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Efficacy and Safety of Bufei Jiedu Granules in Treating Multidrug-Resistant Pulmonary Tuberculosis: A Multi-center, Double-Blinded and Randomized Controlled Trial

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Chinese Journal of Integrative Medicine Aims and scope Submit manuscript

Abstract

Objective

To assess the efficacy and safety of Bufei Jiedu (BFJD) ranules as adjuvant therapy for patients with multidrug-resistant pulmonary tuberculosis (MDR-PTB).

Methods

A large-scale, multi-center, double-blinded, and randomized controlled trial was conducted in 18 sentinel hospitals in China from December 2012 to December 2016. A total of 312 MDR-PTB patients were randomly assigned to BFJD Granules or placebo groups (1:1) using a stratified randomization method, which both received the long-course chemotherapy regimen for 18 months (6 Am-Lfx-P-Z-Pto, 12 Lfx-P-Z-Pto). Meanwhile, patients in both groups also received BFJD Granules or placebo twice a day for a total of 18 months, respectively. The primary outcome was cure rate. The secondary outcomes included time to sputum-culture conversion, changes in lung cavities and quality of life (QoL) of patients. Adverse reactions were monitored during and after the trial.

Results

A total of 216 cases completed the trial, 111 in the BFJD Granules group and 105 in the placebo group. BFJD Granules, as an adjuvant treatment, increased the cure rate by 13.6% at the end of treatment, compared with the placebo (58.4% vs. 44.8%, P=0.02), and accelerated the median time to sputum-culture conversion (5 months vs. 11 months). The cavity closure rate of the BFJD Granules group (50.6%, 43/85) was higher than that of the placebo group (32.1%, 26/81; P=0.02) in patients who completed the treatment. At the end of the intensive treatment, according to the 36-item Short Form, the BFJD Granules significantly improved physical functioning, general health, and vitality of patients relative to the placebo group (all P<0.01). Overall, the death rates in the two groups were not significantly different; 5.1% (8/156) in the BFJD Granules group and 2.6% (4/156) in the placebo group.

Conclusions

Supplementing BFJD Granules with the long-course chemotherapy regimen significantly increased the cure rate and cavity closure rates, and rapidly improved QoL of patients with MDR-PTB (Registration No. ChiCTR-TRC-12002850)

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Data Availability

Ownership of the data arising from this study resides with the study team. Data can be available by the corresponding author upon a reasonable request.

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Acknowledgements

First and foremost, we are grateful to the study participants and their families. We thank the researchers from 18 pulmonary tuberculosis sentinel hospitals for their expertise and contributions. We also thank the National Major Science and Technology projects on infectious diseases and Shanghai Municipal Health Commission for supporting this research.

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Authors and Affiliations

  1. Institute of Respiratory Diseases, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China

    Shao-yan Zhang, Lei Qiu, Hui-yong Zhang & Zhen-hui Lu

  2. Clinical Research Center, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China

    Shun-xian Zhang & Pei-yong Zheng

  3. Department of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University, Shanghai, 200433, China

    He-ping Xiao

  4. Department of Tuberculosis, Beijing Chest Hospital, Capital Medical University, Beijing, 101100, China

    Nai-hui Chu

  5. Department of Tuberculosis, the Second Hospital of Nanjing, Nanjing, 210003, China

    Xia Zhang

  6. Department of Tuberculosis, the First Hospital Affiliated to Xinxiang Medical College, Xinxiang, Henan Province, 453100, China

    Hui-qiang Zhang

Authors
  1. Shao-yan Zhang
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  2. Lei Qiu
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  3. Shun-xian Zhang
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Contributions

Lu ZH designed the study and oversaw the implementation of the entire project. Zhang SY interpreted the data and wrote the first draft of the manuscript. Xiao HP, Chu NH, Zhang X and Zhang HQ, as the leaders of the branch center, guided the implementation of this research. Zhang SY instructed the development of the pharmaceutical experiment of Bufei Jiedu Granules. Zhang SY, Zhang SX and Qiu L collected the data and performed the statistical analysis. Zheng PY and Zhang HY directed the writing of the article. All authors revised the manuscript critically for important intellectual content and gave final approval of the version to be published.

Corresponding author

Correspondence to Zhen-hui Lu.

Ethics declarations

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in the paper.

Additional information

Supported by National Major Science and Technology Projects of Infectious Diseases (Nos. 2008ZX10005011 and 2012ZX10005-008), Traditional Chinese Medicine Innovation Team of Shanghai Municipal Health Commission (No. 2022CX010) and Three-Year Action Plan for Strengthening the Construction of the Public Health System in Shanghai (2023–2025, No. GWVI-11.1-08)

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Zhang, Sy., Qiu, L., Zhang, Sx. et al. Efficacy and Safety of Bufei Jiedu Granules in Treating Multidrug-Resistant Pulmonary Tuberculosis: A Multi-center, Double-Blinded and Randomized Controlled Trial. Chin. J. Integr. Med. (2024). https://doi.org/10.1007/s11655-024-3812-7

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  • DOI: https://doi.org/10.1007/s11655-024-3812-7

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