Percutaneous Electrical Neurostimulation (PENS) of Dermatome T6 with an Ambulatory Self-applied Patch vs PENS of Dermatome T6 with Conventional Procedure: Effect on Appetite and Weight Loss in Moderately Obese Patients.

BACKGROUND: The percutaneous electrical neurostimulation (PENS) of dermatome T6 has emerged as an effective treatment for appetite reduction and weight loss, allowing a better compliance of hypocaloric diets. The main drawback of this approach is the need of attendance to the sanitary institution weekly during 3 months.
METHODS: A prospective, randomized study was performed. The patients were randomized into three groups: those undergoing conventional PENS of dermatome T6 associated with a 1200 kcal diet (group 1), those undergoing PENS of dermatome T6 with a self-applied patch associated with diet (group 2), and those following only a 1200 kcal diet (group 3).
RESULTS: One hundred thirty-five patients were included in the study, 45 in each group, 51 males, and 81 females with a mean age of 54.5 years and BMI 35.9 kg/m2. The median pain perception in group 1 was 1 (range 0-2), while in group 2, it was 4 (range 2-7) (p = 0.024). Seven patients of group 2 abandoned the treatment because the self-application of the patch was painful. Excess weight loss was 32.7 % in group 1, 3.2 % in group 2, and 2.6 % in group 3 (p = 0.001). Appetite, as measured by VAS, decreased from 6 to 1.5 in group 1, while in the other groups remained similar (p = 0.001).
CONCLUSIONS: Conventional PENS of dermatome T6 is associated with an appetite reduction and, along with a proper diet, achieved a significantly greater weight reduction compared to diet alone in morbidly obese patients. PENS of dermatome T6 performed with a self-applied patch failed to demonstrate any effect on appetite and weight loss. Moreover, the self-application therapy was associated with a significantly greater pain, reducing the compliance of the therapy.

RCT Entities:   Population Interventions Outcomes