Cost analysis of photobiomodulation in tibia fracture in the Brazilian public health system.

Managing tibial fractures requires substantial health resources, which costs the health system. This study aimed to describe the costs of photobiomodulation (PBM) with LEDs in the healing process of soft tissue lesions associated with tibial fracture compared to a placebo. Economic analysis was performed based on a randomized controlled clinical trial, with a simulation of the cost-effectiveness and incremental cost model. Adults (n = 27) hospitalized with tibia fracture awaiting definitive surgery were randomized into two distinct groups: the PBM Group (n = 13) and the Control Group with simulated phototherapy (n = 14). To simulate the cost-effectiveness and incremental cost model, the outcome was the evolution of wound resolution by the BATES-JENSEN scale and time of wound resolution in days. The total cost of treatment for the Control group was R$21,164.56, and a difference of R$7,527.10 more was observed when compared to the treatment of the PBM group. The proposed intervention did not present incremental cost since the difference in the costs to reduce measures between the groups was smaller for the PBM group. When analyzing the ICER (Incremental cost-effectiveness ratio), it would be possible to save R$3,500.98 with PBM and decrease by 2.15 points in the daily average on the BATES-JENSEN scale. It is concluded, therefore, that PBM can be a supportive therapy of clinical and economic interest in a hospital setting.

Vitamin C-based regimens for sepsis and septic shock: Systematic review and meta-analysis of randomized clinical trials.

PURPOSE: to critically appraise and synthesize the evidence on the effects of vitamin C-based regimens for patients with sepsis or septic shock. METHODS: a broad search was performed on May 2021 to identify randomized clinical trials (RCTs) assessing vitamin C-based regimens as adjuvant therapy for adults with sepsis or septic shock. We used the Cochrane Risk of Bias table to assess the methodological quality of the included RCTs and the GRADE approach to evaluate the evidence certainty. RESULTS: We included 20 RCTs (2124 participants). Evidence from low to very low certainty showed that vitamin C compared to placebo may reduce all-cause mortality up to 28 days (relative risk [RR] 0.60, 95% confidence interval (CI) 0.45 to 0.80, 4 RCTs, 335 participants). Considering the other comparisons (vitamin C alone or combined with thiamine and/or hydrocortisone, compared to placebo, standard care or hydrocortisone), there were a little to no difference or very uncertain evidence for adverse events, SOFA score, ICU length of stay, acute kidney injury, mechanical ventilation- and vasoactive drugs-free days up to 28 days. CONCLUSION: Further RCTs with higher methodological quality, an increased number of participants and assessing clinically relevant outcomes are needed to provide better decision-making guidance. PROSPERO REGISTER: CRD42021251786.

Non-surgical interventions for the treatment of masticatory muscular spasticity in patients with cerebral palsy. Systematic review of randomized clinical trials.

INTRODUCTION: Muscle disorders caused by cerebral palsy (CP) can affect oral function. The treatment for masticatory muscle spasticity is important to minimize muscle hyperactivity and preclude oral damages. OBJECTIVES: To evaluate the efficacy and safety of non-surgical interventions for the treatment of masticatory muscle spasticity in CP patients. METHODS: A comprehensive search was performed in the following databases: MEDLINE, Embase, Cochrane Library, LILACS, BBO, PEDro, Clinicaltrials.gov and WHO/ICTRP, without date and language restrictions. Randomized controlled trials (RCT) evaluating non-surgical interventions were considered. Primary outcomes such as masticatory function and adverse events were planned to be assessed. The risk of bias assessment was performed using the Cochrane risk of bias tool. The certainty of the evidence was assessed using the GRADE approach. RESULTS: Three RCT assessing the effects of botulinum toxin, functional masticatory training and neuromuscular electrostimulation (NMES) were included. Evidence with a very low certainty showed: (i) no difference between botulinum toxin and placebo regarding maximum chewing strength, chewing efficiency and global oral health scale; (ii) improvement in masticatory function in favor of functional masticatory training versus conventional exercises, and (iii) in favor of strengthening exercises plus NMES versus placebo. CONCLUSIONS: There was insufficient evidence to support the use of botulinum toxin and masticatory muscle strengthening programs alone and associated with NMES for the treatment of masticatory muscle in patients with PC. The clinical decision must be individualized, and further studies are needed to support or refute the use of different non-surgical interventions for PC. PROSPERO register number CRD42020209761.

Creatine Supplementation in Type 2 Diabetic Patients: A Systematic Review of Randomized Clinical Trials.

Type 2 Diabetes Mellitus (DM) is the most common form of diabetes. The initial treatment of type 2 DM consists of the adoption of healthy lifestyle habits together with several classes of hypoglycemic agents. However, these medications are not always able to reduce the blood glucose levels in all patients. Therefore, creatine supplementation has emerged as a new putative candidate for type 2 DM treatment. This systematic review aimed to investigate the effects (benefits and harms) of creatine supplementation in patients with type 2 diabetes through a systematic review. The studies were searched in MEDLINE, EMBASE, LILACS, CENTRAL, SPORTDiscus, and CINAHL databases, without date or language restrictions. Methodological quality was assessed using the Cochrane risk-of-bias table. The certainty of the evidence was classified using the Grading of Recommendations Assessment, Development and Evaluation approach. Three randomized controlled trials (RCTs) were included (87 participants). Overall, the methodological quality was classified as unclear to a high risk of bias. Each trial compared creatine supplementation with a different control group (placebo, metformin, and glibenclamide). Creatine supplementation seems to be effective in decreasing glycemic levels and glycosylated hemoglobin concentrations compared to placebo. No difference was observed compared to metformin or glibenclamide with creatine, and all treatments were able to reduce blood glucose levels. No major adverse effects were observed. Based on the low certainty of evidence, creatine supplementation was shown to be a hypoglycemic intervention for patients with type 2 diabetes, without major adverse events reported. However, well- designed RCTs with larger sample sizes and long-term outcomes are needed to support this evidence.

Efficacy and safety of therapeutic use of cannabis derivatives and their synthetic analogs: Overview of systematic reviews.

The debate on the use of cannabinoids for therapeutic purposes is constantly on the rise. This overview aimed to map the evidence on the therapeutic effects of cannabis derivatives and their synthetic analogs. Systematic reviews (SRs) of randomized trials were identified through a comprehensive search in several databases, and their methodological quality were evaluated with AMSTAR-2. The results for main outcomes are presented, prioritizing those from updated and better quality SRs. Finally, 68 SRs, addressing 37 different health conditions, were included. The methodological quality was high for eight SRs. The evidence certainty (GRADE) for the effects of cannabinoids is not high for any of the outcomes identified. Evidence certainty was moderate for the following: (a) cannabidiol appears to be beneficial for quality of life but increases the risk of adverse events in ulcerative colitis; (b) cannabinoids in general appear to have no clinically important benefit for chronic non-oncologic pain, spasticity-related pain in multiple sclerosis, or for acute post-operative pain; (c) cannabinoids in general appear to have a benefit in reducing chemotherapy-related nausea and vomiting. For all other outcomes from remaining comparisons, the evidence certainty was low, very low, or not evaluated, which prevents recommendations for or against their routine use.

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.

INTERVENTIONS FOR THE TREATMENT OF IRRITABLE BOWEL SYNDROME: A REVIEW OF COCHRANE SYSTEMATIC REVIEWS.

BACKGROUND: Irritable bowel syndrome (IBS) is a complex gastrointestinal disorder, whose understanding is relatively uncertain, and the treatment guidance decision still represents a challenge. OBJECTIVE: To identify and critically appraise systematic reviews (SRs) published in the Cochrane Database of SRs (CDSR) on the effects of interventions (pharmacological and non-pharmacological) for the treatment of IBS. METHODS: The search was conducted at the Cochrane Library in May 2020. The methodological quality of the SRs was evaluated by the AMSTAR-2 tool. RESULTS: Eight SRs with moderate to high quality were included, which addressed the treatments: (a) pharmacological: volume agents, antispasmodics, antidepressants and tegaserod; and (b) non-pharmacological: homeopathy, acupuncture, phytotherapy, biofeedback, psychological interventions and hypnotherapy. The results were favorable to antispasmodic drugs and antidepressants regarding the improvement of clinical symptoms. There was no difference between volume agents or tegaserod when compared to placebo. Acupuncture and homeopathy showed a little improvement in symptoms compared to placebo, but the certainty of this evidence was considered low to very low. Psychological interventions seem to improve the overall assessment of the patient and relief symptoms such as abdominal pain. However, there was no long-term follow-up of these patients. The results of the other treatments were considered uncertain due to the high risk of bias. CONCLUSION: Considering the low quality of the studies included in the SRs, pharmacological treatment with antispasmodics and antidepressants seems to be beneficial for patients with IBS. Among non-pharmacological interventions, psychological interventions seem to be beneficial. However, further clinical trials are recommended with greater methodological rigor to prove these findings.

Effects of Caffeine Supplementation on Physical Performance of Soccer Players: Systematic Review and Meta-Analysis.

CONTEXT: Caffeine is 1 of the most popular supplements consumed by athletes, and the evidence for improving soccer performance remains limited. OBJECTIVE: To investigate and update the effects (benefits and harms) of caffeine to improve performance on soccer players. DATA SOURCES: Electronic search in Medline (via PubMed), CENTRAL, Embase, SPORTDiscus, and LILACS, from inception to March 28, 2020. STUDY SELECTION: Randomized clinical trials (RCTs) assessing the effects of caffeine on the performance of soccer players. STUDY DESIGN: Systematic review with meta-analysis. LEVEL OF EVIDENCE: Level 1. DATA EXTRACTION: Data extraction was conducted independently by 2 authors using a piloted form. We assessed methodological quality (Cochrane risk-of-bias [RoB] table) and the certainty of the evidence (GRADE [Grading of Recommendations Assessment, Development and Evaluation] approach). RESULTS: Sixteen RCTs were included. Overall methodological quality was classified as unclear to low risk of bias. When assessing aerobic endurance, meta-analyses did not demonstrate the differences between caffeine and placebo (mean difference [MD], 44.9 m; 95% confidence interval [CI], -77.7 to 167.6). Similarly, no difference was observed during time to fatigue test (MD, 169.8 seconds; 95% CI, -71.8 to 411.6). Considering anaerobic power, meta-analyses also did not find differences for vertical jump (MD, 1.01 cm; 95% CI, -0.68 to 2.69) and repeated sprint tests (MD, -0.02 seconds; 95% CI, -0.09 to 0.04), as well as reaction time agility test (MD, 0.02 seconds; 95% CI, -0.01 to 0.04) and rating of perceived exertion (MD, 0.16 points; 95% CI, -0.55 to 0.87). Regarding safety, a few minor adverse events were reported. Based on the GRADE approach, the certainty of this evidence was classified as very low to low. CONCLUSION: We found no significant improvement in soccer-related performance with caffeine compared with placebo or no intervention. However, caffeine appears to be safe.

Intervenções para o tratamento da síndrome do intestino irritável: revisão de revisões sistemáticas Cochrane / Interventions for the treatment of irritable bowel syndrome: a review of cochrane systematic reviews

ABSTRACT BACKGROUND: Irritable bowel syndrome (IBS) is a complex gastrointestinal disorder, whose understanding is relatively uncertain, and the treatment guidance decision still represents a challenge. OBJECTIVE: To identify and critically appraise systematic reviews (SRs) published in the Cochrane Database of SRs (CDSR) on the effects of interventions (pharmacological and non-pharmacological) for the treatment of IBS. METHODS: The search was conducted at the Cochrane Library in May 2020. The methodological quality of the SRs was evaluated by the AMSTAR-2 tool. RESULTS: Eight SRs with moderate to high quality were included, which addressed the treatments: (a) pharmacological: volume agents, antispasmodics, antidepressants and tegaserod; and (b) non-pharmacological: homeopathy, acupuncture, phytotherapy, biofeedback, psychological interventions and hypnotherapy. The results were favorable to antispasmodic drugs and antidepressants regarding the improvement of clinical symptoms. There was no difference between volume agents or tegaserod when compared to placebo. Acupuncture and homeopathy showed a little improvement in symptoms compared to placebo, but the certainty of this evidence was considered low to very low. Psychological interventions seem to improve the overall assessment of the patient and relief symptoms such as abdominal pain. However, there was no long-term follow-up of these patients. The results of the other treatments were considered uncertain due to the high risk of bias. CONCLUSION: Considering the low quality of the studies included in the SRs, pharmacological treatment with antispasmodics and antidepressants seems to be beneficial for patients with IBS. Among non-pharmacological interventions, psychological interventions seem to be beneficial. However, further clinical trials are recommended with greater methodological rigor to prove these findings.

RESUMO CONTEXTO: A síndrome do intestino irritável (SII) é um distúrbio gastrointestinal complexo, cujo entendimento é relativamente incerto e a decisão de orientação do tratamento ainda representa um desafio. OBJETIVO: Identificar e avaliar criticamente as revisões sistemáticas (RSs) publicadas na base de dados de RSs Cochrane (CDSR) sobre os efeitos das intervenções (farmacológicas e não farmacológicas) para o tratamento da SII. MÉTODOS: A busca foi realizada na Biblioteca Cochrane em maio de 2020. A qualidade metodológica das RSs foi avaliada pela ferramenta AMSTAR-2. RESULTADOS: Foram incluídas oito RSs com qualidade moderada a alta, as quais abordaram os tratamentos: (a) farmacológico - agentes de volume, antiespasmódicos, antidepressivos e o tegaserod; e (b) não farmacológico - homeopatia, acupuntura, fitoterapia, biofeedback, intervenções psicológicas e hipnoterapia. Os resultados foram favoráveis aos medicamentos antiespasmódicos e antidepressivos em relação à melhora dos sintomas clínicos. Não houve diferença entre os agentes de volume ou tegaserod quando comparados ao placebo. Acupuntura e homeopatia apresentaram pequena melhora dos sintomas em comparação ao placebo, porém a qualidade da evidência foi considerada baixa a muito baixa. As intervenções psicológicas parecem melhorar a avaliação global do paciente e alívio de sintomas como dor abdominal. Contudo, não houve acompanhamento desses pacientes a longo prazo. Os resultados dos demais tratamentos foram considerados incertos devido ao alto risco de viés. CONCLUSÃO: Considerando a baixa qualidade dos estudos incluídos nas RSs, o tratamento farmacológico com antiespasmódicos e antidepressivos parece ser benéfico para os pacientes com SII. Entre os não-farmacológicos, as intervenções psicológicas parecem obter benefícios. Entretanto, novos ensaios clínicos são recomendados com maior rigor metodológico para comprovar estes achados.

Effectiveness and Safety of Ozone Therapy in Dental Caries Treatment: Systematic Review and Meta-analysis.

OBJECTIVE: This systematic review and meta-analysis aimed to investigate the effectiveness and safety of ozone therapy for treating dental caries. METHODS: We searched for randomized controlled trials (RCTs) in 8 databases, from inception to April 4, 2020 (MEDLINE, EMBASE, CENTRAL, LILACS, Bibliografia Brasileira de Odontologia, ClinicalTrials.gov, WHO, and OpenGrey). Primary outcome measures were antimicrobial effect and adverse events. We used the Cochrane risk of bias tool to evaluate methodological quality of included RCTs and GRADE approach to evaluate the certainty of the evidence. We used the Review Manager software to conduct meta-analyses. RESULTS: We included 12 RCTs comparing ozone therapy with no ozone, chlorhexidine digluconate, fissure sealants (alone and added to ozone), and fluoride. Considering primary outcomes, ozone therapy showed (a) lower reduction in the bacterial number than chlorhexidine digluconate in children (mean difference [MD]: -5.65 [-9.79 to -1.51]), but no difference was observed in adults (MD: -0.10 [-1.07 to 0.88]); (b) higher reduction in the bacterial number than sealant (MD: 12.60 [3.86-21.34]), but no difference was observed after final excavation (MD: -0.00 [-0.01 to 0.01]). Regarding safety of ozone therapy, results from individual studies presented no adverse events during or after treatment. Most of these results are imprecise and should be interpreted with caution because of clinical and methodological concerns, small sample size, and wide confidence interval, precluding to determine the real effect direction. CONCLUSION: Based on a very low certainty of evidence, there is not enough support from published RCTs to recommend the use of ozone for the treatment of dental caries. Well-conducted studies should be encouraged, measuring mainly the antimicrobial effects of ozone therapy at long term and following the recommendations of the CONSORT statement for the reporting of RCTs.

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.

Tribulus terrestris for female sexual dysfunction: a systematic review / Tribulus terrestris para disfunção sexual feminina: uma revisão sistemática

Abstract 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, whichmeans that we have very little confidence in the effect estimates, and future studies are likely to change these estimates. Conclusion MoreRCTs are needed to supportor 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

Resumo 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 emmulheres 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.

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.

Effects of photobiomodulation in the treatment of fractures: a systematic review and meta-analysis of randomized clinical trials.

Several therapeutic strategies have been proposed to optimize the conventional treatment of fractures. Photobiomodulation (PBM) appears to help reduce pain and control inflammation, and it also accelerates bone repair. This systematic review aimed to evaluate the effectiveness and safety of PBM with low-level laser therapy (LLLT) in the bone fracture healing process. We included randomized controlled trials (RCTs) comparing the effects of PBM with those of any other intervention in adults with lower or upper limb bone fractures. The primary outcomes investigated were pain reduction, radiographic healing, and adverse events. The searches were conducted in October 2018. Two RCTs were included that compared PBM to the placebo. A meta-analysis showed significant difference in favor of PBM for pain reduction (MD 1.19, 95% CI [0.61 to 1.77], 106 participants, two RCTs), but this difference was not clinically significant. One RCT (50 participants) showed a clinical and statistical improvement in physical function (MD - 14.60, 95% CI [- 21.39 to - 7.81]) and no difference in radiographic healing, regarding absence of fracture line (RR 1.00, 95% CI [0.93 to 1.08]) and visible bone callus (RR 0.33, 95% CI [0.01 to 7.81]). The certainty of evidence was classified as low to very low. Based on the evidence of low to very low certainty, PBM seems to be associated with the improvement of pain and function. Therefore, new RCTs are required that meet the recommendations of CONSORT to prove the effectiveness and safety of this intervention and support its recommendation in clinical practice.

Evaluation of the use of photobiomodulation following the placement of elastomeric separators: Protocol for a randomized controlled clinical trial.

BACKGROUND: Pain stemming from the placement of elastomeric separators and the exchanging of wires and accessories is the greatest reason for abandoning orthodontic treatment. Indeed, discomfort related to treatment exerts a negative impact on quality of life due to the difficulty chewing and biting. This paper proposes a study to evaluate the analgesic effects of photomiobodulation (PBM) on individuals undergoing orthodontic treatment. METHODS: The sample will be composed of 72 individuals who receiving elastomeric separators on the mesial and distal faces of the maxillary first molars. The patients will be randomly allocated to 2 groups: an experimental group irradiated with low-level laser and a sham group submitted to simulated laser irradiation. Upon the placement of the separators, the experimental group will receive a single application of PBM on the mesial and distal cervical portion and apical third of the molars. Perceived pain will be analyzed after one hour using the visual analog scale in both groups. Samples will be taken of the gingival crevice with absorbent paper for 30 seconds for the analysis of cytokines using ELISA and the results of the 2 groups will be compared. The patients will sign a statement of informed consent. Statistical analysis will be performed with the Student's t test and analysis of variance (ANOVA). DISCUSSION: The expectation is that the patients in the irradiated group will have a lower perception of pain and lower quantity of cytokines compared to those in the sham group. The purpose of the study is to establish an effective method for PBM with the use of low-level infrared laser (Ga-Al-As with a wavelength of 808 nm and output power of 100 mW) for reductions in pain and inflammatory cytokines related to orthodontic treatment. TRIAL REGISTRATION: This protocol was registered in ClinicalTrial.gov, under number NCT03939988. It was first posted and last updated in May 6, 2019.

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 ).

What do Cochrane systematic reviews say about interventions for insomnia?

ABSTRACT CONTEXT AND OBJECTIVE: Insomnia is a frequent complaint that generates more than five million visits to doctors per year in the United States. This study summarizes all Cochrane systematic reviews (SRs) that evaluated interventions to treat insomnia. DESIGN AND SETTING: Review of SRs, conducted in the Discipline of Evidence-Based Medicine, Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (UNIFESP). METHODS: A sensitive search was carried out in the Cochrane Database of Systematic Reviews to identify Cochrane SRs that assessed the effects of any type of intervention for people with insomnia. The results, main characteristics of the SRs and the certainty of the evidence obtained from them were synthesized and discussed. RESULTS: Seven SRs were included. They addressed the benefits and harm of acupuncture (n = 1), behavioral interventions (n = 1), music (n = 1), pharmacotherapy (n = 2), phototherapy (n = 1) and physical exercise (n = 1). The certainty of the evidence ranged from moderate to very low. CONCLUSION: Acupuncture, music, physical exercise, paroxetine, doxepin, trimipramine and trazodone seem to present some benefit for patients with insomnia. However, the uncertainty around these results means that no robust and definitive recommendations for clinical practice can be made until the benefits and harms from each intervention for patients with insomnia have been confirmed through further studies.

What do Cochrane systematic reviews say about the use of cannabinoids in clinical practice?

ABSTRACT BACKGROUND: The therapeutic effects of cannabinoid compounds have been the center of many investigations. This study provides a synthesis on all Cochrane systematic reviews (SRs) that assessed the use of cannabinoids as a therapeutic approach. DESIGN AND SETTING: Review of SRs, conducted in the Discipline of Evidence-Based Medicine, Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (UNIFESP). METHODS: A broad search was conducted in the Cochrane Database of Systematic Reviews to retrieve any Cochrane SRs that assessed the efficacy and safety of cannabinoids as a therapeutic approach. The results and key characteristics of all reviews included were summarized and discussed. RESULTS: Eight SRs were included. They assessed the use of cannabinoids for the following types of conditions: neurological (two SRs), psychiatric (two SRs), rheumatological (one SR), infectious (one SR) and oncological (two SRs). There was moderate-quality evidence showing that the use of cannabinoids reduced nausea and vomiting among adults, compared with placebo. Additionally, there was moderate-quality evidence showing that there was no difference between cannabinoids and prochlorperazine regarding the number of participants who reported vomiting, in this same population. CONCLUSIONS: This review identified eight Cochrane systematic reviews that provided evidence of unknown to moderate quality regarding the use of cannabinoids as a therapeutic intervention. Further studies are still imperative for solid conclusions to be reached regarding practical recommendations.

What do Cochrane systematic reviews say about new practices on integrative medicine?

BACKGROUND: This study identified and summarized all Cochrane systematic reviews (SRs) on the effects of ten integrative practices that were recently added to the Brazilian public healthcare system (SUS). DESIGN AND SETTING: Review of systematic reviews, conducted in the Discipline of Evidence-Based Medicine, Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (Unifesp). METHODS: Review of Cochrane SRs on the following interventions were identified, summarized and critically assessed: apitherapy, aromatherapy, bioenergetics, family constellation, flower therapy, chromotherapy, geotherapy, hypnotherapy, hand imposition or ozone therapy. RESULTS: We included a total of 16 SRs: 4 on apitherapy, 4 on aromatherapy, 6 on hypnotherapy and 2 on ozone therapy. No Cochrane SR was found regarding bioenergetics, family constellation, chromotherapy, clay therapy, flower therapy or hand imposition. The only high-quality evidence was in relation to the potential benefit of apitherapy, specifically regarding some benefits from honey dressings for partial healing of burn wounds, for reduction of coughing among children with acute coughs and for preventing allergic reactions to insect stings. CONCLUSION: Except for some specific uses of apitherapy (honey for burn wounds and for acute coughs and bee venom for allergic reactions to insect stings), the use of ten integrative practices that have recently been incorporated into SUS does not seem to be supported by evidence from Cochrane SRs.

What do Cochrane systematic reviews say about new practices on integrative medicine?

ABSTRACT BACKGROUND: This study identified and summarized all Cochrane systematic reviews (SRs) on the effects of ten integrative practices that were recently added to the Brazilian public healthcare system (SUS). DESIGN AND SETTING: Review of systematic reviews, conducted in the Discipline of Evidence-Based Medicine, Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (Unifesp). METHODS: Review of Cochrane SRs on the following interventions were identified, summarized and critically assessed: apitherapy, aromatherapy, bioenergetics, family constellation, flower therapy, chromotherapy, geotherapy, hypnotherapy, hand imposition or ozone therapy. RESULTS: We included a total of 16 SRs: 4 on apitherapy, 4 on aromatherapy, 6 on hypnotherapy and 2 on ozone therapy. No Cochrane SR was found regarding bioenergetics, family constellation, chromotherapy, clay therapy, flower therapy or hand imposition. The only high-quality evidence was in relation to the potential benefit of apitherapy, specifically regarding some benefits from honey dressings for partial healing of burn wounds, for reduction of coughing among children with acute coughs and for preventing allergic reactions to insect stings. CONCLUSION: Except for some specific uses of apitherapy (honey for burn wounds and for acute coughs and bee venom for allergic reactions to insect stings), the use of ten integrative practices that have recently been incorporated into SUS does not seem to be supported by evidence from Cochrane SRs.