Comparative Effectiveness of Cheonwangbosimdan (Tian Wang Bu Xin Dan) Versus Cognitive-Behavioral Therapy for Insomnia in Cancer Patients: A Randomized, Controlled, Open-Label, Parallel-Group, Pilot Trial

Cancer patients have a 2 times higher prevalence of insomnia than healthy populations and cancer-related insomnia has received minimal attention while insomnia can aggravate the rehabilitation of cancer patients. Cheonwangbosimdan is a Korean herbal medicine generally used to relieve sleep deprivati...

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Main Authors: Sun-Young Moon KMD, BS, Ui Min Jerng KMD, PhD, O-Jin Kwon PhD, So-Young Jung BS, Jee Young Lee KMD, Seong Woo Yoon KMD, PhD, Won-Chul Shin MD, PhD, Jung-Ick Byun MD, PhD, Jun-Hwan Lee KMD, PhD
Format: Article
Language:English
Published: SAGE Publishing 2020-07-01
Series:Integrative Cancer Therapies
Online Access:https://doi.org/10.1177/1534735420935643
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author Sun-Young Moon KMD, BS
Ui Min Jerng KMD, PhD
O-Jin Kwon PhD
So-Young Jung BS
Jee Young Lee KMD
Seong Woo Yoon KMD, PhD
Won-Chul Shin MD, PhD
Jung-Ick Byun MD, PhD
Jun-Hwan Lee KMD, PhD
author_facet Sun-Young Moon KMD, BS
Ui Min Jerng KMD, PhD
O-Jin Kwon PhD
So-Young Jung BS
Jee Young Lee KMD
Seong Woo Yoon KMD, PhD
Won-Chul Shin MD, PhD
Jung-Ick Byun MD, PhD
Jun-Hwan Lee KMD, PhD
author_sort Sun-Young Moon KMD, BS
collection DOAJ
description Cancer patients have a 2 times higher prevalence of insomnia than healthy populations and cancer-related insomnia has received minimal attention while insomnia can aggravate the rehabilitation of cancer patients. Cheonwangbosimdan is a Korean herbal medicine generally used to relieve sleep deprivation, however, few studies presented the effects of Cheonwangbosimdan on cancer-related insomnia. The purpose of study is to examine the feasibility of Cheonwangbosimdan treatments for cancer patients. Twenty-two participants were allocated into a Cheonwangbosimdan or cognitive-behavioral therapy for insomnia (CBT-I) control group by equal number. The intervention group took Cheonwangbosimdan liquid once in a day and attend visits once a week for 4 weeks. The CBT-I group underwent individualized behavioral therapy 4 times in 4 weeks. The primary outcome is changes in the Insomnia Severity Index (ISI) from baseline to the end of the trial. Responses to the Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), Zung Self-Rating Anxiety Scale (SAS), Brief Fatigue Inventory (BFI), Euroqol-5 Dimensions-5 Levels (EQ-5D-5L), and Eastern Cooperative Oncology Group Performance Status (ECOG-PS) were secondary outcomes used to evaluate the quality of sleep. Outcomes were measured at a follow-up visit (visit 5) in the fifth week of the trial. There is no difference between 2 groups, but both groups showed tendency to alleviate cancer insomnia symptoms. SAS-K showed significant difference between the 2 groups (P < .001), as treatment group score was highly lowered than control group score. The study can contribute to more attentive care for insomnia in cancer patients.
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spelling doaj.art-2ed2d50de1dd409bb90acf02e97422db2022-12-21T19:32:11ZengSAGE PublishingIntegrative Cancer Therapies1534-73541552-695X2020-07-011910.1177/1534735420935643Comparative Effectiveness of Cheonwangbosimdan (Tian Wang Bu Xin Dan) Versus Cognitive-Behavioral Therapy for Insomnia in Cancer Patients: A Randomized, Controlled, Open-Label, Parallel-Group, Pilot TrialSun-Young Moon KMD, BS0Ui Min Jerng KMD, PhD1O-Jin Kwon PhD2So-Young Jung BS3Jee Young Lee KMD4Seong Woo Yoon KMD, PhD5Won-Chul Shin MD, PhD6Jung-Ick Byun MD, PhD7Jun-Hwan Lee KMD, PhD8University of Science and Technology (UST), Campus of Korea Institute of Oriental Medicine, Daejeon, Republic of KoreaSang-ji University Korean Medicine Hospital, Wonju, Republic of KoreaKorea Institute of Oriental Medicine, Daejeon, Republic of KoreaKorea Institute of Oriental Medicine, Daejeon, Republic of KoreaKyung Hee University, Seoul, Republic of KoreaKyung Hee University, Seoul, Republic of KoreaKyung Hee University Hospital at Gangdong, Seoul, Republic of KoreaKyung Hee University Hospital at Gangdong, Seoul, Republic of KoreaUniversity of Science and Technology (UST), Campus of Korea Institute of Oriental Medicine, Daejeon, Republic of KoreaCancer patients have a 2 times higher prevalence of insomnia than healthy populations and cancer-related insomnia has received minimal attention while insomnia can aggravate the rehabilitation of cancer patients. Cheonwangbosimdan is a Korean herbal medicine generally used to relieve sleep deprivation, however, few studies presented the effects of Cheonwangbosimdan on cancer-related insomnia. The purpose of study is to examine the feasibility of Cheonwangbosimdan treatments for cancer patients. Twenty-two participants were allocated into a Cheonwangbosimdan or cognitive-behavioral therapy for insomnia (CBT-I) control group by equal number. The intervention group took Cheonwangbosimdan liquid once in a day and attend visits once a week for 4 weeks. The CBT-I group underwent individualized behavioral therapy 4 times in 4 weeks. The primary outcome is changes in the Insomnia Severity Index (ISI) from baseline to the end of the trial. Responses to the Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), Zung Self-Rating Anxiety Scale (SAS), Brief Fatigue Inventory (BFI), Euroqol-5 Dimensions-5 Levels (EQ-5D-5L), and Eastern Cooperative Oncology Group Performance Status (ECOG-PS) were secondary outcomes used to evaluate the quality of sleep. Outcomes were measured at a follow-up visit (visit 5) in the fifth week of the trial. There is no difference between 2 groups, but both groups showed tendency to alleviate cancer insomnia symptoms. SAS-K showed significant difference between the 2 groups (P < .001), as treatment group score was highly lowered than control group score. The study can contribute to more attentive care for insomnia in cancer patients.https://doi.org/10.1177/1534735420935643
spellingShingle Sun-Young Moon KMD, BS
Ui Min Jerng KMD, PhD
O-Jin Kwon PhD
So-Young Jung BS
Jee Young Lee KMD
Seong Woo Yoon KMD, PhD
Won-Chul Shin MD, PhD
Jung-Ick Byun MD, PhD
Jun-Hwan Lee KMD, PhD
Comparative Effectiveness of Cheonwangbosimdan (Tian Wang Bu Xin Dan) Versus Cognitive-Behavioral Therapy for Insomnia in Cancer Patients: A Randomized, Controlled, Open-Label, Parallel-Group, Pilot Trial
Integrative Cancer Therapies
title Comparative Effectiveness of Cheonwangbosimdan (Tian Wang Bu Xin Dan) Versus Cognitive-Behavioral Therapy for Insomnia in Cancer Patients: A Randomized, Controlled, Open-Label, Parallel-Group, Pilot Trial
title_full Comparative Effectiveness of Cheonwangbosimdan (Tian Wang Bu Xin Dan) Versus Cognitive-Behavioral Therapy for Insomnia in Cancer Patients: A Randomized, Controlled, Open-Label, Parallel-Group, Pilot Trial
title_fullStr Comparative Effectiveness of Cheonwangbosimdan (Tian Wang Bu Xin Dan) Versus Cognitive-Behavioral Therapy for Insomnia in Cancer Patients: A Randomized, Controlled, Open-Label, Parallel-Group, Pilot Trial
title_full_unstemmed Comparative Effectiveness of Cheonwangbosimdan (Tian Wang Bu Xin Dan) Versus Cognitive-Behavioral Therapy for Insomnia in Cancer Patients: A Randomized, Controlled, Open-Label, Parallel-Group, Pilot Trial
title_short Comparative Effectiveness of Cheonwangbosimdan (Tian Wang Bu Xin Dan) Versus Cognitive-Behavioral Therapy for Insomnia in Cancer Patients: A Randomized, Controlled, Open-Label, Parallel-Group, Pilot Trial
title_sort comparative effectiveness of cheonwangbosimdan tian wang bu xin dan versus cognitive behavioral therapy for insomnia in cancer patients a randomized controlled open label parallel group pilot trial
url https://doi.org/10.1177/1534735420935643
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