Jeffrey A. Welge

A randomized, placebo-controlled, double-blind, flexible-dose study of fluoxetine in the treatment of women with fibromyalgia

PURPOSE To assess the efficacy of fluoxetine in the treatment of patients with fibromyalgia. SUBJECTS AND METHODS Sixty outpatients (all women, aged 21-71 years) with fibromyalgia were randomly assigned to receive fluoxetine (10-80 mg/d) or placebo for 12 weeks in a double-blind, parallel-group, flexible-dose study. The primary outcome measures were the Fibromyalgia Impact Questionnaire total score (score range, 0 [no impact] to 80) and pain score (score range, 0-10). Secondary measures included the McGill Pain Questionnaire, change in the number of tender points, and total myalgic score. RESULTS In the intent-to-treat analysis, women who received fluoxetine (mean [+/- SD] dose, 45 +/- 25 mg/d) had significant (P = 0.005) improvement in the Fibromyalgia Impact Questionnaire total score compared with those who received placebo, with a difference of -12 (95% confidence interval [CI]: -19 to -4). They also had significant (P = 0.002) improvement in the Fibromyalgia Impact Questionnaire pain score (difference, -2.2 [95% CI: -3.6 to -0.9]), as well as in the Fibromyalgia Impact Questionnaire fatigue (P = 0.05) and depression (P = 0.01) scores and the McGill Pain Questionnaire (P = 0.01), when compared with subjects who received placebo. Although counts for the number of tender points and total myalgic scores improved more in the fluoxetine group than in the placebo group, these differences were not statistically significant. CONCLUSIONS In a 12-week, flexible-dose, placebo-controlled trial, fluoxetine was found to be effective on most outcome measures and generally well tolerated in women with fibromyalgia.

Patient Preference for Psychological vs Pharmacologic Treatment of Psychiatric Disorders: A Meta-Analytic Review

OBJECTIVE Evidence-based practice involves the consideration of efficacy and effectiveness, clinical expertise, and patient preference in treatment selection. However, patient preference for psychiatric treatment has been understudied. The aim of this meta-analytic review was to provide an estimate of the proportion of patients preferring psychological treatment relative to medication for psychiatric disorders. DATA SOURCES A literature search was conducted using PubMed, PsycINFO, and the Cochrane Collaboration library through August 2011 for studies written in English that assessed adult patient preferences for the treatment of psychiatric disorders. The following search terms and subject headings were used in combination: patient preference, consumer preference, therapeutics, psychotherapy, drug therapy, mental disorders, depression, anxiety, insomnia, bipolar disorder, schizophrenia, substance-related disorder, eating disorder, and personality disorder. In addition, the reference sections of identified articles were examined to locate any additional articles not captured by this search. STUDY SELECTION Studies that assessed preferred type of treatment and included at least 1 psychological treatment and 1 pharmacologic treatment were included. Of the 644 articles identified, 34 met criteria for inclusion. DATA EXTRACTION Authors extracted relevant data including the proportion of participants reporting preference for psychological or pharmacologic treatment. RESULTS The proportion of adult patients preferring psychological treatment was 0.75 (95% CI, 0.69-0.80), which was significantly higher than equivalent preference (ie, higher than 0.50; P < .001). Sensitivity analyses suggested that younger patients (P = .05) and women (P < .01) were significantly more likely to choose psychological treatment. A preference for psychological treatment was consistently evident in both treatment-seeking and unselected (ie, non-treatment-seeking) samples (P < .001 for both) but was somewhat stronger for unselected samples. CONCLUSIONS Aggregation of patient preferences across diverse settings yielded a significant 3-fold preference for psychological treatment. Given evidence for enhanced outcomes among those receiving their preferred psychiatric treatment and the trends for decreasing utilization of psychotherapy, strategies to maximize the linkage of patients to preferred care are needed.

Proton Pump Inhibitor Therapy for Chronic Laryngo-Pharyngitis: A Randomized Placebo-Control Trial

OBJECTIVE: To determine the efficacy of proton-pump inhibitor (PPI) therapy for chronic laryngo-pharyngitis treated with lifestyle modification. STUDY DESIGN AND METHODS: Double-blind, randomized trial comparing two-month Rabeprazole (20 mg b.i.d.) to placebo control. RESULTS: Compared to baseline, both PPI and control patients had significant improvement in total reflux symptoms (P = 0.002 and P = 0.03 respectively), with significant improvement in “laryngo-pharyngeal” but not “typical” reflux symptoms. No significant difference was noted for change in reflux symptoms between PPI-treated and control patients (P = 0.44). Significant global improvement was noted by 50% of control and 53% of PPI-treated patients (P = 1.0). No significant differences were noted within or between treatment groups for change in health status or videostrobolaryngoscopy grade. Lifestyle modification compliance correlated significantly with global improvement. CONCLUSION: Compared to baseline, lifestyle modification for 2 months significantly improved chronic laryngo-pharyngitis symptoms. When compared to control, treatment with a PPI failed to demonstrate significantly greater improvement in reflux symptoms, health status, or laryngeal appearance.

Total pancreatectomy and autologous Islet cell transplantation as a means to treat severe chronic pancreatitis

Autologous islet cell transplantation after near-total or total pancreatic resection can alleviate pain in patients with severe chronic pancreatitis and preserve endocrine function. From February 2000 to February 2003, a total of 22 patients, whose median age was 38 years, underwent pancreatectomy and autologous islet cell transplantation. Postoperative complications, metabolic studies, insulin usage, pain scores, and quality of life were recorded for all of these patients. The average number of islet cells harvested was 245,457 (range 20,850 to 607,466). Operative data revealed a mean estimated blood loss of 635 ml, an average operative time of 9 hours, and a mean length of hospital stay of 15 days. Sixty-eight percent of the patients had either a minor or major complication. Major complications included acute respiratory distress syndrome (n = 2), intra-abdominal abscess (n = 1), and pulmonary embolism (n = 1). There were no deaths in our series. All patients demonstrated C-peptide and insulin production indicating graft function. Forty-one percent are insulin independent, and 27% required minimal amount of insulin or a sliding scale. All patients had preoperative pain and had been taking opioid analgesics; 82% no longer required analgesics postoperatively. Pancreatectomy with autologous islet cell transplantation can alleviate pain for patients with chronic pancreatitis and preserve endocrine function.

Do Steroids Reduce Morbidity of Tonsillectomy? Meta-Analysis of Randomized Trials†

Objectives/Hypothesis The study aims to reconcile conflicting published reports regarding the clinical efficacy of a single intraoperative dose of dexamethasone in reducing post‐tonsillectomy morbidity.

Steroids for Post-Tonsillectomy Pain Reduction: Meta-Analysis of Randomized Controlled Trials

OBJECTIVES: To determine whether meta-analysis supports the use of corticosteroids to reduce post-tonsillectomy pain for pediatric patients. METHODS: A systematic review of currently available randomized controlled trials using a single-dose, intravenous corticosteroid during pediatric tonsillectomy was performed. Visual analog pain scale (VAS) data was extracted with reviewers blinded to results. Meta-analysis was performed with weighted mean difference and random-effects model using Revman 4.2 software. RESULTS: Eight randomized trials were included in analysis of post-tonsillectomy pain. A statistically significant reduction in pain as measured by VAS on postoperative day 1 was noted (mean VAS difference = −0.97; CI 95 % = −1.74,−0.19; P = 0.01). CONCLUSIONS: A single, intraoperative dose of dexamethasone may reduce post-tonsillectomy pain on postoperative day 1, by a factor of 1 on a 10-point pain scale. As the side effects and cost of dexamethasone dose appear negligible, consideration of routine use seems reasonable.

Continuous Laryngeal Nerve Integrity Monitoring During Thyroidectomy: Does it Reduce Risk of Injury?

OBJECTIVE: To determine if continuous laryngeal nerve integrity monitoring (NIM) during thyroidectomy is associated with a decreased risk of postoperative recurrent laryngeal nerve (RLN) injury. STUDY DESIGN AND SETTING: Retrospective cohort study of 165 patients who underwent thyroidectomy at a resident teaching institution between 1999 and 2002. The control group had 120 nerves at risk (NAR) whereas the NIM group consisted of 116 NAR. Primary outcome measures included postoperative RLN paralysis, paresis, and total injury rates. RESULTS: RLN paralysis occurred in 2.54% NAR in the control group and 0.86% in the NIM group (relative risk (RR) = 0.34, 95% confidence interval (CI95) = 0.04-3.27, P = 0.62). Temporary RLN paresis occurred in 4.24% NAR in the control group and 3.45% in the NIM group (RR = 0.9, CI95 = 0.23-3.55, P = 0.89). Total RLN injury occurred in 6.78% NAR in the control group and 4.31% in the NIM group (RR = 0.66, CI95 = 0.21-2.09, P = 0.48). When compared to all other NAR, advanced T-stage malignancy was associated with a significantly increased risk of RLN paresis (T4 RR = 9.0, CI95 = 2.56-31.67, P = 0.0006; T3+T4 RR = 7.5, CI95 = 2.17-25.86, P = 0.0001) but not paralysis. NIM did not significantly reduce the risk of RLN paresis in the advanced T-stage subset (T3+T4 RR = 0.36, CI95 = 0.04-3.0, P = 0.59). CONCLUSION: There were no statistically significant differences in RLN paralysis, paresis, or total injury rates between control and NIM groups, even in subsets with advanced T-stage and increased baseline risk. Advanced T-stage is a significant predictor of RLN paresis in this cohort.

Functional magnetic resonance imaging brain activation in bipolar mania: evidence for disruption of the ventrolateral prefrontal-amygdala emotional pathway.

BACKGROUND Bipolar I disorder is defined by the occurrence of mania. The presence of mania, coupled with a course of illness characterized by waxing and waning of affective symptoms, suggests that bipolar disorder arises from dysfunction of neural systems that maintain emotional arousal and homeostasis. We used functional magnetic resonance imaging (fMRI) to study manic bipolar subjects as they performed a cognitive task designed to examine the ventrolateral prefrontal emotional arousal network. METHODS We used fMRI to study regional brain activation in 40 DSM-IV manic bipolar I patients and 36 healthy subjects while they performed a continuous performance task with emotional and neutral distracters. Event-related region-of-interest analyses were performed to test the primary hypothesis. Voxelwise analyses were also completed. RESULTS Compared with healthy subjects, the manic subjects exhibited blunted activation to emotional and neutral images, but not targets, across most of the predefined regions of interest. Several additional brain regions identified in the voxelwise analysis also exhibited similar differences between groups, including right parahippocampus, right lingual gyrus, and medial thalamus. In addition to these primary findings, the manic subjects also exhibited increased activation in response to targets in a number of brain regions that were primarily associated with managing affective stimuli. Group differences did not appear to be secondary to medication exposure or other confounds. CONCLUSIONS Bipolar manic subjects exhibit blunted brain fMRI response to emotional cues throughout the ventrolateral prefrontal emotional arousal network. Disruption of this emotional network may contribute to the mood dysregulation of bipolar disorder.

The clinical effects of hyaluronic acid ester nasal dressing (Merogel) on intranasal wound healing after functional endoscopic sinus surgery.

OBJECTIVES We sought to determine the efficacy of MeroGel, an absorbable hyaluronic acid nasal dressing (HA) in reducing synechia after functional endoscopic sinus surgery (FESS) compared with Merocel, a nonabsorbable packing (NAP) requiring removal. METHODS We conducted a blinded, randomized, controlled trial of 37 patients requiring bilateral FESS for chronic sinusitis. Patients were randomized to placement of HA within the right or left middle meatus and NAP on the other side. Patients were evaluated at 2, 4, 6, and 8 weeks postoperatively. RESULTS Blinded evaluation revealed 5 patients (14%) with synechia at last follow-up: 3 sides (8%) with HA and 3 (8%) with NAP. Thirteen patients (35%) had synechia at any visit, 10 sides (27%) with HA and 9 (24%) with NAP. Seven patients (19%) required lysis of synechia, 5 sides (14%) with HA and 3 (8%) with NAP. CONCLUSION We found no statistically significant difference between HA and NAP dressings.

Meta-analysis of amygdala volumes in children and adolescents with bipolar disorder

OBJECTIVE The neurophysiological basis of bipolar disorder in youths remains poorly understood. Neurofunctional and neuropathologic studies have implicated the amygdala as a primary brain structure involved in the regulation of emotion. Because one of the cardinal features of bipolar disorder is mood dysregulation, structural and functional amygdala abnormalities identified with neuroimaging may serve as useful disease and treatment response biomarker. Therefore, we conducted a meta-analysis summarizing the literature examining amygdala size obtained from magnetic resonance imaging in bipolar youths and adults. METHOD A literature search using the National Institutes of Healths PubMed was conducted to identify published peer-reviewed neuroimaging studies of amygdala size in children, adolescents, and adults with bipolar disorder. Eleven studies that met inclusion and exclusion criteria were identified. RESULTS Smaller amygdala volumes were found in children and adolescents with bipolar disorder compared with the control children and adolescents (standardized mean difference -0.74; 95% confidence interval -1.36 to -0.15). Amygdala volumes in bipolar adults were not significantly different from the control adults (standardized mean difference 0.20; 95% confidence interval -0.31 to 0.73). CONCLUSIONS The results of this meta-analysis suggest that structural amygdala abnormalities are present in bipolar youths but that these structural differences do not seem to be present in bipolar adults. Future studies examining whether structural, functional, and neurochemical amygdala differences between bipolar and control youths may be useful as age-specific biomarkers of illness and treatment response are needed.