Efficacy and Safety of Chinese Medicine Resuscitation Pack for Enhanced Recovery after Bronchoscopy: A Randomized, Single-Blind, Placebo-Controlled Clinical Trial
机构:[1]Guangdong Prov Hosp Chinese Med, Guangdong Prov Acad Chinese Med Sci, Dept Pulm & Crit Care Med, Guangzhou 510120, Peoples R China广东省中医院[2]Guangdong Prov Acad Chinese Med Sci, Chron Resp Dis & Chinese Med Res Team, Guangzhou 510120, Peoples R China广东省中医院[3]Guangzhou Univ Chinese Med, Clin Coll 2, Guangzhou 510006, Peoples R China广东省中医院
ObjectiveTo evaluate the efficacy and safety of a hospital-made resuscitation pack, a Chinese medicinal herbal compound formula designed to enhance recovery in post-bronchoscopy patients.MethodsIn this randomized, single-blind, placebo-controlled clinical trial, eligible patients were randomly assigned 1:1 to either the treatment or control groups. The patients in the treatment group applied the resuscitation pack, which contained aromatic compounded Chinese herbs. The patients in the control group applied a hospital-made, single herb placebo pack. Packs were placed on the Tiantu (CV 22) acupuncture point for 4 h as soon as the bronchoscopy finished. Efficacy indicators, such as recovery time, patients' symptoms including nausea and dizziness, and adverse events (AEs) were observed and compared. The outcome indices were evaluated at baseline, 1 and 24 h after the bronchoscopy. Subgroup analysis was further performed by patients' age and depth of sedation.ResultsWhen applying generalized estimating equations (GEE) to evaluate the intensity of post-bronchoscopy nausea and vomiting, the intensity was lower in the treatment group (163 cases) compared with the control group (162 cases; 95% CI: 0.004, 0.099, P=0.03]. Also, significantly lower intensity of nausea was observed in the 60-70 years of age subgroup (95% CI: 0.029, 0.169, P=0.006) and deep sedation subgroup (95% CI: 0.002, 0.124; P=0.04). There was no significant difference in dizziness between two groups by GEE (95% CI: -0.134, 0.297; P=0.459). In addition, no serious AEs were observed in either group.ConclusionsOur study found that the resuscitation pack markedly improved patients' symptoms by reducing nausea and vomiting after bronchoscopy without AEs, compared with placebo in the perioperative period. (Trial registration No. ChiCTR2000038299)
基金:
Specific Research Fund for TCM Science
and Technology of Guangdong Provincial Hospital of Chinese
Medicine (No. YN2018QL02)
第一作者机构:[1]Guangdong Prov Hosp Chinese Med, Guangdong Prov Acad Chinese Med Sci, Dept Pulm & Crit Care Med, Guangzhou 510120, Peoples R China
通讯作者:
推荐引用方式(GB/T 7714):
Tan Xin-yuan,Yao Yao,Xiao Jing-min,et al.Efficacy and Safety of Chinese Medicine Resuscitation Pack for Enhanced Recovery after Bronchoscopy: A Randomized, Single-Blind, Placebo-Controlled Clinical Trial[J].CHINESE JOURNAL OF INTEGRATIVE MEDICINE.2024,doi:10.1007/s11655-024-3569-z.
APA:
Tan, Xin-yuan,Yao, Yao,Xiao, Jing-min,Chen, Yuan-bin,Lin, Ming...&Xu, Yin-ji.(2024).Efficacy and Safety of Chinese Medicine Resuscitation Pack for Enhanced Recovery after Bronchoscopy: A Randomized, Single-Blind, Placebo-Controlled Clinical Trial.CHINESE JOURNAL OF INTEGRATIVE MEDICINE,,
MLA:
Tan, Xin-yuan,et al."Efficacy and Safety of Chinese Medicine Resuscitation Pack for Enhanced Recovery after Bronchoscopy: A Randomized, Single-Blind, Placebo-Controlled Clinical Trial".CHINESE JOURNAL OF INTEGRATIVE MEDICINE .(2024)