Background Duloxetine and pregabalin are among the most widely used medications in the treatment of patients with fibromyalgia syndrome (FM). Objectives To add to the very few lines of evidence that exist on the comparative safety and efficacy of these two medications. Methods In this open-label randomized clinical trial, outpatient women, who were diagnosed with FM based on American College of Rheumatology 2010 criteria, and had an age range of 18-65 years old were assigned to either duloxetine 30-60 mg or pregabalin 75-150 mg per day for 4 weeks. Patients were excluded in cases of having used duloxetine, pregabalin, gabapentin, or antidepressants within 12 weeks prior to the study, having had a history of comorbid medical conditions that could provoke chronic pain, or having had comorbid neuropsychiatric disorders, except for major depressive/anxiety disorders. Primary outcomes were between-group differences in mean score changes from baseline to end point for Widespread Pain Index (WPI) and Beck Depression Inventory-II. Secondary outcomes were the same statistical estimates, but for Fibromyalgia Impact Questionnaire-Revised and 12-Item Short Form Survey. Descriptive statistics and independent samples t-test were the main methods of analysis. (www.irct.ir; IRCT2016030626935N1). Results Among all the scales, only WPI scores improved with a statistically significant difference between the two treatment arms, favoring duloxetine (Mean difference in score change − 2.32, 95% CI, −4.46 to − 0.18; p = 0.034; Cohen's d 0.53 95% CI, 0.04 to 1.02). Drop out rate and cumulative incidence of nausea was significantly higher in the duloxetine arm compared to the pregabalin arm. Conclusion This study provides further evidence on higher efficacy of duloxetine compared to pregabalin for the treatment of pain in patients with fibromyalgia. Future comprehensive pragmatic clinical trials are warranted.
BackgroundThis study was designed to assess serum vitamin D status (25-OHD) in the fibromyalgia (FM) patients and to compare it with a healthy control group. It also aimed to investigate the correlation of serum vitamin D level with FM symptom severity and invalidation experiences.MethodsA total of 74 consecutive patients with FM and 68 healthy control participants were enrolled. The eligible FM patients completed the Illness Invalidation Inventory (3*I), the Revised Fibromyalgia Impact Questionnaire (FIQR) and a short-form health survey (SF-12). Venous blood samples were drawn from all participants to evaluate serum 25-OHD levels. Mann-Whitney tests and multiple logistic regression analyses were performed and Spearman's correlations were calculated.Results88.4% of FM patients had low levels of serum 25-OHD. FM patients had significantly higher level of serum 25-OHD than the control group (17.24 ± 13.50 and 9.91 ± 6.47 respectively, P = 0.0001). There were no significant correlations between serum 25-OHD levels and the clinical measures of disease impact, invalidation dimensions, and health status. Multiple logistic regression analyses revealed that an increased discounting of the disease by the patient's spouse was associated with a 4-fold increased risk for vitamin D deficiency (OR = 4.36; 95% CI, 0.95–19.87, P = 0.05).ConclusionsThis study showed that although high rates of vitamin D insufficiency or deficiency were seen among FM patients and healthy non-FM participants, but it seems there was no intrinsic association between FM and vitamin D deficiency. Addressing of invalidation experience especially by the patient's spouse is important in management of FM.
The aim of this study was to assess validity of the fibromyalgia survey questionnaire (FSQ) and polysymptomatic distress scale (PSD) in an Iranian population. We also sought to classify the severity levels of fibromyalgia (FM) symptoms according to the PSD scale. Participants were divided into FM and non-FM chronic pain disorder groups according to expert physician diagnosis. Patients in both groups answered to Persian-translated version of FSQ, fibromyalgia impact questionnaire (FIQ) and Short-Form-12 (SF-12). Both 1990 ACR criteria and FSDC were assessed in participates of two groups. Internal consistency and construct validity were evaluated. There was good internal consistency measured by Cronbach's alpha (0.814 for FSQ). FSQ and its subscales correlated significantly with FIQ scores and SF-12 subscales, indicating acceptable construct validity. The concordance rates of FSQ with 1990 ACR criteria and expert diagnosis were 61.2 and 75.7, respectively (convergence validity). The mean score of PSD and its components in FM group were significantly more than in control groups (discriminative validity). Using lower PSD score cutoff (≥8.5) for the diagnosis of fibromyalgia appeared to be the most effective approach in our population. ROC analysis of the PSD scores revealed 8.5-11.5, 11.5-15 and more than 15, respectively, as a mild, moderate and severe FM. Persian version of FSQ was a valid instrument for application in survey research among Iranian patients with chronic pain disorders. The current study revealed that PSD could be used as a valid tool for assessment of symptoms intensity regardless of fibromyalgia diagnosis.
This study indicates the high prevalence of cardiac involvement in RA patients.
Background:Interstitial lung disease (ILD) is a type of pulmonary manifestation in patients with rheumatoid arthritis (RA). Mostly RA-ILD has no symptoms and is only diagnosed by clinical examination, pulmonary function test (PFT), and high-resolution computed tomography (HRCT); hence it seems that the diagnosis of pulmonary involvement in early stages of RA is of great importance. Therefore, we decided to answer this question whether the evaluation of RA patients without pulmonary symptoms using methods such as PFT and HRCT are justifiable and reasonable or not.Methods:We conducted a cross-sectional study in a referral rheumatology clinic in Razi hospital of Rasht, Iran. Forty-four consecutive patients, diagnosed with RA, were enrolled. Physical examination of the joints was performed by an rheumatologist. The activity of RA was evaluated in all patients by Disease Activity Score 28. An expert pulmonologist performed the respiratory examination in all participants. Then, all subjects were referred for chest X-ray, PFT, and HRCT of lungs.Results:Patients included in this study, 9 (20.45%) males and 35 (79.55%) females, were 21–73 years old and their mean age was 49 ± 13 years. Significant relation between PFT and respiratory complaints was observed (P = 0.016). PFT had significant relation with respiratory examinations (P = 0.009). Our results indicated a significant relation between disease activity rate and PFT (P = 0.038). While HRCT had any significant relation with above items.Conclusion:We concluded, using PFT in the respiratory assessment of RA patients can be limited to persons with high disease activity, respiratory complaints, and positive findings in the clinical respiratory examination.
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