Efficacy and safety of hemodialysis strategies for pregnant women with chronic kidney disease: Systematic review.

Pregnancy in chronic kidney disease (CKD) women is relatively rare, and the less risky choice of hemodialysis is unknown. The objective of this systematic review was to identify, systematically evaluate and summarize the available evidence on the efficacy and safety of hemodialysis strategies for pregnant CKD women. Sensitive search strategies were applied to six databases without data or language restrictions. Comparative (randomized and non-randomized) studies were prioritized. Two reviewers independently selected, extracted, and critically evaluated data from studies. The risk of bias assessment was performed using the ROBINS-I tool, considering the study design (non-randomized comparative observational studies). The certainty of the evidence was assessed using the GRADE approach. From 7210 references identified, six retrospective cohort studies were included (576 women). The effects of intensive hemodialysis (over 20 h/week) are uncertain for maternal and neonatal mortality (Peto odds ratio [OR] 0.85; 95% confidence interval [95% CI] 0.26-2.80), miscarriage (Peto OR 0, 38; 95% CI 0.12-1.23), stillbirths (Peto OR 0, 56; 95% CI 0.13-2.31), preterm birth (Peto OR 0.87; 95% CI 0.33-2.28), low birth weight (Peto OR 0.71; 95% CI 0.20-2.50) and congenital anomalies rates. The certainty of the evidence was very low due to studies methodological limitations and effect estimates imprecision. The uncertainty about intensive versus conventional hemodialysis effects for pregnant women with CKD and the imprecision in the estimated effects precludes any recommendation. The strategy choice must consider treatment availability, costs, and maternal social aspects until future studies provide more reliable evidence. PROSPERO CRD42021259237.

Photobiomodulation with low-level laser therapy for treating Achilles tendinopathy: a systematic review and meta-analysis.

OBJECTIVE: The purpose of this study was to determine the benefits and harms of low-level laser therapy for Achilles tendinopathy. DATA SOURCES: Search strategies were conducted (from inception to February 2020) in Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Literatura Latino Americana em Ciências da Saúde e do Caribe (LILACS), Physiotherapy Evidence Database (PEDro), SPORTDiscus, ClinicalTrials.gov, World Health Organization (WHO)-ICTRP and OpenGrey databases, to retrieve all randomized controlled trials that compared laser therapy with inactive/active interventions. REVIEW METHODS: This study was reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. The risk of bias was assessed using the Cochrane Risk of bias table. Meta-analyses were performed on dependence of homogeneity, otherwise results were reported narratively. The certainty of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. RESULTS: Four trials (119 participants) were analyzed. Laser therapy associated to eccentric exercises when compared to eccentric exercises and sham had very low to low certainty of evidence in pain and function assessment. Despite one trial favored laser therapy at two months (mean difference (MD) -2.55, 95% confidence interval (95% CI) -3.87 to -1.23), the CIs did not include important differences between groups at 3 and 13 months. The function assessment showed an improvement favoring the placebo group at one month (MD 9.19, 95% CI -16.16 to -2.23) and non-significant difference between groups at 3 and 13 months. Adverse events were poorly reported but restricted to minor events related to the exercises. CONCLUSION: The certainty of evidence was low to very low, and the results are insufficient to support the routine use laser therapy for Achilles tendinopathy.

Efficacy of platelet-rich plasma for non-transfusion use: Overview of systematic reviews.

INTRODUCTION: Platelet-rich plasma (PRP) is a blood component therapy with a supraphysiological concentration of platelets derived from allogenic or, more commonly, autologous blood. PRP has been used in different non-transfusion indications because of its role in the promotion of tissue repair and healing, in fields such as Traumatology, Dermatology and Dentistry. OBJECTIVE: To provide a synthesis of the efficacy of PRP for different clinical situations. METHODS: Systematic searches were carried out in MEDLINE, Embase, Cochrane Library and LILACS in July 2018 to identify systematic reviews (SRs) of randomized clinical trials (RCTs) focusing on PRP for non-transfusion use. Two authors independently screened all retrieved references in two stages (titles and abstracts at a first stage and full texts at a second stage). The methodological quality of SRs that met the eligibility criteria was appraised by AMSTAR 2. Conclusions were based on the most recent SRs with highest quality. RESULTS: One thousand two hundred and forty references were retrieved. After checking the inclusion criteria, 29 SRs of RCTs related to three different fields (wound care, Orthopedics and Dentistry) were included. The results suggest the benefit of PRP for different clinical situations, such as diabetic wounds, acute lesions of musculoskeletal system, rotator cuff lesions, tendinopathies, knee and hip osteoarthritis, total knee arthroplasty, allogenic bone graft for dental implants and periodontal intrabony defects. CONCLUSION: There is low to moderate quality evidence supporting the efficacy of PRP for specific clinical situations. The low quality of the evidence limits the certainty of these findings. Well-planned and well-conducted RCTs are still needed to further assess the efficacy of PRP.

Modafinil for poststroke patients: A systematic review.

INTRODUCTION: Stroke is a major cause of death and disability worldwide. The use of modafinil, a wakefulness-promoting agent, is hypothesised to benefit stroke patients. METHODS: We performed a systematic review in accordance with the Cochrane Handbook for Systematic Reviews of Interventions recommendations to assess the efficacy and safety of modafinil in poststroke patients. We prospectively registered the review protocol in PROSPERO (CRD42017078465) and reported the systematic review following the PRISMA statement. RESULTS: Two published studies (77 participants) and one ongoing randomised controlled trial, with limited methodological quality, assessed the effects of modafinil (200 mg or 400 mg) for adults from 14 days poststroke up to 3 months poststroke and fulfilled our inclusion criteria. The clinical and methodological variability between studies precluded meta-analyses. Overall, these studies showed some benefit of modafinil for fatigue, but no benefit for disability, cognition, and for subscores of stroke-specific quality of life. Data for adverse events were scarce and mortality was not considered by studies. Due to very low quality related to the evidence, we are uncertain about the effects of modafinil for all outcomes assessed by our systematic review. CONCLUSION: Based on two small randomised controlled trial, which provided very low quality evidence, the effects (benefits and harms) of modafinil for stroke patients are unclear and do not support its routinely use in clinical practice for this clinical situation. Number of Protocol registration in PROSPERO database: CRD42017078465 (available from http://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42017078465).

Clinical interventions for Takayasu arteritis: A systematic review.

INTRODUCTION: Takayasu arteritis (TA) is a rare systemic vasculitis that affects large vessels often resistant to treatment and associated with high morbidity and mortality. Treatment is defied by the relapsing nature of the disease and frequent adverse effects of corticosteroids and immunosuppressors, rendering failure of treatment in a significant portion of patients. Considering the low quantity and quality of published studies focusing on treatment of TA, synthesis and critical assessment of the available evidence is fundamental to establish recommendations for clinical practice. OBJECTIVE: To evaluate the effectiveness and safety of clinical interventions for TA. METHODS: Systematic review conducted in accordance to recommendations stated in the Cochrane Handbook, with inclusion of all comparative studies focusing on any type of clinical intervention for TA. RESULTS: Five comparative studies were included (one randomised clinical trial, two non-randomised clinical trials, and two historical cohorts) totalling 342 patients, aiming at the assessment of effectiveness of corticosteroids, immunosuppressors, biologics and other types of pharmacological treatment for distinct clinical presentations of TA. The quality of studies, assessed by the use of instruments developed specifically for each study design, was considered low. Data scarcity and clinical heterogeneity prevented quantitative synthesis (meta-analysis). CONCLUSION: Despite an extensive literature search, few comparative studies with small sample sizes were retrieved. The quality of these studies was considered low, preventing recommendations on effectiveness and safety of the studied interventions for clinical practice. Until new comparative studies with more robust sample sizes are conducted, treatment of TA should be guided individually taking into account the severity of disease and the availability of treatment options.

Mindfulness for palliative care patients. Systematic review.

BACKGROUND: Nineteen million adults worldwide are in need of palliative care. Of those who have access to it, 80% fail to receive an efficient management of symptoms. OBJECTIVES: To assess the effectiveness and safety of mindfulness meditation for palliative care patients. METHODS: We searched CENTRAL, MEDLINE, Embase, LILACS, PEDro, CINAHL, PsycINFO, Opengrey, ClinicalTrials.gov and WHO-ICTRP. No restriction of language, status or date of publication was applied. We considered randomised clinical trials (RCTs) comparing any mindfulness meditation scheme vs any comparator for palliative care. Cochrane Risk of Bias (Rob) Table was used for assessing methodological quality of RCTs. Screening, data extraction and methodological assessments were performed by two reviewers. Mean differences (MD) (confidence intervals of 95% (CI 95%)) were considered for estimating effect size. Quality of evidence was appraised by GRADE. RESULTS: Four RCTs, 234 participants, were included. All studies presented high risk of bias in at least one RoB table criteria. We assessed 4 comparisons, but only 2 studies showed statistically significant difference for at least one outcome. 1. Mindfulness meditation (eight weeks, one session/week, daily individual practice) vs control: statistically significant difference in favour of control for quality of life - physical aspects. 2. Mindfulness meditation (single 5-minute session) vs control: benefit in favour of mindfulness for stress outcome in both time-points. None of the included studies analysed safety and harms outcomes. CONCLUSIONS: Although two studies have showed statistically significant difference, only one showed effectiveness of mindfulness meditation in improving perceived stress. This study focused on one single session of mindfulness of 5 minutes for adult cancer patients in palliative care, but it was considered as possessing high risk of bias. Other schemes of mindfulness meditation did not show benefit in any outcome evaluated (low and very low quality evidence).

Minimally invasive interventions for biopsy of malignancy-suspected pulmonary nodules: a systematic review and meta-analysis.

BACKGROUND: Imaging tests are important for diagnosis during the management of pulmonary nodules; however, biopsy is required to confirm the malignancy. OBJECTIVES: To compare the effects of different techniques used for the biopsy of a pulmonary nodule. DESIGN AND SETTING: Systematic review and meta-analysis were conducted using Cochrane methodology in São Paulo, São Paulo, Brazil. METHODS: We conducted a systematic review of randomized controlled trials (RCTs) on minimally invasive techniques, including tomography-guided percutaneous biopsy (PERCUT), transbronchial biopsies with fluoroscopy (FLUOR), endobronchial ultrasound (EBUSR), and electromagnetic navigation (NAVIG). The primary outcomes were diagnostic yield, major adverse events, and need for another approach. RESULTS: Seven RCTs were included (913 participants; 39.2% female, mean age: 59.28 years). Little to no increase was observed in PERCUT over FLUOR (P = 0.84), PERCUT over EBUSR (P = 0.32), and EBUSR over NAVIG (P = 0.17), whereas a slight increase was observed in NAVIG over FLUOR (P = 0.17); however, the evidence was uncertain. EBUSR may increase the diagnostic yield over FLUOR (P = 0.34). PERCUT showed little to no increase in all bronchoscopic techniques, with uncertain evidence (P = 0.02). CONCLUSION: No biopsy method is definitively superior to others. The preferred approach must consider availability, accessibility, and cost, as safety and diagnostic yield do not differ. Further RCTs planned, conducted, and reported with methodological rigor and transparency are needed, and additional studies should assess cost and the correlation between nodule size and location, as well as their association with biopsy results. SYSTEMATIC REVIEW REGISTRATION: PROSPERO database, CRD42018092367 -https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=92367.

Is Evening Carbohydrate Intake in Healthy Individuals Associated with Higher Postprandial Glycemia and Insulinemia When Compared to Morning Intake? A Systematic Review and Meta-Analysis of Randomized Crossover Studies.

This systematic review aimed to summarize randomized clinical trials that compared the postprandial glycemic and insulinemic metabolic response after eating isocaloric and standardized carbohydrate meals consumed at two moments: morning versus night, in healthy individuals who were not shift workers. The search strategy consisted of an electronic search using the following electronic databases: MEDLINE (via PubMed), EMBASE (via Elsevier), LILACs (Virtual Health Library - VHL), Cochrane Registers of Clinical Trials (CENTRAL, via Wiley) and gray literature (Opengray.eu). The PICO strategy was used to define the search terms (P: healthy adults, I: nocturnal intake, C: morning intake, O: area under the curve (AUC) of the postprandial glucose and insulin response). This review was reported according to the PRISMA statement. From the 3757 articles found, 412 were duplicates and excluded, totaling 3345 that had their titles and abstracts read. A total of 42 articles met the inclusion criteria and were read in full, and eight studies were included in the systematic review. The certainty of the evidence was assessed using GRADE. The results showed, with moderate quality of evidence, a postprandial response with higher glycemic values in the evening compared to the morning (SMD = 1.30; 95% CI, 1.01 to 1.59; I2 = 0%; p < 0.00001; 8 studies and 116 participants). No differences were found between insulin values at night and in the morning (SMD = 0.19; 95% CI, -0.10 to 0.49; 6 studies and 90 participants). We concluded that the intake of carbohydrates at night leads to higher glycemic, but not insulinemic, postprandial values. Revision Record: PROSPERO number CRD42019137862 available at: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42019137862 Key teaching points and nutritional relevanceThis systematic review summarized randomized clinical trials that compared the postprandial glycemic and insulinemic response after eating carbohydrate meals in the morning versus at night.A total of eight studies were included in the systematic review; the results showed a postprandial response with higher glycemic values in the evening compared to the morning.No differences were found between insulin values at night and in the morning;• The intake of carbohydrates at night leads to higher glycemic, but not insulinemic, postprandial values.

Supporting Decisions of the Brazilian Regulatory Agency for Supplementary Healthcare: A Case Study.

OBJECTIVES: This study aimed to report implementation and partial results of the project "Supporting the Brazilian regulatory agency for supplementary healthcare through health technology assessment actions" conducted at Hospital Sírio-Libanês, Brazil, from 2020 to 2023, through Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde, a Brazilian Ministry of Health initiative. METHODS: This was a case study conducted at Health Technology Center, Hospital Sírio-Libanês. RESULTS: From its inception, in 2020, to July 2022, the following activities and products were completed: 59 technical-methodological reports assessing the efficacy, safety, cost-effectiveness, and budget impact of technologies received by Agência Nacional de Saúde Suplementar (ANS) to compose its catalog of drugs products and services; 50 analyses of society contributions from public consultation; 34 methodological or clinical tutorial sessions to support ANS team; 2 templates to systematize the update process of ANS catalog; and one training course on systematic reviews and meta-analysis for ANS team. CONCLUSION: The project has contributed to increasing ANS autonomy in the health technology assessment, collaborating to efficiency in technologies offer to the users. By adopting and fostering evidence-based knowledge construction, the project reinforces its bridging role for supporting the consonance between public and supplementary healthcare sectors in Brazil.

Is self-reported short sleep duration associated with obesity? A systematic review and meta-analysis of cohort studies.

CONTEXT: A possible association between self-reported short sleep duration and risk of obesity has been studied. OBJECTIVE: To analyze the association between sleep duration and obesity. METHODS: The LILACS, Medline, Central, Embase, and OpenGrey databases were searched from inception until July 2020. Two authors screened the studies independently according to the PECO strategy, as follows: participants: > 18 years old; exposure: short sleep duration; control: regular sleep; outcome: obesity). Only cohort studies were included. A total of 3286 studies were retrieved with the search strategy, but only 36 were included. Disagreements were resolved by a third author. The quality of studies was assessed with Newcastle-Ottawa Quality Assessment Form for Cohort Studies. The certainty of the evidence was assessed using Grading of Recommendations Assessment, Development, and Evaluation. RESULTS: Thirty-six studies were included, and 22 contributed quantitative data. Most of the studies (n = 27) assessed sleep by self-report. The meta-analysis showed a significant association between self-reported short sleep and development of obesity, and the chances of developing obesity increased when self-reported sleep duration decreased. CONCLUSIONS: Self-reported short sleep was significantly associated with a higher incidence of obesity, with moderate quality of evidence. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration no. CRD42019130143.

Efficacy and safety of home-based intravenous antibiotic therapy among adults: a systematic review.

The aim of this study was to identify, systematically assess and summarise the available evidence about the efficacy and safety of intravenous home antibiotic therapy. In this systematic review, we considered studies of adults with any kind of infection and recommended intravenous antibiotic therapy. We included studies comparing therapy given at the patient's home versus any other setting (other levels of healthcare services or sites). We performed wide and sensitive literature searches with strategies adjusted for each of the electronic databases, including CINAHL, ClinicalTrials.gov, Cochrane Library, Embase, Epistemonikos, Health System Evidence, LILACS, MEDLINE and grey literature (OpenGrey). We used the Cochrane risk-of-bias and GRADE tools to evaluate the risk of bias and the certainty of evidence. At least two reviewers, working independently, selected the studies, extracted data and critically evaluated the evidence. We performed random-effects meta-analyses where possible. From 20 099 references initially identified, we included 6 randomised controlled trials (RCTs) with 616 participants. We considered the certainty of the body of evidence as low to very low regarding infection resolution after 6 weeks, risk of adverse events, mortality and clinical status. Based on six RCTs with considerable risk of bias, this systematic review found low or very low evidence about the advantages of intravenous antibiotic therapy at home. The imprecision of the results does not allow us to recommend or contraindicate the use of this strategy in clinical practice. [PROSPERO register: this review protocol was prospectively submitted at the PROSPERO register base at 31 January 2021 (submission no. 42021234454)].

Hypofractionated radiotherapy for newly diagnosed elderly glioblastoma patients: A systematic review and network meta-analysis.

OBJECTIVE: To evaluate different hypofractionated radiotherapy (HRT) regimens for newly diagnosed elderly glioblastoma (GBM) patients. METHODS: We performed a systematic review with network meta-analysis (NMA), including searches on CENTRAL, Medline, EMBASE, CINAHL, clinical trial databases and manual search. Only randomized clinical trials (RCTs) were included. Primary outcomes: overall survival (OS) and adverse events (AE). Secondary outcomes: progression-free-survival (PFS) and quality of life (QoL). We used the Cochrane Risk of Bias (RoB) table for assessing individual studies and CINeMA for evaluating the certainty of the final body of evidence. RESULTS: Four RCTs (499 patients) were included. For OS, the estimates from NMA did not provide strong evidence of a difference between the HRTs: 40 Gray (Gy) versus 45 Gy (HR: 0.89; CI 95%: 0.42, 1.91); 34 Gy versus 45 Gy (HR: 0.85; CI 95% 0.43, 1.70); 25 Gy versus 45 Gy (HR: 0.81; CI 95% 0.32, 2.02); 34 Gy versus 40 Gy (HR: 0.95; CI 95% 0.57, 1.61); and 25 Gy versus 34 Gy (HR: 0.95; CI 95% 0.46, 1.97). We performed qualitative synthesis for AE and QoL due to data scarcity and clinical heterogeneity among studies. The four studies reported a similar QoL (assessed by different methods) between arms. One RCT reported grade ≥ 3 AE, with no evidence of a difference between arms. PFS was reported in one study (25 Gy versus 40 Gy), with no evidence of a difference between arms. CONCLUSION: This review found no evidence of a difference between the evaluated HRTs for efficacy and safety.

Systematic reviews on interventions for COVID-19 have rarely graded the certainty of the evidence.

BACKGROUND: Numerous systematic reviews on coronavirus disease-19 (COVID-19) treatment have been developed to provide syntheses of the large volume of primary studies. However, the methodological quality of most of these reviews is questionable and the results provided may therefore present bias. OBJECTIVE: To investigate how many systematic reviews on the therapeutic or preventive options for COVID-19 assessed the certainty of the evidence through the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. METHODS: We conducted a sensitive search in MEDLINE (via PubMed) and included all systematic reviews that assessed any intervention for COVID-19. The systematic reviews included were examined to identify any planned and/or actual assessment using the GRADE approach (or absence thereof) regarding the certainty of the evidence. RESULTS: We included 177 systematic reviews and found that only 37 (21%; 37/177) assessed and reported the certainty of the evidence using the GRADE approach. This number reduced to 27 (16.2%; 27/167) when Cochrane reviews (n = 10), in which an evaluation using GRADE is mandatory, were excluded. CONCLUSION: Most of the systematic reviews on interventions relating to COVID-19 omitted assessment of the certainty of the evidence. This is a critical methodological omission that must not be overlooked in further research, so as to improve the impact and usefulness of syntheses relating to COVID-19.

Methodological quality and redundancy of systematic reviews that compare endarterectomy versus stenting for carotid stenosis.

A review of systematic reviews (SRs) and a critical appraisal study was conducted at Escola Paulista de Medicina, Universidade Federal de São Paulo (Unifesp). The objectives of this review are (1) to identify all published SRs comparing the effectiveness and safety of carotid endarterectomy (CEA) versus carotid artery stenting (CAS) for carotid artery stenosis, (2) to assess their methodological quality and (3) to compare the primary studies contained in each SR. We included 17 SRs published between 2005 and 2017. None of the SRs fulfilled all items of AMSTAR-2. The overall confidence in the results was graded as critically low for 16 SRs (94%) and low for 1 SR (6%). Five items were judged inadequate in all SRs: reference to a published protocol, explanation to the selection of study design, comprehensive search of the literature, methods for statistical combination of findings and consideration of the risk of bias on the results of meta-analysis. In total, 15 randomised clinical trials (RCTs) were included at least in one SR. The number of included RCTs in each SR was inconsistent (4 to 15) and was not related to the year of publication of the SR. Our study found redundant and low methodological quality SR comparing CAS versus CEA for carotid stenosis.

Timing of oxytocin administration to prevent post-partum hemorrhage in women delivered by cesarean section: A systematic review and metanalysis.

BACKGROUND: There is no consensus on the best timing for prophylactic oxytocin administration during cesarean section (CS) to prevent post-partum hemorrhage (PPH). OBJECTIVES: Assess the effects of administrating prophylactic oxytocin at different times during CS. METHODS: We searched nine databases to identify relevant randomized controlled trials (RCT). We pooled results and calculated average risk ratios (RR), mean differences (MD), and 95% confidence intervals (CI). We used GRADE to assess the overall evidence certainty. RESULTS: We screened 13,389 references and included four trials. We found no statistically significant differences between oxytocin given before versus after fetal delivery on PPH (RR 0.60, 95%CI 0.15-2.47; 1 RCT, N = 300) or nausea/vomiting (RR 1.21, 95%CI 0.69-2.13; 1 RCT, N = 300). There was a significant reduction in the need for additional uterotonics when oxytocin was given immediately before uterine incision versus after fetal delivery (RR 0.37, 95%CI 0.18-0.73; I2 = 0%; 2 RCTs; N = 301). Oxytocin given before fetal delivery significantly reduced intra-operative blood loss (MD -146.77mL, 95%CI -168.10 to -125.43; I2 = 0%; 3 RCTs, N = 601) but did not change the incidence of blood transfusion (RR 0.50, 95%CI 0.13-1.95; I2 = 0%; 2 RCTs, N = 301) or hysterectomy (RR 3.00; 95%CI 0.12-72.77; I2 = 0%; 2 RCTs, N = 301). One trial (N = 100) compared prophylactic oxytocin before versus after placental separation and found no significant differences on PPH, additional uterotonics, or nausea/vomiting. CONCLUSIONS: In women having pre-labor CS, there is limited evidence indicating no significant differences between prophylactic oxytocin given before versus after fetal delivery on PPH, nausea/vomiting, blood transfusion, or hysterectomy. Earlier oxytocin administration may reduce the volume of blood loss and need for additional uterotonics. There is very limited evidence suggesting no significant differences between prophylactic oxytocin given before versus after placental separation on PPH, need for additional uterotonic, or nausea/vomiting. The overall certainty of the evidence was mostly low or very low due to imprecision. Protocol: CRD42020186797.

High frequency of spin bias in controlled trials of cannabis derivatives and their synthetic analogues: A meta-epidemiologic study.

OBJECTIVE: To investigate the frequency and perform a qualitative analysis of spin bias in publications of controlled trials assessing the therapeutic use of cannabis derivatives and their synthetic analogues. STUDY DESIGN AND SETTING: Meta-epidemiologic study carried out at the Universidade Federal de São Paulo, Brazil. RESULTS: A total of 65 publications with at least one efficacy primary outcome were considered. The results analysis for the primary outcome indicated statistically significant effects in 44.6% (29/65) of the publications, and 70.7% (45/65) of the conclusions were considered favorable to the intervention. Among the 36 publications that found statistically nonsignificant results for the primary outcome, 44.4% (16/36) presented conclusions favorable to or recommending the intervention, which represents spin bias according to the definition adopted in this study. Qualitative analysis of the 16 studies with spin bias showed selective outcomes reporting (elevating secondary outcomes that had positive results or reporting only subgroup results), deviations from the planned statistical analysis, and failure to consider or report uncertainty in the estimates of treatment effects. CONCLUSION: The frequency of spin bias among publications of controlled trials with statistically nonsignificant results assessing the therapeutic use of cannabis derivatives and their synthetic analogues reached 44.4%. When not observed by readers, such deviation can lead to misconduct in clinical practice through the adoption of interventions that are not effective or whose effectiveness is uncertain.

Route of oxytocin administration for preventing blood loss at caesarean section: a systematic review with meta-analysis.

OBJECTIVES: Assess the effects of different routes of prophylactic oxytocin administration for preventing blood loss at caesarean section (CS). DESIGN: Systematic review and meta-analysis. METHODS: Medline, EMBASE, CINAHL, Cochrane Library, BVS, SciELO and Global Index Medicus were searched through 24 May 2020 for randomised controlled trials (RCTs) comparing different routes of prophylactic oxytocin administration during CS. Study selection, data extraction and quality assessment were conducted by two investigators independently. We pooled results in fixed effects meta-analyses and calculated average risk ratio (RR), mean difference (MD) and 95% CI. We used GRADE to assess the overall quality of evidence for each outcome. RESULTS: Three trials (180 women) were included in the review. All studies compared intramyometrial (IMY) versus intravenous oxytocin in women having prelabour CS. IMY compared with intravenous oxytocin administration may result in little or no difference in the incidence of postpartum haemorrhage (RR 0.14, 95% CI 0.01 to 2.70; N=100 participants; 1 RCT), hypotension (RR 1.00, 95% CI 0.29 to 3.45; N=40; 1 RCT), headache (RR 3.00, 95% CI 0.13 to 69.52; N=40; 1 RCT) or facial flushing (RR 0.50, 95% CI 0.05 to 5.08; N=40; 1 RCT); IMY oxytocin may reduce nausea/vomiting (RR 0.13, 95% CI 0.02 to 0.69; N=140; 2 RCTs). We are very uncertain about the effect IMY versus intravenous oxytocin on the need for additional uterotonics (RR 0.82; 95% CI 0.25 to 2.69; N=140; 2 RCTs). IMY oxytocin may reduce blood loss slightly (MD -57.40 mL, 95% CI -101.71 to -13.09; N=40; 1 RCT). CONCLUSIONS: There is limited, low to very low certainty evidence on the effects of IMY versus intravenous oxytocin at CS for preventing blood loss. The evidence is insufficient to support choosing one route over another. More trials, including studies that assess intramuscular oxytocin administration, are needed on this relevant question. PROSPERO REGISTRATION NUMBER: CRD42020186797.

Tribulus Terrestris for Female Sexual Dysfunction: A Systematic Review.

OBJECTIVE: We performed a systematic review to assess the effectiveness and safety of Tribulus terrestris to treat female sexual dysfunction (FSD). DATA SOURCES: We performed unrestricted electronic searches in the MEDLINE, CENTRAL, EMBASE, LILACS, CINAHL, PsycINFO, WHO-ICTR, Clinicaltrials.gov and OpenGrey databases. SELECTION OF STUDIES: We included any randomized controlled trials (RCTs) that compared T. terrestris versus inactive/active interventions. After the selection process, conducted by two reviewers, 5 RCTs (n = 279 participants) were included. DATA COLLECTION: Data extraction was performed by two reviewers with a preestablished data collection formulary. DATA SYNTHESIS: Due to lack of data and clinical heterogeneity, we could not perform meta-analyses. The risk of bias was assessed by the Cochrane Risk of Bias (RoB) tool, and the certainty of evidence was assessed with Grading of Recommendations, Assessment, Development and Evaluations (GRADE). RESULTS: After 1 to 3 months of treatment, premenopausal and postmenopausal women randomized to T. terrestris had a significant increase in sexual function scores. Three months of treatment with T. terrestris showed a significant increase in the serum testosterone levels of premenopausal women. There was no report of serious adverse events, and none of the studies assessed health-related quality of life. The certainty of the evidence was very low, which means that we have very little confidence in the effect estimates, and future studies are likely to change these estimates. CONCLUSION: More RCTs are needed to support or refute the use of T. terrestris. The decision to use this intervention should be shared with the patients, and the uncertainties around its effects should be discussed in the clinical decision-making process.Number of Protocol registration in PROSPERO database: CRD42019121130.

OBJETIVO: Nós realizamos uma revisão sistemática para avaliar a efetividade e a segurança do Tribulus terrestris no tratamento da disfunção sexual feminina (DSF). FONTES DE DADOS: Nós realizados uma busca eletrônica irrestrita nas seguintes bases de dados: MEDLINE, CENTRAL, EMBASE, LILACS, CINAHL, PsycINFO, WHO-ICTR, Clinicaltrials.gov, e OpenGrey. SELEçãO DOS ESTUDOS: Nós incluímos todos os ensaios clínico randomizados (ECR) que comparou T. terrestris com controles ativos/inativos. Após o processo de seleção, conduzido por 2 revisores, 5 ECRs (n = 279 participantes) foram incluídos. EXTRAçãO DE DADOS: O processo de extração de dados foi realizado por dois revisores, utilizando-se um formulário de extração de dados pré-estabelecido. SíNTESE DE DADOS: Devido à falta de dados disponíveis e à heterogeneidade clínica entre os estudos incluídos, nós não realizamos meta-análises. O risco de viés foi avaliado pela tabela de risco de viés da Cochrane e, a certeza do corpo da evidência foi avaliada pelo Grading of Recommendations, Assessment, Development and Evaluations (GRADE). RESULTADOS: Após 1 a três 3 meses de tratamento, mulheres na pré e pós-menopausa randomizadas ao T. terrestris tiveram um aumento significante nos escores de função sexual. O grupo com 3 meses de tratamento com T. terrestris exibiu um aumento significante dos níveis séricos de testosterona em mulheres pré-menopausa. Não houve relato de eventos adversos graves, e nenhum estudo avaliou qualidade de vida das participantes. A certeza da evidência foi considerada muito baixa, o que significa que existe pouca certeza na estimativa dos efeitos e que é provável que futuros estudos mudem estas estimativas. CONCLUSãO: Mais ECRs são importantes para apoiar ou refutar o uso do T. terrestris. A decisão de usar essa intervenção deve ser compartilhada com pacientes, e as incertezas sobre seus efeitos devem ser discutidas durante o processo de decisão clínica.

Statins and/or fibrates for diabetic retinopathy: a systematic review and meta-analysis.

Evidence from observational studies have found a relationship between serum cholesterol and diabetic retinopathy (DR). Apart of the assumption that cholesterolemic control has benefits for patients with diabetes with or without retinopathy, the effects of lipid-lowering drugs have not been properly mapped and critically assessed so far. The objective of this study was to evaluate the effects of statins and/or fibrates on prevention and progression of DR. We conducted a Systematic review of randomized controlled trials (RCTs) following the Cochrane Handbook for Systematic Reviews of Interventions and reported in accordance to PRISMA Statement. GRADE approach was used to summarize the certainty of the evidence. Eight RCTs that fulfilled our eligibility criteria were included, assessing the effects of fibrates (n = 4), statins (n = 3) and fibrate plus statins (n = 1) for therapy (n = 8) or prevention (n = 4) of DR. Overall, the main concern regarding risk of bias assessment was due to incomplete outcome data because high rate of losses in five RCTs. Furthermore, the risk of reporting bias was rated unclear due the lack of previously published protocol in seven RCTs. Fibrates seemed to be associated with a 45% risk reduction of macular edema incidence (Relative Risk 0.55, 95% confidence interval of 0.38 to 0.81, 1309 participants, 2 RCTs, I2 = 0%, low certainty of the evidence). The certainty of evidence for other outcomes was also very low or low, and we are uncertain regarding the effects of fibrates for DR. Overall, adverse events seemed to be similar between fibrate and placebo, but again based on the width of the confidence intervals, an important increase of adverse events cannot be rule out. The combination statin/fibrate did not seem to have benefit for visual acuity but is likely that further studies can modify this estimate since the current evidence is limited. Adverse events and quality of life were not measured or reported. Concluding, this study found eight RCTs, with limited methodological quality, that assessed the effects of fibrates and/or statins for DR. Based on these findings, we are uncertain about the effects of statins for DR. Fibrates seemed to reduce the incidence of macular edema (low certainty evidence) without increase adverse events (low to very low certainty evidence). Number of Protocol registration PROSPERO CRD42016029746.

Neurodevelopmental Treatment (Bobath) for Children With Cerebral Palsy: A Systematic Review.

AIM: To assess the effects of neurodevelopmental treatment for children with cerebral palsy. METHODS: We conducted a systematic review following the recommendations of the Cochrane Handbook for Systematic Reviews of Interventions and reported in accordance to PRISMA Statement. Through a comprehensive literature search we considered all randomized clinical trials that compared neurodevelopmental treatment with conventional physical therapy for children with cerebral palsy. We used the Cochrane Risk of Bias Table to assess the risk of bias of the included randomized clinical trial, and the GRADE approach to evaluate the certainty of the body of the evidence. RESULTS: We found 3 randomized clinical trials (2 published and 1 ongoing) comprising 66 children. Published randomized clinical trials presented methodological and reporting limitations and only 1 provided data for outcomes of interest. No difference between neurodevelopmental treatment and conventional physical therapy was found for gross motor function (mean difference 1.40; 95% confidence interval -5.47 to 8.27, low certainty evidence). CONCLUSION: This review found that the effects of neurodevelopmental treatment for children with cerebral palsy are still uncertain. Further studies are required to assess the efficacy and safety of neurodevelopmental treatment for this purpose and until there, current evidence do not support its routinely use in practice. Number of protocol registration in PROSPERO database: CRD42017082817 (available from https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=82817 ).