Efficacy and Safety of Bilastine in the Treatment of Allergic Rhinitis: A Systematic Review and Meta-analysis

Bilastine is a non-sedating second generation H1 oral antihistamine (OAH) for treating allergic rhinitis (AR) patients. The effect of bilastine has not previously been evaluated in a meta-analysis. The aim of this review was to determine the efficacy and safety of bilastine in treating AR. An electronic literature search was performed using Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Science Direct and Google Scholar up to March 2021. Randomized controlled trials comparing bilastine with placebo and standard pharmacotherapy were included. The included studies must have diagnosis of AR established by clinicians and the outcomes must have a minimum of 2 weeks of follow-up period. The primary outcomes assessed were total symptom score (TSS), nasal symptom score (NSS) and non-nasal symptom score (NNSS). The secondary outcomes were discomfort due to rhinitis, quality of life (QOL) and adverse events. The risk of bias and quality of evidence for all studies were appraised. The meta-analysis was done using Review Manager 5.3 software based on the random-effects model. The search identified 135 records after removal of duplicates. Following screening and review of the records, fifteen full-text articles were assessed for eligibility. Five trials involving 3,329 patients met the inclusion criteria. Bilastine was superior to placebo in improving TSS, NSS, NNSS, rhinitis discomfort score and QOL but has comparable efficacy with other OAHs in TSS, NSS, NNS, rhinitis discomfort score and QOL. There was no difference in adverse effects when bilastine was compared against placebo and other OAHs except for somnolence. Bilastine has fewer incidence of somnolence compared to cetirizine. The overall quality of evidence ranged from moderate to high quality. Bilastine is effective and safe in treating the overall symptoms of AR with comparable efficacy and safety with other OAHs except somnolence. Whilst bilastine has similar efficacy to cetirizine, somnolence is notably less in bilastine.

The Use of Evidence-Based Acupuncture: Current Evidence

Evidence-based medicine (EBM), which emphasizes that medical decisions must be based on the most recent best evidence, is gaining popularity. Individual clinical expertise is combined with the best available external clinical evidence derived from systematic research in the practice of EBM. The key and core of EBM is the hierarchical system for categorizing evidence. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) system divides evidence quality into four categories: high, moderate, low, and very low. GRADE is based on the lowest quality of evidence for any of the outcomes that are critical to making a decision, reducing the risk of mislabeling the overall evidence quality, when evidence for a critical outcome is lacking. This principle is also used in acupuncture as a complementary and integrative treatment modality, but incorporating scientific evidence is more difficult due to a number of factors. The goal of this chapter is to discuss how to establish a clinical evidence system for acupuncture, with a focus on the current quality of evidence for a variety of conditions or diseases.

Safety of dihydroartemisinin-piperaquine versus artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria among children in Africa: a systematic review and meta-analysis of randomized control trials

Background The efficacies of artemisinin based combinations have been excellent in Africa, but also comprehensive evidence regarding their safety would be important. The aim of this review was to synthesize available evidence on the safety of dihydroartemisinin-piperaquine (DHA-PQ) compared to artemether-lumefantrine (AL) for the treatment of uncomplicated Plasmodium falciparum malaria among children in Africa. Methods A systematic literature search was done to identify relevant articles from online databases PubMed/ MEDLINE, Embase, and Cochrane Center for Clinical Trial database (CENTRAL) for retrieving randomized control trials comparing safety of DHA-PQ and AL for treatment of uncomplicated P. falciparum malaria among children in Africa. The search was performed from August 2020 to 30 April 2021. Using Rev-Man software (V5.4.1), the extracted data from eligible studies were pooled as risk ratio (RR) with 95% confidence interval (CI). Results In this review, 18 studies were included, which involved 10,498 participants were included. Compared to AL, DHA-PQ was associated with a slightly higher frequency of early vomiting (RR 2.26, 95% CI 1.46 to 3.50; participants = 7796; studies = 10; I2 = 0%, high quality of evidence), cough (RR 1.06, 95% CI 1.01 to 1.11; participants = 8013; studies = 13; I2 = 0%, high quality of evidence), and diarrhoea (RR 1.16, 95% CI 1.03 to 1.31; participants = 6841; studies = 11; I2 = 8%, high quality of evidence) were more frequent in DHA-PQ treatment arm. Conclusion From this review, it can be concluded that early vomiting, diarrhoea, and cough were common were significantly more frequent in patients who were treated with the DHA-PQ than that of AL, and both drugs are well tolerated. More studies comparing AL with DHA-PQ are needed to determine the comparative safety of these drugs.

Effectiveness and Efficacy of Therapeutic Interventions Performed by Nurses for Anxiety Disorders: A Systematic Review

BACKGROUND: Anxiety disorders are characterized by excessive anxiety, fear, and behavioral disorders that can lead the individual to have losses in daily, social, and work activities, generating a negative impact on their quality of life. AIM: To evaluate the quality of evidence of the therapeutic interventions performed by nurses for anxiety disorders. METHOD: An analysis of the quality of evidence was performed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. The systematic review protocol was registered in the Prospective Register of Systematic Reviews (Prospero), CRD420202939. RESULTS: The interventions performed by nurses were effective ( d = 0.44), with significant improvement in reducing anxiety levels, reducing drug use, and improving self-control. CONCLUSIONS: The study indicates that therapeutic interventions performed by nurses are beneficial for individuals who suffer from anxiety disorders, with significant improvement in reducing anxiety levels, reducing medication use, improving self-control, and remission of anxiety symptoms.

GRADEing the quality of evidence on safety: an adapted GRADE approach for preparing lists of potentially inappropriate medication for older adults

BackgroundSystematic reviews that synthesize safety outcomes pose challenges (e.g. rare events), which poses questions for grading the strength of the body of evidence. In this contribution, we suggest adaption of the GRADE system for grading the quality of evidence on safety outcomes for developing a potentially inappropriate medication list (PRISCUS).MethodsWe systematically assessed each of the five GRADE domains for rating-down (study limitations, imprecision, inconsistency, indirectness, publication bias) and the criteria for rating-up, considering if special considerations or revisions of the original approach were indicated. The result was gathered in a written document and discussed in a group-meeting. Subsequently, we performed a proof-of-concept application using a convenience sample of systematic reviews. Results We adapted aspects of the criteria study limitations, imprecision, publication bias and rating-up for large effect. In addition, we suggest a new criterion to account for data from subgroup-analyses. The proof-of-concept application did not reveal a need for further revision and thus we used the approach for the systematic reviews that were prepared for the PRISCUS-list. We assessed 51 outcomes for 19 clinical questions. Each of the proposed adaptions was applied. There were neither an excessive number of low and very low ratings, nor an excessive number of high ratings, but the different methodological quality of the safety outcomes appeared to be well reflected.ConclusionThe adaptions appear to have the potential to overcome some of the challenges when grading the methodological quality of harms and thus may be helpful for producers of evidence syntheses considering safety.

Spinal manipulative therapy and acupuncture for chronic low back pain: a systematic review and meta-analysis of RCTs

Background Spinal manipulation therapy (SMT) and acupuncture are commonly used for low back pain (LBP) among complementary and alternative therapies. However, it remains unclear which of the two therapies is more effective for LBP. Therefore, the purpose of this meta-analysis was to evaluate the effectiveness of SMT and acupuncture on LBP. Methods Four electronic databases were searched for randomized controlled trials (all years until July 2021), including PubMed, Embase, Web of Science, and Cochrane Library. Two reviewers independently abstracted data, assessed risk of bias, and rated the quality of evidence. The primary outcome was pain; secondary outcomes included functional status and adverse events. Review Manager 5.3 software and Stata 12.0 were used for all statistical analyses. Results 9 RCTs with a total of 714 participants were identified, who were on average middle aged (39-60 years) without signs of radiating pain. These trials included patients with mild to moderate pain. Overall, moderate quality of evidence suggested that SMT had better effects for pain relief (MD: 0.32, 95%CI: 0.09 to 0.55, I2=34%) and similar effects in function (MD: 0.24, 95%CI: -0.45 to 0.94, I2=21%) when compared to acupuncture. Moderate quality of evidence showed SMT reduced pain better than acupuncture at month 2 (MD: 0.61, 95%CI: 0.08 to 1.14, I2=0%) and at month 12 (MD: 1.02, 95%CI: 0.28 to 1.75, I2=42%). In addition, Low quality of evidence showed SMT may provide better improvement in pain at month 3 (MD: 0.74, 95%CI: 0.09 to 1.39, I2=42%) and in function at month 4 (MD: 3.50, 95%CI: 0.71 to 6.29). Adverse events associated with SMT and acupuncture were rare and mild. Conclusions SMT showed better effects than acupuncture for chronic low back pain, while SMT and acupuncture had similar effects in functional improvement. Although SMT and acupuncture were tolerable and safe, patients should be informed about the potential risks of adverse events before starting therapy.

Opportunities to improve reporting of rapid response in health technology assessment

Introduction Mini health technology assessment (HTA) reports have been used to support policy makers and health systems by providing a timely summary of scientific evidence. The objective of this meta-epidemiologic study was to evaluate the quality of reporting of mini-HTA reports published in Brazil. Methods An electronic search for all mini-HTA reports published between 2014 and March 2019 was conducted in the SISREBRATS and CONITEC databases. The study selection and data extraction were performed by two independent assessors. The following data were extracted: bibliographic data; research question; characteristics of the population, health technologies and outcomes assessed; eligibility criteria; information about searches and study selection; risk of bias assessment; quality of evidence assessment; synthesis of results; and recommendation about the technology evaluated. A descriptive analysis was used to summarize the information retrieved from all the included mini-HTA reports. Results We included 103 mini-HTA reports, the great majority of which (92.3 percent) focused on the coverage of the technologies in the healthcare system, with more than 60 percent being about drugs. Only five mini-HTA reports (4.8 percent) gave reasons for the choice of outcomes, and fifteen (14.5 percent) discriminated between primary and secondary outcomes. All mini-HTAs reported the databases searched and 99 percent of them reported using Medline. Sixty percent of the mini-HTA reported assessing the risk of bias, and 52 percent reported assessing the quality of evidence. Conclusion The quality of reporting of the mini-HTA reports performed in Brazil is insufficient and needs to be improved to guarantee transparency and replicability.