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Hypouricemic and arthritis relapse-reducing effects of compound tufuling oral-liquid in intercritical and chronic gout: A double-blind, placebo-controlled, multicenter randomized trial.

ABSTRACT: In the double-blind, randomized, controlled trial, we aimed to evaluate the effects of compound tufuling oral liquid (CoTOL) on serum uric acid (sUA) levels and recurrence of acute gouty arthritis in intercritical and chronic gout treatment.A total of 210 patients with gout were screened from 8 hospitals to observe the sUA and acute gouty arthritis recurrence rate-reducing effects of CoTOL in intercritical and chronic gout during a 12-week treatment. We treated 139 and 71 patients with CoTOL and the placebo, respectively, and evaluated their sUA levels, acute gouty arthritis recurrence rate, and adverse events at week 0, 6, and 12.Twenty-five and 12 patients in the treatment and control groups, respectively, had interrupted treatments, whereas 114 and 59 cases, respectively, completed their treatments. At the end of the 12-week treatment, the average decrease in sUA was 74.26 (95% confidence interval [CI]: 56.74-91.77??mol/L) and 28.81??mol/L (95% CI: 4.91-52.71??mol/L) in the treatment and control groups, respectively (P?=?0.004). The average decrease rate of sUA was 12.76% (95% CI: 9.82%-15.70%) and 4.57% (95% CI: 0.42%-8.71%) in the treatment and control groups, respectively (P?=?0.004), and the gouty arthritis recurrence rate of the treatment group was lower than that of the control group (from week 6 to 12, 21.93% and 50.88% in the treatment and control group, respectively, P?

SUBMITTER: Xie Z

PROVIDER: S-EPMC5369899 | biostudies-other | 2017 Mar

REPOSITORIES: biostudies-other

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Hypouricemic and arthritis relapse-reducing effects of compound tufuling oral-liquid in intercritical and chronic gout: A double-blind, placebo-controlled, multicenter randomized trial.

Xie Zhijun Z Wu Huaxiang H Jing Xiaoqing X Li Xiuyang X Li Yasong Y Han Yongmei Y Gao Xiangfu X Tang Xiaopo X Sun Jing J Fan Yongshen Y Wen Chengping C

Medicine 20170301 11

<h4>Trial design</h4>In the double-blind, randomized, controlled trial, we aimed to evaluate the effects of compound tufuling oral liquid (CoTOL) on serum uric acid (sUA) levels and recurrence of acute gouty arthritis in intercritical and chronic gout treatment.<h4>Methods</h4>A total of 210 patients with gout were screened from 8 hospitals to observe the sUA and acute gouty arthritis recurrence rate-reducing effects of CoTOL in intercritical and chronic gout during a 12-week treatment. We treat ...[more]

PMID: 28296744

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Project description:OBJECTIVE:Arhalofenate is a novel antiinflammatory uricosuric agent. The objective of this study was to evaluate its antiflare activity in patients with gout. METHODS:This was a 12-week, randomized, double-blind, controlled phase IIb study. Eligible patients had had ?3 flares of gout during the previous year, had discontinued urate-lowering therapy and colchicine, and had a serum uric acid (UA) level of 7.5-12 mg/dl. Patients were randomly assigned at a 2:2:2:2:1 ratio to receive 600 mg arhalofenate, 800 mg arhalofenate, 300 mg allopurinol, 300 mg allopurinol plus 0.6 mg colchicine, or placebo once a day. The primary outcome measure was the flare incidence (number of flares divided by time of exposure). The serum UA level was a secondary outcome measure. RESULTS:A total of 239 gout patients were randomized and took at least 1 dose of study medication. The primary outcome measure comparing flare incidence between 800 mg arhalofenate and 300 mg allopurinol was achieved, with a 46% decrease in the 800 mg arhalofenate group (0.66 versus 1.24; P?=?0.0056). Treatment with 800 mg arhalofenate was also significantly better than placebo (P?=?0.049) and not significantly different from treatment with 300 mg allopurinol plus 0.6 mg colchicine (P?=?0.091). Mean changes in serum UA level were -12.5% with 600 mg arhalofenate and -16.5% with 800 mg arhalofenate (P?=?0.001 and P?=?0.0001, respectively, versus -0.9% with placebo). There were no meaningful differences in adverse events (AEs) between groups, and there were no serious AEs related to arhalofenate. Urinary calculus occurred in 1 patient receiving 300 mg allopurinol. No abnormal serum creatinine values >1.5-fold the baseline value were observed in the arhalofenate-treated groups. CONCLUSION:Arhalofenate at a dosage of 800 mg decreased gout flares significantly compared to allopurinol at a dosage of 300 mg. Arhalofenate was well tolerated and appeared safe. Arhalofenate is the first urate-lowering antiflare therapy.

Project description:Background:Glycyrrhizin is widely used in skin disorders, such as psoriasis, alopecia areata, and allergic diseases, but has not been extensively studied in patients with chronic eczema. Objective:To evaluate the efficacy and safety of oral compound glycyrrhizin (OCG) plus topical corticosteroid (TCS) in adults with chronic eczema. Methods:This was a multicenter, randomized, double-blind, placebo-controlled study in patients with chronic eczema (n?=?199). Randomized participants from 6 centers in China received either 75?mg OCG capsules or placebo capsules three times a day and TCS (i.e., 0.1% mometasone furoate ointment) once a day for 28 days. Efficacy was determined by analyzing the mean change from the baseline using standardized measures including the Investigator's Global Assessment (IGA) score, Eczema Area and Severity Index (EASI), and the visual analogue scale score (VAS) of itching. Results:Decreases in absolute EASI were significantly greater in the OCG-treated group versus placebo on day 14 (-3.41?±?1.41 vs. -2.71?±?1.25, P < 0.001) and day 28 (-7.39?±?1.71 vs. -6.64?±?1.75, P=0.003). OCG-treated patients also saw greater benefit in other EASI metrics including EASI-50 (96.8% vs. 87.9%, P=0.021) and EASI-75 (47.9% vs. 21.2%, P < 0.001) on day 28 compared with placebo. The absolute IGA score reductions were also significantly greater in the OCG group than the placebo (all P < 0.05). In addition, proportions of patients who achieve clear (0) IGA scores or almost clear (1) IGA scores were significantly higher in the treated group than placebo on day 14 (22.8% vs. 6.2%, P=0.001) and day 28 (93.5% vs. 79.4%, P=0.005). Moreover, the proportions of patients with reduced pruritus were significantly greater in the treated group than placebo on day 28 (94.7% vs. 83.8%, P=0.016) and eczema recurrence was notably less in the OCG group versus placebo (3.19% vs. 12.12%, P=0.021). Eleven patients experienced adverse events, but there was no significant difference in the proportion of patients affected (3.0% vs. 8.5%, P > 0.05). The most common adverse events were edema of both lower limbs. Conclusion:For adults with chronic eczema, OCG capsules combined with TCS is an effective and well-tolerated treatment, suggesting that OCG may be a useful nonsteroidal agent with an additional effect for the treatment of chronic eczema by TCS.

Dataset Information

Hypouricemic and arthritis relapse-reducing effects of compound tufuling oral-liquid in intercritical and chronic gout: A double-blind, placebo-controlled, multicenter randomized trial.

Publications

Hypouricemic and arthritis relapse-reducing effects of compound tufuling oral-liquid in intercritical and chronic gout: A double-blind, placebo-controlled, multicenter randomized trial.

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