Insomnia is a prevalent disorder and it leads to relevant impairment in health-related quality of life. Recent clinical guidelines pointed out that Cognitive-Behavior Therapy for Insomnia (CBT-I) should be considered as first-line intervention. Nevertheless, many other interventions are commonly used by patients or have been proposed as effective for insomnia. These include melatonin, light exposure, exercise, and complementary and alternative medicine. Evaluation of comparable effectiveness of these interventions with first-line intervention for insomnia is however still lacking. We conducted a systematic review and network meta-analysis on the effects of these interventions. PubMed, PsycInfo, PsycArticles, MEDLINE, and CINAHL were systematically searched and 40 studies were included in the systematic review, while 36 were entered into the meta-analysis. Eight network meta-analyses were conducted. Findings support effectiveness of melatonin in improving sleep-onset difficulties and of meditative movement therapies for self-report sleep efficiency and severity of the insomnia disorder. Some support was observed for exercise, hypnotherapy, and transcranial magnetic resonance, but the number of studies for these interventions is still too small. None of the considered interventions received superior evidence to CBT-I, which should be more widely disseminated in primary care.
OBJETIVOS DEL ESTUDIO: Investigar la eficacia de la melatonina en comparación con el placebo en la mejora de los parámetros del sueño en pacientes con trastornos primarios del sueño.
DISEÑO: PubMed se buscaron ensayos aleatorios controlados con placebo, que examina los efectos de la melatonina para el tratamiento de los trastornos primarios del sueño. Los resultados primarios examinados fueron la mejora en la latencia del sueño, calidad del sueño y el tiempo total de sueño. Meta-regresión se realizó para examinar la influencia de la dosis y la duración de la melatonina sobre la eficacia informada.
PARTICIPANTES: Adultos y niños diagnosticados con trastornos primarios del sueño.
Intervenciones melatonina en comparación con placebo.
RESULTADOS: Diecinueve estudios que incluyeron a 1.683 pacientes fueron incluidos en este meta-análisis. La melatonina ha demostrado una eficacia significativa en la reducción de la latencia del sueño (diferencia de medias ponderada (DMP) = 7,06 minutos [IC 4,37-9,75 95%], Z = 5.15, p <0.001) y el aumento del tiempo total de sueño (= 8,25 minutos [IC 95%: DMP 1,74 a 14,75], Z = 2,48, p = 0,013). Los ensayos con una duración más larga y el uso de dosis más altas de melatonina mostraron mayores efectos en la disminución de la latencia del sueño y el aumento del tiempo total de sueño. La calidad general del sueño mejoró significativamente en los sujetos que tomaron melatonina (diferencia de medias estandarizada = 0,22 [IC del 95%: 0,12 hasta 0,32], Z = 4,52, p <0,001) en comparación con placebo. No se observaron efectos significativos de la duración del ensayo y la dosis de la melatonina sobre la calidad del sueño.
CONCLUSIÓN: Este meta-análisis demuestra que la melatonina reduce la latencia del sueño, aumenta el tiempo total de sueño y mejora la calidad del sueño en general. Los efectos de la melatonina sobre el sueño son modestas, pero no aparecen para disipar con el uso continuo de la melatonina. Aunque el beneficio absoluto de la melatonina en comparación con el placebo es más pequeño que otros tratamientos farmacológicos para el insomnio, la melatonina puede tener un papel en el tratamiento del insomnio debido a su perfil de efectos secundarios relativamente benigno en comparación con estos agentes.
Insomnia is a prevalent disorder and it leads to relevant impairment in health-related quality of life. Recent clinical guidelines pointed out that Cognitive-Behavior Therapy for Insomnia (CBT-I) should be considered as first-line intervention. Nevertheless, many other interventions are commonly used by patients or have been proposed as effective for insomnia. These include melatonin, light exposure, exercise, and complementary and alternative medicine. Evaluation of comparable effectiveness of these interventions with first-line intervention for insomnia is however still lacking. We conducted a systematic review and network meta-analysis on the effects of these interventions. PubMed, PsycInfo, PsycArticles, MEDLINE, and CINAHL were systematically searched and 40 studies were included in the systematic review, while 36 were entered into the meta-analysis. Eight network meta-analyses were conducted. Findings support effectiveness of melatonin in improving sleep-onset difficulties and of meditative movement therapies for self-report sleep efficiency and severity of the insomnia disorder. Some support was observed for exercise, hypnotherapy, and transcranial magnetic resonance, but the number of studies for these interventions is still too small. None of the considered interventions received superior evidence to CBT-I, which should be more widely disseminated in primary care.
