Chinese medicine treatment of mastitis in COVID-19 patients: A protocol for systematic review

Background: Assessing the effectiveness and safety of Chinese medicine for the mastitis in COVID-19 patients is the main purpose of this systematic review protocol.

Methods: The following electronic databases will be searched from inception to April 2020: MEDLINE, Ovid, EMBASE, the Cochrane Library, the Allied and Complementary Medicine Database (AMED), Chinese National Knowledge Infrastructure (CNKI), Chinese Biomedical Literature Database (CBM), VIP Database and Wanfang Database. In addition, Clinical trial registries, like the Chinese Clinical Trial Registry (ChiCTR), the Netherlands National Trial Register (NTR) and ClinicalTrials.gov, will be searched for ongoing trials with unpublished data. No language restrictions will be applied. The primary outcome will be the time of disappearance of main symptoms (including fever, asthenia, cough disappearance rate, and temperature recovery time), and serum cytokine levels. The secondary outcome will be the accompanying symptoms (such as myalgia, expectoration, stuffiness, runny nose, pharyngalgia, anhelation, chest distress, dyspnea, crackles, headache, nausea, vomiting, anorexia, diarrhea) disappear rate, negative COVID-19 results rate on 2 consecutive occasions (not on the same day), CT image improvement, average hospitalization time, occurrence rate of common type to severe form, clinical cure rate, and mortality. Two independent reviewers will conduct the study selection, data extraction and assessment. RevMan V.5.3 will be used for the assessment of risk of bias and data synthesis.

Results: The results will provide a high-quality synthesis of current evidence for researchers in this subject area.

Conclusion: The conclusion of the study will provide an evidence to judge whether Chinese medicine is effective and safe for mastitis in COVID-19 patients.

Prospero registration number: CRD42020189924.