Dataset Information

A Randomized Controlled Trial of Chuanhutongfeng Mixture for the Treatment of Chronic Gouty Arthritis by Regulating miRNAs.

ABSTRACT: Background:We investigated whether Chuanhutongfeng mixture has actions on chronic gouty arthritis (CGA) by regulating miRNAs. Methods:A total of 255 patients with CGA and 30 controls were enrolled. miRNA expression profiles and cluster analysis were preformed; RT-qPCR was used to detect miRNAs associated with CGA. Patients were allocated into Chuanhutongfeng mixture, allopurinol (positive control), and control (etoricoxib) groups. Expression of plasma miRNAs was measured before and after treatments; expression of chemokine 2 (CCL2) and interleukin 8 (CXCL8) was determined by ELISA. Results:48 miRNAs were differentially expressed and compared to controls. 36 miRNAs expression levels were > 1.5 times and 12 miRNAs < 1.5 times compared to the controls. miR-339-5p, miR-486-5p, and miR-361-5p levels in patients with CGA were lower than in controls (P < 0.05). This trial showed that the Chuanhutongfeng mixture and allopurinol groups had upregulated the expressions of miR-486-5, miR-339-5p, and miR-361-5p and decreased levels of CCL2 and CXCL8 proteins. After 8 weeks of treatment, Chuanhutongfeng mixture decreased serum uric acid levels more than allopurinol (P < 0.05) and reduced levels of CCL2 and CXCL8 protein significantly more than in the allopurinol and control groups. Conclusions:The therapeutic actions of Chuanhutongfeng mixture inhibit the expression of proteins CCL2 and CXCL8 in plasma and upregulated the expressions of three miRNAs (miR-486-5p, miR-339-5p, and miR-361-5p).

SUBMITTER: Wang Y

PROVIDER: S-EPMC6378063 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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A Randomized Controlled Trial of Chuanhutongfeng Mixture for the Treatment of Chronic Gouty Arthritis by Regulating miRNAs.

Wang Yao Y Dong Liping L Liu Peng P Chen Ying Y Jia Shaodan S Wang Yangang Y

Evidence-based complementary and alternative medicine : eCAM 20190203

<h4>Background</h4>We investigated whether Chuanhutongfeng mixture has actions on chronic gouty arthritis (CGA) by regulating miRNAs.<h4>Methods</h4>A total of 255 patients with CGA and 30 controls were enrolled. miRNA expression profiles and cluster analysis were preformed; RT-qPCR was used to detect miRNAs associated with CGA. Patients were allocated into Chuanhutongfeng mixture, allopurinol (positive control), and control (etoricoxib) groups. Expression of plasma miRNAs was measured before an ...[more]

PMID: 30854012

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Project description:In phase-3 clinical trials, the interleukin (IL-1) blocker, rilonacept (IL-1 Trap), demonstrated efficacy for gout flare prevention during initiation of urate-lowering therapy. This trial evaluated rilonacept added to a standard-of-care, indomethacin, for treatment of acute gout flares.Adults, aged 18-70 years, with gout presenting within 48 hours of flare onset and having at least moderate pain as well as swelling and tenderness in the index joint were randomized to subcutaneous (SC) rilonacept 320 mg at baseline plus oral indomethacin 50 mg TID for 3 days followed by 25 mg TID for up to 9 days (n = 74); SC placebo at baseline plus oral indomethacin as above (n=76); or SC rilonacept 320 mg at baseline plus oral placebo (n=75). The primary efficacy endpoint was change in pain in the index joint (patient-reported using a Likert scale (0=none; 4=extreme)) from baseline to the average of values at 24, 48 and 72 hours (composite time point) for rilonacept plus indomethacin versus indomethacin alone. Comparison of rilonacept monotherapy with indomethacin monotherapy was dependent on demonstration of significance for the primary endpoint. Safety evaluation included clinical laboratory and adverse event (AE) assessments.Patient characteristics were comparable among the groups; the population was predominantly male (94.1%), white (75.7%), with mean±SD age of 50.3±10.6 years. All treatment groups reported within-group pain reductions from baseline (P<0.0001). Although primary endpoint pain reduction was greater with rilonacept plus indomethacin (-1.55±0.92) relative to indomethacin alone (-1.40±0.96), the difference was not statistically significant (P=0.33), so formal comparison between monotherapy groups was not performed. Pain reduction over the 72-hour period with rilonacept alone (-0.69±0.97) was less than that in the other groups, but pain reduction was similar among groups at 72 hours. Treatment with rilonacept was well-tolerated with no reported serious AEs related to rilonacept. Across all groups, the most frequent AEs were headache and dizziness.Although generally well-tolerated, rilonacept in combination with indomethacin and rilonacept alone did not provide additional pain relief over 72 hours relative to indomethacin alone in patients with acute gout flare.ClinicalTrials.gov registration number NCT00855920.

Project description:Background and aimThe use of anti-inflammatory and analgesic drugs such as nonsteroidal anti-inflammatory drugs(NSAIDs) for treating acute gout has limitations, such as adverse reactions in the gastrointestinal tract and toxicity in the liver, kidney, and heart. Hence, a new safe and effective treatment approach needs to be explored to reduce the use of anti-inflammatory and analgesic drugs, incidence of adverse reactions, and patients' burden. This randomized controlled clinical trial aimed to investigate the clinical efficacy and safety of the external application of compound Qingbi granules (CQBG) in treating acute gouty arthritis(AGA), providing evidence for designing a safe, effective, and optimized protocol for AGA comprehensive treatment.MethodsA total of 90 patients in line with the diagnostic standard of AGA were recruited and randomly divided into control, T1, and T2 groups (30 in each group). All the participators in the three groups all received Western-medicine-basic treatment (low-purine diet, drinking water more than 2000 mL/days, oral loxoprofen, and NAHCO3). Besides, the T1 group received an external application of diclofenac diethylamine emulgel, while the T2 group received an external application of CQBG. The participants in the control group received single-use Western-medicine-basic treatment. With a treatment course of 7 days and a follow-up of 7 days, the three groups were compared in terms of primary outcome indicators, including swelling, pain improvement, and change in pain duration and secondary outcome indicators, including serum C-reactive protein (CRP) level, uric acid (UA) level, and change in the thickness of the inflammatory synovium of joints under ultrasound. Meanwhile, the safety of the protocol was evaluated.ResultsThe three groups of patients had no apparent differences in age, body mass index, history of gout, complications, and so on before recruitment. A comparison between pretreatment and post-treatment revealed remarkable reductions in the arthralgia visual analog scale score(VAS) and the swelling score in the three groups after the treatment and the improvements in the T2 group were more significant than those in the T1 and control groups (P?<?0.05). Regarding the onset time of pain improvement and pain duration, the T2 group had more significant efficacy compared with the other two groups (P?<?0.05). The serum CRP and blood UA levels in the three groups significantly decreased after the treatment, but with no significant intergroup difference. The improvement in the thickness of the inflammatory synovium in joints tested by ultrasound was more significant in the T2 group than in the control group (P?<?0.05). For safety evaluations, no significant difference in the incidence of adverse events was found.ConclusionsThe external application of CQBG combined with Western-medicine-basic treatment in patients with AGA improved arthralgia and swelling, shortened the period of taking NSAIDs, and reduced the levels of CRP and serum UA. Its therapeutic effect was significantly better than the effect of single-use Western-medicine-basic treatment. The study provided evidence for the clinical application of CQBG combined with Western medicine in treating AGA.Trial registrationChiCTR, ChiCTR1800018020. Registered 27 August 2018, https://www.chictr.org.cn/showproj.aspx?proj=27138.

Project description:OBJECTIVE:To assess the safety and efficacy of etoricoxib, a selective cyclo-oxygenase-2 inhibitor, in comparison with indometacin in the treatment of acute gouty arthritis. DESIGN:Randomised, double blind, active comparator controlled trial. SETTING:43 outpatient study centres in 11 countries. PARTICIPANTS:142 men and eight women (75 patients per treatment group) aged 18 years or over presenting with clinically diagnosed acute gout within 48 hours of onset. INTERVENTIONS:Etoricoxib 120 mg administered orally once daily versus indometacin 50 mg administered orally three times daily, both for 8 days. MAIN OUTCOME MEASURES:Patients' assessment of pain in the study joint over days 2 to 5 (primary end point); investigators' and patients' global assessments of response to treatment and tenderness of the study joint (key secondary end points). RESULTS:Etoricoxib showed efficacy comparable to indometacin. Patients' assessment of pain in the study joint (0-4 point Likert scale, "no pain" to "extreme pain") over days 2 to 5 showed a least squares mean change from baseline of -1.72 (95% confidence interval -1.90 to -1.55) for etoricoxib and -1.83 (-2.01 to -1.65) for indometacin. The difference between treatment groups met prespecified comparability criteria. All other efficacy end points, including those reflecting reduction in inflammation and analgesia, provided corroborative evidence of comparable efficacy. Significant pain relief was evident at the first measurement, 4 hours after the first dose of treatment. Prespecified safety analyses revealed that drug related adverse experiences occurred significantly less frequently with etoricoxib (22.7%) than with indometacin (46.7%) (P=0.003), although overall adverse experience rates were similar between the two treatment groups. CONCLUSION:Etoricoxib 120 mg once daily provides rapid and effective treatment for acute gouty arthritis comparable to indometacin 50 mg three times daily. Etoricoxib was generally safe and well tolerated in this study.

Dataset Information

A Randomized Controlled Trial of Chuanhutongfeng Mixture for the Treatment of Chronic Gouty Arthritis by Regulating miRNAs.

Publications

A Randomized Controlled Trial of Chuanhutongfeng Mixture for the Treatment of Chronic Gouty Arthritis by Regulating miRNAs.

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