Background A meta-analysis of randomized controlled trials (RCTs) was conducted to systematically evaluate the effects of berberine on the inflammatory markers of metabolic syndrome (MetS) and related disorders. Method Databases that were searched from inception to October 2020 included PubMed, Web of Science, the Cochrane Library, CNKI, VIP, WanFang Data, and ClinicalTrials.gov. Two reviewers independently selected articles and extracted data. The pooled evaluations were entered and analyzed in Review Manager 5.3. Results Of the 7387 publications screened, 52 studies were included, and the related trials involved 4616 patients. Pooled estimates showed that the use of berberine could significantly reduce the concentration level of C-reactive protein (CRP) [standardized mean difference (SMD) = − 1.54, 95% confidence intervals (CI) − 1.86, − 1.22, p < 0.05], tumor necrosis factor-α (TNF-α) [SMD = − 1.02, 95% CI − 1.27, − 0.77, p < 0.05], and interleukin 6 (IL-6) [SMD = − 1.17, 95% CI − 1.53, − 0.81, p < 0.05] among patients with MetS and related disorders. However, it did not affect the level of interleukin 1β (IL-1β) [SMD = − 0.81, 95% CI − 1.80, 0.17, p = 0.11]. Conclusion Overall, the use of berberine in patients with MetS and related disorders appeared to significantly decrease several inflammatory markers. Further multi-center and rigorous investigations with larger patient populations are encouraged to confirm the effect of berberine on MetS and related disorders.
Background The disutilities of adverse events (AEs) are important inputs for cost-utility analysis (CUA), reflecting the impacts of AEs on health outcomes. Health technology assessment institutions and scholars have proposed recommendations for applying disutility values in economic evaluations. Objectives This study aimed to identify the current use of disutilities of AEs as model parameters in the CUA of cancer drug therapy and to compare the discrepancies between the use of disutilities and published recommendations. Methods A systematic search was conducted on the PubMed, Web of Science, and Cochrane Library databases, as well as the official websites of the National Institute for Health and Care Research (NIHR), the Institute for Clinical and Economic Review (ICER), the Institute for Quality and Efficiency in Health Care (IQWiG), the Canadian Agency for Drugs and Technologies in Health (CADTH), and the Centre for Reviews and Dissemination (CRD) for CUAs of drug therapy for cancer published in English from January 2019 to April 2022. Information about the use of disutilities of AEs (whether and how disutilities were used, or why they were not used) in selected studies was extracted and compared with published recommendations. Descriptive analyses were used to summarize the results. Results A total of 467 CUAs were included, 54% (254/467) of which included disutilities of AEs in their model. The proportion that included these disutilities increased from 2019 to 2021, ranging from 47% (51/107) to 61% (116/190). Only 6% (15/254) of the CUAs using disutilities of AEs considered all five recommendations about the justification for inclusion and exclusion, description of values and sources, grades of AEs, calculation, and uncertainty analyses. Only 15% (72/467) provided a clear justification for inclusion and exclusion of disutilities of AEs, and 7% (17/254) did not provide values or sources. In total, 69% (175/254) of the analyses focused on AEs of grade 3 or greater, and 11% (28/254) applied utility decrements for grades 1 and 2. Disutilities of AEs were generally calculated using the incidence rates, which were clearly stated in 49% (65/132) of the analyses. Uncertainty analyses were conducted in 84% (214/254) of the CUAs. Conclusions The current use of disutilities of AEs in CUAs shows some discrepancies with recommendations proposed in the literature. One is that detailed information about the use of disutilities of AEs was not reported and the other is that essential methods to analyze the impact of AEs on quality-adjusted life-years were not thoroughly conducted. Therefore, it is suggested that researchers should attach importance to the impact of AEs on health-related quality of life. Furthermore, an application process was developed for the disutilities of AEs to remind and guide researchers to correctly use the disutilities of AEs as parameters in the decision-analytic model...
ObjectivesTo determine the effects of biological disease-modifying anti-rheumatic drugs (bDMARDs) on the quality of life (QoL) among patients with psoriatic arthritis (PsA).DesignMeta-analysis.Data sources and eligibility criteriaPubMed, Web of Science, Cochrane Library, China National Knowledge Infrastructure, WanFang and VIP databases were searched to collect randomised controlled trials (RCTs), which were conducted to evaluate the effect of bDMARDs in the treatment of patients with PsA and reported QoL-related outcomes, from inception to November 2020 and updated on 19 February 2022.Data extraction and synthesisOutcomes about Health Assessment Questionnaire Disability Index (HAQ-DI), Dermatology Life Quality Index, physical component summary and mental component summary of the Short Form 36, EuroQol Visual Analogue Scale, Psoriasis Area Severity Index (PASI) 50/75/90/100 were extracted by two reviewers independently. Data were pooled using the fixed or random effects methods and considered as mean difference (MD) or risk ratio with 95% CI.ResultsOut of 3190 articles screened, 37 RCTs (with 47 articles reported) were included. Pooled estimates showed that bDMARDs were superior versus placebo on all outcomes. Against methotrexate (MTX) and tofacitinib, bDMARDs showed no statistically significant advantages or significant disadvantages. Similar results were found for bDMARDs+MTX versus MTX. For HAQ-DI, the results of the subgroups of bDMARDs versus placebo, bDMARDs+MTX versus MTX, bDMARDs versus tofacitinib and bDMARDs versus MTX were −0.21 (MD, 95% CI, −0.23 to –0.18), −0.22 (MD, 95% CI, −0.58 to 0.14), –0.01 (MD, 95% CI, −0.05 to 0.04) and –0.03 (MD, 95% CI, −0.04 to –0.02), respectively.ConclusionsCompared with placebo, bDMARDs taken by patients with PsA appear to significantly improve the QoL. Compared with other therapeutic agents, more studies are required to confirm the effect of single and combined bDMARDs use further.
Background Almost all traditional Chinese medicine (TCM) quality of life measures are non-preference-based measures (non-PBMs), which do not provide utilities for cost-utility analysis in pharmacoeconomic evaluation. Whereas the mapping has become a new instrument to obtain utilities, which builds a bridge between non-PBMs and PBMs. Purpose To develop mapping algorithms from the health status scale of traditional Chinese medicine (TCM-HSS) onto the three-level EuroQol five-dimensional questionnaire (EQ-5D-3L). Methods The cross-sectional data were collected by questionnaire survey from a tertiary hospital visit population and community residents in China, and randomly divided into training and validation set by 2:1. Based on the training set, direct and indirect mapping methods (7 regression methods and 4 model specifications) were conducted to establish alternative models, which were comprehensively evaluated based on the validation set by mean absolute error, root mean square error, and Spearman correlation coefficient between predicted and observed values. Based on the whole sample, the preferred mapping algorithm was developed. Results A total of 639 samples were included, with an average age of 45.24 years and 61.66% of respondents were female. The mean EQ-5D-3L index was 0.9225 [SD = 0.1458], and the mean TCM-HSS index was 3.4144 [SD = 3.1154]. The final mapping algorithm was a two-part regression model including the TCM-HSS subscales, interaction terms, and demographic covariates (age and gender). The prediction performance was good. The mean error was 0.0003, the mean absolute error was 0.0566, the root mean square error was 0.1039, and 83.10% of the prediction errors were within 0.1; the Spearman correlation coefficient between predicted and observed EQ-5D-3L values was 0.6479. Conclusion It is the first study to develop a mapping algorithm between the TCM-HSS and EQ-5D-3L, which demonstrates excellent prediction accuracy and estimates utility value for economic evaluation from TCM quality of life measures.
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