BackgroundDelivery of therapeutic agents as erythropoietin (EPO) into Central Nervous System through intranasal route could benefit patients with neurological disorders. A new nasal formulation containing a non-hematopoietic recombinant EPO (NeuroEPO) has shown neuroprotective actions in preclinical models. In the current study, the safety of NeuroEPO was evaluated for the first time in humans.MethodsA phase I, randomized, parallel, open-label study was carried out in healthy volunteers. They received, intranasally, 1 mg of NeuroEPO every 8 h during 4 days (Group A) or 0.5 mg of NeuroEPO (Group B) with the same schedule. The working hypothesis was that intranasal NeuroEPO produce <10% of severe adverse reactions in the evaluated groups. Therefore, a rigorous assessment of possible adverse events was carried out, which included tolerance of the nasal mucosa and the effect on hematopoietic activity. Clinical safety evaluation was daily during treatment and laboratory tests were done before and on days 5 and 14 after starting treatment.ResultsTwenty-five volunteers, 56% women, with a mean age of 27 yrs. were included. Twelve of them received the highest NeuroEPO dose. Twenty types of adverse events occurred, with headache (20%) and increase of hepatic enzymes (20%) as the most reported ones. Nasopharyngeal itching was the most common local event but only observed in four patients (16%), all of them from the lowest dose group. About half of the events were very probably or probably caused by the studied product. Most of the events were mild (95.5%), did not require treatment (88.6%) and were completely resolved (81.8%). No severe adverse events were reported. During the study the hematopoietic variables were kept within reference values.ConclusionsNeuroEPO was a safe product, well tolerated at the nasal mucosa level and did not stimulate erythropoiesis in healthy volunteers.Trial registrationCuban Public Registry of Clinical Trials RPCEC00000157, June 10, 2013.

Eficacia de las tabletas de Plectranthus amboinicus (Lour.) Spreng (Orégano francés) en pacientes con catarro común: estudio aleatorizado, a doble ciego, controlado con placebo Efficacy of Plectranthus amboinicus (Lour.) Spreng (French oregano) tablets in patients with common cold: a randomized, double-blind, placebo-controlled study ABSTRACTMedicinal plants with healing properties could be used to improve medical attendance. Common cold is a very high frequent disease but their treatment is not always available and adequate. Particularly, French oregano had demonstrated expectorant and antitussive properties at non-clinical level. A randomized, double-blind, placebo-controlled clinical trial was carried out to evaluate if French oregano tablets could quickly suppress common cold symptoms in patients with upper respiratory tract infections, being superior to symptomatic treatment. Patients received placebo or oregano (300 or 600 mg), daily, during 15 days, combined to abundant liquid and antipyretics on the presence of fever or malaise. Each group was formed by 30 patients. The frequency and intensity of cough and the amount of expectoration were assessed weekly. After first week of treatment, cough frequency was significantly lower in those patients treated with 600 mg comparing other groups (p = 0.003). Cough disappeared in 20 patients from the highest dose group. At that time, this group had best results concerning reduction in cough intensity (p = 0.046) and increase in the amount of expectoration (p = 0.041). None patient treated with 600 mg had severe cough after seventh day when a profuse expectoration arose. Therefore, the highest percentage of patients with successful overall response was recorded in this group. Adverse events were mild and mostly attributed to typical disease reactions. French oregano tablets produced a rapid, dependent-dose outcome in patients with common cold, superior to conventional treatment, being also well-tolerated. Cuban Public Registry of Clinical Trials RPCEC00000124.

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