Recommendation for modifying current cytotoxicity testing standards for biodegradable magnesium-based materials

BackgroundA substantial disadvantage of psychopharmacological treatment of major depressive disorder (MDD) with selective serotonin-reuptake inhibitors (SSRIs) is the impact on sexual dysfunction. The aim of the present study was to investigate whether the oil of Rosa damascena can have a positive influence on SSRI-induced sexual dysfunction (SSRI-I SD) of male patients who are suffering from MDD and are being treated with SSRIs.MethodIn a double-blind, randomized, and placebo-controlled clinical trial, a total of 60 male patients treated with an SSRI and suffering from MDD (mean age =32 years) and SSRI-I SD were randomly assigned to take either verum (R. damascena oil) or a placebo. Patients completed self-ratings of depression and sexual function at baseline, at 4 weeks later, and at the end of the study, 8 weeks after it started.ResultsOver time, sexual dysfunction improved more in the verum group than in the control group. Improvements were observed in the verum group from week 4 to week 8. Self-rated symptoms of depression reduced over time in both groups, but did so more so in the verum group than in the control group.ConclusionThis double-blind, randomized, and placebo-controlled clinical trial showed that the administration of R. damascena oil ameliorates sexual dysfunction in male patients suffering from both MDD and SSRI-I SD. Further, the symptoms of depression reduced as sexual dysfunction improved.

The aim of this study is to examine the effects of quetiapine as an adjuvant treatment for obsessive-compulsive (OC) symptoms in patients with bipolar disorder (BD) type I. In this 8-week double-blind placebo-controlled randomized clinical trial, 47 patients with BD in euthymic phase that had OC symptoms were randomly allocated to receive either quetiapine or placebo plus their routine medications (lithium+clonazepam). Yale-Brown Obsessive-Compulsive Scale (YBOCS) was used to assess the outcomes. Adverse effects were also recorded. Of 47 BD patients with OC symptoms that were randomly allocated in two groups of quetiapine (n=24) and placebo group (n=23), 40 patients (20 in quetiapine group and 20 in placebo group) completed the trial. Throughout the trial, the mean score of YBOCS in the quetiapine group dropped from 24.37±1.51 to 15.26±1.16 (P<.001) and in the placebo group decreased from 24.21±1.33 to 23.94±1.66 (P=1.97). At the end of the study, 12 (60%) patients in the quetiapine group and 1 (5%) patient in the placebo group had more than 34% decline in YBOCS score (P<.001). No serious adverse effects were reported in two groups. Our double-blind placebo-controlled clinical trial showed that quetiapine may be an effective adjuvant agent for reducing OC symptoms in BD patients.

Efficacy and safety of Soshiho-tang in atopic dermatitis patients with gastrointestinal disorders: A double-blinded, randomized, and placebo-controlled clinical trial

Reliability of mooring lines and piles for a permanently manned vessel in a tropical cyclone environment

Rhinix™ Nasal Filters For The Treatment Of Allergic Rhinitis: A Randomized, Double-Blinded Placebo-Controlled Crossover Clinical Trial

Double-blind clinical trials are crucial in the fields of medicine and clinical research for producing reliable and unbiased scientific evidence. Historically, double-blind trials have been instrumental in establishing a rigorous standard for evaluating treatment efficacy by eliminating researcher and participant biases. By concealing treatment allocation, these trials aim to produce objective and replicable data that drive contemporary medical practice. However, the ethical dimensions of double-blind trials raise substantial concerns. Key issues include the potential harm from administering placebos instead of effective treatments and the ethical dilemma of withholding care. This paper seeks to address and highlight these concerns by discussing the relationship between double-blind clinical trials and the scientific community as well as the advantages and disadvantages of double-blind clinical trials within the scientific community and society at large. The analysis emphasizes the necessity of adapting double-blind trials to incorporate ethical considerations without compromising the integrity of the research. By refining trial designs to include usual-care controls, the medical community can uphold both ethical standards and methodological rigor. This balanced approach ensures that double-blind trials continue to contribute valuable insights into treatment efficacy while safeguarding participant welfare.

Background:Dental anxiety is a relatively frequent problem that can lead to more serious problems such as a child entering a vicious cycle as he/she becomes reluctant to accept the required dental treatments. The aim of this randomized double-blind clinical trial study was to evaluate the anxiolytic and sedative effect of pregabalin in children.Materials and Methods:Twenty-five children were randomized to a double-blind placebo-controlled crossover clinical trial. Two visits were scheduled for each patient. At the first visit, 75 mg pregabalin or placebo was given randomly, and the alternative was administered at the next visit. Anxiolytic and sedative effects were measured using the visual analogue scale. The child's behavior was rated with the Frankl behavioral rating scale and the sedation level during the dental procedure was scored using the Ramsay sedation scale. The unpaired, two-tailed Student's t-test was used to compare the mean changes of visual analog scale (VAS) for anxiety in the pregabalin group with that of the placebo group. A repeated measures MANOVA model was used to detect differences in sedation level in the pregabalin and placebo groups regarding the interaction of 3-time measurements; sub-group analysis was performed using Student's t-test. The Mann–Whitney U-test was used to analyze the nonparametric data of the Frankl and Ramsay scales. A P < 0.05 was considered significant.Results:The reduction of the VAS-anxiety score from 2 h post-dose was statistically significant in the pregabalin group. From 2 h to 4 h post-dose, the VAS-sedation score increased significantly in the pregabalin group. The child's behavior rating was not significantly different between the groups. The number of “successful” treatment visits was higher in the pregabalin group compared to the placebo group.Conclusion:Significant anxiolytic and sedative effects can be anticipated 2 h after oral administration of pregabalin without serious side effects.

Effect of azithromycin on bronchial wall thickness in severe persistent asthma: A double-blind placebo-controlled randomized clinical trial

Nigella sativa oil with a calorie-restricted diet can improve biomarkers of systemic inflammation in obese women: A randomized double-blind, placebo-controlled clinical trial

BackgroundThere is a promising outlook regarding the potential effect of spinach-derived thylakoids in the management of obesity and its associated metabolic disturbances. This research aimed to evaluate the effects of spinach-derived thylakoids supplementation combined with a calorie-restricted diet on anthropometric and metabolic profiles in obese women with the polycystic ovary syndrome (PCOS).MethodsIn a 12-week double-blind placebo-controlled randomized clinical trial, 48 females with obesity and PCOS were randomly allocated into either intervention (5 g/day thylakoid) or placebo (5 g/day cornstarch) groups along with calorie-restricted diets. Anthropometric measures, physical activity levels, dietary intakes, insulin resistance markers, as well as serum levels of insulin, fasting blood glucose (FBG), non-esterified fatty acids (NEFA), and sex hormones including dehydroepiandrosterone sulfate (DHEAS), follicle-stimulating hormone (FSH), luteinizing hormone (LH), sex hormone-binding globulin (SHBG), and free androgen index (FAI) were evaluated pre-and post-intervention.ResultsAfter the 12-week intervention, there were significant decreases in weight (− 6.97 ± 0.52 vs. -3.19 ± 0.72 kg; P < 0.001), waist circumference (− 7.78 ± 2.50 vs. -3.73 ± 1.40 cm; P < 0.001), fat mass (− 5.19 ± 0.53 vs. -1.36 ± 0.39 kg; P < 0.001), and insulin levels (− 5.40 ± 1.86 vs. -1.19 ± 0.85 μU/mL; P < 0.001) in the spinach-derived thylakoid group compared to the placebo group. Furthermore, insulin resistance markers and serum levels of testosterone decreased significantly in the thylakoid group compared to the placebo group (P < 0.05). The changes in other parameters did not show significant differences between the two groups.ConclusionsSpinach-derived thylakoid supplementation resulted in more favorable improvements in anthropometric indices and insulin sensitivity compared to the calorie restriction alone.Trial registrationThe study was approved by the Ethics Committee of Research Vice-chancellor of Tabriz University of Medical Sciences, Tabriz, Iran, and was registered in the Iranian Registry of Clinical Trials (registration ID: IRCT20140907019082N9).

l-Carnosine supplementation attenuated fasting glucose, triglycerides, advanced glycation end products, and tumor necrosis factor–α levels in patients with type 2 diabetes: a double-blind placebo-controlled randomized clinical trial

IntroductionPostpartum depression affects 10%–15% of women and has a recurrence rate of 40% in subsequent pregnancies. Women who develop postpartum depression are suspected to be more sensitive to the rapid...

Considering the anti-inflammatory properties of curcumin, the present study was designed to investigate the effect of nano-curcumin on respiratory indices and interleukin-6 (IL-6) levels in severe chronic obstructive pulmonary disease (COPD) patients as a common pulmonary disease causing restricted airflow and breathing problems. In the current double-blind placebo-controlled randomized clinical trial study, 60 patients with stages 3 and 4 COPD were randomly assigned into 80 mg nano-curcumin (n = 30) and placebo groups (n = 30) for 3 months. The effect of nano-curcumin on pulmonary function was evaluated by the first second of forced expiration (FEV1) to the full, forced vital capacity (FVC) ratio. IL-6 serum level, blood pressure, and anthropometric indices were also measured. Nano-curcumin supplementation led to a significant decrease in IL-6 level (p < 0.001) and an increase in FEV1 (p < 0.001), FVC (p = 0.003), and FEV1/FVC (p < 0.001) compared to placebo at the endpoint. Nano-curcumin had a significantly increasing effect on weight and body mass index compared to the placebo group (PANCOVA adjusted for baseline values = 0.042). There was a meaningful improvement in systolic blood pressure in the nano-curcumin group compared to the placebo group (PANCOVA adjusted for baseline values = 0.026). There was no significant difference between the two groups in terms of waist circumference, waist-to-hip ratio, and diastolic blood pressure (PANCOVA adjusted for baseline values >0.05). Nano-curcumin supplement seems to have favorable effects on inflammation status and respiratory indices of patients with severe COPD.

BackgroundThe coronavirus disease 2019 (COVID-19) pandemic continues to affect the globe. After 18 months of the SARS-CoV-2 emergence, clinicians have clearly defined a subgroup of patients with lasting, disabling symptoms. While big strides have been made in understanding the acute phase of SARS-CoV-2 infection, the pathophysiology of long COVID is still largely unknown, and evidence-based, effective treatments for this condition remain unavailable.ObjectivesTo evaluate the efficacy of 10 mg oral montelukast every 24 h versus placebo in improving quality of life associated with mild to moderate respiratory symptoms in patients with long COVID as measured with the COPD Assessment Test (CAT) questionnaire. The secondary objectives will evaluate the effect of montelukast versus placebo on improving exercise capacity, COVID-19 symptoms (asthenia, headache, mental confusion or brain fog, ageusia, and anosmia), oxygen desaturation during exertion, functional status, and mortality.Methods and analysisPhase III, randomized, double-blind clinical trial. We will include 18- to 80-year-old patients with SARS-CoV-2 infection and mild to moderate respiratory symptoms lasting more than 4 weeks. Participants will be randomly allocated in a 1:1 ratio to the intervention (experimental treatment with 10 mg/day montelukast) or the control group (placebo group), during a 28-day treatment. Follow-up will finish 56 days after the start of treatment. The primary outcome will be health-related quality of life associated with respiratory symptoms according to the COPD Assessment Test 4 weeks after starting the treatment. The following are the secondary outcomes: (a) exercise capacity and oxygen saturation (1-min sit-to-stand test); (b) Post-COVID-19 Functional Status Scale; (c) other symptoms: asthenia, headache, mental confusion (brain fog), ageusia, and anosmia (Likert scale); (d) use of healthcare resources; (e) mortality; (f) sick leave duration in days; and (g) side effects of montelukast.Ethics and disseminationThis study has been approved by the Clinical Research Ethics Committee of the IDIAPJGol (reference number 21/091-C). The trial results will be published in open access, peer-reviewed journals and explained in webinars to increase awareness and understanding about long COVID among primary health professionals.Trial registrationClinicalTrials.govNCT04695704. Registered on January 5, 2021. EudraCT number 2021-000605-24. Prospectively registered.

Osteoarthritis is a global health problem, especially for the elderly. A good replacement for non-surgical treatments is the use of traditional medicines. We selected a revere plant (Nigella sativa L.), a widely utilized medicinal herb for the treatment of inflammatory conditions, from the Iranian traditional medicine (ITM) pharmacopoeia with proven anti-inflammatory and analgesic actions. We performed a prospective, randomized, double-blind, and placebo-controlled clinical trial, in order to investigate whether the herb is useful in alleviating the symptoms of knee osteoarthritis. American College of Rheumatology clinical criteria were the basis of diagnosis, while the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire was considered as the main outcome measure. One hundred and ten eligible patients were assigned to receive a placebo or an active intervention (2 g/day of processed N. sativa seed powder in divided doses). Acetaminophen tablets were the rescue medicine. Finally, 40 patients in the placebo group and 37 patients in the active group completed the trial and were included in the statistical analysis. Both cohorts demonstrated statistically significant within-group differences (P < 0.05) in some subscales that were more prominent in the active group without any considerable adverse effects. Nevertheless, KOOS score results and the mean number of acetaminophen tablets used by patients showed no statistically significant between-group differences. It can be concluded that future programmed studies with larger sample sizes, longer follow-up periods, and other forms of N. sativa seeds as an active intervention is necessary to evaluate its efficacy in relieving the symptoms of knee osteoarthritis.