- Discussion
8
- 10.1016/s2215-0366(15)00554-4
PACE: CBT and GET are not rehabilitative therapies
- Jan 19, 2016
- The Lancet Psychiatry
- Frank Twisk
PACE: CBT and GET are not rehabilitative therapies
Patients with CFS may generally benefit and feel less fatigued following exercise therapy, and no evidence suggests that exercise therapy may worsen outcomes. A positive effect with respect to sleep, physical function and self-perceived general health has been observed, but no conclusions for the outcomes of pain, quality of life, anxiety, depression, drop-out rate and health service resources were possible. The effectiveness of exercise therapy seems greater than that of pacing but similar to that of CBT. Randomised trials with low risk of bias are needed to investigate the type, duration and intensity of the most beneficial exercise intervention.
PACE: CBT and GET are not rehabilitative therapies
PACE: CBT and GET are not rehabilitative therapies
The role of iron in the management of chemotherapy-induced anemia in cancer patients receiving erythropoiesis-stimulating agents.
Our systematic review shows that addition of iron to ESAs offers superior hematopoietic response, reduces the risk of RBC transfusions, and improves Hb levels, and appears to be well tolerated. None of the included RCTs reported overall survival. We found no evidence for a difference in quality of life with iron supplementation.
Read morePain relief in hysterosalpingography.
Background Hysterosalpingography (HSG) is a method of testing for tubal patency. Various pharmacological strategies are available that may reduce the pain during the procedure. Objectives To compare the effectiveness of different types of pharmacological interventions for pain relief in women undergoing hysterosalpingography (HSG) for investigation of subfertility. Search methods This review has drawn on the search strategy developed for the Menstrual Disorders and Subfertility Group. In addition MEDLINE and EMBASE were searched up to July 2006. Selection criteria All randomised controlled trials investigating the pharmacological interventions for pain relief during HSG were investigated. Data collection and analysis Data were extracted independently by the first two authors. Differences of opinion were registered and resolved by the third author. Results for each study were expressed as mean pain score and standard error of the mean with 95% confidence intervals. Main results The included eight trials reported on 570 women undergoing HSG. Overall, there was no evidence of benefit of using any analgesia compared with placebo for pain relief during the procedure (standard mean difference (SMD) of -0.05 (95%CI -0.25 to 0.14) or up to 29 minutes after HSG SMD 0.17, (95%CI -1.00 to 1.34)). Four RCTs involving 219 women found evidence of benefit with any analgesia in comparison to placebo for pain relief more than 30 minutes after HSG, with the SMD of -0.82(95%CI-1.18 to -0.45). One RCT involving 91 women compared the effectiveness of opioid analgesics versus non-opioid analgesics and reported no evidence of difference in pain relief at any stage of the procedure. One RCT involving 20 women compared the use of topical analgesia with a paracervical block, with analysis demonstrating more benefit to be gained from using topical analgesia during HSG, with the SMD of -2.03 (95%Cl-3.16 to -0.91). Authors' conclusions There is little evidence of benefit in terms of pain relief of any of the interventions considered in this study during or immediately after HSG. However, there is limited evidence of pain reduction 30 minutes after the procedure. Further RCTs should consider the role of non steroidal antiinflammatories (NSAIDs) and intrauterine anaesthetic during HSG.
Read moreEffects of Exercise Therapy on Anxiety and Depression in Patients With Coronary Heart Disease: A Meta-Analysis of a Randomized Controlled Study.
Objective: The purpose of this review was to evaluate the effect of exercise therapy on anxiety and depression symptoms in patients with coronary heart disease (CHD).Methods: A systematic review of papers published between January 2000 and February 2021 was conducted. MEDLINE, Embase, the Cochrane Library and Web of Science were searched. Meta-analysis was used to compare the results of the included studies. Bias risk assessment was performed using the Cochrane Collaboration bias risk tool. If half or more of the seven items in Randomized controlled trials (RCTs) were low-risk, then the RCT was considered low-risk research; otherwise, it was high-risk. Statistical analyses were performed using RevMan version 5.3 and STATA version 12.0.Results: We performed a meta-analysis of 11 randomized clinical studies including 771 subjects. Eight studies (73%) were of high quality. Compared with the control group, the exercise group showed a significant improvement in anxiety [standard mean difference (SMD) = −0.61; 95% confidence interval (CI): −0.86, −0.35]. The depression level in the exercise group was also significantly reduced (SMD = −0.48; 95% CI: −0.92, −0.04). Aerobic fitness and athletic endurance also improved [mean difference (MD) = 0.77; 95% CI: 0.58, 0.95; and MD = 20.69; 95% CI: 6.91, 34.46; respectively].Conclusions: This meta-analysis suggests that exercise therapy may be effective in alleviating anxiety and depression symptoms in patients with coronary heart disease. Due to methodological weaknesses, rigorous research needs to be designed to further confirm the effectiveness of exercise therapy in improving the mental health of patients with coronary heart disease.Systematic Review Registration: https://inplasy.com/projects/, identifier: INPLASY202160017.
Read moreSilodosin for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia.
A variety of alpha-blockers are used for treating lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH). Silodosin is a novel, more selective alpha-blocker, which is specific to the lower urinary tract and may have fewer side effects than other alpha-blockers. To assess the effects of silodosin for the treatment of LUTS in men with BPH. We performed a comprehensive search using multiple databases (Cochrane Library, MEDLINE, EMBASE, Scopus, Google Scholar, and Web of Science), trials registries, other sources of grey literature, and conference proceedings with no restrictions on the language of publication or publication status up until 13 June 2017. We included all parallel, randomized controlled trials. We also included cross-over designs. Two review authors independently classified studies and abstracted data from the included studies. We performed statistical analyses using a random-effects model and interpreted them according to the Cochrane Handbook for Systematic Reviews of Interventions. We rated the quality of evidence according to the GRADE approach. We included 19 unique studies with 4295 randomized participants across four comparisons for short-term follow-up. The mean age, prostate volume, and International Prostate Symptom Score were 66.5 years, 38.2 mL, and 19.1, respectively. Silodosin versus placeboBased on four studies with a total of 1968 randomized participants, silodosin may reduce urologic symptom scores in an appreciable number of men (mean difference (MD) -2.65, 95% confidence interval (CI) -3.23 to -2.08; low-quality evidence). Silodosin likely does not result in a clinically important reduction in quality of life (MD -0.42, 95% CI -0.71 to -0.13; moderate-quality evidence). It may not increase rates of treatment withdrawal for any reason (relative risk (RR) 1.08, 95% CI 0.70 to 1.66; low-quality evidence). We are uncertain about the effect of silodosin on cardiovascular adverse events (RR 1.28, 95% CI 0.67 to 2.45; very low-quality evidence). Silodosin likely increases sexual adverse events (RR 26.07, 95% CI 12.36 to 54.97; moderate-quality evidence); this would result in 180 more sexual adverse events per 1000 men (95% CI 82 more to 388 more). Silodosin versus tamsulosinBased on 13 studies with a total of 2129 randomized participants, silodosin may result in little to no difference in urologic symptom scores (MD -0.04, 95% CI -1.31 to 1.24; low-quality evidence) and quality of life (MD -0.15, 95% CI -0.53 to 0.22; low-quality evidence). We are uncertain about treatment withdrawals for any reason (RR 1.02, 95% CI 0.62 to 1.69; very low-quality evidence). Silodosin may result in little to no difference in cardiovascular adverse events (RR 0.77, 95% CI 0.53 to 1.12; low-quality evidence). Silodosin likely increases sexual adverse events (RR 6.05, 95% CI 3.55 to 10.31; moderate-quality evidence); this would result in 141 more sexual adverse events per 1000 men (95% CI 71 more to 261 more). Silodosin versus naftopidilBased on five studies with a total of 763 randomized participants, silodosin may result in little to no differences in urologic symptom scores (MD -0.85, 95% CI -2.57 to 0.87; low-quality evidence), quality of life (MD -0.17, 95% CI -0.60 to 0.27; low-quality evidence), treatment withdrawal for any reason (RR 1.25, 95% CI 0.81 to 1.93; low-quality evidence), and cardiovascular adverse events (RR 1.02, 95% CI 0.41 to 2.56; low-quality evidence). Silodosin likely increases sexual adverse events (RR 5.93, 95% CI 2.16 to 16.29; moderate-quality evidence); this would result in 74 more sexual adverse events per 1000 men (95% CI 17 more to 231 more). Silodosin versus alfuzosinBased on two studies with a total of 155 randomized participants, silodosin may or may not result in a clinically important increase in urologic symptom scores (MD 3.83, 95% CI 0.12 to 7.54; low-quality evidence). Silodosin likely results in little to no difference in quality of life (MD 0.14, 95% CI -0.46 to 0.74; moderate-quality evidence). We found no event of treatment withdrawal for any reason. Silodosin may not reduce cardiovascular adverse events (RR 0.67, 95% CI 0.36 to 1.24; low-quality evidence) but likely increases sexual adverse events (RR 37.21, 95% CI 5.32 to 260.07; moderate-quality evidence); this would result in 217 more sexual adverse events per 1000 men (95% CI 26 more to 1000 more). Silodosin may reduce urologic symptom scores in an appreciable number of men compared to placebo. Quality of life and treatment withdrawals for any reason appears similar. Its efficacy appears similar to that of other alpha blockers (tamsulosin, naftopidil and alfuzosin) but the rate of sexual side effects is likely higher. Our certainty in the estimates of effect was lowered due to study limitations, inconsistency and imprecision.
Read moreShoulder specific exercise therapy is effective in reducing chronic shoulder pain: A network meta-analysis.
Exercise therapy (ET) is frequently an early treatment of choice when managing shoulder pain, yet evidence on its efficacy to expedite recovery is inconsistent. Moreover, the value of adding adjunct therapies (i.e. injections, manual therapy, electrotherapy) to ET is currently unclear. This study combined both direct and indirect evidence across studies on the effectiveness of ET with/without adjunct therapies compared to usual medical care for adults with chronic shoulder pain. Using a network meta-analysis, randomized control trials comparing ET along with adjunct therapies were identified in MEDLINE, Embase, CINAHL, Sportdiscus, CENTRAL, Conference Proceedings Citation Index-Science, clinicaltrials.gov, and association websites. Outcomes included pain, range of motion (ROM), and health-related quality of life (HRQL) measures in adult patients with chronic shoulder pain. Data analysis used a Frequentist hierarchical model. CINeMA tool assessed the confidence in the results and Cochrane Risk of Bias tool assessed quality of studies. 54 studies primarily from Europe (40.38%) included 3,893 participants who were followed up to 52 weeks. Shoulder-specific ET (Mean difference (MD) = -2.1; 95% confidence interval (CI) = -3.5 to -0.7) or in combination with electro-physical agents (MD = -2.5; 95% CI = -4.2 to -0.7), injections (MD = -2.4; 95% CI = -3.9 to-1.04) or manual therapy (MD = -2.3; 95% CI = -3.7 to -0.8) decreased pain compared to usual medical care. Trends with ROM and HRQL scores were seen; however, only Manual Therapy (MD = -12.7 and 95% CI = -24.4 to -1.0) achieved meaningfully important changes. Sensitivity analysis excluding studies with high risk of bias showed similar results, with exception of injections that did not reach significance (MD = -1.3; 95% CI = -4.3 to 1.7). Shoulder-specific ET provided pain relief up to 52 weeks. Adjunct therapies to shoulder-specific ET added little value in reducing pain. The quality of evidence varied between moderate and very low.
Read moreStandardised formal resuscitation training programmes for reducing mortality and morbidity in newborn infants.
Approximately 10% of all newborns require resuscitation at birth. Training healthcare providers in standardised formal neonatal resuscitation training (SFNRT) programmes may improve neonatal outcomes. Substantial healthcare resources are expended on SFNRT. To determine whether SFNRT programmes reduce neonatal mortality and morbidity, improve acquisition and retention of knowledge and skills, or change teamwork and resuscitation behaviour. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PREMEDLINE, EMBASE, CINAHL, Web of Science and the Oxford Database of Perinatal Trials, ongoing trials and conference proceedings in April 2014 and updated in March 2015. Randomised or quasi-randomised trials including cluster-randomised trials, comparing a SFNRT with no SFNRT, additions to SFNRT or types of SFNRT, and reporting at least one of our specified outcomes. Two authors extracted data independently and performed statistical analyses including typical risk ratio (RR), risk difference (RD), mean difference (MD), and number needed to treat for an additional beneficial outcome (NNTB) or an additional harmful outcome (NNTH) (all with 95% confidence intervals (CI)). We analysed cluster-randomised trials using the generic inverse variance and the approximate analysis methods. We identified two community-based and three manikin-based trials that assessed the effect of SFNRT compared with no SFNRT. Very low quality evidence from one study suggested improvement in acquisition of knowledge (RR 5.96, 95% CI 3.60 to 9.87) and skills (RR 170, 95% CI 10.8 to 2711) and retention of knowledge (RR 3.60, 95% CI 2.43 to 5.35) and the other study suggested improvement in resuscitation and behavioural scores.We identified three community-based cluster-randomised trials in developing countries comparing SFNRT with basic resuscitation training (Early Newborn Care). In this setting, there was moderate quality evidence that SFNRT decreased early neonatal mortality (typical RR 0.88, 95% CI 0.78 to 1.00; 3 studies, 66,162 neonates) and when analysed by the approximate analysis method (typical RR 0.85, 95% CI 0.75 to 0.96; RD -0.0044, 95% CI -0.0082 to -0.0006; NNTB 227, 95% CI 122 to 1667). Low quality evidence from one trial showed that SFNRT may decrease 28-day mortality (typical RR 0.55, 95% CI 0.33 to 0.91) but the effect on late neonatal mortality was more uncertain (typical RR 0.47, 95% CI 0.20 to 1.11). None of our a priori defined neonatal morbidities were reported. We did not identify any randomised studies in the developed world.We identified two trials that compared SFNRT with team training to SFNRT. Teamwork training of physician trainees with simulation may increase any teamwork behaviour (assessed by frequency) (MD 2.41, 95% CI 1.72 to 3.11) and decrease resuscitation duration (MD -149.54, 95% CI -214.73 to -84.34) but may lead to little or no difference in Neonatal Resuscitation Program (NRP) scores (MD 1.40, 95% CI -2.02 to 4.82; 98 participants, low quality evidence).We identified two trials that compared SFNRT with booster courses to SFNRT. It is uncertain whether booster courses improve retention of resuscitation knowledge (84 participants, very low quality evidence) but may improve procedural and behavioural skills (40 participants, very low quality evidence).We identified two trials on decision support tools, one on a cognitive aid that did not change resuscitation scores and the other on an electronic decision support tool that improved the frequency of correct decision making on positive pressure ventilation, cardiac compressions and frequency of fraction of inspired oxygen (FiO2) adjustments (97 participants, very low quality evidence). SFNRT compared to basic newborn care or basic newborn resuscitation, in developing countries, results in a reduction of early neonatal and 28-day mortality. Randomised trials of SFNRT should report on neonatal morbidity including hypoxic ischaemic encephalopathy and neurodevelopmental outcomes. Innovative educational methods that enhance knowledge and skills and teamwork behaviour should be evaluated.
Read moreTherapist Effects and the Impact of Early Therapeutic Alliance on Symptomatic Outcome in Chronic Fatigue Syndrome.
Few studies have examined therapist effects and therapeutic alliance (TA) in treatments for chronic fatigue syndrome (CFS). Therapist effects are the differences in outcomes achieved by different therapists. TA is the quality of the bond and level of agreement regarding the goals and tasks of therapy. Prior research suffers the methodological problem that the allocation of therapist was not randomized, meaning therapist effects may be confounded with selection effects. We used data from a randomized controlled treatment trial of 296 people with CFS. The trial compared pragmatic rehabilitation (PR), a nurse led, home based self-help treatment, a counselling-based treatment called supportive listening (SL), with general practitioner treatment as usual. Therapist allocation was randomized. Primary outcome measures, fatigue and physical functioning were assessed blind to treatment allocation. TA was measured in the PR and SL arms. Regression models allowing for interactions were used to examine relationships between (i) therapist and therapeutic alliance, and (ii) therapist and average treatment effect (the difference in mean outcomes between different treatment conditions). We found no therapist effects. We found no relationship between TA and the average treatment effect of a therapist. One therapist formed stronger alliances when delivering PR compared to when delivering SL (effect size 0.76, SE 0.33, 95% CI 0.11 to 1.41). In these therapies for CFS, TA does not influence symptomatic outcome. The lack of significant therapist effects on outcome may result from the trial’s rigorous quality control, or random therapist allocation, eliminating selection effects. Further research is needed. Trial Registration: ISRCTN74156610
Read moreAddition of long-acting beta2-agonists to inhaled corticosteroids for chronic asthma in children.
Analysis 1.1. Comparison 1 LABA versus placebo: both groups receiving similar dose of ICS, Outcome 1 # participants with exacerbations requiring systemic steroids. . . . . . . . . . . . . . . . . . . . . . . Analysis 1.2. Comparison 1 LABA versus placebo: both groups receiving similar dose of ICS, Outcome 2 # participants with exacerbations requiring hospitalisation. . . . . . . . . . . . . . . . . . . . . . . . Analysis 1.3. Comparison 1 LABA versus placebo: both groups receiving similar dose of ICS, Outcome 3 # participants with exacerbations requiring urgent care visit. . . . . . . . . . . . . . . . . . . . . . . . Analysis 1.4. Comparison 1 LABA versus placebo: both groups receiving similar dose of ICS, Outcome 4 Serious adverse events. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Read moreDesmopressin use for minimising perioperative blood transfusion
Most of the evidence derived by comparing DDAVP versus placebo was obtained in cardiac surgery, where DDAVP was administered after cardiopulmonary bypass. In adults undergoing cardiac surgery, the reduction in volume of red cells transfused and total blood loss was small and was unlikely to be clinically important. It is less clear whether DDAVP may be of benefit for children and for those undergoing non-cardiac surgery. A key area for researchers is examining the effects of DDAVP for people with platelet dysfunction. Few trials have compared DDAVP versus tranexamic acid or aprotinin; consequently, we are uncertain of the relative efficacy of these interventions.
Read moreBack Schools for chronic non-specific low back pain.
Due to the low- to very low-quality of the evidence for all treatment comparisons, outcomes, and follow-up periods investigated, it is uncertain if Back School is effective for chronic low back pain. Although the quality of the evidence was mostly very low, the results showed no difference or a trivial effect in favour of Back School. There are myriad potential variants on the Back School approach regarding the employment of different exercises and educational methods. While current evidence does not warrant their use, future variants on Back School may have different effects and will need to be studied in future RCTs and reviews.
Read moreThe effectiveness of exercise therapy for temporomandibular dysfunction: a systematic review and meta-analysis
Objective: To investigate the effectiveness of exercise therapy on pain, function, and mobility outcomes in patients with temporomandibular joint dysfunction. Study design: Systematic review with meta-analysis. Methods: A systematic review and meta-analysis undertaken following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Studies that met the inclusion criteria: (1) randomized controlled trials; (2) a population with the diagnosis of temporomandibular joint dysfunction; and (3) interventions that included exercise therapy were considered for review. When studies demonstrated homogeneity on outcome measures, the mean differences or standardized mean differences with 95% confidence interval were calculated and pooled in a meta-analysis for pooled synthesis. Results: Six articles with a total of 419 participants were included in the review and only four studies were included in the meta-analysis. Mobility and mixed exercise therapy approaches appear to be the most common exercise approaches utilized for management of temporomandibular joint dysfunction. Exercise therapy and the associated dosage provide moderate short-term and varying long-term benefits in reduction of pain and improvement of range of motion of the in patients with temporomandibular joint dysfunction. Conclusion: Included studies suggest a mobility or a mixed approach to exercise therapies have impact on reducing pain, significant impact for increasing range of motion, but lack a significant impact for functional improvement. Level of evidence: Therapy, level 1a-.
Read moreInterventions to reduce contaminated aerosols produced during dental procedures for preventing infectious diseases.
We found no studies that evaluated disease transmission via aerosols in a dental setting; and no evidence about viral contamination in aerosols. All of the included studies measured bacterial contamination using colony-forming units. There appeared to be some benefit from the interventions evaluated but the available evidence is very low certainty so we are unable to draw reliable conclusions. We did not find any studies on methods such as ventilation, ionization, ozonisation, UV light and fogging. Studies are needed that measure contamination in aerosols, size distribution of aerosols and infection transmission risk for respiratory diseases such as COVID-19 in dental patients and staff.
Read moreImplementing cognitive behavioral therapy for chronic fatigue syndrome in a mental health center: A benchmarking evaluation.
This study evaluated the success of implementing cognitive behavioral therapy (CBT) for chronic fatigue syndrome (CFS) in a representative clinical practice setting and compared the patient outcomes with those of previously published randomized controlled trials (RCTs) of CBT for CFS. The implementation interventions were the following: spreading information about the new treatment setting to general practitioners and CFS patients; training mental health center (MHC) therapists in CBT for CFS; and organizing changes in the MHC patient workflow. Patient outcomes were documented with validated self-report measures of fatigue and physical functioning before and after treatment. The comparison of the treatment results with RCT results was done following the benchmark strategy. One-hundred forty-three CFS patients were referred to the MHC, of whom 112 started treatment. The implementation was largely successful, but a weak point was the fact that 32% of all referred patients dropped out shortly after or even before starting treatment. Treatment effect sizes were in the range of those found in the benchmark studies. CBT for CFS can successfully be implemented in an MHC. Treatment results were acceptable, but the relatively large early dropout of patients needs attention.
Read moreRanolazine for stable angina pectoris.
Stable angina pectoris is a chronic medical condition with significant impact on mortality and quality of life; it can be macrovascular or microvascular in origin. Ranolazine is a second-line anti-anginal drug approved for use in people with stable angina. However, the effects of ranolazine for people with angina are considered to be modest, with uncertain clinical relevance. To assess the effects of ranolazine on cardiovascular and non-cardiovascular mortality, all-cause mortality, quality of life, acute myocardial infarction incidence, angina episodes frequency and adverse events incidence in stable angina patients, used either as monotherapy or as add-on therapy, and compared to placebo or any other anti-anginal agent. We searched CENTRAL, MEDLINE, Embase and the Conference Proceedings Citation Index - Science in February 2016, as well as regional databases and trials registers. We also screened reference lists. Randomised controlled trials (RCTs) which directly compared the effects of ranolazine versus placebo or other anti-anginals in people with stable angina pectoris were eligible for inclusion. Two authors independently selected studies, extracted data and assessed risk of bias. Estimates of treatment effects were calculated using risk ratios (RR), mean differences (MD) and standardised mean differences (SMD) with 95% confidence intervals (CI) using a fixed-effect model. Where we found statistically significant heterogeneity (Chi² P < 0.10), we used a random-effects model for pooling estimates. Meta-analysis was not performed where we found considerable heterogeneity (I² ≥ 75%). We used GRADE criteria to assess evidence quality and the GRADE profiler (GRADEpro GDT) to import data from Review Manager 5.3 to create 'Summary of findings' tables. We included 17 RCTs (9975 participants, mean age 63.3 years). We found very limited (or no) data to inform most planned comparisons. Summary data were used to inform comparison of ranolazine versus placebo. Overall, risk of bias was assessed as unclear.For add-on ranolazine compared to placebo, no data were available to estimate cardiovascular and non-cardiovascular mortality. We found uncertainty about the effect of ranolazine on: all-cause mortality (1000 mg twice daily, RR 0.83, 95% CI 0.26 to 2.71; 3 studies, 2053 participants; low quality evidence); quality of life (any dose, SMD 0.25, 95% CI -0.01 to 0.52; 4 studies, 1563 participants; I² = 73%; moderate quality evidence); and incidence of non-fatal acute myocardial infarction (AMI) (1000mg twice daily, RR 0.40, 95% CI 0.08 to 2.07; 2 studies, 1509 participants; low quality evidence). Add-on ranolazine 1000 mg twice daily reduced the fervour of angina episodes (MD -0.66, 95% CI -0.97 to -0.35; 3 studies, 2004 participants; I² = 39%; moderate quality evidence) but increased the risk of non-serious adverse events (RR 1.22, 95% CI 1.06 to 1.40; 3 studies, 2053 participants; moderate quality evidence).For ranolazine as monotherapy compared to placebo, we found uncertain effect on cardiovascular mortality (1000 mg twice daily, RR 1.03, 95% CI 0.56 to 1.88; 1 study, 2604 participants; low quality evidence). No data were available to estimate non-cardiovascular mortality. We also found an uncertain effect on all-cause mortality for ranolazine (1000 mg twice daily, RR 1.00, 95% CI 0.81 to 1.25; 3 studies, 6249 participants; low quality evidence), quality of life (1000 mg twice daily, MD 0.28, 95% CI -1.57 to 2.13; 3 studies, 2254 participants; moderate quality evidence), non-fatal AMI incidence (any dose, RR 0.88, 95% CI 0.69 to 1.12; 3 studies, 2983 participants; I² = 50%; low quality evidence), and frequency of angina episodes (any dose, MD 0.08, 95% CI -0.85 to 1.01; 2 studies, 402 participants; low quality evidence). We found an increased risk for non-serious adverse events associated with ranolazine (any dose, RR 1.50, 95% CI 1.12 to 2.00; 3 studies, 947 participants; very low quality evidence). We found very low quality evidence showing that people with stable angina who received ranolazine as monotherapy had increased risk of presenting non-serious adverse events compared to those given placebo. We found low quality evidence indicating that people with stable angina who received ranolazine showed uncertain effect on the risk of cardiovascular death (for ranolazine given as monotherapy), all-cause death and non-fatal AMI, and the frequency of angina episodes (for ranolazine given as monotherapy) compared to those given placebo. Moderate quality evidence indicated that people with stable angina who received ranolazine showed uncertain effect on quality of life compared with people who received placebo. Moderate quality evidence also indicated that people with stable angina who received ranolazine as add-on therapy had fewer angina episodes but increased risk of presenting non-serious adverse events compared to those given placebo.
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