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.

Highlights

  • Sickle cell disease is the most common genetic haemoglobin disorder and most commonly affects individuals of African descent [1]

  • Patients were eligible for inclusion if they had sickle cell disease type SS, SC, Sβ0, or Sβ+ documented by genotypic tests, were at least 14 years old, presented with vaso-occlusive crises (VOCs), and had a score of pain of at least 6 on the visual analogue scale (VAS) that had been progressing for more than 4 hours under analgesics and could not be attributed to another cause

  • Discussion is phase II prospective, single-centre, study evaluated the efficacy of vascular electrical stimulation therapy (VEST) in reducing the average time to severe crisis elimination, i.e., the time spent by patients in crisis with a pain score greater than 2 on the VAS, compared with the current standard of care

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Summary

Introduction

Sickle cell disease is the most common genetic haemoglobin disorder and most commonly affects individuals of African descent [1]. Sickle cell disease or sickle cell anaemia is an autosomal recessive genetic disease involving the inheritance of abnormal haemoglobin. It is a point mutation of haemoglobin in which the glutamic acid in position 6 on the β chain is replaced by valine. One of the severe symptomatic manifestations of sickle cell disease is the occurrence of very intense and painful vaso-occlusive crises (VOCs), which are sometimes resistant to usual analgesics. Vaso-occlusive crisis (VOC) is the primary cause of hospitalization in patients with sickle cell disease. We included thirty (30) adult patients with severe vaso-occlusive crisis. e 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 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). e primary efficacy endpoint was median time to severe crisis elimination

Methods
Results
Conclusion

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