Fibromyalgia: beyond the rhetoric.
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Biomedical subjects
Publications and source records attributed to Manfred Harth.
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Vasculitis as a complication of leflunomide therapy in the treatment of rheumatoid arthritis has been reported. We describe a case of acute necrotizing vasculitis following leflunomide therapy. Characteristics of this case and 4 cases in the literature suggest that vasculitis may be a rare but serious adverse effect of leflunomide therapy.
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OBJECTIVE: To determine if assigning the label of fibromyalgia (FM) to individuals with chronic widespread pain has a significant effect on long-term health status, function, and health service utilization. METHODS: In the London Fibromyalgia Epidemiology Study, 100 individuals with FM were identified by screening 3,395 non-institutionalized adults. Only 28 of the 100 had been previously diagnosed with FM; for 72, the diagnostic label was new. All 28 with prediagnosed FM were female compared with 58 of the 72 newly diagnosed cases. In a prospective, within-group comparison, we compared previously non-labeled FM cases at study entry (prelabeling) and at 18 and 36 months followup (postlabeling) with respect to general health status, fibromyalgia-related symptoms, and all items from the Fibromyalgia Impact Questionnaire (FIQ) (including total FIQ score, and several measures of health service utilization) to see if health status, function, and health services utilization had changed, using paired t-tests. We also compared percentage reporting work disability at baseline and 18 months using Pearson's chi(2). RESULTS: Fifty-six (78%) of the original 72 newly diagnosed FM cases were available for reassessment at 18 months, and 43 (60%) at 36 months. Although physical functioning decreased slightly over time, there also was a statistically significant improvement in satisfaction with health, and newly diagnosed FM cases reported fewer symptoms and major symptoms over the long term. No other differences in clinical status or health service use occurred over time. CONCLUSION: The FM label does not have a meaningful adverse affect on clinical outcome over the long term. Further research is necessary to document the short- and long-term effect of labeling in the chronic pain patient.
OBJECTIVE: To estimate the severity of depression, anxiety, and other symptoms of psychological distress in a representative general population sample of fibromyalgia (FM) cases (FC) compared to pain controls (PC), and to identify strong correlates of depression and anxiety. METHODS: We compared the severity of depression, anxiety, and other symptoms of psychological distress between 2 representative community samples: (1) 74 confirmed FC, and (2) 48 adults with chronic widespread pain (PC) who did not meet the 1990 ACR criteria for FM. Psychological distress was measured using the Centre for Epidemiological Studies Depression (CES-D) Scale, the State-Trait Anxiety Inventory (STAI), and other measures of psychological distress from the literature. Using cutoff scores for CES-D and trait anxiety, we compared demographic and clinical characteristics in those above and below each cutoff score. Simple linear regression was performed to identify factors strongly and independently correlated with depression and trait anxiety. RESULTS: Compared to PC, FC were more symptomatic on virtually all measures of psychological distress. Similarly, individuals who scored above cutoff scores for depression and anxiety had more physical symptoms and had poorer function than those below. Depression and trait anxiety were highly correlated (r = 0.86). In a simple regression model, the best predictors for both depression and trait anxiety were the total number of symptoms and a physical disability score. CONCLUSION: Depression and anxiety are common and frequently severe even among community cases of FM.
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We performed a combined manual and computer search of the FMS literature to identify controlled clinical trials in FMS from 1980 to June 1994 inclusive. Our specific objectives were: 1) to determine which outcome measures have been used in clinical trials for FMS, and the methods utilized to measure these outcomes; 2) to identify which outcome measures were most and least sensitive in distinguishing between treatment groups, and 3) to identify weakness in trial design. Our analysis of 24 clinical trials demonstrates the large diversity of outcome measures and measurement instruments that have been used to detect differences between treatment and placebo in the management of FMS. Whereas certain outcomes, such as self-reported pain and sleep quality, were frequently measured, other clinically important outcomes, such as functional and psychological status, were infrequently included in data collection. Finally, we identified several significant potential sources of bias, including potential flaws in subject selection and group allocation, inadequate randomization, incomplete blinding, errors in outcome measurement, and inappropriate analysis of data.