Original Research

Effectiveness and safety of thread embedding acupuncture for drug-resistant epilepsy outpatient in Viet Nam: a two-arm parallel design, randomized, controlled clinical trial

Abstract

Introduction: People with drug-resistant epilepsy (DRE) are at high risk of sudden unexpected deaths and lower quality of life. Experiments showed thread embedding acupuncture (TEA) has a seizure-reducing effect; however, data on DRE has been limited. This trial aimed to establish the efficacy and safety of TEA in people with DRE.

Method: This was a two-arm, randomized controlled trial conducted on 30 DRE outpatients, which was fulfilled drug-resistant International League Against Epilepsy. The study was conducted at the Epilepsy clinic, Nguyen Tri Phuong Hospital, Ho Chi Minh City, from December 2020 to March 2022. All procedures for TEA and sham TEA (STEA) groups were identical. Seizure frequency diaries at the baseline and monthly follow-up visits by the participants. The Quality of Life in Epilepsy Inventory (QOLIE-31) scores at the baseline and 16 weeks; the National Hospital Seizure Severity Scale (NHS3) scores at the baseline, 8 weeks, and 16 weeks and the adverse events at monthly follow-up visits by a researcher.

Results: A reduction in relative seizure frequency and the score change in QOLIE-31 and NHS3 in the TEA group were significantly different from the STEA group when analyzing each group separately (p<0.05). However, when comparing two groups, no significant difference was found in the change in seizure freedom and QOLIE-31 (p>0.05). Mild pain appeared in all participants after the intervention, but no serious adverse effects of TEA were observed.

Conclusion: TEA is a safe technique to use in people with DRE. However, the effectiveness of TEA needs further study. 

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