Grading Of Recommendations Assessment, Development And Evaluation System Research Articles

Effect of Nuts on Anthropometric and Glycemic Indexes and Blood Pressure in Secondary Cardiovascular Prevention: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

Nut-enriched diets have a positive impact on cardiovascular risk factors, such as body mass, blood pressure, and fasting blood glucose. However, studies in individuals undergoing secondary cardiovascular prevention show controversial results. This systematic review with meta-analysis assessed the effect of nut supplementation on anthropometric, glycemic, and blood pressure indices in patients with atherosclerotic cardiovascular disease, as well as the frequency of adverse events. Six databases were used for the search-PubMed, Cochrane Library, EMBASE, BVS (Biblioteca Virtual da Saude), Web of Science, and ClinicalTrials.gov-until February 2023, with no language restrictions. The Cochrane Handbook for Systematic Reviews of Interventions methodology and the PICOS (Population, Intervention, Comparison, Outcome, Setting/design) strategy were used. Seven independent reviewers were involved in data extraction and resolution of disagreements. Certainty of the evidence was evaluated using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system. From 5187 records identified, 6 publications containing data referring to 5 randomized clinical trials (n = 436) were included in the final analyses. The nuts evaluated were almonds, pecans, Brazil nuts, and mixed nuts, with portions that varied between 5 g and 85 g (median: 30 g/day). The intervention period varied between 6 and 12 weeks. The nuts had no effect on fasting glucose and anthropometric indices, although the certainty of the evidence for most of these outcomes was low or very low. They also had no effect on systolic (mean difference [MD]: -1.16 mmHg [95% CI, -5.68 to 3.35], I2 = 0%-moderate certainty of evidence) or diastolic (MD: 0.10 mmHg [95% CI, -2.30 to 2.51], I2 = 0%-high certainty of evidence) blood pressure. It was not possible to aggregate data on adverse events. Nut supplementation had no effect on blood pressure, fasting glucose, or anthropometric profile in the context of atherosclerotic cardiovascular disease. PROSPERO registration no. CRD42020163456.

International Alliance of Urolithiasis (IAU) guideline on retrograde intrarenal surgery (Russian adaptation)

Introduction. The emergence of new scientific and clinical evidence on the use of retrograde intrarenal surgery (RIRS) for the management of kidney stones has prompted periodic systematisation, analysis, and evaluation of outcomes to standardise its application and determine future directions for research and development.Objective. To present the Russian adaptation of a guideline on retrograde intrarenal surgery from the International Urolithiasis Alliance guideline series to provide a theoretical basis for urologists performing RIRS.Materials & Methods. A systematic review was conducted on the RIRS-associated publications available in the PubMed database to prepare a set of recommendations during the period from 1 January 1964 until 1 October 2021. The recommendations were evaluated using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) system, which classifies, evaluates, develops, and examines recommendations. The modified Oxford Centre for Evidence-Based Medicine's (OCEBM) system for categorising the level of evidence and relevant comments have been applied to assess the strength of the conclusions.Results. The research team conducted a comprehensive analysis of 36 published clinical guidelines on the following topics: 1. Indications and Contraindications 2. Preoperative Imaging 3. Preoperative Ureteral Stenting 4. Preoperative Medications 5. Perioperative Use of Antibiotics 6. Use of Antithrombotic Therapy 7. Anesthesia Issues 8. Intraoperative Positioning 9. Equipment 10. Complications.Conclusion. A series of recommendations for RIRS, offered here should help provide safe and effective performance of RIRS.

Effects of Aromatherapy on Physical and Mental Health of Cancer Patients Undergoing Radiotherapy and/or Chemotherapy: A Meta-Analysis.

Currently, aromatherapy is being increasingly utilized in clinical practice, particularly in managing the side effects associated with radiotherapy and chemoradiotherapy. However, it remains to be established whether aromatherapy can effectively alleviate these symptoms. To investigate the effects of aromatherapy on the physical and mental health of patients with cancer undergoing radiotherapy and chemotherapy. Seven databases were researched from inception until September 29, 2023, including PubMed, Scopus, and Web of Science, Chinese National Knowledge Infrastructure, Wanfang database, China Biology Medicine disc and VIP Chinese Medical Journal Database. Review Manager version 5.3 was utilized for data analysis. The Cochrane Risk of Bias tool RoB2 was employed to evaluate the quality of the literature included in the study. Evidence quality rating was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach through the GRADEpro GDT online tool. Nineteen studies involving 1,541 patients were included. Aromatherapy can alleviate nausea [relative risk (RR)=0.64, 95% confidence interval (CI): 0.53 to 0.78, P<0.05, I2=46%; standardized mean difference (SMD)=-0.86, 95% CI: -1.21 to -0.51, P<0.05, I2=64%] and vomiting (RR=0.54, 95% CI: 0.42 to 0.69, P<0.05, I2=35%; SMD=-1.28, 95% CI: -1.52 to -1.03, P<0.05, I2=92%), improve sleep disorders [mean difference (MD)=-3.39, 95% CI: -3.95 to -2.84, P<0.05, I2=0%], relieve pain (SMD=-1.58, 95% CI: -1.96 to -1.21, P<0.05, I2=0%), mitigate fatigue (SMD=-1.28, 95% CI: -2.44 to -0.11, P<0.05, I2=93%) and enhance quality of life (SMD=0.50, 95% CI: 0.22 to 0.79, P<0.05, I2=0%) in cancer patients after radiotherapy and chemotherapy, but it may not have a significant effect on anxiety. The risk of bias was high in the included studies using the Cochrane Risk of Bias tool RoB2, and no studies were considered to be of high grade according to the GRADE system. Aromatherapy is an efficacious, safe and economic adjunctive therapy for cancer patients, which can mend the physical symptoms and mental health of cancer patients. However, more high-quality studies are needed to verify it. (PROSPERO registration No. CRD42023390171).

Malnutrition as a Risk Factor in the Development of Oral Cancer: A Systematic Literature Review and Meta-Analyses.

This systematic review and meta-analyses aimed to assess whether malnutrition may increase the incidence of oral cancer. Following the PRISMA statement, the research was conducted on PubMed, Scopus, and MEDLINE via OVID without any time restrictions. The risk of bias was assessed, and the quality of evidence for each performed meta-analysis was evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework. Sixty-one articles met the inclusion criteria and seven studies underwent quantitative evaluation. For our meta-analysis on hypovitaminosis B, three studies with a total of 90,011 patients were included. An odds ratio of 2.22 was found. Our meta-analysis on the correlation between vitamin C and oral cancer included one study with a total of 866 patients and the derived odds ratio was 1.06. Our meta-analysis on the relationship between vitamin D deficiency and the incidence of oral cancer included three studies with a total of 12,087 patients and the odds ratio was -2.58. The GRADE system showed a moderate strength of evidence due to the presence of studies with a high risk of bias and high indirectness of the data given. The present findings suggest that an inadequate intake of vitamins, particularly vitamin D, poses a risk for the onset of oral cancer.

Different Acupuncture Therapies for Postherpetic Neuralgia: An Overview of Systematic Reviews and Meta-analysis.

Postherpetic neuralgia (PHN) is the most common complication of herpes zoster infection and affects patients' quality of life. Acupuncture therapy is regarded as a competitive method of treatment for analgesia. To summarize evidence from systematic reviews (SRs) and evaluate the effectiveness and safety of different acupuncture therapies for treating PHN. Eight electronic databases were searched from their inception to August 5, 2022, including 4 international electronic databases (PubMed, EMBASE, the Cochrane Library, and Web of Science) and 4 Chinese databases (Chinese Biomedical Database, China National Knowledge Infrastructure, VIP Database and Wanfang Database). Methodological quality was assessed by A Measurement Tool to Assess Systematic Reviews 2 (AMSTAR 2). The Risk of Bias in Systematic Review (ROBIS) tool was used to assess the risk of bias in SRs. Evidence level was assessed by the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Totally, 7 SRs were included, including 128 studies and 9,792 patients. In AMSTAR 2, most of the SRs were of low or critically low levels since they had more than 1 critical deficiency. In ROBIS, 1 SR (14.29%) was rated as high risk, and the other 6 (85.71%) were rated as low risk. In the GRADE system, 9 outcomes (28.13%) were valued as high level, 5 (15.63%) as moderate level, 1 (3.13%) as low, and 17 (53.13%) as very low. In the effectiveness of acupuncture therapy, the group "moxibustion vs. original medical treatment" [mean difference (MD)=-1.44, 95% confidence interval (CI): -1.80 to -1.08, I2=99%, P<0.00001] was of the highest heterogeneity and the group "bloodletting vs. original medical treatment" (MD=-2.80, 95% CI: -3.14 to -2.46, I2=0, P<0.00001) was of the lowest heterogeneity. Six SRs have reported the safety of their studies and no serious events were shown in the treatment and control groups. Acupuncture therapy seems to be effective in treating PHN. Despite the evidence that suggested the advantages of acupuncture therapy in relieving pain and promoting efficacy and safety, the methodological quality was quite low. Further studies should pay more attention to the quality of original studies and evidence for SRs to confirm these findings. (PROSPERO registration No. CRD42022344790).

Recommendations for psoriasis treatment in Pediatrics

in one third of patients with psoriasis, symptoms start during childhood and adolescence, with a strong emotional and psychosocial impact. to develop a guideline for the systemic treatment of psoriasis in pediatric patients by means of recommendations based on the best available evidence. Sources: articles indexed in PubMed, Epistemonikos, Google Scholar, Cochrane Library and Scielo, published between January 2010 and May 2022, in English, Spanish and Portuguese. Study selection: evidence-based clinical practice guidelines, systematic reviews, meta-analyses, randomized controlled studies, observational studies (case-control, cohort studies, real-life registries) and evaluations of biosimilar drugs in patients up to and including 17 years of age were considered. The keywords "psoriasis" and "treatment" were used in all three languages. Data extraction: the literature was evaluated using Grading of Recommendations Assessment, Development and Evaluation (GRADE) recommendations. Data synthesis: evidence tables were developed and analyzed by the expert committee. The questions for the development of recommendations were based on the PICO system (population, intervention, comparison, outcome). A total of 8 recommendations and 7 points of good practice were developed. The direction and strength of the recommendations were expressed according to the GRADE system. the final decision on a specific therapy should be based on the best opinion of the treating physician, the individual characteristics, and the values and preferences of the patients and their caregivers.

Clinical Implications of Adding SPECT/CT to Radioiodine Whole-Body Scan in Patients With Differentiated Thyroid Cancer: A Systematic Review and Meta-analysis.

This study aimed to determine the usefulness of adding SPECT/CT to radioiodine whole-body scans (WBSs) for the treatment of differentiated thyroid cancer (DTC). A systematic review and meta-analysis were performed following the PRISMA guidelines (PROSPERO registration: CRD42022341732) to compare the feasibility of conclusive readings and the frequency of changes in treatment plans in patients with DTC undergoing WBS + SPECT/CT versus WBS. MEDLINE, EMBASE, and Cochrane databases were searched to identify relevant articles concerning thyroid cancer, radioactive iodine, and SPECT/CT or SPECT, published before August 16, 2023. Studies not comparing WBS + SPECT/CT with WBS, those lacking target outcomes, and those not involving human subjects were excluded. The risk of bias was assessed using the RoBANS 2.0 (Risk of Bias Assessment Tool for Nonrandomized Studies) tool. The GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) system was used to evaluate the quality of evidence and strength of recommendations. A total of 30 studies (prospective n = 9, retrospective n = 21) were included in the meta-analyses. Adding SPECT/CT to WBS was shown to increase conclusive readings for cervical lesions, extracervical lesions, and all regions. Lesion-based analyses showed improvements of 14%, 20%, and 18%, respectively, whereas scan-based analyses showed improvements of 27%, 9%, and 34%. The addition of SPECT/CT to WBS led to changes in 30% of treatment plans after diagnostic scans and 9% of treatment plans after posttherapeutic scans. The quality of evidence and strength of recommendations were low. Compelling evidence demonstrates that the addition of SPECT/CT to WBS improves lesion localization, diagnostic performance, and therapy plan for patients with DTC.

Acellular Dermal Matrix for Treatment of Diabetic Foot Ulcer: An Overview of Systematic Reviews.

Aims: To evaluate the reliability of the methodological quality and outcome measures of systematic reviews (SRs)/metaanalyses (MAs) of the acellular dermal matrix (ADM) for diabetic foot ulcer (DFU). Methods: We searched and retrieved SRs and MAs on the application of ADM for DFU from PubMed, Web of Science, The Cochrane Library, EMBASE, CNKI, CBM, WanFang, and VIP databases. We employed AMSTAR 2 to assess methodological quality, Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system to grade, and the strength of evidence of included SRs/MAs. We excluded the overlapping randomized controlled trials (RCTs) and conducted a re-MA of the primary RCTs. Results: A total of 7 SRs/MAs were included. Results from the AMSTAR 2 evaluation revealed a low overall quality; the GRADE system showed that the evidence was of moderate to very low quality. Our re-MA showed that ADM was superior to standard of care (SOC), with regards to complete wound healing rate at 12 weeks (RR = 1.74, 95% CI:1.34-2.25, P < .0001), complete wound healing rate at 16 weeks (RR = 1.50, 95% CI: 1.26-1.77, P ＜ .00001); healing time (MD = -2.06, 95% CI: -2.57 to -1.54, P < .00001) and adverse events (RR = 0.62, 95% CI: 0.49-0.80, P = .0002). However, a consensus has not yet been reached between ADM and SOC groups with regard to outcome indicators of the reduction of ulcer area and quality of life; and subgroup analyses showed no statistically significant differences between the xenograft ADM and SOC groups (RR = 1.36, 95% CI: 0.95-1.93, P = .09) at 12 weeks. Conclusion: Current evidence suggests that ADM is more effective than the standard of care in the treatment of DFU, particularly for full-thickness, noninfected, and nonischemic foot ulcers, but with low evidence quality. Therefore, the results of this overview should be interpreted dialectically and prudently, and the role of ADM in DFU needs further exploration.

Evidence quality assessment of sodium tanshinone IIA sulfonate injection intervention coronary heart disease angina pectoris: An overview of systematic reviews and meta-analyses.

Sodium tanshinone IIA sulfonate injection (STS) is widely used in the clinical treatment of coronary heart disease angina pectoris (CHDAP). This article systematically summarizes and evaluates the available evidence for STS in the treatment of AP, and assess its quality. Two researchers searched and extracted 8 databases for systematic reviews (SRs)/meta-analyses (MAs), and independently assessed the methodological quality, risk of bias, reporting quality, and quality of evidence of SRs/MAs included in randomized controlled trials (RCTs). Tools used included the Assessment of Multiple Systematic Reviews 2 (AMSTAR-2), the risk of bias in systematic (ROBIS) scale, the list of Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA), and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. This overview includes 11 SRs/MAs that use quantitative calculations to comprehensively evaluate various efficacies of STS in AP intervention. The methodological quality, reporting quality, risk of bias, and quality of evidence for outcome measures of SRs/MAs were all unsatisfactory. All SRs/MAs are of low quality according to the results of the AMSTAR-2 assessment, and only a small number of SRs/MAs were assessed as low risk of bias based on the results of the ROBIS assessment, and none of the SRs/MAs has been fully reported on the checklist. According to GRADE system, 33 outcomes were extracted from the included SRs/MAs for evaluation, of which 12 were rated as moderate-quality evidence, 7 as low-quality evidence, and 14 as very low-quality evidence. Limitations included the lack of essential items such as protocol registration, screening of duplicate studies, provision of a list of excluded studies and assessment of publication bias. Tanshinone IIA Sulfonate Sodium Injection may be an effective and safe treatment method. However, further standardized, comprehensive SRs/MAs and RCTs are needed to provide evidence-based medical support.

Practice and development of male contraception: European Academy of Andrology and American Society of Andrology guidelines.

Despite a wide spectrum of contraceptive methods for women, the unintended pregnancy rate remains high (45% in the US), with 50% resulting in abortion. Currently, 20% of global contraceptive use is male-directed, with a wide variation among countries due to limited availability and lack of efficacy. Worldwide studies indicate that >50% of men would opt to use a reversible method, and 90% of women would rely on their partner to use a contraceptive. Additional reasons for novel male contraceptive methods to be available include the increased life expectancy, sharing the reproductive risks among partners, social issues, the lack of pharma industry involvement and the lack of opinion makers advocating for male contraception. The present guidelines aim to review the status regarding male contraception, the current state of the art to support the clinical practice, recommend minimal requirements for new male contraceptive development and provide and grade updated, evidence-based recommendations from the European Society of Andrology (EAA) and the American Society of Andrology (ASA). An expert panel of academicians appointed by the EAA and the ASA generated a consensus guideline according to the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) system. Sixty evidence-based and graded recommendations were produced on couple-centered communication, behaviors, barrier methods, semen analysis and contraceptive efficacy, physical agents, surgical methods, actions before initiating male contraception, hormonal methods, non-hormonal methods, vaccines, and social and ethical considerations. As gender roles transform and gender equity is established in relationships, the male contribution to family planning must be facilitated. Efficient and safe male-directed methods must be evaluated and introduced into clinical practice, preferably reversible, either hormonal or non-hormonal. From a future perspective, identifying new hormonal combinations, suitable testicular targets, and emerging vas occlusion methods will produce novel molecules and products for male contraception.

A Systematic Review and Meta-Analysis: Safety and Efficacy of Cediranib in the Treatment of Cancer Patients

Objective. Tyrosine kinase inhibitors are exciting new anticancer strategies. As one of the most promising oral tyrosine kinase inhibitors, cediranib has been proven effective in treating various solid malignant tumors. This study aimed to evaluate the efficacy and safety of cediranib in cancer patients. Methods. A comprehensive literature review was conducted for phase II and phase III randomized controlled trials (RCTs) up to June 31, 2021, using databases from PubMed, Cochrane Library, Embase, and Web of Science. Relevant clinical trials reporting the efficacy and toxicity characteristics of cediranib in cancer patients were analyzed using Stata 15.1. The GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) system was used to assess the strength of the evidence. Results. The systematic review yielded 14 eligible trials, comprising 4,387 patients with solid malignant tumors. The analysis results of RCTs showed that the cediranib-containing group had a significantly better PFS than the control group (HR: 0.75; 95% CI 0.69–0.82; P &lt; 0.001), and the pooled OS of the cediranib-containing group was significantly higher than that of the control group (HR: 0.91; 95% CI 0.84–1.00; P = 0.041). The sensitivity analysis revealed that the pooled HR was stable and excluding a single study had no effect on the significance of the pooled HR. In addition, the meta-analysis passed Begg’s and Egger’s tests, indicating no publication bias. Regarding safety, the most common adverse events were diarrhea, nausea, hypertension, fatigue, sensory neuropathy, dyspnea, vomiting, headache, neutropenia, thrombocytopenia, and leukopenia. Conclusion. Cediranib treatment responds better than noncediranib therapy but can increase the risk of specific treatment-related toxicities.

Effectiveness of Multicomponent Interventions in Office-Based Workers to Mitigate Occupational Sedentary Behavior: Systematic Review and Meta-Analysis.

Sedentary time in workplaces has been linked to increased risks of chronic occupational diseases, obesity, and overall mortality. Currently, there is a burgeoning research interest in the implementation of multicomponent interventions aimed at decreasing sedentary time among office workers, which encompass a comprehensive amalgamation of individual, organizational, and environmental strategies. This meta-analysis aims at evaluating the effectiveness of multicomponent interventions to mitigate occupational sedentary behavior at work compared with no intervention. PubMed, Web of Science, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL) databases were searched from database inception until March 2023 to obtain randomized controlled trials (RCTs) assessing the efficacy of multicomponent interventions on occupational sedentary behavior among office-based workers. Two reviewers independently extracted the data and assessed the risk of bias by using the Cochrane Collaboration's risk of bias tool. The average intervention effect on sedentary time was calculated using Stata 15.1. Mean differences (MDs) with 95% CIs were used to calculate the continuous variables. Subgroup analyses were performed to determine whether sit-stand workstation, feedback, and prompt elements played an important role in multicomponent interventions. Further, the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) system was used to evaluate the certainty of evidence. A total of 11 RCTs involving 1894 patients were included in the analysis. Five studies were rated as low risk of bias, 2 as unclear risk of bias, and 4 as high risk. The meta-analysis results showed that compared with no intervention, multicomponent interventions significantly reduced occupational sitting time (MD=-52.25 min/8-h workday, 95% CI -73.06 to -31.44; P<.001) and occupational prolonged sitting time (MD=-32.63 min/8-h workday, 95% CI -51.93 to -13.33; P=.001) and increased occupational standing time (MD=44.30 min/8-h workday, 95% CI 23.11-65.48; P<.001), whereas no significant differences were found in occupational stepping time (P=.06). The results of subgroup analysis showed that compared with multicomponent interventions without installment of sit-stand workstations, multicomponent interventions with sit-stand workstation installment showed better effects for reducing occupational sitting time (MD=-71.95 min/8-h workday, 95% CI -92.94 to -51.15), increasing occupational standing time (MD=66.56 min/8-h workday, 95% CI 43.45-89.67), and reducing occupational prolonged sitting time (MD=-47.05 min/8-h workday, 95% CI -73.66 to -20.43). The GRADE evidence summary showed that all 4 outcomes were rated as moderate certainty. Multicomponent interventions, particularly those incorporating sit-stand workstations for all participants, are effective at reducing workplace sedentary time. However, given their cost, further research is needed to understand the effectiveness of low-cost/no-cost multicomponent interventions.

Low-molecular-weight heparin in thrombophilic women receiving in vitro fertilization/intracytoplasmic sperm injection: A meta-analysis.

This meta-analysis aimed to evaluate the efficacy and safety of low-molecular-weight heparin (LMWH) on pregnancy outcomes in thrombophilic women receiving in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI). A systematic literature search of PubMed, EMBASE, the Cochrane Library, and China National Knowledge Infrastructure was performed to identify randomized controlled trials (RCTs) comparing LMWH with no treatment or placebo published from database inception until February 19, 2023. Primary outcomes were the clinical pregnancy rate and implantation rate, and secondary outcomes were the live birth rate, miscarriage rate, and the risk of bleeding events. The certainty of the evidence was rated using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) system. Meta-analysis was conducted using STATA 14.0. Five RCTs involving 1094 thrombophilic women receiving IVF/ICSI were finally included. Administration of LMWH was associated with statistically higher clinical pregnancy rate (4 RCTs, risk ratio [RR] 1.50, 95% confidence interval [CI] 1.23-1.82, p < 0.001, low certainty evidence), implantation rate (5 RCTs, RR 1.49, 95% CI 1.25-1.78, p < 0.001, very low certainty evidence), and live birth rate (2 RCTs, RR 2.15, 95% CI 1.60-2.89, p < 0.001, very low certainty evidence), but with statistically lower miscarriage rate (2 RCTs, RR 0.36, 95% CI 0.15-0.86, p = 0.021, very low certainty evidence). However, using LMWH was linked to a higher risk of bleeding events (2 RCTs, RR 2.36, 95% CI 1.49-3.74, p < 0.001, very low certainty evidence). Very low certainty evidence suggests that administration of LMWH may benefit pregnancy outcomes in thrombophilic women receiving IVF/ICSI treatment, although it may also increase the risk of bleeding events. However, before putting our findings into practice, healthcare professionals should conduct an in-depth evaluation of the available evidence and specific patient situations. Furthermore, due to the low methodological quality of the included studies, more high-quality studies are needed to validate our findings in the future.

Acupuncture methods for insomnia disorder in the elderly: protocol for a systematic review and network meta-analysis

BackgroundInsomnia disorder remains one of the most common sleep disorders in the elderly, with high prevalence and substantial consequences for patients’ general health. Despite that increasing clinical trials have indicated that acupuncture seems to be effective for insomnia disorder in the elderly, comparative efficacy and safety of different acupuncture methods for elderly individuals with insomnia disorder has been unclear. Therefore, this protocol outlined a plan to evaluate and rank the efficacy and safety of various acupuncture approaches for insomnia disorder in the elderly.MethodsA systematic search of 8 bibliographic databases will be conducted from their inception to 18 June 2023, including Cochrane Library, MEDLINE (via PubMed), Embase, Web of Science, Chinese National Knowledge Infrastructure (CNKI), Wanfang Database, VIP Database, and Chinese Biomedical Literature Database (CBM). Randomized controlled trials investigating acupuncture methods for insomnia disorder in the elderly, published in English or Chinese will be included. The primary outcome is sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI). Two reviewers will independently perform study selection, data extraction and risk assessment of bias. The quality of included literatures will be appraised using Cochrane risk-of-bias tool (ROB 2.0). ADDIS (Aggregate Data Drug Information System) V.1.16.8 will be used to conduct Bayesian network meta-analysis. The quality of evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation System (GRADE).DiscussionIn this study, the results will provide credible evidence to assess the efficacy and safety of acupuncture therapies for elderly patients with insomnia disorder, assisting patients, physicians and clinical research investigators to select the most appropriate acupuncture method.Systematic review registrationThe protocol has been registered at OSF (https://osf.io/3kjpq/) with a registration number https://doi.org/10.17605/OSF.IO/3KJPQ.

Quality assessment of systematic reviews assessing the effects of traditional Chinese exercises in the control of diabetes mellitus

To assess the quality of systematic reviews assessing the effects of traditional Chinese exercises on controlling blood indices, anthropometric indices, psychological indices, and quality of life in patients with diabetes. Systematic studies/meta-analyses of intervention with traditional Chinese exercises on diabetes mellitus were searched in the PubMed, Web of Science, the China National Knowledge Infrastructure Databases (CNKI), Wan Fang Database, and Chinese Scientific Journal Database (VIP). Two researchers independently screened the studies and extracted the data. The methodology and quality of evidence of the included studies were assessed using A Measurement Tool to Assess Systematic Reviews 2 (AMSTAR-2) and Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria, respectively. A total of 32 systematic reviews/meta-analyses were included in the present study. Of them, the methodological quality of 4 studies was graded as low, while that of the other 28 was graded as extremely low. The most common quality flaws in key items included a lack of preliminary proposals for systematic reviews, failure to explain the reasons for the inclusion criteria, failure to provide a list of excluded studies and reasons for exclusion, failure to report potential conflicts of interest, and inadequate assessment of publication bias. The quality of evidence for most of the 18 outcomes was subsequently graded as medium or low. Overall, the results of these studies indicated that Tai Chi, health qigong, and other traditional Chinese exercises lowered fasting blood glucose (FBG), 2-hour postprandial blood glucose (2hPBG), hemoglobin A1c (HbAlc), and body mass index, and relieved anxiety and depression in patients with diabetes. Our findings indicate that the methodological quality of systematic reviews related to traditional Chinese exercises in the diabetic population is generally low, and the quality of evidence is also relatively poor. Therefore, we suggest that the quality of systematic reviews and meta-analyses on traditional Chinese exercises for controlling diabetes mellitus needs to be improved. In the future, researchers should conduct higher-quality clinical studies with reference to the AMSTAR2 checklist and GRADE system.

European Society of Endocrinology Clinical Practice Guidelines on the management of adrenal incidentalomas, in collaboration with the European Network for the Study of Adrenal Tumors.

Adrenal incidentalomas are adrenal masses detected on imaging performed for reasons other than suspected adrenal disease. In most cases, adrenal incidentalomas are non-functioning adrenocortical adenomas, but may also require therapeutic intervention including that for adrenocortical carcinoma, pheochromocytoma, hormone-producing adenoma or metastases. Here, we provide a revision of the first international, interdisciplinary guidelines on incidentalomas. We followed the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system and updated systematic reviews on four predefined clinical questions crucial for the management of incidentalomas: A) How to assess risk of malignancy? ; B) How to define and manage mild autonomous cortisol secretion? ; C) Who should have surgical treatment and how should it be performed? ; D) What follow-up is indicated if the adrenal incidentaloma is not surgically removed? Selected Recommendations: 1) Each adrenal mass requires dedicated adrenal imaging. Recent advances now allow discrimination between risk categories: Homogeneous lesions with HU ≤ 10 on unenhanced CT are benign and do not require any additional imaging independent of size. All other patients should be discussed in a multidisciplinary expert meeting, but only lesions >4 cm that are inhomogeneous or have HU >20 have sufficiently high risk of malignancy that surgery will be the usual management of choice. 2) Every patient needs a thorough clinical and endocrine work-up to exclude hormone excess including the measurement of plasma or urinary metanephrines and a 1-mg overnight dexamethasone suppression test (applying a cutoff value of serum cortisol ≤50 nmol/l (≤1.8 µg/dl)). Recent studies have provided evidence that most patients without clinical signs of overt Cushing's syndrome but serum cortisol levels post dexamethasone >50 nmol/l (>1.8 µg/dl) harbor increased risk of morbidity and mortality. For this condition, we propose the term 'mild autonomous cortisol secretion' (MACS). 3) All patients with MACS should be screened for potential cortisol-related comorbidities that are potentially attributably to cortisol (e.g. hypertension and type 2 diabetes mellitus), to ensure these are appropriately treated. 4) In patients with MACS who also have relevant comorbidities surgical treatment should be considered in an individualized approach. 5) The appropriateness of surgical intervention should be guided by the likelihood of malignancy, the presence and degree of hormone excess, age, general health and patient preference. We provide guidance on which surgical approach should be considered for adrenal masses with radiological findings suspicious of malignancy. 6) Surgery is not usually indicated in patients with an asymptomatic, non-functioning unilateral adrenal mass and obvious benign features on imaging studies. Furthermore, we offer recommendations for the follow-up of non-operated patients, management of patients with bilateral incidentalomas, for patients with extra-adrenal malignancy and adrenal masses, and for young and elderly patients with adrenal incidentalomas. Finally, we suggest ten important research questions for the future.

Certainty of evidence, why?

Optimal clinical decision-making requires understanding of evidence regarding benefits, harms, and burdens of alternative management options. Rigorously conducted systematic reviews and meta-analyses offer accurate summaries of the evidence. However, such summaries may review only low-certainty evidence, in the process highlighting that no single decision is likely to be best for all patients. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach offers a systematic and transparent method for rating certainty of evidence in systematic reviews. In this paper, we will address the importance of assessing the certainty associated with bodies of evidence; explain how the GRADE system rates the certainty of evidence from systematic reviews; and present the GRADE evidence to decision framework for moving from evidence to strong or weak recommendations in clinical practice guidelines.

Clinical efficacy and safety of compound Congrong Yizhi Capsules on Alzheimer's disease in mainland China: A systematic review with trial sequential analysis and GRADE assessment.

Alzheimer's disease (AD) is a degenerative disease of the central nervous system (CNS) with insidious onset. AD is also the most common cause of dementia. Compound Congrong Yizhi Capsules (CCYC), a traditional Chinese medicine compound developed by the team of Beijing University of Chinese Medicine, has been widely used to treat AD. To systematically evaluate the clinical efficacy and safety of CCYC for AD by meta-analysis, Trial Sequential Analysis (TSA) and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. This study was registered at PROSPERO (CRD42022295496). Randomized controlled trials (RCTs) of CCYC as the treatment for AD published before December 1, 2021 were retrieved from 4 Chinses databases, 4 English databases and 2 clinical trials registration systems. RevMan 5.4 and STATA 17.0 was used to conduct the meta-analysis of the included studies, the quality of outcomes was rated by the GRADE system, the TSA was conducted by TSA 0.9.5.10 software. Seven studies were included, and the total sample size was 746. Meta-analysis showed that 6 months of treatment with CCYC plus conventional western medicine treatments (CTs) improved MMSE scores compared with CTs alone (WMD: 4.32, 95% CI: 3.23, 5.42), and TSA confirmed that more trials in the future will not reverse the result. Among which, CCYC combined with donepezil can significantly improve MMSE scores (WMD: 3.54, 95% CI: 2.86, 4.22). CCYC combined with olanzapine also showed good effect on both MMSE (WMD: 6.49, 95% CI: 5.54, 7.44) and ADL scores (WMD: 5.23, 95% CI: 4.63, 5.83). No serious adverse events were reported. The strengths of the evidences above are MODERATE. CCYC combined with cognition-modifying western medicine can improve cognitive function, mental behavioural symptoms, and activities of daily living in AD patients with good safety.

Effect of acupuncture in eczema: An overview of systematic reviews.

Eczema is a common chronic relapsing inflammatory skin disease, which is characterized by intense itching. Acupuncture can be effective for eczema, and it is thus regarded as a common complementary treatment. The intention of this overview is to methodically appraise and synthesize evidence about systematic reviews/meta-analyses (SRs/MAs) on acupuncture in eczema. We searched for SRs/MAs of acupuncture with eczema in eight databases. We evaluated the methodological quality by Assessing the Methodological Quality of Systematic Reviews 2 (AMSTAR-2), the reporting quality with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA 2020 Checkist), and the evidence quality according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. A total of 7 SRs/MAs were included. According to AMSTAR-2, all the SRs/MAs included were categorized as critically low-quality. According to the PRISMA 2020 checklist, none of the reviews completed all the 27 items, thus their compliance was relatively weak. On the base of GRADE system, 2 of the 12 outcomes were rated as moderate, and 5 outcomes were rated as low-quality, while the others were regarded as very low-quality. Compared with the control group, the included reviews of the acupuncture group were more effective and safer; however, the conclusion should be treated cautiously because the quality of evidence was not high enough to support it. In order to improve the quality, more rigorous, standardized, and comprehensive SRs/MAs need designing in the future.

Efficacy of Acupuncture in the Treatment of Essential Hypertension: An Overview of Systematic Reviews and Meta-Analyses.

Acupuncture is widely used in the clinical treatment of essential hypertension (EH). This overview is aimed at summarizing current systematic reviews of acupuncture for EH and assessing the methodological bias and quality of evidence. Two researchers searched and extracted 7 databases for systematic reviews (SRs)/meta-analyses (MAs) and independently assessed the methodological quality, risk of bias, reporting quality, and quality of evidence of randomized controlled trials (RCTs) included in the SRs/MAs. Tools used included the measurement tool to assess systematic reviews 2 (AMSTAR-2), the risk of bias in systematic (ROBIS) scale, the checklist of preferred reporting items for systematic reviews and meta-analyses (PRISMA), and the grading of recommendations assessment, development, and evaluation (GRADE) system. This overview included 14 SRs/MAs that use quantitative calculations to comprehensively assess the various effects of acupuncture in essential hypertension interventions. The methodological quality, reporting quality, risk of bias, and quality of evidence for outcome measures of SRs/MAs were all unsatisfactory. According to the results of the AMSTAR-2 assessment, all SRs/MAs were of low or very low quality. According to the results of the ROBIS evaluation, a few SRs/MAs were assessed as low risk of bias. According to the results of the PRISMA checklist assessment, SRs/MAs that were not fully reported on the checklist accounted for the majority. According to the GRADE system, 86 outcomes were assessed under different interventions in SRs/MAs, and 2 were rated as moderate-quality evidence, 23 as low-quality evidence, and 61 as very low-quality evidence. Limitations of the included SRs/MAs included the lack of necessary items, such as not being registered in the protocol, not providing a list of excluded studies, and not analyzing and addressing the risk of bias. Currently, acupuncture may be an effective and safe treatment for EH, but the quality of evidence is low, and caution should be exercised when applying this evidence in clinical practice.