A Randomized, Double-Blind, and Sham-Controlled Trial of an Innovative Brain-Gut Photobiomodulation Therapy: Safety and Patient Compliance
Blivet G, Relano-Gines A, Wachtel M, Touchon J
Journal of Alzheimer's disease : JAD · 29 citas
Etiquetas de revisión
Financiación no declaradaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2022-09-27 · J Alzheimers Dis · vol. 90 · número 2 · págs. 811–822
- Editorial
- IOS Press
- Citado
- 35 citas · más que el 94% de estudios similares · 3.3× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 53 trabajos
- Acceso
- De pago
- Áreas de investigación
- Laser Applications in Dentistry and Medicine · Dementia and Cognitive Impairment Research · Alzheimer's disease research and treatments
- Palabras clave
- low-level laser therapy, Alzheimer's disease
- MeSH
- brain, humans, alzheimer disease, treatment outcome, pilot projects, double-blind method, patient compliance, pandemics, low-level light therapy, covid-19
4 autores
- Guillaume Blivet · autor de correspondencia
- Aroa Relaño-Ginés
- Mélanie Bodnar‐Wachtel
- Jacques Touchon🇫🇷Université de Montpellier
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Recent innovative non-pharmacological interventions and neurostimulation devices have shown potential for application in the treatment of Alzheimer's disease (AD). These include photobiomodulation (PBM) therapy.
Objective
This pilot study assesses the safety, compliance with, and efficacy of a brain-gut PBM therapy for mild-to-moderate AD patients.
Methods
This double-blind, randomized, monocentric sham-controlled study started in 2018 and ended prematurely in 2020 due to the COVID-19 pandemic. Fifty-three mild-to-moderate AD patients were randomized, 27 in the PBM group and 26 in the sham group. All patients had 40 treatment sessions lasting 25 min each over 8 weeks and were followed for 4 weeks afterwards. Compliance with the treatment was recorded. Safety was assessed by recording adverse events (AEs), and efficacy was evaluated using neuropsychological tests.
Results
The PBM therapy proved to be safe in regard to the number of recorded AEs (44% of the patients), which were balanced between the PBM and sham groups. AEs were mainly mild, and no serious AEs were reported. The majority of the patients (92.5%) were highly compliant, which confirms the feasibility of the PBM treatment. Compared to the sham patients, the PBM patients showed lower ADAS-Cog comprehension subscores, higher forward verbal spans, and lower TMT-B execution times, which suggests an improvement in cognitive functions.
Conclusion
This study demonstrates the tolerability of and patient compliance with a PBM-based treatment for mild-to-moderate AD patients. It highlights encouraging efficacy trends and provides insights for the design of the next phase trial in a larger AD patient sample.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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