Search

Mesotherapy (local intradermal therapy, LIT) is a technique used to slowly spread drugs in tissues underlying the site of injection to prolong the pharmacological effect with respect to intramuscular injection. Recommendations for proper medical use of this technique have been made for pain medicine and rehabilitation, chronic venous disease, sport medicine, musculoskeletal disorders, several dermatological conditions, skin ageing, and immune-prophylaxis. Although mesotherapy is considered a valid technique, unresolved questions remain, which should be answered to standardize methodology and dosing regimen as well as to define the right indications in clinical practice. New randomized controlled trials are needed to test single products (dose, frequency of administration, efficacy and safety). Even infiltration of substances for dermo-cosmetic purposes must be guided by safety and efficacy tests before being proposed by mesotherapy. In this article, we put forth a preclinical and clinical research plan and a health technology assessment as a call to action by doctors, researchers and scientific societies to aid national health authorities in considering mesotherapy for prevention, treatment and rehabilitation paths., Video abstract Point your SmartPhone at the code above. If you have a QR code reader the video abstract will appear. Or use: https://youtu.be/bIuRhGQsUjs

LS Martin-Martin,1 F Giovannangeli,2 E Bizzi,2 U Massafra,2 E Ballanti,2 M Cassol,3 A Migliore2 1Department of Internal Medicine, Regina Apostolorum Hospital, 2Operative Unit of Rheumatology, 3Department of Internal Medicine, San Pietro Fatebenefratelli Hospital, Rome, Italy Background: Biologic agents are currently the strongest immunosuppressive drugs able to induce remission in rheumatoid arthritis (RA). One of the objectives of the medical scientific community now is how to maintain remission or low disease activity (LDA). The aim of this trial is to evaluate the contribution of low-dose sequential kinetic activation (SKA) IL-4, IL-10, and anti-IL-1 antibodies (10 fg/mL) in patients affected by RA in maintaining LDA or remission obtained after biological therapy. Method: This is a randomized, open, active-controlled, prospective, Phase IV trial. Disease activity score (DAS28), clinical disease activity index, simplified disease activity index, erythrocyte sedimentation rate and C-reactive protein levels, global health assessment, and pain visual analog scale were evaluated at baseline visit and then every 3 months together with an assessment of side effects till 12 months. Thirty-nine RA patients were enrolled and randomized to continue disease-modifying antirheumatic drugs (DMARDs) therapy or to receive a combination of SKA low-dose cytokines formulated in concentration of 10 fg/mL orally administered at a dose of 20 drops/d for 12 consecutive months. Results: The rate of maintenance of LDA at 12 months was superior in the group treated with low-dose cytokines compared with patients treated with DMARDs, 66.7% and 42.1%, respectively; however, the difference between the groups was not statistically significant. Noside effects were reported in both groups. Conclusion: This is the first study using a combination of three low-dose cytokines in RA, after data published on psoriasis. These data suggest that the use of a combination of low-dose SKA cytokines may be an opportunity to explore in the management of RA. Keywords: RA, low-dose cytokines, low-dose antibodies, SKA, biological agents, low disease activity

Alberto Migliore,1 Silvana Giannini,2 Emanuele Bizzi,1 Umberto Massafra,1 Maurizio Cassol,3 Martin Jose Michael Abilius,1 Giovanni Boni4 1Operative Unit of Rheumatology, San Pietro Fatebenefratelli Hospital, Rome 00189, Italy; 2Department of Radiology, Villa Stuart Sport Clinic, Rome 00136, Italy; 3Department of Internal Medicine, San Pietro Fatebenefratelli Hospital, Rome 00189, Italy; 4ANTIAGE Sportive Medicine Ambulatory Department (Ambulatorio di Medicina dello Sport Antiage), Foligno, Italy Objective: The aim of this study is to investigate the effect of intra-articular hyaluronic acid administration in active football players complaining of knee pain after sports activity. Efficacy and safety profiles of intra-articular hyaluronic acid and time needed for football players to recover and restart sports activity were examined.Methods: Clinical data of active football players reporting knee pain after sports activity were included in this retrospective study. All patients who received an intra-articular injection at time 0 and after 2 weeks were included in the study. Patients underwent laboratory examination, knee X-ray, ultrasound, and clinical examination before receiving the intra-articular injection. Effusions or cysts were drained before injections. Lequesne index score, pain visual analog scale (VAS) score, and patient’s global assessment score were recorded at time 0 (day of the first injection), 1 and 2 days after the first injection, at 2 weeks (day of the second injection), and at follow-up visits. Only data from patients completing the follow-up were analyzed.Results: Data from 17 patients were analyzed: 16 males and one female, of which three were professional players (two males and one female) and 14 were nonprofessional players. The mean age of patients was 39.8±11.8 years. Two patients (one male and one female) showed joint effusion. Two patients reported relevant joint pain after injection that regressed without any medication. At the first week, all parameters examined indicated improvement that was maintained until the end of follow-up. One day after the first and second injection, patients reported a slight increase in pain VAS score, which was not statistically significant, and the pain resolved after 1 day. All patients successfully restarted playing after the first injection within 3.1±2.0 days and kept playing after the second injection following our indication (1 day of break).Conclusion: The use of a medium-molecular weight hyaluronic acid in football players affected by knee osteoarthritis seems efficacious and safe and resulted, in our experience, a stable improvement of symptoms; moreover, it allowed a rapid restart of sports activity. Larger studies on larger populations are needed to confirm these findings. Keywords: sports, hyaluronic acid, intra-articular, injection, football, trauma

The recent development of compounds with anabolic action on bone have increased the range of therapeutic options for the treatment of osteoporosis and the prevention of fractures. Two major PTH analogs, the synthetic full-length 1-84 PTH molecule and the recombinant 1-34 N-terminal fragment (teriparatide), are available for the treatment of osteoporosis in many countries. There have bee no comparative trials on the bone anabolic effects of these compounds.In this study we applied a mixed treatment comparison (MTC) to compare the efficacy of teriparatide versus PTH 1-84 for the prevention of vertebral and non-vertebral fractures in women with severe osteoporosis. With this approach the relative treatment effect of one intervention over another can be obtained in the absence of head-to-head comparison. Among the candidate papers selected for analysis, two randomized controlled trials investigating the effects of teriparatide and PTH 1-84 met the selection criteria and underwent MTC analysis.Based on a fixed-effect MTC model analysis of data from two RCTs, teriparatide (20 µg/day) showed a 70% and 94% probability of being the best treatment for the prevention of vertebral and non-vertebral fractures, respectively. Together with a lack of statistical significance, this study has additional limitations. Some differences in trial procedures and populations exist; another limitation concerns the impossibility of carrying out a randomized-effect model MTC, due to sample exiguity. Furthermore, in order to consider unknown or unmeasured differences of covariates across trials, a random-effects approach would be preferred in order to assess the presence of heterogeneity across comparisons. In contrast, in our analysis a fixed-effect MTC model only was used.Teriparatide is expected to provide a greater efficacy over PTH 1-84 with both vertebral and non-vertebral fracture prevention in postmenopausal women with severe osteoporosis.

Objective: To evaluate the efficacy and the tolerability of viscosupplementation (VS) with hyaluronic acid (Hylan GF 20) in a cohort of 36 patients affected by hip osteoarthritis through a 18 months follow-up. Methods: Viscosupplementation was performed with an anteriorsagittal approach, under ultrasound guidance. 36 patients were administered hyaluronic acid intraarticularly in the hip, with a unique injection of Hylan G-F20, which could be repeated after at least 3 months. Treatment efficacy was assessed by functional index WOMAC, pain evaluation on a visual analogue scale and NSAID consumption. All such parameters were recorded at the time of the first injection and then 3, 6, 9, 12 and 18 months later. Results: Statistically significant reduction of all parameters was observed three months after the injection, and was still maintained at the timepoints 6, 9, 12 and 18 months. No local side effects have been observed, nor systemic complications. Conclusions: Our data show that viscosupplementation is a promising approach for hip osteoarthritis, providing beneficial effects in a long-tern follow up. Yet, the topic deserves further and wider studies, so to define the number of injections to administer and suggest a fit interval between subsequent injections.

Hip osteoarthritis (OA) is usually managed with systemic treatments such as nonsteroidal anti-inflammatory drugs (NSAIDs) and/or symptomatic slow-acting drugs. Unfortunately, many patients either cannot tolerate NSAIDs or suffer serious, even fatal, NSAID-induced side effects, predominantly gastrointestinal ulceration and bleeding. Viscosupplementation, which aims to restore physiological and rheological features of the synovial fluid, is a well-accepted therapeutic option in knee OA patients, but limited data exist in the literature about its potential benefit for the treatment of hip OA. The purpose of this study is to observe the effects of hylan G-F 20 administered through ultrasound (US)-guided intra-articular (IA) injections in patients with symptomatic hip OA. We treated 30 patients with symptomatic hip OA. Under US guidance, 7 patients received one injection, 21 patients had two injections, and 2 patients received three injections, each with 2 ml of hylan G-F 20. Lequesne index, VAS scale of hip pain, and NSAID consumption were evaluated at baseline as well as 2 and 6 months after the beginning of the treatment. No systemic adverse events were observed. Lequesne index, VAS pain score, and NSAID consumption showed a reduction that was statistically significant to the baseline. The present observation suggests the potentiality for the safety and efficacy of hylan G-F 20 injected under US guidance in patients with symptomatic hip OA. Further controlled studies are needed.

A variety of genetic and environmental factors contribute to the progressive develop of OA. It is necessary to identify people who are developing initial changes in cartilage and/or subchondral bone before onset of classical radiological features in order to detect early phase of OA. Recent quantitative MRI techniques can evaluate the structural, mechanical and biochemical characteristics of cartilage. T2 mapping is able to assess cartilage volume and defects measurement, delayed gadolinium enhanced MRI (dGEMRIC) and Contrast Enhanced Computed Tomography (CECT) can reveal Cartilage GAG content. Accurate and reliable serum, urine and synovial fluid biomarkers are also requested. Several biomarkers have been studied and proposed, but there are many critical issues to consider for inferring useful data from studies on biomarkers in early OA such as phase of disease, specific joint sites, systemic concentrations, circadian rhythm, their clearance from the joint, etc. Recently proteomics has produced great expectations to improve the early diagnosis of OA. These discoveries may open opportunities for the identification of early stage of OA leading to manage the symptoms and ultimately slow the progression of OA.

Multiple chemical sensitivity (MCS) is defined by multiple symptoms, affecting multiple organs, that wax and wane in response to varying chemical exposures at or below previously tolerated levels. Sjögren's syndrome (SS) is a common autoimmune disease affecting 3% of women aged over 55 years. Except for keratoconjunctivitis sicca (which is associated with SS not MCS), systemic features are common between the 2 diseases, leading to considerable morbidity and, occasionally, mortality. The authors report 3 cases of association between SS and MCS. Three women who were diagnosed with SS showed MCS symptoms and also were diagnosed with MCS. Further studies are needed to understand physiopathogenic mechanisms that eventually may be revealed as common to the 2 syndromes.

This prospective, observational, open study aimed to assess the efficacy and safety of hylan G-F 20 in a large cohort of patients with symptomatic hip osteoarthritis (OA), and identify predictors of clinical response.Patients presenting with symptomatic hip OA received one 2 mL intra-articular (IA) injection of hylan G-F 20 under ultrasound guidance. Patients were followed-up every 3 months for a total of 12 months and were offered an optional, additional injection at each follow-up visit if symptomatically justified. At each visit, pain scores (100 mm visual analogue scale [VAS]), Lequesne index scores, NSAID intake, and physician and patient global assessments scores were recorded. Adverse events (AEs) were recorded throughout the study. MAIN OUTCOME MEASURES;250 patients completed the 12 month follow-up and received a total of 734 injections. Statistically significant reductions in VAS pain scores, Lequesne index scores and NSAID usage were reported at all time-points (p0.05). No systemic, serious or severe side effects were observed. Fifty-two local AEs were reported (7.08% per injection) all of which were mild and transient. One predictor of clinical response was identified, with patients75 years of age reporting better outcomes.This study supports the safety, tolerability and effectiveness of hylan G-F 20 in the treatment of symptomatic hip OA. Hylan G-F 20 may also offer economic benefits due to a reduction in NSAID usage and the resultant reduction in management costs of NSAID related side-effects. These data reflect those obtained in previous studies of hylan G-F 20 in patients with knee OA.

Up to now, there have been no reports about the combined use of Teriparatide and Anti- TNFalpha blockers in patients affected by inflammatory bone diseases and osteoporosis. In this report, we evaluate the safety of the combined therapeutic use of Teriparatide and Anti-TNFalpha drugs in patients with inflammatory arthritis and severe osteoporosis. Six female patients were selected and treated with biological therapy (3 patients with Etanercept, 3 with Infliximab) for arthritis (2 RA, 4 SPA), having suffered at least 2 vertebral fragility fractures. The mean T-score value, tested by DEXA densitometry, was -2.8 SD - diagnostic for osteoporosis according to WHO criteria. All patients were treated with Teraparatide s.c. (20 microg daily), together with 1200 mg of calcium and 800 IU of vitamin D daily. Until the present time, we have observed no side-effects or therapeutic discontinuity. During the 9-month follow-up period, we did not observe any new symptomatic fractures or infections in treated patients, but we found a reduction in parameters indicating inflammation; no differences were found in biochemical parameters.

To evaluate the efficacy and the tolerability of viscosupplementation (VS) with hyaluronic acid (Hylan GF 20) in a cohort of 36 patients affected by hip osteoarthritis through a 18 months follow-up.Viscosupplementation was performed with an anteriorsagittal approach, under ultrasound guidance. 36 patients were administered hyaluronic acid intraarticularly in the hip, with a unique injection of Hylan G-F20, which could be repeated after at least 3 months. Treatment efficacy was assessed by functional index WOMAC, pain evaluation on a visual analogue scale and NSAID consumption. All such parameters were recorded at the time of the first injection and then 3, 6, 9, 12 and 18 months later.Statistically significant reduction of all parameters was observed three months after the injection, and was still maintained at the timepoints 6, 9, 12 and 18 months. No local side effects have been observed, nor systemic complications.Our data show that viscosupplementation is a promising approach for hip osteoarthritis, providing beneficial effects in a long-term follow up. Yet, the topic deserves further and wider studies, so to define the number of injections to administer and suggest a fit interval between subsequent injections.

Osteoarthritis and osteoporosis are two major health problems affecting postmenopausal women. Epidemiological observations seem to demonstrate a possible inverse relationship between osteoarthritis and osteoporosis. Erosive osteoarthritis (EOA) of the hand is a destructive form of primary osteoarthritis. This study evaluated bone mineral density and bone metabolism changes in erosive and nonerosive hand osteoarthritis women.Fifty-five women (mean age, 59 years; body mass index, 23 +/- 1.4 kg/m) who had been postmenopausal for an average of 9 years and who presented with hand osteoarthritis according to American College of Rheumatology criteria were enrolled in the study; 15 women showed clinical and radiological evidence of hand EOA. Twenty women matched for age, age at menopause, and body mass index formed the control group. Bone mineral density (g/cm) was measured at the hip and lumbar spine using dual-energy x-ray absorptiometry. Serum and urinary calcium and phosphate, serum 25-hydroxyvitamin D, parathyroid hormone, osteocalcin, and urinary breakdown products of bone matrix (CrossLaps) were analyzed.Women with hand EOA had a statistically significant lower T- and Z-score L2-L4 value than non-hand EOA women and controls (P0.01). Moreover, postmenopausal women with hand EOA had higher significant percentage of osteoporosis at lumbar spine when compared with non-hand EOA postmenopausal women and controls. Any statistically significant difference in osteocalcin and CrossLaps serum levels was noted among women with hand EOA, hand osteoarthritis, and controls.Our data suggest that postmenopausal women with clinical and radiological EOA are at risk for development of osteoporosis.