Evidence map›Paper›PMID 39334186›Full record

ArticleBMC pulmonary medicine2024

Optimized anti-tuberculosis duration for drug-susceptible pulmonary tuberculosis-diabetes mellitus comorbidities: study protocol for a multicenter randomized controlled trial.

Peize Zhang, Huaifang Shi, Yongping Xie, Jiemei Liang, Qiumeng Hu, Liang Fu, Yuxiang Wang, Jie Tan, Senlin Zhan, Hongjuan Qin and 2 more

Abstract readClinical Trial Protocol
In one paragraph

Article in BMC pulmonary medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Peize Zhang *Department of Pulmonary Medicine and Tuberculosis, Third People's Hospital of Shenzhen, Shenzhen, Guangdong, China.
Huaifang Shi *School of Public Health, Shenzhen University Medical School, Shenzhen University, Shenzhen, Guangdong, 518055, China.
Yongping Xie *Jiangmen Institute of Tuberculosis Prevention and Control, Shenzhen, China.
Jiemei LiangDepartment of Pulmonary Medicine and Tuberculosis, Third People's Hospital of Shenzhen, Shenzhen, Guangdong, China.
Qiumeng HuShenzhen University Medical School, Shenzhen University, Shenzhen, Guangdong, 518055, China.
Liang FuDepartment of Pulmonary Medicine and Tuberculosis, Third People's Hospital of Shenzhen, Shenzhen, Guangdong, China.
Yuxiang WangDepartment of Pulmonary Medicine and Tuberculosis, Third People's Hospital of Shenzhen, Shenzhen, Guangdong, China.
Jie TanDepartment of Pulmonary Medicine and Tuberculosis, Third People's Hospital of Shenzhen, Shenzhen, Guangdong, China.
Senlin ZhanDepartment of Pulmonary Medicine and Tuberculosis, Third People's Hospital of Shenzhen, Shenzhen, Guangdong, China.
Hongjuan QinDepartment of Pulmonary Medicine and Tuberculosis, Third People's Hospital of Shenzhen, Shenzhen, Guangdong, China.
Guanghui XuJiangmen Institute of Tuberculosis Prevention and Control, Shenzhen, China. jmxgh0750@126.com.
Guofang DengDepartment of Pulmonary Medicine and Tuberculosis, Third People's Hospital of Shenzhen, Shenzhen, Guangdong, China. jxxk1035@yeah.net.

Funding

The Guangdong Provincial Clinical Research Center for Tuberculosis No. 2020B1111170014The National Natural Science Foundation of China No. 82070016The Shenzhen Clinical Research Center for Tuberculosis No. 20210617141509001
6 · The paper itself

Abstract

backgroundThe coexistence of tuberculosis (TB) and type 2 diabetes mellitus (DM) presents unique challenges in treatment optimization and management, given the mutual exacerbation of disease processes.

objectiveThis multicenter, open-label, randomized controlled trial aims to evaluate the efficacy and safety of two different treatment durations (6-month versus 9-month regimens) regimen for patients with drug-susceptible pulmonary tuberculosis (DS-PTB) and concurrent type 2 diabetes (DM).

methodsPatients with DS-PTB and type-2 DM from 22 hospitals in China are enrolled. They are randomized in a 1:1 ratio into either the 6-month regimen arm(2HRZE/4HR) or the 9-month regimen arm(2HRZE/7HR). At the end of the intensive phase (the 8th week), patients in both arms who with sputum positive smear will extent one more month of intensive treatment. The primary outcome is the proportion of unfavorable outcomes at 24 months after randomization. Secondary outcomes include treatment success rate at the end of treatment, proportion of recurrence at 24 months after randomization, time to recurrence after treatment completion, proportion of intensive phrase extension, occurrence of adverse events grade 3 or above during treatment. DISCUSSION: The study focuses on assessing the optimal treatment duration to maximize treatment success while minimizing recurrence and adverse events. The trial is expected to provide vital insights into the appropriate treatment duration for patients with TB-DM, aiming to reduce recurrence rates and improve overall treatment outcomes in this vulnerable population. TRAIL REGISTRATION: Chictr.org.cn, ChiCTR2100044663. Registered on March 25, 2021.

Indexed as

Antitubercular AgentsDiabetes Mellitus, Type 2Tuberculosis, PulmonaryAdultChinaComorbidityDrug Administration ScheduleFemaleHumansMaleMiddle AgedMulticenter Studies as TopicRandomized Controlled Trials as TopicRecurrenceTreatment OutcomeAntitubercular AgentsDrug-susceptible pulmonary tuberculosis (PTB)Treatment durationTreatment successType 2 diabetes(DM)Unfavorable outcome

Identifiers

PMID39334186
PMCPMC11438111

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.