Efficacy of multivitamin support following bariatric surgery in patients with obesity: a prospective observational study.

PURPOSE: Bariatric surgery (BS), an effective treatment for severe obesity and its comorbidities, may result in micronutrient and vitamin deficiencies. This monocentric prospective observational study aimed at evaluating the efficacy of a specifically designed vitamin/mineral formula (Bariatrifast, BIOITALIA S.r.l., Italy) for preventing and treating micronutrient deficiencies in patients submitted to BS. METHODS: Twenty patients with severe obesity (mean weight and BMI: 123.5 kg (range 88-174) and 43.3 kg/m2 (range 37-54) respectively) underwent BS (10 vertical sleeve gastrectomy VSG, 10 Roux-en-Y gastric bypass, RYGB). The mean age was 49.9 years (range 27-68). After a presurgical visit (V0), follow-up visits were performed at 1, 3, 6 and 12 months after surgery (V1-V4). Recorded data included weight, height and BMI. A complete blood count, measurement of ferritin, folic acid, vitamin B12, ionized calcium, 25 OH vitamin D, parathyroid hormone (PTH) were obtained. Following BS, patients started the daily oral multivitamin and mineral supplement. RESULTS: All patients achieved a significant weight loss (mean - 34.7 ± 11.8 kg). No deficiencies of various vitamins/micronutrients were detected during the entire study period. The serum concentrations of vitamin B12, 25-OH Vitamin D and folic acid increased over the follow-up period compared with V0 (mean increase 243 ng/L, 23 µg /L, 8 µg/L, respectively). Compared to RYGB, patients who underwent sleeve gastrectomy showed higher levels of 25-OH vitamin D at V2, V3 and V4 (all p < 0.05), and higher levels of Vitamin B12 and folic acid at V4 (p < 0.05 and p < 0.005, respectively). No adverse events were reported. CONCLUSION: Following VSG or RYGB, Bariatrifast administration was associated with normal values of essential micronutrients, and it was well-tolerated without evidence of gastrointestinal side effects. Clinical Trial Registration ClinicalTrials.gov, identifiers NCT06152965.

Treatment of Hypothyroid Patients With L-Thyroxine (L-T4) Plus Triiodothyronine Sulfate (T3S). A Phase II, Open-Label, Single Center, Parallel Groups Study on Therapeutic Efficacy and Tolerability.

Sodium salt of levothyroxine (L-T4) is the treatment of choice of hypothyroidism. Yet, L-T4 monotherapy produces supoptimal 3,5,3'-triiodothyronine (T3)/T4 ratio in serum, as compared to normal subjects, and a minority of hypothyroid individuals on L-T4 complain for an incomplete well-being. Orally administered 3,5,3'-triiodothyronine sulfate (T3S) can be converted to T3 in humans, resulting in steady-state serum T3 concentrations for up to 48 h. In this study (EudraCT number 2010-018663-42), 36 thyroidectomized hypothyroid patients receiving 100 (group A), 125 (group B), or 150 µg (group C) L-T4 were enrolled in a 75 days study in which 25 µg L-T4 were replaced by 40 µg of T3S. A significant, progressive reduction in mean FT4 values was observed, being the largest in the group A and the smallest in group C, while no relevant variations in FT3 and total T3 serum values were observed in the three groups. TSH serum levels increased in all groups, the highest value being observed in group A. Lipid parameters did not show clinically significant changes in all groups. No T3S-related changes in the safety laboratory tests were recorded. No adverse event was judged as related to experimental treatment, and no patient discontinued the treatment. Twelve patients judged the L-T4+T3S treatment better than L-T4 alone, while no patient reported a preference for L-T4 over the combined treatment. In conclusion, the results of this study indicate that a combination of L-T4+T3S in hypothyroid subjects may allow mainteinance of normal levels of serum T3, with restoration of a physiological FT4/FT3 ratio and no appearance of adverse events. Further studies are required to verify whether the LT4+T3S chronic combined treatment of hypothyroidism is able to produce additional benefits over L-T4 monotherapy.

Clinical evaluation of the efficacy and safety of a medical device in various forms containing Triticum vulgare for the treatment of venous leg ulcers - a randomized pilot study.

This study was carried out to assess the efficacy and tolerability of the topical application of an aqueous extract of Triticum vulgare (TV) in different vehicles (cream, impregnated gauzes, foam, hydrogel, and dressing gel) for the treatment of venous lower leg ulcers. Fifty patients were randomized to receive one of the five investigational vehicles. Treatment was performed up to complete healing or to a maximum of 29 days. The wound size reduction from baseline was the primary efficacy variable, which was measured by means of a noninvasive laser scanner instrument for wound assessment. In all groups, apart from the foam group, a similar trend toward the reduction of the surface area was observed. The cream showed the greatest effect on the mean reduction of the lesion size. At last visit, six ulcers were healed: two in the cream group, three in the gauze group, and one in the dressing gel group. In the patients treated with the cream, the gauzes, the hydrogel, and the dressing gel, the reduction of lesion size was 40%-50%; the reduction was smaller in the foam group. No impact in terms of age on the healing process was found. The Total Symptoms Score decreased in all groups during the study; a greater efficacy in terms of signs/symptoms was observed in the patients treated with the gauzes. In the dressing gel group, one patient had an infection of the wound after 3 weeks of treatment and 2 of colonization, leading to a systemic antibiotic treatment. The events were judged as nonrelated to the device used. On the basis of the results, it could be argued that the medical device may be useful in the treatment of chronic venous ulcers.

Steady-State Serum T3 Concentrations for 48 Hours Following the Oral Administration of a Single Dose of 3,5,3'-Triiodothyronine Sulfate (T3S).

OBJECTIVE: Sulfate conjugation of thyroid hormones is an alternate metabolic pathway that facilitates the biliary and urinary excretion of iodothyronines and enhances their deiodination rate, leading to the generation of inactive metabolites. A desulfating pathway reverses this process, and thyromimetic effects have been observed following the parenteral administration of 3,5,3'-triiodothyronine (T3) sulfate (T3S) in rats. The present study investigated whether T3S is absorbed after oral administration in humans and if it represents a source of T3. METHODS: Twenty-eight hypothyroid patients (7 men and 21 women; mean age, 44 ± 11 years) who had a thyroidectomy for thyroid carcinoma were enrolled. Replacement thyroid hormone therapy was withdrawn (42 days for thyroxine, 14 days for T3) prior to 131I remnant ablation. A single oral dose of 20, 40, 80 (4 patients/group), or 160 µg (16 patients/group) of T3S was administered 3 days before the planned administration of 131I. Blood samples for serum T3S and total T3 (TT3) concentrations were obtained at various times up to 48 hours after T3S administration. RESULTS: At all T3S doses, serum T3S concentrations increased, reaching a peak at 2 to 4 hours and progressively returning to basal levels within 8 to 24 hours. The T3S maximum concentration (Cmax) and area under the 0- to 48-hour concentration-time curve (AUC0-48h) were directly and significantly related to the administered dose. An increase in serum TT3 concentration was observed (significant after 1 hour), and the concentration increased further at 2 and 4 hours and then remained steady up to 48 hours after T3S administration. There was a significant direct correlation between the TT3 AUC0-48h and the administered dose of T3S. No changes in serum free thyroxine (T4) concentrations during the entire study period were observed, whereas serum thyroid-stimulating hormone levels increased slightly at 48 hours, but this was not related to the dose of T3S. No adverse events were reported. CONCLUSION: (1) T3S is absorbed following oral administration in hypothyroid humans; (2) after a single oral dose, T3S is converted to T3 in a dose-dependent manner, resulting in steady-state serum T3 concentrations for 48 hours; (3) T3S may represent a new agent in combination with T4 in the therapy of hypothyroidism, if similar conversion of T3S to T3 can be demonstrated in euthyroid patients who are already taking T4.

Therapeutic efficacy and tolerability of the topical treatment of inflammatory conditions of the oral cavity with a mouthwash containing diclofenac epolamine: a randomized, investigator-blind, parallel-group, controlled, phase III study.

BACKGROUND: Non-steroidal anti-inflammatory drugs (NSAIDs), including diclofenac, are the mainstay of analgesic and anti-inflammatory treatment in dentistry. Diclofenac epolamine [diclofenac N-(2-hydroxyethyl)pyrrolidine; DHEP] is a diclofenac salt with greater water solubility and better cutaneous absorption properties than other commonly used forms of the drug. IBSA has recently developed a mouthwash formulation of DHEP for the topical treatment of inflammatory conditions of the oral cavity. OBJECTIVE: The aim of this study was to compare the efficacy and tolerability of DHEP mouthwash (Osmal®) with that of a reference product (commercially available diclofenac mouthwash). METHODS: This was a randomized, investigator-blind, parallel-group, controlled, phase III study that enrolled 80 patients with conditions affecting the oral cavity, characterized by an inflammatory component, and eligible for analgesic and anti-inflammatory treatment. Patients were randomized 1:1 to DHEP mouthwash (0.103% DHEP in aqueous solution) or to diclofenac mouthwash (0.074% free diclofenac in aqueous solution). The treatment regimen was the same in both groups: 1-minute rinse with 15 mL of mouthwash, twice daily for 7 days. Visits were scheduled at study inclusion (D0), and 3 days (D3) and 7 days (D7) after treatment initiation. During each visit assessments were made of pain severity (using a 5-point semi-quantitative scale and a 100-mm visual analogue scale [VAS]) and inflammatory signs (using a 5-point scale). The primary study endpoint was the change in pain severity scores from D0 to D3 and D7. Secondary endpoints included effects of treatment on inflammation score, quality of sleep, compliance with treatment and the safety and tolerability of treatment. RESULTS: The two treatment arms were homogeneous in terms of patient characteristics. The most prevalent oral condition was gingivitis. Overall both topical treatments were effective in alleviating pain and inflammation, as evidenced by decreases in pain and inflammation scores within 3 days after treatment initiation. Notably, a significantly greater proportion of patients treated with DHEP were free of pain and inflammatory symptoms at D3 compared with those treated with the diclofenac mouthwash (40% vs 20% of patients; p < 0.05). Also, DHEP was associated with more marked, but not statistically significant, decreases in VAS pain scores versus baseline after 3 days' treatment. Compliance with both treatments was good and both mouthwashes were well tolerated. CONCLUSION: DHEP mouthwash was at least as effective as diclofenac mouthwash at alleviating pain and inflammation symptoms and is well tolerated in patients with painful inflammatory conditions of the oral cavity. The potential of DHEP mouthwash deserves to be investigated in a larger patient population.

Efficacy and Tolerability of Clarema 1% Cream and Hirudoid 40000 U.APTT Gel in the Topical Treatment of Haematomas and/or Subcutaneous Haematic Extravasations.

Ninety-six caucasian both-gender patients with haematomas and/or subcutaneous haematic extravasation of traumatic or surgical origin were randomized to receive local treatment (max 10 days) with heparan sulfate cream or glycosaminoglycan-polysulphate (GAGPS) gel. Signs (oedema, disability, and colour of the lesion) and symptoms (pain at rest and at movement) (scored 0-3), the sum of the scores (primary end point), and the size of the lesion were evaluated at the baseline visit and afterwards every 5 days. The rate of the patients completely healed at the end of the study was also recorded. The results of the study showed that heparan sulfate 1% cream was comparable or superior to GAGPS gel in relieving signs and symptoms. No AEs were recorded.

Efficacy and tolerability of fitostimoline in two different forms (soaked gauzes and cream) and citrizan gel in the topical treatment of second-degree superficial cutaneous burns.

A total of 227 patients (mean age 41.3 years, 52% females) with at least one second-degree superficial cutaneous burn of thermal origin of a smallest transverse diameter ≥20 mm and a largest transverse diameter ≤90 mm were randomised to receive the topical application of aqueous extract of Triticum vulgare (Fitostimoline) in two different forms (soaked gauzes and cream) or catalase of horse origin in form of gel (Citrizan Gel), given up to healing or to a maximum of 20 days. The rate of lesion healing at end of study was significantly higher in patients treated with Fitostimoline (gauzes 97.3%, cream 91.5%) than in those receiving catalase (84.5%). The pooled Fitostimoline groups were also significantly more effective than catalase gel in reducing total symptoms score, pain at medication, pain at rest, and burning at end of study. Both formulations of Fitostimoline and catalase gel were well tolerated in terms of adverse effects in the site of application.

Effects of L-arginine on the Minnesota Living with Heart Failure Questionnaire quality-of-life score in patients with chronic systolic heart failure.

BACKGROUND: L-arginine, the precursor of nitric oxide, may restore nitric oxide levels and bioavailability and influence symptom severity, quality of life (QoL), physical performance, and left ventricular (LV) diastolic abnormalities in patients with chronic systolic heart failure (HF). The aim was to evaluate the effects of orally administered L-arginine in chronic HF patients. MATERIAL/METHODS: A parallel double-blind multicenter randomized study was performed in 68 patients (mean age: 64+/-11 years) with mild-to-moderate systolic HF (NYHA class II-III) and LV ejection fraction (EF)