Nicotinic acid and related compounds: A meta-analysis of their use for hyperphosphatemia in dialysis patients.
ABSTRACT: Studies indicate that nicotinic acid and related compounds may decrease phosphorus concentrations effectively by reducing the absorption in the gastrointestinal tract. However, the efficacy and safety of oral niacin treatments have only been investigated in a limited number of small-scale studies.We performed this meta-analysis by pooling 12 qualified relevant preclinical and clinical trials to evaluate the association of nicotinic acid (and its related compounds) treatment and hyperphosphatemia among dialysis patients. Baseline and after treatment data were collected from the studies to evaluate drug efficacy, effect on lipid profile, and drug safety. To evaluate drug efficacy, subgroups were created based on different exposure time (i.e., 4 wks, 8 wks, 12 wks, and 24 wks) and each subgroup was compared against baseline data. In the assessment of lipid profile and drug safety, results of 8-week treatment were compared against baseline data.Our study showed that in the efficacy assessment of drug treatment, serum phosphorus concentration was only significantly reduced in the 4-week (SMD, 0.68; 95% CI, 0.40 to 0.97; P?=?.000; n?=?8), and 8-week (SMD, 1.05; 95% CI, 0.68 to 1.42; P?=?.000; n?=?10) treatment groups. The calcium × phosphorus product showed significantly reduced concentration in all the drug exposure time settings, and no rebound was detected (4-wk treatment: SMD, 0.61; 95% CI, 0.18 to 1.04; P?=?.005; n?=?5; 8-wk treatment: SMD, 0.76; 95% CI, 0.32 to 1.18, P?=?.001; n?=?8; and 12-wks treatment: SMD, 0.28, 95% CI, -0.06 to 0.61; P?=?.103; n?=?3). Lipid profile monitoring showed that high-density lipoprotein (HDL) and triglycerides (TG) significantly changed after 8 weeks of treatment (HDL: SMD, -0.63; 95% CI, -1.03 to 0.24; P?=?.002; n?=?5) and TG: SMD, 0.25; 95% CI, 0.02 to 0.49; P?=?.033; n?=?5). Assessment of drug safety detected significant association for incidence of diarrhea (8% incidence rate; 95% CI, 4% to 12%; P?=?.001) and total adverse event (41% incidence rate, 95% CI: 12% to 69%, P?=?.001).Our study concludes that nicotinic acid and related compounds can significantly reduce serum phosphorus concentration with additive antilipemic effects. We also recommend that the safety of this drug be further studied, as our results suggest significant incidence of adverse events.
Project description:Paricalcitol, a new vitamin D receptor activator (VDRA), is reported to be more effective than other VDRAs in reducing calcium and phosphorus levels in patients undergoing hemodialysis. However, the efficacy and safety of paricalcitol remain controversial. This analysis compares paricalcitol with other VDRAs in patients undergoing hemodialysis. We searched the Cochrane Library, PubMed, EMBASE, Web of Science, and CNKI up to April 22, 2019. Standardized mean difference (SMD), risk ratio (RR) and 95% confidence interval (CI) values were estimated to compare the outcomes of the groups. Two reviewers extracted data and assessed trial quality independently. All statistical analyses were performed using the standard statistical procedures of RevMan 5.2 and Stata 12.0. Fifteen studies (N = 110,544) were included in this meta-analysis. Of these studies, 11 were randomized controlled trials (RCTs) and 4 were non-randomized studies of interventions (NRSIs). Patients receiving paricalcitol experienced better overall survival (OS) than patients receiving other VDRAs, with a pooled hazard ratio of 0.86 (95% CI 0.80-0.91; P < 0.00001). Intact parathyroid hormone (iPTH) levels were significantly reduced in the paricalcitol group compared to the group receiving other VDRAs, with a pooled SMD of -0.53 (95% CI -0.89- -0.16; P = 0.004). There was a significant increase in serum calcium levels from baseline in the paricalcitol group compared to the other VDRAs group when limiting the analysis to RCTs, with a pooled SMD of 2.14 (95% CI 0.90-3.38; P = 0.0007). Changes in serum calcium levels were significantly lower in the paricalcitol group when the analysis was limited to NRSIs, with a pooled SMD of -0.85 (95% CI -1.34--0.35; P = 0.0008). The NSRI analysis also showed a significant reduction in serum phosphorus levels in the paricalcitol group, with a pooled SMD of -0.57 (95% CI -1.00--0.13; P = 0.01). No significant differences were observed in the incidence of hypercalcemia, hyperphosphatemia, or adverse events. Generally, paricalcitol seems superior to other VDRAs in reducing mortality and iPTH levels in patients undergoing hemodialysis. However, the comparative effectiveness of paricalcitol in reducing serum calcium and phosphorus levels needs further exploration. No significant difference was found in the rate of adverse events.
Project description:BACKGROUND:This study aim at evaluating the efficacy and safety of dapagliflozin plus saxagliptin vs monotherapy as added to metformin in patients with type 2 diabetes mellitus (T2DM). METHOD:PubMed, Cochrane library, Embase, CNKI and Wanfang databases were searched up to 31 December 2019. Randomized controlled trials (RCTs) applicable in dapagliflozin plus saxagliptin vs monotherapy as added to metformin in the treatment of T2DM were included. The outcomes included changes in HbA1c, FPG, body weight, SBP, DBP and adverse reactions. Fixed or random effects model were used to assess these outcomes. RESULTS:In this study, 8 RCTs involved 7346 patients were included. Compared with dapagliflozin plus metformin(DM) group, patients treated with dapagliflozin plus saxagliptin add on to metformin(DSM) could significantly increase the adjusted mean change levels of HbA1c, FPG, SBP and DBP(P?<?.00001, SMD?=?-4.88, 95%CI?=?-6.93?-2.83; P?<?.00001, SMD?=?-6.50, 95%CI?=?-8.55?-4.45; P?<?.00001, SMD?=?-0.97, 95%CI?=?-1.15?-0.78; P?<?.00001, SMD?=?-2.00, 95%CI?=?-2.20?-1.80), but no major difference in body weight loss showed(P?=?.12, SMD?=?0.92, 95%CI?=?-0.22?2.06). Furthermore, DSM therapy displayed better effects than saxagliptin plus metformin(SM) in the adjusted mean change levels of HbA1c, FPG, body weight and SBP(P?<?.00001, SMD?=?-7.75, 95%CI?=?-8.84?-6.66; P?<?.00001, SMD?=?-7.75, 95%CI?=?-8.84?-6.66; P?=?.04, SMD?=?-3.40, 95%CI?=?-6.64?-0.17; P?=?.04, SMD?=?-7.75, 95%CI?=?-8.84?-6.66), whereas no obvious difference in lowering DBP(P?=?.18, SMD?=?-16.35, 95%CI?=?-40.12?7.41). Additionally, compared with DM and SM groups, there were no remarkable difference in the incidence of nausea, influenza, headache, diarrhea, urinary tract infection and renal failure for patients taking DSM, but the incidence of genital infection and hypoglycemia were higher in DSM group. CONCLUSIONS:Patients taking the DSM therapy had better effects in reducing the level of HbA1c, FPG, body weight, SBP and DBP than the DM and SM therapy. However, patients treated with DSM therapy are more likely to have hypoglycemia and genital infection. Dapagliflozin plus saxagliptin may be a suitable therapy strategy for patients with T2DM inadequately controlled with metformin, and this will provide a clinical reference for the treatment of T2DM.
Project description:The efficacy and safety of polymer-free stent (PFS) versus permanent polymer drug-eluting stent (PPDES) in patients undergoing percutaneous coronary intervention (PCI) remain controversial. Our meta-analysis was undertaken to evaluate and compare the efficacy and safety of PFS with those of PPDES in patients undergoing PCI.We searched PubMed, Cochrane Library, EMBASE, and Clinical Trials.gov databases for randomized controlled trials (RCTs). The primary endpoints were incidence of stent thrombosis (ST) and target-lesion revascularization (TLR). The secondary endpoints included the incidence of major adverse cardiovascular events (MACE), myocardial infarction (MI), cardiac death (CD), late lumen loss (LLL), and diameter stenosis (DS). Subgroup analyses were also conducted based on the follow-up time.Eleven RCTs met the including criteria, and 8616 patients were included in the study. No significant differences were observed between PFS and PPDES treatments in the incidence of ST (RR 0.90; 95% CI: 0.62-1.31; P = 0.58; I 2 = 0), TLR (RR 0.87; 95% CI: 0.76-1.00; P = 0.05; I 2 = 37%), CD (RR 0.89; 95% CI: 0.72-1.10; P = 0.28; I 2 = 0), MI (RR 0.87; 95% CI: 0.71-1.05; P = 0.15; I 2 = 0), LLL (SMD 0.01; 95% CI: -0.29-0.30; P = 0.96; I2 = 90%), and DS (SMD -0.01; 95% CI: - 0.25 to 0.23; P = 0.93; I2 = 83%). Meanwhile, the patients with PFS had a lower incidence of MACE (RR 0.87; 95% CI: 0.78-0.97; P = 0.01; I 2 = 0) than those with PPDES.In the overall analysis, patients with PFS presented a lower risk of MACE versus PPDES, but no significant difference were obtained in the risk of ST, TLR, MI, CD, DDD and DS. In the Short term follow up, patients with PSF presented a lower risk of TLR compared with PPDES.
Project description:<h4>Objectives</h4>The purpose of this study is to assess the efficacy and safety of nocturnal hemodialysis on end-stage renal disease (ESRD) patients.<h4>Methods</h4>We searched Medline, EmBase, and the Cochrance Central Register of Controlled Trials for studies up to January 2016. Analysis was done to compare variant outcomes of different hemodialysis schedules, including mortality, cardiovascular-associated variables, uremia-associated variables, quality of life (QOL), side-effects, and drug usage.<h4>Results</h4>We collected and analyzed the results of 28 studies involving 22,508 patients in our meta-analysis. The mortality results in this meta-analysis indicated that the nocturnal hemodialysis (NHD) group was not significantly different from conventional hemodialysis (CHD) group (Mortality: OR: 0.75; 95% confidence intervals (CIs): 0.52 to 1.10; p = 0.145), but the CHD group had significantly fewer number of hospitalizations than the NHD group (OR: 1.54; 95%CI: 1.32 to 1.79; p<0.001). NHD was superior to CHD for cardiovascular-associated (left ventricular hypertrophy [LVH]: SMD: -0.39; 95%CI: -0.68 to -0.10; p = 0.009, left ventricular hypertrophy index [LVHI]: SMD: -0.64; 95%CI: -0.83 to -0.46; p<0.001) and uremia-associated intervention results (Serum albumin: SMD: 0.89; 95%CI: 0.41 to 1.36; p<0.001). For the assessment of quality of life, NHD treatment significantly improved the patients' QOL only for SF36-Physical Components Summary (SMD: 0.43; 95%CI: 0.26 to 0.60; p<0.001). NHD intervention was relatively better than CHD for anti-hypertensive drug usage (SMD: -0.48; 95%CI: -0.91 to -0.05; p = 0.005), and there was no difference between groups in our side-effects assessment.<h4>Conclusion</h4>NHD and CHD performed similarly in terms of ESRD patients' mortality and side-effects. NHD was superior to CHD for cardiovascular-associated and uremia-associated results, QOL, and drug usage; for number of hospitalizations, CHD was relatively better than NHD.
Project description:OBJECTIVES:To systematically assess the evidence of Craniosacral Therapy (CST) for the treatment of chronic pain. METHODS:PubMed, Central, Scopus, PsycInfo and Cinahl were searched up to August 2018. Randomized controlled trials (RCTs) assessing the effects of CST in chronic pain patients were eligible. Standardized mean differences (SMD) and 95% confidence intervals (CI) were calculated for pain intensity and functional disability (primary outcomes) using Hedges' correction for small samples. Secondary outcomes included physical/mental quality of life, global improvement, and safety. Risk of bias was assessed using the Cochrane tool. RESULTS:Ten RCTs of 681 patients with neck and back pain, migraine, headache, fibromyalgia, epicondylitis, and pelvic girdle pain were included. CST showed greater post intervention effects on: pain intensity (SMD?=?-0.32, 95%CI?=?[-?0.61,-0.02]) and disability (SMD?=?-0.58, 95%CI?=?[-?0.92,-0.24]) compared to treatment as usual; on pain intensity (SMD?=?-0.63, 95%CI?=?[-?0.90,-0.37]) and disability (SMD?=?-0.54, 95%CI?=?[-?0.81,-0.28]) compared to manual/non-manual sham; and on pain intensity (SMD?=?-0.53, 95%CI?=?[-?0.89,-0.16]) and disability (SMD?=?-0.58, 95%CI?=?[-?0.95,-0.21]) compared to active manual treatments. At six months, CST showed greater effects on pain intensity (SMD?=?-0.59, 95%CI?=?[-?0.99,-0.19]) and disability (SMD?=?-0.53, 95%CI?=?[-?0.87,-0.19]) versus sham. Secondary outcomes were all significantly more improved in CST patients than in other groups, except for six-month mental quality of life versus sham. Sensitivity analyses revealed robust effects of CST against most risk of bias domains. Five of the 10 RCTs reported safety data. No serious adverse events occurred. Minor adverse events were equally distributed between the groups. DISCUSSION:In patients with chronic pain, this meta-analysis suggests significant and robust effects of CST on pain and function lasting up to six months. More RCTs strictly following CONSORT are needed to further corroborate the effects and safety of CST on chronic pain. PROTOCOL REGISTRATION AT PROSPERO:CRD42018111975.
Project description:Background: Previous meta-analysis evaluated a limited number of parameters regarding the comparison of BTPV and TURP for BPH.Method: PubMed, Embase and Cochrane Library were searched for literature comparing BTPV with TURP. Data of efficacy (IPSS, Qmax, PVR and QoL) and safety were extracted and evaluated using either SMD or OR with 95% CI. All analyses were performed by RevMan 5.3.Results: Eleven trials with 1690 patients were selected. Compare to BTPV, TURP had better 6-month IPSS (SMD=0.36, 95% CI 0.08 to 0.63), better 1- (SMD=-0.38, 95% CI -0.63 to -0.12), 6- (SMD=-0.73, 95% CI -0.99 to -0.46) and 12-month Qmax (SMD=-0.47, 95% CI -0.85 to -0.10), better 6-month PVR (SMD=1.18, 95% CI 0.87 to 1.48), as well as better 3- (SMD=-0.24, 95% CI -0.48 to -0.01) and 6-month QoL (SMD=-0.62, 95% CI -0.91 to -0.33). However, BTPV had shorter catheterization time (SMD=-0.96, 95% CI -1.12 to -0.79) and hospital stay (SMD=-0.71, 95% CI -0.89 to -0.53), less hemoglobin decrease (SMD=-1.09, 95% CI -1.27 to -0.91) and virtually shorter operation time (SMD=-0.15, 95% CI -0.31 to 0.01). Moreover, BTPV had fewer occurrence of overall complications (OR=0.52, 95% CI 0.40 to 0.69), Clavien III-IV complications (OR=0.61, 95% CI 0.37 to 1.02), blood transfusion (OR=0.25, 95% CI 0.09 to 0.69), hematuria (OR=0.27, 95% CI 0.13 to 0.56) and capsular perforation (OR=0.19, 95% CI 0.08 to 0.48). Subgroup analysis indicated BTPV and bipolar TURP had similar total complications (OR 1.08, 95% CI 0.40-2.88, P=0.88) and Clavien III-IV complications (OR 1.42, 95% CI 0.36-5.57, P=0.61) and blood transfusion rate (OR 0.28, 95% CI 0.04-1.73, P=0.17).Conclusion: Both TURP and BTPV could significantly improve IPPS, Qmax, PVR and QoL. TURP had slightly better short-term efficacy, while BTPV had better safety. However, subgroup analysis found bipolar TURP and BTPV had similar safety.
Project description:Background:This meta-analysis aimed to evaluate the efficacy and safety of Javanica oil emulsion injection (JOI) combined with chemotherapy versus chemotherapy in patients with advanced non-small-cell lung cancer (NSCLC). Methods:Electronic databases including EMBASE, PUBMED, the Cochrane library, and Chinese Biological Medical disc (CBM) were searched until May 2018. The clinical trials reporting efficacy and immune function of JOI combined with chemotherapy versus chemotherapy in advanced NSCLC were included according to the inclusion and exclusion criteria. Stata 11 and RevMan 5.3 were used for meta-analysis. Results:Twenty-four studies involving 2089 cases were included. The results of the meta-analysis showed that there were significant differences in objective response rate (risk ratio (RR)?=?1.17; 95% confidence interval (CI): 1.05-1.29; P < 0.05), improvement in Karnofsky Performance Status (standard mean difference (SMD)?=?1.59; 95% CI: 1.41-1.77; P < 0.01), incidence of adverse events (RR?=?0.78; 95% CI: 0.7-0.87; P < 0.05), percentage changes of CD3 + cells (SMD?=?2.0; 95% CI: 1.49-2.50; P < 0.01), CD4 + cells (SMD?=?1.55; 95% CI, 1.2-1.9; P < 0.01), natural killer cells (SMD?=?1.98; 95% CI: 1.15-2.82; P < 0.01), but not CD8 + (SMD?=?-1.44; 95% CI: -4.53-1.65; P=0.36), and value of CD4 +/CD8 + (SMD?=?0.32; 95% CI: 0.28-0.36; P < 0.01) between the JOI combination group and control group. Funnel plot and Begg's and Egger's analysis indicated that there was no significant publication bias (P > 0.05). Conclusions:JOI may be effective to improve the efficacy of chemotherapy in advanced NSCLC patients, accompanied with better levels of immune cells.
Project description:Surgical or nonsurgical treatment for scaphoid waist fracture with slight or no displacement is still controversial. This study compared the efficacy of the 2 methods through meta-analysis to provide a reference for the choice of clinical treatment options. Two individuals independently searched for relevant RCTs and cohort studies from PubMed (1946-February 2018), Embase (1946-February 2018), and Cochrane library (1997-February 2018). After quality assessment and data extraction, Stata 14 software was used for combining the effect size, testing heterogeneity, and studying bias. GRADEpro was used to rate the level of evidence. Ten RCTs and 4 cohort studies with 765 patients were included. No statistical difference in satisfaction, pain, and Disability of the Arm, Shoulder, and Hand score was found after surgical and nonsurgical treatments. Compared with nonsurgical treatment, surgical treatment shortened the time to union (SMD?=?-5.01, 95% CI: -7.47 to -2.58, P?=?.000), decreased the convalescence (SMD?=?-2.09, 95% CI: -3.08 to -1.11, P?=?.000), and reduced the incidence of nonunion (RR?=?0.47, 95% CI: 0.24-0.90), P?=?.023). Subgroup analyses showed that the percutaneous fixation treatment can shorten the time to union [SMD?=?-1.82, 95%CI (-2.22 to -1.42), P?=?=?.000] and the convalescence (SMD?=?-4.26, 95%CI: -6.16 to -2.35, P?=?=?.054), and open reduction fixation treatment can reduce the incidence of nonunion (RR?=?0.20, 95%CI: 0.06-0.69, P?=?=?.01). For scaphoid waist fractures with slight or no displacement, there was no statistical difference in patient satisfaction, pain, and The Disability of the Arm, Shoulder, and Hand scores between surgical treatment and nonsurgical treatment. Closed surgical treatment can shorten the time to union and convalescence, and open reduction can reduce the incidence of nonunion. On the basis of this conclusion, chief physicians can consider which treatment to use according to the patient's clinical situation and their subjective intention.
Project description:Importance:Atypical antipsychotics offer modest effectiveness compared with placebo but with serious safety risks, including a boxed warning for the risk of death in the treatment of behavioral and psychological symptoms of dementia (BPSD). Their comparative effectiveness and safety are not fully known. Objective:To assess the relative benefits and safety of atypical antipsychotics in the treatment of BPSD shown in randomized clinical trials using network meta-analysis. Data Sources:PubMed/MEDLINE, Embase, PsychINFO, and Cochrane Library were searched from their inception until May 31, 2018. Key terms included dementia and atypical antipsychotics. Study Selection:Randomized clinical trials comparing any atypical antipsychotic with another atypical antipsychotic or with placebo were included in the analysis. Data Extraction and Synthesis:Two independent reviewers used a standardized data extraction and quality assessment form. Random-effects network meta-analyses were performed. Effect sizes were reported as standardized mean differences (SMDs) for continuous outcomes and odds ratios (ORs) for dichotomous outcomes with 95% CIs. In addition to ORs, the surface under the cumulative ranking curve (SUCRA) was ascertained, which represents the percentage of the effectiveness or safety for each treatment compared with a hypothetical treatment that would be ranked first without uncertainty. Main Outcomes and Measures:The primary effectiveness outcome assessed was the Neuropsychiatric Inventory (NPI); secondary effectiveness outcomes were the Brief Psychiatric Rating Scale (BPRS) and Cohen-Mansfield Agitation Inventory (CMAI). The primary safety outcomes were death and cerebrovascular adverse events (CVAEs). Secondary safety outcomes were extrapyramidal signs/symptoms; somnolence/sedation; falls, fracture, or injury; and urinary tract infection/incontinence. Results:Seventeen studies (5373 patients) were included. The mean (SD) age of all participants was 80.8 (3.1) years, and most were women (3748 [69.8%]). Compared with placebo, aripiprazole was associated with improvement in outcomes on the NPI (SMD, -0.17; 95% CI, -0.31 to -0.02), BPRS (SMD, -0.20; 95% CI, -0.35 to -0.05), and CMAI (SMD, -0.30; 95% CI, -0.55 to -0.05); quetiapine was associated with improvement in outcomes on the BPRS (SMD, -0.24; 95% CI, -0.46 to -0.01), and risperidone was associated with improvement in outcomes on the CMAI (SMD, -0.26; 95% CI, -0.37 to -0.15). Differences between atypical antipsychotics were not significant for effectiveness, death, or CVAE. Compared with placebo, risperidone (OR, 3.85; 95% CI, 1.55-9.55) and olanzapine (OR, 4.28; 95% CI, 1.26-14.56) were associated with increased risk of CVAEs. The SUCRA estimated relative ranking of treatments suggested that aripiprazole might be the most effective and safe atypical antipsychotic and that olanzapine provides the least benefit overall; however, these results should be interpreted with caution where point estimates (OR and SMD) show that there is no statistically significant difference. Conclusions and Relevance:This network meta-analysis supports the existence of a trade-off between the effectiveness and safety of atypical antipsychotics in the treatment of BPSD and confirms that a single most effective and safe treatment option does not exist. Clinicians should individualize the assessment of safety risks against expected benefits when prescribing these medications to patients with dementia.
Project description:BACKGROUND:To comprehensively evaluate the treatment efficacy and safety of silymarin for patients with glucose/lipid metabolic dysfunction using a meta-analysis. METHODS:A systematic literature search in PubMed, EMBASE and Cochrane Library databases was performed up to October 1, 2019. STATA 13.0 software was used to estimate pooled standardized mean difference (SMD) and 95% confidence interval (95% CI). RESULTS:Sixteen studies involving 1358 patients were identified. Overall meta-analysis showed that compared with control, silymarin significantly reduced levels of fasting blood glucose (SMD: -1.27, 95% CI?=?[-1.78, -0.76]; P?<?.001), homeostatic model assessment for insulin resistance (SMD: -0.41, 95% CI?=?[-0.70, -0.12]; P?=?.005), hemoglobin A1c (SMD: -1.88, 95% CI?=?[-2.57, -1.20]; P?<?.001), total cholesterol (SMD: -1.13, 95% CI?=?[-1.82, -0.77]; P?<?.001), triglyceride (SMD: -0.37, 95% CI?=?[-0.69, -0.05]; P?=?.025), low-density lipoprotein-cholesterol (SMD: -1.30, 95% CI?=?[-1.93, -0.67]; P?<?.001), C-reactive protein (SMD: -0.63, 95% CI?=?[-1.01, -0.27]; P?=?.001), and increased high-density lipoprotein-cholesterol (SMD: 0.17, 95% CI?=?[0.05, 0.29]; P?=?.005), but had no impacts on function indicators of liver and kidney (alanine transaminase, aspartate aminotransferase, creatinine phosphokinase, creatinine) and the complication rate. Subgroup analyses indicated that insulin (which was negative in overall analysis) was significantly decreased in patients undergoing silymarin monotherapy (SMD: -2.03, 95% CI?=?[-3.03, -1.04]; P?=?.044) for more than 3 months (SMD: -0.01, 95% CI?=?[-0.25, -0.24]; P?=?.035). CONCLUSION:Supplementation of silymarin may be effective and safe for the management of diabetes mellitus and hyperlipidemia.