[Quality of life and associated clinical distress in fibromyalgia]. / Fibromialgia: qualità di vita e sindromi associate.

OBJECTIVES: Fibromyalgia (FM) is a syndrome characterized by chronic, diffuse musculoskeletal pain and by a low pain threshold at specific anatomical points (tender points). Numerous other conditions (Irritable bowel syndrome, tension-type headache, migraine headaches, etc.) may overlap with FM. Aim of this study was to evaluate the quality of life and associated clinical distress in patients with FM. METHODS: 53 females affected by primary fibromyalgia and 40 healthy females were examined were examined by an experienced rheumatologist and interviewed using the Fibromyalgia Impact Questionnaire (FIQ). Clinical monitoring included Visual Analogue Scale for pain and pain pressure threshold measurements. RESULTS: Mean FIQ scores were 66.39+/-14.94 in FM patients and 13.15+/-5.37 in control subjects and the difference was statistically significant. Among associated clinical distress higher frequencies have been found for paraesthesia (87%), sleep disturbance (72%), tension type headache (70%), oto-vestibule syndrome (72%) and irritable colon (60%). An R.O.C. bend was developed in the presence of paraesthesias and oto-vestibule syndromes at the same time. This allowed us to identify a FIQ cut off value of 66.85 so FM patients were divided into 2 groups according to their FIQ scores: severe degree and mild or slight degree. CONCLUSIONS: Based on our data, it would appear possible to use a FIQ value equal to or higher than 66.85 for the clinical picture of FM to be classified as severe.

[Safety of lornoxicam in G-6-PDH deficiency]. / Sicurezza terapeutica di lornoxicam in soggetti G-6-PDH carenti.

OBJECTIVE: To assess the safety of lornoxicam in subjects with G-6-PDH deficiency. METHODS: Open controlled 2-week in vivo study on lornoxicam 8 mg bid in subjects with G-6-PDH deficiency suffering from rheumatic diseases. RESULTS: In 8 male patients with the Mediterranean form of G-6-PDH deficiency (mean age +/- SD, 54.3 years +/- 7.2) lornoxicam showed no influence on red blood cells (RBC) survival curve. The RBC half-life was the same before and after two weeks of treatment. CONCLUSIONS: Lornoxicam caused no RBC damage and evidenced favourable safety in subjects with G-6-PDH deficiency, suffering from rheumatic diseases.

Nonsurgical synovectomy in the treatment of arthropathy in Von Willebrand's Disease.

Von Willebrand's disease is the most common inherited bleeding disorder, with an overall prevalence in the general population of 0.8% to 1.3%. Hemarthrosis occurs mainly in the severest forms of the disease (type III), with a frequency of 3.5% to 11%, and can cause severe arthropathy similar to that seen in hemophilia. We retrospectively reviewed our experience with nonsurgical synovectomy in the treatment of recurrent hemarthrosis with arthropathy in patients with von Willebrand's disease. Four of our six patients had type III disease and the remaining two had type II disease. The age range was 13 to 63 years. The frequency of hemarthrosis prior to synovectomy was one to four per month. One (n = 2) or both (n = 1) knees were treated in 4 cases, one (n = 1) or both (n = 1) ankles in 3 cases and an elbow in one case. We used yttrium 90 in a dose of 5 mCi for one knee, rhenium 186 in a dose of 2 mCi for two ankles and the elbow and osmic acid for two knees and one ankle. Clinical and radiological results were evaluated six months after synovectomy using the World Federation of Hemophilia score. Radiologic lesions remained stable and clinical manifestations improved in every case (p < 0.05). Five patients achieved a complete remission. Safety was satisfactory. The clinical efficacy of synovectomy done, using radiocolloids or osmic acid in arthropathy due to von Willebrand's disease, seems similar to that in hemophilia.

Quality of life assessment during six months of NSAID treatment [Gonarthrosis and Quality of Life (GOAL) Study].

OBJECTIVE: To identify the time point of the greatest degree of improvement in daily living activities, pain and depression in patients with osteoarthritis (OA) of the knee during 6 months of treatment with NSAIDs, in order to define compliance and drop-out rate. METHODS: 107 patients were recruited into a multicentre, prospective, randomized, controlled trial comparing two treatments, piroxicam-beta-cyclodextrin (PBCD) and slow release diclofenac (DCL). RESULTS: The greatest improvement in quality of life occurred in both groups after 3 months, with a slight further gain observed by the end of treatment. The Stanford Health Assessment Questionnaire score improved (p < 0.05 vs baseline) at 3 and 6 months with PBCD and at 6 months with DCL. The Arthritis Impact Measurement Scale score improved (p < 0.05 vs baseline) after 6 months in both groups. Significant (p < 0.05 vs baseline) improvement in other psychological and pain scores were recorded in both groups after 3 and 6 months. Compliance with treatment at 3 months was 73% for PBCD and 72% for DCL, and was 60% in both groups at 6 months. CONCLUSIONS: The results of this study indicate that the optimal length of time for an NSAID trial in OA patients is 3 months, when assessment of daily living activities is considered as the main outcome criterion.

Efficacy and tolerability of ketoprofen 200 mg controlled-release cps vs indomethacin 50 mg cps in patients with symptomatic hip osteoarthritis. A multicentre study.

BACKGROUND: An open-label, randomised, multicentre study was carried out to compare the efficacy and tolerability of indomethacin capsules and ketoprofen controlled-release capsules in the symptomatic treatment of coxarthrosis. MATERIALS AND METHODS: 113 out-patients were enrolled: 57 were assigned to receive indomethacin 50 mg twice daily and 56 ketoprofen 200 mg once daily for 4 weeks. RESULTS: Indomethacin and ketoprofen proved equally effective in relieving osteoarticular pain and stiffness and in improving the quality of life of patients. There was essentially no difference as to gastrointestinal adverse events which occurred in 25% of patients on indomethacin and in 27% of those on ketoprofen. Indomethacin caused more non-gastrointestinal untoward effects, especially CNS effects (headache and dizziness: 11%) which were not observed with ketoprofen. Indomethacin was discontinued because of adverse events in a larger proportion of patients (20%) than ketoprofen (11%).

Development of arthritis and hypothyroidism during alpha-interferon therapy for chronic hepatitis C.

Alpha-interferon (alpha-IFN) therapy may induce, reveal or exacerbate various autoimmune-related disorders. The most common is the development of autoantibodies, while clinically overt autoimmune diseases are rare. We describe a 49-year-old woman who developed seronegative rheumatoid-like arthritis and autoimmune hypothyroidism after 7 months of human lymphoblastoid alpha-IFN therapy given for hepatitis C virus-related chronic active hepatitis (CAH-HCV). There was no family or personal history of autoimmune, thyroid or articular diseases. Our patient required continuous therapy for arthritis and hypothyroidism despite discontinuation of alpha-IFN. This suggests that alpha-IFN therapy may induce the contemporary appearance of two different persistent autoimmune-related diseases in the same patient. However, chronic HCV infection may play an important adjuvant role in the development of these diseases.

Effects of cyclosporin on joint damage in rheumatoid arthritis. The Italian Rheumatologists Study Group on Rheumatoid Arthritis.

According to the most recent literature, few antirheumatic drugs can claim disease-controlling properties over the anatomical joint damage in rheumatoid arthritis (RA). A small number of studies have favored one or another of the available agents, in particular parenteral gold salts, sulphasalazine and methotrexate, but the evidence regarding their efficacy is not convincing when analysed using methodological criteria known to be important in evaluating radiologic evidence of joint damage. The radiologic results in long-standing RA patients have shown that CsA may be of benefit in reducing disease progression. Data from the second year of a clinical trial designed to compare the disease-controlling, anti-rheumatic properties of CsA with those of conventional disease-modifying anti-rheumatic drugs (DMARDs) in early RA support the hypothesis that CsA may be useful in delaying the appearance of new joint erosion.

[RS3PE syndrome. A new rheumatic inflammatory syndrome in advanced age]. / La sindrome RS3PE. Un nuovo reumatismo infiammatorio dell'età avanzata.

RS3PE syndrome (Remitting Seronegative Symmetrical Synovitis with Pitting Edema) is a new form of arthritis in the elderly, characterized by symmetrical polysynovitis of acute onset associated with distal pitting edema. Tests for serum IgM rheumatoid factor are typically negative. RS3PE syndrome affects Caucasians aged over 60, predominantly males. It has a benign course and remits completely without residua.

Somatostatin 14 and joint inflammation: evidence for intraarticular efficacy of prolonged administration in rheumatoid arthritis.

Previous studies with intraarticular administration of somatostatin (SST14) in rheumatoid arthritis showed an antiinflammatory and analgesic effect. The aim of the present study was to demonstrate the efficacy and tolerability of SST14 in rheumatoid arthritis (RA) patients for a longer period of treatment than previously scheduled. Forty-one patients with RA of the knee were treated with a cycle of intraarticular injection of 750 micrograms of SST14, every 15 days. The efficacy of SST14 was evaluated by determining acute phase parameters (erythrocyte sedimentation rate, C-reactive protein [CRP]) and by clinical assessment (pain at rest and on movement, joint tenderness, morning stiffness, spontaneous pain). Additionally, telethermography was performed to evaluate the intensity of the joint inflammation. The tolerability of the treatment was also assessed both by patients and physicians. SST14 produced a reduction in all parameters; this was already statistically significant after the second injection in terms of pain at rest and on movement, and after the third injection for all other symptoms. The treatment showed an excellent tolerability, both local and systemic. Our results indicate the analgesic property of SST14 and demonstrate its capacity to reduce progressively joint inflammation confirmed by thermography and by reduction of pain, after a month of therapy.

Ipriflavone-treatment of senile osteoporosis: results of a multicenter, double-blind clinical trial of 2 years.

Eighty-four out of 100 enrolled female patients affected by osteoporosis completed a double-blind, randomized trial, using ipriflavone (IP) in a dose of 3 x 200 mg/day (41 patients) or placebo (P)(43 patients). All patients received 1 g/day oral calcium supplementation. Inclusion criteria were: age over 65 years; at least one vertebral fracture in the past; bone mineral density measured at the distal tenth of the radius lower than the normal average -2 x S.D. The trial period was between June 1990 and November 1993. Patients of the IP group showed a significant increase in bone mineral density (P < 0.05) compared with the starting values during the whole study period. Pain decreased rapidly, intake of analgesics dropped, and often significant decreases in calciuria, hydroxyprolinuria, alkaline phospatase, osteocalcin and parathormone values were observed. Only two new fractures occurred during the trial in the IP group. Patients of the P group at the end of the study displayed decreased bone mineral densities (P < 0.05), increased pain, greater consumption of analgesics, and often significant increases in the bone metabolism parameters listed for the IP group. In the

Double-blind comparison of the efficacy and safety of etodolac SR 600 mg u.i.d. and of tenoxicam 20 mg u.i.d. in elderly patients with osteoarthritis of the hip and of the knee.

Etodolac SR is the sustained-release formulation of etodolac, an effective anti-inflammatory drug used in the treatment of various rheumatic diseases. The efficacy and safety of etodolac SR were compared with those of tenoxicam in 120 elderly patients with radiographic and clinical evidence of active osteoarthritis (OA) of the knee and/or the hip. This was a double-blind, double-dummy, randomized, parallel-group, multicentre study conducted at 4 Italian rheumatic-disease units. Sixty patients received 600 mg of etodolac SR once daily (u.i.d.) for 8 weeks; the remaining 60 patients received 20 mg of tenoxicam u.i.d. Significant improvements in all 6 efficacy parameters (viso-analogic scale of the global pain, pain at active movements, night pain, joint tenderness, joint motility, and Lequesne's algofunctional index) were observed within each of the treatment groups even after the first 2 weeks of therapy. There were no significant differences in the therapeutic response between the two groups for any efficacy parameters. Adverse reactions, mostly regarding the G-I tract, were significantly more frequent in the tenoxicam group than in the etodolac group: 23.3% vs 8.3% respectively, albeit in the majority of the cases they were not considered to be so severe as to cause the interruption of the study. There were no clinically important changes from baseline in laboratory tests performed during the study. Endoscopy of the upper G-I tract was performed both at baseline and after 8 weeks of therapy in 30 patients per treatment group in order to obtain a reliable comparative evaluation of the G-I safety of the two drugs. Both drugs were found to be well tolerated; only 2 ulcers were observed after therapy in both groups, but minor lesions were more frequently detected in the mucosa of the stomach in the patients who received tenoxicam. The cumulative endoscopic index that reflected both the erosive and the haemorrhagic lesions found in the stomach taken as a whole was significantly (p < 0.03) higher after therapy in the tenoxicam group. These results indicate that 600 mg of etodolac SR u.i.d. for 8 weeks is as effective as 20 mg of tenoxicam u.i.d. in the treatment of OA of the knee and/or of the hip. Both the overall and the G-I specific safety profiles were found to be more favourable in patients treated with etodolac SR. Renal function was not substantially affected in either treatment group.(ABSTRACT TRUNCATED AT 250 WORDS)

[Clinical experience with the use of piroxicam in fast-dissolving sublingual capsules in acute recurrent osteoarthritis]. / Esperienza clinica sull'impiego del piroxicam compresse sublinguali a rapida dissoluzione nell'osteoartrosi riacutizzata.

Open, non comparative study to evaluate the efficacy and safety of piroxicam Fast Dissolving Dosage Form (FDDF) for sublingual administration in treatment of reacutized osteoarthritis. Fifty-four patients with flare-ups of osteoarthritis involving various joints were enrolled in the study. They were treated with 20 mg/die piroxicam sublingual tablets for a total of 4 weeks. Drug efficacy was evaluated on the basis of the variation of spontaneous pain, pain on passive motion, functional limitation and capacity of performing a specific activity. Intensity of spontaneous pain on the first day showed a statistically significant improvement (p < 0.0001) only 15 minutes after the drug administration. This improvement in pain intensity increased until day 3. All other efficacy parameters showed a statistically significant improvement (p < 0.0001) 7 days after the beginning of treatment. Local and systemic tolerability was good. No patient showed local side effects; only 6 patients experienced systemic side effects. In conclusion, piroxicam sublingual tablets for treatment of osteoarthritis flare-ups showed analgesic efficacy already 15 minutes after drug administration, and good anti-inflammatory efficacy with good local and systemic tolerability.

[Acromegalic arthropathy]. / L'artropatia acromegalica.

Six acromegalic patients, three males (aged 28 to 48 years) and three females (aged 57 to 75 years), with GH-producing pituitary adenoma, were studied through clinical examination, laboratory and instrumental tests. In all the patients frequent involvement of large joints, with crepitus and provoked pain, was found; while articular mobility was normal especially in the dorso-lumbar spine, a frequent seat of pain. Radiology showed typical features of an osteoarthritic process with characteristic widening of articular spaces, especially in weight-bearing large joints in symptomatic patients. The evolution of this arthropathy lead to anatomo-clinical pictures almost indistinguishable from osteoarthritis; however, in the early stages, the marked cartilaginous hypertrophy is responsible for peculiar anatomo-radiological pictures, principally represented by widening of articular spaces and intervertebral discal spaces, especially in the dorso-lumbar spine. As far as bone metabolism is concerned, neoproduction and reabsorption, both increased, proceed simultaneously; bone mass reduction is described in some segments. In our study, the two patients with active acromegaly showed bone mass reduction in the lumbar spine.

[Physical activity and osteoporosis]. / Attività fisica ed osteoporosi.

The aim of the present research was to underline the importance of physical activity in the prevention and treatment of osteoporosis. Therefore the authors considered age-related bone loss and the value of weight-bearing exercise on bone-remodeling. Moreover the authors examined current world literature on physical exercise in post-menopausal age and bone mineral content in athletes, reporting their study's results.

[Ocular involvement in rheumatoid arthritis]. / Interessamento oculare in corso di artrite reumatoide.

The authors evaluated ocular involvement in 23 patients affected by rheumatoid arthritis (RA) according to ARA criteria. Slit-lamp biomicroscopic examination showed signs of keratoconjunctivitis sicca in one patient (4%), while a positive bilateral Schirmer test was found in six subjects (26%). Fluorescein angiography, carried out in 11 of the 23 RA patients, showed retinal vasculitis in 18% of the patients examined, even if no clinical and ophthalmoscopic signs of retinal vessel inflammation were present. The authors suggest that fluorescein angiography should be performed in patients affected by particularly active RA, with recent onset of the disease (< 12 months), high titres of classical IgM rheumatoid factor and raised concentrations of circulating immune complexes. The study confirmed moreover the uncommon ocular toxicity related to the drugs frequently employed in RA treatment (antimalarials, gold salts, glucocorticoids). Indeed, only one case (4%) of posterior subcapsular cataract clearly related to steroid therapy was found.

[Fangotherapy and diacerein in the treatment of osteoarthrosis of the hip and knee]. / Fangobalneoterapia e diacereina nel trattamento dell'osteoartrosi dell'anca e del ginocchio.

The clinical efficacy and safety of thermal mud and diacetylrhein (DAR) was evaluated in 135 patients suffering from osteoarthritis of the hip and e knee. Pain at rest, during movement, on pressure, and functional impairment of the affected joints were evaluated in base-line conditions and after six months and twelve months of treatment. These clinical parameters showed a significant improvement after thermal mud and DAR; tolerance of both treatments was excellent in all patients.

[Spinal cord and cauda equina compression in 2 patients with beta-thalassemia intermedia]. / Compression médullaire et de la queue de cheval chez deux patients atteints de béta-thalassémie intermédiaire.

Spinal cord compression as a consequence of mass lesions due to extramedullary hematopoiesis is a well described but rare syndrome occurring in thalassemia and some other hematologic conditions. The authors report two cases of patients with a genetic variant of beta-thalassemia, who suffered from a progressive compression of the spinal cord in one case, of the cauda equina in the other caused by epidural hematopoietic tissue. The first patient recovered after partial surgical removal of this tissue and subsequent radiotherapy. The second one recovered after only radiotherapy.