Seizure · 2025
Modified Atkins diet versus topiramate in young children with epileptic spasms refractory to steroids and vigabatrin: a randomised open-label trial.
Клиническое исследование II фазыКлиническое исследование III фазыСравнительное исследованиеСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Meena Rashmi, Roy Chowdhury Sayoni, Elwadhi Aman, Jain Puneet, Mukherjee Sharmila B, Sharma Suvasini
Аннотация
BACKGROUND: There is a paucity of evidence regarding the best treatment options for children with infantile epileptic spasm syndrome who have failed the first-line treatments, i.e. hormonal therapy and/or vigabatrin. The study aimed to compare the efficacy and tolerability of the Modified Atkins Diet (MAD) versus Topiramate in this population.
METHODS: This was a randomized open-label trial that enrolled children with infantile epileptic spasm syndrome who had failed a trial of hormonal therapy and vigabatrin. Patients were randomly assigned to receive either MAD or Topiramate. Both groups were assessed at 12 weeks for spasm frequency through parental records, improvement in electroencephalographic findings as measured by the BASED (Burden of AmplitudeS and Epileptiform Discharges) score, adverse effects, and improvement in non-seizure domains. Intention-to-treat analysis was performed.
RESULTS: A total of 80 children were recruited, with 40 children each in the MAD and topiramate arms. Children in the MAD arm showed a statistically significant improvement compared to the Topiramate arm at 12 weeks in terms of >50% spasm reduction (27/40, 67.5% vs. 17/40, 42.5%, p- 0.02), >90% spasm reduction (9/40, 22.5% vs. 2/40, 4.76%, p- 0.02), > 1 point improvement in BASED score (16/40, 40% vs. 5/40, 12.5%, p- 0.005), and improvement in alertness (7/40, 17.5% vs. 1/40, 2,5%, p=0.026). Both interventions were well tolerated by the children, with mild side effects, including constipation, diarrhoea, and anorexia in the MAD arm, and anorexia and somnolence in the topiramate arm.
CONCLUSION: MAD proved to be more effective than Topiramate in managing epileptic spasms refractory to first-line treatment. However, further studies with larger sample sizes and longer follow-up periods are required to generalize the findings. (ClinicalTrials.gov, NCT05958160).
METHODS: This was a randomized open-label trial that enrolled children with infantile epileptic spasm syndrome who had failed a trial of hormonal therapy and vigabatrin. Patients were randomly assigned to receive either MAD or Topiramate. Both groups were assessed at 12 weeks for spasm frequency through parental records, improvement in electroencephalographic findings as measured by the BASED (Burden of AmplitudeS and Epileptiform Discharges) score, adverse effects, and improvement in non-seizure domains. Intention-to-treat analysis was performed.
RESULTS: A total of 80 children were recruited, with 40 children each in the MAD and topiramate arms. Children in the MAD arm showed a statistically significant improvement compared to the Topiramate arm at 12 weeks in terms of >50% spasm reduction (27/40, 67.5% vs. 17/40, 42.5%, p- 0.02), >90% spasm reduction (9/40, 22.5% vs. 2/40, 4.76%, p- 0.02), > 1 point improvement in BASED score (16/40, 40% vs. 5/40, 12.5%, p- 0.005), and improvement in alertness (7/40, 17.5% vs. 1/40, 2,5%, p=0.026). Both interventions were well tolerated by the children, with mild side effects, including constipation, diarrhoea, and anorexia in the MAD arm, and anorexia and somnolence in the topiramate arm.
CONCLUSION: MAD proved to be more effective than Topiramate in managing epileptic spasms refractory to first-line treatment. However, further studies with larger sample sizes and longer follow-up periods are required to generalize the findings. (ClinicalTrials.gov, NCT05958160).