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Clinical Conference A randomized controlled trial of dehydroepiandrosterone in postmenopausal women with fibromyalgia. 2005
Finckh A, Berner IC, Aubry-Rozier B, So AK. · Rheumatology Department, University Hospital of Vaud (CHUV), Lausanne, Switzerland. · J Rheumatol. · Pubmed #15996074 No free full text.
Abstract: OBJECTIVE: Patients with fibromyalgia (FM) consistently have adrenal hyporesponsiveness and low dehydroepiandrosterone (DHEA) levels. DHEA is promoted for and used by patients with FM. We tested the efficacy and safety of DHEA supplementation in ameliorating the symptoms of FM. METHODS: In a double-blind crossover study, postmenopausal women with FM were randomized to DHEA supplementation (50 mg/day) or placebo for 3 months, with a one-month washout period in between. Patients were assessed monthly for well-being and pain and by medical evaluations at the beginning and the end of each treatment period. The primary outcome was well being; secondary outcomes were pain, fatigue, cognition, sexuality, functional impairment, depression, and anxiety. RESULTS: A total of 52 patients were randomized, 47 patients completed the DHEA treatment period, and 45 the placebo treatment period. After 3 months of treatment with 50 mg of DHEA, median DHEA sulfate blood levels had tripled, but there was no improvement in well-being, pain, fatigue, cognitive dysfunction, functional impairment, depression, or anxiety, nor in objective measurements made by physicians. Androgenic side effects (greasy skin, acne, and increased growth of body hair) were more common during the DHEA treatment period (p = 0.02). CONCLUSION: DHEA does not improve quality of life, pain, fatigue, cognitive function, mood, or functional impairment in FM.
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Clinical Conference A 58-year-old man with a diagnosis of chronic lyme disease. 2002
Steere AC. · Harvard Medical School and Comprehensive Arthritis Center, Massachusetts General Hospital, Boston, MA 02129, USA. · JAMA. · Pubmed #12190371 No free full text.
This publication has no abstract.
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Clinical Conference The effects of progressive strength training and aerobic exercise on muscle strength and cardiovascular fitness in women with fibromyalgia: a pilot study. 2002
Rooks DS, Silverman CB, Kantrowitz FG. · New England Baptist Bone and Joint Institute, New England Baptist Hospital, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston, MA 02115, USA. · Arthritis Rheum. · Pubmed #11932874 No free full text.
Abstract: OBJECTIVE: To determine the safety, feasibility and consequences of a program of progressive strength training and cardiovascular exercise in women with fibromyalgia syndrome (FMS). METHODS: Fifteen women with confirmed FMS were monitored for injury and exercise compliance, and assessed for muscle strength (1-repetition maximum technique), cardiovascular endurance (6-minute walk test), and functional status (Fibromyalgia Impact Questionnaire [FIQ]) before and after a 20-week exercise intervention. RESULTS: Zero injuries and an 81% compliance rate occurred during training. Improvement was seen in muscle strength of the lower (191 +/- 75 to 265 +/- 67 pounds; P < 0.001) and upper (61 +/- 18 to 76 +/- 18 pounds; P < 0.001) body, 6-minute walk distance (530 +/- 80 to 629 +/- 74 meters; P < 0.001), and in FIQ score (44 +/- 9 to 32 +/- 14; P < 0.01). CONCLUSION: A program of progressive strength training and cardiovascular exercise can be safe, well tolerated, and effective at improving muscle strength, cardiovascular endurance and functional status in women with FMS without exacerbating symptoms. This program may also contribute to a reduction in the severity of several symptoms.
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Clinical Conference Does self-management education benefit all populations with arthritis? A randomized controlled trial in a primary care physician network. 2002
Solomon DH, Warsi A, Brown-Stevenson T, Farrell M, Gauthier S, Mikels D, Lee TH. · Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115, USA. · J Rheumatol. · Pubmed #11838857 No free full text.
Abstract: OBJECTIVE: Studies have suggested that the Arthritis Self-Management Program (ASMP) course is effective at reducing arthritis pain and health care costs in volunteer participants. There have been no reports of trials of the ASMP in the context of primary care physicians' practices, where the potential for spreading the program may be greatest. We conducted a randomized controlled trial of the ASMP course in a large primary care physician network. METHODS: Patients with osteoarthritis, rheumatoid arthritis, or fibromyalgia were recruited for the study. Subjects in the intervention practices received the 6 week course and those in the control practices received only the ASMP book, without course. Disability, pain, self-efficacy, mental health, and satisfaction were measured using validated instruments at baseline and at 4 months. RESULTS: One hundred thirteen patients were recruited for the ASMP course (intervention) and completed baseline and 4 month followup questionnaires. Eighty-four percent completed at least 4 of 6 classes. Seventy-four patients received the ASMP manual (controls) and completed both questionnaires. Patients in the intervention and control groups had similar baseline pain (p = 0.94), self-efficacy to control pain (p = 0.90), mental health (p = 0.10), and vitality scores (p = 0.21), but those in the intervention arm had slightly less disability (p = 0.04). At 4 months, there was no significant improvement from baseline in any endpoint and no difference between patients in the intervention and control groups (all p > 0.2). Patient satisfaction with arthritis care and outcomes was no different for intervention and control patients (all p > 0.3). All types of health care resource use were similar at baseline and followup for both intervention and control groups (all p > 0.2). CONCLUSION: While the ASMP course has been found to be effective in other patient groups, there were no significant clinical benefits noted at 4 months in patients recruited from primary care practices.
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Article Using multidisciplinary care to treat fibromyalgia. 2009
Goldenberg DL. · Department of Medicine and Rheumatology, Newton-Wellesley Hospital, Newton, MA, USA. · J Clin Psychiatry. · Pubmed #19552860 No free full text.
Abstract: Fibromyalgia is a common condition associated with abnormal central pain processing, chronic widespread musculoskeletal pain, tenderness at various points on the body, fatigue, and sleep abnormalities. Individuals with fibromyalgia often have comorbid anxiety, depression, and/or other pain syndromes. Multiple pharmacologic agents have demonstrated efficacy in alleviating some fibromyalgic symptoms, but pharmacology is only one piece of the puzzle in the successful management of fibromyalgia. Thorough medical and psychiatric evaluations are necessary after confirming a diagnosis of fibromyalgia, and a multidisciplinary treatment strategy including patient education, aerobic exercise, and cognitive-behavioral therapy as well as pharmacotherapy has been shown to be effective in alleviating fibromyalgic symptoms.
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Article The status and future of acupuncture clinical research. 2008
Napadow V, Ahn A, Longhurst J, Lao L, Stener-Victorin E, Harris R, Langevin HM. · Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Charleston, MA 02129, USA. · J Altern Complement Med. · Pubmed #18803495 No free full text.
Abstract: On November 8-9, 2007, the Society for Acupuncture Research (SAR) hosted an international conference to mark the tenth anniversary of the landmark NIH [National Institutes of Health] Consensus Development Conference on Acupuncture. More than 300 acupuncture researchers, practitioners, students, funding agency personnel, and health policy analysts from 20 countries attended the SAR meeting held at the University of Maryland School of Medicine, Baltimore, MD. This paper summarizes important invited lectures in the area of basic and translational acupuncture research. Specific areas include the scientific assessment of acupuncture points and meridians, the neural mechanisms of cardiovascular regulation by acupuncture, mechanisms for electroacupuncture applied to persistent inflammation and pain, basic and translational research on acupuncture in gynecologic applications, the application of functional neuroimaging to acupuncture research with specific application to carpal-tunnel syndrome and fibromyalgia, and the association of the connective tissue system to acupuncture research. In summary, mechanistic models for acupuncture effects that have been investigated experimentally have focused on the effects of acupuncture needle stimulation on the nervous system, muscles, and connective tissue. These mechanistic models are not mutually exclusive. Iterative testing, expanding, and perhaps merging of such models will potentially lead to an incremental understanding of the effects of manual and electrical stimulation of acupuncture needles that is solidly rooted in physiology.
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Article Characteristics and patterns of healthcare utilization of patients with fibromyalgia in general practitioner settings in Germany. 2008
Berger A, Sadosky A, Dukes E, Martin S, Edelsberg J, Oster G. · Policy Analysis, Inc., Brookline, MA 02445, USA. · Curr Med Res Opin. · Pubmed #18664319 No free full text.
Abstract: OBJECTIVE: To examine characteristics and patterns of healthcare utilization of patients with fibromyalgia (FM) under the care of general practitioners (GPs) in Germany. RESEARCH DESIGN AND METHODS: Retrospective cohort study, using a large electronic database with information on GP encounters in Germany (IMS MediPlus). We identified all patients, aged > or =18 years, with any encounters for FM (ICD-10 diagnosis code M79.7) between February 1, 2004 and January 31, 2007. We also constituted a comparison group consisting of randomly selected patients with one or more GP encounters - but none for FM - during this period, who we matched to FM patients based on age and sex. Characteristics and healthcare utilization of patients in the FM and comparison groups were then examined over the 1-year period, February 1, 2006-January 31, 2007. MAIN OUTCOME MEASURES: Prevalence of co-morbidities; use of pain-related pharmacotherapy; number of GP office visits; number of specialist referrals; and number of sick notes (physician-excused absences from work). RESULTS: The study sample consisted of 4983 FM patients and an identical number in the comparison group. Mean age was 58 years; 87% were women. The prevalence of various co-morbidities was greater among FM patients, including painful neuropathies (33% vs. 18% for comparison group) and depression (20% vs. 5%) (both p<0.01); more FM patients also received pain-related pharmacotherapy (67% vs. 28%; p<0.01). Compared with patients in the comparison group, FM patients averaged approximately twice as many GP visits (11.4 [SD=10.1] vs. 5.8 [7.5]), referrals (4.5 [5.2] vs. 2.2 [3.6]), and sick notes (0.6 [1.8] vs. 0.3 [1.1]) (all p<0.01). LIMITATIONS: Information in the study database is limited to GP encounters, and the sensitivity and specificity of our case-finding methods are unknown. CONCLUSIONS: Patients with FM under the care of GPs in Germany have comparatively more co-morbidities and higher levels of healthcare utilization.
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Article Co-occurrence of binge eating disorder with psychiatric and medical disorders. 2008
Javaras KN, Pope HG, Lalonde JK, Roberts JL, Nillni YI, Laird NM, Bulik CM, Crow SJ, McElroy SL, Walsh BT, Tsuang MT, Rosenthal NR, Hudson JI. · Department of Biostatistics, Harvard School of Public Health, Boston, Mass., USA. · J Clin Psychiatry. · Pubmed #18348600 No free full text.
Abstract: BACKGROUND: Prior studies suggest that certain psychiatric and medical disorders co-occur with binge eating disorder (BED). However, there has been no large, community-based study with diagnoses made by clinician interviewers. We used data from that type of study to assess the co-occurrence of various psychiatric and medical disorders with DSM-IV BED and with subthreshold BED. METHOD: From October 2002 to July 2004, we interviewed 150 probands with BED, 150 probands without BED, and 888 of their first-degree relatives (135 of whom had BED, and 54 of whom met specific partial criteria for BED that we defined as subthreshold BED). Study participants were interviewed using the Structured Clinical Interview for DSM-IV to assess BED and other psychiatric disorders and a supplemental structured interview to assess certain medical disorders; participants also completed a self-report questionnaire, the Bad Things Scale. For each psychiatric and medical disorder, we calculated the age- and sex-adjusted co-occurrence odds ratio: the odds of having that disorder in one's lifetime among individuals with (full or subthreshold) lifetime BED compared to individuals without lifetime BED. We also used subjects' responses to the Bad Things Scale to adjust for adversity over-reporting, a type of response bias that could result in spurious findings of co-occurrence. RESULTS: Full BED co-occurred significantly with bipolar disorder, major depressive disorder, bulimia nervosa but not anorexia nervosa, most anxiety disorders, substance use disorders, body dysmorphic disorder, kleptomania, irritable bowel syndrome, and fibromyalgia. These results changed little after correcting for adversity over-reporting. Subthreshold BED co-occurred significantly with many, but not all, of the significantly co-occurring disorders for full BED. CONCLUSION: BED and, to a lesser degree, subthreshold BED exhibit substantial lifetime co-occurrence with psychiatric and medical disorders.
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Article Employees with fibromyalgia: medical comorbidity, healthcare costs, and work loss. 2008
White LA, Birnbaum HG, Kaltenboeck A, Tang J, Mallett D, Robinson RL. · Analysis Group, Inc., 111 Huntington Avenue, Boston, MA 02199, USA. · J Occup Environ Med. · Pubmed #18188077 No free full text.
Abstract: OBJECTIVES: To compare 2005 health care resources among matched samples of employees with fibromyalgia (FM), osteoarthritis (OA), and controls. METHODS: Using a claims database of privately insured individuals, FM and OA samples were derived from those with two or more disease-specific claims in 1999 to 2005 (> or =1 in 2002 to 2005). RESULTS: Total costs for employees with FM ($10,199) approached OA costs ($10,861, P = 0.3758) and were significantly higher than controls ($5274, P < 0.0001). Cost components varied across disease-specific samples (direct medical: FM $7286 vs OA $8325, P < 0.0287; pharmacy: FM $1630 vs OA $1341; indirect: FM $2913 vs OA $2537, P < 0.0001). Employees with FM had more claims than OA for psychiatric diagnoses, chronic fatigue, and most pain conditions. Use of multiple prescription drug classes was common in both samples. CONCLUSIONS: FM imposes significant economic burden. Work loss contributes substantially to the impact.
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Article Group exercise, education, and combination self-management in women with fibromyalgia: a randomized trial. free! 2007
Rooks DS, Gautam S, Romeling M, Cross ML, Stratigakis D, Evans B, Goldenberg DL, Iversen MD, Katz JN. · Novartis Institutes for Biomedical Research, Inc, Translational Medicine, 400 Technology Square, Cambridge, MA 02139, USA. · Arch Intern Med. · Pubmed #17998491 links to free full text
Abstract: BACKGROUND: Self-management has increasingly been recommended as part of standard care for fibromyalgia, a common, poorly understood condition with limited treatment options. Data that assess popular self-management recommendations are scarce. We evaluated and compared the effectiveness of 4 common self-management treatments on function, symptoms, and self-efficacy in women with fibromyalgia. METHODS: A total of 207 women with confirmed fibromyalgia were recruited from September 16, 2002, through November 30, 2004, and randomly assigned to 16 weeks of (1) aerobic and flexibility exercise (AE); (2) strength training, aerobic, and flexibility exercise (ST); (3) the Fibromyalgia Self-Help Course (FSHC); or (4) a combination of ST and FSHC (ST-FSHC). The primary outcome was change in physical function from baseline to completion of the intervention. Secondary outcomes included social and emotional function, symptoms, and self-efficacy. RESULTS: Improvements in the mean Fibromyalgia Impact Questionnaire score in the 4 groups were -12.7 for the ST-FSHC group, -8.2 for the AE group, -6.6 for the ST group, and -0.3 for the FSHC group. The ST-FSHC group demonstrated greater improvement than the FSHC group (mean difference, -12.4; 95% confidence interval [CI], -23.1 to -1.7). The ST-FSHC (mean difference, 13.6; 95% CI, 2.3 to 24.9) and AE (mean difference, 13.1; 95% CI, 1.6 to 25.6) groups had similar improvements in physical function scores on the 36-Item Short-Form Health Survey. Bodily pain scores on the 36-Item Short-Form Health Survey improved in the ST-FSHC (14.8), AE (13.2), and ST (5.7) groups. Social function, mental health, fatigue, depression, and self-efficacy also improved. The beneficial effect on physical function of exercise alone and in combination with education persisted at 6 months. CONCLUSIONS: Progressive walking, simple strength training movements, and stretching activities improve functional status, key symptoms, and self-efficacy in women with fibromyalgia actively being treated with medication. The benefits of exercise are enhanced when combined with targeted self-management education. Our findings suggest that appropriate exercise and patient education be included in the treatment of fibromyalgia.
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Article Opinion: pseudoscientific explanations of arm pain. 2007
Ring D, McCarthy M. · Department of Orthopaedic Surgery, Massachusetts General Hospital, ACC 525, 15 Parkman St., Boston, MA 02114, USA. · J Surg Orthop Adv. · Pubmed #17963652 No free full text.
This publication has no abstract.
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Article Characteristics and healthcare costs of patients with fibromyalgia syndrome. free! 2007
Berger A, Dukes E, Martin S, Edelsberg J, Oster G. · Policy Analysis, Inc., Brookline, MA 02445, USA. · Int J Clin Pract. · Pubmed #17655684 links to free full text
Abstract: PURPOSE: To examine the characteristics and healthcare costs of fibromyalgia syndrome (FMS) patients in clinical practice. MATERIALS AND METHODS: Using a US health-insurance database, we identified all patients, aged > or = 18 years, with any healthcare encounters for FMS (ICD-9-CM diagnosis code 729.1) in each year of the 3-year period, 1 July 2002 to 30 June 2005. A comparison group was then constituted, consisting of randomly selected patients without any healthcare encounters for FMS during this 3-year period. Comparison group patients were matched to FMS patients based on age and sex. Characteristics and healthcare costs of FMS patients and comparison group patients were then examined over the 1-year period, 1 July 2004 to 30 June 2005 (the most recent year for which data were available at the time of the study). RESULTS: The study sample consisted of 33,176 FMS patients and an identical number in the comparison group. Mean age was 46 years, and 75% were women. FMS patients were more likely to have various comorbidities, including painful neuropathies (23% vs. 3% for comparison group), anxiety (5% vs. 1%), and depression (12% vs. 3%) (all p < 0.001); they also were more likely to have used pain-related pharmacotherapy (65% vs. 34% for comparison group; p < 0.001). Mean (SD) total healthcare costs over 12 months were about three times higher among FMS patients [$9573 ($20,135) vs. $3291 ($13,643); p < 0.001]; median costs were fivefold higher ($4247 vs. $822; p < 0.001). CONCLUSIONS: Patients with FMS have comparatively high levels of comorbidities and high levels of healthcare utilization and cost.
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Article A closer look at pain and hepatitis C: preliminary data from a veteran population. 2007
Silberbogen AK, Janke EA, Hebenstreit C. · Department of Veterans Affairs (VA) Boston Healthcare System, Psychology Service (116B), 150 South Huntington Avenue, Boston, MA 02130, USA. · J Rehabil Res Dev. · Pubmed #17551875 No free full text.
Abstract: An association between the hepatitis C virus (HCV) and various pain diagnoses, including arthritis, fibromyalgia, and peripheral neuropathy, has been reported. In this article, we review the literature on the relationship between HCV and pain, highlighting current knowledge as well as methodological issues that exist in many studies. We also present preliminary findings from a survey conducted at two Department of Veterans Affairs facilities to assess the scope and impact of pain on functioning in veterans with HCV. Our results indicate that pain is very prevalent within this population and that HCV-positive veterans who experience persistent pain have significant depressive symptoms and engage in high-risk behaviors, such as cigarette smoking and alcohol use. Finally, we draw upon our review and preliminary results to propose areas of future rehabilitative research and to address the implications for clinicians working with patients with comorbid HCV and pain.
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Article Gabapentin in the treatment of fibromyalgia: a randomized, double-blind, placebo-controlled, multicenter trial. free! 2007
Arnold LM, Goldenberg DL, Stanford SB, Lalonde JK, Sandhu HS, Keck PE, Welge JA, Bishop F, Stanford KE, Hess EV, Hudson JI. · University of Cincinnati College of Medicine, Cincinnati, Ohio 45219, and Newton-Wellesley Hospital, Newton, MA, USA. · Arthritis Rheum. · Pubmed #17393438 links to free full text
Abstract: OBJECTIVE: To assess the efficacy and safety of gabapentin in patients with fibromyalgia. METHODS: A 12-week, randomized, double-blind study was designed to compare gabapentin (1,200-2,400 mg/day) (n=75 patients) with placebo (n=75 patients) for efficacy and safety in treating pain associated with fibromyalgia. The primary outcome measure was the Brief Pain Inventory (BPI) average pain severity score (range 0-10, where 0=no pain and 10=pain as bad as you can imagine). Response to treatment was defined as a reduction of >or=30% in this score. The primary analysis of efficacy for continuous variables was a longitudinal analysis of the intent-to-treat sample, with treatment-by-time interaction as the measure of effect. RESULTS: Gabapentin-treated patients displayed a significantly greater improvement in the BPI average pain severity score (P=0.015; estimated difference between groups at week 12=-0.92 [95% confidence interval -1.75, -0.71]). A significantly greater proportion of gabapentin-treated patients compared with placebo-treated patients achieved response at end point (51% versus 31%; P=0.014). Gabapentin compared with placebo also significantly improved the BPI average pain interference score, the Fibromyalgia Impact Questionnaire total score, the Clinical Global Impression of Severity, the Patient Global Impression of Improvement, the Medical Outcomes Study (MOS) Sleep Problems Index, and the MOS Short Form 36 vitality score, but not the mean tender point pain threshold or the Montgomery Asberg Depression Rating Scale. Gabapentin was generally well tolerated. CONCLUSION: Gabapentin (1,200-2,400 mg/day) is safe and efficacious for the treatment of pain and other symptoms associated with fibromyalgia.
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Article A randomized, sham-controlled, proof of principle study of transcranial direct current stimulation for the treatment of pain in fibromyalgia. free! 2006
Fregni F, Gimenes R, Valle AC, Ferreira MJ, Rocha RR, Natalle L, Bravo R, Rigonatti SP, Freedman SD, Nitsche MA, Pascual-Leone A, Boggio PS. · Harvard Medical School, Boston, Massachusetts 02215, USA. · Arthritis Rheum. · Pubmed #17133529 links to free full text
Abstract: OBJECTIVE: Recent evidence suggests that fibromyalgia is a disorder characterized by dysfunctional brain activity. Because transcranial direct current stimulation (tDCS) can modulate brain activity noninvasively and can decrease pain in patients with refractory central pain, we hypothesized that tDCS treatment would result in pain relief in patients with fibromyalgia. METHODS: Thirty-two patients were randomized to receive sham stimulation or real tDCS with the anode centered over the primary motor cortex (M1) or the dorsolateral prefrontal cortex (DLPFC) (2 mA for 20 minutes on 5 consecutive days). A blinded evaluator rated the patient's pain, using the visual analog scale for pain, the clinician's global impression, the patient's global assessment, and the number of tender points. Other symptoms of fibromyalgia were evaluated using the Fibromyalgia Impact Questionnaire and the Short Form 36 Health Survey. Safety was assessed with a battery of neuropsychological tests. To assess potential confounders, we measured mood and anxiety changes throughout the trial. RESULTS: Anodal tDCS of the primary motor cortex induced significantly greater pain improvement compared with sham stimulation and stimulation of the DLPFC (P < 0.0001). Although this effect decreased after treatment ended, it was still significant after 3 weeks of followup (P = 0.004). A small positive impact on quality of life was observed among patients who received anodal M1 stimulation. This treatment was associated with a few mild adverse events, but the frequency of these events in the active-treatment groups was similar to that in the sham group. Cognitive changes were similar in all 3 treatment groups. CONCLUSION: Our findings provide initial evidence of a beneficial effect of tDCS in fibromyalgia, thus encouraging further trials.
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Article Lessons learned combining N-of-1 trials to assess fibromyalgia therapies. 2006
Zucker DR, Ruthazer R, Schmid CH, Feuer JM, Fischer PA, Kieval RI, Mogavero N, Rapoport RJ, Selker HP, Stotsky SA, Winston E, Goldenberg DL. · Tufts University School of Medicine and Tufts-New England Medical Center, Boston, Massachusetts 02111, USA. · J Rheumatol. · Pubmed #17014022 No free full text.
Abstract: OBJECTIVE: Applying population research to individual treatment requires understanding the connections between patient-specific characteristics, population-based studies, and treatment responses. Conducting practice-based research using individual-focused (N-of-1) trials may aid this process. We combined N-of-1 trials to compare fibromyalgia therapies and to assess the feasibility and outcomes of this approach for practice-based effectiveness research. METHODS: Community- and center-based rheumatologists enrolled patients with fibromyalgia syndrome in randomized, double-blind, multi-crossover, N-of-1 trials comparing amitriptyline and the combination amitriptyline and fluoxetine. Fibromyalgia Impact Questionnaire outcomes were used for the individuals' treatment and combined across patients for sample-based analyses. Outcomes were compared with results from more standard trial designs. RESULTS: Eight rheumatologists enrolled 58 patients in N-of-1 trials. Most physicians and patients had not previously participated in clinical trials. Using several analytic methods, the pooled results showed a better outcome score (mean difference: -6.1 +/- 2.0 to -8.0 +/- 3.7 points) in patients taking combination therapy. These population results are similar to published outcomes from a more traditional crossover trial. Neither practice type nor patient characteristics were significantly associated with the observed treatment-effect variation. Most participants, irrespective of selected treatment, felt their individual N-of-1 trials were helpful. CONCLUSION: Implementation of the combined N-of-1 methodology is feasible in rheumatology practices and results confirm greater fibromyalgia improvement with combination therapy. This research approach broadens participation, although our trials' specifics likely influenced enrollment eligibility. In addition to individual benefits, combining N-of-1 trial data provides population research benefits. This patient-focused approach should be further explored to bridge research and practice.
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Article Migraine, fibromyalgia, and depression among people with IBS: a prevalence study. free! 2006
Cole JA, Rothman KJ, Cabral HJ, Zhang Y, Farraye FA. · Department of Epidemiology, Boston University School of Public Health, Boston MA, USA. · BMC Gastroenterol. · Pubmed #17007634 links to free full text
Abstract: BACKGROUND: Case descriptions suggest IBS patients are more likely to have other disorders, including migraine, fibromyalgia, and depression. We sought to examine the prevalence of these conditions in cohorts of people with and without IBS. METHODS: The source of data was a large U.S. health plan from January 1, 1996 though June 30, 2002. We identified all people with a medical claim associated with an ICD-9 code for IBS. A non-IBS cohort was a random sample of people with an ICD-9 code for routine medical care. In the cohorts, we identified all claims for migraine, depression, and fibromyalgia. We estimated the prevalence odds ratios (PORs) of each of the three conditions using the Mantel-Haenszel method. We conducted quantitative sensitivity analyses to quantify the impact of residual confounding and in differential outcome identification. RESULTS: We identified 97,593 people in the IBS cohort, and a random sample of 27,402 people to compose the non-IBS comparison cohort. With adjustment, there was a 60% higher odds in the IBS cohort of having any one of the three disorders relative to the comparison cohort (POR 1.6, 95% CI 1.5 - 1.7). There was a 40% higher odds of depression in the IBS cohort (POR 1.4, 95% CI 1.3 - 1.4). The PORs for fibromyalgia and migraine were similar (POR for fibromyalgia 1.8, 95% CI 1.7 - 1.9; POR for migraine 1.6, 95% CI 1.4 - 1.7). Differential prevalence of an unmeasured confounder, or imperfect sensitivity or specificity of outcome detection would have impacted the observed results. CONCLUSION: People in the IBS cohort had a 40% to 80% higher prevalence odds of migraine, fibromyalgia, and depression.
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Article Is milnacipran effective in treating pain in patients with fibromyalgia? 2006
Simon LS. · Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA 02215, USA. · Nat Clin Pract Rheumatol. · Pubmed #16932669 No free full text.
This publication has no abstract.
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Article A retrospective claims database analysis to assess patterns of interstitial cystitis diagnosis. 2006
Wu EQ, Birnbaum H, Kang YJ, Parece A, Mallett D, Taitel H, Evans RJ. · Analysis Group, Inc., Boston, MA 02199, USA. · Curr Med Res Opin. · Pubmed #16574033 No free full text.
Abstract: OBJECTIVE: Interstitial cystitis (IC) is often misdiagnosed as one of several other conditions manifesting similar symptoms. This analysis assesses the potential extent of IC misdiagnosis while considering concomitant conditions in a managed care population and identifies predictors of IC diagnosis. RESEARCH DESIGN AND METHODS: Administrative insurance claims data covering 1.7 million lives (1999-2003) were analyzed. Insurance enrollees with >or= 1 IC diagnosis (ICD-9-CM of 595.1x) were identified as IC patients. A random sample of non-IC controls was selected using a 10:1 matching ratio. Six-month incidence rates of 'commonly misdiagnosed conditions', (overactive bladder, urinary tract infection, chronic pelvic pain, endometriosis, prostatitis) were compared before and after patients' initial IC diagnosis and the reduction in incidence rate of commonly misdiagnosed conditions was used as a suggestive measure of the extent of IC misdiagnosis. The Kaplan-Meier method was used to assess the extent that commonly misdiagnosed conditions were predictors of subsequent IC. A Cox Proportional Hazards regression model (that adjusts for patient demographics, concomitant and misdiagnosed conditions) was used to estimate the hazard ratio (HR) of these conditions. Similar analyses were performed for the 'commonly concomitant conditions' (fibromyalgia, irritable bowel syndrome, vulvodynia). RESULTS: There were 992 IC patients and 9920 controls identified. The reduced incidence of commonly misdiagnosed conditions after initial IC diagnosis suggests that the misdiagnosis rate could be as high as 38% within the 6-month period before initial IC diagnosis. CONCLUSIONS: Diagnoses of commonly misdiagnosed conditions are significant predictors of future IC diagnosis. When overlooked, potential misdiagnosis of IC can lead to underestimation of the true prevalence of IC. Similarly, diagnoses of commonly concomitant conditions are significant predictors of future IC diagnosis. These initial findings based on claims data suggest hypotheses for further investigation with clinical data. These results suggest more consideration of IC as a diagnosis is warranted, especially when certain diagnoses are repeatedly made and the resulting treatments do not alleviate the patient's symptoms.
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Article The association between borderline personality disorder and chronic medical illnesses, poor health-related lifestyle choices, and costly forms of health care utilization. 2004
Frankenburg FR, Zanarini MC. · Laboratory for the Study of Adult Development, McLean Hospital, Belmont, and the Department of Psychiatry, Harvard Medical School, Boston, MA 02478, USA. · J Clin Psychiatry. · Pubmed #15641871 No free full text.
Abstract: OBJECTIVE: The physical health of patients with borderline personality disorder has not been well studied. The purpose of this study was to compare the physical health, lifestyle choices affecting physical health, and health care utilization of patients with remitted and nonremitted borderline personality disorder. METHOD: 200 patients who no longer met the Revised Diagnostic Interview for Borderlines (DIB-R) and DSM-III-R criteria for borderline personality disorder and 64 patients who still met study criteria for borderline personality disorder were interviewed from June 1992 through December 2001 concerning their physical health, lifestyle choices, and use of medical care 6 years after their initial participation in a larger study of the longitudinal course of borderline personality disorder. RESULTS: Remitted borderline patients were found to be significantly less likely than non-remitted borderline patients to have a history of a "syndrome-like" condition (i.e., chronic fatigue, fibromyalgia, or temporomandibular joint syndrome) (p = .049) or to have a history of obesity (p = .026), osteoarthritis (p = .025), diabetes (p = .001), hypertension (p = .028), back pain (p < .001), or urinary incontinence (p < .001). They were also found to be significantly less likely to report pack per day smoking (p = .002), daily consumption of alcohol (p = .003), lack of regular exercise (p = .006), daily use of sleep medications (p < .001), and sustained use of pain medications (p = .026). In addition, remitted borderline patients were significantly less likely than nonremitted borderline patients to have had at least 1 medically related emergency room visit (p < .001), 1 medical hospitalization (p = .003), or 1 of each (p< .001). CONCLUSIONS: The failure to remit from borderline personality disorder seems to be associated with a heightened risk of suffering from chronic physical conditions, making poor health-related lifestyle choices, and using costly forms of medical services.
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Article Family study of fibromyalgia and affective spectrum disorder. 2004
Hudson JI, Arnold LM, Keck PE, Auchenbach MB, Pope HG. · Biological Psychiatry Laboratory, McLean Hospital Department of Psychiatry, Harvard Medical School, Belmont, MA 02478, USA. · Biol Psychiatry. · Pubmed #15576066 No free full text.
Abstract: BACKGROUND: Fibromyalgia is one member of a proposed group of psychiatric and medical disorders, collectively termed affective spectrum disorder (ASD), hypothesized to share possibly heritable pathophysiologic features. Two predictions of the ASD hypothesis were tested: ASD, taken as a single entity, aggregates in families; and fibromyalgia coaggregates with other forms of ASD in families. METHODS: Probands with and without fibromyalgia, together with their first-degree relatives, were administered structured diagnostic interviews. Noninterviewed relatives were diagnosed according to information provided by interviewed relatives. Aggregation and coaggregation of disorders were analyzed with proband predictive logistic and linear regression models. RESULTS: In 533 relatives of 78 probands with fibromyalgia and 272 relatives of 40 probands without fibromyalgia, the estimated odds ratio (OR) (95% confidence interval) for the familial aggregation of ASD was 1.8 (.97, 3.2), p = .065, and the increase in number of forms of ASD in a relative for each additional form of ASD in a proband was .076 (.027, .1240), p = .002. The OR for the coaggregation of fibromyalgia with other forms of ASD was 2.0 (1.2, 3.2), p = .004; this remained significant even after excluding all mood-disorder diagnoses: 1.8 (1.1, 3.0), p = .012. CONCLUSIONS: These findings support familial aggregation of ASD collectively and familial coaggregation of fibromyalgia with other forms of ASD.
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Article Clinical characteristics and economic costs of patients with painful neuropathic disorders. 2004
Berger A, Dukes EM, Oster G. · Policy Analysis Inc., Brookline, Massachusetts 02445, USA. · J Pain. · Pubmed #15106126 No free full text.
Abstract: Using a large US health insurance claims database, we identified all persons aged 18 years or older with 2 or more medical encounters in calendar year 2000 for painful neuropathic disorders (PNDs). We also identified an age- and gender-matched group of patients without PNDs (matched control subjects). We then compared the clinical characteristics and economic costs of PND patients with those of matched control subjects. There were a total of 55,686 patients with PNDs in the study database. The most frequently noted PNDs were back and neck pain with neuropathic involvement (62.3% of PND patients), causalgia (12.1%), and diabetic neuropathy (10.8%). In comparison with matched control subjects, PND patients were more likely to have other pain-related conditions, including fibromyalgia (6.0% vs 0.6% for control subjects), osteoarthritis (13.6% vs 3.6%), and other chronic comorbidities, such as coronary heart disease (13.6% vs 6.5%) and depression (6.4% vs 2.3%). Total calendar year 2000 health care charges were 3-fold higher for PND patients than matched control subjects ($17,355 vs $5,715, respectively). Our results suggest that patients with PNDs are generally in poorer health and have higher health care costs than their peers without these conditions. PERSPECTIVE: Use of nonsteroidal anti-inflammatory agents and opioids was widespread in patients with PNDs, while relatively few received antiepileptic drugs and tricyclic antidepressants, both of which are often more effective against neuropathic pain. Our study raises questions about the optimality of PND treatment in clinical practice.
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Article Growth hormone and insulin-like growth factor-1 concentrations in women with fibromyalgia. 2003
McCall-Hosenfeld JS, Goldenberg DL, Hurwitz S, Adler GK. · Endocrine-Hypertension Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115, USA. · J Rheumatol. · Pubmed #12672204 No free full text.
Abstract: OBJECTIVE: To determine activity of the growth hormone-insulin-like growth factor-1 (GH-IGF-1) axis in women with fibromyalgia (FM). METHODS: Premenopausal women with FM (n = 24) and premenopausal healthy women (n = 27) were studied. IGF-1 was measured in 23 patients with FM and 25 controls. GH was measured during a stepped hypoglycemic hyperinsulinemic clamp procedure (blood glucose decreased from 90 to 40 mg/dl every 30 min in 10 mg/dl decrements) in 12 FM and 13 control subjects. RESULTS: IGF-1 concentrations were similar in the FM (200 +/- 71 ng/ml, mean +/- SD) and control (184 +/- 70 ng/ml) groups. By multiple variable analysis, IGF-1 was negatively associated with age (p = 0.0006), body mass index (BMI) (p = 0.006), and 24 h urinary free cortisol (p = 0.007) in healthy controls. Even after accounting for these factors, there was no association between FM and IGF-1. The average peak GH achieved during hypoglycemia was lower in patients with FM (range 5 to 58 ng/ml, median 13 ng/ml) versus controls (6 to 68 ng/ml, median 21 ng/ml) (p = 0.04). However, BMI was a significant predictor of average peak GH in FM (r = -0.62, p < 0.01) and control subjects (r = -0.40, p = 0.06). After considering BMI, there was no significant association between FM subjects and the average peak GH (p = 0.20). CONCLUSION: In this sample of premenopausal women with FM, the activity of the GH-IGF-1 axis was similar to that of healthy controls. Increases in age and obesity were both strongly associated with lower activity of this axis, suggesting that these factors must be considered when studying activity of the GH-IGF-1 axis in FM.
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Article Family study of affective spectrum disorder. free! 2003
Hudson JI, Mangweth B, Pope HG, De Col C, Hausmann A, Gutweniger S, Laird NM, Biebl W, Tsuang MT. · Department of Psychiatry, Harvard Medical School, Boston, Mass, USA. · Arch Gen Psychiatry. · Pubmed #12578434 links to free full text
Abstract: BACKGROUND: Affective spectrum disorder (ASD) represents a group of psychiatric and medical conditions, each known to respond to several chemical families of antidepressant medications and hence possibly linked by common heritable abnormalities. Forms of ASD include major depressive disorder (MDD), attention-deficit/hyperactivity disorder, bulimia nervosa, cataplexy, dysthymic disorder, fibromyalgia, generalized anxiety disorder, irritable bowel syndrome, migraine, obsessive-compulsive disorder, panic disorder, posttraumatic stress disorder, premenstrual dysphoric disorder, and social phobia. Two predictions of the ASD hypothesis were tested: that ASD, taken as a single entity, would aggregate in families and that MDD would coaggregate with other forms of ASD in families. METHODS: Probands with and without MDD, together with their first-degree relatives, were interviewed using the Structured Clinical Interview for DSM-IV and a supplemental interview for other forms of ASD. The familial aggregation and coaggregation of disorders were analyzed using proband predictive logistic regression models, including a novel bivariate model for the presence or absence of each of 2 disorders in a relative as predicted by the presence or absence of each of 2 disorders in the associated proband. RESULTS: In the 178 interviewed relatives of 64 probands with MDD and 152 relatives of 58 probands without MDD, the estimated odds ratio (95% confidence interval) for the familial aggregation of ASD as a whole was 2.5 (1.4-4.3; P =.001) and for the familial coaggregation of MDD with at least one other form of ASD was 1.9 (1.1-3.2; P =.02). CONCLUSIONS: Affective spectrum disorder aggregates strongly in families, and MDD displays a significant familial coaggregation with other forms of ASD, taken collectively. These results suggest that forms of ASD may share heritable pathophysiologic features.
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Article Pushing through solid rock: words of wisdom for clinicians from four patients with life-threatening conditions. 2002
Zucker R. · Private Practice, Northampton, Massachusetts 01061, USA. · J Clin Psychol. · Pubmed #12412151 No free full text.
Abstract: Four subjects living with profoundly debilitating and life-threatening illnesses reflect on how psychotherapy has contributed to their ability to cope and survive. With frankness and eloquence they address issues related to cancer, heart disease, fibromyalgia, and AIDS.
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