Background
Many studies have shown that NAFLD is indeed closely related to the occurrence of colon tumors. The aim of this study was to further establish an assessment for the risk associated with NAFLD and the site-specificity of colon tumors.
Methods
We searched the PubMed, Embase, Cochrane, and Scopus databases published from January 1, 1981, to December 15, 2019, assessing the risk of colorectal neoplasms in patients with NAFLD. The primary outcome measure was the incidence of site-specific risk of colorectal neoplasms in patients with NAFLD reported as ORs which pooled under a random-effects model and calculated via Mantel-Haenszel weighting. The study is registered with PROSPERO, number CRD42020162118.
Results
11 articles (12,081 participants) were included in this meta-analysis. After heterogeneity removed, the overall risk-value pooled for right colon tumors(OR = 1.60,95% CI 1.27–2.01,I2 = 58%,P = 0.02)was higher than the left(OR = 1.39,95% CI 1.11–1.73,I2 = 59%,P = 0.02).However, this outcome was unclear when considering gender differences (Male&Right:OR = 1.05; Male&Left:OR = 1.26; Female&Right: OR = 1.17; Female&Left:OR = 1.17).The incidence of right colon tumors(Asian&Right:OR = 1.56)was obviously higher in Asians with NAFLD than the left (Asian&Left:OR = 1.23),while the risk relevance was similar and moderately associated with an increased risk of incident double-sided colorectal tumors in Europeans (European&Right:OR = 1.47; European&Left:OR = 1.41). The outcome of pathological morphology includes: the advanced adenoma OR = 1.82;the tubular adenoma OR = 1.24;the serrated adenoma OR = 2.16.
Conclusions
NAFLD is associated with a high risk of colon tumors, especially in regard to tumors of the right colon, which are more prevalent in Asian populations.
Introduction
Metastatic colorectal cancer (mCRC) causes high cancer-related morbidity and mortality worldwide. Although chemotherapy and targeted agents treatment improve median survival and 5-year survival rates, there is only one-third of patients who adhere to treatment protocol until the pause of disease progression. Hezhong granule is a traditional Chinese herbal formula used for mCRC, which has shown good potential in alleviating the adverse effects of chemotherapy, enhancing the effectiveness of chemotherapy, and improving the quality of life. Therefore, the purpose of the study is to further validate the clinical efficacy and safety of the Chinese herbal medicine formula named Hezhong (HZ) in combination with standard chemotherapy and cetuximab (CET) or bevacizumab (BV) for treating mCRC.
Methods
In this multi-center, randomized, double-blinded, placebo-controlled trial, 360 eligible mCRC patients who will be randomly assigned to Hezhong or placebo group with a 1: 1 ratio. Participants in the Hezhong group will receive standard chemotherapy and CET or BV plus Hezhong Granule until the pause of disease progression, death, the exhibition of intolerable toxicity, or up to 6 months, while the placebo group will treat with standard chemotherapy and CET or BV plus placebo. The primary endpoint is progression-free survival (PFS). The secondary endpoints are overall survival (OS), objective response rate (ORR), safety, quality of life years (QOL), and chemotherapy-induced nausea and vomiting (CINV).
Expected results
The expected results of this trial are to improve the PFS and QOL of patients with mCRC and provide evidence-based recommendations for the treatment of mCRC with traditional Chinese medicine in China.
Trial registration
The trial has been registered with the Chinese Clinical Trial Registry (ChiCTR). The trial registration number was ChiCTR2100041643.
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