Correction to: Sleep Quality and Congestion with Breathe Right Nasal Strips: Two Randomized Controlled Trials.

The article "Sleep Quality and Congestion with Breathe Right Nasal Strips: Two Randomized Controlled Trials", written by Michael J. Noss, Renee Ciesla, and Gilbert Shanga, was originally published electronically on the publisher's internet portal (currently SpringerLink) on June 17, 2019 without Open Access. The article has now been made Open Access.

Sleep Quality and Congestion with Breathe Right Nasal Strips: Two Randomized Controlled Trials.

INTRODUCTION: Two multicenter, double-blind, randomized controlled trials assessed the effect of Breathe Right Nasal Strips (BRNS) on sleep-related quality of life in otherwise healthy subjects with chronic nocturnal nasal congestion who reported trouble sleeping. METHODS: Subjects were randomized to BRNS or a placebo strip for approximately 8 h each night for 14 days. Efficacy was assessed in the clinic using the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ). RESULTS: A total of 140 subjects were randomized in Study 1, and 130 in Study 2. There was no significant difference between BRNS and placebo on either the NRQLQ "Sleep Problems" domain or the "Feel Tired and Unrefreshed" item of the "Symptoms on Waking in the Morning" domain at day 7 or 14. There was, however, a significant change in the least squares mean difference from baseline to days 7 and 14 in both the BRNS and placebo arms for each of these endpoints. BRNS were well tolerated. CONCLUSIONS: BRNS did not significantly improve subjective measures of sleep quality and nasal congestion compared with placebo strips in this population of chronic nocturnal congestion sufferers with self-reported sleep impairment, possibly due to a strong placebo effect. FUNDING: GlaxoSmithKline Consumer Healthcare. CLINICALTRIALS. GOV REGISTRATION NUMBERS: Study 1: NCT03549117; Study 2: NCT03549130.

A Randomized Controlled Multicenter Trial of an Investigational Liquid Nutritional Formula in Women with Cyclic Breast Pain Associated with Fibrocystic Breast Changes.

OBJECTIVE: A randomized, multicenter, controlled double-blind trial was performed in women with cyclic breast pain (mastalgia) associated with fibrocystic breast changes (FBCs) to determine whether a nutritional formula reduced breast pain and/or nodularity. STUDY DESIGN: Women were randomized to receive a specifically designed liquid formulation (n = 93) (1 g gamma-linolenic acid [GLA], 750 µg iodine, and 70 µg selenium) or control formula (n = 95) (without GLA, iodine, and selenium) daily for three cycles. Women recorded breast pain, medications, and menstrual signs daily using interactive voice-response system. Nodularity was determined by physical breast examination. RESULTS: Breast pain scores decreased similarly in the experimental (-32.2%) and control (-33.1%) groups (p = 0.64). Nodularity was reduced in the experimental, but not the control group (p = 0.03). Among women who continued pain medication, the amount was reduced in the experimental group relative to controls (p = 0.02). CONCLUSION: Women with FBC using the formula containing GLA, iodine, and selenium experienced reduced nodularity and in those women who took over-the-counter breast pain medication, a decrease in the quantity of pain medication was observed.

Safety and immunogenicity of a quadrivalent inactivated influenza vaccine compared to licensed trivalent inactivated influenza vaccines in adults.

PURPOSE: To evaluate the safety and immunogenicity of a prototype quadrivalent inactivated influenza vaccine (QIV) containing two influenza B strains, one of each lineage, compared with licensed trivalent inactivated influenza vaccines (TIVs) containing either a Victoria B-lineage strain (2009-2010 TIV) or a Yamagata B-lineage strain (2008-2009 TIV). METHODS: Healthy adults ≥18 years of age were eligible to participate in this phase II, open-label, randomized, controlled, multicenter study conducted in the US. Participants received a single dose of 2009-2010 TIV, 2008-2009 TIV, or QIV. Sera were collected before and 21 days after vaccine administration to test for hemagglutination inhibition (HAI) antibodies to each of the four influenza strains. Immunogenicity endpoints included geometric mean HAI antibody titers (GMTs) and rates of seroprotection (titer ≥1:40) and seroconversion (4-fold rise pre- to post-vaccination). Safety endpoints included frequency of solicited injection-site and systemic reactions occurring within 3 days of vaccination, and unsolicited non-serious adverse events (AEs) and serious AEs (SAEs) within 21 days of vaccination. RESULTS: One hundred and ninety participants were enrolled to each vaccine group. QIV induced GMTs to each A and B strain that were noninferior to those induced by the 2009-2010 and 2008-2009 TIVs (i.e., lower limit of the two-sided 95% confidence interval of the ratio of GMT(QIV)/GMT(TIV)>0.66 for each strain). Rates of seroprotection and seroconversion were similar in all groups. Incidence and severity of solicited injection-site and systemic reactions, AEs, and SAEs were similar among groups. CONCLUSION: QIV, containing two B strains (one from each B lineage), was as safe and immunogenic as licensed TIV. QIV has the potential to be a useful alternative to TIV and offer protection against both B lineages.

Extract of Salacia oblonga lowers acute glycemia in patients with type 2 diabetes.

BACKGROUND: Two previous studies tested the efficacy of Salacia oblonga extract in healthy adults. OBJECTIVE: This study evaluated the effect of an herbal extract of Salacia oblonga on postprandial glycemia and insulinemia in patients with type 2 diabetes after ingestion of a high-carbohydrate meal. DESIGN: Sixty-six patients with diabetes were studied in this randomized, double-blinded crossover study. In a fasted state, subjects consumed 1 of the following 3 meals: a standard liquid control meal, a control meal + 240 mg Salacia oblonga extract, and a control meal + 480 mg Salacia oblonga extract. Serum glucose and insulin samples were measured at baseline and at postprandial intervals up to 180 min. RESULTS: Both doses of the Salacia extract significantly lowered the postprandial positive area under the glucose curve (14% for the 240 mg extract and 22% for the 480 mg extract) and the adjusted peak glucose response (19% for the lower dose and 27% for the higher dose of extract) to the control meal. In addition, both doses of the herbal extract significantly decreased the postprandial insulin response, lowering both the positive area under the insulin curve and the adjusted peak insulin response (14% and 9%, respectively, for the 240 mg extract; 19% and 12%, respectively, for the 480 mg extract) in comparison with the control meal. CONCLUSIONS: The extract of Salacia oblonga lowers acute glycemia and insulinemia in persons with type 2 diabetes after a high-carbohydrate meal. The results from this study suggest that Salacia may be beneficial to this population for postprandial glucose control.

Effect of a viscous fiber-containing nutrition bar on satiety of patients with type 2 diabetes.

To assess the satiety-promoting effect of a novel viscous fiber-containing nutrition bar, overweight and obese adult subjects with type 2 diabetes (n=99) were randomized into a double blind, crossover study. They were fed a 300kcal lunch consisting of viscous fiber-containing nutrition bars (VF) or commercial nutrition control bars designed for people with diabetes (CH). VF resulted in a 27.1% increase in fullness (p<0.05), a 15.8% decrease in prospective consumption (p<0.001), and a 14.2% decrease in hunger (p<0.001) in the 120-240min post-lunch areas under the curve (AUC) compared to CH, but no differences were observed for nausea or thirst (p>0.05). Similar results were noted for 0-300min AUC values. VF were associated with greater frequencies and intensities of abdominal distention (p<0.001) and flatulence (p<0.001), and greater frequency of stools (p<0.001) compared to CH, but there were no differences in mean or maximum (loosest) stool consistency (p>0.05). Overall, these results suggest that VF could be a useful tool in weight management of type 2 diabetes.