Efficacy and Safety of Cordyceps militaris as an Adjuvant to Duloxetine in the Treatment of Insomnia in Patients With Depression: A 6-Week Double- Blind, Randomized, Placebo-Controlled Trial

Background: Insomnia is a common clinical manifestation in patients with depression. Insomnia is not only a depression symptom but also an independent risk factor for recurrence. Cordyceps militaris (C. militaris) is thought to have the potential to treat insomnia. This study aimed to examine the ef...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Jiaojiao Zhou, Xu Chen, Le Xiao, Jingjing Zhou, Lei Feng, Gang Wang
Formato:	article
Lenguaje:	EN
Publicado:	Frontiers Media S.A. 2021
Materias:	depression insomnia Cordyceps militaris duloxetine efficacy safety Psychiatry RC435-571
Acceso en línea:	https://doaj.org/article/03f10036210646b288b047fa635ffb53
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:03f10036210646b288b047fa635ffb53
record_format	dspace
spelling	oai:doaj.org-article:03f10036210646b288b047fa635ffb532021-11-11T06:43:00ZEfficacy and Safety of Cordyceps militaris as an Adjuvant to Duloxetine in the Treatment of Insomnia in Patients With Depression: A 6-Week Double- Blind, Randomized, Placebo-Controlled Trial1664-064010.3389/fpsyt.2021.754921https://doaj.org/article/03f10036210646b288b047fa635ffb532021-11-01T00:00:00Zhttps://www.frontiersin.org/articles/10.3389/fpsyt.2021.754921/fullhttps://doaj.org/toc/1664-0640Background: Insomnia is a common clinical manifestation in patients with depression. Insomnia is not only a depression symptom but also an independent risk factor for recurrence. Cordyceps militaris (C. militaris) is thought to have the potential to treat insomnia. This study aimed to examine the efficacy and safety of duloxetine with C. militaris in improving sleep symptoms in patients with depression.Methods: This study was a single-center, randomized, double-blind, placebo-controlled study that recruited outpatients admitted to Beijing Anding hospital from January 2018 to January 2019. Major depressive disorder (MDD) with insomnia was diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria and Mini-International Neuropsychiatric Interview (M.I.N.I.). Eligible subjects will be randomly assigned to two treatment groups in a 1:1 ratio, and receive treatment and follow-up of about 6 weeks of duloxetine plus Cordyceps militaris or placebo, respectively. The severity of depression and insomnia was evaluated at baseline and at 1, 2, 4, and 6 weeks using the 17-item Hamilton Depression Scale (HAMD-17) and Athens Insomnia Scale (AIS).Results: A total of 59 subjects were included in the study (31 in the placebo group and 28 in the C. militaris group). 11 (18.6%) participants withdrew during the study period, 5 (17.9%) in the C. militaris group, and 6 (19.3%) in the placebo group. Depressive and sleep symptoms in all patients reduced over time. We found that the total scores of AIS and its subscales decreased more in the placebo group compared to the C. militaris group (p < 0.05). Secondary outcome revealed that there were no significant differences between the two groups in total HAMD-17 and its sleep factor scores (p > 0.05) at 1, 2, 4, and 6 weeks after treatment initiation. The incidences of adverse events were not significantly different between the two groups (all p > 0.05).Conclusion:C. militaris at the current dose and duration did not improve sleep symptoms in patients with depression, but it is safe with rare side effects.Jiaojiao ZhouXu ChenLe XiaoJingjing ZhouLei FengGang WangFrontiers Media S.A.articledepressioninsomniaCordyceps militarisduloxetineefficacysafetyPsychiatryRC435-571ENFrontiers in Psychiatry, Vol 12 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	depression insomnia Cordyceps militaris duloxetine efficacy safety Psychiatry RC435-571
spellingShingle	depression insomnia Cordyceps militaris duloxetine efficacy safety Psychiatry RC435-571 Jiaojiao Zhou Xu Chen Le Xiao Jingjing Zhou Lei Feng Gang Wang Efficacy and Safety of Cordyceps militaris as an Adjuvant to Duloxetine in the Treatment of Insomnia in Patients With Depression: A 6-Week Double- Blind, Randomized, Placebo-Controlled Trial
description	Background: Insomnia is a common clinical manifestation in patients with depression. Insomnia is not only a depression symptom but also an independent risk factor for recurrence. Cordyceps militaris (C. militaris) is thought to have the potential to treat insomnia. This study aimed to examine the efficacy and safety of duloxetine with C. militaris in improving sleep symptoms in patients with depression.Methods: This study was a single-center, randomized, double-blind, placebo-controlled study that recruited outpatients admitted to Beijing Anding hospital from January 2018 to January 2019. Major depressive disorder (MDD) with insomnia was diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria and Mini-International Neuropsychiatric Interview (M.I.N.I.). Eligible subjects will be randomly assigned to two treatment groups in a 1:1 ratio, and receive treatment and follow-up of about 6 weeks of duloxetine plus Cordyceps militaris or placebo, respectively. The severity of depression and insomnia was evaluated at baseline and at 1, 2, 4, and 6 weeks using the 17-item Hamilton Depression Scale (HAMD-17) and Athens Insomnia Scale (AIS).Results: A total of 59 subjects were included in the study (31 in the placebo group and 28 in the C. militaris group). 11 (18.6%) participants withdrew during the study period, 5 (17.9%) in the C. militaris group, and 6 (19.3%) in the placebo group. Depressive and sleep symptoms in all patients reduced over time. We found that the total scores of AIS and its subscales decreased more in the placebo group compared to the C. militaris group (p < 0.05). Secondary outcome revealed that there were no significant differences between the two groups in total HAMD-17 and its sleep factor scores (p > 0.05) at 1, 2, 4, and 6 weeks after treatment initiation. The incidences of adverse events were not significantly different between the two groups (all p > 0.05).Conclusion:C. militaris at the current dose and duration did not improve sleep symptoms in patients with depression, but it is safe with rare side effects.
format	article
author	Jiaojiao Zhou Xu Chen Le Xiao Jingjing Zhou Lei Feng Gang Wang
author_facet	Jiaojiao Zhou Xu Chen Le Xiao Jingjing Zhou Lei Feng Gang Wang
author_sort	Jiaojiao Zhou
title	Efficacy and Safety of Cordyceps militaris as an Adjuvant to Duloxetine in the Treatment of Insomnia in Patients With Depression: A 6-Week Double- Blind, Randomized, Placebo-Controlled Trial
title_short	Efficacy and Safety of Cordyceps militaris as an Adjuvant to Duloxetine in the Treatment of Insomnia in Patients With Depression: A 6-Week Double- Blind, Randomized, Placebo-Controlled Trial
title_full	Efficacy and Safety of Cordyceps militaris as an Adjuvant to Duloxetine in the Treatment of Insomnia in Patients With Depression: A 6-Week Double- Blind, Randomized, Placebo-Controlled Trial
title_fullStr	Efficacy and Safety of Cordyceps militaris as an Adjuvant to Duloxetine in the Treatment of Insomnia in Patients With Depression: A 6-Week Double- Blind, Randomized, Placebo-Controlled Trial
title_full_unstemmed	Efficacy and Safety of Cordyceps militaris as an Adjuvant to Duloxetine in the Treatment of Insomnia in Patients With Depression: A 6-Week Double- Blind, Randomized, Placebo-Controlled Trial
title_sort	efficacy and safety of cordyceps militaris as an adjuvant to duloxetine in the treatment of insomnia in patients with depression: a 6-week double- blind, randomized, placebo-controlled trial
publisher	Frontiers Media S.A.
publishDate	2021
url	https://doaj.org/article/03f10036210646b288b047fa635ffb53
work_keys_str_mv	AT jiaojiaozhou efficacyandsafetyofcordycepsmilitarisasanadjuvanttoduloxetineinthetreatmentofinsomniainpatientswithdepressiona6weekdoubleblindrandomizedplacebocontrolledtrial AT xuchen efficacyandsafetyofcordycepsmilitarisasanadjuvanttoduloxetineinthetreatmentofinsomniainpatientswithdepressiona6weekdoubleblindrandomizedplacebocontrolledtrial AT lexiao efficacyandsafetyofcordycepsmilitarisasanadjuvanttoduloxetineinthetreatmentofinsomniainpatientswithdepressiona6weekdoubleblindrandomizedplacebocontrolledtrial AT jingjingzhou efficacyandsafetyofcordycepsmilitarisasanadjuvanttoduloxetineinthetreatmentofinsomniainpatientswithdepressiona6weekdoubleblindrandomizedplacebocontrolledtrial AT leifeng efficacyandsafetyofcordycepsmilitarisasanadjuvanttoduloxetineinthetreatmentofinsomniainpatientswithdepressiona6weekdoubleblindrandomizedplacebocontrolledtrial AT gangwang efficacyandsafetyofcordycepsmilitarisasanadjuvanttoduloxetineinthetreatmentofinsomniainpatientswithdepressiona6weekdoubleblindrandomizedplacebocontrolledtrial
_version_	1718439462402260992

Efficacy and Safety of Cordyceps militaris as an Adjuvant to Duloxetine in the Treatment of Insomnia in Patients With Depression: A 6-Week Double- Blind, Randomized, Placebo-Controlled Trial

Ejemplares similares