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Chinese herbal extract granules combined with 5- aminosalicylic acid for patients with moderately active ulcerative colitis: study protocol for a multicenter randomized double-blind placebo- controlled trial Zhaofeng Shen Aliated Hospital of Nanjing University of Chinese Medicine https://orcid.org/0000-0002-7914-3965 Kai Zheng Department of Gastroenterology,Jiangsu Province Hospital of Chinese Medicine Jiandong Zou Aliated Hospital of Nanjing University of Chinese Medicine Peiqing Gu Jiangsu Province Academy of Traditional Chinese Medicine Jing Xing Michigan State University Eli Broad College of Business Lu Zhang Department of Gastroenterology, Jiangsu Province Hospital of Chinese Medicine Lei Zhu ( [email protected] ) Hong Shen Department of Gastroenterology, Jiangsu Province Hospital of Chinese Medicine Study protocol Keywords: Ulcerative colitis, Chinese herbal medicine, 5-aminosalicylic acid, Multicenter randomized controlled trial, Study protocol Posted Date: January 11th, 2021 DOI: https://doi.org/10.21203/rs.3.rs-29723/v2 License: This work is licensed under a Creative Commons Attribution 4.0 International License. Read Full License Page 1/19 Version of Record: A version of this preprint was published on January 13th, 2021. See the published version at https://doi.org/10.1186/s13063-020-05012-8. Page 2/19 Abstract Background: Ulcerative colitis (UC) is an intestinal inammatory disease characterized by inammation of the colonic mucosa. With unknown pathogenesis, it has become a chronic lifetime disorder worldwide. In patients with moderately active UC, several therapies (e.g. aminosalicylates, corticosteroids, immunosuppressants and biologics) are recommended for induction (or maintenance) of remission. Given the side effects and disease burden, it is dicult for most patients to achieve ideal treatment goals in clinical practice. Chinese herbal medicine (CHM), as a complementary therapy, has been widely used in the management of UC in China. Qing-Chang-Hua-Shi granule (QCHS) is a classical Chinese herbal formula. Our preliminary study suggested that the QCHS decoction has a signicant effect on patients with moderately active UC. However, its effectiveness and safety has not been evaluated convincingly. Therefore, we designed this protocol to investigate the ecacy of QCHS granule for moderately active UC. Methods: This is a multicenter, randomized, double-blind, placebo-controlled, superiority trial. A total of 120 patients with moderately active UC will be recruited from 10 hospitals in China. Each eligible participant will be randomly assigned to receive QCHS granule or placebo for 12 weeks. Both groups will be given basic treatment with mesalazine (4g/d). The primary outcomes are the clinical response (remission) rate. The secondary outcomes are health-related quality of life, endoscopic response rate, mucosal healing rate and inammatory markers (e.g. Fecal calprotectin and CRP). The whole study period will last 36 weeks, including 24 weeks follow-up time. According to the intention-to-treat principle, variables will be assessed at 2, 4, 6, 8, 10 and 12 weeks after study commencement. Discussion: This is the rst randomized controlled clinical study protocol regarding Chinese herbal extract granules in the management of moderately active UC. We aim to investigate the superiority of QCHS granules over placebo in terms of induction of remission. If the trial shows signicant benets of QCHS granules, it will help clinical practitioners, UC patients and policymakers make more informed choices in the decision-making. Trial registration: Chinese Clinical Trial Registry, ChiCTR-IOR-14005554. Registered on 27 November 2014. Background Ulcerative colitis (UC) refers to a subtype of inammatory bowel disease (IBD), which is characterized by chronic idiopathic inammation of the large intestine (e.g. colonic mucosa) [1,2]. As a lifelong disease [3,4], UC has a signicant impact on health-related quality of life [5,6]. To date, the pathogenesis mechanism of UC is not fully understood, associated with multiple factors (e.g. heredity, environment, immunity and behavior) [7,8]. As a result, it has become a global refractory disease with worldwide shifting epidemiological characteristics. According to a recent survey, the incidence and prevalence in developed areas such as North America and Europe have been stable [9]. However, the data in in Asia and other developing countries have encountered a signicant increase over the past decade [10,11]. Currently, the optimal goal of management is to induce (steroid-free) remission, maintain remission, Page 3/19 prevent disease-related complication and health-related quality of life [12]. Besides, it is believed that an emerging goal in UC management is mucosal healing. To achieve these goals, 5-aminosalicylic acid, corticosteroids, immunosuppressants, biological agents and other promising treatment (e.g. fecal microbiota transplantation) have been developed one by one [13]. As a consequence, budesonide, corticosteroids and anti-TNF therapy (e.g. adalimumab, golimumab and iniximab) have been strongly recommended to induce remission for moderately active UC with moderate to high quality of evidence [14]. However, many patients do not react well to these conventional drugs in clinical practice. What’s worse, most of these treatments have limitations in safety and ecacy, such as serious side-effects, long course of treatment, heavy burden of disease, and so on [15,16]. Therefore, there still seems to be room for improvement in the management of moderately active UC. Historically, in Asia (especially in China), Chinese herbal medicine (CHM) has been widely used for UC due to the unique advantages of ecacy and safety [17]. Under the circumstance, an increasing amount of evidences have shown that CHM have potentially positive effects on UC [18–20]. According to the theory of traditional Chinese medicine (TCM), CHM plays an irreplaceable role in the management of UC. Over the past decade, our group has been searching for Chinese herbs that can be used for UC. Through years of our clinical practice, we found that QCHS formula developed from classical Chinese herbal formulas could not only relieve patients' clinical symptoms, but also promote mucosal healing by adjusting the balance of the body. Our previous studies in vivo have proved that QCHS was associated with signicant benets regarding ameliorating the damage to colon length, suppressing inammatory cytokines and mediators, alleviating oxidative stress through β2AR/β-arrestin2/NF-κB signaling pathway [21,22]. Furthermore, QCHS could signicantly inhibit apoptosis in HT-29 cells through MEK/ERK signaling via SGK1 [23]. However, our preliminary studies were limited to systematic top-level design (e.g. small sample size, placebo effect). Given these ndings, the evidence of its effectiveness and safety was unconvincing, especially in patients with moderately active UC. Under the circumstance, we designed this protocol, a prospective, multicenter, randomized, double-blind, placebo-controlled, superiority trial, to further determine the ecacy and safety of QCHS granule combination therapy for UC patients who do not respond to 5-ASA after 4 weeks. We predict that patients with moderately active UC will benet in terms of clinical remission, mucosal healing and quality of life. Hypothesis and objective In our protocol, we hypothesize that QCHS granule combined with basic treatment (5-ASA) is superior to placebo plus 5-ASA on clinical response (remission) rate, mucosal healing rate, clinical syndromes, quality of life, inammatory mediators (e.g. Fecal calprotectin, TNF-α and hs-CRP) and adverse side- effects. The primary objective of this trial is to investigate the ecacy of QCHS granule combined with 5-ASA in the management of patients with moderately active UC. Furthermore, the secondary objective is to explore the safety of QCHS granule for moderately active UC. Page 4/19 Methods Study design This is a prospective, multicenter, randomized, double-blind, placebo-controlled, superiority clinical trial, which conforms to the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement guidelines [24], the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Statement [25] and the Standard Protocol Items for Clinical Trials with Traditional Chinese Medicine: Recommendations, Explanation and Elaboration (SPIRIT-TCM) Extension 2018 Statement [26]. The study began in January 2016 and will last until October 2022. A total of 120 eligible patients will be enrolled and randomized into QCHS granule group or placebo group. All patients will voluntarily sign the informed consent prior to enrollment. Prior to allocation, each of them will be screened by the eligibility criteria. According to patients’ included sequence number equally, block randomization will be performed to ensure equal group sizes with an allocation of 1:1 (permuted block sizes of 6). Participants in QCHS granule group will receive QCHS granule (125 g daily, orally) for continuous 12 weeks, while patients in placebo group will receive QCHS granule placebo (125 g daily, orally) for the same duration. Both groups will be given basic treatment with mesalazine (5-aminosalicylic acid, 4g/d). Researchers and patients will be blinded from the beginning of the trial. All interested outcomes including patient-reported outcomes will be collected before (0 week) and after intervention (2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 12 weeks). The whole study period will
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