Evidence map›Paper›PMID 30314508›Full record

Trial reportTrials2018

"Yellow-dragon Wonderful-seed Formula" for hyperuricemia in gout patients with dampness-heat pouring downward pattern: a pilot randomized controlled trial.

Xiao Ning Yu, Hai Yan Wu, Yuan Ping Deng, Guang Tong Zhuang, Bang Huan Tan, Yan Zhou Huang, Shi Yun Tang, Xiang Tu, James B Jordan, Sen Zhong

Abstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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

13 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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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

10 authors.

Xiao Ning YuBasic Medical College of Chengdu University of Traditional Chinese Medicine, Chengdu, 611137, Sichuan Province, China.
Hai Yan WuDepartment of Gerontology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, 610072, Sichuan Province, China.
Yuan Ping DengDepartment of Internal Medicine, Traditional Chinese Medicine Hospital of Fushun County, Fushun, 643200, Sichuan Province, China.
Guang Tong ZhuangDepartment of Internal Medicine, Traditional Chinese Medicine Hospital of Pidu District, Chengdu, 611730, Sichuan Province, China.
Bang Huan TanDepartment of Internal Medicine, Traditional Chinese Medicine Hospital of Kaizhou District, Chongqing City, 405400, China.
Yan Zhou HuangDepartment of Internal Medicine, Traditional Chinese Medicine Hospital of Kaizhou District, Chongqing City, 405400, China.
Shi Yun TangCollege of Clinical Medicine, Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, Sichuan Province, China.
Xiang TuNational Traditional Chinese Medicine Clinical Research Base for Diabetes Mellitus/Teaching Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, 610072, Sichuan Province, China. tuxiang2005@163.com.
James B JordanNational Traditional Chinese Medicine Clinical Research Base for Diabetes Mellitus/Teaching Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, 610072, Sichuan Province, China.
Sen ZhongAdministration Committee of Affiliated Hospitals of Chengdu University of Traditional Chinese Medicine, Chengdu, 611137, Sichuan Province, China. zhongsen6606@163.com.

Funding

Physician Investigator Foundation of National TCM Clinical Research Base for Diabetes Mellitus CSZYJ2011010
6 · The paper itself

Abstract

backgroundIn Traditional Chinese Medicine (TCM) theories, the typical clinical manifestations of gout are attributed to the "dampness-heat pouring downward." Therefore, TCM practitioners always consider prescribing the formulae which are believed to clear heat and drain dampness for the management of gout. This clinical trial aims: (1) to determine the hypouricemic effect of "Yellow-dragon Wonderful-seed Formula" (YWF) decoction in gout patients with dampness-heat pouring downward pattern and (2) to determine if gypsum could provide additional significant benefits to YWF.

methodsA total of 72 hyperuricemic individuals with gout and dampness-heat pouring downward pattern were included with 62 of them completing the trial. Participants were randomly assigned to the YWF group, the YWF + gypsum group, or the allopurinol group. YWF and YWF + gypsum decoctions were orally administered for four weeks. Allopurinol was also orally administered for four weeks as the active control. Serum uric acid (sUA) level was the primary outcome measure. Urine urate level, scores on the SF-36 scale, erythrocyte sedimentation rate (ESR), X ray film, and C reactive protein (CRP) level were the secondary outcome measures.

resultsCompared with the values at week 0, YWF and YWF + gypsum did not significantly decrease the sUA level at each weekend reading. YWF, YWF + gypsum, and allopurinol decreased the urine urate levels and there were significant differences between the YWF group and the YWF + gypsum group. All the changes in the eight structures of SF-36 during the intervention period were not significantly different among the three groups and there was no significant difference in the CRP level among the three groups at each weekend reading.

conclusionsYWM, which modified on the basis of Two Wonderful Herbs Powder (2WHP), does not show significant hypouricemic effect. There is a possibility that Gypsum Fibrosum may provide additional effects to YWF in decreasing the urine urate levels but cannot add benefits to YWF in other outcome measures.

trial registrationChinese Clinical Trial Registry, ChiCTR-TRC-12001933 . Registered on 10 February 2012.

Indexed as

AdultBiomarkersChinaDown-RegulationDrugs, Chinese HerbalGoutGout SuppressantsHumansHyperuricemiaMaleMiddle AgedPilot ProjectsTime FactorsTreatment OutcomeUric AcidBiomarkersDrugs, Chinese HerbalGout SuppressantsUric AcidChinese herbal medicine formulaGoutGypsum FibrosumHyperuricemiaRandomized controlled trialYellow-dragon Wonderful-seed formula

Identifiers

PMID30314508
PMCPMC6186073

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Registered trials

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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.