Assessing Early Behavioral Indicators of Tolerance in Infants Receiving Formula with Added Lactobacillus rhamnosus GG (LGG)

Abstract Objectives To evaluate the nutritive effects of an infant formula with added LGG on early behavioral indicators of tolerance in infants experiencing crying and fussing often associated with infantile colic. Methods In this single-center, double-blind, controlled, parallel, prospective study, infants (14 to 28 days of age) determined to cry and/or fuss ≥3 hours/day for ≥3 days/week (in a one-week period) were randomized to receive one of two formulas over a 21-day feeding period: marketed partially hydrolyzed (PH) cow's milk-based infant formula (PH: n, 35) or a similar formula with added LGG (PH-LGG: n, 36). Parents/caregivers used a validated parent-report diary to record crying/fussing and awake/content behavior at three time points: Study Days 2–4 (baseline), Days 10–12, and Days 18–20 (Study End). The primary outcome, duration (hours/day) of crying/fussing (averaged over each three-day period), was analyzed by repeated measures, mixed-effects models. Results Birth characteristics (sex, race, weight) and age (days; mean ± SE) at study entry (PH: 19.7 ± 0.8; PH-LGG: 19.3 ± 0.8) were similar for study groups. No group differences in mean study formula intake (g/day) or mean achieved weight (g) at any study time point were detected. Completion rates were similar through Day 21 (PH: n = 33, 94%; PH-LGG: n = 33, 92%). Duration of crying/fussing (mean ± SE) decreased over time with no significant differences detected in the PH vs PH-LGG group at Baseline (4.8 ± 0.3 vs 4.0 ± 0.3; P = 0.086), Days 10–12 (3.5 ± 0.3 vs 2.6 ± 0.3; P = 0.056), and Days 18–20 (2.1 ± 0.3 vs 1.5 ± 0.3; P = 0.227). Duration of awake/content behavior increased over time with no significant differences detected in PH vs PH-LGG: Baseline (1.0 ± 0.5 vs 1.2 ± 0.5; P = 0.786), Days 10–12 (1.3 ± 0.5 vs 1.6 ± 0.5; P = 0.627), and Days 18–20 (2.1 ± 0.5 vs 2.2 ± 0.5; P = 0.884). By Study End, only 8 (24%) in the PH and 9 (27%) in the PH-LGG group continued to cry and/or fuss ≥3 hours/day for ≥3 days/week. Conclusions In the present pilot study, we identified a study population of infants early in life experiencing crying and fussing often associated with infantile colic. Both study formulas were well tolerated. Crying/fussiness decreased and awake/content behavior increased in both study groups over the course of the study. Funding Sources Mead Johnson Nutrition.

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Urine and Plasma Catecholamine and Cortisol Concentrations after Myocardial Revascularization

Anesthesiology ◽

10.1097/00000542-199704000-00008 ◽

1997 ◽

Vol 86 (4) ◽

pp. 785-796 ◽

Cited By ~ 42

Author(s):

J. Jerill Plunkett ◽

John D. Reeves ◽

Long Ngo ◽

Wayne Bellows ◽

Steven L. Shafer ◽

...

Keyword(s):

Cardiopulmonary Bypass ◽

Repeated Measures ◽

Bypass Graft ◽

Myocardial Revascularization ◽

Study Groups ◽

Plasma Catecholamine ◽

Bolus Administration ◽

Opioid Use ◽

Double Blind ◽

Urine Cortisol

Background Cardiopulmonary bypass is associated with substantial release of catecholamines and cortisol for 12 or more h. A technique was assessed that may mitigate the responses with continuous 12-h postoperative sedation using propofol. Methods One hundred twenty-one patients having primary elective cardiopulmonary bypass graft (CABG) surgery were enrolled in a double-blind, randomized trial and anesthetized using a standardized sufentanil-midazolam regimen. When arriving at the intensive care unit (ICU), patients were randomly assigned to either group SC (standard care), in which intermittent bolus administration of midazolam and morphine were given as required to keep patients comfortable; or group CP (continuous propofol), in which 12 h of continuous postoperative infusion of propofol was titrated to keep patients deeply sedated. Serial perioperative measurements of plasma and urine cortisol, epinephrine, norepinephrine, and dopamine were obtained; heart rate and blood pressure were recorded continuously, and medication use, including requirements for opioids and vasoactive drugs, was recorded. Repeated-measures analysis was used to assess differences between study groups for plasma catecholamine and cortisol levels at each measurement time. Results In the control state-before the initiation of postoperative sedation in the ICU-no significant differences between study groups were observed for urine or plasma catecholamine or cortisol concentrations. During the ICU study period, for the first 6-8 h, significant differences were found between study groups SC and CP in plasma cortisol (SC = 28 +/- 15 mg/dl; CP = 19 +/- 12 mg/dl; estimated mean difference [EMD] = 9 mg/dl; P = 0.0004), plasma epinephrine (SC = 132 +/- 120 micrograms/ml; CP = 77 +/- 122 micrograms/ml; EMD = 69 micrograms/ml; P = 0.009), urine cortisol (SC = 216 +/- 313 micrograms/ml; CP = 93 +/- 129 micrograms/ml; EMD = 127 micrograms/ml; P = 0.007), urine dopamine (SC = 85 +/- 48 micrograms; CP = 52 +/- 43 micrograms; EMD = 32 micrograms; P = 0.002), urine epinephrine (SC = 7 +/- 8 micrograms; CP = 4 +/- 5 micrograms; EMD = 3 micrograms; P = 0.0009), and urine norepinephrine (SC = 24 +/- 14 mg; CP = 13 +/- 9 mg; EMD = 11 mg; P = 0.0004). Reductions in urine and plasma catecholamine and cortisol concentrations found for the CP group generally persisted during the 12-h propofol infusion period and then rapidly returned toward control (SC group) values after propofol was discontinued. Postoperative opioid use was reduced in the CP group (SC = 97%; CP = 49%; P = 0.001), as was the incidence of tachycardia (SC = 79%; CP = 60%; P = 0.04) and hypertension (SC = 58%; CP = 33%; P = 0.01), but the incidence of hypotension was increased (SC = 49%; CP = 81%; P = 0.001). Conclusions Cardiopulmonary bypass graft surgery is associated with substantial increases in plasma and urine catecholamine and cortisol concentrations, which persist for 12 or more h. This hormonal response may be mitigated by a technique of intensive continuous 12-h postoperative sedation with propofol, which is associated with a decrease in tachycardia and hypertension and an increase in hypotension.

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Absence of adverse events in healthy individuals using probiotics – analysis of six randomised studies by one study group

Beneficial Microbes ◽

10.3920/bm2015.0096 ◽

2016 ◽

Vol 7 (2) ◽

pp. 161-169 ◽

Cited By ~ 9

Author(s):

L. Tapiovaara ◽

L. Lehtoranta ◽

T. Poussa ◽

H. Mäkivuokko ◽

R. Korpela ◽

...

Keyword(s):

Adverse Events ◽

Lactobacillus Rhamnosus ◽

Study Groups ◽

Elderly Subjects ◽

Study Group ◽

Double Blind ◽

Lack Of Information ◽

Individual Participant ◽

Live Bacteria ◽

Study Population

Consumption of live bacteria as probiotic supplements is increasing. There is, however, a lack of information on the safety of ingested probiotics. The main objective of this study was to investigate the adverse events (AEs) of specific probiotics (Lactobacillus rhamnosus GG (LGG) alone or LGG in combination with L. rhamnosus Lc705, Propionibacterium freudenreichii JS, Bifidobacterium lactis BB12, or Bifidobacterium breve 99) studied in six of our study groups’ clinical trials, by analysing individual participant data. A secondary objective was to study AEs associated with the consumed probiotic species and mixtures in three specific categories; ‘gastrointestinal disorders’, ‘respiratory, thoracic and mediastinal disorders’ and ‘infections and infestations’. Six randomised, double-blind, placebo-controlled clinical studies by our study group were included in this AE analysis (study population n=1,909). All AE data were classified according to the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE) v4.0. From the 26 CTCAE System Organ Classes, we identified AEs in 20 classes among 1,909 subjects. Probiotic ingestion did not result in statistically significant differences in AEs in different groups, when compared to placebo. A subgroup analysis of gastrointestinal, respiratory, thoracic and mediastinal disorders, infections and infestations, found no differences between the intervention groups or for different probiotic combinations (risk ratio (RR) = 0.97, 95% confidence interval (CI): 0.93-1.02, P=0.30; RR=0.99, 95% CI: 0.97-1.01, P=0.35; RR=0.99, 95% CI: 0.93-1.06, P=0.62, respectively). As a conclusion, ingestion of probiotic supplementations containing LGG alone, or LGG in combination with L. rhamnosus Lc705, P. freudenreichii JS, B. breve 99, or B. lactis BB12 did not seem to cause AEs in young and elderly subjects in this analysis.

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Bimonthly assessment of magnetization transfer magnetic resonance imaging parameters in multiple sclerosis: a 14-month, multicentre, follow-up study

Multiple Sclerosis Journal ◽

10.1177/1352458509358713 ◽

2010 ◽

Vol 16 (3) ◽

pp. 325-331 ◽

Cited By ~ 7

Author(s):

S. Mesaros ◽

MA Rocca ◽

MP Sormani ◽

P. Valsasina ◽

C. Markowitz ◽

...

Keyword(s):

Multiple Sclerosis ◽

Treatment Effect ◽

Repeated Measures ◽

Magnetization Transfer ◽

Random Effect ◽

Lesion Volume ◽

Sample Sizes ◽

Double Blind ◽

Over Time

This study was performed to assess the temporal evolution of damage within lesions and the normal-appearing white matter, measured using frequent magnetization transfer (MT) MRI, in relapsing—remitting multiple sclerosis (RRMS). The relationship of MT ratio (MTR) changes with measures of lesion burden, and the sample sizes needed to demonstrate a treatment effect on MTR metrics in placebo-controlled MS trials were also investigated. Bimonthly brain conventional and MT MRI scans were acquired from 42 patients with RRMS enrolled in the placebo arm of a 14-month, double-blind trial. Longitudinal MRI changes were evaluated using a random effect linear model accounting for repeated measures, and adjusted for centre effects. The Expanded Disability Status Scale (EDSS) score remained stable over the study period. A weak, but not statistically significant, decrease over time was detected for normal-appearing brain tissue (NABT) average MTR (—0.02% per visit; p = 0.14), and MTR peak height (—0.15 per visit; p = 0.17), while average lesion MTR showed a significant decrease over the study period (—0.07% per visit; p = 0.03). At each visit, all MTR variables were significantly correlated with T2 lesion volume (LV) (average coefficients of correlation ranging from —0.54 to —0.28, and p-values from <0.001 to 0.02). At each visit, NABT average MTR was also significantly correlated with T1-hypointense LV (average coefficient of correlation = —0.57, p < 0.001). The estimation of the sample sizes required to demonstrate a reduction of average lesion MTR (the only parameter with a significant decrease over the follow-up) ranged from 101 to 154 patients to detect a treatment effect of 50% in a 1-year trial with a power of 90%. The steady correlation observed between conventional and MT MRI measures over time supports the hypothesis of axonal degeneration of fibres passing through focal lesions as one of the factors contributing to the overall MS burden.

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Abstract 52: Efficacy and Safety of Mipomersen in Patients with Familial Hypercholesterolemia and Inadequately Controlled LDL-C Levels

Arteriosclerosis Thrombosis and Vascular Biology ◽

10.1161/atvb.36.suppl_1.52 ◽

2016 ◽

Vol 36 (suppl_1) ◽

Author(s):

Christie Ballantyne ◽

Alberico L Catapano ◽

Michael Davidson ◽

Robert Mittleman ◽

Patrick M Moriarty ◽

...

Keyword(s):

Adverse Events ◽

Familial Hypercholesterolemia ◽

Repeated Measures ◽

Mixed Model ◽

Primary Objective ◽

Tolerability Profile ◽

Primary Analysis ◽

Double Blind ◽

Absolute Reduction ◽

Over Time

Aim: Mipomersen is an antisense oligonucleotide inhibitor of apolipoprotein B-100 synthesis, FDA-approved to treat homozygous familial hypercholesterolemia. The primary objective of this study was to determine whether mipomersen significantly reduced atherogenic lipid levels in patients with severe heterozygous familial hypercholesterolemia (HeFH). Methods: This was a randomized, double-blind, placebo-controlled, parallel-group study comprised of two cohorts (NCT01475825). Cohort 1 had severe HeFH (LDL-C ≥200 mg/dL + coronary heart disease, or LDL-C ≥300 mg/dL) and Cohort 2 had milder HeFH (LDL-C ≥160 and <200 mg/dL). For each cohort, patients were randomized 1:1 to 200 mg SC once weekly or 70 mg SC thrice weekly, then 2:1 to receive mipomersen or placebo for 60 weeks. The primary outcome was percent change from baseline in LDL-C in Cohort 1. The % change from baseline in LDL-C at Week 61 for mipomersen treated patients was compared to placebo using a mixed model for repeated measures (MMRM), as well as by ANCOVA on the value closest to 7 days post last treatment (LOCF). Results: Mean baseline LDL-C levels were 265 mg/dL in Cohort 1 (N=200) and 176 mg/dL in Cohort 2 (N=109). In Cohort 1, mipomersen 200 mg weekly reduced LDL-C levels by -29.7% (vs -7.9% placebo, P <.001) in the mixed model, and by -36.3% (vs -7.6% placebo, P <.001) using the LOCF. Analysis of LDL-C over time (Figure) showed a mean absolute reduction of 138 mg/dL in mipomersen patients who completed the blinded treatment period (n=32), achieving a mean level of 147 mg/dL from a mean 285 mg/dL baseline level. Tolerability to treatment and adverse events were similar between dose regimens. Adverse events were consistent with the drug’s known safety and tolerability profile. Conclusions: The primary analysis showed a significant reduction in LDL-C levels in patients with severe HeFH who received mipomersen 200 mg once weekly versus placebo. A highly relevant absolute reduction in LDL-C was achieved over time.

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Individualized Whole-Body Vibration: Neuromuscular, Biochemical, Muscle Damage and Inflammatory Acute Responses

Dose-Response ◽

10.1177/1559325820931262 ◽

2020 ◽

Vol 18 (2) ◽

pp. 155932582093126

Author(s):

Riccardo Di Giminiani ◽

Nadia Rucci ◽

Lorenzo Capuano ◽

Marco Ponzetti ◽

Federica Aielli ◽

...

Keyword(s):

Muscle Damage ◽

Repeated Measures ◽

Whole Body Vibration ◽

Voluntary Contraction ◽

Whole Body ◽

Electromyographic Activity ◽

Double Blind ◽

Body Vibration ◽

Neuromuscular Responses ◽

Over Time

Objective. We aimed to investigate the acute residual hormonal, biochemical, and neuromuscular responses to a single session of individualized whole-body vibration (WBV) while maintaining a half-squat position. Methods. Twenty male sport science students voluntarily participated in the present study and were randomly assigned to an individualized WBV group (with the acceleration load determined for each participant) or an isometric group (ISOM). A double-blind, controlled parallel study design with repeated measures was employed. Results. Testosterone and growth hormone increased significantly over time in the WBV group ( P < .05 and P < .01, respectively; effect size [ES] ranged from 1.00 to 1.23), whereas cortisol increased over time in both groups ( P < .01; ES ranged from 1.04 and 1.36). Interleukin-6 and creatine kinase increased significantly over time only in the WBV group ( P < .05; ES = 1.07). The maximal voluntary contraction decreased significantly over time in the ISOM group ( P = .019; ES = 0.42), whereas in the WBV group, the decrease did not reach a significant level ( P = .05). The ratio of electromyographic activity and power decreased significantly over time in the WBV group ( P < .01; ES ranged from 0.57 to 0.72). Conclusion. Individualized WBV increased serum hormonal concentrations, muscle damage, and inflammation to levels similar to those induced by resistance training and hypertrophy exercises.

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Effects of Inhalation Anesthetics on the Profile of Urinary Neopterin as an Immune Marker in Patients who Underwent Laparoscopic Cholecystectomy

Pteridines ◽

10.1515/pteridines.2011.22.1.18 ◽

2011 ◽

Vol 22 (1) ◽

pp. 18-23

Author(s):

Zeynep Capan ◽

Terken Baydar ◽

Gozde Girgin ◽

Anil Dolgun ◽

Beyazit Dikmen ◽

...

Keyword(s):

Immune Response ◽

Laparoscopic Cholecystectomy ◽

Immune System ◽

Repeated Measures ◽

High Performance ◽

Study Groups ◽

Urine Samples ◽

Double Blind ◽

Inhalation Anesthetics ◽

Urinary Neopterin

Abstract It has been claimed that inhalational anesthetics affect many phases of immune response. Although, there are a lot of studies on the effects of widely used anaesthetic agents and methods on the immune system, there are only a few studies to show the effects by evaluation of neopterin concentrations as an important marker of cellular immunity. This study was done to evaluate possible effects of inhalation anesthetics, such as desflurane, isoflurane, and sevoflurane on the immune system by measuring urinary neopterin concentrations in patients who underwent laparoscopic cholecystectomy. The study is randomized, prospective and double blind. Urinary neopterin was measured in patients submitted to general anesthesia with either desflurane (n = 20) or isoflurane (n = 11), or sevoflurane (n = 13) in laparoscopic cholecystectomy. Urine samples were collected preoperatively, at 2nd and 24th hours post-operatively and the neopterin per creatinine concentrations were measured by using high-performance liquid chromatography.The preoperative neopterin levels were similar across the study groups. Variance analysis of repeated measures showed an effect of time (p <0.05): Neopterin concentrations increased over time, but the effect of different anesthetics on neopterin was similar. The mean increases in neopterin concentrations were similar among all the applied anesthetics. In conclusion, this report shows changes of immune response by investigation of neopterin in urine samples during 24 hours in patients exposed to three different inhalational anesthetic agents sevoflurane, desflurane and isoflurane in laparoscopic cholecystectomy.

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Acute Paraxanthine Ingestion Improves Cognition and Short-Term Memory and Helps Sustain Attention in a Double-Blind, Placebo-Controlled, Crossover Trial

Nutrients ◽

10.3390/nu13113980 ◽

2021 ◽

Vol 13 (11) ◽

pp. 3980

Author(s):

Choongsung Yoo ◽

Dante Xing ◽

Drew Gonzalez ◽

Victoria Jenkins ◽

Kay Nottingham ◽

...

Keyword(s):

Response Time ◽

Side Effect ◽

Repeated Measures ◽

Short Term Memory ◽

Short Term ◽

Double Blind ◽

Term Memory ◽

Double Blind Placebo ◽

Psychomotor Vigilance ◽

Over Time

This study examined the effects of acute paraxanthine (PXN) ingestion on markers of cognition, executive function, and psychomotor vigilance. In a randomized, double blind, placebo-controlled, crossover, and counterbalanced manner, 13 healthy male and female participants were randomly assigned to consume a placebo (PLA) or 200 mg of PXN (ENFINITY™, Ingenious Ingredients, L.P.). Participants completed stimulant sensitivity and side effect questionnaires and then performed the Berg Wisconsin Card Sorting Test (BCST), the Go/No-Go test (GNG), the Sternberg task test (STT), and the psychomotor vigilance task test (PVTT). Participants then ingested one capsule of PLA or PXN treatment. Participants completed side effect and cognitive function tests after 1, 2, 3, 4, 5, and 6 h after ingestion of the supplement. After 7 days, participants repeated the experiment while consuming the alternative treatment. Data were analyzed by general linear model (GLM) univariate analyses with repeated measures using body mass as a covariate, and by assessing mean and percent changes from baseline with 95% confidence intervals (CIs) expressed as means (LL, UL). PXN decreased BCST errors (PXN −4.7 [−0.2, −9.20], p = 0.04; PXN −17.5% [−36.1, 1.0], p = 0.06) and perseverative errors (PXN −2.2 [−4.2, −0.2], p = 0.03; PXN −32.8% [−64.4, 1.2], p = 0.04) at hour 6. GNG analysis revealed some evidence that PXN ingestion better maintained mean accuracy over time and Condition R Round 2 response time (e.g., PXN −25.1 [−52.2, 1.9] ms, p = 0.07 faster than PLA at 1 h), suggesting better sustained attention. PXN ingestion improved STT two-letter length absent and present reaction times over time as well as improving six-letter length absent reaction time after 2 h (PXN −86.5 ms [−165, −7.2], p = 0.03; PXN −9.0% [−18.1, 0.2], p = 0.05), suggesting that PXN enhanced the ability to store and retrieve random information of increasing complexity from short-term memory. A moderate treatment x time effect size (ηp2 = 0.08) was observed in PVTT, where PXN sustained vigilance during Trial 2 after 2 h (PXN 840 ms [103, 1576], p = 0.03) and 4 h (PXN 1466 ms [579, 2353], p = 0.002) compared to PL. As testing progressed, the response time improved during the 20 trials and over the course of the 6 h experiment in the PXN treatment, whereas it significantly increased in the PL group. The results suggest that acute PXN ingestion (200 mg) may affect some measures of short-term memory, reasoning, and response time to cognitive challenges and help sustain attention.

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Evaluation of the Efficacy of Probiotics in the Treatment of Infantile Colic; a Randomized, Double Blind; Placebo Controlled Trial

ACTA MEDICA IRANICA ◽

10.18502/acta.v57i7.2325 ◽

2020 ◽

Author(s):

Mojdeh Habibi Zoham ◽

Fatemeh Zafar ◽

Armen Malekiantaghi ◽

Reyhaneh Ettehadi ◽

Seyed Behnam Jazayeri ◽

...

Keyword(s):

Lactobacillus Reuteri ◽

Controlled Trial ◽

Demographic Data ◽

Intervention Group ◽

Lactobacillus Rhamnosus ◽

Infantile Colic ◽

Double Blind ◽

Double Blind Clinical Trial ◽

Significant Difference ◽

Potential Strategy

The infantile colic is one of the most common complaints in the infancy; however, limited therapeutic approaches are described in the literature. Recently probiotics have been suggested as a potential strategy in the treatment of infantile colic. We conducted this study to investigate the efficacy of probiotics in relieving colic symptoms in Iranian infants. This double-blind clinical trial was performed among 70 infants aged 3 to 16 weeks with the presumed diagnosis of infantile colic according to Wessel criteria who were breastfed or formula fed. They were assigned at random to receive Pedilact® (Bifidobacterium infantis, Lactobacillus reuteri, and Lactobacillus rhamnosus) (N=33) or placebo (N=32). Demographic data were recorded in the questionnaires at the beginning of the study. The number of daily episodes of crying and fussiness, number of weekly crying days, and duration of crying were separately analyzed on 7, 21, and 30th days of investigation. Baseline demographic data showed no statistically significant difference between intervention and placebo groups. Infants given Pedilact® showed a significant reduction in daily episodes of crying, duration of crying, and the weekly number of crying days at the end of the treatment period compared with those receiving placebo (P=0.000). On 21th day of the study, daily episodes of fuss and crying (P=0.032) and duration of crying reduced significantly in the intervention group in comparison to the placebo group (P=0.000). Administration of Pedilact® drop significantly improved colic symptoms by reducing crying and fussing times in breastfed or formula fed in Iranian infants with colic. © 2019 Tehran University of Medical Sciences. All rights reserved. Acta Med Iran 2019;57(7):405-411.

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The effect of Reiki on blood hypertension

Acta Paulista de Enfermagem ◽

10.1590/1982-0194201400078 ◽

2014 ◽

Vol 27 (5) ◽

pp. 479-484 ◽

Cited By ~ 3

Author(s):

Léia Fortes Salles ◽

Luciana Vannucci ◽

Amanda Salles ◽

Maria Júlia Paes da Silva

Keyword(s):

Blood Pressure ◽

Repeated Measures ◽

Study Groups ◽

Control Group ◽

Double Blind Study ◽

Double Blind ◽

Anova Model ◽

Significant Difference ◽

Before And After ◽

Experimental Group

Objective Determining the immediate effect of Reiki on abnormal blood pressure. Methods An experimental, double-blind study, in which were included 66 hypertensive patients, randomized to the three following study groups: control, placebo and experimental. The intervention lasted 20 minutes, the control group remained at rest, the placebo group received an imitation of the studied technique (mock Reiki) and the experimental group received the Reiki technique. Blood pressure was measured before and after the intervention by the same person with the same instrument. Results There was a decrease in blood pressure in the three groups and the reduction was greater in the experimental group, followed by the placebo and the control group. The ANOVA model for repeated measures showed a statistically significant difference among the groups (p <0.0001). Conclusion Reiki had a positive effect on reducing abnormal blood pressure, suggesting to be a complementary technique for the control of hypertension.

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Comparison between Gradual Reduced Nicotine Content and Usual Nicotine Content Groups on Subjective Cigarette Ratings in a Randomized Double-Blind Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph17197047 ◽

2020 ◽

Vol 17 (19) ◽

pp. 7047

Author(s):

Wenxue Lin ◽

Nicolle M. Krebs ◽

Junjia Zhu ◽

Jonathan Foulds ◽

Kimberly Horn ◽

...

Keyword(s):

Repeated Measures ◽

The United States ◽

Double Blind ◽

Change Over Time ◽

Subjective Responses ◽

Treatment Groups ◽

Nicotine Content ◽

The Impact ◽

Over Time ◽

Nicotine Reduction

In 2018, the United States Food and Drug Administration (FDA) issued an advanced notice of proposed rulemaking to reduce nicotine in tobacco products to produce a minimally addictive or nonaddictive effect, but there was a research gap in the subjective responses of reduced-nicotine-content cigarettes. We compared the responses of the modified cigarette evaluation questionnaire (mCEQ) and cigarette-liking scale (CLS) between the gradually reduced nicotine content (RNC) group and the usual nicotine content (UNC) group. Linear mixed-effects models for repeated measures were used to analyze and compare the change over time for the mCEQ and CLS across the two treatment groups (RNC and UNC). We found that the change over time for the mCEQ and CLS was significant between the RNC and the UNC treatment groups at the beginning of visit 6 with 1.4 mg nicotine/cigarette. At visits 8 and 9, the RNC group reported significantly lower satisfaction scores compared to UNC. Subscale analysis showed that smoking satisfaction decreased in RNC while other measures, such as cigarette enjoyment, did not change. Understanding the impact of nicotine reduction on cigarette subjective responses through evaluation and liking scales would provide valuable information to the FDA on nicotine reduction policies for cigarettes.

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