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Chinese Medicine JQ Granule Combined with Half-Dose European Journal of Integrative Medicine 31 (2019) 100974 Contents lists available at ScienceDirect European Journal of Integrative Medicine journal homepage: www.elsevier.com/locate/eujim Protocol Chinese medicine JQ granule combined with half-dose omeprazole for T nonerosive reflux disease: A multicenter, randomized, double-blind, placebo-controlled trial study protocol Xiaoshuang Shia,b,1, Xia Lia,1, Jinxin Mab,1, Hui Cheb, Xiangxue Maa, Jingyi Xiea, Xiaolan Yinb, Haomeng Wuc, Lin Lvb, Ting Chenb, Jiaqi Zhangb, Enjin Zenga, Xudong Tangb,*, Fengyun Wangb,* a Graduate School, Beijing University of Chinese Medicine, No. 11, Beisanhuandong Road, Chaoyang District, Beijing 100029, PR China b Department of Gastroenterology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Xiyuan Road, Haidian District, Beijing 100091, PR China c The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, 55 Neihuan Xilu, Xiaoguwei Street, Panyu District, Guangzhou Higher EducationMega Center, Guangzhou 510006, PR China ARTICLE INFO ABSTRACT Keywords: Introduction: Nonerosive reflux disease (NERD) is a kind of esophageal disease manifesting mainly as heartburn Chinese medicine and regurgitation. The prevalence of NERD in patients with gastroesophageal reflux disease is up to 70%, and it JQ granule significantly affects the quality of life of patients. In China, besides proton-pump inhibitors (PPIs), aherbal Nonerosive reflux disease formula is widely used in nonerosive reflux disease, which can improve intestinal and extra-intestinal symptoms Omeprazole of patients. This study will evaluate in a large, independent, randomized controlled trial (RCT) the comparative Randomized controlled trial effectiveness of a specific type of Chinese herbal granule with half-dose PPI and full-dose PPI inmanaging Protocol nonerosive reflux disease. Methods and analysis: This trial will be a multicenter, randomized, double-blind, placebo-controlled RCT. A total of 204 participants will be enrolled and randomized (1:1) to each group: herb granules plus 10 mg omeprazole plus 10 mg dummy omeprazole; and dummy herb granules plus 20 mg omeprazole. The efficacy measures will be the changes in scores in the Gastroesophageal Reflux Disease Questionnaire, the Short-Form 36, the Patient Report Outcome, the 17-item Hamilton Depression Scale, and the Signs and Symptoms Scale. Discussion: This study will focus on the quality control of a Chinese medical formulation. The RCT research procedure will be conducted under the supervision of the Good Clinical Practice (GCP) center. This trial will reduce the routine dosage of omeprazole while adding Jianpi Qinghua JQ granule, with the aim to discuss the safety and effectiveness of the Chinese herbal granule on esophageal and extraesophageal symptoms while meeting the ethical requirements. 1. Introduction [1]. GERD is prevalent worldwide, and the disease burden has in- creased. The typical symptoms of GERD are heartburn and regurgita- Gastroesophageal reflux disease (GERD) is one of the most common tion. Atypical symptoms, including dyspepsia, epigastric pain, chest diseases in gastroenterology. GERD is characterized by symptoms re- pain, bloating, nausea, and belching, may be indicative of GERD but sulting from the reflux of gastric contents into the esophagus, oral overlap with other conditions [2]. A retrospective study found that the cavity, larynx, or lung. Based on the results of esophagoscopy, GERD frequency of regurgitation and heartburn had an incremental negative can be classified into two types according to the erosion of theeso- impact on health-related quality of life [3]. The patients had an increase phagus: nonerosive reflux disease (NERD), which is without erosions, in time off work and decrease in work productivity and physical func- and reflux esophagitis (RE) with erosions. The prevalence estimates tioning. show considerable geographic variations. The range of GERD pre- To treat GERD, lifestyle intervention is the first choice. It contains valence estimate is 18.1%–27.8% in North America and 8.8%–25.9% in weight loss, tobacco and alcohol cessation, avoidance of late-night Europe, but only East Asia shows estimates consistently lower than 10% meals, and cessation of high-glucose and high-fat diet that can ⁎ Corresponding authors. E-mail addresses: [email protected] (X. Tang), [email protected] (F. Wang). 1 Xiaoshuang Shi, Xia Li, Jinxin Ma contributed equally to this work. https://doi.org/10.1016/j.eujim.2019.100974 Received 18 December 2018; Received in revised form 4 September 2019; Accepted 13 September 2019 1876-3820/ © 2019 Elsevier GmbH. All rights reserved. X. Shi, et al. European Journal of Integrative Medicine 31 (2019) 100974 aggravate reflux symptoms. Patients failing in lifestyle interventions participants’ use will be prescribed and overseen by the respective chief can try medical treatments including antacids, histamine-receptor an- physician and ethics committee. tagonists (H2RA), or proton-pump inhibitor (PPI) therapy. However, a Cochrane systematic review demonstrated that PPIs were more effec- 2.2. Participants tive than H2RAs in relieving symptoms of heartburn in patients with GERD [4]. At present, PPIs have a definite effect and are the most 2.2.1. Inclusion criteria widely used drugs for treating GERD. The diagnostic criteria of NERD will be in accordance with the China However, adverse events concerning PPIs have received increasing Consensus Opinion on Gastroesophageal Reflux Disease, 2006 edition. attention in recent years. The main adverse events include headache, Participants aged between 18 and 70 years who meet the following diarrhea, and dyspepsia. Other potential adverse reactions include vi- diagnostic criteria will be included: typical symptoms of heartburn and tamin and mineral deficiencies, pneumonia and diarrhea, hip fractures regurgitation appearing at least 1 day a week; elimination of RE, and osteoporosis, and cardiovascular events in patients using clopido- Barrett’s esophagus, and other upper gastrointestinal diseases revealed grel. A research found that PPIs are likely to encourage the growth of by esophagogastroduodenoscopy (EGD) in recent 1 month; participants’ some gut microflora and increase susceptibility to pathogenic bacteria score on GerdQ no less than eight; and participants willing and able to [5]. The American Gastroenterological Association suggested that the give informed consent. dose of long-term PPIs should be reevaluated periodically to guarantee the lowest-effective PPI dose that can be prescribed to adapt tothe treatment protocols [6]. Further, during maintenance PPI therapy, pa- 2.2.2. Exclusion criteria tients with GERD sometimes complain of upper gastrointestinal symp- The exclusion criteria will be as follows: potential participants with toms. A study found that upper gastrointestinal symptoms were more severe primary disease of other systems or cancer; women who are severe in patients with NERD than in patients with RE. These patients pregnant, breastfeeding, or preparing for pregnancy; people currently with NERD paid more attention to their upper GI symptoms, wanted to using drugs that interacted with PPIs and reduced their effectiveness, or change PPI therapy [7], and had severe epigastric pain or burning involved in another clinical trial; and people allergic to any herb in the symptoms, severe depression, and less therapeutic response compared JQ granule. with patients with RE [8]. Although PPIs are the most commonly used medical treatment for GERD, they cannot resolve all GERD symptoms; a 2.2.3. Participant timeline part of the patients are not satisfied with the PPI therapy [9]. The participants will be enrolled for a total of 6 weeks (4 weeks for The use of herbal decoction is prevalent in clinic in China. Jianpi the treatment phase and 2 weeks as the follow-up period). During the Qinghua (JQ) granule is often used in the gastroenterology department prescreening and screening period, the participants need to discontinue for patients with NERD. It is used as a granulated extract obtained by the NERD-related drugs, including PPI, H2RA, antacids, anti- spray drying the hot water extract of a mixture of 10 crude herbs. The depressants, and any herbs; complete the EGD safety test; and sign the combination of herbs in the JQ granule is based on traditional Chinese informed consent form (the specific content of informed consent form medicine (TCM) theories and the clinical experience of TCM practi- can be found in online supplementary appendix 1). During the baseline tioners (meanwhile, the JQ granule is being reviewed by the China phase, the participants need to complete the first assessment and be National Intellectual Property Administration). The herbs in the JQ randomly assigned to one group. During the treatment phase, they will granule have different effects, including protective effects on gastric be guided how to take medicines, followed by assessment after 2 and 4 mucosa [10,11], antispasmodic effects [12], accelerating gastric emp- weeks for compliance and outcome. The follow-up phase will be 2 tying and intestinal transit [13,14], anti-inflammatory effects [15], and weeks after completion of the treatment. even antidepressant effects [13]. The dosage is within the safe limit specified in the Chinese Pharmacopoeia (2015 edition). 2.2.4. Recruitment This study will be performed to evaluate the comparative safety and Potential participants will be identified through gastroenterology effectiveness of omeprazole and
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