Efficacy and Tolerance of Vascular Electrical Stimulation Therapy in the Management of Vaso-Occlusive Crises in Patients with Sickle Cell Disease: A Phase II Single-Centre Randomized Study in Ivory Coast.
Renée-Paule Botti, Sie Saïda Bokoum, Etienne L'Hermite, Dohoma Alexis Silue, Boidy Kouakou, Sarah Anastasie Bognini, Serge Arnaud Agoua, Edgar Mandeng Ma Linwa, Roméo Ayemou, Kouassi Gustave Koffi
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Abstract
Background: Vaso-occlusive crisis (VOC) is the primary cause of hospitalization in patients with sickle cell disease. Treatment mainly consists of intravenous morphine or nonsteroidal anti-inflammatory drugs (NSAIDs), which have many dose-related side effects. The question arises as to whether vascular electrical stimulation therapy (VEST) could be effective or not on VOCs.
Objective: To measure the effectiveness and safety of VEST in reducing the median time spent in severe VOC.
Methods: We conducted a phase II, single blinded, randomized, controlled, triple-arm, comparative trial. We included thirty (30) adult patients with severe vaso-occlusive crisis. The study arms were divided as follows: our control group (group 0) constituted of 10 patients followed with conventional therapy (Analgesics + Hydration + NSAIDs), while 20 patients were divided equally into two interventional arms-10 patients followed with VEST + Analgesics + Hydration (group 1) and the other 10 patients followed with VEST + Analgesics + Hydration + NSAIDs (group 2). The primary efficacy endpoint was median time to severe crisis elimination. The secondary end points were median time to end-of-crisis, median tramadol consumption, progress of the haemoglobin level over 3 days, side effects, and treatment failure.
Results: The age ranged from 14 to 37 years, including 23 women. We noted a beneficial influence of the VEST on the median time to severe crisis (VAS greater than 2) elimination; 17 hours (group 1) against 3.5 hours (group 2) p=0.0166 and 4 hours (group 3) with p value = 0.0448. Similar significant results were obtained on the diminution of total duration of the crisis (VAS over 0) and median tramadol consumption in patients in the interventional arms.
Conclusion: These statistically significant results in the interventional arms suggest that VEST could be an alternative treatment of VOC in sickle cell patients.
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