The Use of Antidepressants in the Long-Term Treatment Should not Improve the Impact of Fibromyalgia on Quality of Life.

BACKGROUND: Antidepressant (AD) drugs are effective in the short term treatment of fibromyalgia (FM). It may be useful to study the long-term impact of AD on patients with FM. METHODS: One-year follow-up study on 23 females with FM divided into groups on AD (ADg-N=7), and not taking AD (NADg-N=11). Evaluation at t1 and at the end (t2) with the Fibromyalgia Impact Questionnaire (FIQ); at t2 with: SCID-IV; Mood Disorder Questionnaire (MDQ); Short Form-12; Hamilton Depression Rating Scale (HAM-D); Functioning Assessment Short Test (FAST). RESULTS: After a year the AD group showed a worst impact of the disease by FIQ (p=0.017), worsened quality of life by SF-12 (p<0.01), and disability linked to bipolar symptoms by FAST (p=0.05). About 40% of the sample was screened positive at MDQ without difference in the two groups. The patients who recovered from a depressive episode did not differ between ADg and NADg (20% vs 33.3%), and were fewer than expected from the literature (40-60%). The HAM-D score at the end of the trial was worse in the ADg (p<0.03). LIMITATIONS: Observational research on few patients, not specifically designed to test the hypothesis. The results have a heuristic value only. DISCUSSION: The results should be read in the light of the high prevalence of patients screened positive for Bipolar Disorders and of the well-known poor response of the mood symptoms to antidepressants in Bipolar Depression. The deterioration in the long-term management of FM patients following AD treatments suggests the need for new and robust studies.

Purine metabolites in fibromyalgia syndrome.

OBJECTIVE: To evaluate serum purine metabolite concentrations in patients affected by fibromyalgia syndrome (FMS) and the relationships between their levels and FM clinical parameters. DESIGN AND METHODS: Serum purine levels were quantified using LC/UV-vis in 22 fibromyalgic females (according to the American College of Rheumatology classification criteria) and 22 healthy females. RESULTS: Significantly higher serum inosine, hypoxanthine and xanthine levels (p<0.001) and significantly lower serum adenosine (p<0.05) were detected in the FMS patients vs healthy controls. Our data show a negative correlation between adenosine and Fibromyalgia Impact Questionnaire (FIQ). CONCLUSIONS: Study results suggest that purines, in particular adenosine and inosine, may be involved in pain transmission in fibromyalgia.

Double-blind, multicenter trial comparing acetyl l-carnitine with placebo in the treatment of fibromyalgia patients.

OBJECTIVE: Fibromyalgia (FMS) is a chronic syndrome characterized by widespread pain, troubled sleep, disturbed mood, and fatigue. Several analgesic strategies have been evaluated but the results are moderate and inconsistent. Antidepressant agents are now considered the treatment of choice in most patients. It has been recently suggested that FMS may be associated with metabolic alterations including a deficit of carnitine. In this multicenter randomized clinical trial we evaluated the efficacy of acetyl L-carnitine (LAC) in patients with overt FMS. METHODS: One hundred and two patients meeting the American College of Rheumatology criteria for FMS were randomized into the study. The treatment consisted of 2 capsules/day of 500 mg LAC or placebo plus one intramuscular (i.m.) injection of either 500 mg LAC or placebo for 2 weeks. During the following 8 weeks the patients took 3 capsules daily containing either 500 mg LAC or placebo. The patients were seen during treatment after 2 (visit 3), 6 (visit 4) and 10 weeks (visit 5). The patients were also visited 4 weeks after treatment discontinuation (follow-up visit). Outcome measures included the number of positive tender points, the sum of pain threshold (kg/cm2 or "total myalgic score"), the Short Form 36 (SF36), a 100 mm visual analog scale (VAS) for self-perceived stiffness, fatigue, tiredness on awakening, sleep, work status, depression, and muscular-skeletal pain, and the Hamilton depression scale. RESULTS: The "total myalgic score" and the number of positive tender points declined significantly and equally in both groups until the 6th week of treatment. At the 10th week both parameters remained unchanged in the placebo group but they continued to improve in the LAC group with a statistically significant between-group difference. Most VAS scores significantly improved in both groups. A statistically significant between-group difference was observed for depression and musculo-skeletal pain. Significantly larger improvements in SF36 questionnaire were observed in LAC than in placebo group for most parameters. Treatment was well-tolerated. CONCLUSION: Although this experience deserves further studies, these results indicate that LAC may be of benefit in patients with FMS, providing improvement in pain as well as the general and mental health of these patients.

[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.

The role of heterocellular hereditary persistence of fetal haemoglobin in beta(0)-thalassaemia intermedia.

Beta(0)-thalassaemia intermedia (beta(0)-TI) describes patients who lack beta-globin synthesis yet manifest a non-transfusion-dependent form of beta-thalassaemia. Co-inheritance of alpha-thalassaemia, certain variants of the beta-like globin gene cluster and elevated fetal haemoglobin (HbF) production are all associated with beta(0)-TI. However, the mild phenotypes of many beta(0)-TI patients are unexplained. Genetically determined HbF levels in beta-thalassaemia are difficult to assess because erythrocytes containing HbF (F cells) preferentially survive over erythrocytes without HbF. To evaluate the importance of genetically elevated HbF in beta-thalassaemia, F-cell levels of 19 TI patients' relatives were compared with relatives of transfusion-dependent beta-thalassaemia major patients and those of beta-globin genotype-matched controls. The beta-globin and alpha-globin genotypes, as well as their Ggamma promoter were also examined. Using this approach, in all but one patient the mild phenotype was attributable to either alpha-globin genotype, gamma-globin promoter polymorphism or inherited elevated F-cell levels. The findings of this study establish the F-cell levels required to modify the degree of disease severity significantly and demonstrate that F-cell level is a crucial parameter in the understanding of phenotypic variation in beta-thalassaemia.

Validation of an Italian version of the arthritis impact measurement scales 2 (ITALIAN-AIMS2) for patients with osteoarthritis of the knee. Gonarthrosis and Quality of Life Assessment (GOQOLA) Study Group.

OBJECTIVE: To validate a translated version of the revised and expanded Arthritis Impact Measurement Scales (AIMS2) to be used by Italian patients with osteoarthritis (OA) of the knee. METHODS: The AIMS2 was translated into Italian and administered to a cohort of 178 outpatients with symptomatic OA of the knee who attended 12 participating rheumatological institutes in northern, central and southern Italy. A random sample of 71 patients were readministered the AIMS2, 7 days after the first visit, to evaluate the instrument's test-retest reliability. After 6 months, the subjects were asked to return to the institutes for a second administration of the questionnaire. RESULTS: The internal consistency reliability of each scale score, as estimated by Cronbach's alpha coefficient, was high and indicated that the components of the scale measured the same construct. The items all correlated with each other, but there was no redundancy; this indicates that each domain addressed a somewhat different aspect of functional disability. The test-retest reliability equalled or exceeded 0.80 for eight of the 12 scales. Factor analysis provided a three-factor health status model explaining 63.5% of the variance. Arthritis pain and psychological scale were loaded on the first factor, together with physical scales for mobility level and walking and bending. The upper limb function scales formed the second factor. The third factor was determined by the social dimension. These results demonstrate that the physical health status scales of the AIMS2 are valid, as shown by the significant, moderate to high correlations between the AIMS2 subscales and the majority of the clinical measures. CONCLUSION: Our data suggest that, like the original questionnaire, the translated version of AIMS2 is a reliable, consistent and valid instrument for measuring health status and physical functioning in patients with OA of the knee.

Optic nerve compression by extramedullary hematopoietic tissue in a patient suffering from beta-thalassemia intermedia.

We carried out an encephalic magnetic resonance (MR) study in a patient with thalassemia intermedia who complained about change of the visual acuity and of the visual field. Narrowing of the optical canal was present and it was related to the compression of hemopoietic tissue masses. We found a clear relationship between the elderly age, the irregular transfusions, and the optic neuropathy. RMN screening of patients w ith thalassemia intermedia should be mandatory if changes in visual function occur.

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.

Adult celiac disease is frequently associated with sacroiliitis.

No data are available on the presence and frequency of peripheral or central joint disease, routinely determined by bone scintigraphy with 740 MBq of [99mTc]MDP, in adult celiac disease. Bone scintigraphy was carried out to detect early acute inflammatory lesions in 22 adult celiac patients (15 females and seven males; mean age 36.72 years, range 17-63). Bone scintigraphy was positive for sacroiliitis in 14 cases (63.6%). Except in the case of one patient suffering from rheumatoid arthritis, laboratory data were normal. Our data suggest that as in other chronic intestinal diseases, celiac disease in adults, is frequently associated with central joint disease. This high incidence of sacroiliitis, the joint disease most frequently found in our patients, has not been previously reported in other series. We believe, therefore, this difference could be explained by the different methodology used for the screening of joint disease.

[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.

[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.

Molecular analysis of beta zero-thalassemia intermedia in Sardinia.

In this study we have carried out alpha- and beta-globin gene analysis and defined the beta-globin gene polymorphisms in a group of patients with thalassemia intermedia of Sardinian descent. A group of patients (109) with thalassemia major of the same origin served as control. Characterization of the beta-thalassemia mutation showed either a frameshift mutation at codon 6 or a codon 39 nonsense mutation. We found that homozygotes for the frameshift mutation at codon 6 or compound heterozygotes for this mutation and for the codon 39 nonsense mutation develop thalassemia intermedia more frequently than thalassemia major. The frameshift mutation at codon 6 was associated with haplotype IX that contains the C-T change at position -158 5' to the G gamma globin gene implicated in high gamma chain production and thus the mild phenotype. In patients' homozygotes for codon 39 nonsense mutation, those with thalassemia intermedia more frequently had the two-gene deletion form of alpha-thalassemia, or functional loss of the alpha 2 gene as compared with those with thalassemia major. In a few siblings with thalassemia major and intermedia, the thalassemia intermedia syndrome correlated with the presence of the -alpha/-alpha genotype. No cause for the mild phenotype was detected in the majority of patients who had not inherited either haplotype IX or alpha-thalassemia.