Parallel-group Comparative Study Research Articles

A Comparative Clinical Study to Evaluate the Effect of Vatari Guggulu and Shatpushpadi Churna with Simhanada Guggulu in the Management of Amavata w.s.r. to Rheumatoid Arthritis

The disease Amavata described in classical Ayurvedic literature is closely resembles with Rheumatoid Arthritis (RA). Amavata is a crippling condition where simultaneously aggravated Vata and Ama associated with each other settles in Sandhis and produce Sandhishoola, Sandhishotha, Sparshaasahitwa, which is similar to Rheumatoid Arthritis. Amavata is the challenging problem for medical science with different treatment protocol. The objectives of this randomized parallel group Comparative study were to evaluate the effect of Vatari Guggulu and Shatpushpadi Churna with Simhanada Guggulu in the management of Amavata w.s.r. to Rheumatoid Arthritis This Study was conducted on 32 patients selected randomly from OPD and IPD of R.G.G.P.G. Ayurvedic College and Hospital, Paprola, Dist. Kangra (H.P.) and divided into 2 groups. Group I and Group II having 16 patients in each group. Group A were managed with Vatari Guggulu 500mg BD with lukewarm water and Shatpushpadi Churna 3gm BD with lukewarm water while Group B were managed with Simhanada Guggulu 500mg BD with lukewarm water for 6 weeks. Results showed statistically significant difference in effect of Group I and Group II on subjective parameters – Angamarda, Trishna, Apaka, Jadya, Sparsh Ashyata, Vidvibandha, Nidravipraya, ESR, walking time and grip strength. Percent wise Vatari Guggulu and Shatpushpadi Churna are found to be more effective than Simhanada Guggulu for all assessment criteria in the management of Amavata.

Comparison of Effects of Injectable Semaglutide and Dulaglutide on Oxidative Stress and Glucose Variability in Patients with Type 2 Diabetes Mellitus: A Prospective Preliminary Study.

Recent trials have shown that glucagon-like peptide-1 receptor agonists considerably reduce atherosclerotic cardiovascular disease in patients with type 2 diabetes mellitus (T2DM). Oxidative stress, a surrogate marker of cardiovascular risk, is associated with glucose variability. However, to the best of our knowledge, no studies have compared the effects of injectable semaglutide and dulaglutide therapies on oxidative stress and glucose variability assessed via continuous glucose monitoring (CGM). This study aimed to analyze and compare the effects of semaglutide and dulaglutide therapies on oxidative stress and glucose variability as assessed through CGM. This is an open-label, multicenter, randomized, prospective, parallel-group comparison study. Overall, 37 patients with T2DM treated with dulaglutide for at least 12weeks were randomized into two groups: one receiving continuous dulaglutide therapy (n = 19) and one receiving injectable semaglutide therapy (n = 18) groups. The coprimary endpoints were changes in the results of the diacron-reactive oxygen metabolites test, an oxidative stress marker, and CGM-evaluated glucose variability after 24weeks. The secondary endpoint was changes in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) scores. Switching to semaglutide therapy was better than continuous dulaglutide therapy in reducing oxidative stress, glucose variability, and glycated hemoglobin levels. Conversely, continuous dulaglutide therapy was better than semaglutide therapy in terms of DTSQ scores for "Convenience" and "Recommend." Injectable semaglutide therapy may be more effective than dulaglutide therapy in ameliorating oxidative stress and regulating glucose metabolism, including glucose variability, in patients with T2DM, while dulaglutide therapy may be more effective in terms of treatment satisfaction. UMIN-CRT ID: UMIN000042670 (registered 7 December 2020).

The Effect of the Timing of Banana Intake on Postprandial Glucose Spike: Randomized Parallel-Group Comparison Study

Objective: To elucidate the effects of the timing of banana intake on postprandial glucose spike and glucose metabolism. Methods: This randomized parallel-group comparison study was designed to randomize 54 adults aged 41- 60 years into three groups. The first group consumed 120 g of banana at breakfast daily for 2 weeks, the second group consumed 120 g of banana after dinner daily for 2 weeks, and the third consumed no banana or banana-containing food for 2 weeks. The participants in each group wore a continuous glucose monitor on their arms for 2 weeks to measure their blood glucose trend. Body composition and serum biomarkers were evaluated before and after intervention. Results: There were 16 participants in the banana-at-breakfast group, 16 in the banana-after-dinner group, and 15 in the control group. We defined a postprandial blood glucose increase of >140 mg/dL as a “glucose spike.” When comparing the glucose spike incidence ratio (incidence of glucose spikes divided by number of times measured), the point estimate of the incidence ratio of banana-at-breakfast group at dinner compared with breakfast was 1.55 (point estimate. 95% confidence interval: 1.09- 2.20), that of banana-after dinner group 1.83 (point estimate. 95% confidence interval: 1.28-2.61), and control group 2.03 (point estimate. 95% confidence interval: 1.36-3.04). In addition, the banana-afterdinner and control groups showed a higher incidence ratio, compared with the banana-at-breakfast group. Glycoalbumin decreased significantly in the banana-at- breakfast group compared with the other groups. Conclusions: The results showed that glucose spikes were less generated when consuming bananas at breakfast than when consuming them after dinner or not consuming them at all. The level of glycoalbumin, an index for average blood glucose, was lower in the banana-at-breakfast group than in the banana-after-dinner and control groups within 2 weeks. Clinical Trial Registry: UMIN 000050025

A randomized, open-label, controlled, parallel-group comparative study of two varieties of Carica papaya leaves in dengue-induced thrombocytopenia

Background: Dengue-induced thrombocytopenia can be life-threatening. However, supportive and symptomatic treatment is the current management protocol. The leaf extract of papaya has shown promising results in improving the platelet count. There are many varieties of Carica papaya such as Washington, Honeydew, Coorg honeydew, Solo, Surya, Red lady, C0-1, CO-3, CO-5, C0-6. Aims and Objectives: The aim is to evaluate the efficacy and safety of two varieties (“Red Lady” and “Solo”) of C. papaya fresh leaf extract in patients diagnosed with dengue-induced thrombocytopenia. Materials and Methods: The study was conducted for 2 months, and 18 dengue-confirmed inpatients with thrombocytopenia (platelet count <1,50,000/μL) were enrolled. The study participants were grouped into the standard “Control” group, “Solo” group who received fresh papaya leaf extract “Solo” and “Red Lady” group who received fresh papaya leaf extract of “Red Lady.” About 30 mL of leaf extract was given thrice daily for 5 days. Results: The mean change from the baseline value of platelets was found to be 59,168/µL for the control group and 57,000/µL for Red Lady, and 93,167/µL for the solo group. The study showed a positive trend with improvement in platelet count in “Solo” Variety group when compared to “Red Lady” group and the control group. The safety results showed that both the papaya leaf extracts have a favorable safety profile. Conclusion: There was an improvement in platelet count in “Solo” variety group when compared to “Red Lady” and the control group. However, the results were not statistically significant. No adverse events were observed during the study.

Community-Based Trial Educational Heat Disorder Program in Local Salons for Older Adults.

We investigated whether a combined program for heat disorder prevention can improve the behaviors and knowledge of heat disorder prevention in older adults participating in salons. This non-randomized parallel-group comparison study includes 59 participants from two salons. The intervention group met on alternate weeks on a salon day to watch an educational DVD and conduct hands-on education (Wet-Bulb Globe Temperature (WBGT) measurements inside and outside the meeting place). The intervention group conducted calls every other week except salon week to prevent action for heat disorder prevention information based on a leaflet and monitored WBGT in their bedrooms daily at bedtime. We assessed changes in recognition of heat disorders and prevention behavior between baseline, one and a half months after intervention, and post-season (approximately two months after baseline), using the Wilcoxon signed rank test. Recognition of heat disorder scores and preventive behavior improved from pre- to post-season in the intervention group. It was suggested that the approach toward older adults participating in salons could improve their recognition and behavior in preventing heat disorders.

Foods Containing Pantoea agglomerans LPS Reduce Eye-Nose Allergies—A Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Comparative Pilot Study

In this study, the effects of foods containing lipopolysaccharide (LPS) from Pantoea agglomerans (LPSp) on immunity were preliminarily investigated using a double-blind, placebo-controlled, randomized, parallel-group comparative study design. Thirty healthy subjects aged ≥ 20 years (four males and twenty-six females; mean age 49 ± 9.2 years) were randomly assigned to the LPS-containing food group (488 μg/day; LPS) or placebo group. Each food was consumed for 8 weeks, and a subjective survey of cold symptoms (Wisconsin Upper Respiratory Symptom Questionnaire) and allergic symptoms of the eyes and nose were conducted. Phagocytic capacity and lymphocyte counts were measured as indicators of immune function. There were no significant between-group differences with respect to any of the investigated items. On sub-group analysis of eye–nose allergy symptom score, confined only to subjects who reported eye–nose allergic symptoms in previous years, the LPS group showed a trend toward milder symptoms compared to the placebo group. In addition, when the symptom scores were compared only for subjects who developed eye–nose allergies during the study period, the LPS group showed significantly lower overall scores and eye symptom scores compared to the placebo group. These results suggest that the consumption of LPS-containing foods may alleviate or prevent eye–nose allergies. There were no statistically predominant changes in hematology and blood biochemistry tests, indicating that continued consumption of LPS-containing foods is safe. (UMIN000046154).

Effects of sulforaphane glucosinolates from broccoli seed extract on the immune system of healthy Japanese adults

Background: The Purpose of this study was to investigate the effects of sulforaphane glucosinolate (SGS) from broccoli seed extracts on immune function and common cold symptoms in healthy Japanese adults.Methods: This randomized, placebo-controlled, double-blind, parallel-group comparison study was conducted on Japanese adults who had worse health-related quality of life on the SF-8 and were more likely to catch colds from October 22, 2020 to April 2, 2021.Individuals who agreed to participate in the study were randomly assigned to either the SGS 100 mg/day group or the placebo group (n = 33 each). The intervention lasted 8 weeks. The outcomes of this study were the cumulative and the maximum number of days for which common cold symptoms persisted during the intervention period per subject (primary), and the frequency with which subjects experienced these symptoms per group (secondary). Additionally, the incidence rate of subjects infected with the influenza virus, immune indices, and SF-8 were assessed.Results: Based on a per protocol set, 64 subjects (33 in the SGS group and 31 in the placebo group) were analyzed. After the 8-week interventional period, the cumulative number of days for which common cold symptoms per subject was significantly lower for the SGS group than the placebo group (12.1 ± 13.5 for the SGS group and 20.2 ± 18.2 for the placebo group). The cumulative number of days of common cold symptoms per group was also significantly lower in the SGS group than in the placebo group (400 days in the SGS group and 626 days in the placebo group). No changes attributable to the SGS intervention were observed in the other outcomes. There were no adverse events due to food ingestion.Conclusion: A period of 8 weeks of SGS intake was shown to alleviate the onset of common cold symptoms in healthy Japanese adults who were prone to catching colds and had a low subjective sense of wellness.Keywords: Broccoli, sulforaphane, glucoraphanin, cold symptoms, immunityTrial registration: UMIN-CTR: UMIN000042195.Foundation: Murakami Farm Co., Ltd.

A randomized, single-blind, parallel-group comparative study on the effects of long-term pineapple intake for improvement of skin function and intestinal environment in healthy subjects

本研究では, パイナップルの8週間の摂取によって, 肌トラブルが気になり便秘傾向の日本人男女の肌質と腸内環境が改善される可能性が示唆された. 特に肌質に関しては, 先行研究と同様に肌の乾燥やシミの自覚的評価が改善したことに加え, これらの効果について機器測定値による裏付けも得られた. 本研究により, パイナップル摂取による健康効果について更なる知見が得られたことから, 人々の美容や健康に貢献できる食材であることが期待される.

Intake of Lactobacillus paragasseri SBT2055 improves subjective symptoms of common cold during winter season in healthy adults: A randomized, double-blind, placebo-controlled parallel-group comparative study.

Lactobacillus paragasseri SBT2055 (LG2055) has been reported to show immunostimulating effects. This study aimed to investigate the effects of LG2055 on the subjective symptoms of the physical condition in healthy adults. In this randomized, double-blind, placebo-controlled, parallel-group comparative study, Japanese individuals aged 20-64 years were recruited. A total of 200 participants were randomly divided into two groups by an independent controller (LG2055 and placebo groups; 100 participants per group). Drinkable yogurts containing LG2055 or lacking LG2055 (placebo) were used as test samples. The participants ingested one bottle of the test sample once a day for 12 weeks. A daily physical health questionnaire survey (about common cold symptoms) was performed as the primary outcome, and immunological and oxidative stress markers in saliva and serum were evaluated as secondary outcomes. In total, 198 participants completed the scheduled intake of the test samples, and five participants were excluded from the final analysis. Consequently, 193 participants (LG2055 group, n = 97; placebo group, n = 96) in the Per-Protocol Set were included in the efficacy analysis. The cumulative days of each symptom were evaluated, and the LG2055 group showed a significantly higher ratio of "without symptom" in runny nose, plugged nose, sneezing, sore throat, hoarseness, cough, headache, feeling tired, and fever than the placebo group, indicating that the incidence rates of common cold symptoms were lower in the LG2055 group. Additionally, changes in the salivary secretory IgA levels were significantly higher, and the serum derivatives of reactive oxygen metabolites levels were significantly lower in the LG2055 group. Our study revealed that intake of LG2055 decreased common cold symptoms and improved immune parameters in healthy adults. This suggests that LG2055 contributes to the maintenance of physical conditions by improving the host immune system. [https://www.umin.ac.jp/ctr/index.htm], identifier [UMIN000045901].

Effects of inhaled β‑caryophyllene on vascular stiffness in smokers: A randomized, double‑blind, placebo‑controlled trial.

Approximately 1.14 billion smokers worldwide are at risk of developing tumors, cardiovascular diseases and respiratory diseases. Smoking cessation is the first choice of health care; however, the disease should be attenuated in individuals who never stop smoking, which escalates medical costs. Therefore, alternative options are needed to manage the social burden. The present study proposed an alternative method to prevent such diseases by inhalation of β-caryophyllene (BCP). A placebo-targeted, dose-searching, double-blind, parallel-group comparative study was conducted on 19 subjects. The BCP intervention was performed using a flavor capsule inserted in a cigarette filter. The primary endpoint was the reducibility of brachial-ankle pulse wave velocity (baPWV). The secondary endpoints were confirmation of the bioavailability of BCP inhalation with cigarette smoke, confirmation of the effect of BCP inhalation on respiratory function, and association between respiratory function and blood concentration and baPWV reduction. The BCP concentration in the blood reached 4 ng/ml in the BCP 15% group 10 min after inhalation. The baPWV decreased in BCP-inhaling subjects whose initial baPWV was >1,300 cm/sec. The correlation analyses revealed that the higher the forced expiratory volume in 1 sec, the better the transition of baPWV. Inhaled BCP with cigarette smoke could reduce the baPWV and the risk of cardiovascular diseases in smokers. These findings indicated that with the introduction of BCP capsule-cigarettes in the future, smokers will be able to take care of their health, which may help reduce national medical costs. BCP microcapsules placed in cigarette wrapping paper may possibly reduce the risk of sidestream smoke and contribute to improved public health. This clinical research was retrospectively registered in the University Hospital Medical Information Network (UMIN)-Clinical Trials Registry with the following identifications: UMIN000048510 and UMIN000048512 on August 15, 2022.

Banana Intake Relieves the Stress of Daily Life in Healthy Adult Volunteers: An Open, Randomized, Parallel-Group Comparative Study

Bananas are a well-balanced typical prebiotic food rich in dietary fiber, oligosaccharides, vitamins, and minerals. However, evidence supporting the stress-relieving effects of banana consumption in daily life is scarce. Therefore, we investigated the effects of banana-intake on stress-related markers, such as the intestinal environment, biochemical markers, autonomic balance, and mood status, in an open, randomized, parallel-group controlled trial using 20 healthy adult volunteers divided into a banana-intake group (n = 13 subjects, two bananas daily for 2 weeks) and a non-intake control group (n = 7, no banana-intake for 2 weeks). We measured the intestinal environmental marker urinary indoxyl sulfate, stress markers (salivary cortisol and chromogranin A), autonomic nervous system activity markers (heart rate, natural logarithm of low-frequency power [LnLF], natural logarithm of high-frequency power [LnHF], and LnLF/LnHF ratio), and mood status before and after the 2-week experimental period. We assessed the rate of change before and after banana-intake for all parameters by performing comparisons between the banana-intake and the non-intake control group as well as between the effective and ineffective groups within the banana-intake group. There was no significant difference in the rate of change for all parameters before and after banana-intake compared with the non-intake group. However, approximately 50% of the banana-intake group showed decreased urinary indoxyl sulfate; decreased cortisol and chromogranin A levels; decreased heartbeat and LnLF power, increased LnHF power, and decreased LnLF/LnHF ratio; a decrease in the five negative subscales, an increase in the two positive subscales, and a decrease in total mood disorder score. Our findings suggest that banana-intake for 2 weeks improves the intestinal environment, leads to predominant parasympathetic activity, and provides stress relief and psychological stability in approximately 50% of healthy adults.

Add-on imeglimin versus metformin dose escalation regarding glycemic control in patients with type 2 diabetes treated with a dipeptidyl peptidase-4 inhibitor plus low-dose metformin: study protocol for a multicenter, prospective, randomized, open-label, parallel-group comparison study (MEGMI study)

IntroductionImeglimin is a novel anti-hyperglycemic drug that improves both insulin resistance and insulin secretion. The effects of imeglimin on glycemic control were confirmed in phase III clinical trials, but little...

Ameliorating prediabetic subject status via fermented tea supplementation: A randomized, double-blind, parallel-group comparison study

Fermented tea consumption has been reported to alleviate diabetes and dyslipidemia, inducing an antiobesity effect. Here, we investigated the effects of microbial fermented tea and microbial fermented twig tea, which are made from Camellia sinensis by fermentation with Aspergillus sp., on glucose tolerance and metabolic syndrome in prediabetic subjects in a randomized, double-blind study. They were asked to consume the tea three times a day for 12 weeks. Fasting blood glucose, HbA1c, and 2-h oral glucose tolerance test (OGTT) were measured as primary endpoints. After 12 weeks, fasting blood glucose level was significantly reduced in the microbial fermented twig tea group (n = 19) as compared with that in the microbial fermented tea group (n = 16, p = 0.017). There was no significant difference in the 2-hour OGTT and HbA1c values between the two groups. Triglyceride levels were significantly lower in the microbial fermented tea group than in the microbial fermented twig tea group at 12 weeks (p = 0.049).

A probiotic blend improves defecation, mental health, and productivity in healthy Japanese volunteers under stressful situations

We investigated whether a blend of probiotics (KABP-021, KABP-022, and KABP-023) improved diarrhea-related problems in healthy Japanese adults who routinely lived under stressful conditions. Twenty-six females and 34 males were divided randomly into the probiotic and placebo groups in this double-blind, placebo-controlled, parallel-group comparison study. All participants ingested 1 capsule of probiotics or placebo per day for 4 weeks. Intervention with probiotics significantly reduced diarrhea-related problems assessed by the Izumo scale compared with placebo treatment (P < 0.001). In the Short Form-8 questionnaire, probiotic intervention improved mental component scores (P = 0.002), role emotional scores (P = 0.002), and mental health scores (P < 0.001). Treatment with probiotics also reduced the effects of diarrhea on daily activities (P < 0.001) and overall working habits (P = 0.010), including missing work (absenteeism) and impaired productivity (presenteeism), as assessed by the Work Productivity and Activity Impairment Questionnaire: General Health. Furthermore, there was a correlation between improved scores for diarrhea on the Izumo scale and increased abundance of Faecalibacterium, a butyric acid-producing bacterium, in the gut in the probiotic group (P = 0.047), whereas no such a correlation or trend was found in the placebo group. Our strategy of supplementation for 4 weeks with a specific blend of probiotics reduced diarrhea-related symptoms and may improve the mental health and daily activities of healthy individuals under stress.

Food-derived antioxidant ergothioneine improves sleep difficulties in humans

• Volunteers with reported high anxiety and sleep complaints daily took ergothioneine (EGT) for 4 weeks. • A questionnaire survey showed that EGT significantly ameliorate sleeping difficulties. • Electroencephalograph measurements showed that ingesting EGT resulted in a significant improvement in objective sleep quality. • Metabolome analysis suggested that EGT reduces consumption of antioxidant substances while enhancing lipid metabolism. Sleep disorders interfere with daily life and are associated with the development of various diseases. Here, we evaluated the effect of orally ingested ergothioneine (EGT) on improving sleep quality. We conducted a randomized, placebo-controlled, double-blind, parallel-group comparison study. A 20 mg EGT or placebo capsule was ingested daily for 4 weeks by volunteers with reported high anxiety and sleep complaints. A survey showed that EGT significantly ameliorates sleeping difficulties. Electroencephalograph measurements showed that EGT intake increases the N2 stage, while decreasing the N1 stage in non-REM sleep and the frequency of waking after sleep onset. Serum metabolome analysis suggested that EGT reduces serum glutamate as well as the consumption of antioxidant and anti-inflammatory substances while enhancing lipid metabolism. Molecular targeting assays revealed that EGT inhibits histamine N-methyltransferase and aldehyde dehydrogenase activity and binding to α3β4 nicotinic acetylcholine receptor. Hence, EGT may improve sleep difficulties via multiple mechanisms of action.

Continuous partially hydrolyzed guar gum intake reduces cold-like symptoms: a randomized, placebo-controlled, double-blinded trial in healthy adults.

Partially hydrolyzed guar gum (PHGG), a water-soluble dietary fiber produced by the controlled partial enzymatic hydrolysis of guar gum beans, has various physiological roles. PHGG is expected to influence the immune function and prevent infections. The objective of this study was to examine the effect of continuous ingestion of PHGG for 12 weeks on the development of cold-like symptoms. A placebo-controlled, double blind, randomized, parallel-group comparative study was conducted. 96 healthy Japanese adults received 5.2 g PHGG or placebo daily for 12 weeks. Cold-like symptoms were assessed based on patient diary, and the levels of short-chain fatty acids (SCFAs) in stool and blood immune markers at baseline and at weeks 6 and 12. The cumulative number of "no symptoms" days for all symptoms was significantly larger in the PHGG than in the placebo group. The result of the analysis by severity of cold-like symptoms also showed significant differences, with the PHGG group having a lower severity of cold-like symptoms. Propionic acid at weeks 6 and 12 and n-butyric acid and total SCFAs at week 12 were significantly higher in the PHGG than in the placebo group. The Interferon-γ level was significantly lower at week 6 in the PHGG than in the placebo group. PHGG intake may affect immune function and suppress cold-like symptoms through the production of SCFAs in healthy adults.

A Study of Lifestyle Modifications with and Without Metformin in Prediabetic Subjects

Purpose: Prediabetes is a stage in the natural history of impaired glucose metabolism rather than as a distinctive clinical entity. The primary objective was to compare the effect of lifestyle modifications (LSMs) with and without metformin in prolonging the onset of diabetes mellitus in prediabetics. Materials and Methods: This study is an open label, parallel group comparative study conducted from 2016 to 2020. One hundred and four prediabetic subjects were assigned to two groups: group I (51) LSM and group II (53) metformin 500 mg along with LSM. Baseline investigations included fasting blood sugar (FBS), post-prandial blood sugar (PPBS), HbA1c, and lipid profile, followed up for 12 months. Results: The baseline parameters were comparable between the groups. In both the groups, there was a significant reduction in abdominal circumference, total cholesterol, triglycerides, low-density lipoprotein, FBS, PPBS, and HbA1c between baseline and 1 year. There was no significant difference between groups I and II in reduction of all the above-mentioned parameters. The outcomes of prediabetic subjects after 1 year of treatment in both the groups were comparable. Only one (2.1%) subject had more than 126 mmHg FBS in the LSM group. The adverse effects observed were dizziness, nausea, flatulence, myalgia, abdominal pain, and heart burn, which were mild to moderate in intensity and in most patients it subsided with time. Conclusion: LSM alone was equivalent to LSM along with metformin in effective control of blood sugars. Lipid profile and weight may be significantly reduced.

The relationship between chronic kidney disease and denosumab-induced hypocalcemia in high-age osteoporotic patients.

A few studies have reported the safety of the treatment of elderly osteoporotic patients with chronic kidney disease (CKD) and the possibility of hypocalcemia. The aim of the present study was to examine the relationship between the incidence of hypocalcemia and the CKD stage in elderly osteoporotic patients treated with denosumab. This study was designed as a parallel-group comparison study between the denosumab-associated hypocalcemia (DAH) groups: the concentration of serum calcium was under 8.6mg/dl and the normal calcium (NC) groups: the concentration of serum calcium was over 8.6mg/dl. Fifty-two subjects over 70years old were enrolled in this study, with 16 patients classified into the DAH group and 36 patients assigned to the NC group. All patients were further classified into two subgroups according to their age, into an around 75years group to clarify the relevance of old age and an around 85years group and also into a mild CKD group and a moderate CKD group by based on estimated glomerular filtration (eGFR). Serum calcium concentration, tartrate-resistant acid phosphatase (TRACP-5b), and type 1 procollagen N terminal propeptide (P1NP) were measured, and adverse drug reactions were evaluated. The eGFR and serum calcium were significantly lower in the DAH group than in the NC group in the starting phase. Moreover, TRACP-5b was significantly higher in the DAH group than in the NC group in the starting phase. There were no significant differences in P1NP. The incidence of hypocalcemia was significantly higher in the around 85 groups than in the around 75 groups. The frequency of hypocalcemia was also significantly higher in the severe CKD group than in the mild CKD group. Advanced age combined with low eGFR and low serum Ca status appear to be associated with the incidence of hypocalcemia when using denosumab for the treatment of osteoporosis.

Vaccination With Oral Polio Vaccine Reduces COVID-19 Incidence.

BackgroundEffective response to emerging pandemic threats is complicated by the need to develop specific vaccines and other medical products. The availability of broadly specific countermeasures that could be deployed early in the pandemic could significantly alter its course and save countless lives. Live attenuated vaccines (LAVs) were shown to induce non-specific protection against a broad spectrum of off-target pathogens by stimulating innate immune responses. The purpose of this study was to evaluate the effect of immunization with bivalent Oral Poliovirus Vaccine (bOPV) on the incidence of COVID-19 and other acute respiratory infections (ARIs).Methods and FindingsA randomized parallel-group comparative study was conducted in Kirov Medical University. 1115 healthy volunteers aged 18 to 65 were randomized into two equal groups, one of which was immunized orally with a single dose of bOPV “BiVac Polio” and another with placebo. The study participants were monitored for three months for respiratory illnesses including COVID-19. The endpoint was the incidence of acute respiratory infections and laboratory confirmed COVID-19 in both groups during 3 months after immunization. The number of laboratory-confirmed cases of COVID-19 was significantly lower in the vaccinated group than in placebo (25 cases vs. 44, p=0.036). The difference between the overall number of clinically diagnosed respiratory illnesses in the two groups was not statistically significant.ConclusionsImmunization with bOPV reduced the number of laboratory-confirmed COVID-19 cases, consistent with the original hypothesis that LAVs induce non-specific protection against off-target infections. The findings are in line with previous observations of the protective effects of OPV against seasonal influenza and other viral and bacterial pathogens. The absence of a statistically significant effect on the total number of ARIs may be due to the insufficient number of participants and heterogeneous etiology of ARIs. OPV could be used to complement specific coronavirus vaccines, especially in regions of the world where the vaccines are unavailable, and as a stopgap measure for urgent response to future emerging infections. Clinical trial registration number NCT05083039 at clinicaltrals.gov https://clinicaltrials.gov/ct2/show/NCT05083039?term=NCT05083039&draw=2&rank=1

Effects of switching from a dipeptidyl peptidase-4 inhibitor to oral semaglutide on glucose metabolism in patients with type 2 diabetes: protocol for a multicentre, prospective, randomised, open-label, parallel-group comparison study (the SWITCH-SEMA 2 study)

IntroductionIncretin-based therapies exert antihyperglycaemic effects in patients with type 2 diabetes (T2D) in a blood glucose concentration-dependent fashion. The first-in-class oral glucagon-like peptide-1 receptor agonist semaglutide has potent effects on...