Traditional Chinese medicine for sjögren's syndrome: a national survey of attitudes and perceptions among Chinese patients and rheumatologists.

BACKGROUND: This study explored similarities and differences among Chinese patients and rheumatologists in their attitudes towards and perceptions of traditional Chinese medicine (TCM) for Sjögren's syndrome (SS), including analyzing factors that influenced their decision making. METHODS: An anonymous questionnaire was used to conduct a multicenter survey among patients with SS at three tertiary care medical centers in Beijing and among rheumatology clinicians at several hospitals across China. Results were analyzed using descriptive statistics. RESULTS: There were 942 valid questionnaires from patients from 31 provinces and cities in China, with a male-to-female ratio of approximately 1:14, a mean age of 48.81 years, and a median disease duration of 7 (4, 10) years. There were 320 valid questionnaires from rheumatologists, covering 30 provinces and cities in China, with a male-to-female ratio of approximately 0.87:1, a mean age of 48 years, and a median work duration of 10.5 (6, 15) years. The rheumatologists treated a median of 15 (11, 50) SS cases per month, and the median proportion of SS to all rheumatic diseases was 6.66% (6-10%). Many patients believed TCM could cure the root of the disease, and the most expected TCM therapies were TCM patent prescriptions and medicinal teas. Conversely, rheumatologists placed high value on the efficacy of TCM, and most commonly prescribed Chinese herbal decoctions. Most doctor-patient groups were positive about TCM treatment, citing the low side effects as the major advantage. Regression analysis showed that for patients over 40 years old with a course of disease > 4 years, the probability of using TCM has increased by 1-6 times; the probability of recommending TCM in clinical work of doctors who have worked for more than 15 years, TCM and integrated traditional Chinese and western medicine has increased 1-2 times. CONCLUSIONS: TCM has become widely accepted and earned attention from doctor-patient groups, especially among older patients and experienced rheumatologists. However, negative prejudices and absence of accurate information about TCM treatments and SS itself require improvement. The contradiction between TCM dosage form and efficacy is a major problem, and patient demand for convenient and efficient TCM patent preparations suggests future work should focus on developing TCM patent preparations with clear compositions and mechanisms.

Effect of acupuncture on regulating IL-17, TNF-ɑ and AQPs in Sjögren's syndrome.

AIM: The aim of the study was to observe the effect of acupuncture on regulating interleukin (IL)-17, tumor necrosis factor (TNF)-ɑ, and aquaporins (AQPs) in Sjögren's syndrome (SS) on patients and on non-obese diabetic (NOD) models. METHODS: Levels of anti-AQP 1, 5, 8, and 9 antibodies, IL-17, and TNF-ɑ in the serum of SS patients were compared prior and following 20 acupuncture treatment visits during 8 weeks. While in murine model, five groups were divided to receive interventions for 4 weeks, including control, model, acupuncture, isoflurane, and hydroxychloroquine. The submaxillofacial gland index, histology, immunohistochemistry of AQP1, 5, salivary flow, together with IL-17, and TNF-ɑ expression in peripheral blood were compared among the groups. RESULTS: Acupuncture reduced IL-17, TNF-ɑ, and immunoglobin A levels, and numeric analog scale of dryness in 14 patients with SS (p < 0.05). The salivary flow was increased, and the water intake decreased in NOD mice receiving acupuncture treatments. IL-17 and TNF-ɑ levels in peripheral serum were down-regulated (p < 0.05) and AQP1, 5 expression in the submandibular glands up-regulated in mice. CONCLUSION: The effect on relieving xerostomia with acupuncture may be achieved by up-regulating the expression of AQP1. AQP5, down-regulating levels of IL-17 and TNF-ɑ, and a decrease in inflammation of glands.

China rheumatoid arthritis registry of patients with Chinese medicine (CERTAIN): Rationale, design, and baseline characteristics of the first 11,764 enrollees.

BACKGROUND: Chinese medicine (CM) has become a popular interventional treatment for rheumatoid arthritis (RA). However, limited knowledge about general characteristics and long-term clinical outcomes hampers the development of CM for RA. PURPOSE: The main objectives of the China Rheumatoid Arthritis Registry of Patients with Chinese Medicine (CERTAIN) were to describe the population of RA patients receiving CM treatment in multiple centers in China using different variables and compare these findings with internationally reported data. STUDY DESIGN: The CERTAIN is a prospective, multicenter, observational disease registry. METHODS: Adult RA patients who fulfilled the 2010 American College of Rheumatology/ European League Against Rheumatism classification criteria for RA and received CM treatment were recruited into the CERTAIN by rheumatologists from 145 hospitals across 30 provinces in China. Data on demographics, disease characteristics, comorbidities, treatments, and adverse events, with a 2-year follow-up, were collected and documented using a predefined protocol. RESULTS: In the 2 years since the study began in September 2019, 11,764 patients have been enrolled (enrolment is ongoing), and 13.10% of participants have completed the 6-month follow-up. We present the baseline characteristics of the first 11,764 enrollees. CONCLUSIONS: The CERTAIN is the first nationwide registry to document comprehensive data on CM treatment in patients with RA. The development of the CERTAIN resource is a significant step forward for Chinese RA patients, herbal medicine users, and research communities and will deepen our understanding of CM for RA. REGISTRATION: The study was registered at ClinicalTrials.gov (NCT05219214).

Efficacy and Safety of Acupuncture on Symptomatic Improvement in Primary Sjögren's Syndrome: A Randomized Controlled Trial.

Aim: We sought to evaluate the efficacy of acupuncture in treating the main symptoms of primary Sjögren's syndrome, specifically dryness, pain, and fatigue. Methods: A total of 120 patients with primary Sjögren's syndrome were randomized in a parallel-group, controlled trial. Participants received acupuncture or sham acupuncture for the first 8 weeks, then were followed for 16 weeks thereafter. The primary outcome was the proportion of participants with a ≥ 30% reduction in ≥ 2 of 3 numeric analog scale scores for dryness, pain, and fatigue. The secondary outcomes included the European League Against Rheumatism (EULAR) Sjögren's Syndrome Patient-reported Index (ESSPRI); the EULAR Sjögren's Syndrome Disease Activity Index; the Schirmer test score; unstimulated saliva flow; serum immunoglobulin G, A, and M concentrations; the Medical Outcome Study Short Form 36 score; salivary gland ultrasound imaging; and the Hospital Anxiety and Depression Scale score. Results: The proportions of patients meeting the primary endpoint were 28.33% (17/60) in the acupuncture group and 31.66% (19/60) in the sham group, without a statistically significant difference (P = 0.705). The IgG concentration at week 16 and the homogeneity in ultrasonography of the salivary glands at week 8 showed significant differences between the 2 groups (P = 0.0490 and P = 0.0334, respectively). No other differences were observed between the 2 groups. ESSPRI and unstimulated saliva flow were improved in both groups compared to baseline, albeit with a significant difference between them. Conclusion: In patients with primary Sjögren's syndrome, acupuncture did not satisfactorily improve symptoms compared to placebo. However, interesting discoveries and possible underlying reasons were demonstrated and discussed, which may be useful to studies in the future. Clinical Trial Registration: [www.ClinicalTrials.gov], identifier [NCT02691377].

The Impact of Traditional Chinese Medicine QingreHuoxue Treatment and the Combination of Methotrexate and Hydroxychloroquine on the Radiological Progression of Active Rheumatoid Arthritis: A 52-Week Follow-Up of a Randomized Controlled Clinical Study.

Traditional Chinese medicine (TCM) has been used successfully to treat rheumatoid arthritis (RA). QingreHuoxue treatment (QingreHuoxue decoction [QRHXD]/QingreHuoxue external preparation [QRHXEP]) is a Chinese medicine treatment for RA. To date, very few studies have compared the long-term effects of QRHXD with those of conventional disease-modifying antirheumatic drugs on RA disease activity and radiological progression. QRHXD delayed the radiological progression and showed long-term clinical efficacy of RA. In clinical experiments, the clinical evidence of delaying the radiological progression of RA patients was obtained. A portion of the patients who participated in the "Traditional Chinese Medicine QingreHuoxue Treatment vs. the Combination of Methotrexate and Hydroxychloroquine for Active Rheumatoid Arthritis" study were followed up for 52 weeks, and intention-to-treat (ITT) and compliance protocol (PP) analyses were used to collect and compare the clinical indicators and imaging data between baseline and week 52. Two radiologists who were blind to treatment scored the images independently. Of the 468 subjects, 141 completed the 52-week follow-up. There were no significant differences among the three groups: the traditional Chinese medicine comprehensive treatment group, the Western medicine treatment group, and the integrated traditional Chinese and Western medicine treatment group. There were no differences in the total Sharp score, joint space stenosis score, and joint erosion score at baseline or 52 weeks. In the comparison of the estimated annual radiographic progression (EARP) and the actual annual Sharp total score changes among the three groups, the actual changes were much lower than the EARP at baseline. The radiological progress in all three groups was well controlled. Results of the ITT and PP data sets showed that the disease activity score 28 level of the three groups at 52 weeks was significantly lower than that at baseline. During the 52-week treatment period, the clearance of heat and promotion of blood circulation controlled disease activity and delayed the radiological progress of active RA.

The Multiple Roles of B Cells in the Pathogenesis of Sjögren's Syndrome.

Primary Sjögren's syndrome (pSS) is a chronic autoimmune disease characterized by lymphocytic infiltration and tissue destruction of exocrine glands such as salivary glands. Although the formation of ectopic lymphoid tissue in exocrine glands and overproduction of autoantibodies by autoreactive B cells highlight the critical involvement of B cells in disease development, the precise roles of various B cell subsets in pSS pathogenesis remain partially understood. Current studies have identified several novel B cell subsets with multiple functions in pSS, among which autoreactive age-associated B cells, and plasma cells with augmented autoantibody production contribute to the disease progression. In addition, tissue-resident Fc Receptor-Like 4 (FcRL4)+ B cell subset with enhanced pro-inflammatory cytokine production serves as a key driver in pSS patients with mucosa-associated lymphoid tissue (MALT)-lymphomas. Recently, regulatory B (Breg) cells with impaired immunosuppressive functions are found negatively correlated with T follicular helper (Tfh) cells in pSS patients. Further studies have revealed a pivotal role of Breg cells in constraining Tfh response in autoimmune pathogenesis. This review provides an overview of recent advances in the identification of pathogenic B cell subsets and Breg cells, as well as new development of B-cell targeted therapies in pSS patients.

Traditional Chinese Medicine Qingre Huoxue Treatment vs. the Combination of Methotrexate and Hydroxychloroquine for Active Rheumatoid Arthritis: A Multicenter, Double-Blind, Randomized Controlled Trial.

Traditional Chinese medicine (TCM) has been used successfully to treat rheumatoid arthritis (RA). Qingre Huoxue treatment (Qingre Huoxue decoction (QRHXD)/Qingre Huoxue external preparation (QRHXEP)) is a therapeutic scheme of TCM for RA. To date, there have been few studies comparing the efficacy and safety of QRHXD and conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) for the treatment of active RA. This was investigated in a multicenter, double-blind, randomized controlled trial involving 468 Chinese patients with active RA [disease activity score (DAS)-28 > 3.2] treated with QRHXD/QRHXEP (TCM group), methotrexate plus hydroxychloroquine [Western medicine (WM) group], or both [integrative medicine (IM) group]. Patients were followed up for 24 weeks. The primary outcome measure was the change in DAS-28 from baseline to 24 weeks. The secondary outcome measures were treatment response rate according to American College of Rheumatology 20, 50, and 70% improvement criteria (ACR-20/50/70) and the rate of treatment-related adverse events (TRAEs). The trial was registered at ClinicalTrials.gov (NCT02551575). DAS-28 decreased in all three groups after treatment (p < 0.0001); the score was lowest in the TCM group (p < 0.05), while no difference was observed between the WM and IM groups (p > 0.05). At week 24, ACR-20 response was 73.04% with TCM, 80.17% with WM, and 73.95% with IM (based on the full analysis set [FAS], p > 0.05); ACR-50 responses were 40.87, 47.93, and 51.26%, respectively, (FAS, p > 0.05); and ACR-70 responses were 20.87, 22.31, and 25.21%, respectively, (FAS, p > 0.05). Thus, treatment efficacy was similar across groups based on ACR criteria. On the other hand, the rate of TRAEs was significantly lower in the TCM group compared to the other groups (p < 0.05). Thus, QRHXD/QRHXEP was effective in alleviating the symptoms of active RA-albeit to a lesser degree than csDMARDs-with fewer side effects. Importantly, combination with QRHXD enhanced the efficacy of csDMARDs. These results provide evidence that QRHXD can be used as an adjunct to csDMARDs for the management of RA, especially in patients who experience TRAEs with standard drugs. Clinical Trial Registration: ClinicalTrials.gov, identifier NCTNCT025515.

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.

[Study advances in regulation effect of Tripterygium wilfordii and its extracts on innate immune system in rheumatoid arthritis cases].

Rheumatoid arthritis( RA) is an autoimmune disease characterized by chronic and aggressive polyarthritis. The innate immunity mechanism plays a key role in the pathogenesis of RA. Tripterygium wilfordii and its extracts have regulatory effects on innate immune cells including macrophages,dendritic cells,neutrophils,mast cells,NK cells,NKT cells,etc.,as well as a variety of innate immune molecules including cytokines,adhesion molecules,patterns recognition receptor( PRR) and the complement molecules,showing a regulatory effect in the pathogenesis of RA innate immunity. In this paper,the recent domestic and foreign researches on the pathogenesis of RA with innate immunity involved were reviewed and the research status of T. wilfordii and its extracts on the regulation of innate immunity involved in RA was summarized.

[Regularity of prescription and medication of Jiang Quan in treating rheumatoid arthritis].

The data mining method was used to analyze and summarize the prescription and medicate regularities of chief physician Jiang Quan in the treatment of rheumatoid arthritis,in order to provide references for the clinical treatment of rheumatoid arthritis. Totally 121 prescriptions of rheumatoid arthritis treated by chief physician Jiang Quan from 2007 to 2017 were collected and input into the Chinese medicine inheritance auxiliary system. The " prescription statistics" function of the software " statistical report" system,and the " prescription analysis" function of the " data analysis" system,the data mining methods such as rule analysis,integration correlation,complex system entropy clustering,and unsupervised entropy hierarchical clustering,were used to analyze the prescription regularity of chief physician Jiang Quan. A total of 121 prescriptions were included,involving 144 herbs,in which 30 herbs had a higher frequency of more than 20 times,20 two-herb combinations had a frequency of more than 59 times; after evolution,14 core combinations and 7 new prescriptions were obtained. Among the prescriptions in the treatment of rheumatoid arthritis,those for clearing heat and dampness,promoting blood circulation and removing blood stasis had a higher frequency,and the core prescriptions were modified " Qingre Huoxue Decoction" and modified " Ermiao Pills". The newly evolved prescriptions not only reflected director Jiang Quan' s method of treating rheumatoid arthritis by clearing away heat and dampness and promoting blood circulation by the,but also included the treatment methods of removing wind and removing dampness,dredging collaterals and removing phlegm,nourishing Yin and clearing heat,nourishing Yin and nourishing kidney,nourishing blood and nourishing Qi. The method can be used to analyze the pathogenetic changes of the mutual knot of phlegm and blood stasis,injury of Qi and blood,long-term implication on liver and kidney. At the same time,it also reflects the treatment principles of treating phlegm and strengthening the evil.

Classifying rheumatoid arthritis by Traditional Chinese Medicine Zheng: a multi-center cross-sectional study.

OBJECTIVE: To assess the relationship between disease symptoms and traditional Chinese medicine (TCM) syndrome (Zheng) in rheumatoid arthritis (RA) patients. METHODS: RA Patients were recruited in Guang'anmen Hospital, China Academy of Chinese Medical Sciences and in the Second Affiliated Hospital of Zhejiang Chinese Medical University, and diagnosed with a particular RA Zheng from their symptoms. Demographic characteristics, self-reported symptoms, and blood samples were collected from patients. All data were input into EpiData and analyzed using SPSS software. RESULTS: The study included 302 RA patients (age range: 18-86 years). All patients were Chinese, and 85.1% were women. Cold and fatigue triggers were reported by 8.6% of patients, followed by triggers such as childbirth (4.3%), cold (3.0%), dampness (2.0%), menopause (1.3%), and psychentonia (0.7%). The most prevalent Zheng was dampness and heat blockage (Shire Yuzu in Chinese, SRYZ), diagnosed in 39.4% of patients (119), followed by phlegm and stagnation blockage (Tanyu Bizu, TYBZ) in 21.5%, liver and kidney deficiency (Ganshen Buzu, GSBZ) in 18.5%, dual deficiency of Qi and blood (Qixue Liangxu, QXLX) in 9.6%, cold and dampness blockage (Hanshi Bizu, HSBZ) in 6%, and wind and dampness blockage (Fengshi Bizu, FSBZ) in 5%. Increased length of time since RA diagnosis was associated with the GSBZ group. Patients diagnosed with the SRYZ Zheng had the highest disease activity score. Patients diagnosed with the QXLX Zheng had the lowest blood platelet counts; patients diagnosed with the QXLX and HSBZ Zhengs had lower C-reactive protein levels and lower health assessment questionnaire scores. Patients diagnosed with the GSBZ and QXLX Zhengs had the highest health assessment questionnaire scores. CONCLUSION: The specific Zheng was related to RA characteristics. The findings suggest that eliminating dampness, cooling the patient, and promoting blood circulation may assist in treating severe RA.

Effect of cream, prepared with Tripterygium wilfordii Hook F and other four medicinals, on joint pain and swelling in patients with rheumatoid arthritis: a double-blinded, randomized, placebo controlled clinical trial.

OBJECTIVE: To investigate the effectiveness a cream onjoint pain and swelling in patients with rheumatoid arthritis (RA). The cream, topically used, in was prepared with Tripterygium wilfordii Hook F (TwHF), Mangxiao (Nalrii Sulfas), Chuanxiong (Rhizoma Chuanxiong), stir-frying with liquid adjuvant Ruxiang (Olibanum), and stir-frying with liquid adjuvant Moyao (Myrrh). METHODS: Patients were 1∶1 randomized to add-on TwHF cream twice a day or placebo for 4 weeks. The primary endpoint was achievement rate of 20% improvement in American College of Rheumatology criteria (ACR20) at week 4. Secondary endpoints were ACR50, 28-joint count Disease Activity Score (DAS28) improvement and safety profiles. Statistical analyses were performed using intention to treat analysis (ITT) set. RESULTS: A total of 70 active RA patients were enrolled. At week 4, the ACR20 was 34.3% (12/35) in TwHF cream group and 11.4% (4/35) in placebo group (P = 0.015). Similarly, a higher ACR50 responder proportion was seen in TwHF cream group with 17.1% (6/35) comparing to it in placebo group with 2.9% (1/35) (P = 0.046). The TwHF cream group also had more improvement than the placebo group on DAS28-ESR (1.1 vs 0.5, P = 0.001), DAS28- CRP (1.4 vs 0.7, P = 0.001), tender joint count (5.5 vs 2.6, P = 0.018), swollen joint count (3.5 vs 1.6, P = 0.003) and Physician's global assessment (25.8 vs 13.0, P = 0.002), as well as C-reactive protein (11.2 vs 2.7, P = 0.048). Except 2 skin allergy events in TwHF cream group, no other substantive adverse events were observed. CONCLUSION: On the short term, TwHF cream is likely to be an effective and safety complimentary treatment in patients with active RA.

Will Chinese external therapy with compound Tripterygium wilfordii hook F gel safely control disease activity in patients with rheumatoid arthritis: design of a double-blinded randomized controlled trial.

BACKGROUND: Chinese external therapy (CET) is a topical application with mainly Chinese herb medicine therapy with thousands of years of historical implications and is a clinical routine that is commonly used for relieving joint-related symptoms in patients with arthritis in Chinese hospitals. However, there is a paucity of modern medical evidence to support its effectiveness and safety. Thus, we propose to implement a randomized, double-blinded, placebo-controlled clinical trial in patients with rheumatoid arthritis (RA) using, as the experimental intervention, topical application of a hospital-compounded gel preparation of Tripterygium wilfordii Hook F (TwHF). METHODS: This study will be an 8-week double-blinded, randomized, placebo-controlled clinical trial conducted at Guang'anmen Hospital in Beijing, China, and 168 patients with moderately active RA will be randomly assigned with a 1:1 ratio to apply a topical gel preparation containing TwHF or placebo. The primary outcome variable will be the proportion of subjects, by study group, to achieve a 20% improvement in the American College of Rheumatology criteria (ACR20) by week 8. Secondary outcome measures to be assessed at weeks 4 or 8 will include: measurement of ACR20 response rate at week 4, ACR50 response rate, the changes in DAS28 score, and joint synovitis classification assessment monitored by musculoskeletal ultrasound. Safety evaluations conducted at weeks 4, 8 and 12 will be based on spontaneous complaints by the study subjects, but special emphasis will be focused on cutaneous allergy and alterations of menstruation in premenopausal female participants. Statistical analyses will be performed using the intention to treat analysis data set. DISCUSSION: This proposed clinical trail is designed to evaluate the efficacy and safety of CET based on a single topically-applied agent in a relatively large patient population with RA. This study protocol gives a detailed description of the usage and dosage of the topical compound TwHF gel and the methodology of this study. In addition, it is hoped that the outcomes of this study will be viewed as supporting the generalizability of CET in the setting of inflammatory rheumatic diseases. The results of this study are expected to have important public health implications for Asian RA patients that currently utilize CET as a complimentary treatment. TRIAL REGISTRATION: Clinical trial gov Identifier: NCT02818361 . Registrated on Jun. 15, 2016.

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

TRIAL DESIGN: 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. METHODS: 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. RESULTS: 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 µmol/L) and 28.81 µmol/L (95% CI: 4.91-52.71 µmol/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 < 0.001; from baseline to week 12, 38.5% and 63.16%, respectively, P = 0.003). Severe adverse events were not observed in either groups, and fewer leucopenia incidences were observed in the treatment group than those in the control group (3/139 vs. 7/71, respectively, P = 0.033). CONCLUSION: CoTOL reduced sUA levels and effectively prevented acute arthritis recurrence in intercritical and chronic gout without serious adverse events.

[Effect of External Applying Compound Tripterygium wilfordii Hook F. on Joint Pain of Rheumatoid Arthritis Patients].

OBJECTIVE: To observe the effectiveness and safety of external applying Compound Tripterygium wilfordii Hook F. (TwHF) in relieving joint pain in rheumatoid arthritis (RA) patients. METHODS: In this double-blinded, randomized multicenter trial, a total of 174 moderately active RA patients were enrolled and randomly assigned to the treatment group (treated with Compound TwHF, 87 cases) and the placebo control group (87 cases). Compound TwHF or placebo was externally applied in painful joints, 20 g each time, once per day for 8 weeks. Self-reported joint pain relief was taken as a primary effective indicator. Visual analogue scale for pain (VAS), disease activity score of 28 joints (DAS28), VAS for general health (GH) were evaluated before treatment, at week 4 and after treatment. Erythrocyte sedimentation rate (ESR) and hypersensitive C reactive protein (hs-CRP) were tested before and after treatment. Menstrual changes in females were observed during treatment. Skin irritation occurred during the recording process was assessed using skin irritation strength. Intention to treat (ITT) was statistically analyzed. RESULTS: The joint pain relief rate in the treatment group was 90.8% (79/87 cases), higher than that in the placebo control group (69.0%, 60/87 cases; P = 0.001). VAS pain score, DAS28, VAS for GH score were significantly improved in the two groups at week 4 of treatment and after treatment, as compared with before treatment (P < 0.01). ESR and hs-CRP levels significantly decreased in the treatment group after treatment (P < 0.05, P < 0.01). No difference was found in post-treatment VAS pain score, DAS28, VAS for GH score, ESR, or hs-CRP between the two groups (P > 0.05). Eight adverse events occurred in the treatment group (5 skin allergy, 1 intolerance of medical odor, and 2 mild liver injury), while 3 adverse events occurred in the placebo control group (2 skin allergy, 1 mild liver injury). There was no statistical difference in adverse event between the two groups (P > 0.05). No menstrual change occurred in the treatment group. CONCLUSION: External applying Compound TwHF was an effective and safe way to relieve-joint pain of RA patients, which could be taken as an adjuvant therapy.

[Clinical effect analysis of ankylosing spondylitis treated by Chinese medical syndrome differentiation].

OBJECTIVE: To evaluate the curative effect and safety of Bushen Qiangji Decoction (BQD) and Qingre Qiangji Decoction (QQD) in treating ankylosing spondylitis (AS) patients, and to verify the clinical utility of AS syndrome differentiation and treatment scheme [Shen-deficiency induced stasis obstruction syndrome (SDISOS) and dampness-heat obstruction syndrome (DHOS) being two basic syndrome types, Shen invigorating blood activating method (SIBAM) and heat clearing dampness resolving method (HCDRM) being two basic treatment methods]. METHODS: Totally 354 AS patients of SDISOS and DHOS were randomly assigned to the treatment group and the control group using a multi-center randomized, positive drug parallel-controlled clinical trail. Patients in treatment group were treated by BQD or QQD according to syndrome typing, while those in the control group took Sulfasalazine enteric-coated tablet (SECT), 24 weeks as one therapeutic course. After treatment, the clinical efficacy was evaluated by using ASAS20 standard (set by Asessment in Ankylosing Spondylitis working group), Chinese medical efficacy evaluation standards, and BASDAI, BASFI, BASMI, night-pain index, spinal pain index, PGA, C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR). RESULTS: After 24 weeks of treatment by BQD or QQD, ASAS20 standard rate was 86.75% in the treatment group, and the total effective rate of Chinese medical syndrome was 85.47%. They could significantly reduce patients' integrals of Chinese medical syndrome, BASDAI, BASFI, BASMI, night-pain index, spinal pain index, and PGA (all P < 0.01). CONCLUSIONS: QQD and BQD got confirmable clinical effects in treating AS, providing strong evidence of evidence-based medicine for syndrome differentiation and treatment of AS.

A one-year evaluation of radiographic progression in patients with rheumatoid arthritis treated by Qingre Huoxue Decoction ().

OBJECTIVE: To investigate the effects of Qingre Huoxue Decoction , clearing heat and promoting blood flow; QRHXD), on the radiographic progression in patients with rheumatoid arthritis (RA) by X-ray imaging. METHODS: Eighty-six patients with active RA diagnosed as damp-heat and blood stasis syndrome were randomized into a QRHXD group and a QRHXD plus methotrexate (MTX) group, with 43 cases in each group. After one-year of treatment, 21 cases in each group (42 in total) were evaluated. Radiographs of hands were obtained at the baseline and after 12 months of treatment. Images were evaluated by investigators blinded to chronology and clinical data, and assessed according to the Sharp/Van der Heijde methods. RESULTS: High intrareader agreements were reached (mean intraobserver intraclass coefficients: 0.95). No significant change in any imaging parameters of joint destruction was observed at 12 months in either group; and the differences between the two groups were not significant (P>0.05). The mean of the changing score in the QRHXD group was 3.5 ± 4.1, and 2.4 ± 3.5 in the QRHXD+MTX group, while the baseline radiographic score of patients in the QRHXD group was relatively higher (18.9 ± 19.1 vs. 14.0 ± 14.0). The mean rates of the changing scores of the two groups were similar (0.24 ± 0.28 vs. 0.25 ± 0.44, P=0.40). The severity of progression in the two groups was also similar (P=0.46), 7 cases without radiographic progression in the QRHXD group and 8 in the QRHXD+MTX group, 3 cases with obvious radiographic progression in the QRHXD group and 1 in the QRHXD+MTX group. CONCLUSION: Radiographic progression of RA patients in both groups is similar, indicating that the QRHXD Decoction has a potential role in preventing bone destruction.

[One-year evaluation of radiographic progress in patients with rheumatoid arthritis treated by Qingre Huoxue decoction].

OBJECTIVE: To investigate the effect of Qingre Huoxue decoction, (QRHX) on radiographic progression in patients with rheumatoid arthritis (RA) with X-ray imaging. METHODS: From July 2007 to March 2009, 86 patients with active RA who were diagnosed as damp-heat and blood stasis syndrome were randomly divided into QRHX group and QRHX plus methotrexate (MTX) group, 43 cases in each group. Patients in the QRHX group were treated with QRHX decoction [composed of Huangbai, Chishao, Bixie, Danshen, Ezhu, Qingfengteng, raw Huangqi, Jinyinhua, Tufuling, Wugong, Fengfang, raw Yiyiren, which was cooked with water as 400 ml liquid); while patients in the other group were treated with QRHX decoction plus MTX. After one-year observation, 21 patients in each group (42 in total) were evaluated,with 19 females in QRHX group, average age of (43.0 +/- 11.3) years, and the course of the disease was 2 (1,3) years; and 18 females in QRHX+MTX group, average age of (44.5 +/- 14.0) years, and the course of the disease was 3 (1.7, 5) years. Radiographs of hands were obtained at baseline and 12 months after treatment. Images were evaluated by investigators blinded to chronology and clinical data, and assessed according to Sharp/van der Heijde methods. RESULTS: High intrareader agreements were reached (mean intraobserver intraclass coefficients: 0.95). No significant change in any imaging parameters of joint destruction was observed at 12 months after treatment in both groups; and there were no statistical differences between the two groups (P > 0.05). The severity of progress in two groups was also similar (P = 0.46), 7 patients without radiographic progress in QRHX group and 8 patients in QRHX+MTX group,3 patients with obvious radiographic progress in QRHX group and 1 patient in QRHX+MTX group. CONCLUSION: Radiographic progress of RA patients in two groups is similar, indicating QRHX decoction has a potential role in preventing bone destruction.

[Tripterygium wilfordii extract for treating rheumatoid arthritis: systematic review].

OBJECTIVE: To evaluate the efficacy and safety of Tripterygium wilfordii extract (TWE) in treating rheumatoid arthritis. METHOD: Mainly using the simple methods from the International Cochrane Collaboration as systematic evaluation methods. Using Revman 4.2.5 which Cochrane Cooperation Web recommended to analysis. Using American College of Rheumatology (ACR) core set (ACR20, ACR50, and ACR70) of therapeutic efficacy measures which recommended by ACR, radiographic change of bone and the rate of inefficacy as efficacy methods. Dividing into placebo subgroup and DMARDs (disease modifying anti rheumatism drugs) subgroup according to different control treatments. RESULT: A total of seven randomized controlled trials (RCTs) were collected. They are all of small sample size, six of which exist some methodological defects, resulting in many possible biases. As evaluated by ACR20/50/70, TWE was as effective as DMARDs in reducing number of swelling joints, level of C-reactive protein (CRP), and was more effective than DMARDs in reducing erythrocyte sedimentation rate (ESR) (P <0.01). While TWE was no effect in delaying bone destruction. The incidence of adverse reactions of TWE is higher than DMARDs. CONCLUSION: TWE can be used as an alternative medicine in treating RA. But owing to lacking of data from high-quality RCTs, however, the efficacy and safety of TWE are desired for further exploration.

[Effects of Jianpi Yishen Recipe on recurrence, metastasis and life span of mice transplanted with proventriculus squamous carcinoma after tumorectomy].

OBJECTIVE: To observe the effects of Jianpi Yishen Recipe (JPYSR), a compound Chinese herbal medicine, on recurrence, metastasis and life span of mice transplanted with proventriculus squamous carcinoma cells after tumorectomy. METHODS: JPYSR was orally administered to 615 mice transplanted with proventriculus squamous carcinoma cells in the palma of left hind limb after tumorectomy. The local tumor recurrence, lung metastasis and life span of the mice were evaluated and compared with those of the 5-FU-treated mice and untreated mice. RESULTS: The pulmonary metastasis rate was 94.4% and the recurrence rate was 94.44% in untreated group. The pulmonary metastasis rate was 68.4%, the inhibition rate of pulmonary metastasis was 27.5%, the recurrence rate was 78.95%, and the inhibition rate of tumor recurrence was 65.35% in JPYSR-treated group. The average and median life spans were obviously prolonged in JPYSR-treated group, as compared with those in untreated group. The life-prolonging rate was 100%. CONCLUSION: JPYSR can effectively inhibit the local recurrence and pulmonary metastasis of the transplanted proventriculus squamous carcinoma in mice after tumorectomy, and prolong the life span.