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Efficacy and Safety of Traditional Chinese Medicine Exercise Versus Oral Medication in the Treatment of Neck Pain: Study Protocol for a Systematic Review and Meta-Analysis

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BackgroundNeck pain poses a significant and growing public health challenge, with rising prevalence among younger populations and negative impacts on both quality of life and socioeconomic costs. Clinical manifestations are diverse, including restricted movement, muscle spasms, headaches, and upper limb numbness. Although drug therapy is widely used, its long-term use is limited by adverse effects. Traditional Chinese medicine (TCM) exercises offer a promising alternative, but high-quality evidence directly comparing their efficacy and safety to oral medications is currently lacking.ObjectiveThis study aims to compare the efficacy and safety of TCM exercises and oral medication in treating neck pain.MethodsWe will identify relevant randomized controlled trials (RCTs) through a systematic search of multiple databases (including PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure [CNKI], Chinese Biomedical Literature Database [CBM], VIP, and Wanfang) from inception through September 2025. Only RCTs directly comparing TCM exercise to oral medication will be included. Study quality will be assessed using the Cochrane RoB2 tool, and the overall evidence will be graded via the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. For heterogeneity, the I² statistic and Cochran Q test will be applied. A fixed-effect model will be adopted if I²<50% and P≥.10; otherwise, subgroup analysis will be performed. Should heterogeneity persist, sensitivity analysis or a random-effects model will be employed, leading to a reduction in the GRADE rating.ResultsThis is a study protocol; therefore, no results are available at this stage. The systematic review is scheduled to commence in August 2025, with the literature search from August to September 2025, study screening from September to December 2025, data extraction and analysis from January to May 2026, and manuscript submission by June 2026.ConclusionsThis protocol outlines a systematic review and meta-analysis designed to compare the efficacy and safety of TCM exercises versus oral medications for neck pain. The completed review aims to synthesize the available evidence and clarify whether TCM exercises offer a comparable or superior alternative to pharmacotherapy. By systematically evaluating direct head-to-head RCTs, this study seeks to provide evidence-based insights to inform clinical decision-making. Potential limitations of the forthcoming review may include heterogeneity in exercise protocols, challenges in blinding, and a possible limited number or geographic concentration of available trials, which could affect the generalizability of the findings. These limitations will be considered when interpreting the results.

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Fluphenazine decanoate (depot) and enanthate for schizophrenia.
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Intramuscular injections (depot preparations) offer an advantage over oral medication for treating schizophrenia by reducing poor compliance. The benefits gained by long-acting preparations, however, may be offset by a higher incidence of adverse effects. To assess the effects of fluphenazine decanoate and enanthate versus oral anti-psychotics and other depot neuroleptic preparations for individuals with schizophrenia in terms of clinical, social and economic outcomes. We searched the Cochrane Schizophrenia Group's Trials Register (February 2011 and October 16, 2013), which is based on regular searches of CINAHL, BIOSIS, AMED, EMBASE, PubMed, MEDLINE, PsycINFO, and registries of clinical trials. We considered all relevant randomised controlled trials (RCTs) focusing on people with schizophrenia comparing fluphenazine decanoate or enanthate with placebo or oral anti-psychotics or other depot preparations. We reliably selected, assessed the quality, and extracted data of the included studies. For dichotomous data, we estimated risk ratio (RR) with 95% confidence intervals (CI). Analysis was by intention-to-treat. We used the mean difference (MD) for normal continuous data. We excluded continuous data if loss to follow-up was greater than 50%. Tests of heterogeneity and for publication bias were undertaken. We used a fixed-effect model for all analyses unless there was high heterogeneity. For this update. we assessed risk of bias of included studies and used the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach to create a 'Summary of findings' table. This review now includes 73 randomised studies, with 4870 participants. Overall, the quality of the evidence is low to very low.Compared with placebo, use of fluphenazine decanoate does not result in any significant differences in death, nor does it reduce relapse over six months to one year, but one longer-term study found that relapse was significantly reduced in the fluphenazine arm (n = 54, 1 RCT, RR 0.35, CI 0.19 to 0.64, very low quality evidence). A very similar number of people left the medium-term studies (six months to one year) early in the fluphenazine decanoate (24%) and placebo (19%) groups, however, a two-year study significantly favoured fluphenazine decanoate (n = 54, 1 RCT, RR 0.47, CI 0.23 to 0.96, very low quality evidence). No significant differences were found in mental state measured on the Brief Psychiatric Rating Scale (BPRS) or in extrapyramidal adverse effects, although these outcomes were only reported in one small study each. No study comparing fluphenazine decanoate with placebo reported clinically significant changes in global state or hospital admissions.Fluphenazine decanoate does not reduce relapse more than oral neuroleptics in the medium term (n = 419, 6 RCTs, RR 1.46 CI 0.75 to 2.83, very low quality evidence). A small study found no difference in clinically significant changes in global state. No difference in the number of participants leaving the study early was found between fluphenazine decanoate (17%) and oral neuroleptics (18%), and no significant differences were found in mental state measured on the BPRS. Extrapyramidal adverse effects were significantly less for people receiving fluphenazine decanoate compared with oral neuroleptics (n = 259, 3 RCTs, RR 0.47 CI 0.24 to 0.91, very low quality evidence). No study comparing fluphenazine decanoate with oral neuroleptics reported death or hospital admissions.No significant difference in relapse rates in the medium term between fluphenazine decanoate and fluphenazine enanthate was found (n = 49, 1 RCT, RR 2.43, CI 0.71 to 8.32, very low quality evidence), immediate- and short-term studies were also equivocal. One small study reported the number of participants leaving the study early (29% versus 12%) and mental state measured on the BPRS and found no significant difference for either outcome. No significant difference was found in extrapyramidal adverse effects between fluphenazine decanoate and fluphenazine enanthate. No study comparing fluphenazine decanoate with fluphenazine enanthate reported death, clinically significant changes in global state or hospital admissions. There are more data for fluphenazine decanoate than for the enanthate ester. Both are effective antipsychotic preparations. Fluphenazine decanoate produced fewer movement disorder effects than other oral antipsychotics but data were of low quality, and overall, adverse effect data were equivocal. In the context of trials, there is little advantage of these depots over oral medications in terms of compliance but this is unlikely to be applicable to everyday clinical practice.

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Psychoeducation (brief) for people with serious mental illness.
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  • Sai Zhao + 3 more

Those with serious/severe mental illness, especially schizophrenia and schizophrenic-like disorders, often have little to no insight regarding the presence of their illness. Psychoeducation may be defined as the education of a person with a psychiatric disorder regarding the symptoms, treatments, and prognosis of that illness. Brief psychoeducation is a short period of psychoeducation; although what constitutes 'brief psychoeducation' can vary. A previous systematic review has shown that the median length of psychoeducation is around 12 weeks. In this current systematic review, we defined 'brief psychoeducation' as programmes of 10 sessions or less. To assess the efficacy of brief psychoeducational interventions as a means of helping severely mentally ill people when added to 'standard' care, compared with the efficacy of standard care alone.The secondary objective is to investigate whether there is evidence that a particular kind (individual/ family/group) of brief psychoeducational intervention is superior to others. We searched the Cochrane Schizophrenia Group register September 2013 using the phrase:[*Psychoeducat* in interventions of STUDY]. Reference lists of included studies were also inspected for further relevant studies. We also contacted authors of included study for further information regarding further data or details of any unpublished trials. All relevant randomised controlled trials (RCTs) comparing brief psychoeducation with any other intervention for treatment of people with severe mental illness. If a trial was described as 'double blind' but implied randomisation, we entered such trials in a sensitivity analysis. At least two review authors extracted data independently from included papers. We contacted authors of trials for additional and missing data. We calculated risk ratios (RR) and 95% confidence intervals (CI) of homogeneous dichotomous data. For continuous data, we calculated the mean difference (MD), again with 95% CIs. We used a fixed-effect model for data synthesis, and also assessed data using a random-effects model in a sensitivity analysis. We assessed risk of bias for each included study and created 'Summary of findings' tables using GRADE (Grading of Recommendations Assessment, Development and Evaluation). We included twenty studies with a total number of 2337 participants in this review. Nineteen studies compared brief psychoeducation with routine care or conventional delivery of information. One study compared brief psychoeducation with cognitive behavior therapy.Participants receiving brief psychoeducation were less likely to be non-compliant with medication than those receiving routine care in the short term (n = 448, 3 RCTs, RR 0.63 CI 0.41 to 0.96, moderate quality evidence) and medium term (n = 118, 1 RCT, RR 0.17 CI 0.05 to 0.54, low quality evidence).Compliance with follow-up was similar between the two groups in the short term (n = 30, 1 RCT, RR 1.00, CI 0.24 to 4.18), medium term (n = 322, 4 RCTs, RR 0.74 CI 0.50 to 1.09) and long term (n = 386, 2 RCTs, RR 1.19, CI 0.83 to 1.72).Relapse rates were significantly lower amongst participants receiving brief psychoeducation than those receiving routine care in the medium term (n = 406, RR 0.70 CI 0.52 to 0.93, moderate quality evidence), but not in the long term.Data from a few individual studies supported that brief psychoeducation: i) can improve the long-term global state (n = 59, 1 RCT, MD -6.70 CI -13.38 to -0.02, very low quality evidence); ii) promote improved mental state in short term (n = 60, 1 RCT, MD -2.70 CI -4.84 to -0.56,low quality evidence) and medium term; iii) can lower the incidence and severity of anxiety and depression.Social function such as rehabilitation status (n = 118, 1 RCT, MD -13.68 CI -14.85 to -12.51, low quality evidence) and social disability (n = 118, 1 RCT, MD -1.96 CI -2.09 to -1.83, low quality evidence) were also improved in the brief psychoeducation group. There was no difference found in quality of life as measured by GQOLI-74 in the short term (n = 62, 1 RCT, MD 0.63 CI -0.79 to 2.05, low quality evidence), nor the death rate in either groups (n = 154, 2 RCTs, RR 0.99, CI 0.15 to 6.65, low quality evidence). Based on mainly low to very low quality evidence from a limited number of studies, brief psychoeducation of any form appears to reduce relapse in the medium term, and promote medication compliance in the short term. A brief psychoeducational approach could potentially be effective, but further large, high-quality studies are needed to either confirm or refute the use of this approach.

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Non-pharmacological interventions for postpartum depression
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Evidence Evaluation Process and Management of Potential Conflicts of Interest: 2020 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations.
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Effectiveness and Safety of Tuina Therapy Combined With Yijinjing Exercise for Neck Pain: Protocol for a Systematic Review and Meta-Analysis
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BackgroundNeck pain with high incidence and recurrence rates significantly impairs patients’ quality of life and imposes a considerable economic burden. Traditional Chinese medicine therapies such as Yijinjing exercise and Tuina have shown promising efficacy in alleviating the local symptoms of neck pain. However, there is currently insufficient high-level evidence to robustly support these findings.ObjectiveThis study aims to evaluate the efficacy and safety of combining Yijinjing exercise with Tuina for the treatment of neck pain.MethodsPubMed, Cochrane Library, Embase, Web of Science, China National Knowledge Infrastructure, Chinese Biomedical Database, VIP Chinese Science and Technology Periodicals Full-Text database, and Wanfang database will be systematically searched for all relevant randomized controlled trials (RCTs) from their inception to September 2025, without language or publication status restrictions. The Cochrane Risk of Bias 2 assessment tool will be used to evaluate the risk of bias in the included studies, and the GRADE (Grades of Recommendation, Assessment, Development, and Evaluation) system will be employed to grade the quality of evidence. Heterogeneity will be evaluated through I2 statistics and Cochran’s Q test: a fixed-effect model will be used when I2<50% and P≥.01. If I2≥50% or P<.01, subgroup analysis will be conducted. When heterogeneity still exists, sensitivity analysis or exploratory subgroup analysis will be performed. If it cannot be explained ultimately, the random-effects model will be adopted and the GRADE evidence level will be reduced.ResultsAs of June 2025, we have completed the preliminary screening of titles and abstracts for 573 studies. The full-text screening is expected to be completed by September 2025, and data analysis is planned to be completed by December 2025. About two-thirds of the studies were published after 2015. Geographically, the samples in the studies were highly concentrated in Asia. The results were comprehensively developed around the core outcomes. The primary outcome was presented by changes in the visual analog scale. The secondary outcomes were evaluated by the neck disability index, self-rating anxiety scale score, mean vertebral artery blood flow velocity, and Cobb angle.ConclusionsIf the results of this study confirm the effectiveness of massage combined with Yijinjing, it can provide a direction for the nonpharmaceutical treatment of neck pain. However, some studies have risks of bias such as insufficient standardization of massage operations and difficulty in implementing blinding methods. The expected heterogeneity is significant due to differences in intervention plans and patients’ cultural backgrounds, and the original RCTs are few and regionally concentrated, with limited extrapolation of conclusions. In the future, it is necessary to optimize the plan and supplement data through high-quality multicenter research to enhance reliability.Trial RegistrationPROSPERO CRD420251026508; https://www.crd.york.ac.uk/PROSPERO/view/CRD420251026508International Registered Report Identifier (IRRID)DERR1-10.2196/77864

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Efficacy and safety of Chinese herbal compound in the treatment of acute gouty arthritis: A systematic review and meta-analysis of randomized controlled trials.
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  • International immunopharmacology
  • Xiaoying Zhao + 7 more

The present study aimed to comprehensively assess the efficacy and safety of Chinese herbal compounds in the management of acute gouty arthritis (AGA). A systematic search was performed across multiple databases, including PubMed, The Cochrane Library, Embase, Web of Science, CBM, CNKI, VIP, and Wanfang, from their inception until December 1, 2024, to identify relevant randomized controlled trials (RCTs) involving Chinese herbal compounds for AGA. Two independent researchers were responsible for the retrieved literature screening, data extraction, and quality evaluation. A meta-analysis of RCTs that fulfill the inclusion criteria will be executed utilizing Stata 14.0 software. The quality of the outcomes will be assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE). A total of 28 studies, encompassing 2100 participants, were included in the analysis. The meta-analysis showed that compared with conventional Western medicine, Chinese herbal compounds significantly enhance the overall efficacy of AGA treatment (RR=1.11, 95%CI (1.05, 1.16), P<0.00001; Level of evidence: very low). It also demonstrated improvements in the Visual Analogue Scale (VAS) (SMD=-1.46, 95%CI(-2.17, -0.75), P<0.00001; Level of evidence: very low), serum uric acid levels (SMD=-0.67, 95%CI (-1.00, -0.33), P<0.00001; Level of evidence: very low), blood sedimentation levels (SMD=-0.71, 95%CI (-1.08, -0.33), P<0.00001; Level of evidence: very low), C-reactive protein (CRP) levels (SMD=0.89, 95%CI(-1.33, -0.45), P<0.00001; Level of evidence: very low), and the traditional Chinese medicine syndrome score(SMD=-0.93, 95%CI (-1.37, -0.49), P<0.00001; Level of evidence: very low). Additionally, a reduced incidence of adverse effects was noted (RR=0.26, 95%CI (0.18, 0.39), P<0.00001; Level of evidence: moderate). Subgroup analysis revealed that regardless of whether the treatment duration was less than or more than 1week, Chinese herbal compounds were effective in improving the total effective rate of AGA treatment, VAS scores, serum uric acid levels, blood sedimentation levels, CRP levels, and Traditional Chinese medicine symptom scores, while simultaneously decreasing the occurrence of adverse reactions. Chinese herbal compounds demonstrated superior efficacy and safety compared to conventional Western medicine in treating AGA. However, further validation through multicenter, high-quality RCTs is warranted to strengthen this conclusion.

  • Research Article
  • Cite Count Icon 26
  • 10.12659/msm.917421
Salvianolic Acids for Injection Combined with Conventional Treatment for Patients with Acute Cerebral Infarction: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
  • Oct 22, 2019
  • Medical Science Monitor
  • Jian Lyu + 3 more

BackgroundThis meta-analysis was conducted to evaluate the clinical effectiveness and safety of Salvianolic acids for injection (SAFI) plus conventional treatment (CT) for patients with acute cerebral infarction (ACI) and to assess the evidence to guide clinical practice.Material/MethodsPubMed, EMBASE, Cochrane Library, Web of Science, and 4 Chinese electronic databases were searched to identify relevant randomized controlled trials (RCTs). The methodological quality of eligible studies was evaluated using the Cochrane risk of bias tool. The reporting quality of eligible studies was evaluated by Consolidated Standards of Reporting Trials (CONSORT) for traditional Chinese medicine. Meta-analysis and evidence quality were performed using RevMan 5.3 and Grading of Recommendations Assessment, Development, and Evaluation (GRADE).ResultsA total of 14 RCTs involving 1309 patients were included. Meta-analysis showed that SAFI plus CT was better than CT alone in improving the total effective rate (RR=1.35, 95% CI 1.25 to 1.44, P<0.00001), reducing the National Institutes of Health Stroke Scale (NIHSS) score (130 mg: WMD=−3.31, 95% CI −3.80 to −2.47, P<0.00001; 100 mg: WMD=−1.91, 95% CI −2.28 to −1.54, P<0.00001), improving the activity of daily living and cognitive function of ACI, and improving the hemorheology (HBV: high shear rate blood viscosity, LBV: low shear rate blood viscosity, PV: plasma viscosity) and C-reactive protein (CRP).ConclusionsSAFI plus CT in the treatment of ACI can improve the total effective rate, neurological deficit, and ability to perform activities of daily living, and there is no serious adverse reaction. Based on the GRADE system, the evidence quality is low. More large-scale, well-designed, and high-quality RCTs are required to confirm the positive results.

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  • 10.1016/j.eujim.2021.101372
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  • 10.1097/md.0000000000023891
Effect of electroacupuncture on postoperative cognitive dysfunction for patients undergoing total knee arthroplasty
  • Jan 29, 2021
  • Medicine
  • Zixuan Ye + 16 more

Background:Electroacupuncture is increasingly used in rehabilitation for postoperative cognitive dysfunction (POCD), but relevant evidence remains unclear for patients receiving total knee arthroplasty (TKA).Methods:The databases research of PubMed, EMBASE, CINAHL, and China National Knowledge Infrastructure (CNKI) will be conducted from inception to December 31, 2020. The relevant randomized controlled trials (RCTs) from data will be screened one by one. The remaining studies that meet the inclusion criteria will be extracted and analyzed using RevMan V.5.3 software. Paired 2 reviewers will assess quality of the included studies and publication bias by using the Cochrane Collaboration risk of bias tool, and Egger test and Begg test respectively. And grading of recommendations assessment, development and evaluation (GRADE) will be used to estimate the quality of evidence.Results:In this study, we will analyze the effect of electroacupuncture on Mini-Mental State Examination (MMSE), interleukin 1β (IL-1β), tumor necrosis factor-α (TNF-α), S100-β protein, and adverse events for patients with TKA.Conclusion:Our findings will provide evidence for the effectiveness of electroacupuncture on the treatment and prevention of POCD for TKA patients.Registration number:Available at: https://osf.io/azyt9 (DOI number: 10.17605/OSF.IO/AZYT9).

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