LDL-cholesterol lowering effect of a new dietary supplement: an open label, controlled, randomized, cross-over clinical trial in patients with mild-to-moderate hypercholesterolemia.

BACKGROUND: Hypercholesterolemia is a major risk factor for cardiovascular disorders and requires specific intervention through an adequate lifestyle (diet and physical exercise) and, if necessary, an appropriate drug treatment. Lipid-lowering drugs, although generally efficacious, may sometimes cause adverse events. A growing attention has been devoted to the correction of dyslipidemias through the use of dietary supplements. The aim of this study was to assess the lipid-lowering activity and safety of a dietary supplement containing monacolin K, L-arginine, coenzyme Q10 and ascorbic acid, named Argicolina (A), compared to a commercially available product containing monacolin K and coenzyme Q10, Normolip 5 (N). METHODS: This was a single center, controlled, randomized, open-label, cross-over clinical study enrolling 20 Caucasian outpatients aged 18-75 years with serum LDL-C between 130 and 180 mg/dL. Patients assumed two different dietary supplements (A and N) both containing monacolin K 10 mg for 8 weeks each, separated by a 4-week wash-out period. Evaluated parameters were: Total cholesterol (Tot-C), low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), triglycerides (TG), fasting blood glucose, aspartate aminotransferase, alanine aminotransferase, creatinekinase, gamma-glutamyl-transpeptidase, brachial arterial pressure and heart rate, measured at the start and at the end of each treatment period. Safety was monitored through the study. RESULTS: LDL-C decreased by 23.3% during treatment with N (p < 0.0001) and by 25.6% during treatment with A (p < 0.0001); the LDL-C mean reduction was 36.4 (95% CI: 45,6-27,1) mg/dL during N treatment and 40.1 (95% CI: 49.2-30,9) mg/dL during A treatment. Tot-C decreased significantly (p < 0.0001) within each treatment period. HDL-C increase was negligible during A whereas it was significant during N. TG diminished markedly during A and not significantly during N. The difference between treatments was not statistically significant for all variables. No serious or severe adverse events occurred during the study. CONCLUSIONS: Our results confirm the clinically meaningful LDL-C lowering properties of monacolin K. At variance with a supplement already in the market (N), the novel association (A) of monacolin K with L-arginine, coenzime Q10 and ascorbic acid also produces a significant reduction of triglycerides without significant effects on HDL. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT03425630 .

Efficacy and tolerability of fitostimoline (vaginal cream, ovules, and vaginal washing) and of benzydamine hydrochloride (tantum rosa vaginal cream and vaginal washing) in the topical treatment of symptoms of bacterial vaginosis.

Two hundred and 91 patients showing signs and symptoms of bacterial vaginosis (BV) were randomized to receive topical treatment with Fitostimoline (vaginal cream and vaginal ovules + vaginal washing) or benzydamine hydrochloride (vaginal cream + vaginal washing) for 7 days. Signs (leucorrhoea, erythema, oedema, and erosion) and symptoms (burning, pain, itching, vaginal dryness, dyspareunia, and dysuria) (scored 0-3) were evaluated at baseline and at the end of treatment; the total symptoms score (TSS) was also calculated. In 125 patients, a bacterial vaginosis was confirmed by vaginal swab test. The primary efficacy variable analysis, that is, the percentage of patients with therapeutic success (almost complete disappearance of signs and symptoms), demonstrated that Fitostimoline ovules and vaginal cream were therapeutically equivalent and that pooled Fitostimoline treatment was not inferior to benzydamine hydrochloride. All the treatments were well tolerated, with only minor local adverse events infrequently reported. The results of this study confirmed that gynaecological Fitostimoline is a safe and effective topical treatment for BV.

Comparison of the antiinflammatory efficacy of chondroitin sulfate and diclofenac sodium in patients with knee osteoarthritis.

OBJECTIVE: To assess the clinical efficacy of chondroitin sulfate (CS) in comparison with the nonsteroidal antiinflammatory drug (NSAID) diclofenac sodium (DS) in a medium/longterm clinical study in patients with knee osteoarthritis (OA). METHODS: This was a randomized, multicenter, double blind, double dummy study. 146 patients with knee OA were recruited into 2 groups. During the first month, patients in the NSAID group were treated with 3 x 50 mg DS tablets/day and 3 x 400 mg placebo (for CS) sachets; from Month 2 to Month 3, patients were given placebo sachets alone. In the CS group, patients were treated with 3 x 50 mg placebo (for diclofenac) tablets/day and 3 x 400 mg CS sachets/day during the first month; from Month 2 to Month 3, these patients received only CS sachets. Both groups were treated with 3 x 400 mg placebo sachets from Month 4 to Month 6. Clinical efficacy was evaluated by assessing the Lequesne Index, spontaneous pain (using the Huskisson visual analog scale), pain on load (using a 4 point ordinal scale), and paracetamol consumption. RESULTS: Patients treated with the NSAID showed prompt and plain reduction of clinical symptoms, which, however, reappeared after the end of treatment; in the CS group, the therapeutic response appeared later in time but lasted for up to 3 months after the end of treatment. CONCLUSION: CS seems to have slow but gradually increasing clinical activity in OA; these benefits last for a long period after the end of treatment.

[Tests of autonomic nervous system functioning in children: normal values]. / Le prove di funzionalità del sistema nervoso autonomo nel bambino: valori normali.

The study of cardiovascular autonomic reflexes is the most physiological and reliable test for the assessment of autonomic function: they consist of the analysis of variation of heart rate and arterial pressure provoked by many physiological stimuli. Up to now normal pediatric reference data were not available: we have standardized these tests in 198 normal children (94 M, 104 F), aged 8.3-15.7 years, without any symptom of possible autonomic dysfunction pathology. A complete auxological evaluation has been performed. Autonomic tests were performed by ECG recording and arterial pressure monitoring during normal and deep breathing, Valsalva manoeuvre, lying to standing postural change, isometric muscular contraction (sustained hand-grip and leg rising). Eleven autonomic parameters were obtained. Many statistical correlation between autonomic parameters and auxological features have been explored, without remarkable results. A significative difference emerged only between sexes. Normal reference values has been calculated. Their utility for the study of autonomic dysfunction is discussed.

[Autonomic neural functioning in children with the periodic syndrome]. / Studio della funzionalità neurovegetativa in bambini con sindrome periodica.

The pathogenesis of periodic syndrome (recurrent abdominal pain, cyclic vomiting, headache and other equivalents of childhood migraine) is often related in the literature to a "neuro-vegetative dysfunction", by which occasional stimuli (environmental, metabolic, emotional) should find a particular somatic expression. The homeostatic role of the autonomic nervous system could be deficient in these cases, but systematic research has never been done to explore this hypothesis. We have evaluated the autonomic nervous function in 38 children (12 M, 26 F) with periodic syndrome, by cardiovascular autonomic function tests. They consist of ortho- and parasympathetic parameters obtained by ECG registration and pressure monitoring during deep breathing, Valsalva manoeuvre, lying to standing postural change, sustained handgrip. In the absence of adequate pediatric references values, we have previously standardized these tests in a population of 198 healthy children (94 M, 104 F), aged 8.3-15.7 years. Results have been compared with our standard reference values, matching them by t-test for independent data: in both sexes, significant differences have been found out in only one of 11 parameters (p < 0.05) of the autonomic tests performed. Children affected by periodic syndrome reveal a reduced heart rate variation in transition from the early orthosympathetic phase to the late parasympathetic one after lying to standing passage, showing a smaller fluctuation of autonomic feedback systems. The physiological meaning of this result is unclear. However, in children with periodic syndrome no prevalence of ortho- or parasympathetic systems is evident.

Lack of effect of a new spasmolytic agent, rociverine, on intraocular pressure, pupil size and iridocorneal angle in patients with angle-closure glaucoma.

Twenty patients with angle-closure glaucoma (38 glaucomatous eyes - 17 surgically operated, 21 non-operated) were treated with rociverine (60 mg orally per day for 7 days), a new direct myolitic and mildly anticholinergic antispasmodic drug. Intraocular pressure, pupil size, iridocorneal angle, blood pressure and heart rate were checked before and during treatment. No clinically significant variations were observed in the parameters tested. It is suggested, therefore, that rociverine may be administered, if necessary, even to patients with angle-closure glaucoma.

Possible glucagon-mediated hypocholesterolemic activity of a nicotinic acid derivative (sorbinicate).

The antilipolytic activity of nicotinic acid was investigated in 7 patients with type II b hyperlipoproteinemia and in 7 with type IV hyperlipoproteinemia treated for two months with a nicotinic acid derivative, sorbinicate (1600 mg daily, ie 1454 mg NA). Before and after treatment the blood levels of total cholesterol and triglycerides were determined and three dynamic tests -- oral glucose tolerance test, insulin test and tolbutamide test -- were done to check in each test the variations in blood glucose, NEFA, insulin (excluding obviously the insulin test), glucagon and growth hormone levels. At the end of the treatment, there was a significant reduction of cholesterol (type IIb and type IV) and of triglycerides (type IV), a marked reduction of the glucagon response, a slight increase in the insulin response and in the basal secretion of the growth hormone. It is suggested that the antilipolytic activity of nicotinic acid (and hence of sorbinicate) is at least partly mediated by an inhibition of glucagon secretion (and/or synthesis).

Effectlessness of a new spasmolytic (rociverine) on intraocular pressure, pupil size, and iridocorneal angle in ophthalmically healthy subjects.

Thirty-seven subjects without eye diseases were treated with rociverine, a new direct myolytic and parasympatholytic antispasmodic: 15 by intravenous injection (20 mg) and 22 by oral administration (20 mg three times daily for four days). Intraocular pressure, pupil size, iridocorneal angle, blood pressure, and heart rate were checked before and during treatment. No clinically significant variations were observed in the parameters tested.

The use of rociverine as premedication for endoscopy of the upper gastro-intestinal tract: a double-blind controlled clinical trial.

The effect of rociverine (10 or 20 mg given intravenously) as premedication in upper gastro-intestinal tract endoscopy was examined and compared to that of hyoscine butylbromide (20 or 40 mg given i.v.) in a double-blind study involving 121 patients. The drugs' effects were assessed on the degree of opening of the pyloric sphincter and the endoscopist's rating of drug performance. The study showed that rociverine did not differ statistically from the reference drug on either count. No adverse effects were noted.