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As lactoferrin is a nutritional supplement with proven antiviral and immunomodulatory abilities, it may be used to improve the clinical course of COVID-19. The clinical efficacy and safety of bovine lactoferrin were evaluated in the LAC randomized double-blind placebo-controlled trial. A total of 218 hospitalized adult patients with moderate-to-severe COVID-19 were randomized to receive 800 mg/die oral bovine lactoferrin (n = 113) or placebo (n = 105), both given in combination with standard COVID-19 therapy. No differences in lactoferrin vs. placebo were observed in the primary outcomes: the proportion of death or intensive care unit admission (risk ratio of 1.06 (95% CI 0.63-1.79)) or proportion of discharge or National Early Warning Score 2 (NEWS2) ≤ 2 within 14 days from enrollment (RR of 0.85 (95% CI 0.70-1.04)). Lactoferrin showed an excellent safety and tolerability profile. Even though bovine lactoferrin is safe and tolerable, our results do not support its use in hospitalized patients with moderate-to-severe COVID-19.

Patients with refractory erythema of rosacea have limited treatment options.
To evaluate the efficacy and safety of a 12-week course of paroxetine for moderate-to-severe erythema of rosacea.
In a multicenter, randomized, double-blinded, placebo-controlled trial, patients with refractory erythema of rosacea were randomly assigned (1:1) to receive paroxetine 25 mg daily or placebo for 12 weeks.
Overall, 97 patients completed the study (paroxetine: 49; placebo: 48). The primary end point was the proportion of participants achieving Clinical Erythema Assessment success (defined as Clinical Erythema Assessment score of 0, 1, or ≥2-grade improvement from baseline) at week 12; this was significantly greater in the paroxetine group than in the placebo group (42.9% vs 20.8%, P = .02). Some secondary end points were met, such as flushing success with point reductions ≥2 (44.9% vs 25.0%, P = .04) and improvement in overall flushing (2.49 ± 3.03 vs 1.68 ± 2.27, P = .047), burning sensation (46.9% vs 18.8%, P = .003), and depression (P = .041). The most reported adverse events associated with paroxetine were dizziness, lethargy, nausea, dyspepsia, and muscle tremors.
Only a single-dosage regimen of paroxetine within a 12-week study was evaluated.
Paroxetine is an effective and well-tolerated alternative treatment for moderate-to-severe erythema of rosacea.

OBJECTIVE: Considering the complex pathobiology of oral mucositis, especially in oral cancer patients, the prevention and treatment of oral mucositis in patients undergoing radiotherapy remains an essential and clinically crucial unmet need. The present study aims to investigate and compare the effects of synbiotic mouthwash with normal saline mouthwash on the prevention and control of radiotherapy-induced oral mucositis in oral cancer patients.
METHODS: Double-blind, randomized clinical trial (RCT) performed on 64 oral cancer patients who underwent radiotherapy (IRCT20201106049288N1, registration date: 2020-12-23). Patients were divided randomly into the case (32 subjects) and control (32 subjects) groups. All patients underwent intensity-modulated radiotherapy and received 6000 cGY of radiotherapy in 34 fractions. All patients received the usual treatment for mucositis, but in the case group, synbiotic mouthwash was prescribed and in the control group, normal saline mouthwash was prescribed from a day before the start to the end of radiotherapy treatment. Patients were monitored every session for 6 weeks to check the progression, oral involvement severity, and mucositis grade.
RESULTS: The case group showed a significant reduction in the oral mucositis severity. The mucositis grade in the case group from the 7th session of oral examination was significantly lower than the control (p < 0.05), and this significant difference persisted until the last session of oral examination. Incidence rates of severe oral mucositis (grade 3) during the treatment period were 11.59% in the case and 36.45% in control (p < 0.001).
CONCLUSIONS: Synbiotic mouthwash significantly reduces and prevents oral mucositis intensity in oral cancer patients undergoing radiotherapy.

BACKGROUND: For men, early ejaculation is a serious health concern. Here, we tested the influence of modafinil (Profinil®) on early ejaculation. To this end, we performed a double-blind randomized clinical trial among men with early ejaculation.
METHODS: A total of 46 men with early ejaculation (mean age: 37.35 years) and in stable marital relationships with regular weekly penile-vaginal intercourse were randomly assigned either to the modafinil (100 mg) or to the placebo condition. Compounds were taken about 4-6h before intended penile-vaginal intercourse. At baseline and four weeks later at the end of the study, participants completed a series of self-rating questionnaires covering early ejaculation. Female partners also rated their male partners\' early ejaculation profile.
RESULTS: Dimensions of early ejaculation improved over time, but only so in the modafinil condition, while no improvements were observed in the placebo condition.
CONCLUSIONS: Among male adults in stable marital relationships with regular weekly penile-vaginal intercourse modafinil improved dimensions of early ejaculation, always compared to placebo. Given the strong effect of modafinil on cognitive-executive processes, it is conceivable, that modafinil acted both via physiological and cognitive-executive pathways.

BACKGROUND: Bauhinia forficata Link, is a Brazilian native plant and popularly known as pata-de-vaca (\"paw-of-cow\"). The tea prepared with their leaves has been extensively used in the Brazilian traditional practices for the diabetes treatment. The aim of the present study was to investigate the effect of capsules containing granules of a standardized extract of B. forficata leaves as adjuvant treatment on the glycemic control of patients with type-2 diabetes melitus.
METHODS: A double-blind, randomized clinical trial using capsules containing granules prepared by wet granulation of a standardized extract from B. forficata leaves as adjuvant treatment, was conducted. 92 patients aged 18-75 years from an outpatient clinic with type-2 diabetes were randomly assigned by a simple randomization scheme, in a 1:1 ratio to receive capsules of B. forficata or placebo for four months. The capsules used contain 300 mg of standardized extract from B. forficata leaves, yielding 2% of total flavonoid content per capsule. Primary outcome was glycated hemoglobin levels and fasting plasma glucose at 4 months. Possible harms were also determined.
RESULTS: The findings showed that at 4 months, the mean fasting plasma glucose levels and glycated hemoglobin were both significantly lower in the B. forficata group than in the placebo group.
CONCLUSIONS: The present study suggests that the adjunctive use of capsules containing standardized extract of B. forficata can add to regular oral anti-diabetics in the metabolic and inflammatory control of type-2 diabetes patients.

BACKGROUND: Among male sexual dysfunctions, erectile dysfunction and early ejaculation have the highest prevalence rates. Here, we tested the influence of lisdexamfetamine dimesylate (Vyas®) on early ejaculation. To this end, we performed a double-blind randomized clinical trial among males with early ejaculation.
METHODS: A total of 46 males with early ejaculation (mean age: 35.23 years) and in stable marital relationships with regular weekly penile-vaginal intercourse were randomly assigned either to the lisdexamfetamine dimesylate condition (30 mg) or to the placebo condition. Compounds were taken about six hours before intended penile-vaginal intercourse. At baseline and four weeks later at the end of the study, participants completed a series of self-rating questionnaires covering early ejaculation. Female partners also rated participants\' early ejaculation profile.
RESULTS: Compared to the placebo condition, dimensions of early ejaculation improved over time in the lisdexamfetamine condition, though improvements were also observed in the placebo condition.
CONCLUSIONS: Among male adults in stable marital relationships with regular weekly penile-vaginal intercourse, lisdexamfetamine dimesylate improved dimensions of early ejaculation. Given that improvements were also observed in the placebo condition, psychological factors such as increased attention to early ejaculation and favorable expectations of the compound should be considered.

Spinal muscular atrophy (SMA) is an autosomal recessive neuromuscular disorder, due to the loss of function of the survival motor neuron (SMN1) gene. The first treatment for the condition, recently approved, is based on the reduction of exon 7 skipping in mRNAs produced by a highly homologous gene (SMN2). The primary objective of the present study was to evaluate the applicability of the dosage of SMN gene produts in blood, as biomarker for SMA, and the safety of oral salbutamol, a beta2-adrenergic agonist modulating SMN2 levels.
We have performed a 1-year multicentre, double-blind, placebo-controlled study with salbutamol in 45 adult patients with SMA. Patients assumed 4 mg of salbutamol or placebo/three times a day. Molecular tests were SMN2 copy number, SMN transcript and protein levels. We have also explored the clinical effect, by the outcome measures available at the time of study design.
Thirty-six patients completed the study. Salbutamol was safe and well tolerated. We observed a significant and progressive increase in SMN2 full-length levels in peripheral blood of the salbutamol-treated patients (p<0.00001). The exploratory analysis of motor function showed an improvement in most patients.
Our data demonstrate safety and molecular efficacy of salbutamol. We provide the first longitudinal evaluation of SMN levels (both transcripts and protein) in placebo and in response to a compound modulating the gene expression: SMN transcript dosage in peripheral blood is reliable and may be used as pharmacodynamic marker in clinical trials with systemic compounds modifying SMN2levels.
EudraCT no. 2007-001088-32.

OBJECTIVE: Nail damage is common amongst patients receiving chemotherapy causing disfigurement and pain. This investigation evaluated whether a topical balm containing steam-extracted, bioactive polyphenolic-rich herbal oils blended with organic waxes could protect the nails via their reported anti-inflammatory, analgesic, anti-oxidant and anti-microbial properties.
METHODS: 60 patients (23M, 37F) were randomised to apply (2-3/day) either the plant balm (PB) or a petroleum control (PC) to their nail beds. Demographics, type and number of chemotherapy cycles did not differ between the two groups, recruited between Sept 2015 and Sept 2016. An unpaired t test was used to test the differences in symptoms and physical nail damage between the two groups.
RESULTS: Symptom scores recorded with the dermatology life quality questionnaire (DLQQ) were significantly better, between the start and end of chemotherapy, in the group applying the PB versus PC. Likewise, the mean fall in nail damage, scored with the Nail Psoriasis Index by the supervising physician, was also significantly different.
CONCLUSIONS: The polyphenolic-rich essential oils and plant-based waxes in this nail bed balm profoundly reduced chemotherapy-related nail damage and improved nail-related quality of life, compared to a control. A further analysis is planned combining this balm with nail bed cooling.