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

Original Research

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. 

Graphical abstract

31-item Quality of Life in Epilepsy Inventory: Translation and validation in Vietnamese

Original Research

Abstract

Introduction: This study aimed to translate the 31-item Quality of Life in Epilepsy Inventory (QOLIE-31) into Vietnamese and validate the translation.

Methods: The inventory was translated through “forward – backward” translation, and culturally adapted for standardization. To ensure the reliability of the inventory, the internal consistency and the temporal consistency was determined. Clinical variables were tested for discriminant validity by comparing their scores.

Results: Cronbach’s alpha coefficient ranged from 0.91 to 0.57, with the lowest in the Overall quality of life subscale. Test-retest reliability showed high reproducibility with intra-class correlation coefficients ranging from 0.72 to 0.87 (p<0.001). The mean score of QOLIE-31 was 71.31. Further, the study used the statistical differences of QOLIE-31 scores in the drug-resistant group to show discriminant validity.

Conclusion: The Vietnamese QOLIE-31 is a reliable and valid instrument as proven by the statistical data and can be used to assess quality of life in people with epilepsy. 

Graphical abstract

The Vietnamese Version of the Health-related Quality of Life Measure for Children with Epilepsy (CHEQOL-25): Reliability

Original Research

Abstract

Purpose: This study aimed to translate and culturally adapt the self-report and parent-proxy Health-Related Quality of Life Measure for Children with Epilepsy (CHEQOL-25) into Vietnamese and to evaluate their reliability.

Methods: Both English versions of the self-report and parent-proxy CHEQOL-25 were translated and culturally adapted into Vietnamese by using the Principles of Good Practice for the Translation and Cultural Adaptation Process. The Vietnamese versions were scored by 77 epileptic patients, who aged 8–15 years, and their parents/caregivers at neurology outpatient clinic of Children Hospital No. 2 – Ho Chi Minh City. Reliability of the questionnaires was determined by using Cronbach’s coefficient α and intra-class correlation coefficient (ICC).

Results: Both Vietnamese versions of the self-report and parent-proxy CHEQOL-25 were shown to be consistent with the English ones, easy to understand for Vietnamese children and parents. Thus, no further modification was required. Cronbach’s α coefficient for each subscale of the Vietnamese version of the self-report and parent-proxy CHEQOL-25 was 0.65 to 0.86 and 0.83 to 0.86, respectively. The ICC for each subscale of the self-report and parent-proxy CHEQOL-25 was in the range of 0.61 to 0.86 and 0.77 to 0.98, respectively.

Conclusion: The Vietnamese version of the self-report and parent-proxy CHEQOL-25 were the first questionnaires about quality of life of epileptic children in Vietnam. This Vietnamese version was shown to be reliable to assess the quality of life of children with epilepsy aged 8–15 years.

Graphical abstract

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