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Although hemodialysis treatment is one of the main treatment methods in chronic kidney failure, it also causes many health problems. A variety of complementary and integrative therapies are used to relieve or minimize hemodialysis symptoms. Fatigue (60%-97%) is also one of these problems. Therefore, we have conducted a systematic review to determine the effect of complementary and integrative therapies on fatigue in hemodialysis patients. Relevant studies published from 2005 to 2019, in PubMed, EBSCOhost, ScienceDirect, and Cochran Library databases have been reviewed. In the study, initially, 21 039 pieces of data were obtained, and then 14 randomized controlled studies meeting the inclusion criteria were reviewed. The methodological qualities of the articles included in the study were determined by using the quality evaluation checklist in Jadad randomized controlled studies. In the literature, acupressure, aromatherapy, reflexology, massage, and yoga practice were found to be applied to hemodialysis patients and be effective in reducing pain and anxiety as well as improving sleep quality. It is recommended that these methods be included in the routine clinical care of patients receiving hemodialysis.

Background Alveolar cleft grafting is a necessary procedure to restore bone defects. Randomized clinical trials (RCTs) are regarded as a golden standard for investigating the efficacy of treatments. Nevertheless, risk of bias (RoB) can still affect the validity of these trials. We aimed to conduct a systemic review of all control trials (CTs) using regenerative materials for alveolar cleft reconstructions to evaluate their RoB and perform a meta-analysis of new bone formation. Methods Cochrane Oral Health Group's Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (PubMed), EMBASE AND Google Scholar were searched up to October 2020. Thereafter, the articles underwent quality assessment (according to the Jadad scale and the Delphi list) for the evaluation of the RoB. Results A total of 15 trials met the inclusion criteria, none of which reached a full score. Of these, 20% didn't randomize the trails, 73,33% failed to describe the way of randomization, and none reported the double-blinded criteria. Furthermore, allocation concealment (99.9%), intention to treat (100%), and patient awareness (100%) were inadequately described. The meta-analysis found no significant difference between regenerative materials and iliac crest graft. Conclusion This review showed high RoB in CTs implying quality improvement of CTs is necessary. Meta-analysis showed no significant difference between the regenerative materials and autogenous grafts.

Background: The benefits of baricitinib, which is a Janus kinase inhibitor, in coronavirus disease-2019 (COVID-19) are inadequately defined. We performed a systematic review and meta-analysis of randomised, controlled trials and observational studies of baricitinib to determine its clinical efficacy and adverse events in patients with COVID-19. Methods: Major databases were searched from 2019 to 2021 inclusive. The primary outcome was the coefficient of mortality. We also compared increasing different doses of baricitinib, intensive care unit admission, the requirement for mechanical ventilation, the oxygenation index, and adverse events between baricitinib treatment and placebo or other treatments. Findings: Twelve studies of 3564 patients were included and assessed qualitatively (Jadad and Newcastle–Ottawa Scale scores). Baricitinib effectively improved the mortality rate (relative risk of mortality = 0.56; 95% confidence interval: 0.46–0.69; P < 0.00001; I2 = 2%), and this result was unchanged by subgroup analysis. Baricitinib also improved intensive care unit admission, the requirement for invasive mechanical ventilation, and the oxygenation index. Data from these studies also showed that baricitinib slightly reduced the risk of adverse events. With regard to the choice of the drug dosage of baricitinib, the high-dose group appeared to have additional benefits for clinical efficacy. Interpretation: Our study shows that baricitinib may be a promising, safe, and effective anti-severe acute respiratory syndrome-coronavirus-2 drug candidate, with the advantages of a low cost, easy production, and convenient storage. Funding Information: We gratefully acknowledge the financial supports by the Basic research program of Guangzhou (202102010224), Clinical Transformation program of the first affiliated hospital of Guangzhou medical university (ZH201802, ZH201914), High-level university program of Guangzhou medical university (2017(160)) and Opening Project of State Key Laboratory of Respiratory Disease (SKLRD-0P-202115). Declaration of Interests: The authors have no potential conflict of interest to disclose.

Summary Background & aims Sarcopenia is characterized by the progressive loss of skeletal muscle mass and function, which reduces mobility and quality of life. Risk factors for sarcopenia include advanced age, physical inactivity, obesity, and chronic diseases such as cancer or rheumatoid arthritis. Omega-3 long chain polyunsaturated fatty acids (LC PUFAs) might be associated with a reduction in risk of sarcopenia due to their anti-inflammatory effects. Methods We conducted a systematic review and meta-analysis to quantify the effects of omega-3 LC PUFAs on muscle mass, volume and function parameters. The National Library of Medicine's MEDLINE/PubMed database was searched on 9th October 2020 for randomized controlled trials that used omega-3 LC PUFAs as an intervention with muscle-related endpoints. A snowballing search to identify additional studies was completed on 23rd April 2021. The meta-analysis was conducted using meta-essentials worksheet 3. Bias was assessed using the Jadad scale. Results 123 studies were identified with the systematic searches. Most studies were performed in disease populations, such as cancer or chronic obstructive pulmonary disease (COPD), or in healthy individuals after a fatiguing exercise bout. The endpoints lean body mass, skeletal muscle mass, mid-arm muscle circumference, handgrip strength, quadriceps maximal voluntary capacity (MVC), and 1-repetition maximum chest press were selected for meta-analysis based on the number of available studies; thus 66 studies were included in the quantitative synthesis. Using a random effects model and 2-tailed p-value, there was a significant relationship in favor of omega-3 LC PUFA supplementation for lean body mass (effect size 0.27, 95%CI 0.04 to 0.51), skeletal muscle mass (effect size 0.31, 95%CI 0.01 to 0.60) and quadriceps MVC (effect size 0.47, 95%CI 0.02 to 0.93). Conclusion The results indicate that there is a positive effect of omega-3 LC PUFA supplementation on overall body muscle mass and strength. Small study size and heterogeneity limit the applicability of these findings for sarcopenia prevention. Larger trials in populations at risk of sarcopenia would strengthen the evidence base.

BACKGROUND: Approximately one-fourth of TKAs will be performed in patients 55 years or younger within the next decade. Postoperative outcomes for younger patients who had a knee arthroplasty were systematically reviewed in 2011; however, numerous studies evaluating young patients who had both a TKA and unicompartmental knee arthroplasty (UKA) have been reported in the past decade. Therefore, to better counsel this growing population of young patients undergoing knee arthroplasty, an updated understanding of their expected postoperative outcomes is warranted. QUESTIONS/PURPOSES: In this systematic review, we evaluated (1) all-cause survivorship, (2) reasons for revision, (3) patient-reported outcomes, and (4) return to physical activity and sport in patients 55 years or younger undergoing primary TKA or UKA. METHODS: A comprehensive search of PubMed, Medline, SportDiscus, and CINAHL was performed to identify all original studies evaluating outcomes after primary knee arthroplasty for young patients (55 years of age or younger) from inception until March 2021. The following keywords were used: knee, arthroplasty, replacement, pain, function, revision, survivorship, sport, physical activity, and return to play. Only original research studies that were related to knee arthroplasty and reported postoperative outcomes with a minimum 1-year follow-up for patients 55 years or younger were included. Unpublished materials, publications not available in English, and studies with a primary diagnosis of rheumatoid arthritis were excluded. The Methodological Index for Non-Randomized Studies (MINORS) score was used to evaluate the study quality of case series and comparative studies, while the Cochrane Risk of Bias tool and the Jadad scale were used for randomized studies. The primary outcomes of interest for this study were all-cause survivorship rate, reasons for all-cause revision, Knee Society and Knee Society Function scores (minimum clinically important difference [MCID] 7.2 and 9.7, respectively), WOMAC scores (MCID 10), Tegner scores (no reported MCID for knee arthroplasty), and return to physical activity or sport. Knee Society and Knee Society Function scores range from 0 to 100, with scores from 85 to 100 considered excellent and below 60 representing poor outcomes. All-cause survivorship rate and reasons for revision were both reported in 17 total studies. Knee Society scores were presented in 19 and Knee Society Function scores were reported in 18 included studies. WOMAC scores and Tegner scores were each found in four included studies, and return to physical activity and return to sport analyses were performed in seven studies. Overall, 21 TKA studies and five UKA studies were included in this analysis, featuring 3095 TKA knees and 482 UKA knees. RESULTS: Kaplan-Meier estimates of all-cause survivorship ranged from 90% to 98% at 5 to 10 years of follow-up after TKA and from 84% to 99% (95% CI 93% to 98%) at 10 years to 20 years post-TKA. All-cause UKA survivorship was 90% at 10 years and 75% at 19 years in the largest Kaplan-Meier estimate of survivorship for patients younger than 55 who underwent UKA. Common reasons for revision in TKA patients were polyethylene wear/loosening, aseptic tibial loosening, and infection, and in UKA patients the common reasons for revision were knee pain, aseptic loosening, progression of knee osteoarthritis, and polyethylene wear/loosening. Knee Society scores ranged from 85 to 98 for 5-year to 10-year follow-up and ranged from 86 to 97 at 10-year to 20-year follow-up in TKA patients. Knee Society Function scores ranged from 70 to 95 for 5-year to 10-year follow-up and ranged from 79 to 86 at 10-year to 20-year follow-up. Return to physical activity and sport was reported variably; however, most patients younger than 55 have improved physical activity levels after knee arthroplasty relative to preoperative levels. CONCLUSION: Although all-cause survivorship rates were frequently above 90% and patient-reported outcome scores were generally in the good to excellent range, several studies reported long-term survivorship rates from 70% to 85% and fair patient-reported outcome scores, which must be factored into any preoperative counseling with patients. We could not control for surgeon volume in this report, and prior research suggests that increasing volume is associated with less frequent complications; in addition, the studies we included were variably affected by selection bias, transfer bias, and assessment bias, which makes it likely that the findings of our review represent best-case estimates. To limit the frequency of revision in patients younger than 55 years undergoing TKA, clinicians should be cautious of polyethylene wear/loosening, aseptic tibial loosening, and infection, while knee pain and progression of knee osteoarthritis are also common reasons for revision in patients younger than 55 undergoing UKA. Further research should isolate younger knee arthroplasty patients and evaluate postoperative activity levels while accounting for preoperative physical activity and sport participation. LEVEL OF EVIDENCE: Level IV, therapeutic study.

Objectives Rhus coriaria L. (RC) is a deciduous shrub with several pharmacological activities. Evidence of the effects of RC on weight, hyperlipidaemia, hypertension and diabetes mellitus have been presented in this study. Books, thesis and internet-based resources such as PubMed, Web of Science, Scopus, EMBASE, Cochrane, Ovid and Google Scholar were searched for the English, Arabic and Persian literature from 1966 to 2020 (December). The keywords were Rhus coriaria L., Sumac, metabolic syndrome and all its medical conditions (hyperlipidaemia, hypertension, obesity and diabetes mellitus). The inclusion criteria were full-text animal and human studies conducted on RC to evaluate its efficacy on any components of metabolic syndrome (MetS). Jadad scale was used to assess the quality of evidence. Key findings Reviewing 23 relevant studies demonstrated that RC is able to decrease the level of blood glucose, glycated haemoglobin, serum insulin and insulin resistance. Studies on hyperlipidaemia and obesity have very contradicting results, and there is no definite conclusion on the effect of RC on lipid profile. However, the hypotensive and effect of RC was confirmed in the existing studies. Summary According to the literature, RC can be considered as a promising curative candidate for MetS. However, further studies with larger sample size and higher methodological quality are needed.

Helicobacter pylori infection is one of the most common chronic bacterial infections. Cranberry has been suggested for H. pylori eradication. We aimed to conduct the first meta-analysis to summarise current evidence on effects of cranberry supplementation on H. pylori eradication in H. pylori positive subjects. We searched the online databases up to December 2020. Four randomised clinical trials (RCT) were included with human subjects, investigating the effect of cranberry on H. pylori eradication. The pooled results were expressed as the OR with 95 % CI. Based on five effect sizes with a total sample size of 1935 individuals, we found that according to the OR, there was a positive effect of cranberry supplementation on H. pylori eradication, increasing the chance of H. pylori eradication by 1·27 times, but this relationship was not statistically significant (overall OR: 1·27; 95 % CI 0·63, 2·58). The results also indicated the moderate between-study heterogeneity (I2 = 63·40 %; P = 0·03) of the studies. However, there were no significant differences in some subgroup analyses in the duration of treatment, the duration of follow-up and the Jadad score. Our findings revealed that although cranberry had a positive effect on H. pylori eradication in adults, this effect was not statistically significant. Due to the small number of included studies and moderate heterogeneities, the potential of cranberry supplementation on H. pylori eradication should be validated in large, multicentre and well-designed RCT in the future.

Blood loss is a potential cause of morbidity and mortality in craniosynostosis surgery. Recent reports have suggested that the use of tranexamic acid (TXA), an antifibrinolytic agent, mitigates this blood loss. A comprehensive systematic review and subsequent meta-analysis was undertaken, with the view to clarify the effectiveness of TXA in reducing blood loss and transfusion requirements in craniosynostosis surgery. Medline and PubMed databases were searched using the preferred reporting items for systematic reviews and meta-analyses technique, and 7003 articles were assessed based on predefined selection criteria. Seven trials were identified, of which 2 were randomized controlled trials and the remainder retrospective cohort studies. All trials were assessed using the Jadad and strengthening the reporting of observational studies in epidemiology scores. The meta-analysis found a clear statistical reduction in blood loss in those patients who received TXA perioperatively, with a combined blood loss reduction of 7.06 ml/kg (95% confidence interval -8.97 to -5.15, P

BACKGROUND Studies have identified that nurse-led telephone health coaching benefited the continuity of care in patients with heart failure. However, the effect of nurse-led telephone health coaching remains inconclusive among the previous studies. AIM This review aimed to determine the effects of nurse-led telecoaching among patients with heart failure. DESIGN This study was a systematic review and meta-analysis of randomised controlled trials. This study was reported in accordance with the PRISMA guideline. METHODS Seven databases (PubMed, Embase, CINAHL, Web of Science, MEDLINE, Cochrane library and Ovid) were electronically searched up to 20 October 2020. The eligibility criteria were a randomised controlled trial study on heart failure patients, with the intervention led by a nurse through telephone coaching. Two authors independently evaluated the methodological quality using the modified Jadad scale. The Comprehensive Meta-Analysis software version 3.0 with a random effect model was used to conduct a meta-analysis, and Begg's and Egger's tests were performed to assess publication bias. Furthermore, sensitivity analysis was carried out. RESULTS A total of 12 randomised controlled trials were met eligibility criteria and representing 1938 heart failure patients. The results showed that the nurse-led telecoaching significantly enhanced patients' self-care behaviour (SMD = .84, 95%CI [0.45-1.24], p

BACKGROUND Low vitamin D status is a global public health issue that vitamin D food fortification and biofortification may help to alleviate. OBJECTIVES We investigated the effect of vitamin D food fortification and biofortification on circulating 25-hydroxyvitamin D (25(OH)D) concentrations. We expanded the scope of earlier reviews to include adults and children, to evaluate effects by vitamin D vitamer, and investigate linear and nonlinear dose-response relations. METHODS We conducted a systematic review and meta-analysis. We searched CINAHL, MEDLINE, PubMed, Embase, the Cochrane Library, and gray and unpublished literature sites for randomized controlled trials, including people of all ages, with the criteria: absence of illness affecting vitamin D absorption, duration ≥4 wk, equivalent placebo food control, dose quantification, dose ≥5 μg/d, baseline and endpoint or absolute change in 25(OH)D concentrations reported, random allocation, and participant blinding. Quality was assessed using the Jadad Scale. RESULTS Data from 34 publications (2398 adults: 1345 intervention, 1053 controls; 1532 children: 970 intervention, 562 controls) were included. Random-effects meta-analysis of all studies combined (mean dose 16.2 μg/d) indicated a pooled treatment effect of 21.2 nmol/L (95% CI: 16.2, 26.2), with a greater effect for studies using cholecalciferol than ergocalciferol. Heterogeneity was high (I2 > 75%). Metaregression analyses for all studies combined suggested positive effect differences for baseline circulating 25(OH)D concentrations

Objective: To establish the CQS inter-rater reliability and rating time and to compare both against that of the Jadad scale and Cochrane's Risk of Bias Tool (ROBT). Material and methods: Four independent raters rated 45 trial reports. The inter-rater reliability was established by use of the Brennan- Prediger coefficient (BPC). The coefficients were compared using the two-sample z- test. Secondary analysis included comparison of the inter-rater reliability of the randomization component of all tools, as well as of the allocation concealment component of the CQS to that of the ROBT. The mean rating time with standard deviation (SD) for each tool was determined using one-way repeated measures analysis of variance. Post hoc comparisons were made using the Tukey-Kramer adjustment for three pair-wise multiple comparisons. Results: The inter-rater reliability was significantly higher for the CQS (BPC, 95% CI: 0.95, 0.87-1.00) compared to Jadad (0.70, 0.58- 0.82) (adjusted p = 0.0005) and most components of ROBT. The mean (SD) time to complete the CQS (4.0 (1.0) min) did not differ significantly from that of the Jadad scale 4.8 (1.1) min (adjusted p = 0.11), but was significantly shorter compared to that of the ROBT 15.3 (5.9) min (adjusted p < 0.0001). Conclusions: The results suggest the CQS to be a very reliable and fast trial appraisal tool. Clinical relevance The higher the inter-rater reliability, the higher the probability that trial results reflect therapeutic truth. The CQS will need to take further bias sources into consideration, in order to increase its utility.

Background: It has been found that there is a link between hypertension and elevated risk of Alzheimer’s Disease (AD). Herein, a meta-analysis based on Randomized Clinical Trials (RCTs) was used to assess the effect of antihypertensive drugs on cognition and behavioral symptoms of AD patients. Methods: The three databases, PubMed/Medline, Scopus, and Cochrane Library, were searched up to March 2020. The quality of the studies included in the meta-analysis was evaluated by the Jadad score. Clinical Global Impression of Change (CGIC) included in two studies, Mini-Mental State Examination (MMSE) included in three studies, and Neuropsychiatric Inventory (NPI) in three studies were the main outcomes in this systematic review. Results: Out of 1506 studies retrieved in the databases, 5 RCTs were included and analyzed in the meta-analysis. The pooled mean differences of CGIC, MMSE, and NPI in patients with AD receiving antihypertensive drugs compared to placebo were -1.76 with (95% CI = -2.66 to -0.86; P=0.0001), 0.74 (95% CI = 0.20 to 1.28; P= 0.007), and -9.49 (95% CI = -19.76 to 0.79; P = 0.07), respectively. Conclusion: The findings of the present meta-analysis show that antihypertensive drugs may improve cognition and behavioral symptoms of patients with AD. However, more well-designed RCTs with similar drugs are needed to achieve more conclusive results.

Purpose To review the current literature to determine which injection technique and needle portal placement provide the greatest accuracy for intra-articular access to the knee. Methods This study followed Preferred Reporting Items and Systematic Reviews and Meta-Analyses guidelines. A comprehensive literature search was conducted in March 2020 and repeated in May 2020 using electronic databases PubMed, MEDLINE, and the Cochrane Library. Data on the accuracy of intra-articular knee injection (successful injections/total number of injections) were collected. Only Level I studies were included. Study design, demographic variables, needle sizes, and method of validating accuracy were recorded. The Jadad score was used to assess methodologic quality, and a risk-of-bias assessment was performed. Results A total of 12 Level I human studies (1431 patients, 1315 knees) were included in this review. Seven of the studies did a direct comparison between ultrasound-guided and blind knee injections. Ultrasound-guided injections were more accurate compared with blinded knee injections in every study. The most accurate anatomical approach was an isometric quadricep contraction method with the superolateral approach. Conclusions This study showed that ultrasound-guided knee injections were more accurate across every anatomical needle injection site compared with blind injections. Injections made by a blind/anatomically guided method had inconsistent accuracy rates that seemed highly dependent on the portal of entry. Level of Evidence Level I, systematic review of Level I studies.

Objective To compare the perioperative parameters between single- and triple-port video-assisted thoracoscopic surgery (VATS) lobectomy in the treatment of lung cancer. Methods The Pubmed, Embase, Cochrane library, and the Web of Science databases were electronically searched from inception to September 2019 for all relevant studies. Study quality was evaluated using the Jadad scale or the Newcastle-Ottawa scale. The results were pooled using the generic inverse-variance method and expressed as mean differences or risk ratios, with 95% confidence intervals. Results Three randomized controlled trials (RCTs) and ten cohort studies with 2,278 subjects were included in the meta-analysis. Whether based on RCTs or cohort studies, the pooled results showed no significant difference in the operation time, chest tube duration, intraoperative blood loss, postoperative hospital stays, lymph node dissection number, postoperative drainage volume, and postoperative complications between single- and triple-port VATS lobectomy (P > 0.05). Single-port VATS could relieve postoperative pain better than triple-port VATS, especially in the first day and fifth day (P < 0.05). No evidence of significant publication bias was found (P > 0.05). Conclusion Single-port VATS lobectomy can yield similar perioperative results to those of triple-port VATS lobectomy and is more effective in relieving postoperative pain.

Tungiasis (sand flea disease) is an epidermal parasitic skin disease occurring in resource-limited communities. There is no standard treatment for tungiasis, and available treatment options are scarce. To our knowledge, this is the first systematic review aimed to assess randomised controlled trials (RCTs) investigating interventions for tungiasis. We systematically searched databases including MEDLINE (EBSCOhost), CENTRAL, CINAHL, PubMed, Web of Science, SciELO, LILACS and Embase (Scopus) for RCTs in any language, from inception of the databases until June 12, 2021. RCTs exploring preventive and therapeutic interventions for tungiasis were eligible. We used the revised Cochrane Collaboration's risk of bias tool to assess the risk of bias and Jadad scale to quantify the methodological quality of the RCTs. Of the 1839 identified records, only eight RCTs involving 808 participants were included, and several methodological deficiencies were identified in most of the trials. Trial interventions included: oral drugs niridazole and ivermectin and topical interventions of ivermectin lotion, metrifonate lotion, thiabendazole lotion, thiabendazole ointment, dimeticones (NYDA), and a neem seed and coconut oils-based mixture for treatment and coconut oil-based lotion (Zanzarin) for prevention. The coconut oil-based lotion for prevention and dimeticones for treatment of tungiasis have displayed the most promise. Most of the RCTs included in this study had low methodological quality. There is a clear unmet need for high-quality RCTs examining safe and effective prevention and treatment alternatives of tungiasis in endemic settings.

Background and objectives According to current guidelines, oral antihistamines are the first line treatment for chronic spontaneous urticaria (CSU). Up-dosing antihistamines up to fourfold the licensed dose is recommended if control is not achieved. Such indications are based mainly on expert´s opinions. Objectives: To critically review and analyze clinical evidence regarding to efficacy and safety of higher-than-licensed dosage of second-generation oral antihistamines in CSU treatment. Material and methods A systematic literature review following a sensitive search strategy was performed. All articles published in MEDLINE, EMBASE, and Cochrane Library between 1961 and October 2018 were examined. Publications with CSU patients treated with prescribed second-generation antihistamines in monotherapy comparing with either placebo, licensed dosage and/or higher dosage were included. Articles were evaluated by peer revisors. Quality was evaluated using Jadad and Oxford scores. Results We identified 337 articles, 14 were included in the final evaluation; 6 focus on fexofenadine, 2 on cetirizine, levocetirizine, rupatadine and desloratadine, and 1 for ebastine and bilastine. Only 5 studies were placebo-controlled. The number of included patients ranged from 20 to 439. Observation lapse was ≤ 16 weeks. High fexofenadine doses produced dose-dependent significant response and controlled urticaria in a majority of patients. Cetirizine, levocetirizine, rupatadine and bilastine showed an increased effectiveness when up-dosing. Most frequent adverse events were headache and drowsiness. Conclusion The low quality and heterogeneity of the articles reviewed made impossible to reach any robust conclusions and unveil the need to develop large-scale randomized clinical trials.

Background:. The neoadjuvant chemotherapy is increasingly used in advanced gastric cancer, but the effects on safety and survival are still controversial. The objective of this meta-analysis was to compare the overall survival and short-term surgical outcomes between neoadjuvant chemotherapy followed by surgery (NACS) and surgery alone (SA) for locally advanced gastric cancer. Methods:. Databases (PubMed, Embase, Web of Science, Cochrane Library, and Google Scholar) were explored for relative studies from January 2000 to January 2021. The quality of randomized controlled trials and cohort studies was evaluated using the modified Jadad scoring system and the Newcastle-Ottawa scale, respectively. The Review Manager software (version 5.3) was used to perform this meta-analysis. The overall survival was evaluated as the primary outcome, while perioperative indicators and post-operative complications were evaluated as the secondary outcomes. Results:. Twenty studies, including 1420 NACS cases and 1942 SA cases, were enrolled. The results showed that there were no significant differences in overall survival (P = 0.240), harvested lymph nodes (P = 0.200), total complications (P = 0.080), and 30-day post-operative mortality (P = 0.490) between the NACS and SA groups. However, the NACS group was associated with a longer operation time (P

Aim To determine whether hysteroscopy (HSC) increases the risk of intraperitoneal dissemination in endometrial cancer patients. Methods We conducted a comprehensive review of multiple databases. Quality assessments of eligible studies were performed using the Newcastle-Ottawa and Jadad scales. Positive peritoneal cytology (PPC) as the outcome of interest was compared between endometrial cancer patients with and without HSC. Odds ratios (ORs) with 95% confidence intervals (CIs) were calculated as a measure of effects. Results Three case-control studies and eight retrospective cohort studies included 3364 patients, of whom 1116 underwent preoperative HSC, which resulted in a significantly higher PPC rate (OR, 1.82; 95% CI, 1.31-2.54; p = 0.0004). I2 was 11%, and the heterogeneity was acceptable. The difference between the groups with stages I-II was statistically insignificant (OR, 1.50; 95% CI, 0.75-2.99; p = 0.25). When liquid was used as the uterine distension medium during HSC and the intrauterine pressure was controlled under 80 mmHg, the difference between the two groups was also insignificant (OR, 1.18; 95% CI, 0.50-2.79; p = 0.71). However, when the intrauterine pressure exceeded 80 mmHg, the difference between the two groups was statistically significant (OR, 2.18; 95% CI, 1.28-3.73; p = 0.004). Conclusion This meta-analysis indicates that preoperative HSC in patients with endometrial cancer may increase the risk of intraperitoneal dissemination of malignant cells, which may be associated with intrauterine pressure >80 mmHg but not with stages I-II. There is no reason to avoid HSC for the diagnosis of endometrial cancer, especially in early stages, but intrauterine pressure should possibly be controlled below 80 mmHg.

Aims and objectives To evaluate the effectiveness of cold application methods in reducing postpartum episiotomy pain. Background Many women suffer from pain after giving birth due to an episiotomy. This prolonged pain affects their daily lives as they recover. Various methods can help alleviate this pain; however, the effects of cold application specifically are still under discussion. Design Systematic review and meta-analysis were used. Methods In this review, we investigated studies from the CINAHL, PubMed, Google Scholar and Science Direct databases that met PICOS inclusion criteria. We also assessed the studies' methodological quality with the JADAD and JBI checklists. This study was performed based on the Guidelines of Systematic Reporting of Examination presented in the PRISMA checklist (Appendix S1). The search protocol has been registered at the PROSPERO International Prospective Register of Systematic Reviews. Results A total of seven published studies including 700 total participants were included in this review. Various cold application methods (cold gel pack/pad, crushed ice gel pad, ice pack) significantly reduced the pain after an episiotomy. Ice packs in particular did not significantly differ from lavender oil and acupressure in reducing pain after an episiotomy. Conclusions Cold application methods can be an effective, non-pharmacological midwifery and nursing intervention to reduce pain after an episiotomy. Relevance to clinical practice The use of cold application methods to reduce pain after episiotomy may reduce the need for pharmacological medication in women due to the reduction in pain in the perineum.

Objectives The pathogeneses of chronic tension-type headache (CTTH) and cervicogenic headache (CEH) are not well established. Peripheral activation or sensitization of myofascial nociceptors is suggested as a potential mechanism and injections of botulinum toxin (BONTA) have thus been used in the treatment for both headache conditions. BONTA inhibits the release of acetylcholine at the neuromuscular junction and inhibits contraction of skeletal muscles. If the pain is precipitated by increased tone in cervical muscles, local injections of BONTA could represent a prophylactic measure. However, the treatment is still controversial, and a thorough assessment of the current evidence is required. This review aims to assess the evidence of BONTA injection as a prophylactic treatment for CTTH and CEH by reviewing and examining the quality of placebo-controlled, randomized trials. Methods Data sources: we searched in the following databases: PubMed (including Medline), Embase, Cochrane Central register of Controlled Trials, Cinahl, Amed, SCOPUS and Google Scholar including other repository sources. Both MeSH and free keywords were used in conducting the systematic search in the databases. The search covered publications from the root of the databases to November 2020. Study eligibility criteria The review included RCTs, comparing single treatment of BONTA with placebo on patients with CTTH or CEH above 18 years of age, by measuring pain severity/relief or headache frequency. Data extraction The following data were extracted: year of publication, country, setting, trial design, number of participants, injection procedure, BONTA dosages, and clinical outcome measures. Study appraisal To assess validity and quality, and risk of bias, the Oxford Pain Validity Scale, Modified Jadad Scale, last version of Cochrane Collaboration’s tool for assessing risk of bias (RoB 2), and the CONSORT 2010 Checklist were used. The trials were assessed, and quality scored independently by two of the reviewers. A quantitative synthesis and meta-analyses of headache frequency and intensity were performed. Results We extracted 16 trials, 12 on prophylactic BONTA treatment for CTTH and four on CEH. Of these 12 trials (8 on CTTH and 4 on CEH) were included in the quantitative synthesis. A majority of the trials found no significant difference on the primary outcome measure when BONTA treatment was compared with placebo. Three “positive” trials, reporting significant difference in favor of BONTA treatment, but two of these were hampered by low validity and quality scores and high risk of bias. Conclusions There is no clear clinical evidence supporting prophylactic treatment with BONTA for CTTH or CEH.

Background: Alzheimer's disease (AD) is the main cause of dementia and it is a progressive neurogenerative disease characterized by the accumulation of neurofibrillary tangles and senile plaques. There is currently no cure; however, some treatments are available to slow down the progression of the disease, including gene therapy, which has been investigated to have great potential for the treatment of AD. Objective: The aim of this review was to identify the efficacy of gene therapy to restore cognition in AD. Methods: A systematic review was carried out using papers published up to May 2020 and available in the Web of Science, Scopus, and Medline/PUBMED databases. Articles were considered for inclusion if they were original researches that investigated the effects of gene therapy on cognition in AD. The methodological quality of the selected studies was evaluated using the Risk of Bias Tool for Animal Intervention Studies (SYRCLE’s Rob tool) and the Jadad Scale. Results: Most preclinical studies obtained positive results in improving memory and learning in mice that underwent treatment with gene therapy. On the other hand, clinical studies have obtained inconclusive results related to the delivery methods of the viral vector used in gene therapy. Conclusion: Gene therapy has shown a great potential for the treatment of AD in preclinical trials, but results should be interpreted with caution since preclinical studies presented limitations to predict the efficacy of the treatment outcome in humans.

The efficacy and safety of Hydroxychloroquine (HCQ) in treating coronavirus disease (COVID-19) is disputed. This systematic review and meta-analysis aimed to examine the efficacy and safety of HCQ in addition to standard of care (SOC) in COVID-19. PubMed, the Cochrane Library, Embase, Web of sciences, and medRxiv were searched up to March 15, 2021. Clinical studies registry databases were also searched for identifying potential clinical trials. The references list of the key studies was reviewed to identify additional relevant resources. The quality of the included studies was evaluated using the Cochrane Collaboration tool and Jadad checklist. Meta-analysis was performed using RevMan software (version 5.3). Eleven randomized controlled trials with a total number of 8161 patients were identified as eligible for meta-analysis. No significant differences were observed between the two treatment groups in terms of negative rate of polymerase chain reaction (PCR) (Risk ratio [RR]: 0.99, 95% confidence interval (CI) 0.90, 1.08; P = 0.76), PCR negative conversion time (Mean difference [MD]: − 1.06, 95% CI − 3.10, 0.97; P = 0.30), all-cause mortality (RR: 1.09, 95% CI 1.00, 1.20; P = 0.06), body temperature recovery time (MD: − 0.64, 95% CI − 1.37, 0.10; P = 0.09), length of hospital stay (MD: − 0.17, 95% CI − 0.80, 0.46; P = 0.59), use of mechanical ventilation (RR: 1.12, 95% CI 0.95, 1.32; P = 0.19), and disease progression (RR = 0.82, 95% CI 0.37, 1.85; P = 0.64). However, there was a significant difference between two groups regarding adverse events (RR: 1.81, 95% CI 1.36, 2.42; P

Venous access procedures are painful and feared by children and their parents. Virtual reality has become increasingly prominent and has been shown to be effective in various procedures. The aim of this meta-analysis was to examine virtual reality’s effect on pain and fear in children from 4 to 12 in the context of vascular access. From the 20th to the 26th December 2020, we searched Sciencedirect, Springerlink, CENTRAL, Pubmed and PMC. Studies using virtual reality versus a control in vascular access for children were included in a meta-analysis to evaluate the effect of virtual reality regarding pain as a primary and fear/anxiety as a secondary endpoint during the procedures. The Jadad scale and Delphi List were used to assess study quality. 20,894 citations were identified, 9 met our inclusion criteria. One publication was conducted in two different situations and was thus considered as 2 studies. Compared to standard of care, virtual reality significantly reduced pain (10 studies, 930 participants: standardized mean difference [SMD] 2.54, 95%CI 0.14–4.93, p = 0.038), and fear/anxiety (6 studies, 648 participants: SMD 0.89, 95%Cl 0.16–1.63, p = 0.017). For both parameters, we found significant heterogeneity between studies. This is the first meta-analysis to look at the use virtual reality in young children undergoing vascular access procedures, providing weak to moderate evidence for its use. Although large effect sizes provide evidence for a positive effect of virtual reality in reducing pain and fear, there is significant heterogeneity between studies. More research with larger groups and age stratification is required.

Background: Clinically significant weight loss improves glycaemic control and cardiovascular disease risk in patients with type 2 diabetes (T2DM). Aim : To identify and assess the efficacy of medical treatments for weight loss in adults with T2DM. Methods: A systematic review was conducted of peer- reviewed literature between July 2004 and July 2020 via PubMed, Embase, Web of Science, medRxiv and Cochrane Central Register of Controlled Trials. Randomised controlled trials (RCTs) in English investigating medical treatments for weight loss in patients with T2DM were included. RCTs of pharmacotherapy withdrawn from the market were excluded. No minimum length of follow-up time was established. Outcomes of interest were changes from baseline in body weight (%), changes from baseline in HbA 1c (%, mmol/mol) and proportion of patients who achieved ≥5% weight loss. Quality assessment was evaluated using the Jadad score. Results : Fifteen RCTs were included with a total of 4,207 participants with T2DM. Interventions included medications approved for obesity management (orlistat, liraglutide, naltrexone-bupropion and phentermine-topiramate) and other agents investigated for the primary purpose of weight loss (topiramate, metreleptin, dapagliflozin and exenatide) compared with placebo. The duration of the intervention varied from 12 to 56 weeks. Placebo-adjusted body weight loss ranged from 2.2% to 7.3%. Furthermore, 30.5–77.0% of patients achieved ≥5% weight loss. Placebo-adjusted change in glycated haemoglobin was 0.3–1.5% (3.3–16.4 mmol/mol). Conclusion : Current evidence demonstrates that pharmacotherapy for weight loss, except for leptin, is associated with weight loss and glycaemic improvement in patients with T2DM.

Background: Due to the fear of childbirth (FOC) and failure to provide painless delivery in Iran, the prevalence rate of elective cesarean section (C-section) performed on request by pregnant women is on the rise. However, no systematic review assessing the results of studies in this respect has been thus far developed. Objective: To systematically review published psychological intervention research reflecting on FOC in Iran. Materials and Methods: In this systematic review, the databases of PubMed, MEDLINE, PsycINFO, Wiley, ISI Web of Science, Scopus, Science Direct, Cochrane Library, Google Scholar, and Scientific Information Database were searched to retrieve the relevant studies. Manual searches were performed to find the relevant articles and finally 21 intervention studies were reviewed. Results: Based on the modified Jadad Scale, a methodological quality (risk of bias) assessment tool, 14 and 7 studies had acceptable or good and low quality, respectively. The included articles covered fear, fear of childbirth, pregnancy, and psychological intervention in Iran. Cognitive behavioral therapy, relaxation techniques, psychological counseling, childbirth preparation classes (CPCs), mindfulness programs, and psychoeducation had been also practiced as the main types of psychological interventions for reducing FOC in pregnant women. Conclusion: There was no clear evidence to establish the most effective method for minimizing levels of FOC in pregnant women. Based on the assessment tool and since most of the studies had moderate or low quality, conducting standard and high-quality randomized controlled trials focusing on FOC in pregnant women is of most importance in Iranian population. Key words: Fear, Childbirth, Pregnancy, Psychological intervention, Iran.

espanolIntroduccion. Dada la prevalencia y el impacto socioeconomico del cancer, es de vital importancia la investigacion en todas sus vertientes, que requiere una evaluacion previa de la informacion cientifica disponible. Metodos. Se realizo una revision sistematica de la informacion referente a tratamientos en investigacion sobre el cancer en Europa en los ultimos diez anos. Resultados. Las investigaciones incluidas pueden clasificarse y analizarse segun tipo de estudio, tipo de cancer, tipo de tratamiento, aspectos evaluados, localizacion geografica e idioma de publicacion. Se evaluo la calidad metodologica de los EC incluidos de acuerdo con la escala de Jadad. Conclusiones. Se analizaron siete tipos de investigaciones cientificas. La mayoria fueron EC con una puntuacion ≥3 (sobre 5) en la escala de Jadad. Mayormente se referian a canceres de mama y prostata, y tratamientos de tipo farmacologico e inmunologico. Se estudio preferentemente seguridad y eficacia. Se llevaron a cabo sobre todo en regiones del centro, oeste y sur de Europa, y se publicaron en ingles. English:ntroduction. Given the prevalence and socioeconomic impact of cancer, research in all its aspects is of vital importance, and it requires a prior evaluation of the available scientific information. Methods. A systematic review of information on investigational cancer treatments in Europe over the last ten years was carried out. Results. The investigations included can be classified and analyzed according to the type of study, type of cancer, type of treatment, aspects evaluated, geographic location and language of publication. The methodological quality of the included CTs was assessed according to the Jadad scale. Conclusions. Seven types of scientific investigations were analyzed. The majority were CT with a score ≥3 (out of 5) on the Jadad scale. Most referred to breast and prostate cancers, and pharmacological and immunological treatments. Safety and efficacy were preferably studied. They were carried out mainly in regions of Central, Western and Southern Europe, and they were published in English

Background and Purpose. Mild cognitive impairment (MCI) is a common condition, which threatens the quality of life of older adults. Tai Chi (TC) is growing in popularity among patients with MCI. This study is aimed at evaluating the effectiveness and safety of TC in older adults with MCI. Design. Randomized controlled trials (RCTs) from multiple databases from inception to December 2020 published in English were searched. Two researchers independently performed eligible study screening and data extraction. The methodological quality was assessed with the Jadad score. Meta-analysis of RCTs on TC in the treatment of MCI was performed with RevMan Version 5.4.1. Results. Seven RCTs with 1265 participants were included. For most RCTs, the overall reporting of methodological quality was high. Results of the meta-analysis indicate that TC improved MCI patients’ cognitive function significantly, including overall cognitive function ( MD = − 2.24 , 95% CI -3.51 to -0.97, P = 0.0005 ), memory and learning ( SMD = 0.83 , 95% CI 0.22 to 1.45, P = 0.008 ), visuospatial ability ( MD = 3.15 , 95% CI 0.74 to 5.56, P = 0.01 ), executive functions ( MD = 0.32 , 95% CI 0.03 to 0.61, P = 0.03 ), and physical activity ( MD = 18.78 , 95% CI 10.80 to 26.76, P < 0.00001 ). However, no significant benefit was found for TC on psychological activity ( MD = 0.17 , 95% CI -0.62 to 0.96, P = 0.36 ) and biomarker improvement. Conclusion. The meta-analysis confirmed the clinical therapeutic effect of TC for MCI. More rigorous and long-term follow-up RCTs should be conducted in the future.

Literature supporting the efficacy of complementary and integrative medicine (CIM) alongside radiotherapy is fragmented with varying outcomes and levels of evidence. This review summarizes the available evidence on CIM used with radiotherapy in order to inform clinicians. A systematic literature review identified studies on the use of CIM during radiotherapy. Inclusion required the following criteria: the study was interventional, CIM therapy was for human patients with cancer, and CIM therapy was administered concurrently with radiotherapy. Data points of interest were collected from included studies. A subset was identified as high-quality using the Jadad scale. Fisher’s exact test was used to assess the association between study results, outcome measured, and type of CIM. Overall, 163 articles met inclusion. Of these, 68 (41.7%) were considered high-quality trials. Articles published per year increased over time (p < 0.01). Frequently identified therapies were biologically based therapies (47.9%), mind-body therapies (23.3%), and alternative medical systems (13.5%). Within the subset of high-quality trials, 60.0% of studies reported a favorable change with CIM while 40.0% reported no change. No studies reported an unfavorable change. Commonly assessed outcome types were patient-reported (41.1%) and provider-reported (21.5%). Rate of favorable change did not differ based on type of CIM (p = 0.90) or outcome measured (p = 0.24). Concurrent CIM may reduce radiotherapy-induced toxicities and improve quality of life, suggesting that physicians should discuss CIM with patients receiving radiotherapy. This review provides a broad overview of investigations on CIM use during radiotherapy and can inform how radiation oncologists advise their patients about CIM.

It is widely accepted that oxidative stress plays an important role in the pathophysiology of male infertility and that antioxidants could have a significant role in the treatment of male infertility. The main objectives of this study are: 1) to systematically review the current evidence for the utility of antioxidants in the treatment of male infertility; and 2) propose evidence-based clinical guidelines for the use of antioxidants in the treatment of male infertility. A systematic review of the available clinical evidence was performed, with articles published on Scopus being manually screened. Data extracted included the type of antioxidant used, the clinical conditions under investigation, the evaluation of semen parameters and reproductive outcomes. The adherence to the Cambridge Quality Checklist, Cochrane Risk of Bias for randomized controlled trials (RCTs), CONSORT guidelines and JADAD score were analyzed for each included study. Further, we provided a Strength Weakness Opportunity Threat (SWOT) analysis to analyze the current and future value of antioxidants in male infertility. Of the 1,978 articles identified, 97 articles were included in the study. Of these, 52 (53.6%) were uncontrolled (open label), 12 (12.4%) unblinded RCTs, and 33 (34.0%) blinded RCTs, whereas 44 (45.4%) articles tested individual antioxidants, 31 (32.0%) a combination of several products in variable dosages, and 22 (22.6%) registered antioxidant products. Based on the published evidence, we 1) critically examined the necessity of additional double-blind, randomized, placebo-controlled trials, and 2) proposed updated evidence-based clinical guidelines for antioxidant therapy in male infertility. The current systematic review on antioxidants and male infertility clearly shows that antioxidant supplementation improves semen parameters. In addition, it provides the indications for antioxidant treatment in specific clinical conditions, including varicocele, unexplained and idiopathic male infertility, as well as in cases of altered semen quality.

The quadratus lumborum block is a novel truncal block where local anaesthetic is injected adjacent to the quadratus lumborum muscle. It is used for caesarean sections, hip arthroplasty, gynecologic surgery, colectomy, and recently nephrectomy. To date, there are no reviews that outline the efficacy and performance of the quadratus lumborum blocks in patients receiving laparoscopic nephrectomy. The objective of this project was to outline the current available data from both clinical trials along with case series and reports regarding the methods and utility of quadratus lumborum blocks for analgesia in patients receiving nephrectomy. For this literature review, we searched Pubmed, Embase, and Web of Science from their inception until 5/31/2020. Our search terms were as follows: “(nephrectomy OR laparoscopic nephrectomy) AND (QL block OR Quadratus Lumborum block OR QL OR TQL OR Thoracolumbar fascia block).” We analyzed all relevant clinical trials for quality using the Jadad scale. Our search yielded a total of 30 articles, 23 of which we ultimately reviewed for this manuscript. The qualitative sum of these data show that patients receiving quadratus lumborum block for nephrectomies have reduced opioid requirements, reduced pain scores, and improved side-effects relative to other analgesic modalities like epidurals. Based on these findings, we conclude that the quadratus lumborum block is a useful analgesic for patients undergoing nephrectomy.

Introduction and hypothesis Variations in outcome measures and reporting of outcomes in trials on surgery for pelvic organ prolapse (POP) using synthetic mesh have been evaluated and reported. However, the quality of outcome reporting, methodology of trials and their publication parameters are important considerations in the process of development of Core Outcome Sets. We aimed to evaluate these characteristics in randomized controlled trials on surgery for POP using mesh. Methods Secondary analysis of randomized controlled trials on surgical treatments using synthetic mesh for POP previously included in a systematic review developing an inventory of reported outcomes and outcome measures. The methodological quality was investigated with the modified Jadad criteria. Outcome reporting quality was evaluated with the MOMENT criteria. Publication parameters included publishing journal, impact factor and year of publication. Results Of the 71 previously reviewed studies published from 2000 to 2017, the mean JADAD score was 3.59 and the mean MOMENT score was 4.63. Quality of outcomes (MOMENT) was related to methodological quality (JADAD) (rho = 0.662; p = 0.000) and to year of publication (rho = 0.262; p = 0.028). Conclusions Methodological quality and outcome reporting quality appear correlated. However, publication characteristics do not have strong associations with the methodological quality of the studies. Evaluation of the quality of outcomes, methodology and publication characteristics are all an indispensable part of a staged process for the development of Core Outcome and Outcome Measure Sets.

ObjectiveTo assess the risk of neuropsychiatric adverse effects (ie, depression, anxiety, insomnia, dizziness, suicidal behaviour) among patients treated with rilpivirine, dolutegravir and dolutegravir/rilpivirine.DesignThis is a systematic review and meta-analysis of randomised controlled trials. Quality of evidence was assessed using Jadad scoring system.Data sourcesThree electronic databases were searched for available publications up to 1 May 2020. Searches included relevant studies, trial registers, conference proceeding abstracts and grey literature.Inclusion criteriaRandomised controlled trials with data focused on adult participants (ie, 18 years of age or older) receiving dolutegravir 50 mg, rilpivirine 25 mg or combination of dolutegravir 50 mg/rilpivirine 25 mg once daily.ResultsTwenty studies with a minimum duration of 48 weeks and average Jadad score of 4 were included (n=10 998). Primary objective demonstrated a relative risk (RR) synergistic effect on depressive symptoms for dolutegravir/rilpivirine (RR=2.82; 95% CI (1.12 to 7.10)) when compared with dolutegravir (RR=1.10; 95% CI (0.88 to 1.38)) and rilpivirine (RR=1.08; 95% CI (0.80 to 1.48)). Secondary objectives showed no difference between dolutegravir, rilpivirine and dolutegravir/rilpivirine to efavirenz. Additionally, excluding efavirenz studies, dolutegravir and dolutegravir/rilpivirine yielded increased depression (RR=1.34; 95% CI (1.04 to 1.74)).ConclusionThe combination of dolutegravir/rilpivirine appears to increase the risk of depressive symptoms. Despite the increase, the clinical significance is unknown and needs further study. Additionally, neurotoxicity risk appears similar between dolutegravir, rilpivirine and dolutegravir/rilpivirine antiretroviral therapy when compared with efavirenz-based antiretroviral therapy.

Autism spectrum disorders (ASD) are an emerging health problem worldwide. So far, no definite cure for ASD exists. L-Carnosine is an amino acid containing β-alanine and L-histidine which has been proposed to have neuroprotective, antioxidant and anti-convulsive properties that may benefit affected children with this disorder. This review aimed to assess the effect of L-Carnosine in the management of ASD in children. We systematically reviewed randomised controlled trials (RCTs) which documented the effect of L-Carnosine in children with ASD. A literature search was performed in PubMed, Cochrane Library, Google Scholar, ClinicalTrials.gov, Clinical Trial Registry-India databases from inception to December 20, 2020. Articles were selected based on pre-set inclusion/exclusion criteria. The primary outcomes were changes in social, communication and behavioural responses and the secondary outcomes were improvement in sleep disorders, gastrointestinal problems, oxidative stress markers and adverse effects. Jadad scale was used to assess the quality of RCTs and modified Cochrane risk of bias tool was used to check the risk of bias of the included studies. The meta-analysis was reported based on the fixed-effects model. Four double-blinded, placebo-controlled, RCTs and one open label trial with a total of 215 participants were selected for the review. All the trials were methodological of high quality according to the Jadad scale. The modified Cochrane risk of bias tool showed a low to high risk of bias. Results from the meta-analysis of three studies showed no significant difference between L-Carnosine and placebo groups in the Gilliam autism rating scale (GARS) (MD = - 2.57; 95% CI - 10.30, 5.16, p = 0.52) and in its socialisation (MD = - 1.51; 95% CI - 6.16, 3.14, p = 0.53), behaviour (MD = - 0.48; 95% CI - 4.82, 3.87, p = 0.83) and communication (MD = - 3.94; 95% CI - 10.00, 2.11, p = 0.20) subscales as well as the childhood autism rating scale (CARS) (MD = - 0.88; 95% CI - 6.96, 5.20; p = 0.78). Current data do not support the use of L-Carnosine in the management of children with ASD due to a low number of studies and sample size available. Further studies are warranted to know the effect of L-Carnosine for ASD management.

Objective A meta-analysis and systematic review was performed to compare outcomes of open reduction and internal fixation (ORIF), hemiarthroplasty (HA), and reverse total shoulder arthroplasty (rTSA) for complex proximal humerus fractures. Data sources: MEDLINE, Embase, and Cochrane Library databases were screened. Search terms included reverse total shoulder arthroplasty, open reduction internal fixation, hemiarthroplasty, and proximal humerus fracture. Study selection English-language studies published within the past 15 years evaluating outcomes of ORIF, rTSA, or HA for complex proximal humerus fractures with minimum of 1-year follow-up were included, resulting in 51 studies with 3064 total patients. Review articles, basic science studies, biomechanical studies, and cadaveric studies were excluded. Data extraction The methodological quality of evidence was assessed using the Jadad scale and methodological index for nonrandomized studies. Data synthesis Demographic data were compared using the χ2 test. Mean data were weighted by study size and used to calculate composite mean values and confidence intervals. Continuous data were compared using the Metan module with fixed effects. Count data were compared using the Kruskal-Wallis test. Alpha was set at 0.05 for all tests. Conclusions Patients undergoing rTSA had lower risks of complication (relative risk 0.41) and reoperation (relative risk 0.28) than HA patients. rTSA resulted in higher Constant scores (standard mean difference 0.63) and improved active forward flexion when compared with HA (standard mean difference 0.76). Pooled mean data demonstrated better outcome scores and active forward flexion of ORIF versus HA and rTSA, although the patients were younger and had more simple fracture patterns. Level of evidence Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Objective To conduct a systematic review and meta-analysis of the efficacy of anti-nerve growth factor (NGF) monoclonal antibodies in osteoarthritis pain (hip and knee). Design Grade the evidence for anti-NGF use. Methods An interdisciplinary work group conducted a literature search for anti-NGF use in osteoarthritis. The systematic review was performed in accordance with methods described by the Cochrane collaboration. General inclusion criteria included all osteoarthritis trials studying any monoclonal anti-NGF antibody at any dose/phase. Excluded studies were those where participants received NSAIDs or analgesics other than anti-NGF antibodies. The Jadad Scale score was used to assess the quality of the included studies. Results Thirteen studies were included in the analysis, involving 8145 participants with a diagnosis of hip and/or knee osteoarthritis. Anti-NGF antibody treatment was associated with a significant improvement in all Western Ontario and McMaster Universities Arthritis Index (WOMAC) indices when compared to placebo. These agents were not associated with a significantly increased incidence of serious adverse events but were associated with significant increases in therapy discontinuation due to adverse events or side effects (e.g., peripheral neuropathy). Conclusions Future randomized clinical trials are needed to characterize the overall risk-to-benefit ratio of anti-NGF antibodies in managing pain associated with OA, particularly with long-term use, in order to verify their efficacy and safety in clinical practice.

Study design Systematic Review. Objectives We performed this systematic overview on the overlapping meta-analyses that analyzed autologous bone marrow-derived mesenchymal stem cell(BM-MSC) therapy along with core decompression(CD) for the management of osteonecrosis of the femoral head(ONFH) and identify which study provides the current best evidence on the topic and generate recommendations for the same. Materials and methods We conducted independent and duplicate electronic database searches in PubMed, Web of Science, Embase, Cochrane Database of Systematic Reviews, and the Database of Abstracts of Reviews of Effects till September 2020 for meta-analyses that analyzed the efficacy of BM-MSC therapy along with CD for ONFH. Methodological quality assessment was made using Oxford Levels of Evidence, AMSTAR scoring, and AMSTAR 2 grades. We then utilized the Jadad decision algorithm to identify the study with the highest quality to represent the current best evidence to generate the recommendation. Results 6 meta-analyses fulfilling the eligibility criteria were included. The AMSTAR scores of the included studies varied from 4 to 9 (mean:7) and all the included studies had critically low reliability in their summary of results due to their methodological flaws according to AMSTAR 2 grades. The current best evidence showed that utilization of BM-MSC therapy along with CD for ONFH resulted in significant improvement in Harris hip scores at 12 and 24 months along with a significant reduction in the necrotic area of the femoral head and the rate of conversion to total hip arthroplasty(THA) without a significant rise in adverse events due to the procedure. Conclusion Based on this systematic overview, we give a Level II recommendation that BM-MSC therapy is more efficacious along with CD in the management of ONFH compared to CD alone. BM-MSC therapy provides better pain relief with significant functional improvement and delaying the collapse of the femoral head thereby preventing further treatment such as THA.

Background One of the most common complaints for women is dysmenorrhea. Several studies investigated the treatment effects of medicinal plants on primary dysmenorrhea. Objectives This systematic review and meta-analysis investigates the effect of Foeniculum vulgare (Fennel) on pain in primary dysmenorrhea in comparison to non-steroidal anti-inflammatory drugs such as mefenamic acid. Methods PubMed, EMBASE, EBSCO Web of Science, Scopus, Cochrane library, Cochrane Central Register of Controlled Trials (CENTRAL), Science Direct, ProQuest, ISI Web of Science, Google Scholar, Magiran, SID, Iran Medex, and Irandoc were searched up to January 2019. Quality assessment of clinical trials was conducted using Jadad scoring system. Totally, 12 studies were entered in the meta-analysis. I 2 was calculated to determine heterogeneity. Fixed effects and/or random effects models were applied. Results Meta-analysis of these trials showed that F. vulgare intake decreased significantly the intensity of dysmenorrhea compared to the placebo (SMD −0.632; CI: −0.827 to −0.436; pI 2=0%; fixed effect model; seven articles). However, the effect of Mefenamic acid with F. vulgare was not different from each other (SMD=−0.214; CI: −0.446 to 0.017; p=0.07; heterogeneity p=0.58; I 2=0%; fixed effect model; six trials). Conclusion The F. vulgare alleviates dysmenorrhea. Regarding the same effect of F. vulgare with NSAIDs, it is highly recommend to the women suffered from dysmenorrhea specifically the ones who have high tendency toward herbal medicine.

Background. Acupuncture had long been a primary treatment in the healthcare system of China. In recent years, there were more and more network meta-analyses (NMAs) in the field of acupuncture and moxibustion, but the quality evaluation of NMAs was rare. Objectives. The goal of this study was to evaluate the methodological and reporting quality of NMAs and summarize the effects of different treatments of acupuncture and moxibustion. Methods. PubMed, Embase, the Cochrane Library, China National Knowledge Infrastructure Database (CNKI), WanFang Database (WF), Chinese Scientific Journal Database (VIP), and Chinese Biomedical Literature Database (CBM) were searched from inception to January 2020 without any language restriction. In addition, the unpublished studies and the references of initially included literature were also retrieved manually. We included all relevant NMAs treated with acupuncture and moxibustion; other therapies such as traditional Chinese medicine and Western medicine may also be included, but at least three types fall under the category of acupuncture in each NMA. Outcome indicators were not limited. We selected AMSTAR2 and PRISMA-NMA to evaluate the methodological and reporting quality of eligible studies, respectively. Results. In total, 29 NMAs were included finally, including 12 Chinese references and 17 English references. All eligible studies were published from May 2013 to August 2019. The number of interventions was between 4 and 22. The number of clinical trials included ranged from 10 to 121, with a total of 1098 clinical trials. The NMAs were involved in up to 23 diseases, knee osteoarthritis and primary dysmenorrhea covered with 3 NMAs separately, others focusing on chronic functional constipation, lumbar disc herniation, chronic fatigue syndrome, and the like. The Jadad scale and RoB scale were used as the bias risk assessment tools. Among them, 7 articles adopted the Jadad scale, 22 articles adopted the RoB scale (1 article adopted both the Jadad scale and RoB scale), and only 1 article did not mention the risk assessment tool. The AMSTAR2 methodological evaluation showed that the highest score was 13.5 points and the lowest was 4, with an average of 8.64 and a median of 9.5. According to the quality criteria, only one of them was in high quality, twenty-four were in medium quality, and four were in low quality. The PRISMA-NMA reporting quality evaluation showed that the highest score was 29 points and the lowest was 13.5, with an average of 23.62 and a median of 24.5; severe flaws also existed in some items, especially in “Structured summary,” “Protocol and registration,” “Search,” “Data collection process,” “Data items,” “Additional analyses,” “Risk of bias across studies,” and “Results of additional analyses.” Conclusion. The number of NMAs in the field of acupuncture and moxibustion was still in the initial stage. Overall, their methodology and reports were of moderate quality. However, severe flaws also existed in some items. Because the eligible NMAs were limited, the conclusion needed further research to confirm its authenticity and reliability.

Animal studies have suggested that angiotensin II receptor blockers (ARBs) can attenuate or reverse the progression of hypertrophic cardiomyopathy, while clinical studies yielded conflicting results. We sought to conduct a meta-analysis to investigate the effect of ARBs in patients with hypertrophic cardiomyopathy. PubMed and EMBASE databases were searched through June 2020. Only randomized controlled trials (RCTs) were included, and each study’s quality was assessed using the Jadad scale. The primary outcome was left ventricular mass reduction, and the secondary outcome was the change in left ventricular ejection fraction (LVEF). Data were pooled using the random effects model. A total of 1294 articles were screened. Five RCTs were included in the final analysis, enrolling 209 patients with hypertrophic cardiomyopathy (101 patients were in the ARB arm). ARB treatment was not associated with either significant left ventricular mass reduction (standardized mean difference: − 0.25; 95% CI: − 0.73, 0.22; p = 0.29) or change in LVEF (weighted mean difference: 0.73%; 95% CI: − 1.10%, 2.56%; p = 0.43). Subgroup analysis showed that losartan, one of the most investigated and commonly used ARBs, was also not associated with significant decreases of left ventricular mass (standardized mean difference: − 0.13; 95% CI: − 0.61, 0.36; p = 0.61). This meta-analysis showed that ARB treatment is not associated with reduced left ventricular mass nor remarkable LVEF change among patients with hypertrophic cardiomyopathy. Further studies with a larger number of patients will be required to confirm these findings.

Introduction: The long head of biceps tendon is a common source of anterior shoulder pain and impaired function. Multiple surgical procedures are available as treatment options, but the optimal procedure is not known. The aim of this systematic review and meta-analysis is to review the literature to assess the clinical effectiveness of various surgical procedures to treat pain arising from the long head of biceps. Methods: The study protocol was designed and registered prospectively on PROSPERO (International prospective register for systematic reviews). Electronic databases used for the literature search will include MEDLINE, EMBASE, PsycINFO, and The Cochrane Library. Randomised controlled trials (RCTs) evaluating surgical procedures on the long head of biceps will be included. Our primary outcome is any functional patient-reported outcome measure related to the shoulder. Secondary outcomes will include the rate of ‘Popeye’ deformity, the rate of biceps cramping pain, the rate of complications, objective measurements of strength testing such as dynamometer, and other patientreported outcome measures not specific to the shoulder such as the Visual-Analog Scale (VAS) for pain. Methodological quality of included studies will be assessed using The Cochrane Risk of Bias Tool 2.0 and the Jadad score. Inconsistency and bias across included studies will be assessed statistically. Comparable outcome data will be pooled and analysed quantitatively or qualitatively as appropriate. Ethics and dissemination: No ethical clearances required for this study. We plan to publish this systematic review and meta-analysis in a peer-reviewed journal. It will also be presented at various national and international conferences. Highlights Evaluating the clinical effectiveness of surgical procedures for long head of biceps pathology. Randomised controlled trials. Biceps tenodesis and biceps tenotomy. Systematic review compliant with the PRISMA guideline.

The current systematic review and meta-analysis aims to evaluate the efficacy and safety of iguratimod (IGU) combined with methotrexate (MTX) versus MTX alone in rheumatoid arthritis (RA). Two independent investigators searched for original randomized controlled trials (RCTs) related to the combination of IGU and MTX in RA published before November 1, 2019, in PubMed, Cochrane Library, Embase, the China National Knowledge Infrastructure (CNKI), the Chinese Biomedical Literature Database (CBM), and WanFang Data. Additionally, we searched clinical trial registry websites. We assessed the methodological quality of the included trials using the Cochrane Collaboration tool and the seven-point Jadad scale. Statistical analyses were performed using Review Manager (RevMan) 5.3 (Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014). Meta-regression and publication bias analyses were performed using Stata version 14 software (StataCorp., College Station, TX, USA). A total of 7 RCTs consisting of 665 participants, with 368 participants in the active arm and 297 in the placebo arm, were included in the meta-analysis. The American College of Rheumatology (ACR) value was better in the IGU + MTX group than in the MTX alone group, with a pooled relative risk (RR) for ACR20 (American College of Rheumatology 20% improvement criteria), ACR50, and ACR70 of 1.40 (95% CI, 1.13–1.74), 2.09 (95% CI, 1.67–2.61), and 2.24 (95% CI, 1.53–3.28), respectively. The results of the meta-analysis demonstrated that there was no statistical significance in adverse events (1.06 (95% CI, 0.92–1.23)). The combined treatment is an effective, safe, and economical treatment option for patients who do not respond well to methotrexate alone or for patients who cannot afford expensive biologics that have no confirmed efficacy.

Objective: to find the most up-to-date evidence of the effectiveness and safety of supervised physical therapy in polymyositis/dermatomyositis patients. Methods: a systematic review of the literature in the main scientific databases was carried out. We searched for randomized controlled trials concerning supervised physical therapy and polymyositis/dermatomyositis. The PICOS method was used for the formulation of the clinical query. Methodological quality and the level of evidence of the included studies were assessed using the modified Jadad scale and the Oxford Centre for Evidence-Based Medicine Levels of Evidence guide, respectively. Results: a total of 2591 articles were found. By applying the inclusion/exclusion criteria, six randomized controlled clinical trials were admitted to the final phase of the review. The compared approaches concerned supervised exercise programs based on strategies of muscle strengthening or aerobic work. Following these exercises, an increase in the maximum rate of oxygen consumption, a decrease in creatine phosphokinase levels, an enhancement in the patient’s aerobic performance and an improvement in the quality of life indexes were registered. The methodological quality of the included studies ranged from 3 to 4.5. All the studies were classified as presenting an evidence level of 2b. Conclusions: supervised physical therapy in polymyositis/dermatomyositis is an effective, safe and free-of-contraindications tool to be used both in the acute and in the established phases of the pathology. However, further and higher-quality studies are necessary to confirm those findings, to clarify the timing of exercise delivery and to guide the choice towards different types of muscle contraction exercises.

Purpose Injuries of both pelvic ring and acetabulum as rare very few articles are available in literature. There are no set protocols in defining the injury let alone defining early and definitive management strategies. This article is an attempt to encompass all available data to give us guidelines in managing these injuries. Methods An extensive literature review was carried out on PubMed/Medline, google scholar and Embase databases was done with the eligibility criteria of 1) Case series with a minimum of 20 cases. 2) The patient’s outcome reported. 3) Full article available. 4) Article in English. 5) Minimum Jadad score of 3. As per PRISMA guidelines the search was done and gradually filtered down to relevant articles which were 8 in number. Results The incidence of these injuries range from 5 to 16%. The transverse acetabular fracture pattern is the commonest followed by associated both column fractures. There is equal propensity of Anteroposterior compression and lateral compression injuries. The injury mechanism appears to transmitted lateral force from the greater trochanter inwards with an implosion injury causing acetabular and pelvic injury as a continuum. The initial management is similar to managing pelvic ring injuries with focus on patient resuscitation, hemodynamic stabilization and temporary stabilization. The injury severity score and the mortality rates are comparable to isolated unstable pelvic ring injuries. Definitive management focuses on fixing the posterior pelvic ring first followed by the acetabular fracture and then the anterior pelvic ring. The displacement rates and outcome is worse than isolated acetabular injuries or pelvic injuries. Conclusion Combined Pelvic and acetabular injuries are complex injuries which need to be managed initially as we manage pelvic injury and later as we fix as an acetabular fracture meticulously.

Objetivo: establecer las necesidades de los cuidadores familiares de personas con enfermedades huérfanas teniendo en cuenta el Modelo de la Enfermería Adventista. Metodología: revisión de literatura que abarcó artículos cuantitativos y cualitativos hallados en bases de datos y revistas indexadas en idiomas español, inglés y portugués, entre los años 2014 y 2019, cuyo rigor metodológico cumplieran criterios STROBE, COREQ, PRISMA y JADAD. La información obtenida fue relacionada con el modelo de la Enfermería Adventista, NOC y NIC. Resultados: Se seleccionaron 28 artículos que analizaban necesidades físicas, psicológicas, sociales, educativas, espirituales, sanitarias y económicas en los cuidadores de personas con enfermedades huérfanas, que requerían soporte multidisciplinar e integral, incluyendo apoyo espiritual enfermero mediante intervenciones propuestas por la NIC y el modelo de Enfermería Adventista (cuidado, conexión con Dios y el otro, y empoderamiento del cuidador en su propia salud). Conclusión: Las necesidades de los cuidadores abarcan diferentes áreas del ser, que pueden ser abordadas con intervenciones independientes e interdependientes, identificadas mediante modelos teóricos.

Aims/Introduction In recent years, mesenchymal cellular therapies have received much attention in the treatment of diabetes. In this meta‐analysis, we aimed to evaluate the efficacy of mesenchymal stem cell therapy in type 2 diabetes mellitus patients. Materials and Methods A comprehensive literature search was carried out using PubMed, Scopus, Web of Science and Central databases. A total of 1,721 articles were identified, from which nine full‐text clinical trials were qualified to enter the current meta‐analysis. The assessment groups included patients with type 2 diabetes, and levels of C‐peptide, glycosylated hemoglobin and insulin dose were analyzed before and after mesenchymal stem cell infusion. Data analysis was carried out in Stata version 11, and the Jadad Score Scale was applied for quality assessment. Results Changes in levels of C‐peptide after mesenchymal stem cell therapy were: standardized mean difference 0.20, 95% confidence interval −0.61 to 1.00, glycosylated hemoglobin levels were: standardized mean difference −1.45, 95% confidence interval −2.10 to −0.79 and insulin dose were: standardized mean difference −1.40, 95% confidence interval −2.88 to 0.09. Conclusions This meta‐analysis of prospective studies showed associations between mesenchymal stem cell therapy and control of glucose level in patients with type 2 diabetes., Mesenchymal stem cell therapy can improved glycosylated hemoglobin in diabetes patients.

Background: Recently a number of trials investigated the effect of N-acetylcysteine (NAC) administration on inflammatory markers and homocysteine (Hcy). However, their findings are controversial. The aim of this paper is to present a meta-analysis and give a review of all randomized controlled trials (RCTs) in order to determine the effects of NAC on inflammatory markers and Hcy. Methods: An electronic search was conducted using PubMed, Scopus, Cochrane Library, Google scholar and Web of Science databases from inception until April 2019. A study quality assessment was performed using the Jadad scale and heterogeneity between studies was statistically computed using Cochrane’s Q test and I-square (I2). Data were pooled using a random-effects model and weighted mean difference (WMD) was considered as the overall effect size. Results: Out of 1115 potential citations, 10 studies (reported 13 effect sizes for different parameters) met the inclusion criteria and were eligible for this meta-analysis. NAC supplementation resulted in a significant reduction in Hcy levels (WMD: -2.05; 95% CI: -3.73, -0.37). NAC administration did not affect C-reactive protein (CRP) levels (WMD: 0.06; 95% CI: -0.21, 0.34), tumor necrosis factor-α (TNF-α) levels (WMD: 0.07; 95% CI: -0.27, 0.40), and interleukin 6 (IL-6) (WMD: -0.23; 95% CI: -1.23, 0.77). Conclusions: It could be concluded that this meta-analysis of RCTs demonstrated that NAC administration to various patients significantly improved circulating Hcy, but did not affect CRP IL-6 and TNF-α levels.

OBJECTIVE We sought to revise, qualify and summarize the body of evidence based on current information on the known associations and risk factors for traumatic dental injury (TDI) occurrence with an overview of systematic reviews. METHODS Electronic searches were performed with no language nor date restrictions.According to the PECO strategy, systematic reviews that investigated participants (P) with (E) and without (O) the presentation of factors relating to TDI and these factors' association with TDI episodes (O) as primary or secondary outcomes were included. Quality assessment and bias control were carried out according to the AMSTAR 2 checklist. In cases of systematic review results of discordance, the Jadad decision algorithm was applied. RESULTS After titles, abstracts and full texts were read, 19 systematic reviews were included in this overview. Four were classified with critically low, eleven with low and four with moderate methodological quality, respectively. In all studies, 249 cross-sectional, 34 epidemiological surveys, 22 cohort, 9 case-control, 4 longitudinal, 3 ecological and 30 unspecified studies were included. Male gender, child age, greater overjet, inadequate lip coverage, anterior open bite, caries in the permanent dentition, overweight, a previous history of TDI, tongue piercing, the use of alcoholic beverages and participation in sports were all associated with a greater chance of suffering TDI. CONCLUSIONS Sociodemographic, clinical and environmental factors are associated with a greater chance of TDI occurrence. However, most of the systematic reviews included were of a low quality and may not provide an accurate and comprehensive summary of the available research that addresses the question of interest. Well-designed primary studies on different aspects of TDI are encouraged to provide higher quality scientific evidence.