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. 2021 Feb 4:2021:1373754.
doi: 10.1155/2021/1373754. eCollection 2021.

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  1 , Sie Saïda Bokoum  1 , Etienne L'Hermite  2 , Dohoma Alexis Silue  1 , Boidy Kouakou  1 , Sarah Anastasie Bognini  1 , Serge Arnaud Agoua  1 , Edgar Mandeng Ma Linwa  3 , Roméo Ayemou  1 , Kouassi Gustave Koffi  1
Affiliations

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 et al. Adv Hematol. .

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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Conflict of interest statement

The authors declare that they have no conflicts of interest.

Figures

Figure 1
Figure 1
Severe crisis elimination time (VAS >2) by treatment (Cox test survival curve equality).
Figure 2
Figure 2
Time to end-of-crisis (tEC) by group of patients (Cox test survival curve equality).
See this image and copyright information in PMC

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