergic disposition and pruritus could not be found. Therefore, we suggest infusions with 250 ml 10% HES 200/0.5 per day for patients with sudden sensorineural hearing loss and hematocrit values above 44% and/or hemoglobin values above 14 g/dl. Indications for a long lasting HES-therapy should be restrictive. The effectiveness of HES has not been yet demonstrated in patients with lower hemoglobin and hematocrit values.

RCT Entities:   Population Interventions Outcomes