Evidence map›Paper›PMID 34702311›Full record

ArticleTrials2021

Effect of alkalized urine on renal calculi in patients with gout: a protocol for a placebo-controlled, double-blinded randomized controlled trial.

Ertao Jia, Haiqiong Zhu, Hongling Geng, Yadong Wang, Li Zhong, Shangwen Liu, Feng Lin, Jianyong Zhang

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 39% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 1 country.

Ertao Jia *The Department of Rheumatology, Shenzhen Traditional Chinese Medicine Hospital, No. 1, Fuhua Road, Futian District, Shenzhen, 518033, Guangdong, China.
Haiqiong Zhu *Shenzhen Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.
Hongling Geng *The Department of Gynecology, Guangdong Provincial Hospital of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.
Yadong WangThe Department of Urology, Shenzhen Traditional Chinese Medicine Hospital, Shenzhen, China.
Li ZhongThe Department of Rheumatology, Shenzhen Traditional Chinese Medicine Hospital, No. 1, Fuhua Road, Futian District, Shenzhen, 518033, Guangdong, China.
Shangwen LiuThe Department of Urology, Shenzhen Traditional Chinese Medicine Hospital, Shenzhen, China.
Feng LinThe Department of Urology, Shenzhen Traditional Chinese Medicine Hospital, Shenzhen, China. 531548985@qq.com.
Jianyong ZhangThe Department of Rheumatology, Shenzhen Traditional Chinese Medicine Hospital, No. 1, Fuhua Road, Futian District, Shenzhen, 518033, Guangdong, China. 13823396319@163.com.
Shenzhen Pingle Orthopedic Hospital · CNGuangzhou University of Chinese Medicine · CNNanjing University of Chinese Medicine · CN

Funding

sanming project of medicine in shenzhen SZSM201612080science and technology planning project of shenzhen municipality JCYJ20180302173532311shenzhen science and technology plan project JCYJ20170817094922513
6 · The paper itself

Abstract

backgroundThe prevalence of renal calculi in patients with gout is high. Alkalized urine has been recommended by the 2020 European Association of Urology (EAU) guidelines to promote calculus dissolution. However, randomized controlled trials are lacking.

methodsIn the protocol of this randomized, placebo-controlled, double-blinded trial, patients with gout combined with renal calculi are randomized (1:1) to the placebo and sodium bicarbonate groups. The intervention would be performed for 24 weeks, the 1-12 weeks are double-blinded, and the 13-24 weeks are open-labeled. Sodium bicarbonate (1 g tid) will be performed for 24 weeks in the sodium bicarbonate group. The placebo will be performed for 12 weeks and not be performed from 13 weeks to 24 weeks in the placebo group. All subjects will be administered febuxostat (40 mg/day) for 24 weeks and receive concomitant anti-inflammatory prophylaxis therapy for 12 weeks. The primary outcome is the proportion of patients whose renal calculus volume will be reduced after 12 weeks of treatment. The secondary outcomes include the volume changes of renal calculi, uric acid changes, the proportion of patients with serum uric acid (sUA) levels < 360 μmol/L, the changes in estimated glomerular filtration rate (eGFR), the pH value of urine, and the incidence of adverse events after treatment for 12 and 24 weeks. DISCUSSION: This study will evaluate the efficacy and safety of sodium bicarbonate-alkalized urine on renal calculi in patients with gout.

trial registrationClinicalTrials.gov ChiCTR2100045183. Registered on April 7, 2021, with ChiCTR.

Indexed as

GoutKidney CalculiDouble-Blind MethodFebuxostatGout SuppressantsHumansRandomized Controlled Trials as TopicTreatment OutcomeUric AcidFebuxostatGout SuppressantsUric AcidGoutRenal calculusSodium bicarbonateUrine alkalization

Identifiers

PMID34702311
PMCPMC8547024
OpenAlexW3209014125

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.