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.     

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.     

Smoking reduction fails to improve clinical and biological markers of cardiac disease: a randomized controlled trial.

Cigarette reduction has been proposed as a treatment goal for smokers who are not interested in stopping completely. This randomized controlled trial was designed to determine the effect of a smoking reduction intervention on smoking behavior, symptoms of heart disease, and biomarkers of tobacco exposure. It included 152 patients with heart disease who did not intend to stop smoking in the next 30 days. Participants were randomly assigned to smoking reduction (SR) or usual care (UC). SR subjects received counseling and nicotine replacement therapy to encourage > or =50% reduction in cigarettes per day (CPD). They were followed at 1, 3, 6, 12 and 18 months to assess smoking, heart disease symptoms, quality of life and nicotine, cotinine, carbon monoxide (CO), white blood cell (WBC) count, fibrinogen, hs-C-reactive protein (hs-CRP), F2-isoprostane, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and its glucuronides (total NNAL), and 1-hydroxypyrene (1-HOP). At 6 months SR participants reduced by 10.9 CPD, compared with 7.4 CPD in UC (difference NS). At 18 months, 9/78 SR vs. 9/74 UC participants quit smoking. There were no significant differences between treatment groups in angina, quality of life or adverse events, nicotine, cotinine, CO, WBC count, fibrinogen, hs-CRP, F2-isoprostane, total NNAL or 1-HOP levels at any time point. To determine if smoking reduction, regardless of treatment condition, was associated with improved outcomes, we compared all subjects at 6 months to baseline (mean reduction in CPD from 27.4 to 18.1, p<.01). There were no significant changes in outcome variables except CO, which decreased by 5.5 ppm (p<.01). There were also no significant improvements considering only subjects who reduced by > or =50%, or those who had no history of reduction prior to enrollment in the study. The SR intervention did not significantly reduce CPD or toxin exposure, or improve smoking cessation or clinical outcomes compared to UC. These results emphasize the importance of abstinence for smokers with heart disease to minimize health risks from tobacco.     

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.     

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.     

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.     

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.     

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.     

Improving growth rates in preweaning calves on dairy farms: A randomized controlled trial

Previous research has identified key factors associated with improved average daily gain (ADG) in preweaning dairy calves and these factors have been combined to create a web app–based calf health plan (www.nottingham.ac.uk/herdhealthtoolkit). A randomized controlled trial was conducted to determine the effect of implementing this evidence-based calf health plan on both productivity and health outcomes for calves reared on British dairy farms. Sixty dairy farms were randomized by location (North, South, and Midlands) to either receive the plan at the beginning (INT) or after the end of the trial (CON) and recorded birth and weaning weights by weigh tape, and cases of morbidity and mortality. Calf records were returned for 3,593 calves from 45 farms (21 CON, 24 INT), with 1,760 calves from 43 farms having 2 weights recorded >40 d apart for ADG calculations, with 1,871 calves from 43 farms born >90 d before the end of the trial for morbidity and mortality calculations. Associations between both intervention group and the number of interventions in place with ADG were analyzed using linear regression models. Morbidity and mortality rates were analyzed using beta regression models. Mean ADG was 0.78 kg/d, ranging from 0.33 to 1.13 kg/d, with mean rates of 20.12% (0–96.55%), 16.40% (0–95.24%), and 4.28% (0–18.75%) for diarrhea, pneumonia, and mortality. The INT farms were undertaking a greater number of interventions (9.9) by the end of the trial than CON farms (7.6). Mean farm ADG was higher for calves on INT farms than CON farms for both male beef (MB, +0.22 kg/d) and dairy heifer (DH, +0.03 kg/d) calves. The MB calves on INT farms had significantly increased mean ADG (0.12 kg/d, 95% confidence interval: 0.02–0.22) compared with CON farms. No significant differences were observed between intervention groups for morbidity or mortality. Implementing one additional intervention from the plan, regardless of intervention group, was associated with improvements in mean ADG for DH calves of 0.01 kg/d (0.01, 0–0.03) and MB calves of 0.02 kg/d (0.00–0.04). Model predictions suggest that a farm with the highest number of interventions in place (15) compared with farms with the lowest number of interventions in place (4) would expect an improvement in growth rates from 0.65 to 0.81 kg/d for MB, from 0.73 to 0.88 kg/d for DH, a decrease in mortality rates from 10.9% to 2.8% in MB, and a decrease in diarrhea rates from 42.1% to 15.1% in DH. The calf health plan tested in this study represents a useful tool to aid veterinarians and farmers in the implementation of effective management interventions likely to improve the growth rates, health, and welfare of preweaning calves on dairy farms.     

Hypnosis for smoking cessation: a randomized trial

The purpose of this study was to determine whether hypnosis would be more effective in helping smokers quit than standard behavioral counseling when both interventions are combined with nicotine patches (NP). A total of 286 current smokers were enrolled in a randomized controlled smoking cessation trial at the San Francisco Veterans Affairs Medical Center. Participants in both treatment conditions were seen for two 60-min sessions, and received three follow-up phone calls and 2 months of NP. At 6 months, 29% of the hypnosis group reported 7-day point-prevalence abstinence compared with 23% of the behavioral counseling group (relative risk [RR] = 1.27; 95% confidence interval, CI 0.84-1.92). Based on biochemical or proxy confirmation, 26% of the participants in the hypnosis group were abstinent at 6 months compared with 18% of the behavioral group (RR = 1.44; 95% CI 0.91-2.30). At 12 months, the self-reported 7-day point-prevalence quit rate was 24% for the hypnosis group and 16% for the behavioral group (RR = 1.47; 95% CI 0.90-2.40). Based on biochemical or proxy confirmation, 20% of the participants in the hypnosis group were abstinent at 12 months compared with 14% of the behavioral group (RR = 1.40; 95% CI 0.81-2.42). Among participants with a history of depression, hypnosis yielded significantly higher validated point-prevalence quit rates at 6 and 12 months than standard treatment. It was concluded that hypnosis combined with NP compares favorably with standard behavioral counseling in generating long-term quit rates.     

Cluster randomized controlled trial of the plastic BioSand Water filter in Cambodia

About half of the rural population of Cambodia lacks access to improved water; an even higher percentage lacks access to latrines. More than 35,000 concrete BioSand Water filters (BSF) have been installed in the country. However, the concrete BSF takes time to produce and weighs hundreds of pounds. A plastic BSF has been developed but may not perform to the same benchmarks established by its predecessor. To evaluate plastic BSF performance and health impact, we performed a cluster randomized controlled trial in 13 communities including 189 households and 1147 participants in the Angk Snoul district of Kandal Province from May to December 2008. The results suggest that villages with plastic BSFs had significantly lower concentrations of E. coli in drinking water and lower diarrheal disease (incidence rate ratio 0.41, 95% confidence interval: 0.24-0.69) compared to control villages. As one of the first studies on the plastic BSF in Cambodia, these are important findings, especially in a setting where the concrete BSF has seen high rates of continued use years after installation. The study suggests the plastic BSF may play an important role in scaling up the distribution/implementation of the BSF, potentially improving water quality and health in the region.