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Efficacy and Safety of Chinese Medicine Resuscitation Pack for Enhanced Recovery after Bronchoscopy: A Randomized, Single-Blind, Placebo-Controlled Clinical Trial

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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)

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Acknowledgments

The authors thank the patients for participating in this trial and the study investigators at the hospital centers for their role in data collection.

Author information

Authors and Affiliations

  1. Department of Pulmonary and Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, 510120, China

    Xin-yuan Tan, Yao Yao, Ming Lin, Xiao-shan Zhang, Dan-yan Cai, Zhen-hu Wu & Yin-ji Xu

  2. Chronic Respiratory Disease and Chinese Medicine Research Team, Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, 510120, China

    Jing-min Xiao, Yuan-bin Chen & Fei-ting Fan

  3. The Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510006, China

    Li-li Sun

Authors
  1. Xin-yuan Tan
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  2. Yao Yao
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  3. Jing-min Xiao
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  4. Yuan-bin Chen
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  5. Ming Lin
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  6. Xiao-shan Zhang
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  7. Dan-yan Cai
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  8. Zhen-hu Wu
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  9. Li-li Sun
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  10. Fei-ting Fan
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  11. Yin-ji Xu
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Contributions

Conception and design, writing the original draft: Tan XY; methodology and investigation: Xu YJ; methodology and formal analysis: Yao Y and Xiao JM; provision of materials: Zhang XS; investigation (participant enrolment, experimental intervention, and follow-up): Chai DY and Fan FT; paper review and editing: Wu ZH; data management: Sun LL; operation: Tan XY; anesthetization: Lin M. All authors read and approved the final version for publication.

Corresponding author

Correspondence to Yin-ji Xu.

Ethics declarations

There are no known conflicts of interest associated with this publication and there has no financial support for this work that could have influenced its outcome.

Additional information

Supported by the Specific Research Fund for TCM Science and Technology of Guangdong Provincial Hospital of Chinese Medicine (No. YN2018QL02)

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Tan, Xy., Yao, Y., Xiao, Jm. et al. Efficacy and Safety of Chinese Medicine Resuscitation Pack for Enhanced Recovery after Bronchoscopy: A Randomized, Single-Blind, Placebo-Controlled Clinical Trial. Chin. J. Integr. Med. (2024). https://doi.org/10.1007/s11655-024-3569-z

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  • DOI: https://doi.org/10.1007/s11655-024-3569-z

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