Parallel-group Comparative Study Research Articles

Effect of Food Containing Paramylon Derived from Euglena gracilis EOD-1 on Fatigue in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial.

Euglena gracilis EOD-1, a kind of microalgae, is known to contain a high proportion of paramylon, a type of β-1,3-glucan. Paramylon derived from E. gracilis EOD-1 is presumed to suppress cellular oxidative injury and expected to reduce fatigue and fatigue sensation. Therefore, we aimed to examine whether food containing paramylon derived from E. gracilis EOD-1 (EOD-1PM) ingestion reduced fatigue and fatigue sensation in healthy adults. We conducted a randomized, double-blind, placebo-controlled, parallel-group comparison study in 66 healthy men and women who ingested a placebo or EOD-1PM daily for 4 weeks (daily life fatigue). Furthermore, at the examination days of 0 and 4 weeks, tolerance to fatigue load was evaluated using mental tasks (task-induced fatigue). We evaluated fatigue sensation using the Visual Analogue Scale, the work efficiency of the advanced trail making test and measured serum antioxidant markers. The EOD-1PM group showed significantly lower levels of physical and mental fatigue sensations and higher levels of work efficiency as well as serum biological antioxidant potential levels than the placebo group. These results indicate that EOD-1PM ingestion reduced fatigue and fatigue sensation, which may be due to an increase in antioxidant potential and maintenance of selective attention during work.

Effects of paprika carotenoid supplementation on bone turnover in postmenopausal women: a randomized, double-blind, placebo-controlled, parallel-group comparison study.

BackgroundPaprika (Capsicum annuum L.) is a good source of carotenoids, including capsanthin, β-carotene, β-cryptoxanthin, and zeaxanthin. Several epidemiological studies have shown a beneficial association of intake of these carotenoids or their blood concentration with bone mineral density (BMD) and fracture risk. However, little information is available regarding the effect of intake of these carotenoids on bone metabolism in postmenopausal women.ObjectiveThe objective of the present study was to investigate the effects of paprika carotenoid extract (PCE) on bone turnover in healthy, postmenopausal women.DesignWe conducted a randomized, double-blind, placebo-controlled, parallel-group comparison study. One hundred participants were randomly assigned to PCE or placebo groups. Each group was given a 20 mg PCE (equivalent to 1.4 mg of carotenoids) a day or a placebo for 24 weeks. We measured bone resorption markers (tartrate-resistant acid phosphatase 5b [TRACP-5b] and serum type I collagen cross-linked N-telopeptide [sNTX]) at 12 and 24 weeks and bone formation markers (bone alkaline phosphatase and osteocalcin) at 24 weeks.ResultsThe percentage decrease of TRACP-5b at 24 weeks was significantly higher for PCE than the placebo. There were no significant differences in sNTX or bone formation markers, although PCE decreased each marker compared with the placebo.ConclusionOur findings suggest that PCE supplementation suppresses bone resorption and contributes to maintaining bone quality in postmenopausal women.

A prospective comparative efficacy of azilsartan and telmisartan in hypertensive patients

Background: Hypertension (HT) is defined as either a sustained systolic blood pressure of greater than 140 mmHg or a sustained diastolic blood pressure of greater than 90 mmHg, according to joint national committee (JNC VIII) on hypertension.Methods: A prospective, open, randomized parallel group comparative study of AZL versus telmisartan was done in patients of stage-I HT. The study included 80 patients, 40 in each group (group I and group II) coming to the Department of Pharmacology, Mahatma Gandhi Medical College and Research Institute, Pillayarkuppam, Pondicherry from January 2016 to December 2017. The study was conducted over 8 weeks. Group-I, patients received azilsartan 40-80 mg per day in divided doses and group-II, patients received telmisartan 40-80 mg per day in divided doses according to severity of hypertension.Results: Patients receiving AZL 40 mg and telmisartan 40 mg showed a significant fall (p<0.05) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at 4 weeks and 8 weeks, when compared to baseline. The difference in SBP and DBP between group I (AZL) and II (telmisartan) was statistically significant at 4 weeks (p<0.05) and was highly significant at 8 weeks (p<0.001). Adverse effects such as nasopharyngitis, upper respiratory tract infection, gastroenteritis, headache, dizziness, and fatigue were reported with both drugs.Conclusions: Reduction of BP with AZL was more as compared to telmisartan at 4 weeks and 8 weeks. Safety and tolerability were similar in both groups.

Tofogliflozin does not delay progression of carotid atherosclerosis in patients with type 2 diabetes: a prospective, randomized, open-label, parallel-group comparative study

BackgroundThis study aimed to investigate the preventive effects of tofogliflozin, a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor, on atherosclerosis progression in type 2 diabetes (T2DM) patients without apparent cardiovascular disease (CVD) by monitoring carotid intima-media thickness (IMT).MethodsThis prospective, randomized, open-label, blinded-endpoint, multicenter, parallel-group, comparative study included 340 subjects with T2DM and no history of apparent CVD recruited at 24 clinical units. Subjects were randomly allocated to either the tofogliflozin treatment group (n = 169) or conventional treatment group using drugs other than SGLT2 inhibitors (n = 171). Primary outcomes were changes in mean and maximum common carotid IMT measured by echography during a 104-week treatment period.ResultsIn a mixed-effects model for repeated measures, the mean IMT of the common carotid artery (mean-IMT-CCA), along with the right and left maximum IMT of the CCA (max-IMT-CCA), significantly declined in both the tofogliflozin (− 0.132 mm, SE 0.007; − 0.163 mm, SE 0.013; − 0.170 mm, SE 0.020, respectively) and the control group (− 0.140 mm, SE 0.006; − 0.190 mm, SE 0.012; − 0.190 mm, SE 0.020, respectively). Furthermore, the tofogliflozin and the conventional treatment group did not significantly differ in the progression of the mean-IMT-CCA (mean change (95% CI) 0.008 (− 0.009, 0.025) mm, P = 0.34), along with the right (mean change (95% CI) 0.027 (− 0.005, 0.059) mm, P = 0.10) and the left max-IMT-CCA (mean change (95% CI) 0.020 (− 0.030, 0.070), P = 0.43). Similar findings were obtained even after adjusting for traditional CV risk factors and/or administration of drugs at baseline. Relative to the control treatment effects, tofogliflozin significantly reduced the HbA1c, blood glucose level, body weight/body mass index, abdominal circumference, and systolic blood pressure, and significantly increased the HDL-C. The total and serious adverse events incidences did not significantly vary between the treatment groups.Conclusions/interpretationNo IMT changes were observed between the tofogliflozin and the conventional treatment groups. However, tofogliflozin is a safe and effective treatment option for managing primary CVD risk factors in this population.Clinical Trial Registration UMIN000017607 (https://www.umin.ac.jp/icdr/index.html).

Comparative Study to Evaluate Efficacy & Cost Effectiveness of Olmesartanversus Telmisartan, In Patients of Stage I Hypertension

Background: Hypertension is one of the most common diseases in the world. It is an important and independent risk factor for atherosclerosis, heart failure, renal disease, and peripheral arterial disease. It is directly responsible for 57% of all stroke deaths and 42% of coronary heart disease deaths in India. Aims and Objectives: To evaluate and compare efficacy and cost effectiveness in hypertensive patients receiving Olmesartan and Telmisartan in Stage I hypertensionSubjects and Methods:The present study was an open, prospective, randomized, parallel group comparative study conducted in 60 patients of stage I hypertension over a period of 16 weeks. Patients were randomly allocated to two, age and sex, matched groups of 30 patients each. Group I patients were started on Olmesartan at a dose of 20 mg & Group II patients were put on Telmisartan at a dose of 40 mg. The BP lowering efficacy and cost effective analysis of Olmesartan versus Telmisartan was calculated & compared. The data was entered in Microsoft excel and compiled. Statistical analysis was done using various tests.Results:Maximum patients in both the groups were in age group of 51-60 years. In group I there were 13 males and 17 females. In group II there were 14 males and 16 females. Both Olmesartan and Telmisartan are effective in lowering systolic & diastolic BP in supine & sitting positions & mean BP is also lowerer, more in Olmesartan group. By cost effective analysis Telmisartan was found more cost effective. Incremental cost effective ratio was found to be 218.35.Conclusion: Both Olmesartan and Telmisartan belong to the same antihypertensive drug class, effectively reduce systolic and diastolic blood pressure at various visits. Taking into account Total cost Telmisartan was more cost effective than Olmesartan. ICER was found to be 218.35.

Efficacy and safety of curcumin in combination with paclitaxel in patients with advanced, metastatic breast cancer: A comparative, randomized, double-blind, placebo-controlled clinical trial

Background: The clinical efficacy of curcumin has not yet been established for the treatment of cancer, despite a large body of evidence from numerous preclinical studies suggesting the therapeutic potential of curcumin, particularly in a synergistic combination with paclitaxel. The main obstacle in using curcumin for adjunctive cancer therapy is its low bioavailability via oral administration. Purpose: We assessed the efficacy and safety of intravenous curcumin infusion in combination with paclitaxel in patients with metastatic and advanced breast cancer. Study Design: A randomized, double-blind, placebo-controlled, parallel-group comparative clinical study was conducted. Methods: A total of 150 women with advanced and metastatic breast cancer were randomly assigned to receive either paclitaxel (80 mg/m2) plus placebo or paclitaxel plus curcumin (CUC-1®, 300 mg solution, once per week) intravenously for 12 weeks with 3 months of follow-up. The primary outcome was determined based on the objective response rate (ORR), as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). The secondary outcomes were progression-free survival (PFS), time to tumor progression (TTP), time to tumor treatment failure (TTTF), safety, and quality of life. Results: The intention-to-treat (ITT) analysis revealed that the ORR of curcumin was significantly higher than that of the placebo (51% vs. 33%, p < 0.01) at 4 weeks of follow-up. The difference between the groups was even greater when only patients who had completed the treatment (61% vs. 38%, odds ratio ==2.64, p < 0.01) were included. A superior effect of curcumin vs placebo was observed in both patients who had completed the treatment and all patients included in the ITT analysis, 3 months after termination of the treatment. No other significant differences were observed between the curcumin and the placebo groups, except for fatigue (3 vs. 10 patients, respectively; odds ratio ==3.7, p = 0.05). However, the patients’ self-assessed overall physical performance was significantly higher with curcumin than the placebo during the treatment and at the end of the follow-up, suggesting better tolerance in the curcumin group. Conclusions: Overall, treatment with curcumin in combination with paclitaxel was superior to the paclitaxel-placebo combination with respect to ORR and physical performance after 12 weeks of treatment. Intravenously administered curcumin caused no major safety issues and no reduction in quality of life, and it may be beneficial in reducing fatigue. Advances in knowledge: This is the first clinical study to explore the efficacy and safety of administering curcumin intravenously in combination with chemotherapy in the treatment of cancer patients.

Effect and safety of Echigoshirayukidake (Basidiomycetes-X) on fatty liver: Stratified randomized, double-blind, parallel-group comparison study and safety evaluation study.

Effect and safety of Echigoshirayukidake (Basidiomycetes-X) on fatty liver: Stratified randomized, double-blind, parallel-group comparison study and safety evaluation study.

Effects of switching from a dipeptidyl peptidase-4 inhibitor to luseogliflozin on nocturnal blood pressure in patients with type 2 diabetes: protocol for a multicentre, prospective, randomised, open-label, blinded endpoint parallel-group comparison study

IntroductionNocturnal hypertension is clinically important for patients with type 2 diabetes (T2D), considering its strong correlation with cardiovascular events. We aim to test the hypothesis that the sodium-glucose cotransporter 2...

The Comparative Study of Azilsartan with Telmisartan in Terms of Efficacy, Safety and Cost - Effectiveness in Hypertension

Introduction: Hypertension (HT) represents the most common cardiovascular risk factor amongst the cluster group of Cardiovascular Diseases (CVD). Clinically, HT might be defined as that level of Blood Pressure (BP) at which the institution of therapy reduces the BP-related morbidity and mortality. Azilsartan (AZL) is a relatively new Angiotensin Receptor Blocker (ARB) available for the treatment of any stage of HT. Aim: To compare the efficacy, safety and cost-effectiveness of AZL 40-80 mg once daily versus telmisartan 40-80 mg once daily in patients of stage-I HT. Methods: A prospective, open, randomized parallel group comparative study of AZL versus telmisartan was done in patients of stage-I HT. The study included 80 patients, 40 in each group (group I and group II) coming to the department of Medicine, Rajindra Hospital attached to Government Medical College, Patiala. The study was conducted over 8 weeks. Group I, patients received Azilsartan 40-80 mg per day in divided doses and group II, patients received telmisartan 40-80 mg per day in divided doses according to severity of hypertension. The therapeutic efficacy of drugs was evaluated by monitoring BP. Adverse drug reactions were monitored in patients. The daily cost for each medication was noted and total cost of drugs taken over 8 weeks was calculated. Effectiveness of the drugs was calculated in terms of mm Hg fall in mean BP. All the observations thus made were statistically analyzed using appropriate tests. Results: Patients receiving AZL 40mg and telmisartan 40mg showed a significant fall (p<0.05) in systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at 4 weeks and 8 weeks, when compared to baseline. The difference in SBP and DBP between Group I (AZL) and II (Telmisartan) was statistically significant at 4 weeks (p<0.05) and was highly significant at 8 weeks (p<0.001). Adverse effects such as nasopharyngitis, upper respiratory tract infection, gastroenteritis, headache, dizziness, and fatigue were reported with both drugs. Conclusions: Reduction of BP with AZL was more as compared to telmisartan at 4 weeks and 8 weeks. Safety and tolerability was similar in both groups.

The Effectiveness of Applying Soft Tissue Bonding Adhesive Composed of 2-Ethyl Cyanoacrylate to Epidural Catheter Fixations Using Film Dressings: An Open-Label, Randomized, Parallel-Group Comparative Study

(Anesth Analg. 2019;129(1):149–154) During a cesarean section, epidural catheters that are not adequately fixed can migrate or even fail; this failure can result in insufficient anesthesia for the patient. Although there are various fixation methods for epidural catheters, there is currently no commonly agreed upon technique. These authors conducted their study in patients having a cesarean delivery to determine if a film dressing used in combination with a surgical adhesive (Aron Alpha A) would provide superior fixation in comparison to a film dressing used independently.

Daily Ingestion of Eggplant Powder Improves Blood Pressure and Psychological State in Stressed Individuals: A Randomized Placebo-Controlled Study.

Eggplant (Solanum melongena) is a globally popular vegetable and its significant health effect has not been reported in randomized controlled trials. Recently, we reported that eggplant was rich in choline esters, including acetylcholine (ACh), and had an antihypertensive effect in spontaneously hypertensive rats. Here, we evaluated the effects of a continuous intake of eggplant powder on blood pressure (BP), stress, and psychological state (PS) in 100 stressed participants with normal-high BP or grade 1 hypertension in a randomized, double-blind, placebo-controlled, parallel-group comparative study. The participants were randomly assigned to the eggplant or placebo group. Participants in the eggplant group ingested capsules containing eggplant powder (1.2 g/day; 2.3 mg of ACh/day) for 12 weeks, whereas participants in the placebo group ingested placebo capsules. The primary outcome assessed was hospital BP. Secondary outcomes were stress and PS. Eggplant powder intake significantly decreased the hospital diastolic blood pressure (DBP) at week 8 overall and in the normal-high BP group, and the systolic blood pressure (SBP) and DBP at week 12 overall and in the grade 1 hypertension group, compared to those of the placebo group. It also improved negative PSs at week 8 or 12 in the normal-high BP group. This is the first evidence of the BP- and PS-improving effects of eggplant intake in humans. The functional substance responsible for the effects was estimated to be eggplant-derived choline ester, namely ACh.

Rationale, Design, and Methods of the Study of Comparison of Canagliflozin vs. Teneligliptin Against Basic Metabolic Risks in Patients with Type 2 Diabetes Mellitus (CANTABILE study): Protocol for a Randomized, Parallel-Group Comparison Trial.

BackgroundDipeptidyl peptidase-4 (DPP-4) inhibitors and sodium-glucose co-transporter 2 (SGLT2) inhibitors are widely used antidiabetic drugs. However, to date, no studies have directly compared the effects of these two drugs on the components of the metabolic syndrome in patients with type 2 diabetes mellitus (T2DM).ObjectivesThe Comparison of Canagliflozin vs. Teneligliptin against Basic Metabolic Risks in Patients with T2DM (CANTABILE) study aims to examine whether the DPP-4 inhibitor (teneligliptin) or the SGLT2 inhibitor (canagliflozin) is the more effective drug for reducing metabolic risk factors as a composite in Japanese patients with T2DM.MethodsThe CANTABILE study is a prospective, multicenter, open-label, randomized, parallel-group comparison study. A total of 200 patients with T2DM treated with metformin alone or without glucose-lowering agents will be enrolled if they have one or more of the metabolic risk factors, such as obesity, borderline high blood pressure, and dyslipidemia. They will then will be randomized into the Teneligliptin group or the Canagliflozin group and treated for 24 weeks. The primary endpoint is the composite ratio of subjects with one or more improved metabolic risk factors. The secondary endpoints are the changes in each component of the primary endpoint.Planned outcomesThe CANTABILE study provides valuable evidence to indicate the suitability of SGLT2 inhibitors or DPP-4 inhibitors for Japanese patients with T2DM and metabolic risks.Trial Registration NumberUniversity Hospital Medical Information Network Clinical Trial Registry number: UMIN000030343.FundingMitsubishi Tanabe Pharma Corporation.

COMPARATIVE OUTCOMES BETWEEN INHALED BUDESONIDE AND ORAL MONTELUKAST IN MILD PERSISTENT CHILDHOOD ASTHMA

Background: Asthma is a heterogeneous disease, usually characterized by chronic airway inflammation. It is defined by the history of recurrent respiratory symptoms such as wheeze, shortness of breath, chest tightness and cough that vary over time and in intensity, together with variable expiratory airflow limitation.&#x0D; Aim: To compare the clinical efficacy of oral montelukast with inhaled budesonide as controller medication in mild persistent childhood asthma.&#x0D; Methods: 54 Children of both genders aged 3 to 12 years, diagnosed as mild persistent childhood asthma in OPD and in pediatric indoor admissions at the tertiary care Hospital in Mumbai were enrolled in this randomized prospective parallel-group comparative study. 28 (51.9%) patients of group A were started on Oral montelukast &amp; 26 (48.1%) of group B were started on inhaled budesonide.&#x0D; Results: Amongst patients of Group A, 9 were asymptomatic &amp; 19 were symptomatic at 4 weeks of treatment.10 were asymptomatic &amp; 18 were symptomatic at 3 months of treatment. P-Value was 0.09 suggesting no significant change/improvement in control of asthma symptoms at 3months than at 4 weeks in children treated with oral montelukast. Out of 26 patients of Group B, 6 were asymptomatic &amp; 20 were symptomatic at 4 weeks of treatment. 17 were asymptomatic &amp; 9 were symptomatic at 3 months of treatment. P-Value was 0.046 suggesting a statistically significant improvement in control of asthma symptoms at 3 months than at 4 weeks in children treated with inhaled budesonide.&#x0D; Conclusion: More children on inhaled budesonide were controlled on their asthma symptoms, required significantly less reliever medications, had lesser episodes of night awakening due to asthma symptoms and had improvement in their day-time symptoms and activity than those on oral montelukast.

Rationale and Design of the CANONICAL Study - Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Canagliflozin for Heart Failure With Preserved Ejection Fraction With Type 2 Diabetes Mellitus.

Background: Sodium-glucose cotransporter 2 inhibitors (SGLT2-I) have beneficial cardiovascular effects, including reduction in hospitalization for heart failure (HF). The aim of this study is to explore the efficacy and safety of canagliflozin compared with standard diabetes treatment in elderly patients with type 2 diabetes (T2DM) and HF with preserved ejection fraction (HFpEF).Methods and Results: This is a multicenter, randomized, open-label, parallel-group comparison study designed to evaluate the effects of canagliflozin on fluid retention and cardiac function in T2DM patients with HFpEF. Eligible participants are patients aged ≥65 years with insufficient glycemic control. Qualified patients will be randomly assigned to treatment with 100 mg of canagliflozin or standard diabetic treatment other than SGLT2-I; both groups will be treated for 24 weeks. The primary endpoints are changes in body weight as an indicator of fluid retention and plasma brain natriuretic peptide as an indicator of cardiac function. The secondary endpoints include cardiovascular event rates, changes in the dose of loop diuretics, echocardiographic left ventricular function, and nutritional status.Conclusions: This study is expected to provide valuable findings regarding the mechanisms of canagliflozin on cardiac function and a potential new therapeutic approach for HFpEF. (UMIN000028668 and jRCTs051180030)

Hydrogen-producing milk to prevent reduction in tear stability in persons using visual display terminals

PurposeTo examine the effect of hydrogen (H2)-producing milk, which induces H2 production by intestinal microbiota, on the prevention of dry eye disease. MethodsA randomized, double-blind, placebo-controlled, parallel-group comparative study was conducted in humans. Of 118 candidates aged 20–60 years who were using visual display terminals daily, 54 subjects (mean age, 42.4 years) with mild-to-moderate dry eye symptoms, who were not dry eye patients based on the 2006 Japanese Diagnostic Criteria for Dry Eye, were included in the study. Subjects were assigned to the H2-producing milk group or the placebo group. They were instructed to ingest the assigned test beverage once per day for three consecutive weeks. Breath H2 concentration, fluorescein tear film breakup time (fTBUT), Schirmer's test, 8-OHdG concentration in tears, reported ocular symptoms using the dry eye-related QOL score questionnaire, and the visual analogue scale were assessed at weeks 0 and 3. ResultsChange in fTBUT in the H2-producing milk group was significantly greater than that in the placebo group. A significant decline in fTBUT was observed in the placebo group (p = 0.04), but not the H2-producing group (p = 0.26). This phenomenon was strongly observed in females. We found a positive correlation between the change in fTBUT and net H2 production, and a negative correlation between the change in 8-OHdG concentration and net H2 production in young females. ConclusionsH2-producing milk appeared to retard the decline in tear stability and may prevent short fTBUT-type dry eye by decreasing oxidative stress in the lacrimal functional unit.

The Effectiveness of Applying Soft Tissue Bonding Adhesive Composed of 2-Ethyl Cyanoacrylate to Epidural Catheter Fixations Using Film Dressings: An Open-Label, Randomized, Parallel-Group Comparative Study.

Insufficient fixation of an epidural catheter may result in migration of the catheter and eventual catheter failure. However, the best fixation method remains to be established. Aron Alpha A (2-ethyl cyanoacrylate) adhesive is approved for clinical use and can be used for surgical adhesion to both skin and blood vessels. We hypothesized that the addition of Aron Alpha A adhesive to film dressing would result in consistent and dependable catheter fixation. In this study, 58 women who were scheduled for cesarean delivery under spinal and epidural anesthesia were recruited. Patients were randomly assigned to a control or treatment group. In the control group, the catheter was fixed solely by film dressing. In the treatment group, a small amount of Aron Alpha A was applied at 2 sites along the catheter. The fixation area was then covered by film dressing. The catheter insertion length was recorded after fixation (T0), immediately postoperatively (T1), on postoperative day 1 (T2), and when the catheter was removed (T3). The change in insertion length from T0 to T3 between the 2 groups was the primary outcome measure. The incidence of catheter failure was also recorded. For all comparisons, P < .05 was considered statistically significant. Initially, 58 women were enrolled; however, 3 patients were excluded. From the remaining 55 patients, 27 and 28 were assigned to the control and treatment groups, respectively, and were evaluated. The change in insertion length from T0 to T3 was significantly more in the control group compared with the treatment group (-1.9 ± 2.2 vs 0 ± 0 cm, respectively; P < .001). In the control group, 11 catheters (41%) failed; in the treatment group, all catheters provided effective analgesia throughout the study (P < .001). Epidural catheter fixation using film dressing combined with 2-ethyl cyanoacrylate adhesive application at 2 sites along the catheter resulted in secure fixation in patients receiving postoperative epidural analgesia for cesarean delivery.

A randomized phase 3b/4 study to evaluate concomitant use of topical ivermectin 1% cream and doxycycline 40-mg modified-release capsules, versus topical ivermectin 1% cream and placebo in the treatment of severe rosacea

Randomizedcontrolled studies of combination therapies in rosacea are limited. Evaluate the efficacy and safety of combining ivermectin 1% cream (IVM) and doxycycline 40-mg modified-release capsules (ie, 30-mg immediate-release and 10-mg delayed-release beads) (DMR) versus IVM and placebo for treatment of severe rosacea. This 12-week, multicenter, randomized, investigator-blinded, parallel-group comparative study randomized adult subjects with severe rosacea (Investigator's Global Assessment [IGA] score, 4) to receive either IVM and DMR (combination arm) or IVM and placebo (monotherapy). A total of 273 subjects participated. IVM and DMR displayed superior efficacy in reduction of inflammatory lesions (-80.3% vs -73.6% for monotherapy [P=.032]) and IGA score (P=.032). Combination therapy had a faster onset of actionas of week 4; it significantly increased the number of subjects achieving an IGA score of 0 (11.9% vs 5.1% [P=.043]) and 100% lesion reduction (17.8% vs 7.2% [P=.006]) at week 12. Both treatments reduced the Clinician's Erythema Assessment score, stinging/burning, flushing episodes, Dermatology Life Quality Index score, and ocular signs/symptoms and were well tolerated. The duration of the study prevented evaluation of potential recurrences or further improvements. Combining IVM and DMR can produce faster responses,improve response rates, and increase patient satisfaction in cases of severe rosacea.

Endothelial Function is improved by Inducing Microbial Polyamine Production in the Gut: A Randomized Placebo-Controlled Trial.

Recently, it was demonstrated that spermidine-induced autophagy reduces the risk of cardiovascular disease in mice. Intestinal bacteria are a major source of polyamines, including spermidine. We previously reported that the intake of both Bifidobacterium animalis subsp. lactis (Bifal) and arginine (Arg) increases the production of putrescine, a spermidine precursor, in the gut. Here, we investigated the effects of Bifal and Arg consumption on endothelial function in healthy subjects. Healthy individuals with body mass index (BMI) near the maximum value in the “healthy” range (BMI: 25) (n = 44) were provided normal yogurt containing Bifal and Arg (Bifal + Arg YG) or placebo (normal yogurt) for 12 weeks in this randomized, double-blinded, placebo-controlled, parallel-group comparative study. The reactive hyperemia index (RHI), the primary outcome, was measured using endo-peripheral arterial tone (EndoPAT). The change in RHI from week 0 to 12 in the Bifal + Arg YG group was significantly higher than that in the placebo group, indicating that Bifal + Arg YG intake improved endothelial function. At week 12, the concentrations of fecal putrescine and serum putrescine and spermidine in the Bifal + Arg YG group were significantly higher than those in the placebo group. This study suggests that consuming Bifal + Arg YG prevents or reduces the risk of atherosclerosis.

Effect of 12-Week Daily Intake of the High-Lycopene Tomato (Solanum Lycopersicum), a Variety Named “PR-7”, on Lipid Metabolism: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study

Tomato (Solanum lycopersicum) is a rich source of lycopene, a carotenoid that confers various positive biological effects such as improved lipid metabolism. Here, we conducted a randomized, double-blind, placebo-controlled, parallel-group comparative study to investigate the effects of regular and continuous intake of a new high-lycopene tomato, a variety named PR-7, for 12 weeks, based on 74 healthy Japanese subjects with low-density lipoprotein cholesterol (LDL-C) levels ≥120 to <160 mg/dL. The subjects were randomly assigned to either the high-lycopene tomato or placebo (lycopene-free tomato) group. Each subject in the high-lycopene group ingested 50 g of semidried PR-7 (lycopene, 22.0–27.8 mg/day) each day for 12 weeks, while subjects in the placebo group ingested placebo semidried tomato. Medical interviews were conducted, vital signs were monitored, body composition was determined, and blood and saliva samples were taken at weeks 0 (baseline), 4, 8, and 12. The primary outcome assessed was LDL-C. The intake of high-lycopene tomato increased lycopene levels in this group compared to levels in the placebo group (p < 0.001). In addition, high-lycopene tomato intake improved LDL-C (p = 0.027). The intake of high-lycopene tomato, PR-7, reduced LDL-C and was confirmed to be safe.

The Effect of Branched Chain Amino Acids-Enriched Nutritional Supplements on Activities of Daily Living and Muscle Mass in Inpatients with Gait Impairments: A Randomized Controlled Trial.

To investigate the effects of continuous intervention with branched chain amino acids-enriched nutritional supplements from the acute phase to convalescent rehabilitation wards in inpatients with gait impairments. Open-label, randomized, parallel-group comparison study (UMIN Clinical Trials Registry ID: UMIN000018640). Acute care and convalescent rehabilitation wards. We studied 80 patients undergoing stand/gait training. Participants in the intervention group (RJ group) received nutritional supplements (jelly foods comprising 2500 mg BCAA and 20 IU vitamin D) twice a day until hospital discharge. The primary outcome was the motor components of the Functional Independence Measure (FIM-m), and the secondary outcome was skeletal muscle mass index. Analyses were conducted on 55 patients who were able to perform stand/gait training continuously from the acute until the recovery phases. FIM-m was significantly elevated in the RJ group and the control group , but no difference was noted between the two groups. Only the RJ group showed a significant increase in skeletal muscle mass index, and the amount of variation was significantly different between the two groups (the control group decreased an average of 2.2% and the RJ group increased an average of 4.3%; P = 0.014). A significant decrease in body weight was found only in the control group (P = 0.084). Nutritional interventions using branched chain amino acids (BCAA)-enriched nutritional supplements demonstrated no significant difference in activities of daily living; however, an increase in skeletal muscle mass was noted. Skeletal muscle mass and body weight differed significantly between the two groups, and BCAA-enriched nutritional supplements intake in acute and convalescent rehabilitation wards may be effective for the prevention of malnutrition and sarcopenia.