Efficacy and Safety of Small Molecule Water in Patients with Asymptomatic Hyperuricemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial
Wenhui He, Department of Nephrology, Shanghai Ocean University, Shanghai, China, Email: whhe@shou.edu.cn
Abstract
Background: To date, there is no appropriate scheme to lower Serum Uric Acid (SUA) in patients with SUA between 7.0-9.0 mg/dL without symptoms and comorbidities. We wondered whether Small Molecule Water (SMW) lower SUA in these patients.
Methods: This multicenter, randomized, double-blind, placebo-controlled trial was conducted at six tertiary hospitals in China. Participants aged at least 18 years with asymptomatic hyperuricemia who had no comorbidities were screened. Patients were randomly assigned (1:1) to either SMW (1600 ml/day, intervention) or placebo (raw water, 1600ml/day, control), simultaneously recommending to follow a conventional low-purine (i.e., plant-dominant low-protein) diet. The primary outcome was the mean change of SUA from baseline to 12 weeks.
Results: 232 participants were enrolled from 6 tertiary hospitals. Mean SUA decreased by 0.71 mg/dL (95% CI 0.37-1.03 mg/dL) from baseline to 12 weeks in the intervention group and by 0.36 mg/dL (95% CI 0.26-0.45 mg/dL) in the control group, with a group difference of 0.35 mg/dL (95% CI 0.25-0.35 mg/dL; p<0∙0001). At 12 weeks, 44 (35.3%) of 116 patients in the intervention group and 24 (20.7%) of 116 patients in the control group had an SUA of less than 7.0 mg/dl, with a relative risk of 1.71 (95% CI 1.33-2.14). Also, body mass index, total cholesterol, and low-density lipoprotein cholesterol decreased, but high-density lipoprotein cholesterol increased in the intervention group.
Conclusion: SMW may short-termly lower SUA and improve body metabolism in adult patients with asymptomatic hyperuricemia on a conventional low-purine diet.
Keywords
Hyperuricemia
INTRODUCTION
Hyperuricemia refers to the fasting blood uric acid level exceeding 7.0 mg/dL in adults, regardless of gender, twice on different days on a normal purine diet [1]. Although clinically relevant manifestations may develop in a hyperuricemic individual at any point, about two-thirds or more of such individuals remain asymptomatic, never developing gout flares, tophaceous gout, acute or chronic hyperuricemic nephropathy, or uric acid nephrolithiasis [2,3]. Asymptomatic hyperuricemia is a term traditionally applied to settings where the serum urate concentration is elevated but in which neither symptoms nor signs of monosodium urate crystal deposition disease, such as gout or uric acid renal disease, have occurred. In addition to its relationship with urate or uric acid crystal deposition, asymptomatic hyperuricemia has also been associated with other disorders that appear to be largely unrelated to crystal deposition, including hypertension, chronic kidney disease, cardiovascular disease, and insulin resistance syndrome. Our previous studies reported that asymptomatic hyperuricemia was associated with adverse cardiovascular disease in elderly patients without comorbidities [4-6]. A five-year Japanese cohort study also found that asymptomatic hyperuricemia carried a significant risk of developing cardiometabolic conditions in Japanese individuals without comorbidities [7].
Author Info
Xianfeng Wu 1Xiaojiang Zhan 2
Yueqiang Wen 3
Ziran Peng 4
Fenfen Peng 5
Junnan Wu 6
Na Tian 7
Wenhui He 8
Received: 22-Aug-2025 Accepted Date: 08-Sep-2025 Published: 10-Oct-2025
Citation: Wu X, Jian G, Yang R, Zhan X, Wen Y, Peng Z, et al. (2021) Efficacy and Safety of Small Molecule Water in Patients with Asymptomatic Hyperuricemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial. J Nephrol.1: 001.
Copyright: © 2025 Wu X, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
