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

摘要

Cancer patients have a 2 times higher prevalence of insomnia than healthypopulations and cancer-related insomnia has received minimal attention whileinsomnia can aggravate the rehabilitation of cancer patients. Cheonwangbosimdanis a Korean herbal medicine generally used to relieve sleep deprivation,however, few studies presented the effects of Cheonwangbosimdan oncancer-related insomnia. The purpose of study is to examine the feasibility ofCheonwangbosimdan treatments for cancer patients. Twenty-two participants wereallocated into a Cheonwangbosimdan or cognitive-behavioral therapy for insomnia(CBT-I) control group by equal number. The intervention group tookCheonwangbosimdan liquid once in a day and attend visits once a week for 4weeks. The CBT-I group underwent individualized behavioral therapy 4 times in 4weeks. The primary outcome is changes in the Insomnia Severity Index (ISI) frombaseline to the end of the trial. Responses to the Pittsburgh Sleep QualityIndex (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) weresecondary outcomes used to evaluate the quality of sleep. Outcomes were measuredat a follow-up visit (visit 5) in the fifth week of the trial. There is nodifference between 2 groups, but both groups showed tendency to alleviate cancerinsomnia symptoms. SAS-K showed significant difference between the 2 groups (P< .001), as treatment group score was highly lowered than control groupscore. The study can contribute to more attentive care for insomnia in cancerpatients.