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Randomized Controlled Trial
. 2018 Oct 11;19(1):551.
doi: 10.1186/s13063-018-2917-8.

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

Affiliations
Randomized Controlled Trial

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

Xiao Ning Yu et al. Trials. .

Abstract

Background: In 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.

Methods: A 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.

Results: Compared 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.

Conclusions: YWM, 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 registration: Chinese Clinical Trial Registry, ChiCTR-TRC-12001933 . Registered on 10 February 2012.

Keywords: Chinese herbal medicine formula; Gout; Gypsum Fibrosum; Hyperuricemia; Randomized controlled trial; Yellow-dragon Wonderful-seed formula.

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Conflict of interest statement

Ethics approval and consent to participate

The protocol was approved by the ethics committee of the Teaching Hospital of Chengdu University of TCM and all patients provided a written informed consent.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Participant flow. A total of 72 patients were randomized to the three arms. All 72 participants received the allocated intervention and therefore all 72 were included in the FAS. Ten individuals dropped out and therefore 62 participants were included in the PPS
Fig. 2
Fig. 2
Changes in sUA of the three intervention groups. The sUA level of the YWF arm and YWF + gypsum arm did not significantly decrease at each reading, whereas allopurinol significantly reduced the sUA level. There was no significant change among the three arms at each reading
Fig. 3
Fig. 3
Changes in urine urate of the three intervention groups. The level of urine urate of all three arms significantly decreased at each reading in comparison with the values at week 0. There was a significant difference between YWF arm and YWF + gypsum arm at each reading

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