Zhengqing fengtongning sustained-release tablets prevents gout flares in the process of ULT: A randomized, positive control, double-blind, double-simulation, multicenter trial.

INTRODUCTION: When initiating urate-lowering therapy, using anti-inflammatory prophylaxis therapy for at least 3 to 6 months is strongly recommended. Previous studies have found that zhengqing fengtongning sustained-release tablets (sinomenine) can improve inflammation in the acute phase of gout; however, the efficacy of urate-lowering therapy in reducing frequency of acute flares still needs to be investigated. The aim of the present study is to explore the efficacy and safety of sinomenine for prophylaxis of acute flares when initiating urate-lowering therapy. METHODS AND ANALYSIS: This randomized, placebo-controlled, double-blinded trial will include a total of 210 gout patients who meet the study criteria. The patients will be randomized (1:1) to the test group and the control group. The intervention is planned to be performed for 12 weeks with a follow-up of 12 weeks. All patients would be administered febuxostat (40 mg/d) and concomitant anti-inflammatory prophylaxis therapy. Sinomenine and colchicine placebo are administered in the sinomenine group, sinomenine placebo and colchicine are administered in the colchicine group. The primary outcome is the rate of acute gout flares in subjects within 12 weeks of the treatment period. The secondary outcomes include the times of acute gout flares and the duration of each acute flares within 12 weeks; the compliance rate in patients whose UA levels ≤6.0 mg/dL (360 µmol/L) at the weekend of 2nd, 4th, 8th, and 12th week in each group; the proportion of patients with ≥1 and ≥2 gout flares within 12 weeks; average visual analogue scale/score pain score during gout flares; and the oral dose of etoricoxib will be used to control the onset of acute flares within 12 weeks. ETHICS AND DISSEMINATION: The Institutional Medical Ethics Committee have approved the trial protocol. We plan to publish the results of this study in a peer-reviewed journal. TRIAL REGISTRATION: ChiCTR, ChiCTR2100045114, Registered 8 April 2021 http://www.chictr.org.cn/showproj.aspx?proj=124688.

Acupuncture for primary fibromyalgia: Study protocol of a randomized controlled trial.

BACKGROUND: Acupuncture is well recognized for its unique therapeutic effect for many diseases as a nonpharmacological therapy in traditional Chinese medicine (TCM). However, whether acupuncture can effectively treat fibromyalgia is currently unclear. Therefore, we aim to design a study protocol of a randomized controlled clinical trial and assess the effectiveness of acupuncture for patients with fibromyalgia, which may lead to alleviation of clinical symptoms and improvement of patients' quality of life. METHODS: The study is designed as a randomized, blinded, placebo-controlled trial of two cohorts conducted at Guang'anmen Hospital of China Academy of Chinese Medical Sciences and Shenzhen Traditional Chinese Medicine Hospital, respectively. A total of 68 patients with primary fibromyalgia, diagnosed with the American College of Rheumatology criteria, are randomly allocated with a 1:1 ratio to acupuncture or sham acupuncture groups. All subjects will receive acupuncture intervention for 8 weeks with follow-up assessments every 4 weeks for 16 weeks. The primary outcome will be evaluated using the visual analogue scale (VAS) and revised fibromyalgia impact questionnaire (FIQR) for pain intensity. The secondary outcome measures will include: Multidimensional Assessment of Fatigue scale (MAF), Short Form-36 (SF-36), Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Index (PSQI), Chinese perceived stress scales (pss-14), changes in the number of 18 tender points, patient satisfaction for the treatment and adverse events. The mentioned outcome measurements will be assessed every 4 weeks for 6 months. DISCUSSION: This clinical trial will use advanced research methods to evaluate the efficacy and safety of acupuncture on fibromyalgia. The results of this trial may provide clinical evidence on the beneficial effects of acupuncture in treating fibromyalgia. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR1800016826: AMCTR-IOR-18000184. Registered 27 June 2018, http://www.acmctr.org/listbycreater.aspx.

Serum Metabolic Profiling Analysis of Gout Patients Treated with Traditional Chinese Medicine Tongfengtai Granules Based on Gas Chromatography-Mass Spectrometry.

Gout has become a public health problem that seriously threatens human health. Traditional Chinese medicines (TCMs) have a long history of treating gout and have some advantages compared with the conventional medicines. Compound TCM Tongfengtai granules are gradually being used for clinical treatment of gout, but its mechanism is still unclear. The purpose of this study was to explore the metabolic profiling of serum from gout patients before and after treatment with Tongfengtai granules and identify the differential metabolites and related metabolic pathways. A total of 40 gout patients hospitalized in Shenzhen Traditional Chinese Medicine Hospital from 2018 to March 2019 were recruited in the current study, and serum samples from these patients before and after treatment with Tongfengtai granules were collected. Gas chromatography-mass spectrometry (GC-MS) assay was used to identify serum metabolites. The OPLS-DA VIP method was used to screen for potential metabolic biomarkers, and MetaboAnalyst 4.0 was used to identify related metabolic pathways. The result showed that there was a significant difference in the concentrations of six metabolites in the serum after treatment: D-galactose, lactic acid, 3-hydroxybutyric acid, D-pyran (type) glucose, alanine, and L-isoleucine. Except D-pyran (type) glucose, the serum concentrations of the other five metabolites were all significantly reduced. Besides, pathway enrichment analysis found that these potential metabolic biomarkers were mainly involved in lactose degradation and the glucose-alanine cycle. Thus, the serum metabolic profiling of gout patients treated with Tongfengtai granules changed, and the differential metabolites and related metabolic pathways might provide clues for understanding the mechanism of Tongfengtai granules.

Indicators of Male Gout Patients' Comorbidities with the Theory on Traditional Chinese Medicine.

Gout, typically manifesting as acute burning pain and swelling in a joint, has a high frequency of comorbidities. Based on Traditional Chinese Medicine syndrome (TCMS) theory, obstruction of dampness and heat syndrome (ODHS) and intermingled phlegm-stasis blood syndrome (IPSBS) were the two main TCMS subtypes in Chinese suffering from acute gout. In this study, we did a retrospective study enrolling 4,417 ODHS male gout cases and 1,413 IPSBS male gout cases, to investigate the comorbidities distribution difference between the two subtype groups and seek the potential indicators of male gout with some comorbidities. Interestingly, we found male ODHS group with higher prevalence of possible kidney damage (ODHS: 4.34%; IPSBS: 0.78%), lower prevalence of cardiac-cerebral vascular diseases (ODHS: 0.52%, IPSBS: 0.85%) and diabetes (ODHS: 1.06%; IPSBS: 1.63%) than male IPSBS group. And cystatin C is the only index reflecting that renal function showed significant difference between the two groups and the average levels were out of the normal range (1.09 ± 0.28 versus 1.17 ± 0.31, p=0.001). Further, we also observed significance difference on abnormality rates of cystatin C between the two groups. (χ2=5.543, p= 0.019). Besides, the comparison between the two subtypes also showed significant difference on hematocrit (43.12 ± 3.60 versus 42.26 ± 4.17%, p=0.007), mean corpuscular volume (89.52 ± 6.07 versus 86.81 ± 7.11fL, p=0.001), and mean corpuscular hemoglobin concentration (338.00 ± 11.67 versus 334.86 ± 13.58g/L, p=0.004). In general, we put forward that male gout patients with ODHS should be more vigilant of damage of renal function, and those with IPSBS should pay more attention to prevent cardiac-cerebral vascular diseases and diabetes. Increased Cys C level might be correlated with risk of comorbidities, especially diabetes . Thus, it is of significance to diagnose the TCMS in acute gout accurately and monitored related indices to prevent comorbidities.