Effectiveness and Safety of Manufactured Chinese Herbal Formula for Knee Osteoarthritis: Insights from a Systematic Review.
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ABSTRACT:
SUBMITTER: Zhu L
PROVIDER: S-EPMC4644564 | biostudies-other | 2015
REPOSITORIES: biostudies-other
Publications
Effectiveness and Safety of Manufactured Chinese Herbal Formula for Knee Osteoarthritis: Insights from a Systematic Review.
Zhu Liguo L Yang Shaofeng S Wang Shangquan S Gong Hao H Li Linghui L Wei Xu X
Evidence-based complementary and alternative medicine : eCAM 20151101
Objective. To assess the current clinical evidence of manufactured Chinese herbal formulae (MCHF) for knee osteoarthritis (KOA). Methods. Seven databases were searched from inception to May 2015. Eligible randomized controlled trials investigating the effectiveness of MCHF for KOA were included. Data extraction, methodological assessment, and meta-analyses were conducted according to the Cochrane standards. Results. A total of 17 kinds of MCHF were identified from the twenty-six included trials. ...[more]
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Project description:BackgroundKnee osteoarthritis (OA) is a major public health concern causing chronic disability as well as a substantial burden on health care and the economy. However, effective treatments for knee OA were still not available. Numerous clinical studies have suggested that Chinese herbal medicine (CHM) seems to be clinically effective in treating knee OA. Thus, this study aims to evaluate the efficacy and safety of CHM in the treatment of knee OA through a systematic review and network meta-analysis.MethodsA comprehensive search will be performed in PubMed, Cochrane Library, Embase, Web of Science, China National Knowledge Infrastructure, VIP Database, Wanfang Database, Chinese Biomedical Database, and 3 clinical trials registration websites, from the database inception to May 2021. Randomized controlled trials meeting the eligible criteria based on the PICOS framework will be included. All studies fulfilling the eligible criteria will be assessed for risk of bias using the Cochrane Collaboration's tool. The primary outcome will be the visual analog scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index, and total effective rate. The secondary outcome is the incidence of adverse events. Data analysis will be performed using Stata, Addis, and WinBUGS.DiscussionThis study will provide a reliable evidence to assess effectiveness and safety of CHM for knee OA, which may provide guidance for clinical practice.Systematic review registrationThis study protocol has been registered on INPLASY202160060.
| S-EPMC8294919 | biostudies-literature
Project description:BackgroundAnkylosing spondylitis (AS) is a chronic progressive inflammatory disease of the spine, which mainly invades the sacroiliac joint, spine, and large joints near the trunk, leading to fibrous and skeletal ankylosis and deformity, and can cause damage to the eyes, lung, cardiovascular, kidney and other organs. Chinese herbal formulas (CHF) is an important interventions of Traditional Chinese Medicine (TCM), and CHFs combined with western medicine are widely used in clinical practice to treat AS.MethodsEight databases will be systematically retrieved from their inceptions to March 2021. Only randomized controlled trials (RCTs) of CHFs combined with western medicine for AS treatment will meet the inclusion criteria. The primary outcomes we focus on include clinical effectiveness rate, TCM syndrome score, TCM symptom score, Bath ankylosing spondylitis disease activity index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), chest expansion, nocturnal spinal pain, adverse reactions, erythrocyte sedimentation rate (ESR), and C protein response (CRP). The research screening, data extraction, and risk of bias assessment will be performed independently by 2 researchers, and divergence will be solved by a third researcher. Revman 5.3 software will be used for meta-analysis. The confidence of evidence will be graded using grading of recommendations assessment, development, and evaluation (GRADE) algorithm and methodological quality will be assessed adopting risk of bias in systematic reviews (ROBIS).ResultsThis systematic review (SR) will provide evidence-based medical evidence for AS therapy by CHF combined with western medicine and we will submit the findings of this SR for peer-review publication.ConclusionsThis SR will provide latest and updated summary proof for assessing the effectiveness and safety of CHF combined with western medicine for AS.Registration numberINPLASY 202150089.
| S-EPMC8238346 | biostudies-literature
Project description:BackgroundKnee osteoarthritis (KOA), known as severe degenerative arthritis, commonly occurs in middle-aged and elderly people all over the world. Acupuncture as traditional oriental intervention is getting widely used and several systematic reviews (SRs) have reported the effectiveness of acupuncture on pain relief and functional recovery in patients with KOA.ObjectiveConducting an overview of SRs to provide more reliable evidence-based medical references for clinical practitioners and researchers of the effectiveness and safety of acupuncture for KOA.Data sourcesEMBASE, Medline, Web of science, the Cochrane library, China National Knowledge Infrastructure, the Chinese Science and Technology Periodical Database, China Biology Medicine, Wan Fang Digital Journals, and PROSPERO databases from inception to December 2018, magazines, websites, and unpublished sources.Selection criteriaPotential SRs were independently selected by 2 reviewers following a predetermined protocol.Data extractionData information of included SRs were independently extracted by 2 reviewers following a predetermined standardized data extraction form.Review appraisalThe risk of bias and reporting quality of included SRs were evaluated by the Risk of Bias in Systematic reviews (ROBIS) tool and the Preferred Reporting Item for Systematic Review and Meta-analysis (PRISMA) statement. The quality of evidence of outcomes was evaluated by the Grading of Recommendations Assessment, Development and Evaluation (GRADE).ResultsA total of 12 SRs were included. All the SRs were published in recent 12 years, ranging from 2006 to 2017. According to ROBIS, 4 SRs were in low risk in domain 1 and 7 in domain 3 of phase 2, and 2 SRs were low risk in phase 3. Among 27 items of PRISMA, 19 items were reported over 70% of compliance. Using GRADE assessment, of 34 outcomes, high quality of evidence was found in 5 outcomes, 17 outcomes were rated moderate quality, and 11 outcomes were low quality. According to high-quality outcomes, acupuncture had more total effective rate, short-term effective rate, and less adverse reactions than western medicine in treating KOA. In terms of Lequesne index and Lysholm knee score scale score, the effectiveness of electroacupuncture was better than that of western medicine.LimitationsThere might be missing information. There may be duplicated clinical trials included by each SR that might have impact on the synthetic findings.ConclusionsAccording to the high-quality evidence, we concluded that acupuncture may have some advantages in treating KOA. However, there are some risk of bias and reporting deficiencies still needed to be improved.
| S-EPMC6641846 | biostudies-literature
Project description:Objective. The aim of this study is to systematically evaluate the evidence whether traditional Chinese herbal patches (TCHPs) for osteoarthritis (OA) are effective and safe and analyze their medication patterns. Methods. A systematic literature search was performed using all the possible Medical Subject Headings (MeSH) and keywords from January 1979 to July 2013. Both randomized controlled trials (RCTs) and observational studies were included. Estimated effects were analyzed using mean difference (MD) or relative risk (RR) with 95% confidence intervals (CI) and meta-analysis. Results. 86 kinds of TCHPs were identified. RCTs and controlled clinical trials (CCTs) which were mostly of low quality favored TCHPs for local pain and dysfunction relief. TCHPs, compared with diclofenac ointment, had significant effects on global effectiveness rate (RR = 0.50; 95% CI (0.29, 0.87)). Components of formulae were mainly based on the compounds "Xiao Huo Luo Dan" (Minor collateral-freeing pill) and "Du Huo Ji Sheng Tang" (Angelicae Pubescentis and Loranthi decoction). Ten kinds of adverse events (AEs), mainly consisting of itching and/or local skin rashes, were identified after 3-4 weeks of follow-up. Conclusions. TCHPs have certain evidence in improving global effectiveness rate for OA; however, more rigorous studies are warranted to support their use.
| S-EPMC3914464 | biostudies-literature
Project description:ObjectiveThis systematic review and meta-analysis were performed to investigate the efficacy and safety of Chinese herbal medicine (CHM) in the treatment of knee osteoarthritis (KOA).MethodsAn electronic search was conducted in eight databases (PubMed, EMBASE, Web of Science, Cochrane Library, Chinese National Knowledge Infrastructure, Chinese Biomedical Literature Database, Chinese VIP Database, and Wanfang Database) from inception until December 2019. The risk of bias assessment of the included RCTs was evaluated by Cochrane collaboration's tool. The inclusion criteria were RCTs that investigated the efficacy and safety of CHM in the treatment of KOA, with no restrictions on publication status or language. The exclusion criteria included nonrandomized or quasi-RCTs, no clear KOA diagnostic approach, combined Chinese medicinal herbs with other traditional Chinese medicine treatment modalities, and published using repeated data and missing data. We computed the relative risk (RR) and the standard mean difference (SMD) for dichotomous outcomes and continuous outcomes, respectively. When heterogeneity was detected or there was significant statistical heterogeneity (P < 0.05 or I 2 > 50%), a random-effects model was employed, followed by further subgroup analysis and metaregression estimations to ascertain the origins of heterogeneity. Otherwise, we used a fixed-effects model (P ≥ 0.05 or I 2 ≤ 50%). The primary outcome measures were visual analog score (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lysholm score, and Lequesne index. Secondary outcome measures were the total clinical effective rate and adverse events. The meta-analysis was performed using the Stata 14.0 software.ResultsA total of 56 RCTs comprising 5350 patients met the inclusion criteria. This meta-analysis showed that application of CHM as adjuvant therapy or monotherapy for KOA can significantly decrease VAS, WOMAC, and the Lequesne index and improve the Lysholm score as well as the total effective rate. In addition, this treatment has fewer adverse effects, suggesting that CHM is generally safe and well tolerated among patients with KOA.ConclusionOur study offers supportive evidence that CHM, either adjuvant therapy or monotherapy, reduces the VAS, WOMAC, and Lequesne index and improves the Lysholm score and overall effective rate in patients with KOA. Additionally, CHM was well tolerated and safe in KOA patients. We found frequently used CHMs that might contribute to the formulation of a herbal formula that could be considered for further clinical use. However, given the heterogeneity and limited sample size in this study, larger multicenter and high-quality RCTs are needed to validate the benefits of CHM in the treatment of KOA.
| S-EPMC8759838 | biostudies-literature
Project description:BackgroundFood Allergy Herbal Formula-2 (FAHF-2) is a 9-herb formula based on traditional Chinese medicine that blocks peanut-induced anaphylaxis in a murine model. In phase I studies FAHF-2 was found to be safe and well tolerated.ObjectiveWe sought to evaluate the safety and effectiveness of FAHF-2 as a treatment for food allergy.MethodsIn this double-blind, randomized, placebo-controlled study 68 subjects aged 12 to 45 years with allergies to peanut, tree nut, sesame, fish, and/or shellfish, which were confirmed by baseline double-blind, placebo-controlled oral food challenges (DBPCFCs), received FAHF-2 (n = 46) or placebo (n = 22). After 6 months of therapy, subjects underwent DBPCFCs. For those who demonstrated increases in the eliciting dose, a repeat DBPCFC was performed 3 months after stopping therapy.ResultsTreatment was well tolerated, with no serious adverse events. By using intent-to-treat analysis, the placebo group had a higher eliciting dose and cumulative dose (P = .05) at the end-of-treatment DBPCFC. There was no difference in the requirement for epinephrine to treat reactions (P = .55). There were no significant differences in allergen-specific IgE and IgG4 levels, cytokine production by PBMCs, or basophil activation between the active and placebo groups. In vitro immunologic studies performed on subjects' baseline PBMCs incubated with FAHF-2 and food allergen produced significantly less IL-5, greater IL-10 levels, and increased numbers of regulatory T cells than untreated cells. Notably, 44% of subjects had poor drug adherence for at least one third of the study period.ConclusionFAHF-2 is a safe herbal medication for subjects with food allergy and shows favorable in vitro immunomodulatory effects; however, efficacy for improving tolerance to food allergens is not demonstrated at the dose and duration used.
| S-EPMC4600418 | biostudies-literature
Project description:Background Manual therapy has been used as an alternative approach to treat knee osteoarthritis (KOA) for many years. Numerous systematic reviews (SRs) or meta-analyses (MAs) were published to evaluate its effectiveness and safety. Nevertheless, the conclusions of SRs/MAs are inconsistent, and the uneven quality needs to be critically appraised. Objectives To conduct a comprehensive overview of the effectiveness and safety of manual therapy for KOA and the quality of relevant SRs/MAs, thus providing critical evidence and valuable direction for future researchers to promote the generation of advanced evidence. Methods The pre-defined search strategies were applied to eight electronic databases from inception to September 2022. Suitable SRs/MAs were included in accordance with the inclusion and exclusion criteria. The methodological quality, risk of bias, reporting quality, and evidence quality were assessed by two independent reviewers who used respectively the A Measurement Tool to Assess Systematic Reviews 2 (AMSTAR-2), the Risk of Bias in Systematic Reviews (ROBIS), the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 Version (PRISMA 2020), and Grades of Recommendations, Assessment, Development and Evaluation (GRADE) based on the method of narrative synthesis. We excluded the overlapping randomized controlled trials (RCTs) and performed a re-meta-analysis of the total effective rate. Results A total of eleven relevant SRs/MAs were included: nine SRs/MAs were rated critically low quality, and two were rated low quality by AMSTAR-2. According to ROBIS, all SRs/MAs were rated low risk in Phase 1 (assessing relevance) and Domain 1 (study eligibility criteria) of Phase 2. Three SRs/MAs (27.27%) were rated low risk in Domain 2 (identification and selection of studies). Ten SRs/MAs (90.91%) were rated low risk in Domain 3 (data collection and study appraisal). Five SRs/MAs (45.45%) were rated low risk in Domain 4 (synthesis and findings). And five SRs/MAs (45.45%) were rated low risk in Phase 3 (risk of bias in the review). By PRISMA 2020, there were some reporting deficiencies in the aspects of abstract (2/11, 18.18%), search strategy (0/11, 0%), preprocessing of merging data (0/11, 0%), heterogeneity exploration (6/11, 54.55%), sensitivity analysis (4/11, 36.36%), publication bias (5/11, 45.45%), evidence quality (3/11, 27.27%), the list of excluded references (3/11, 27.27%), protocol and registration (1/11, 9.09%), funding (1/11, 9.09%), conflict of interest (3/11, 27.27%), and approach to relevant information (0/11, 0%). In GRADE, the evidence quality was defined as moderate quality (8 items, 21.05%), low quality (16 items, 42.11%), and critically low quality (14 items, 36.84%). Among the downgraded factors, risk of bias, inconsistency, imprecision, and publication bias were the main factors. A re-meta-analysis revealed that manual therapy can increase the total effective rate in KOA patients (risk ratio = 1.15, 95% confidence interval [1.12, 1.18], p < 0.00001; I2 = 0, p = 0.84). There are four reviews that narratively report adverse effects, and no severe adverse reactions occurred in the manual therapy group. Conclusions Manual therapy may be clinically effective and safe for patients with KOA. However, this conclusion must be interpreted with caution because of the generally unsatisfactory study quality and inconsistent conclusions of the included SRs/MAs. Further rigorous and normative SRs/MAs are expected to be carried out to provide robust evidence for definitive conclusions. Systematic review registration https://www.crd.york.ac.uk/PROSPERO/#myprospero, identifier: CRD42022364672.
| S-EPMC9999021 | biostudies-literature
Project description:BackgroundThere is no cure for knee osteoarthritis (KOA) and typically patients live approximately 30-years with the disease. Most common medical treatments result in short-term palliation of symptoms with little consideration of long-term risk. This systematic review aims to appraise the current evidence for the long-term (≥12 months) safety of common treatments for knee osteoarthritis (KOA).MethodsCochrane Database of Systematic Reviews, Medline and PubMed were systematically searched from 1990 to July 2017, inclusive. Inclusion criteria were 1) peer-reviewed publications investigating treatments for KOA referred to in the Australian Clinical Care Standard and/or Therapeutic Guidelines: Rheumatology 2) specifically addressing safety of the treatments 3) with ≥12 months of follow-up and 4) Downs and Black quality score ≥ 13.ResultsThirty-four studies fulfilled the inclusion criteria. Lifestyle modifications (moderate exercise and weight loss), paracetamol, glucosamine, Intraarticular Hyaluronic Acid (IAHA) and platelet-rich-plasma (PRP) injections have a low risk of harm and beneficial ≥12 month outcomes. Although Nonsteroidal Anti-inflammatory Drugs (NSAIDs) provide pain relief, they are associated with increased risk of medical complications. Cortisone injections are associated with radiological cartilage degeneration at > 12 months. Arthroscopy for degenerative meniscal tears in KOA leads to a 3-fold increase in total knee arthroplasty (TKA). TKA improves primary outcomes of KOA but has a low rate of significant medical complications.ConclusionsGiven the safety and effectiveness of lifestyle interventions such as weight loss and exercise, these should be advocated in all patients due to the low risk of harm. The use of NSAIDs should be minimized to avoid gastrointestinal complications. Treatment with opioids has a lack of evidence for use and a high risk of long-term harm. The use of IAHA and PRP may provide additional symptomatic benefit without the risk of harm. TKA is associated with significant medical complications but is justified by the efficacy of joint replacement in late-stage disease.Trial registrationPROSPERO International prospective register for systematic reviews; registration number CRD42017072809 .
| S-EPMC6454763 | biostudies-literature
Project description:Traditional Chinese medicine (TCM) has been accepted as a complementary therapy for knee osteoarthritis. However, the efficacy and safety of the intervention were still conflicting and uncertain. Meanwhile, the quality of methodology and evidence in the field was unknown.To summarize the characteristics and critically evaluate the quality of methodology, as well as the evidence of systematic reviews (SRs) on TCM for knee osteoarthritis.Five electronic databases were searched from inception to April 2016. The methodological quality of the included studies was assessed by AMSTAR and ROBIS. The quality of the evidence was determined using the GRADE approach.Ten SRs were included. The conclusions suggest that TCM provides potential benefits for patients with knee osteoarthritis. These benefits include pain relief, functional improvement, and presence of few adverse events. Limitations of the methodological quality mainly included the lack of a-priori protocol or protocol registration and incomprehensive literature search. A list of excluded studies was also not provided. The overall quality of evidence in the SRs was poor, ranging from "very low" to "low," mainly because of the serious risk of bias of original trials, inconsistencies, and imprecision in the outcomes.TCM generally appears to be effective for knee osteoarthritis treatment. However, the evidence is not robust enough because of the methodological flaws in SRs. Hence, these conclusions on available SRs should be treated with caution for clinical practice.
| S-EPMC5739454 | biostudies-literature
Project description:BackgroundThis study was conducted to evaluate the efficacy of the herbal formula PM012 on an Alzheimer's disease model, human presenilin 2 mutant transgenic mice (hPS2m), and also to evaluate the toxicity of PM012 in Sprague-Dawely rats after 4 or 26 weeks treatment with repeated oral administration.MethodsSpatial learning and memory capacities of hPS2m transgenic mice were evaluated using the Morris Water Maze. Simultaneously, PM012 was repeatedly administered orally to male and female SD rats (15/sex/group) at doses of 0 (vehicle control), 500, 1,000 and 2,000 mg/kg/day for 4 or 26 weeks. To evaluate the recovery potential, 5 animals of each sex were assigned to vehicle control and 2,000 mg/kg/day groups during the 4-week recovery period.ResultsThe results showed that PM012-treated hPS2m transgenic mice showed significantly reduced escape latency when compared with the hPS2m transgenic mice. The repeated oral administration of PM012 over 26 weeks in male and female rats induced an increase and increasing trend in thymus weight in the female treatment groups (main and recovery groups), but the change was judged to be toxicologically insignificant. In addition, the oral administration of the herbal medicine PM012 did not cause adverse effects as assessed by clinical signs, mortality, body weight, food and water consumption, ophthalmology, urinalysis, hematology, serum biochemistry, blood clotting time, organ weights and histopathology. The No Observed Adverse Effects Levels of PM012 was determined to be 2,000 mg/kg/day for both sexes, and the target organ was not identified.ConclusionThese results suggest that PM012 has potential for use in the treatment of the Alzheimer's disease without serious adverse effects.
| S-EPMC3342231 | biostudies-literature