Integrated traditional Chinese and conventional medicine in treatment of severe community-acquired pneumonia: study protocol for a randomized placebo-controlled trial

Haifeng Wang, Jiansheng Li, Xueqing Yu, Su-Yun Li, Haifeng Wang, Jiansheng Li, Xueqing Yu, Su-Yun Li

Abstract

Background: Community-acquired pneumonia, especially severe community-acquired pneumonia (SCAP), remains the leading cause of death in the world. Despite advances in antimicrobial therapy, the mortality rates due to SCAP have not decreased significantly since antibiotics became routinely available. Traditional Chinese medicine (TCM) has been used for treating pneumonia for thousands of years. It is popular and widely practiced in Asia. In recent decades, evidence from both clinicians and patients suggests that TCM has some beneficial effect on SCAP. Thus, this study aims to compare the efficacy of a combination of a conventional drug and TCM to the conventional drug alone, to provide a scientific basis for clinical decisions.

Methods/design: A prospective, multi-center, single-blinded, double-dummy, and randomized controlled clinical trial is being conducted to test the therapeutic effects of a combination of conventional medicine and TCM versus conventional medicine in the treatment of SCAP. A total of 198 patients will be enrolled in this study, with 99 in each treatment group (combination group or conventional medicine group). The TCM will be administered twice daily for 28 days. All patients will be followed for 3 months. The primary outcome measure is treatment failure, which is defined as clinical deterioration. Secondary outcome measures are time to clinical stability, length of hospital stay, in-hospital mortality, SOFA questionnaire, quality of life and cost of treatment.

Discussion: It is hypothesized that the combination of a conventional drug and TCM will reduce treatment failure, time to clinical stability, length hospital of stays, and in-hospital mortality, and improve the quality of life of SCAP patients.

Trial registration: ClinicalTrials.gov, NCT03185923 . Registered on 20 June 2017.

Keywords: Clinical trials; Community-acquired pneumonia; Pulmonary infection; Traditional Chinese medicine; Treatment.

Conflict of interest statement

Ethics approval and consent to participate

The study has been approved after meeting conditions imposed by the ethical research committees of the First Affiliated Hospital of Henan University of Traditional Chinese Medicine (2017HL-002-01). Based on the Declaration of Helsinki, written informed consent will be received from each participant. Any modifications to the protocol that may impact the conduct of the study, the potential benefits to the patients, or patient safety will require a formal amendment to the protocol, which should be approved by the ethics committee prior to implementation. Protocol modifications will be communicated to all centers involved through regular meetings and telephone conversations. All staff will be notified, trained, and qualified prior to conducting the trial.

All subject-related information including case reports, laboratory specimens, and evaluation forms will be kept strictly confidential. All records will be kept in a secure, locked place and secured with password-protected access systems. To protect confidentiality, identification information will be deleted from all study documents.

Consent for publication

Written informed consent will be taken from all participants prior to their taking part in the study.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow chart of study design. TCM traditional Chinese medicine
Fig. 2
Fig. 2
Schedule of enrolment, interventions and assessments (as per SPIRIT [9]). CAP community-acquired pneumonia, PSI, pneumonia severity index, TCM traditional Chinese medicine

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Source: PubMed

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