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

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.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2917-8) contains supplementary material, which is available to authorized users.

The Impact of Natural Product Dietary Supplements on Patients with Gout: A Systematic Review and Meta‐Analysis of Randomized Controlled Trials

“…A total of nine RCTs with 1156 participants were included in this review. Seven trials were conducted in China [20][21][22][23][24][25][26], 1 in the USA [27], and 1 in New Zealand [28]. All the studies were published from 2008 to 2019.…”

“…Seven studies evaluated herbal therapies, with the remaining two evaluating skim milk and cherry extract. Six trials had two arms; [20,25], one adopted the random envelope method [21], and the other used online computer random number generator [27]. e other two trials had an unclear risk for random sequence generation due to lack of detail [23,26].…”

“…e other two trials had an unclear risk for random sequence generation due to lack of detail [23,26]. Two trials had high-risk bias for allocation concealment [20,25]. Two trials had unclear randomization without description in sufficient detail [23,26].…”

“…ree trials were doubleblinded trials with a lower risk for blinding participants and study personnel [21,22,28]. Two trials did not use a blinding method to participants and study personnel during the study with a high risk due to the great appearance difference between Chinese medical formulation pills and decoction with conventional pharmaceutics such as indomethacin, benzbromarone, and allopurinol [20,25]. e other four trials had insufficient information to permit a judgment [23,24,26,27].…”

“…e other four trials had insufficient information to permit a judgment [23,24,26,27]. ree trials could be regarded as lower risk for blinding of outcome assessors [20][21][22]. One trial had high risk in outcome assessment due to a lack of blinding [25].…”