Sijunzi decoction granules in the prevention and treatment of recurrence of colorectal adenoma: Study protocol for a multicenter, randomized, double-blind, placebo-controlled trial

Wenjing Ni; Tao Liu; Yujing Liu; Lu Lu; Bingduo Zhou; Yancheng Dai; Hang Zhao; Hanchen Xu; Guang Ji

doi:10.3389/fphar.2023.1175811

Sijunzi decoction granules in the prevention and treatment of recurrence of colorectal adenoma: Study protocol for a multicenter, randomized, double-blind, placebo-controlled trial

Front Pharmacol. 2023 Apr 5:14:1175811. doi: 10.3389/fphar.2023.1175811. eCollection 2023.

Authors

Wenjing Ni^{1

2}, Tao Liu¹, Yujing Liu^{1

2}, Lu Lu^{1

2}, Bingduo Zhou³, Yancheng Dai⁴, Hang Zhao⁵, Hanchen Xu^{1

2}, Guang Ji^{1

2}

Affiliations

¹ Institute of Digestive Diseases, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
² Shanghai Frontier Research Center of Disease and Syndrome Biology of Inflammatory Cancer Transformation, Shanghai, China.
³ Department of Gastroenterology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
⁴ Department of Gastroenterology, Shanghai Traditional Chinese Medicine-Integrated Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
⁵ Department of Gastroenterology, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.

Abstract

Background: The recurrence of colorectal adenomas (CRAs) after endoscopy predisposes patients to a risk of colorectal cancer. Guided by the traditional Chinese medicine (TCM), patients with colorectal diseases usually manifest with spleen deficiency syndrome (SDS) and are treated with Sijunzi decoction (SJZD). Therefore, this trial aims to explore the efficacy and safety of SJZD in the prevention and treatment of CRAs recurrence. Methods: SJZD on prevention and treatment of CRAs recurrence after resection: a multicenter, randomized, double-blind, placebo-controlled trial was designed. Patients who undergo polypectomy of CRAs will be recruited and randomized into a SJZD group and a placebo group in a 1:1 ratio. The intervention phase will be 12 months. The follow-up period will last 24 months. The primary outcome is the CRA recurrence rate after intervention. The secondary outcomes include the CRA recurrence rate at the second year post-polypectomy, the pathological type of adenoma and the alterations in SDS scores after intervention. Discussion: Previous clinical practice has observed the sound effect of SJZD in the context of gastrointestinal diseases. A number of experiments have also validated the active components in SJZD. This trial aims to provide tangible evidence for the usage of SJZD, hoping to reduce the recurrence of CRAs.

Keywords: Sijunzi decoction; colorectal adenoma; randomized controlled trial; spleen deficiency syndrome; traditional Chinese medicine.

Grants and funding

This research is funded by the Clinical Cultivation Projects of National Medical Center of Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (grant number GY202202). The funders have no right in study design, data collection, management, analysis, interpretation, publication decisions, or manuscript preparation.