Efficacy and Safety of Chinese Medicine Resuscitation Pack for Enhanced Recovery after Bronchoscopy: A Randomized, Single-Blind, Placebo-Controlled Clinical Trial.
10.1007/s11655-024-3569-z
- Author:
Xin-Yuan TAN
1
;
Yao YAO
1
;
Jing-Min XIAO
2
;
Yuan-Bin CHEN
2
;
Ming LIN
1
;
Xiao-Shan ZHANG
1
;
Dan-Yan CAI
1
;
Zhen-Hu WU
1
;
Li-Li SUN
3
;
Fei-Ting FAN
2
;
Yin-Ji XU
4
Author Information
1. Department of Pulmonary and Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, 510120, China.
2. Chronic Respiratory Disease and Chinese Medicine Research Team, Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, 510120, China.
3. The Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510006, China.
4. Department of Pulmonary and Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, 510120, China. xuyinji@gzucm.edu.cn.
- Publication Type:Randomized Controlled Trial
- Keywords:
Chinese medicine;
aromatherapy;
bronchoscopy;
enhanced recovery;
placebo-controlled trial;
randomized
- MeSH:
Humans;
Male;
Middle Aged;
Female;
Bronchoscopy/adverse effects*;
Single-Blind Method;
Aged;
Drugs, Chinese Herbal/adverse effects*;
Treatment Outcome;
Resuscitation;
Adult;
Medicine, Chinese Traditional
- From:
Chinese journal of integrative medicine
2025;31(5):441-447
- CountryChina
- Language:English
-
Abstract:
OBJECTIVE:To 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.
METHODS:In 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.
RESULTS:When 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.
CONCLUSIONS:Our 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).
