Mesotherapy: From Historical Notes to Scientific Evidence and Future Prospects.

Intradermal therapy, known as mesotherapy, is a technique used to inject a drug into the surface layer of the skin. In particular, it involves the use of a short needle to deposit the drug in the dermis. The intradermal microdeposit modulates the drug's kinetics, slowing absorption and prolonging the local mechanism of action. It is successfully applied in the treatment of some forms of localized pain syndromes and other local clinical conditions. It could be suggested when a systemic drug-sparing effect is useful, when other therapies have failed (or cannot be used), and when it can synergize with other pharmacological or nonpharmacological therapies. Despite the lack of randomized clinical trials in some fields of application, a general consensus is also reached in nonpharmacological mechanism of action, the technique execution modalities, the scientific rationale to apply it in some indications, and the usefulness of the informed consent. The Italian Mesotherapy Society proposes this position paper to apply intradermal therapy based on scientific evidence and no longer on personal bias.

Anti-TNF treatment response in rheumatoid arthritis patients with moderate disease activity: a prospective observational multicentre study (MODERATE).

OBJECTIVES: Rheumatoid arthritis (RA) patients with moderate disease activity show progression of joint damage and have impaired quality of life, physical function, work and daily activities. Little is known about management of patients with moderate RA. The aim of the study was to assess the 1-year response to anti-TNF in biologic-naïve RA patients with moderate (3.2 3.2 and ≤5.1), and were naïve to anti-TNF treatment. RESULTS: Among 157 RA patients, 93 (59%) underwent etanercept, 43 (22%) adalimumab, 26 (17%) certolizumab, 10 golimumab and 2 infliximab; 80% of patients were still in treatment after 12-month observation. One-year clinical remission was achieved by 27 RA patients (21%), reduction of DAS28 score greater than 1.2 was observed in 75 (58%) patients. Moderate and good response according to EULAR criteria was observed in 59 (46%) and 45 (35%) patients, respectively. CONCLUSIONS: Results confirm the efficacy of anti-TNF alpha also in moderate RA patients, who may achieve a substantial decrease of disease activity, and improve their quality of life. The low rate of patients achieving remission may suggest that therapeutic strategies should be more timely and aggressive.

A double blind randomized active-controlled clinical trial on the intra-articular use of Md-Knee versus sodium hyaluronate in patients with knee osteoarthritis ("Joint").

BACKGROUND: To evaluate the clinical outcomes of a group of patients affected by knee osteoarthritis (OA) treated with MD-Knee (Guna S.p.a., Milan, Italy) versus a group of patients treated with sodium hyaluronate. METHOD: This non-inferiority prospective randomized controlled trial involved 60 patients affected by knee OA, grade 2-3 of Kellgren-Lawrence scale. The MD-Knee Group, Group A (n = 29) was administered five intra-articular injections at 1 week interval; the sodium hyaluronate Group, Group B (n = 31), was administered five doses of intra-articular injection of sodium hyaluronate at 1 week interval. All patients were prospectively evaluated before and at 3 and 6 months after the treatment by the Lequesne Knee Index (LKI) as primary endpoint and the Visual Analogue Scale (VAS), Pain Killer consumption and SF-36 questionnaires as secondary endpoints. RESULTS: At the 3- and 6 month follow-up, LKI and VAS improved significantly in both groups compared to baseline and no statistically significant differences were observed between Group A and Group B. There was no statistically significant difference in the SF36 questionnaire score and pain killer consumption between two groups at any time point. CONCLUSIONS: This study shows that both preparations exert similar clinical effects as assessed through multiple outcome measures. MD-Knee is effective on knee OA symptoms over 6 months after a 5-weekly injection course, and it is equally effective as the reference sodium hyaluronate. TRIAL REGISTRATION NUMBER: ISRCTN93862496 . Registration date: January 18th, 2016.

Towards the identification of early stage osteoarthritis.

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.

Viscosupplementation in the management of ankle osteoarthritis: a review.

INTRODUCTION: Osteoarthritis (OA) is a disease of synovial joints and is the most common cause of chronic pain. Viscosupplementation (VS) with hyaluronic acid (HA) is largely used for knee osteoarthritis therapy but the evidence for its usefulness in ankle osteoarthritis is limited. The objective of this review is to assess the efficacy of viscosupplementation treatment of ankle osteoarthritis in the current literature. METHODS: The following databases were searched: Medline (period 2006-2008), Database of Abstract on Reviews and Effectiveness and Cochrane Database of Systematic Reviews. Reference lists of relevant articles were controlled for additional references. The search terms Review, Viscosupplementation (VS), Osteoarthritis (OA), Hyaluronic acid (HA), Hyaluronan, Sodium hyaluronate, Ankle OA, Ankle joint were used to identify all studies relating to the use of VS therapy for the ankle OA. Methodological quality of included studies was assessed by assigning level of evidence as previously defined by the Centre for Evidence Based Medicine (CEBM). RESULT: Seven articles concerning the efficacy of a total of 275 patients undergoing VS treatment for ankle OA were included. One European study, one Taiwanese study, one Italian study, one Turkish study and three American studies with level of evidence ranging from I to IV evaluated the following products: Hyalgan, Synvisc, Supartz, Adant. CONCLUSION: Viscosupplementation is used widely in knee OA and is included in the professional guidelines for treatment of the disease in this joint. The potential for treating osteoarthritis of the ankle joint by viscosupplementation has been suggested in the literature, however, no dosing studies have been published to date, and dosing in the ankle joint remains an area for discussion. Viscosupplementation could potentially provide an useful alternative in treating such patients with painful ankle OA.

Intra-articular injection of hyaluronic acid (MW 1,500-2,000 kDa; HyalOne) in symptomatic osteoarthritis of the hip: a prospective cohort study.

INTRODUCTION: Clinical trials have demonstrated the safety and efficacy of hyaluronic acid-based products for the treatment of hip osteoarthritis, but data from observational studies of normal medical practice are scarce. This study investigated the long-term efficacy and tolerability of ultrasound-guided intra-articular sodium hyaluronate (MW 1,500-2,000 kDa; Hyalone) injections in daily clinical practice. METHODS: In this observational, cohort study of patients with hip osteoarthritis, Hyalone was administered under the ultrasound guidance, every 6 months, with the possibility of an additional injection at the intervening 3-month intervals on clinical request. Efficacy measurements included the Lequesne algofunctional index, self-reported pain via the visual analogue scale (VAS), the concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs) and safety. The patients were followed up for 18 months after the first intra-articular injection. RESULTS: Data from 120 patients were collected. During the study, a statistically significant reduction in algofunctional indexes was demonstrated at 3 months after study product injection, while at 12 months 80% of the patients achieved a decrease of at least 30% in symptoms. These results were maintained over time through cyclical and personalized repetition of ultrasound guided injections, at least one injection every 6 months. CONCLUSIONS: The study treatment reduced pain and improved mobility in osteoarthritis of the hip. These results in daily clinical practice demonstrate a beneficial effect and the safety of the study product and suggest adding intra-articular injections of HyalOne to the armamentarium of conservative management of symptomatic hip osteoarthritis.

Mycobacterium tuberculosis Immune Response in Patients With Immune-Mediated Inflammatory Disease.

Subjects with immune-mediated inflammatory diseases (IMID), such as rheumatoid arthritis (RA), have an intrinsic higher probability to develop active-tuberculosis (TB) compared to the general population. The risk ranges from 2.0 to 8.9 in RA patients not receiving therapies. According to the WHO, the RA prevalence varies between 0.3% and 1% and is more common in women and in developed countries. Therefore, the identification and treatment of TB infection (TBI) in this fragile population is important to propose the TB preventive therapy. We aimed to study the M. tuberculosis (Mtb) specific T-cell response to find immune biomarkers of Mtb burden or Mtb clearance in patients with different TB status and different risk to develop active-TB disease. We enrolled TBI subjects as example of Mtb-containment, the active-TB as example of a replicating Mtb status, and the TBI-IMID as fragile population. To study the Mtb-specific response in a condition of possible Mtb sterilization, we longitudinally enrolled TBI subjects and active-TB patients before and after TB therapy. Peripheral blood mononuclear cells were stimulated overnight with Mtb peptides contained in TB1- and TB2-tubes of the Quantiferon-Plus kit. Then, we characterized by cytometry the Mtb-specific CD4 and CD8 T cells. In TBI-IMID, the TB therapy did not affect the ability of CD4 T cells to produce interferon-γ, tumor necrosis factor-α, and interleukin-2, their functional status, and their phenotype. The TB therapy determined a contraction of the triple functional CD4 T cells of the TBI subjects and active-TB patients. The CD45RA- CD27+ T cells stood out as a main subset of the Mtb-specific response in all groups. Before the TB-preventive therapy, the TBI subjects had higher proportion of Mtb-specific CD45RA-CD27+CD4+ T cells and the active-TB subjects had higher proportion of Mtb-specific CD45RA-CD27-CD4+ T cells compared to other groups. The TBI-IMID patients showed a phenotype similar to TBI, suggesting that the type of IMID and the IMID therapy did not affect the activation status of Mtb-specific CD4 T cells. Future studies on a larger and better-stratified TBI-IMID population will help to understand the change of the Mtb-specific immune response over time and to identify possible immune biomarkers of Mtb-containment or active replication.

A Call to Action by the Italian Mesotherapy Society on Scientific Research.

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.

Use of viscosupplementation for the recovery of active football players complaining of knee pain.

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.

Characterization of QuantiFERON-TB-Plus results in latent tuberculosis infected patients with or without immune-mediated inflammatory diseases.

OBJECTIVES: Screening for latent tuberculosis infection (LTBI) diagnosis is mandatory in patients with immune-mediated inflammatory diseases (IMID) requiring biologics. QuantiFERON-TB-Plus (QFT-P), an LTBI diagnostic test, measures IFN-γ after M. tuberculosis-stimulation in TB1 and TB2 tubes in which a "CD4" or a "CD4 and CD8" response is respectively elicited. Aim of this study is to compare the response to QFT-P of IMID-LTBI patients candidates to a new biological therapy vs LTBI-subjects without IMID. METHODS: We prospectively enrolled 167 subjects: 61 IMID-LTBI and 106 NON-IMID-LTBI. RESULTS: All subjects were mitogen-responders. IFN-γ production was significantly lower in IMID-LTBI-patients compared to NON-IMID-LTBI-subjects. We observed discordant TB1 and TB2 results in 6.5% of IMID-LTBI-patients and in 8% of NON-IMID-LTBI-subjects. Applying a logistic regression analysis, we found that IMID-LTBI patients had a higher probability (TB1 stimulation OR 3.32; TB2 stimulation OR 4.33) to have IFNγ results ≤0.7 IU/mL compared to NON-IMID-LTBI-subjects. Interestingly, IMID-treatment did not interfere with the distribution of IFNγ-values. CONCLUSIONS: These results indicate that IMID-LTBI-patients have a low IFN-γ response to QFT-P, a high proportion of results ranging in the grey zone and a distribution of IFNγ-values independent from the IMID-treatment. These results are important for the management of LTBI screening in IMID patients.

Osteoporosis and bone metabolism in postmenopausal women with osteoarthritis of the hand.

OBJECTIVE: 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. DESIGN: 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. RESULTS: Women with hand EOA had a statistically significant lower T- and Z-score L2-L4 value than non-hand EOA women and controls (P < 0.01). 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. CONCLUSIONS: Our data suggest that postmenopausal women with clinical and radiological EOA are at risk for development of osteoporosis.

The symptomatic effects of intra-articular administration of hylan G-F 20 on osteoarthritis of the hip: clinical data of 6 months follow-up.

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.

[18-month observational study on efficacy of intraarticular hyaluronic acid (Hylan G-F 20) injections under ultrasound guidance in hip osteoarthritis]. / Studio osservazionale sull'efficacia a 18 mesi di iniezioni intraarticolari di acido ialuronico (Hylan G-F 20) sotto guida ecografica nell'artrosi dell'anca.

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-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.

Open pilot study of ultrasound-guided intra-articular injection of hylan G-F 20 (Synvisc) in the treatment of symptomatic hip osteoarthritis.

Patients suffering from hip osteoarthritis (OA) are frequently symptomatic, and the disease can result in significant limitation of patients' activity and high social costs. Hip OA is generally managed with systemic treatments such as nonsteroidal anti-inflammatory drugs (NSAIDs) and/or symptomatic slow acting drugs. Viscosupplementation with hyaluronan (HA) or its derivatives, which aims to restore the physiological and rheological features of the synovial fluid to improve symptoms, is now a routinely prescribed treatment for OA of the knee. However, few data exist in the literature regarding the use of viscosupplementation in the treatment of hip OA. The objective of this prospective, open, uncontrolled pilot study was to investigate the safety and effectiveness of intra-articular injection, under ultrasound control, of hylan G-F 20 for the treatment of OA of the hip. Twelve patients (> or =40 years old) with symptomatic hip OA were treated with one injection of 2 ml of hylan G-F 20 under ultrasound guidance. During the study, patients were evaluated for safety and efficacy using the Lequesne index, a visual analogue scale (VAS) measure of hip OA pain and analysis of NSAID consumption. Patients treated with hylan G-F 20 in this study showed clinically significant reductions in Lequesne and VAS scores and in the consumption of NSAIDs up to 3 months after the injection. In the 12 patients treated (total of 14 injections), no systemic adverse events were observed. Three patients reported mild, local pain post-injection. This study demonstrates the potential of ultrasound-guided intra-articular injections of a viscosupplement into the hip joint and gives positive preliminary information about the safety and efficacy of hylan G-F 20 for the treatment of symptomatic hip OA.

Prevalence study of iliopsoas bursitis in a cohort of 860 patients affected by symptomatic hip osteoarthritis.

We used ultrasound to evaluate iliopsoas bursitis (IB) prevalence in 860 patients (568 males, 292 females, 62 ± 7 years) suffering from symptomatic Kellgren-Lawrence grade II-III-IV hip osteoarthritis. Lequesne index and visual analogue scale (VAS) were recorded. Anterior hip was scanned and images recorded. Maximum IB diameter was measured and drained (volume recorded). Two radiologists evaluated the presence of IB, joint effusion, synovial hypertrophy, communication between bursa and articular space. IB was found in 19/860 (2.2%) patients (16 males, 3 females, 65 ± 11 years; grade II osteoarthritis = 4; III = 9; IV = 6). Mean bursa diameter = 2.9 ± 0.9 cm, volume = 35 ± 34 mL. Effusion was present in 9/19 patients, hypertrophy in 6/19 and communication in 9/19. In patients with no IB, effusion was detected in 27/860 and hypertrophy in 25/860 (p < 0.001 compared with IB patients). κ = 1 for all. VAS index and Lequesne index were not significantly different between patients with or without IB (p ≥ 0.468). Ultrasound can detect associate findings in grade II-IV hip osteoarthritis patients with high reproducibility.

Total hip replacement rate in a cohort of patients affected by symptomatic hip osteoarthritis following intra-articular sodium hyaluronate (MW 1,500-2,000 kDa) ORTOBRIX study.

Hip osteoarthritis is very common and costly. The European League Against Rheumatology Committee agenda asks for research to investigate treatments able to slow down the progression of hip osteoarthritis (OA), to delay joint replacement, and to determine the comparative effectiveness and cost-effectiveness of non-surgical and surgical treatment modalities as well as criteria relating to the indications for and timing of total hip replacement (THR). After publishing the results of a randomized controlled trial and a cohort study on the efficacy of Intra-articular sodium hyaluronate (MW 1,500-2,000 kDa) on symptomatic hip OA, we performed this retrospective study in patients suffering from hip OA treated with ultrasound-guided intra-articular injections of HyalOne (Hyalubrix 60 Italian brand name) involving a group of THR expert orthopedic surgeons to appraise whether or not considered eligible for THR and the frequency and timing of THR. Six orthopedists, not routinely performing hip intra-articular injections, each independently assessed whether 176 patients suffering from hip OA and treated with ultrasound-guided intra-articular injections of sodium hyaluronate (MW 1,500-2,000 kDa) were candidates for THR according to the clinical data (age, body mass index, Pain Visual Analog Scale, Lequesne Algofunctional Index, global patient assessment, global physician assessment, nonsteroidal anti-inflammatory drug intake, and hip X-ray) collected at the first intra-articular sodium hyaluronate injection visit and provided as anonymous electronic data. At 24 months, 159 out of 76 (90 %) patients did not undergo to THR. At 48 months, 82 % (N = 144) of the study population treated with intra-articular hyaluronic acid avoided THR. In the group of 93 patients considered candidates for THR (that is, in which 4, 5, or 6 orthopedic surgeons agreed that the patient was a suitable candidate for THR), only 17 had undergone THR, with survival results of 82 % at 24 months. At 48 months, this percentage reduced to 66 % in this group. In the other groups of patients (in which respectively 3, 2, 1 or no surgeons were in agreement that the patient was a candidate for THR) arthroplasty is not recorded. Sodium hyaluronate (MW 1,500-2,000 kDa) given by ultrasound-guided injection seems to delay THR in the real context of actual overall management of symptomatic hip OA patients. Although further studies are necessary to confirm these data and to identify outcome predictors, hip viscosupplementation should be considered as conservative treatment to perform before proposing patients for THR.

Comparative, double-blind, controlled study of intra-articular hyaluronic acid (Hyalubrix) injections versus local anesthetic in osteoarthritis of the hip.

INTRODUCTION: Comparison of intra-articular bacterial-derived hyaluronic acid (Hyalubrix) (HA) with local analgesia (mepivacaine) for osteoarthritis (OA) of the hip. METHODS: A pilot prospective, double-blind, 6-month randomized trial of 42 patients with hip OA. HA or mepivacaine was administered twice (once a month) under ultrasound guidance. Efficacy measurements included the Lequesne's algofunctional index, a visual analog scale for pain, concomitant use of analgesia, patient and physician global measurement, and safety. RESULTS: Patients in the HA group exhibited a significantly reduced Lequesne's algofunctional index 3 and 6 months after treatment (P < 0.001) and significantly reduced visual analog scale pain scores 3 and 6 months after treatment (P < 0.05) compared with the local anesthetic group. All primary and secondary measures were significantly improved versus baseline, but other than the above were not different from each other at 3 or 6 months. Adverse effects were minimal. CONCLUSIONS: This comparative study suggests a beneficial effect and safety of intra-articular HA in the management of hip OA. TRIAL REGISTRATION NUMBER: ISRCTN39397064.

Intra-articular administration of hylan G-F 20 in patients with symptomatic hip osteoarthritis: tolerability and effectiveness in a large cohort study in clinical practice.

OBJECTIVE: 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. RESEARCH DESIGN AND METHODS: 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; RESULTS: 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 (p < 0.05). 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 patients < 75 years of age reporting better outcomes. CONCLUSIONS: 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.

Combined use of teriparatide and TNFalpha blockade: safety.

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.

Multiple chemical sensitivity syndrome in Sjögren's syndrome patients: casual association or related diseases?

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.