No abstract

Objectives: During menopausal transition, women are frequently affected by vulvovaginal atrophy (VVA), due to the decline of estrogen levels. Resulting symptoms are itching, burning, dyspareunia, and vaginal dryness (reported in up to 85%). The aim of this trial was to verify if medical device polycarbophil vaginal (PCV) moisturizer gel is not less effective than hyaluronic acid (HA) gel in treating vaginal dryness. Material and methods: This was a multicenter, open label, randomized, parallel group, comparative study with non-inferiority design. Female included were !45 to 55 years in the menopausal transition, with subjective dryness, any objective sign of VVA, pH > 5, and body mass index of !18.5 to 36 kg/m 2 . Subjects were randomized to 1 g of PCV gel twice a week for 30 days or 3 g of HA vaginal gel every 3 days for 30 days. Results: 53 subjects (mean age 49.45 ± 2.96 years) were analyzed. Vaginal health index showed an improvement (p < 0.001) in both groups (from 12.54 ± 1.37 to 16.36 ± 2.66 for PCV, from 12.00 ± 1.91 to 16.60 ± 2.50 for HA), but the difference between final means (95%CI: À1.66 to 1.18) evidenced that PCV is non-inferior to HA treatment. Similarly, an improvement was evidenced in vaginal maturation index (p = 0.005 for PCV, ns. for HA), female sexual function index (p < 0.001 for PCV, p < 0.001 for HA), and SF-12 (p < 0.001 for PCV, p < 0.001 for HA), with no difference between groups. Safety was optimal and no adverse events were reported. Conclusions: The use of HA gel does not give additional benefits to those that are already provided by the moisturizing PCV.

The study was in preparation for a future randomized clinical trial (RCT) with oral hyaluronic acid (HA) in knee osteoarthritis. Its purpose was to evaluate the feasibility of i) ultrasonography (US) and range of motion (ROM) parameters as objective measurements to correlate the improvement of knee mobility with its pain reduction; ii) the planned recruitment monthly rate to estimate the resources for the main study. In addition, it should give by US, ROM, visual analogue scale (VAS) and KOOS questionnaire, preliminary data on efficacy. This open-label pilot trial was performed in an orthopedic clinic (Timisoara, Romania). Male and female subjects (from 50 to 70 years) diagnosed with symptomatic OA of the knee with i) mild joint discomfort for at least 6 months, ii) Kellgren/Lawrence score 2 by X-ray, iii) pain for at least 15 of the 30 previous days, were included. Exclusion criteria were: inflammatory arthritic condition; oral corticosteroids within 4 weeks; intra-articular injections of HA or corticosteroids within 3 months; anti-inflammatory or chondroprotective drugs within 2 weeks. Following protocol, 8 patients administered for 8 weeks Syalox� 300 Plus (River Pharma, Italy) a product based on HA of high molecular weight. US parameters improved from baseline, even if no statistically significant differences were found. ROM and VAS (at rest, on moving and on pressing) values improved significantly at week 4 and 8 in comparison with baseline. The correlation between objective improvement of knee mobility and subjective pain reduction was documented. The enrolment rate was 8 patients/month. The KOOS subscales scores evidenced statistically significant differences during the study. No adverse event. US and ROM can be used as objective measurements to correlate improvement of knee mobility with pain reduction. The recruitment capability evidenced a realistic estimation of time and budget for the main study. Preliminary data on efficacy using objective measurements (US, ROM) and subjective parameters (VAS, KOOS questionnaire) showed significant improvements and will be used for sample size calculation in the main study.

BACKGROUND Osteoarthritis (OA) is one of the top five most disabling conditions and it affects more than one third of persons over 65 years of age. Currently 80% of persons affected by OA already report having some movement limitation, 20% of people are not be able to perform major activities of daily living, and about 11% of the total affected population need of personal care. On 2014 the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) suggested as first step of pharmacological treatment for knee OA a background therapy with chronic symptomatic slow-acting drugs for osteoarthritis (SYSADOAs), such as glucosamine sulphate, chondroitin sulphate and hyaluronic acid (HA). In studies with oral HA, symptoms of OA are often measured using subjective parameters such as the visual analog scale (VAS) or the quality of life questionnaire (QoL) and objective measurements as ultrasonography (US) or range of motion (ROM) are employed in very few trials. This affects the quality of data in the literature. OBJECTIVE The primary objective of this work is to assess the feasibility of implementing US and ROM as objective measurements to correlate the improvement of knee mobility with pain reduction, evaluated using a subjective scale (VAS) in patients assuming a nutraceutical containing HA. The secondary objective is to evaluate the enrollment rate in one month to verify the feasibility for time and budget of the planned future main study. The explorative objective of the trial is to obtain preliminary data on efficacy of the tested product. METHODS This open-label pilot trial is performed in an orthopedic clinic (Timisoara, Romania). Male and female subjects (from 50 to 70 years) diagnosed with symptomatic OA of the knee with mild joint discomfort for at least 6 months are included. Following protocol, 8 patients are administered for 8 weeks Syalox® 300 Plus (River Pharma, Italy), a product based on HA of high molecular weight. Baseline and final visit assessments include orthopedic assessment, US, Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire, VAS and ROM of knee. RESULTS Data collection occurred between February 2018 and June 2018. All results are expected to be available by the end of 2018. CONCLUSIONS This pilot trial will be the first study to analyze the potential correlation between subjective evaluation (VAS, KOOS questionnaire) and objective measurements (US, ROM and actigraphy). The data from this study will assess the feasibility of the planned monthly recruitment rate and the necessary time and budget, and should provide preliminary information on efficacy of the tested product. CLINICALTRIAL ClinicalTrials.gov (NCT number: NCT03421054).