Fair-quality Trials Research Articles

Effects of Whole-Body Vibration Therapy on Knee Osteoarthritis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

IntroductionKnee osteoarthritis is a leading cause of disability and medical costs. The effect of whole-body vibration in knee osteoarthritis is controversial. The aim of this study was to assess the effects and safety of whole-body vibration on pain, stiffness, physical function, and muscle strength in patients with knee osteoarthritis.MethodsPubMed, Scopus, Web of Science, Physiotherapy Evidence Database (PEDro) and EMBASE databases were searched (date last accessed 1 April 2021) using the key words “vibration” and “knee osteoarthritis”, to identify all randomized controlled trials related to whole-body vibration and knee osteoarthritis. Outcomes related to pain, stiffness, physical function, muscle strength, adverse events were included. The risk of bias and quality were assessed by the Cochrane Collaboration tool and PEDro scale. A systematic review and meta-analysis were performed. Subgroup analysis was performed for low- and high-frequency interventions.ResultsA total of 14 randomized controlled trials involving 559 patients with knee osteoarthritis met the inclusion criteria. Nine studies were good-quality trials (PEDro score=6–8), and 5 studies were fair-quality trials (PEDro score=4–5). Ten studies were included in the meta-analysis. One study showed negative effects of whole-body vibration on knee osteoarthritis. The duration of whole-body vibration ranged from 4 to 24 weeks. Meta-analysis revealed that whole-body vibration with strengthening exercises has a significant treatment effect on pain score (standardized mean difference (SMD) = 0.46 points, 95% confidence interval (95% CI) = 0.20–0.71, p = 0.0004), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-function) (SMD = 0.51 points, 95% CI = 0.27–0.75, p < 0.0001), Timed Up and Go (TUG) test (SMD = 0.82 points, 95% CI = 0.46–1.18, p < 0.00001), extensor isokinetic peak torque (SMD = 0.65 points, 95% CI = 0.00–1.29, p = 0.05), peak power (SMD = 0.68 points, 95% CI = 0.26–1.10, p = 0.001), and extensor isometric strength (SMD = 0.44 points, 95% CI = 0.13–0.75, p = 0.006). Both low-frequency (10–30 Hz) and high-frequency (30–40 Hz) whole-body vibration were associated with significant changes in pain, physical function, and knee extensor strength (p < 0.05). WBV was not associated with significant changes in stiffness, balance ability, quality of life, and knee flexor strength. No adverse events were reported.ConclusionMeta-analysis showed that low-frequency and high-frequency whole-body vibration had additional positive effects compared with strengthening exercises alone on pain, knee extensor muscle strength, and physical function in individuals with knee OA. Whole-body vibration with strengthening exercises can be incorporated into treatment protocols.LAY ABSTRACTKnee osteoarthritis is a leading cause of disability and medical costs. Osteoarthritis leads to pain, stiffness, swelling and loss of function, resulting in poor quality of life. Whole-body vibration is a non-invasive treatment that has been proposed to improve muscle strength and physical performance. This analysis of 14 randomized controlled trials showed that, compared with exercise alone, whole-body vibration with exercise had positive effects on pain, physical function, and knee extensor muscle strength in patients with knee osteoarthritis. Based on these findings, we recommend whole-body vibration used together with strengthening exercises for knee osteoarthritis.

Aspirin for the Prevention of Cancer Incidence and Mortality: Systematic Evidence Reviews for the U.S. Preventive Services Task Force.

Cancer is the second leading cause of death in the United States. To conduct systematic reviews of aspirin and 1) total cancer mortality and incidence in persons eligible for primary prevention of cardiovascular disease (CVD) and 2) colorectal cancer (CRC) mortality and incidence in persons at average CRC risk. MEDLINE, PubMed, and the Cochrane Central Register of Controlled Trials through January 2015 and relevant references from other reviews. Trials comparing oral aspirin versus placebo or no treatment in adults aged 40 years or older were included. Two investigators independently reviewed abstracts and articles against inclusion and quality criteria. Data from 20 good- or fair-quality trials were abstracted by one reviewer and checked by another. In CVD primary prevention trials, cancer mortality (relative risk [RR], 0.96 [95% CI, 0.87 to 1.06]) (10 trials; n= 103787) and incidence (RR, 0.98 [CI, 0.93 to 1.04]) (6 trials; n= 72926) were similar in aspirin and control groups over 3.6 to 10.1 years. In CVD primary and secondary prevention trials, 20-year CRC mortality was reduced among persons assigned to aspirin therapy (RR, 0.67 [CI, 0.52 to 0.86]) (4 trials; n= 14033). Aspirin appeared to reduce CRC incidence beginning 10 to 19 years after initiation (RR, 0.60 [CI, 0.47 to 0.76]) (3 trials; n= 47464). Most data were from clinically and methodologically heterogeneous CVD prevention trials. Outcome assessment and follow-up length varied across studies. Data on non-CRC cancer types and subgroups were limited. In CVD primary prevention populations, aspirin's effect on total cancer mortality and incidence was not clearly established. Evidence from CVD primary and secondary prevention studies suggested that aspirin therapy reduces CRC incidence and perhaps mortality approximately 10 years after initiation. Agency for Healthcare Research and Quality.

Screening for asymptomatic carotid artery stenosis: a systematic review and meta-analysis for the U.S. Preventive Services Task Force.

Approximately 10% of ischemic strokes are caused by carotid artery stenosis (CAS). Estimated prevalence of asymptomatic CAS is 1%. To evaluate evidence on screening and treating asymptomatic adults for CAS. MEDLINE, the Cochrane Library, EMBASE, and trial registries through September 2013; MEDLINE through March 2014 for trials. Good- or fair-quality trials of screening, carotid endarterectomy (CEA), or stenting compared with medical therapy or of intensification of medical therapy; systematic reviews; multi-institution studies reporting harms; and externally validated risk-stratification tools. Dual extraction and quality assessment. No trials compared screening with no screening or stenting with medical therapy or assessed intensification of medical therapy, and no externally validated, reliable risk-stratification tools were found. Given the specificity of ultrasonography (range, 88% to 94% for CAS ≥ 50% to ≥ 70%), its use in low-prevalence populations would yield many false-positive results. Absolute reduction of nonperioperative strokes was 5.5% (95% CI, 3.9% to 7.0%; 3 trials; 5223 participants) over approximately 5 years for CEA compared with medical therapy. The 30-day rates of stroke or death after CEA in trials and cohort studies were 2.4% (CI, 1.7% to 3.1%; 6 trials; 3435 participants) and 3.3% (CI, 2.7% to 3.9%; 7 studies; 17474 participants), respectively. Other harms of interventions included myocardial infarction, nerve injury, and hematoma. Trials may have overestimated benefits and used highly selected surgeons. Medical therapy used in trials was outdated, and stroke rates have declined in recent decades. Harms may have been underreported. Current evidence does not establish incremental overall benefit of CEA, stenting, or intensification of medical therapy. Potential for overall benefit is limited by low prevalence and harms. Agency for Healthcare Research and Quality.

Screening for hepatitis B virus infection in adolescents and adults: a systematic review to update the U.S. Preventive Services Task Force recommendation.

In 2004, the U.S. Preventive Services Task Force (USPSTF) recommended against screening for hepatitis B virus (HBV) infection. To update the 2004 USPSTF review on screening for HBV infection in adolescents and adults. MEDLINE (through January 2014), the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, and PsycINFO. Randomized trials of screening and treatment and observational studies of screening or the association between intermediate and clinical outcomes after antiviral therapy. One investigator abstracted data, and a second investigator checked them; 2 investigators independently assessed study quality. No study directly evaluated the effects of screening for HBV infection versus no screening on clinical outcomes. Vaccination against HBV infection was associated with decreased risk in high-risk populations. On the basis of 11 primarily fair-quality trials, antiviral therapy may be more effective than placebo for reducing the risk for clinical outcomes associated with HBV infection. However, differences were not statistically significant. On the basis of 22 primarily fair-quality trials, antiviral therapy was more effective than placebo for various intermediate outcomes, with limited evidence that first-line antiviral agents are superior to lamivudine. Antiviral therapy was associated with a higher risk for withdrawal due to adverse events than placebo, but risk for serious adverse events did not differ. Only English-language articles were included, clinical outcome data for antiviral therapies were limited, and several studies were done in countries where the prevalence and natural history of HBV infection differ from those of the United States. Antiviral treatment for chronic HBV infection is associated with improved intermediate outcomes, but more research is needed to understand the effects of screening and subsequent interventions on clinical outcomes and to identify optimal screening strategies. Agency for Healthcare Research and Quality.

Primary Care Behavioral Interventions to Prevent or Reduce Illicit Drug Use and Nonmedical Pharmaceutical Use in Children and Adolescents: A Systematic Evidence Review for the U.S. Preventive Services Task Force

Drug use among youths is associated with negative health and social consequences. Even infrequent use increases the risk for serious adverse events by increasing risk-taking behaviors in intoxicated or impaired persons. To systematically review the benefits and harms of primary care-relevant interventions designed to prevent or reduce illicit drug use or the nonmedical use of prescription drugs among youths. PubMed, PsycINFO, and the Cochrane Central Register of Controlled Trials through 4 June 2013; MEDLINE through 31 August 2013; and manual searches of reference lists and gray literature. Two investigators independently reviewed 2253 abstracts and 144 full-text articles. English-language trials of primary care-relevant behavioral interventions that reported drug use, health outcomes, or harms were included. One investigator abstracted data from good- and fair-quality trials into prespecified evidence tables, and a second investigator checked these data. Six trials were included, 4 of which examined the effect of the intervention on a health or social outcome. One trial found no effect of the intervention on marijuana-related consequences or driving under the influence of marijuana; 3 trials generally found no reduction in depressed mood at 12 or 24 months. Four of the 5 trials assessing self-reported marijuana use found statistically significant differences favoring the intervention group participants (such as a between-group difference of 0.10 to 0.17 use occasions in the past month). Three trials also reported positive outcomes in nonmedical prescription drug use occasions. The body of evidence was small, and there were heterogeneous measures of outcomes of limited clinical applicability. Trials primarily included adolescents with little or no substance use. Evidence is inadequate on the benefits of primary care-relevant behavioral interventions in reducing self-reported illicit and pharmaceutical drug use among adolescents. Agency for Healthcare Research and Quality.

Use of Medications to Reduce Risk for Primary Breast Cancer: A Systematic Review for the U.S. Preventive Services Task Force

Medications to reduce risk for primary breast cancer are recommended for women at increased risk; however, use is low. To update evidence about the effectiveness and adverse effects of medications to reduce breast cancer risk, patient use of such medications, and methods for identifying women at increased risk for breast cancer. MEDLINE and Cochrane databases (through 5 December 2012), Scopus, Web of Science, clinical trial registries, and reference lists. English-language randomized trials of medication effectiveness and adverse effects, observational studies of adverse effects and patient use, and diagnostic accuracy studies of risk assessment. Investigators independently extracted data on participants, study design, analysis, follow-up, and results, and a second investigator confirmed key data. Investigators independently dual-rated study quality and applicability using established criteria. Seven good- and fair-quality trials indicated that tamoxifen and raloxifene reduced incidence of invasive breast cancer by 7 to 9 cases in 1000 women over 5 years compared with placebo. New results from STAR (Study of Tamoxifen and Raloxifene) showed that tamoxifen reduced breast cancer incidence more than raloxifene by 5 cases in 1000 women. Neither reduced breast cancer-specific or all-cause mortality rates. Both reduced the incidence of fractures, but tamoxifen increased the incidence of thromboembolic events more than raloxifene by 4 cases in 1000 women. Tamoxifen increased the incidence of endometrial cancer and cataracts compared with placebo and raloxifene. Trials provided limited and heterogeneous data on medication adherence and persistence. Many women do not take tamoxifen because of associated harms. Thirteen risk-stratification models were modest predictors of breast cancer. Data on mortality and adherence measures and for women who are nonwhite, are premenopausal, or have comorbid conditions were lacking. Medications reduced the incidence of invasive breast cancer and fractures and increased the incidence of thromboembolic events. Tamoxifen was more effective than raloxifene but also increased the incidence of endometrial cancer and cataracts. Use is limited by adverse effects and inaccurate methods to identify candidates. Agency for Healthcare Research and Quality.

Primary Care–Relevant Interventions for Tobacco Use Prevention and Cessation in Children and Adolescents: A Systematic Evidence Review for the U.S. Preventive Services Task Force

Interventions to prevent smoking uptake or encourage cessation among young persons might help prevent tobacco-related illness. To review the evidence for the efficacy and harms of primary care-relevant interventions that aim to reduce tobacco use among children and adolescents. Three systematic reviews that collectively covered the relevant literature; MEDLINE, PsycINFO, the Cochrane Central Register of Controlled Trials, and the Database of Abstracts of Reviews of Effects through 14 September 2012; and manual searches of reference lists and gray literature. Two investigators independently reviewed 2453 abstracts and 111 full-text articles. English-language trials of behavior-based or medication interventions that were relevant to primary care and reported tobacco use, health outcomes, or harms were included. One investigator abstracted data from good- and fair-quality trials into an evidence table, and a second checked these data. 19 trials (4 good-quality and 15 fair-quality) that were designed to prevent tobacco use initiation or promote cessation (or both) and reported self-reported smoking status or harms were included. Pooled analyses from a random-effects meta-analysis suggested a 19% relative reduction (risk ratio, 0.81 [95% CI, 0.70 to 0.93]; absolute risk difference, -0.02 [CI, -0.03 to 0.00]) in smoking initiation among participants in behavior-based prevention interventions compared with control participants. Neither behavior-based nor bupropion cessation interventions improved cessation rates. Findings about the harms related to bupropion use were mixed. No studies reported health outcomes. Interventions and measures were heterogeneous. Most trials examined only cigarette smoking. The body of evidence was largely published 5 to 15 years ago. Primary care-relevant interventions may prevent smoking initiation over 12 months in children and adolescents.

Comparative Effectiveness of Antiviral Treatment for Hepatitis C Virus Infection in Adults: A Systematic Review

Multiple treatments are available for chronic hepatitis C virus (HCV) infection. To compare benefits and harms of antiviral regimens for chronic HCV infection in treatment-naive adults. English-language literature from MEDLINE (1947 to August 2012), the Cochrane Library Database, Embase, Scopus, PsychINFO, and clinical trial registries. Randomized trials of antiviral treatments and cohort studies examining associations between sustained virologic response (SVR) after therapy and clinical outcomes. Several investigators abstracted study details and quality by using predefined criteria. No trial evaluated effectiveness of treatment on long-term clinical outcomes. Dual therapy with pegylated interferon alfa-2b plus ribavirin was associated with a lower likelihood of SVR than was pegylated interferon alfa-2a plus ribavirin (absolute difference, 8 percentage points [95% CI, 3 to 14 percentage points]) on the basis of 7 poor- to fair-quality trials. For genotype 2 or 3 infection, dual therapy for 12 to 16 weeks was associated with a lower likelihood of SVR than was therapy for 24 weeks, and lower doses of pegylated interferon alfa-2b were less effective than standard doses (2 to 4 fair-quality trials). For genotype 1 infection, fair-quality trials found that triple therapy with pegylated interferon, ribavirin, and either boceprevir (2 trials) or telaprevir (4 trials) was associated with a higher likelihood of SVR than was dual therapy (absolute difference, 22 to 31 percentage points). Compared with dual therapy, boceprevir triple therapy increased risk for hematologic adverse events and telaprevir triple therapy increased risk for anemia and rash. A large well-designed cohort study and 18 smaller cohort studies found that an SVR after antiviral therapy was associated with lower risk for all-cause mortality than was no SVR. Trials involved highly selected populations. Observational studies did not always adequately control for confounders. SVR rates for genotype 1 infection are higher with triple therapy that includes a protease inhibitor than with standard dual therapy. An SVR after antiviral therapy appears associated with improved clinical outcomes. Agency for Healthcare Research and Quality.

Menopausal Hormone Therapy for the Primary Prevention of Chronic Conditions: A Systematic Review to Update the U.S. Preventive Services Task Force Recommendations

Menopausal hormone therapy to prevent chronic conditions is currently not recommended because of its adverse effects. To update evidence about the effectiveness of hormone therapy in reducing risk for chronic conditions and adverse effects, and to examine whether outcomes vary among women in different subgroups. MEDLINE (January 2002 to November 2011), Cochrane Central Register of Controlled Trials and Cochrane Database of Systematic Reviews (through the 3rd quarter of 2011), Scopus, and reference lists. Randomized, placebo-controlled trials of menopausal hormone therapy published in English since 2002 that assessed primary prevention of chronic conditions. Investigators extracted data on participants, study design, analysis, follow-up, and results; 2 investigators independently rated study quality by using established criteria. 9 fair-quality trials met the inclusion criteria. The Women's Health Initiative reported most of the results, had 11 years of follow-up, and had data most applicable to postmenopausal women in the United States. It showed that estrogen plus progestin therapy reduced fractures (46 fewer per 10 000 woman-years) and increased invasive breast cancer (8 more per 10 000 woman-years), stroke (9 more per 10 000 woman-years), deep venous thrombosis (12 more per 10 000 woman-years), pulmonary embolism (9 more per 10 000 woman-years), lung cancer death (5 more per 10 000 woman-years), gallbladder disease (20 more per 10 000 woman-years), dementia (22 more per 10 000 woman-years), and urinary incontinence (872 more per 10 000 woman-years). Estrogen-only therapy reduced fractures (56 fewer per 10 000 woman-years), invasive breast cancer (8 fewer per 10 000 woman-years), and death (2 fewer per 10 000 woman-years) and increased stroke (11 more per 10 000 woman-years), deep venous thrombosis (7 more per 10 000 woman-years), gallbladder disease (33 more per 10 000 woman-years), and urinary incontinence (1271 more per 10 000 woman-years). Outcomes did not consistently differ by age or comorbid conditions. Limitations of the trials included low adherence, high attrition, inadequate power to detect risks for some outcomes, and evaluation of few regimens. Estrogen plus progestin and estrogen alone decreased risk for fractures but increased risk for stroke, thromboembolic events, gallbladder disease, and urinary incontinence. Estrogen plus progestin increased risk for breast cancer and probable dementia, whereas estrogen alone decreased risk for breast cancer. Agency for Healthcare Research and Quality.

Primary Care–Relevant Interventions to Prevent Falling in Older Adults: A Systematic Evidence Review for the U.S. Preventive Services Task Force

Falls among older adults are both prevalent and preventable. To describe the benefits and harms of interventions that could be used by primary care practitioners to prevent falling among community-dwelling older adults. The reviewers evaluated trials from a good-quality systematic review published in 2003 and searched MEDLINE, the Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and CINAHL from the end of that review's search date to February 2010 to identify additional English-language trials. Two reviewers independently screened 3423 abstracts and 638 articles to identify randomized, controlled trials (RCTs) of primary care-relevant interventions among community-dwelling older adults that reported falls or fallers as an outcome. Trials were independently critically appraised to include only good- or fair-quality trials; discrepancies were resolved by a third reviewer. One reviewer abstracted data from 61 articles into standardized evidence tables that were verified by a second reviewer. Overall, the included evidence was of fair quality. In 16 RCTs evaluating exercise or physical therapy, interventions reduced falling (risk ratio, 0.87 [95% CI, 0.81 to 0.94]). In 9 RCTs of vitamin D supplementation, interventions reduced falling (risk ratio, 0.83 [CI, 0.77 to 0.89]). In 19 trials involving multifactorial assessment and management, interventions with comprehensive management seemed to reduce falling, although overall pooled estimates were not statistically significant (risk ratio, 0.94 [CI, 0.87 to 1.02]). Limited evidence suggested that serious clinical harms were no more common for older adults in intervention groups than for those in control groups. Interventions and methods of fall ascertainment were heterogeneous. Data on potential harms of interventions were scant and often not reported. Primary care-relevant interventions exist that can reduce falling among community-dwelling older adults. Agency for Healthcare Research and Quality.

A Critical Review of Interventions to Increase Compliance with Medication-Taking, Obtaining Medication Refills, and Appointment-Keeping in the Treatment of Cardiovascular Disease

Background. The aim of this study was to critically review the literature regarding interventions to improve cardiovascular patients' compliance with medication-taking, obtaining medication refills, or appointment keeping.Methods. The search for relevant randomized trials involved searching the Medline, Healthplan, and Psychlit databases from 1985 to 1996; searching the bibliographies of located studies; contacting Austral ian government departments, nongovernment organizations, and pharmaceutical companies; and ultimate review of the resulting list by two field experts. The 33 located trials were critically appraised and classified as being of good, fair, or poor methodological quality. Descriptive and effectiveness data were then extracted from the 20 good and fair quality trials. Interrater reliability was high on the 20% of references double-coded.Results. The 20 studies reviewed evaluated the effectiveness of 18 intervention strategies. Tentative recommendations were made for many patient-focused and structural strategies across all three target behaviors. Physician-focused strategies, tested only for appointment keeping, were all tentatively recommended against.Conclusions. The methodological quality of many of the located trials was less than optimal, prohibiting strong recommendations. Therefore, further good-quality, randomized trials are necessary in order to clarify the effectiveness of those strategies identified as potentially useful in this review.