Provider feedback to improve 5A's tobacco cessation in primary care: a cluster randomized clinical trial.

The electronic health record (EHR) may be an effective tool to help clinicians address tobacco use more consistently. To evaluate the impact of EHR-generated practice feedback on rates of referral to a state-level tobacco quitline, we conducted a cluster randomized clinical trial (feedback versus no feedback) within 19 primary care clinics in Oregon. Intervention clinics received provider-specific monthly feedback reports generated from EHR data. The reports rated provider performance in asking, advising, assessing, and assisting with tobacco cessation compared with a clinic average and an achievable benchmark of care. During 12 months of follow-up, EHR-documented rates of advising, assessing, and assisting were significantly improved in the intervention clinics compared with the control clinics (p<.001). A higher case-mix index and presence of a clinic champion were associated with higher rates of referral to a state-level quitline. EHR-generated provider feedback improved documentation of assistance with tobacco cessation. Connecting physician offices to a state-level quitline was feasible and well accepted.     

Effects of greens+: a randomized, controlled trial.

Greens+ is a popular natural health product marketed as energy-enhancing; however, no objective data substantiate this claim. The study objective was to determine if ingestion of greens+ 1. increases vitality, energy, and perception of well-being; 2. increases overall mental health and general health, and 3. decreases the incidence of colds and flus in an otherwise healthy female population. A total of 105 women were enrolled in this 12-week, randomized, double-blind, placebo-controlled clinical trial; 63 (60%) completed the treatment protocol. Both treatment and placebo groups showed a significant time trend effect, scoring better on all outcome measures as the trial progressed. Compared with the placebo group, the greens+ group scored marginally higher on vitality, the primary outcome measure (p=0.055), and significantly higher on energy (a secondary outcome measure, p=0.018). Findings were based on repeated measures analysis of variance; baseline scores were used as covariates. Although a trend toward greater improvement in the greens+ group was noted in the other secondary outcome measures, this trend did not reach statistical significance. Overall, our findings were positive but not conclusive that greens+ increases vitality and energy. These results provide justification for further study of the effects of greens+.     

Smoking cessation in homeless populations: a pilot clinical trial.

This study, which tested two motivational interviewing treatment approaches, assessed the feasibility of conducting a community-based smoking cessation intervention among homeless smokers. Participants (N = 46) were recruited from multiple facilities in the Kansas City area and were randomized to two counseling conditions in which they received five individual motivational interviewing sessions, six group meetings, and their choice of 8 weeks of 21-mg nicotine patch or 4-mg nicotine lozenge. The two counseling conditions consisted of motivational interviewing targeted either to smoking behaviors exclusively (smoking only) or to smoking and other addictions or life events that could affect ability to quit (smoking plus). Group meetings were designed to provide educational information and social support. Measures of feasibility assessed included the proportion of participants who returned for randomization among those eligible, adherence to prescribed nicotine replacement therapies, retention rates at the week 26 final study visit, and biochemically verified 7-day abstinence at week 26. Most participants (69.6%) chose nicotine patches, and 32% of those participants reported using at least four patches per week. Carbon monoxide verified 7-day abstinence rates in the smoking-only and smoking-plus groups were 13.04% and 17.39% (ns), respectively, at week 8 and 8.70% and 17.39% (ns), respectively, at week 26. Participants who used at least four patches per week were more likely to have quit at 8 weeks than were those who used fewer patches (33.3% vs. 10.5%, p = .30). Results support the feasibility of conducting a smoking cessation intervention among homeless smokers. Findings also show promising effects for nicotine replacement therapy and counseling in this population. Developing programs to improve smoking cessation outcomes in underserved populations is an essential step toward achieving national health objectives and for ultimately reducing tobacco-related health disparities.     

Smoking cessation with smokeless tobacco and group therapy: an open, randomized, controlled trial

Smokeless tobacco might be effective as an adjunct for smoking cessation. We evaluated the efficacy of smokeless tobacco and group support for smoking cessation in an open, randomized study that compared smokeless tobacco plus group support versus group support only. The study enrolled 263 healthy smokers (M (age) = 49 years) who smoked a mean of 24 cigarettes/day, with a mean of 31 pack-years. Smokeless tobacco was provided for 7 weeks (or up to 12), combined with eight group support visits provided by nurses. The control group received group support only. Smoking cessation rates were statistically significantly better in the smokeless tobacco group than in the control group during the first 7 weeks. Point-prevalence abstinence rates at 7 weeks were 36.4% versus 20.8% (OR = 2.52, p = .001), respectively; and continuous abstinence rates from weeks 4 to 7 were 31.5% versus 19.2% (OR = 1.94, p = .023), respectively. The primary outcomes (i.e., 6-month point prevalence) were 23.1% versus 20.8%, respectively (OR = 1.31, ns). Smokeless tobacco was relatively well tolerated, although 15 subjects (11.2%) stopped use due to adverse events. A total of 25 subjects (17.5 %) were still using smokeless tobacco after 6 months. This trial demonstrated short-term efficacy of smokeless tobacco in combination with group support for smoking cessation but no long-term efficacy.     

A randomized controlled clinical trial of bupropion SR and individual smoking cessation counseling.

Efficacy of bupropion SR and individual counseling as smoking cessation treatments was assessed in a randomized, placebo-controlled clinical trial among adult daily smokers. Bupropion SR treatment and counseling were fully crossed in this factorial design so that the efficacy of each treatment and the combination could be estimated, relative to a placebo medication and assessment control condition. Intent-to-treat analyses indicated that bupropion SR increased abstinence rates at the end of treatment, relative to the placebo medication conditions, for both biochemically confirmed 7-day point-prevalence abstinence (OR = 1.97, 95% CI 1.04-3.72) and self-reported prolonged abstinence (OR = 2.90, 95% CI 1.66-5.06). Bupropion SR treatment also improved latency to lapse and relapse and improved the latency between lapse and relapse in survival analyses. Medication effects were more modest for both 12-month point-prevalence abstinence (OR = 1.47, 95% CI 0.74-2.92) and prolonged abstinence (OR = 1.34, 95% CI 0.66-2.72). Counseling was not associated with increases in the likelihood of abstinence at any time point (odds ratios ranged from 0.80 to 1.16 across abstinence outcomes in the full intent-to-treat sample). Counseling and medication did not significantly interact at any time point, and adding counseling did not improve end-of-treatment point-prevalence abstinence (OR = 1.17, 95% CI 0.68-2.03) or prolonged abstinence (OR = 1.26, 95% CI 0.75-2.12) substantially when offered in conjunction with active medication.     

Interventions to increase use of nicotine gum: a randomized, controlled, single-blind trial.

Medication noncompliance with smoking cessation pharmacotherapies is a significant problem in both research and clinical settings. This randomized, controlled, single-blind study compared three single-session psychological interventions to increase use of nicotine gum during a 15-day treatment period. A total of 97 adult smokers were randomized to receive standard treatment (ST, n = 31), brief feedback (BF, n = 32) plus ST, or contingency management (CM; i.e., payment for chewing at least 12 pieces/day on 10 of 15 intervention days, n = 34) plus ST and BF. Only the CM condition led to significantly greater average daily gum use (pieces/day: ST, 6.17; BF, 7.81; CM, 10.17 [p values <.05]) and higher rates of compliance (ST, 13.6%; BF, 25.2%; CM, 65.6% [p values <.001]). No differences were observed in smoking abstinence, nicotine withdrawal, or urinary cotinine as a function of treatment. Implications of the present findings are discussed, including application to clinical trials and extension to real-world use of nicotine gum.     

Effect of egg consumption on inflammatory markers: a systematic review and meta-analysis of randomized controlled clinical trials

There is little evidence about whether eggs affect inflammation. The aim of this meta-analysis was to explore the effects of egg consumption on inflammation. A systematic search of online databases (Institute for Scientific Information (ISI), Scopus, Ovid, PubMed, Cochrane) was used to gather clinical trials that assessed the effect of egg consumption on circulating inflammatory biomarkers. Using a random-effects model, pooled weighted mean differences (WMD) and corresponding standard deviations (SD) were calculated. Of the 21 eligible studies found, nine trials were eligible for analysis. Eight trials assessed high-sensitivity C-reactive protein (hs-CRP), four trials assessed interleukin-6 (IL-6), and five trials assessed tumor necrosis factor-alpha (TNF-α). Egg consumption did not affect hs-CRP (WMD 0.24 mg/L; 95% CI: -0.43, 0.90; I² = 53.8; P = 0.48), IL-6 (WMD 0.20 pg/mL; 95% CI: -0.71, 1.11; I² = 69.3; P = 0.50), and TNF-α (WMD: -0.38 pg/mL; 95% CI: -0.87, 0.10; I² = 0.00; P = 0.12) relative to controls. Overall, this meta-analysis revealed that egg consumption had no significant effect on serum biomarkers of inflammation in adults. © 2019 Society of Chemical Industry     

Negatively controlled,randomized clinical trial to evaluate intramammary treatment of nonsevere,gram-negative clinical mastitis

The objective of this negatively controlled, randomized clinical trial was to examine clinical outcomes of 2-d or 8-d treatment using an approved intramammary (IMM) product containing ceftiofur hydrochloride compared with no antimicrobial treatment of nonsevere, gram-negative cases of clinical mastitis (CM). Additionally, we contrasted clinical outcomes of cases caused by Escherichia coli (n = 56) or Klebsiella pneumoniae (n = 54). Cases (n = 168) of nonsevere (abnormal milk or abnormal milk and udder) CM were randomly assigned to receive 2 d (n = 56) or 8 d (n = 56) of IMM ceftiofur or assigned to a negative control group (n = 56). At enrollment, quarter milk samples were collected and used for on-farm culture, somatic cell count (SCC), and confirmatory microbiological analysis. Quarter milk samples were collected weekly from 7 to 28 d after enrollment for microbiological and SCC analysis. Clinical outcomes were followed for 90 d or until the end of lactation (follow-up period, FUP). Overall, no significant differences in quarter-level recurrence of CM (32% for negative control, 34% for the 2-d treatment, and 32% for the 8-d treatment), culling (18% for negative control, 12% for 2-d treatment, and 11% for 8-d treatment), voluntary dry-off of affected quarters (20% for negative control, 30% for 2-d treatment, and 27% for 8-d treatment), days until return to normal milk (4.2 days for negative control, 4.8 days for 2-d treatment, 4.5 days for 8-d treatment), weekly quarter-SCC during the FUP (6.1, 6.3, and 6.0 log₁₀SCC for the negative control, 2-d, and 8-d treatments, respectively), or daily milk yield during the FUP (37.1, 36.3, and 37.6 kg/cow per day for the negative control, 2-d, and 8-d treatments, respectively) were observed among experimental groups. Days of discarded milk were greater for cows assigned to 8-d IMM ceftiofur (11.1 d) than for cows assigned to 2-d (6.9 d) or cows assigned to negative control (5.6 d). Bacteriological cure (BC) at 14 and 21 d after enrollment was greater in cows assigned to 8-d (89%) and 2-d (84%) treatment than in cows assigned to negative control (67%), but this outcome was confounded by pathogen. For CM caused by Kleb. pneumoniae, BC was greater for quarters assigned to receive treatment (combined 2-d and 8-d groups; 74% BC) than for quarters assigned to negative control (18%). In contrast, no differences in BC were observed for CM caused by E. coli (97–98%). Culling and voluntary dry-off of affected quarters were significantly greater for cows with quarters affected by Kleb. pneumoniae (22% culled, 39% voluntary dry-off of quarters) than for cows with quarters affected with E. coli (7% culled, 11% voluntary dry-off of quarters). Overall, use of IMM ceftiofur did not result in improvement of most clinical outcomes, but differences between E. coli and Kleb. pneumoniae were evident. In contrast to E. coli, Kleb. pneumoniae caused chronic intramammary infection and induced worse clinical outcomes. Intramammary antibiotic treatment of most mild and moderate cases of CM caused by E. coli is not necessary, but more research is needed to identify which quarters affected by Kleb. pneumoniae may benefit from antimicrobial therapy.     

Impact of salt reduction interventions on salt taste sensitivity and liking,a cluster randomized controlled trial

BackgroundExcessive intake of salt is associated with high blood pressure, a risk factor for cardiovascular disease. Moreover, a high salt consumption has been related to a reduced salt taste sensitivity, and an increased liking of high salt content foods. Whether a reduction in salt intake over a long period of time can increase salt taste sensitivity and liking of foods with lower salt content requires further research.ObjectiveThis study aims to investigate the effect of gradually lowering salt content in bread, either alone or in combination with dietary counselling, on salt taste sensitivity and liking of salt reduced bread.MethodsA four-month, single blinded, cluster RCT with a parallel design was conducted among Danish families. Families were randomized to receive bread gradually reduced in salt content (Intervention A), bread gradually reduced in salt content in combination with dietary counselling (Intervention B) or bread with regular salt content (control). Salt taste detection thresholds (DT) and recognition thresholds (RT) were measured at baseline and follow-up. Moreover, overall liking of bread with very low (0.4 g/100 g), low (0.8 g/100 g) and normal (1.2 g/100 g) salt content was measured using a 7-point hedonic scale.ResultsEighty-nine families (n = 215) participated in the study. No significant differences between groups were found for DT or RT, but a significant reduction in DT of 18% (−28, −7) and a trend towards a reduction in RT of −16% (−30, 2) was found in Intervention B from baseline to follow-up. The intervention resulted in significantly higher liking of bread with 0.4 g salt/100 g in intervention B compared to the control and borderline significantly higher liking in intervention A compared to the control (p-value = 0.055). No differences were seen between groups in liking of bread with 0.8 g and 1.2 g salt/100 g. From baseline to follow-up all three groups reduced their liking of bread with 1.2 g salt/100 g and in the control group liking of bread with 0.4 g salt/100 g was significantly reduced.ConclusionReducing salt intake by lowering salt content in bread and receiving dietary counselling increased salt taste sensitivity (baseline to follow-up) and resulted in higher liking of bread with very low salt content (0.4 g salt/100 g) compared to control.     

The serotonin transporter 5-HTTLPR polymorphism and treatment response to nicotine patch: follow-up of a randomized controlled trial.

In this follow-up of a randomized placebo-controlled clinical trial of nicotine replacement transdermal patch for smoking cessation, 741 smokers of European ancestry who were randomized to receive active patch or placebo patch were genotyped for the serotonin transporter gene-linked polymorphic region. The study setting was a primary care research network in Oxfordshire, United Kingdom. The primary outcome measures were biochemically verified sustained abstinence from cigarette smoking at end of treatment and 24-week follow-up. The main effect of genotype was not associated with sustained abstinence from smoking at either end of treatment (SL: p=.33; SS: p=.81) or 24-week follow-up (SL: p=.05; SS: p=.21), and we found no evidence for a genotypextreatment interaction effect. In summary, despite the theoretically important contribution of serotonin neurotransmission to smoking cessation, the serotonin transporter gene was not associated with treatment response to nicotine patch for smoking cessation in this primary care-based trial.     

Negatively controlled,randomized clinical trial to evaluate use of intramammary ceftiofur for treatment of nonsevere culture-negative clinical mastitis

The objective of this negatively controlled randomized clinical trial was to compare clinical outcomes of 5-d intramammary treatment using ceftiofur hydrochloride and no antimicrobial treatment of nonsevere culture-negative cases of clinical mastitis (CM). A total of 121 cases of nonsevere (abnormal milk or abnormal milk and udder) culture-negative CM were randomly assigned to either treatment (n = 62) or negative control (n = 59) groups. Quarters assigned to treatment received 1 daily intramammary infusion with an approved commercially available product containing ceftiofur hydrochloride for 5 d. Quarters assigned to the negative control group did not receive any interventions. Enrolled cows were followed for 90 d or until the end of lactation. At enrollment, milk samples from the affected quarter were used for on-farm culture, somatic cell count (SCC) analysis, and further microbiological analysis. During the follow-up period, milk samples were collected for microbiological analysis and SCC analysis. No significant differences between treatment and negative control groups were identified for treatment failure (5% for treatment vs. 10% for negative control, n = 121), quarter-level CM recurrence (8 vs. 5%, n = 91), intramammary infection at 14 or 28 d after enrollment (13 vs. 26%, n = 86), days until clinical cure (4.2 vs. 4.0 d), days to culling (48.3 vs. 36.8 d), daily milk production (43.3 vs. 43.6 kg/cow per day), or weekly quarter SCC (5.5 vs. 5.4 log₁₀ SCC). Days of milk discard were greater for cows assigned to the treatment group (8.5 d) compared with cows assigned to the negative control group (5.6 d). During the follow-up period, cases in the treatment group had a 50% risk reduction in IMI compared with cases in the negative control group. Irrespective of group, negative outcomes such as quarter-level CM recurrence (12%), treatment failure (12%), and culling (5%) occurred infrequently in nonsevere culture-negative cases of CM. Use of intramammary ceftiofur for treatment of nonsevere culture-negative cases of CM did not improve any economically relevant clinical outcome such as culling, milk production, or SCC.     

Correction to: Effect of wheat germ on metabolic markers: a systematic review and meta-analysis of randomized controlled trials

Food Science and Biotechnology - The article “Effect of wheat germ on metabolic markers: a systematic review and meta-analysis of randomized controlled trials”, written by Humna Liaqat,...     

Computer-tailored smoking cessation intervention in a general population setting in Germany: outcome of a randomized controlled trial.

This study reports the outcome of a randomized controlled trial testing a computer-tailored smoking cessation intervention based on the transtheoretical model in a general population setting in Germany. Participants of the smoking intervention study were recruited from an existing general population health examination survey in a university hospital. The sample consisted of 611 current and former smokers at baseline, and of 485 participants in the core group of baseline daily cigarette smokers. Follow-ups were conducted 6, 12, 18, and 24 months after baseline. The intervention was designed for both current and former smokers, involved up to three individualized feedback letters, and was created using expert-system technology. Based on 7-day point-prevalence abstinence and 6-month prolonged abstinence as the outcome measures, the study identified no significant differences between the intervention and control groups. Modeling the full longitudinal data in generalized estimation equation analyses, using different nonresponse procedures, and adjusting for covariates did not alter the results. We conclude that the computer-tailored transtheoretical model-based smoking cessation intervention, as delivered in this study and in this special setting, was ineffective.     

Effect of wheat germ on metabolic markers: a systematic review and meta-analysis of randomized controlled trials

Food Science and Biotechnology - This systematic review and meta-analysis aim to evaluate the association of wheat germ interventions and metabolic markers. An electronic search was performed by...     

Efficacy of the nicotine inhaler in smoking reduction: A double-blind, randomized trial.

Many smokers are not ready to quit but are interested in changing their smoking behavior, particularly if such a change is associated with a reduction in health risk. The present study evaluated the efficacy of the nicotine inhaler in reducing smoking. Exploratory studies assessed whether reduction in smoking was associated with reduction in markers of disease risk. A total of 429 healthy smokers (smoking at least 20 cigarettes/day) were randomly assigned to either nicotine-containing or placebo inhalers, which subjects were allowed to use ad libitum for up to 1 year. The nicotine inhaler was significantly superior to placebo in achieving reduction in daily cigarette consumption by at least 50% after 4 months, compared with baseline (18% vs. 8%, p = .004). Active treatment promoted smoking cessation: 8% of subjects in the nicotine group and 1% in the placebo group were abstinent at month 15. Throughout the study, smoking reduction, per se, independent of treatment group, was associated with a statistically significant decrease in exhaled carbon monoxide and serum cotinine and thiocyanate. Smoking reduction also improved established risk markers for cardiovascular disease over 4 months. The incidence of adverse events did not differ significantly between the active and placebo groups. The most common treatment-related adverse events were throat irritation and cough. In conclusion, the nicotine inhaler can help smokers who are unable or unwilling to quit to reduce daily cigarette consumption, which may be a health benefit on its own and may further promote quitting.