Dataset Information

A Traditional Herbal Formula Xianlinggubao for Pain Control and Function Improvement in Patients with Knee and Hand Osteoarthritis: A Multicenter, Randomized, Open-Label, Controlled Trial.

ABSTRACT: Evidence of efficacy of a traditional herbal formula Xianlinggubao (XLGB) for treatment of osteoarthritis (OA) is limited. The present study was designed to evaluate the efficacy of XLGB in the management of patients with knee and hand OA. This was a multicenter, stratified, open-label, randomized controlled trial conducted at six centers in China. People aged 40 or above, diagnosed with OA of the knee or hand, were randomly assigned to the XLGB treatment group or watchful waiting control group. Main outcome measures were the changes in the numeric pain rating scales (NPRS) and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) or the Australian/Canadian Osteoarthritis Hand Index (AUSCAN) scores, from baseline to 6 months. In total 534 patients (272 to XLGB and 262 to control group) received interventions. Participants in the XLGB group exhibited significant improvement in NPRS (P < 0.001) and WOMAC score (P < 0.001) or AUSCAN score (P < 0.001) compared to control group. Treatment with XLGB at current regime significantly reduced pain and improved function of the knee and hand in patients with OA over a 6-month period, implying that XLGB could be suggested as an alternative treatment for patients with knee or hand OA.

SUBMITTER: Wang F

PROVIDER: S-EPMC5829359 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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A Traditional Herbal Formula Xianlinggubao for Pain Control and Function Improvement in Patients with Knee and Hand Osteoarthritis: A Multicenter, Randomized, Open-Label, Controlled Trial.

Wang Fei F Shi Lei L Zhang Yaonan Y Wang Kunzheng K Pei Fuxing F Zhu Hanmin H Shi Zhanjun Z Tao Tianzun T Li Zhihua Z Zeng Ping P Wang Xiaobing X Ji Quan Q Qin Ling L Xue Qingxun Q

Evidence-based complementary and alternative medicine : eCAM 20180212

Evidence of efficacy of a traditional herbal formula Xianlinggubao (XLGB) for treatment of osteoarthritis (OA) is limited. The present study was designed to evaluate the efficacy of XLGB in the management of patients with knee and hand OA. This was a multicenter, stratified, open-label, randomized controlled trial conducted at six centers in China. People aged 40 or above, diagnosed with OA of the knee or hand, were randomly assigned to the XLGB treatment group or watchful waiting control group. ...[more]

PMID: 29619064

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Project description:Accumulating evidence implicates gut microbiota as promising targets for the treatment of type 2 diabetes mellitus (T2DM). With a randomized clinical trial, we tested the hypothesis that alteration of gut microbiota may be involved in the alleviation of T2DM with hyperlipidemia by metformin and a specifically designed herbal formula (AMC). Four hundred fifty patients with T2DM and hyperlipidemia were randomly assigned to either the metformin- or AMC-treated group. After 12 weeks of treatment, 100 patients were randomly selected from each group and assessed for clinical improvement. The effects of the two drugs on the intestinal microbiota were evaluated by analyzing the V3 and V4 regions of the 16S rRNA gene by Illumina sequencing and multivariate statistical methods. Both metformin and AMC significantly alleviated hyperglycemia and hyperlipidemia and shifted gut microbiota structure in diabetic patients. They significantly increased a coabundant group represented by Blautia spp., which significantly correlated with the improvements in glucose and lipid homeostasis. However, AMC showed better efficacies in improving homeostasis model assessment of insulin resistance (HOMA-IR) and plasma triglyceride and also exerted a larger effect on gut microbiota. Furthermore, only AMC increased the coabundant group represented by Faecalibacterium spp., which was previously reported to be associated with the alleviation of T2DM in a randomized clinical trial. Metformin and the Chinese herbal formula may ameliorate type 2 diabetes with hyperlipidemia via enriching beneficial bacteria, such as Blautia and Faecalibacterium spp.IMPORTANCE Metabolic diseases such as T2DM and obesity have become a worldwide public health threat. Accumulating evidence indicates that gut microbiota can causatively arouse metabolic diseases, and thus the gut microbiota serves as a promising target for disease control. In this study, we evaluated the role of gut microbiota during improvements in hyperglycemia and hyperlipidemia by two drugs: metformin and a specifically designed Chinese herbal formula (AMC) for diabetic patients with hyperlipidemia. Both drugs significantly ameliorated blood glucose and lipid levels and shifted the gut microbiota. Blautia spp. were identified as being associated with improvements in glucose and lipid homeostasis for both drugs. AMC exerted larger effects on the gut microbiota together with better efficacies in improving HOMA-IR and plasma triglyceride levels, which were associated with the enrichment of Faecalibacterium spp. In brief, these data suggest that gut microbiota might be involved in the alleviation of diabetes with hyperlipidemia by metformin and the AMC herbal formula.

Project description:This study determined whether injection with hypertonic dextrose and morrhuate sodium (prolotherapy) using a pragmatic, clinically determined injection schedule for knee osteoarthritis (KOA) results in improved knee pain, function, and stiffness compared to baseline status.This was a prospective three-arm uncontrolled study with 1-year follow-up.The setting was outpatient.The participants were 38 adults who had at least 3 months of symptomatic KOA and who were in the control groups of a prior prolotherapy randomized controlled trial (RCT) (Prior-Control), were ineligible for the RCT (Prior-Ineligible), or were eligible but declined the RCT (Prior-Declined).The injection sessions at occurred at 1, 5, and 9 weeks with as-needed treatment at weeks 13 and 17. Extra-articular injections of 15% dextrose and 5% morrhuate sodium were done at peri-articular tendon and ligament insertions. A single intra-articular injection of 6?mL 25% dextrose was performed through an inferomedial approach.The primary outcome measure was the validated Western Ontario McMaster University Osteoarthritis Index (WOMAC). The secondary outcome measure was the Knee Pain Scale and postprocedure opioid medication use and participant satisfaction.The Prior-Declined group reported the most severe baseline WOMAC score (p=0.02). Compared to baseline status, participants in the Prior-Control group reported a score change of 12.4±3.5 points (19.5%, p=0.002). Prior-Decline and Prior-Ineligible groups improved by 19.4±7.0 (42.9%, p=0.05) and 17.8±3.9 (28.4%, p=0.008) points, respectively; 55.6% of Prior-Control, 75% of Prior-Decline, and 50% of Prior-Ineligible participants reported score improvement in excess of the 12-point minimal clinical important difference on the WOMAC measure. Postprocedure opioid medication resulted in rapid diminution of prolotherapy injection pain. Satisfaction was high and there were no adverse events.Prolotherapy using dextrose and morrhuate sodium injections for participants with mild-to-severe KOA resulted in safe, significant, sustained improvement of WOMAC-based knee pain, function, and stiffness scores compared to baseline status.

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Project description:BackgroundIntra-articular injections of hyaluronic acid-also called viscosupplementation (VS)-is frequently used for the symptomatic treatment of knee osteoarthritis, a painful and debilitating long-term disease, affecting an important fraction of elderly populations. Severity of knee osteoarthritis is generally described by Kellgren-Lawrence (KL) radiological classification. VS has been widely studied in many clinical trials; however, the results are rarely analyzed in detail according to KL grade.MethodA large, clinical, open-label study was performed in 2004-2007 on 1177 patients with knee osteoarthritis, each treated with VS consisting of 3 injections of Arthrum H 2% (LCA Pharmaceutical, Chartres, France). The characteristics of the patients at baseline included demographic profile, body mass index, KL grade, and clinical scores for pain and function using the Western Ontario and McMaster Universities index. Follow-up visits were at 3, 6, and 9 months after VS procedure. This large database was entirely reprocessed in 2019 to provide a separate analysis per KL grade, complemented by the assessment of the Outcome Measures in Rheumatoid Arthritis Clinical Trials-Osteoarthritis Research Society International rates (%) of responders to the treatment. The analysis was carried out for both intention-to-treat and per-protocol completer populations.ResultsA primary outcome in the intention-to-treat analysis, variations of the Western Ontario and McMaster Universities index pain subscore from inclusion to the end of the study were 19.8, 19.8, 17.8, and 14.2 for KL grade I to KL grade IV patients, respectively, on a 0 to 100 scale. In the per-protocol analysis, under the same conditions, the variations were 20.6, 19.9, 17.1, and 11.7. All results were significant (P < 0.001) and clinically relevant for each KL grade. Significant improvements were also observed for the Western Ontario and McMaster Universities index function subscore and for the other secondary outcomes. The Outcome Measures in Rheumatoid Arthritis Clinical Trials-Osteoarthritis Research Society International responders rate reached 72% to 82% for KL grade I through III patients at Month 6 and Month 9. For KL grade IV patients, the maximum rate reached was 47.7% at Month 6. There was evidence that KL grade is a critical parameter, particularly if KL grade IV is present. Other parameters such as gender, body mass index, and age were not identified as prognostic factors of response to VS based on χ2 and odds ratio (95% CI) testing.ConclusionsDetailed analysis by KL grade supports that VS treatment with Arthrum H 2% applies to a large variety of patients with knee osteoarthritis.

Dataset Information

A Traditional Herbal Formula Xianlinggubao for Pain Control and Function Improvement in Patients with Knee and Hand Osteoarthritis: A Multicenter, Randomized, Open-Label, Controlled Trial.

Publications

A Traditional Herbal Formula Xianlinggubao for Pain Control and Function Improvement in Patients with Knee and Hand Osteoarthritis: A Multicenter, Randomized, Open-Label, Controlled Trial.

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