Efficacy and safety of the Chinese herbal formula Hewei Jiangni recipe for NERD with cold-heat complex syndrome: study protocol for a double-blinded randomized controlled trial

Abstract

Background Proton pump inhibitor (PPI) is effective for the treatment of nonerosive gastroesophageal reflux (NERD), but long-term use of PPI is prone to have complications and recurrence after withdrawal. Traditional Chinese medicine (TCM) can relieve the symptoms of reflux and improve the quality of life. The purpose of this study is to evaluate the safety and efficacy of Hewei Jiangni recipe (HWJNR) in the treatment of NERD with cold-heat complex syndrome, and clarify the mechanism of HWJNR on NERD based on the correlation analysis of intestinal flora and metabolites. Methods This is a single-center, randomized controlled, double-blind, placebo-controlled clinical trial in which 72 eligible participants with NERD and TCM syndrome of intermingled heat and cold will be randomly allocated in the ratio of 1:1 to two groups: TCM group and western medicine group. The TCM group will receive HWJNR with omeprazole enteric-coated tablets placebo, while the western medicine group will receive omeprazole enteric-coated tablets with HWJNR placebo. Each group will be treated for 8 weeks. The primary outcome is the score of gastroesophageal reflux disease (GERD) health-related quality of life questionnaire (GERD-Q). Secondary outcomes include SF-36 quality of life scale (SF-36), patient-reported outcomes (PRO) self-rating scale score, syndrome score of TCM, and adverse events. Mechanistic outcome is the correlation analysis of intestinal flora and metabolites from healthy individuals and NERD participants before and after the treatment respectively. Discussion The goal of this trial is to investigate the efficacy and safety of HWJNR in the treatment of NERD with cold-heat complex syndrome, and to study the composition structure and metabolite expression profile of intestinal flora in patients with NERD through 16SrRNA sequencing and metabolomic correlation analysis of fecal flora, which makes us identify the dominant links of treatment and reveal the potential mechanism of HWJNR. ChiCTR2000041225. Registered on 22 December 2020

DataSheet1.PDF

“…After washing and immersion intervention, patients in both groups are to apply vaseline moisturizer on their hands and feet for local moisturizing. Treatment duration lasts for 7 consecutive days [274]. ② Test drugs including FBD and placebo were prepared by the Department of Pharmacy of the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine.…”

“…④ "Not Applicable" was considered if TCM intervention was patent proprietary CHMFs. ① Administration method: 32 g of the granules will be dissolved in 60°C to 70°C water and diluted to 1000 mL in thermostatic foot bath tub with herbal liquid temperature 35°C to 38°C [274]. ② The participants assigned to intervention group will take DGSY granules (8.4 g/pack × 2 packs, bid) and those assigned to placebo group will take placebo granules (2 packs, bid) for 24 weeks.…”

“…(This entry has not been fully reported in any study, and examples of partial reporting are applicable for reference) ① Administration method: 32 g of the granules will be dissolved in 60°C to 70°C water and diluted to 1000 mL in thermostatic foot bath tub with herbal liquid temperature 35°C to 38°C [274]. ② The trial group will be given QZWTG (2.5 G each time) and Mosapride citrate tablet placebo (5mg each time).…”