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

Shao-Yan Zhang; Lei Qiu; Shun-Xian Zhang; He-Ping Xiao; Nai-Hui Chu; Xia Zhang; Hui-Qiang Zhang; Pei-Yong Zheng; Hui-Yong Zhang; Zhen-Hui Lu

doi:10.1007/s11655-024-3812-7

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 May 11. doi: 10.1007/s11655-024-3812-7. Online ahead of print.

Authors

Affiliations

¹ Institute of Respiratory Diseases, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China.
² Clinical Research Center, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China.
³ Department of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University, Shanghai, 200433, China.
⁴ Department of Tuberculosis, Beijing Chest Hospital, Capital Medical University, Beijing, 101100, China.
⁵ Department of Tuberculosis, the Second Hospital of Nanjing, Nanjing, 210003, China.
⁶ Department of Tuberculosis, the First Hospital Affiliated to Xinxiang Medical College, Xinxiang, Henan Province, 453100, China.
⁷ Institute of Respiratory Diseases, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China. Dr_luzh@shutcm.edu.cn.

PMID: 38733454
DOI: 10.1007/s11655-024-3812-7

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).

Keywords: Bufei Jiedu Granules; Chinese herbal formula; alternative medicine; long-course chemotherapy regimen; multidrug-resistant tuberculosis; randomized controlled trial.