Measuring impairments of functioning and health in patients with axial spondyloarthritis by using the ASAS Health Index and the Environmental Item Set: translation and cross-cultural adaptation into 15 languages.

INTRODUCTION: The Assessments of SpondyloArthritis international society Health Index (ASAS HI) measures functioning and health in patients with spondyloarthritis (SpA) across 17 aspects of health and 9 environmental factors (EF). The objective was to translate and adapt the original English version of the ASAS HI, including the EF Item Set, cross-culturally into 15 languages. METHODS: Translation and cross-cultural adaptation has been carried out following the forward-backward procedure. In the cognitive debriefing, 10 patients/country across a broad spectrum of sociodemographic background, were included. RESULTS: The ASAS HI and the EF Item Set were translated into Arabic, Chinese, Croatian, Dutch, French, German, Greek, Hungarian, Italian, Korean, Portuguese, Russian, Spanish, Thai and Turkish. Some difficulties were experienced with translation of the contextual factors indicating that these concepts may be more culturally-dependent. A total of 215 patients with axial SpA across 23 countries (62.3% men, mean (SD) age 42.4 (13.9) years) participated in the field test. Cognitive debriefing showed that items of the ASAS HI and EF Item Set are clear, relevant and comprehensive. All versions were accepted with minor modifications with respect to item wording and response option. The wording of three items had to be adapted to improve clarity. As a result of cognitive debriefing, a new response option 'not applicable' was added to two items of the ASAS HI to improve appropriateness. DISCUSSION: This study showed that the items of the ASAS HI including the EFs were readily adaptable throughout all countries, indicating that the concepts covered were comprehensive, clear and meaningful in different cultures.

Evidence-based hydro- and balneotherapy in Hungary--a systematic review and meta-analysis.

Balneotherapy is appreciated as a traditional treatment modality in medicine. Hungary is rich in thermal mineral waters. Balneotherapy has been in extensive use for centuries and its effects have been studied in detail. Here, we present a systematic review and meta-analysis of clinical trials conducted with Hungarian thermal mineral waters, the findings of which have been published by Hungarian authors in English. The 122 studies identified in different databases include 18 clinical trials. Five of these evaluated the effect of hydro- and balneotherapy on chronic low back pain, four on osteoarthritis of the knee, and two on osteoarthritis of the hand. One of the remaining seven trials evaluated balneotherapy in chronic inflammatory pelvic diseases, while six studies explored its effect on various laboratory parameters. Out of the 18 studies, 9 met the predefined criteria for meta-analysis. The results confirmed the beneficial effect of balneotherapy on pain with weight bearing and at rest in patients with degenerative joint and spinal diseases. A similar effect has been found in chronic pelvic inflammatory disease. The review also revealed that balneotherapy has some beneficial effects on antioxidant status, and on metabolic and inflammatory parameters. Based on the results, we conclude that balneotherapy with Hungarian thermal-mineral waters is an effective remedy for lower back pain, as well as for knee and hand osteoarthritis.

2010 update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis.

This first update of the ASAS/EULAR recommendations on the management of ankylosing spondylitis (AS) is based on the original paper, a systematic review of existing recommendations and the literature since 2005 and the discussion and agreement among 21 international experts, 2 patients and 2 physiotherapists in a meeting in February 2010. Each original bullet point was discussed in detail and reworded if necessary. Decisions on new recommendations were made - if necessary after voting. The strength of the recommendations (SOR) was scored on an 11-point numerical rating scale after the meeting by email. These recommendations apply to patients of all ages that fulfill the modified NY criteria for AS, independent of extra-articular manifestations, and they take into account all drug and non-drug interventions related to AS. Four overarching principles were introduced, implying that one bullet has been moved to this section. There are now 11 bullet points including 2 new ones, one related to extra-articular manifestations and one to changes in the disease course. With a mean score of 9.1 (range 8-10) the SOR was generally very good.

Efficacy of etanercept on rheumatic signs and pulmonary function tests in advanced ankylosing spondylitis: results of a randomised double-blind placebo-controlled study (SPINE).

OBJECTIVES: Patients with advanced ankylosing spondylitis (AS) experience disability because of reduced spinal mobility and pulmonary function impairment. This placebo-controlled study evaluated the effect of etanercept (ETN) in patients with advanced AS. METHODS: A multicentre randomised double-blind placebo-controlled trial of 12 weeks' duration was performed. Patients had definite (modified New York criteria), active (Bath AS Disease Activity Index (BASDAI) ≥40), severe (radiological intervertebral bridges) AS refractory to non-steroidal anti-inflammatory drugs and were antitumour necrosis factor naive. They were treated with ETN 50 mg once weekly or identical placebo (PBO). RESULTS: Of the 95 patients screened, 82 were randomised to receive ETN (n=39) or PBO (n=43). At baseline the disease was active (mean BASDAI 61.0±13.4, C reactive protein (CRP) 20.7±25.5 mg/l) and severe (mean Bath AS Metrology Index (BASMI) 5.7±1.3, mSASSS 36.5±20.5); forced pulmonary vital capacity (FVC) was 3.3±0.7 l. Improvement in BASDAI (normalised net incremental area under the curve between baseline and week 12, primary end point) was significantly greater in the ETN group than in the PBO group (-19.8±16.5 vs -11.0±16.4, p=0.019). Moreover, at week 12, ETN gave better results than PBO for the BASDAI (-26.4±19.7 vs -14.4±19.7; p=0.008), total back pain (-29.2±24.0 vs -14.9±24.0; p=0.010), BASFI (-21.7±17.6 vs -10.1±17.6; p=0.004), BASMI (-0.6±0.6 vs -0.2±0.6; p=0.011), CRP level (-15.7±14.2 vs -1.3±14.2; p<0.001) and FVC (+160±280 ml vs -20±280 ml; p=0.006). CONCLUSIONS: ETN has short-term efficacy for patients with advanced AS, as was previously reported for less advanced disease. The efficacy is observed for the main symptoms (pain) and on markers of inflammation (CRP), as well as disease severity in terms of spinal mobility and pulmonary function.

Comparison of the Psoriatic Arthritis Quality of Life (PsAQoL) questionnaire, the functional status (HAQ) and utility (EQ-5D) measures in psoriatic arthritis: results from a cross-sectional survey.

OBJECTIVES: To compare the Psoriatic Arthritis Quality of Life (PsAQoL) instrument, the Health Assessment Questionnaire (HAQ) as a measure of functional status, and the generic health status (utility) measure the EuroQoL (EQ-5D) in terms of ability to assess disease severity in psoriatic arthritis (PsA). METHODS: The differences between known groups and correlations of the PsAQoL, the HAQ and the EQ-5D with clinical measures were analysed in a sample of 183 PsA patients. RESULTS: Different severities of PsA determined by known groups were distinguished well by all three questionnaires; more severe disease was associated with significantly worse values of the instruments. The correlations revealed a strong relationship between each of the measures, and with the patients' pain on the visual analogue scale (VAS), the patient global VAS, and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and a weak relationship with the disease duration and the Psoriasis Area Severity Index (PASI). The PsAQoL also correlated strongly with the 28-joint Disease Activity Score (DAS28). CONCLUSIONS: The PsAQoL, the HAQ, and the EQ-5D are able to distinguish well across levels of PsA severity.

[Ankylosing spondylitis in Central and Eastern Europe. Cross-sectional study on treatment modalities, disease activity and quality of life]. / Ankylosierende Spondylitis in Mittel- und Osteuropa. Querschnittsstudie zu Behandlungsmustern, Krankheitsaktivität und Lebensqualität.

OBJECTIVES: To obtain information on the profile of patients with ankylosing spondylitis (AS), disease activity, previous and current treatments, and the proportion and profile of patients treated with conventional medications but considered eligible for anti-tumour necrosis factor (TNF) therapy. METHODS: Participants were rheumatologists from seven Central and Eastern European countries who were considered experts in the treatment of AS and were to include 3-5 patients who had never received anti-TNF therapy. Rheumatologists were asked to decide whether they considered their patients candidates for anti-TNF therapy. RESULTS: A total of 1506 patients were analysed. Overall, 61% of AS patients who had never received anti-TNF therapy until the time of the survey were considered candidates for anti-TNF therapy based on the clinical judgement of their rheumatologists. This proportion ranged from 40% in Slovakia to 84% in Romania. Candidates had higher levels of disease activity and functional impairment, and they were more likely to report a lower quality of life. Only 38% of candidates fulfilled the Assessment in Ankylosing Spondylitis (ASAS) recommendations with respect to a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 combined with previous use of at least two non-steroidal anti-inflammatory drugs, ranging from 18% in Poland to 57% in Hungary. CONCLUSION: More than half of AS patients currently treated with other medications may be eligible for anti-TNF therapy. Also, rheumatologists regarded disease activity as the determining factor for starting anti-TNF drugs, but their decision did not always fully comply with the ASAS recommendations, confirming the need for continued exchange among the medical community to increase awareness of the ASAS recommendations.

Etanercept 50 mg once weekly is as effective as 25 mg twice weekly in patients with ankylosing spondylitis.

OBJECTIVE: To compare the efficacy, pharmacokinetics and safety of etanercept 50 mg once weekly with 25 mg twice weekly and placebo in patients with ankylosing spondylitis. METHODS: A 12-week, double-blind, placebo-controlled study compared the effects of etanercept 50 mg once weekly, etanercept 25 mg twice weekly and placebo in 356 patients with active ankylosing spondylitis (3:3:1 randomisation, respectively). The primary end point was the proportion of patients achieving a response at week 12 based on the Assessment in Ankylosing Spondylitis Working Group criteria (ASAS 20). The pharmacokinetics of etanercept 50 mg once weekly and 25 mg twice weekly were analysed. RESULTS: Baseline characteristics and disease activity were similar among the three groups: etanercept 50 mg once weekly, etanercept 25 mg twice weekly and placebo. The percentage of patients discontinuing therapy was 9.0%, 9.3% and 13.7% for the three respective groups. ASAS 20 response at 12 weeks was achieved by 74.2% of patients with etanercept 50 mg once weekly and 71.3% of those with etanercept 25 mg twice weekly, both significantly higher than the percentage of patients taking placebo (37.3%, p<0.001). Percentages of patients with ASAS 5/6 response (70.3%, 72.0% and 27.5%, respectively; p<0.001) and those with ASAS 40 response (58.1%, 53.3% and 21.6%, respectively; p<0.001) followed a similar pattern. Significant improvement (p<0.05) was seen in measures of disease activity, back pain, morning stiffness and C reactive protein levels as early as 2 weeks. Serum etanercept exposure was similar between the etanercept groups. Incidence of treatment-emergent adverse events, including infections, was similar among all three groups, and no unexpected safety issues were identified. CONCLUSIONS: Patients with ankylosing spondylitis can expect a comparable significant improvement in clinical outcomes with similar safety when treated with etanercept 50 mg once weekly or with 25 mg twice weekly.

A short Larsen score is effective when evaluating radiographs in early rheumatoid arthritis.

PURPOSE: To compare the efficacy of the short Larsen score (LS 12) based on analysis of 12 areas with the original Larsen score (LS 40), which includes 40 areas for assessing radiographic changes in rheumatoid arthritis. MATERIAL AND METHODS: The radiographs of the hands, wrists, and feet of 122 patients with early rheumatoid arthritis were evaluated by two radiologists using both the LS 40 and LS 12 methods. Cross-sectional analysis of radiographs of 122 patients and longitudinal analysis in 68 patients were performed. RESULTS: There was no significant difference between the mean LS 40 and mean LS 12 in the cross-sectional study. LS 12 correlated strongly (r=0.93, P<0.01) with LS 40 at the baseline, and the rate of progression was similar in both methods (r=0.89, P<0.01) in the longitudinal study. CONCLUSION: The short Larsen score was as efficient as the original method.

ASAS/EULAR recommendations for the management of ankylosing spondylitis.

OBJECTIVE: To develop evidence based recommendations for the management of ankylosing spondylitis (AS) as a combined effort of the 'ASsessment in AS' international working group and the European League Against Rheumatism. METHODS: Each of the 22 participants was asked to contribute up to 15 propositions describing key clinical aspects of AS management. A Delphi process was used to select 10 final propositions. A systematic literature search was then performed to obtain scientific evidence for each proposition. Outcome data for efficacy, adverse effects, and cost effectiveness were abstracted. The effect size, relative risk, number needed to treat, and incremental cost effectiveness ratio were calculated. On the basis of the search results, 10 major recommendations for the management of AS were constructed. The strength of recommendation was assessed based on the strength of the literature evidence, risk-benefit trade-off, and clinical expertise. RESULTS: The final recommendations considered the use of non-steroidal anti-inflammatory drugs (NSAIDs) (conventional NSAIDs, coxibs, and co-prescription of gastroprotective agents), disease modifying antirheumatic drugs, treatments with biological agents, simple analgesics, local and systemic steroids, non-pharmacological treatment (including education, exercise, and physiotherapy), and surgical interventions. Three general recommendations were also included. Research evidence (categories I-IV) supported 11 interventions in the treatment of AS. Strength of recommendation varied, depending on the category of evidence and expert opinion. CONCLUSION: Ten key recommendations for the treatment of AS were developed and assessed using a combination of research based evidence and expert consensus. Regular updating will be carried out to keep abreast of new developments in the management of AS.

Beta endorphin-like immunoreactivity in human aqueous humor and crystalline lens.

We measured the concentration of beta-endorphin (beta-End) in plasma, as well as in aqueous humor and crystalline lens removed during cataract surgery. beta-End was detected both in the aqueous humor and in the crystalline lens. The concentration of beta-End in the aqueous humor corresponded to almost the half of the plasma level (2.18 fmol/l and 4.55 fmol/l). Endogenous beta-End is presumed to enter the intraocular structures by passive diffusion.

Repeated cyclosporine therapy of peripheral arthritis associated with ankylosing spondylitis.

BACKGROUND: A case history of a patient with ankylosing spondylitis and peripheral arthritis unresponsive to the conventional drug therapy, but successfully controlled by the use of cyclosporin. MATERIAL AND METHODS: In a 68 years old female patient with a 36 years history of typical ankylosing spondylitis a peripheral polyarthritis (hands, feet, wrists, and knees) developed. The patient did not suffer any other disease known to cause secondary spondylitis (psoriasis, inflammatory, bowel, disease). After the unsuccessful use of non-steroidal antiinflammatory drugs a combination therapy with cyclosporin (4 mg/kg/day) and azapropazone (300 mg t.i.d.) was introduced. RESULTS: Clinical improvement was achieved after 6 months of combined therapy, the polyarthritis completely resolved after one year. Therefore cyclosporin was discontinued. After one year the polyarthritis reappeared therefore the cyclosporin therapy was reinstituted with success. CONCLUSION: Cyclosporin has proved consistently effective in our case to control the peripheral arthritis associated with ankylosing spondylitis.

[Two familial cases of hereditary multiple exostoses]. / Exostosis cartilaginea multiplex két esete egy családban.

Hereditary multiple exostoses is an autosomal dominant disorder. Three different chromosomal loci have been implicated in this genetically heterogeneous disease. The authors describe a family in which 3 generations were affected, there were data about the disease of an already died grandmother, the father and his daughter were investigated by conventional X-ray and the disease was proved. The disease caused only minor complaints. The exostosis of the father's pelvis showed increased isotope uptake during bone scintigraphic examination, the same region exhibited malignant degeneration on MR examination. Regular check-up of the patients is necessary because of the possibility to a malignant transformation in 1-27% of the cases.

Video-assisted thoracoscopic pleurodesis for malignant pleural effusions.

AIM: The objective was to analyse the efficiency, and safety of thoracoscopic pleurodesis (TP). A retrospective study was made of an initial series of 75 patients undergoing lifetime follow-up who received TP in our department for the treatment of malignant pleural effusions (MPE). MATERIAL AND METHODS: From May 1994 to December 1998, 34 men and 41 women with a median age of 63.4 +/- 12.5 years were treated by TP. We performed 36 partial diathermic abrasions on pleura combined with talc insufflation, and in 39 cases only talc poudrage. The mean duration of insention of the chest tube was 4.1 (range 2 to 17) days, with 8.4 (range 5 to 20) days of postoperative hospitalization. There were no severe intraoperative or postoperative complications. The 30-day mortality rate was 1.3% (1 case). The period of follow-up ranged from 2.5 to 40 months (average 6.8). No case of late recurrence has been observed to date. CONCLUSION: Videothoracoscopic pleurodesis (talc poudrage) as a simple and efficient procedure seems to be the best alternative treatment regimen for the management of MPE in a group of selected patients.

The value of Asamura-Naruke type main bronchus stump closure and pleuro-pericardial flap covering by own method to avoid broncho-pleural fistula (BPF).

1. Authors present an "old-new" main bronchus closure procedure, which combines the Sweet's and Overholt's methods, recommended by Asamura-Naruke. 2. The A-N procedure decreased the prevalence of BPF from 2.8% to 0.09% in case of thoracotomy and from 9.5% to 2.4% in case of pneumonectomy compared 2 different stump-closing types. 3. There was not BPF in the "covered subgroup" (0%/92 PN) recommended by us, independent of the closing types. 4. All bronchial stumps closed like A-N and covered by our method (0% BPF/62 PN) healed.

Epileptogenic activity of folic acid after drug induces SLE (folic acid and epilepsy)

OBJECTIVE: To study the effect of folic acid-containing multivitamin supplementation in epileptic women before and during pregnancy in order to determine the rate of structural birth defects and epilepsy-related side effects. STUDY DESIGN: First a randomised trial, later periconception care including in total 12225 females. RESULTS: Of 60 epileptic women with periconceptional folic acid (0.8 mg)-containing multivitamin supplementation, no one developed epilepsy-related side effects during the periconception period. One epileptic woman delivered a newborn with cleft lip and palate. Another patient exhibited with a cluster of seizures after the periconception period using another multivitamin. This 22-year-old epileptic woman was treated continuously by carbamazepine and a folic acid (1 mg)-containing multivitamin from the 20th week of gestation. She developed status epilepticus and later symptoms of systemic lupus erythematodes. Her pregnancy ended with stillbirth. CONCLUSIONS: The epileptic pregnant patient's autoimmune disease (probably drug-induced lupus) could damage the blood-brain barrier, therefore the therapeutic dose (> or =1 mg) of folic acid triggered a cluster of seizures. Physiological dose (<1 mg) of folic acid both in healthy and 60 epileptic women, all without any autoimmune disease, did not increase the risk for epileptic seizures.

Cardiac and cardiopulmonary disorders in patients with ankylosing spondylitis and rheumatoid arthritis.

One hundred patients suffering from ankylosing spondylitis (AS) and one hundred patients suffering from rheumatoid arthritis (RA) were examined by clinical, non-invasive cardiological, radiological and laboratory methods to determine the prevalence of their cardiac and cardiopulmonary disorders. Fourteen patients with AS and 24 patients with RA had several valvular abnormalities. Among the patients not having any valvular abnormality, systolic dysfunction of the myocardium was detectable in 15 and 11 cases respectively, and cor pulmonale was diagnosed in 16 and 7 cases respectively. Conduction disturbances were demonstrated in 17 patients suffering from AS and in 14 patients suffering from RA.