VEST Lowers Duration of Painful SCD Crises
Vascular electrical stimulation therapy (VEST), a form of local electrical stimulation applied to the skin, can lower the duration of painful vaso-occlusive crises (VOCs) in patients with sickle cell disease (SCD), according to data from a Phase 2 clinical trial.
Based on these findings, study investigators argue that VEST might be a useful alternative to manage VOCs in these patients and ought to be tested in future larger studies.
Trial findings were reported in the study, “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,” published in the journal Advances in Hematology.
VOCs are one of the most severe complications of SCD and are the main cause of hospital admissions among patients with this inherited blood disorder. Such painful crises are caused by the obstruction of small blood vessels, leading to oxygen shortage and tissue damage.
Conventional treatments for VOCs include the use of opioids for pain relief and nonsteroidal anti-inflammatory drugs (NSAIDs) to reduce tissue inflammation. However, both treatments can have several unwanted side effects, which has prompted researchers to look for alternative options to manage these crises.
VEST is a form of local electrical stimulation that has been investigated as a potential preventive treatment for blood clotting events, due to its ability to promote blood vessel relaxation and increase blood flow. The therapy uses electrodes that are placed on a patient’s skin to deliver a small electrical current generated by a medical device.
“The question arises as to whether vascular electrical stimulation therapy (VEST) could be effective or not on VOCs,” the researchers wrote.
Here, investigators reported the findings of a Phase 2 trial that assessed the safety and effectiveness of VEST at reducing the duration of severe VOCs in SCD patients.
The five-month study was conducted at a single site on the Ivory Coast, Africa, a country with one of the highest SCD incidence rates worldwide. It enrolled 30 patients (23 women and seven men), ages 14–37, with severe VOCs, who were divided randomly into three groups of 10 people each.
Severe crises were defined as those causing patients to achieve a minimum pain level of 6 in a 0–10 pain scale, and that lasted more than four hours despite analgesic treatment.
Patients assigned to the control group received conventional treatment for their VOCs, which consisted of a combination of NSAIDs, pain killers, and hydration. The remaining 20 patients received VEST in combination with pain killers and hydration, with or without NSAIDs.
The study’s main goal was to assess the effects of treatment on the median time to severe VOCs elimination, meaning the time it took for patients’ pain levels to drop below a 2 in a 0–10 pain scale. Additional measures included safety, as well as the median time to end-of-crisis, and tramadol use.
Compared with patients on conventional treatment, those who received VEST spent less time in severe pain, the researchers found.
According to study findings, less than 25% of patients on the VEST groups required more than 10 hours of treatment to see their pain levels drop below the defined threshold. In contrast, approximately 25% of those receiving conventional treatment required 30 hours of treatment to achieve the same outcome.
These beneficial effects seemed to be stronger in the group of patients where VEST was given in combination with NSAIDs. In this group, all patients ceased to experience severe pain within less than 20 hours of treatment. Conversely, more than 65 hours of conventional treatment were needed for all 10 patients in the control group to see their pain levels drop below the defined threshold.
VOCs also lasted longer in patients receiving standard treatment (maximum of 120 hours) than in those who were treated with VEST (maximum of 54 hours) or without NSAIDs (maximum of 42 hours).
Median tramadol consumption also was lower in patients in the VEST groups, compared with those receiving conventional VOC treatment (2.5–3 vs. 5).
Apart from one patient who experienced a mild unusual tingling sensation in the legs shortly after VEST, no other treatment side effects were observed.
“This study demonstrated a significant and clinically important reduction in time spent in severe crisis when patients received VEST and non-NSAID analgesics alone or in combination with NSAIDs compared with the current standard of care,” the researchers wrote.
According to investigators, these promising findings support the launch of larger studies investigating the therapeutic potential of VEST as an alternative treatment to manage VOCs in SCD patients. A Phase 3 trial (PACTR201907740118144) assessing VEST’s effectiveness at reducing VOCs duration in adolescents and adults with SCD is already underway.