Disfunción tiroidea en mujeres con sospecha de fibromialgia / Thyroid dysfunction in women with suspected fibromyalgia

Fundamento y objetivo: La fibromialgia (FM), por su prevalencia, morbilidad y tasa de frecuentación, representa un problema de salud y genera un elevado consumo de recursos sanitarios. La medida de tirotropina (TSH) en el suero se recomienda como prueba complementaria de primera línea para descartar hipotiroidismo como anomalía simuladora de la enfermedad. El objetivo fue analizar, en mujeres con sospecha de FM, la prevalencia de disfunción tiroidea (DT), la frecuencia de solicitud analítica de tirotropina, el efecto del tratamiento con levotiroxina y si se justifica o no el escrutinio de DT. Pacientes y métodos: Estudio descriptivo transversal. Desde enero de 2001 a octubre de 2004 se estudió a 400 mujeres consecutivas con sospecha de FM y a 384 controles. La medida de tirotropina se usó como primera prueba para detectar DT. Resultados: La prevalencia de DT en la sospecha de FM (40/400; 10%, intervalo de confianza [IC] del 95%, 7-13%) no difirió de la de controles (46/384; 12%, IC del 95%, 9-15%); tampoco al comparar distintos tipos y grados de DT. En la sospecha de FM, la DT fue más prevalente (p = 0,001) en portadoras (12%) que en no portadoras (5%) de enfermedad del tejido conectivo. La DT más frecuente fue el hipotiroidismo subclínico (5,5% en FM y 6,7% en controles), y en el 93% de casos nuevos la concentración de TSH fue < 10 mUI/l. La FM persistió en todas las pacientes hipotiroideas al lograrse el eutiroidismo. En 360 pacientes eutiroideas con sospecha de FM se realizaron 870 determinaciones de TSH. Conclusiones: En mujeres con sospecha de FM, la prevalencia de DT no difiere de la descrita en la población general, no parece justificarse el escrutinio de DT en no portadoras de enfermedad de riesgo y la demanda analítica es en muchos casos excesiva; el tratamiento del hipotiroidismo no influye en la FM(AU)

Background and objective: Due to its prevalence, morbidity, and frequency rate, fibromyalgia (FM) represents a health problem and produces high healthcare resource utilization. Serum thyrotropin (TSH) measurement is recommended as a first-line laboratory test to exclude hypothyroidism as a cause of FM syndrome. The aim of this study was to analyze the prevalence of thyroid dysfunction (TD), the frequency of TSH measurement, the effect of levothyroxine treatment, and whether screening for TD is justified in women with suspected FM. Patients and methods: A cross-sectional descriptive study was performed in 400 consecutive female outpatients with suspected FM and in 384 controls from January 2001 to October 2004. TSH measurement was used as the first line test to detect TD. Results: The prevalence of TD in patients with suspected FM (40/400; 10%; 95% CI: 7-13%) and controls was similar (46/384; 12%; 95% CI: 9-15%). No differences were found in the types and grades of TD. The prevalence of TD was higher in patients with suspected FM and connective tissue diseases (12%) than in those without these diseases (5%). The most frequent TD was subclinical hypothyroidism (5.5% in suspected FM and 6.7% in controls), and in 93% of these cases TSH concentrations were <10 mIU/L. FM persisted in all women with hypothyroidism even after euthyroidism was achieved with levothyroxine. A total of 870 TSH determinations were performed in 360 euthyroid patients with suspected FM. Conclusions: The prevalence of TD in women with suspected FM does not differ from that in the general population. Screening for TD does not appear to be justified in women without diseases that increase their risk. In many cases the request for thyroid function tests is excessive. Treatment for hypothyroidism does notaffect FM(AU)

[Thyroid dysfunction in women with suspected fibromyalgia]. / Disfunción tiroidea en mujeres con sospecha de fibromialgia.

BACKGROUND AND OBJECTIVE: Due to its prevalence, morbidity, and frequency rate, fibromyalgia (FM) represents a health problem and produces high healthcare resource utilization. Serum thyrotropin (TSH) measurement is recommended as a first-line laboratory test to exclude hypothyroidism as a cause of FM syndrome. The aim of this study was to analyze the prevalence of thyroid dysfunction (TD), the frequency of TSH measurement, the effect of levothyroxine treatment, and whether screening for TD is justified in women with suspected FM. PATIENTS AND METHODS: A cross-sectional descriptive study was performed in 400 consecutive female outpatients with suspected FM and in 384 controls from January 2001 to October 2004. TSH measurement was used as the first line test to detect TD. RESULTS: The prevalence of TD in patients with suspected FM (40/400; 10%; 95% CI: 7-13%) and controls was similar (46/384; 12%; 95% CI: 9-15%). No differences were found in the types and grades of TD. The prevalence of TD was higher in patients with suspected FM and connective tissue diseases (12%) than in those without these diseases (5%). The most frequent TD was subclinical hypothyroidism (5.5% in suspected FM and 6.7% in controls), and in 93% of these cases TSH concentrations were <10 mIU/L. FM persisted in all women with hypothyroidism even after euthyroidism was achieved with levothyroxine. A total of 870 TSH determinations were performed in 360 euthyroid patients with suspected FM. CONCLUSIONS: The prevalence of TD in women with suspected FM does not differ from that in the general population. Screening for TD does not appear to be justified in women without diseases that increase their risk. In many cases the request for thyroid function tests is excessive. Treatment for hypothyroidism does not affect FM.

Leflunomida: eficacia y seguridad / Leflunomide: efficacy and safety

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A comparison of the efficacy and safety of leflunomide and methotrexate for the treatment of rheumatoid arthritis.

OBJECTIVE: To compare the clinical efficacy and safety of leflunomide and methotrexate for the treatment of rheumatoid arthritis (RA). METHODS: In this multicentre, double-blind trial, 999 subjects with active RA were randomized to leflunomide (n = 501; loading dose 100 mg/day for 3 days, maintenance dose 20 mg/day) or methotrexate (n = 498; 10-15 mg/week) for 52 weeks. After 1 yr the subjects could choose to stay for a second year of double-blind treatment. The primary end-points were tender and swollen joint counts and overall physician and patient assessments. Analyses were of the intent-to-treat group. RESULTS: After 1 yr, the mean changes in the leflunomide and methotrexate groups, respectively, were -8.3 and -9.7 for tender joint count; -6.8 and -9.0 for swollen joint count; -0.9 and -1.2 for physician global assessment; -0.9 and -1.2 for patient global assessment; -14.4 and -28.2 for erythrocyte sedimentation rate. Improvements seen with methotrexate were significantly greater than those with leflunomide. No further improvement occurred after the second year of treatment and the distinction between the two treatments in terms of tender joint count and patient global assessment was lost. During the first year of treatment, a small and equivalent degree of radiographically assessed disease progression was seen with both drugs. After 2 yr, disease progression was significantly less with methotrexate. The most common treatment-related adverse events in both groups were diarrhoea, nausea, alopecia, rash, headache, and elevated plasma liver enzyme levels. Over 2 yr, 21 subjects receiving methotrexate were withdrawn due to elevated plasma liver enzymes vs eight subjects taking leflunomide. Two drug-related deaths from pulmonary causes were recorded with methotrexate vs no drug-related deaths among the subjects receiving leflunomide. CONCLUSIONS: Both leflunomide and methotrexate are efficacious for prolonged treatment of RA. At the doses used, some clinical benefit of methotrexate over leflunomide was observed in the first year of treatment. This benefit must be weighed against the potential toxicity of this drug when used without folate supplementation.

Impacto socioeconómico de la artritis reumatoide / Socioeconomic impact of rheumatoid arthritis

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Colchicine treatment for recurrent pericarditis. A decade of experience.

BACKGROUND: The most troublesome complication of acute pericarditis is recurrent episodes of pericardial inflammation, occurring in 15% to 32% of cases. The cause of the recurrence is usually unknown, although in some cases it may be traced to viral infection or may be a consequence of coronary artery bypass grafting. The optimal method for prevention has not been fully established; accepted modalities include nonsteroidal anti-inflammatory drugs, corticosteroids, immunosuppressive agents, and pericardiectomy. METHODS AND RESULTS: Based on the proven efficacy of colchicine therapy for familial Mediterranean fever (recurrent polyserositis), several small studies have used colchicine successfully to prevent recurrence of acute pericarditis after failure of conventional treatment. Recently, we reported the results from the largest multicenter international study on 51 patients who were treated with colchicine to prevent further relapses and who were followed up for < or = 10 years. CONCLUSIONS: In light of new trial data that have accumulated in the past decade, we review the evidence for the efficacy and safety of colchicine for the prevention of recurrent episodes of pericarditis. Clinical and personal experience shows that colchicine may be an extremely promising adjunct to conventional treatment and may ultimately serve as the initial mode of treatment, especially in idiopathic cases.

Sodium fluoride treatment is a major protector against vertebral and nonvertebral fractures when compared with other common treatments of osteoporosis: a longitudinal, observational study.

In a 5-year observational study we have compared sodium fluoride (NaF) with different treatments commonly used in the treatment of osteoporosis: calcium, estrogens, androgens, and calcitonin, referred to as non-NaF. We have looked at the incidence of vertebral and nonvertebral fractures. At baseline, the NaF group, consisting of 125 patients (89% females) aged 65 +/- 10 (X +/- SE) had more crush fractures (P < 0.0001) and more months since menopause (P = 0.004) than the non-NaF group, consisting of 127 patients (90% females) aged 63 +/- 10. Fractures were evaluated by X-ray. The entire follow-up of patients treated with NaF accounted for 361 person-years, of whom 43 patients suffered one or more new vertebral fractures (68 vertebral fractures in total) and 18 patients suffered one or more new nonvertebral fractures (22 complete peripheral fractures in total); follow-up of patients treated with non-NaF regimes accounted for 382 person-years, of whom 53 patients suffered one or more new vertebral fractures (69 vertebral fractures in total) and 20 patients suffered one or more new nonvertebral fractures (27 complete peripheral fractures in total). After adjusting for significant covariates at baseline, NaF proved to be a significant protector for vertebral fractures [odds ratio (OR) 0.48, 95% confidence interval (CI) 0.2-0.9], and for peripheral fractures (QR 0.41, 95% CI 0.2-0.9). On the other hand, the probability of suffering undesired effects was much higher with NaF treatment (OR 5.04, 95% CI 2.1-11.9). We conclude that in the treatment of osteoporosis, NaF has a protective effect against vertebral and nonvertebral fractures, does not increase the risk of femoral fractures, but has a higher incidence of untoward symptomatology.

Multicenter clinical trial of zinc acexamate in the prevention of nonsteroidal antiinflammatory drug induced gastroenteropathy. Spanish Study Group on NSAID Induced Gastroenteropathy Prevention.

OBJECTIVE: To assess in a multicenter double blind clinical trial the gastroenteroprotective effect of zinc acexamate (ZAC). METHODS: 276 patients with rheumatic disease and history of peptic ulcer or intolerance to nonsteroidal antiinflammatory drugs (NSAID), and requiring treatment with these drugs were included. An initial normal endoscopy was needed for inclusion. Patients were treated with one NSAID (diclofenac, piroxicam, naproxen or ketoprofen) and one capsule (300 mg) of either ZAC (141 patients) or placebo (135 patients) at single nocturnal dose. After 28 days, patients underwent a clinical and endoscopic control. RESULTS: 26 patients withdrew from the trial (10 of ZAC and 16 of placebo) and 41 were lost to followup (22 of ZAC and 19 of placebo). Gastroduodenal mucosal damage was graded according to a modified Lanza score. The incidence of gastric ulcer was null with ZAC and 6.0% with placebo (6 cases) (p < 0.05). The incidence of duodenal ulcer was 0.9% with ZAC (1 case) and 6.0% with placebo (12 cases) (p < 0.001). Nine patients of ZAC group (8%) and 25 of placebo (25%) presented some gastric damage (p < 0.001), and 5 (5%) and 19 (19%) respectively presented some duodenal damage (p < 0.005). After treatment, 88% of patients treated with ZAC and 66% with placebo had a completely normal endoscopy (p < 0.0005). No major side effects were reported through the study. CONCLUSION: ZAC has shown to be effective and well tolerated for the prevention of NSAID induced gastroduodenal damage in patients with rheumatic disease at risk. The incidence of gastric and duodenal ulcers decreased in 92% (13 times the risk), when compared to placebo.

Erythroid abnormalities in rheumatoid arthritis: the role of erythropoietin.

Erythroid alterations were studied in 136 patients with rheumatoid arthritis (RA). Anemia was present in 75 cases. A definite diagnosis was determined in 65. The most frequent anemia was that of chronic disease (ACD) (43 cases); 14 patients with ACD presented with moderate to severe anemia. Prevalence of deficiencies were also high (15 cases had iron deficiency anemia, IDA). Serum erythropoietin levels were different in patients with RA compared with a healthy control group (p < 0.00001). Serum erythropoietin was increased in ACD (49 +/- 28.8 U/l) with respect to both RA (38.6 +/- 12.7 U/l, p = 0.0036) and controls (18.2 +/- 7.6 U/l, p < 0.00001). Although hemoglobin (Hb) was similar in ACD and IDA, serum erythropoietin in ACD was lower than in IDA (p = 0.01). There was a negative relationship between Hb and serum erythropoietin in ACD (r = -0.42, p = 0.005). In conclusion, almost 50% of patients with RA have anemia and ACD is the most frequent. As serum erythropoietin in ACD is blunted, patients with moderate to severe ACD are possible candidates for erythropoietin treatment.

Comparative double-blind study of droxicam (new NSAID) versus indomethacin in rheumatoid arthritis.

This randomized, controlled and double-blind clinical trial compares the efficacy of droxicam (20mg/day) with that of indomethacin (75mg/day) in 40 RA patients (11 male, 29 female) aged (+/- SD) 53 +/- 12.5 years. After a 7-day single-blind run-in placebo period, patients were divided into two groups and treated for 9 weeks. Assessments were done at baseline and at the end of the 1st, 2nd, 4th, 6th and 9th weeks. Both drugs improved significantly the articular pain, the duration of morning stiffness, the articular index, the functional status and the degree of fatigue. Patient's and doctor's opinions were in accordance with the above-mentioned results. The effect of both drugs was more noticeable in the first 2 weeks of treatment. Droxicam was found to be statistically more active than indomethacin in alleviating morning stiffness and improving the functional status. The improvement of the variables induced by droxicam increased progressively throughout the study whereas that induced by indomethacin remained unchanged after the 2nd or 4th week of treatment. One patient treated with indomethacin withdrew from the study due to staggering and dizziness and several patients reported dyspepsia. Droxicam seems to be as effective as indomethacin (75mg/day) in the symptomatic relief of RA patients. The possibility of the use of droxicam for the relief of morning stiffness is of particular interest.

Droxicam: a pharmacological and clinical review of a new NSAID.

Droxicam acts by inhibition of PGE2 varies. Although it belongs to the oxicam family, it is characterised by being a pro-drug of piroxicam, the molecule undergoing conversion by hydrolysis once dissolved in the digestive tract. This allows us to suppose in principle that, there being less contact between the active drug (piroxicam) and the gastric mucosa, the side effects in the said mucosa would be slight. The studies which have already been performed in healthy volunteers and in patients with osteoarthritis and rheumatoid arthritis, to evaluate the efficacy and the tolerance of droxicam in patients suffering from such clearly inflammatory processes demonstrate an analgesic potential and anti-inflammatory effects which become noticeable after two weeks of treatment, and the drug is well-tolerated.

Recurrent pericarditis. Relief with colchicine.

Recurrence is one of the major complications of pericarditis. Treatment of recurrence is often difficult, and immunosuppressive drugs or surgery may be necessary. We conducted an open-label prospective study of nine patients (seven men and two women; age, 18-64 years; mean age, 41.7 +/- 13.7 years). Patients were treated with colchicine (1 mg/day) to prevent recurrences. All patients had suffered at least three relapses despite treatment with acetylsalicylic acid, indomethacin, prednisone, or a combination. Pericarditis was classified as idiopathic in five patients, postpericardiotomy in two, post-myocardial infarction in one, and associated with disseminated lupus erythematosus in one. For statistical analysis, we conducted a paired comparison design (Student's t test). All patients treated with colchicine responded favorably to therapy. Prednisone was discontinued in all patients after 2-6 weeks (mean, 26.33 +/- 10.9 days), and colchicine alone was continued. After a mean follow-up of 24.3 months (minimum, 10 months; maximum, 54 months), no recurrences were observed in any patient; there was a significant difference between the symptom-free periods before and after treatment with colchicine (p less than 0.002). Our study suggests that colchicine may be useful in avoiding recurrence of pericarditis, although these results need to be confirmed in a larger, double-blind study.