Chronic fatigue syndrome and the somatic expression of emotional distress: Applying the concept of illusory mental health to address the controversy.

OBJECTIVE: The process of somatization in chronic fatigue syndrome (CFS) was investigated using the concept of illusory mental health (IMH). IMH involves self-reporting low emotional distress alongside performance-based assessment of distress. METHOD: We studied IHM and physical symptoms in 175 women across four groups: (a) CFS plus depression; (b) CFS with no depression (CFS-ND); (c) depressive disorder without CFS; and (d) healthy controls (HC). IMH was assessed using a self-report measure plus the performance-based Early Memory Index (EMI). RESULTS: CFS-NDs were no more likely to have IMH compared with HCs. Among the CFS-NDs, IMH was associated with more physical symptoms. For CFS-NDs, EMI added meaningfully beyond self-reported mental health in predicting physical symptoms. CONCLUSION: Findings refute reducing CFS to somatization, but there is a subgroup of CFS whose lacking access to emotional distress is associated with heightened physical symptomatology.

A randomised trial of lung sealant versus medical therapy for advanced emphysema.

Uncontrolled pilot studies demonstrated promising results of endoscopic lung volume reduction using emphysematous lung sealant (ELS) in patients with advanced, upper lobe predominant emphysema. We aimed to evaluate the safety and efficacy of ELS in a randomised controlled setting.Patients were randomised to ELS plus medical treatment or medical treatment alone. Despite early termination for business reasons and inability to assess the primary 12-month end-point, 95 out of 300 patients were successfully randomised, providing sufficient data for 3- and 6-month analysis.57 patients (34 treatment and 23 control) had efficacy results at 3 months; 34 (21 treatment and 13 control) at 6 months. In the treatment group, 3-month lung function, dyspnoea, and quality of life improved significantly from baseline when compared to control. Improvements persisted at 6 months with >50% of treated patients experiencing clinically important improvements, including some whose lung function improved by >100%. 44% of treated patients experienced adverse events requiring hospitalisation (2.5-fold more than control, p=0.01), with two deaths in the treated cohort. Treatment responders tended to be those experiencing respiratory adverse events.Despite early termination, results show that minimally invasive ELS may be efficacious, yet significant risks (probably inflammatory) limit its current utility.

Bronchial thermoplasty: Long-term safety and effectiveness in patients with severe persistent asthma.

BACKGROUND: Bronchial thermoplasty (BT) has previously been shown to improve asthma control out to 2 years in patients with severe persistent asthma. OBJECTIVE: We sought to assess the effectiveness and safety of BT in asthmatic patients 5 years after therapy. METHODS: BT-treated subjects from the Asthma Intervention Research 2 trial (ClinicalTrials.govNCT01350414) were evaluated annually for 5 years to assess the long-term safety of BT and the durability of its treatment effect. Outcomes assessed after BT included severe exacerbations, adverse events, health care use, spirometric data, and high-resolution computed tomographic scans. RESULTS: One hundred sixty-two (85.3%) of 190 BT-treated subjects from the Asthma Intervention Research 2 trial completed 5 years of follow-up. The proportion of subjects experiencing severe exacerbations and emergency department (ED) visits and the rates of events in each of years 1 to 5 remained low and were less than those observed in the 12 months before BT treatment (average 5-year reduction in proportions: 44% for exacerbations and 78% for ED visits). Respiratory adverse events and respiratory-related hospitalizations remained unchanged in years 2 through 5 compared with the first year after BT. Prebronchodilator FEV1 values remained stable between years 1 and 5 after BT, despite a 18% reduction in average daily inhaled corticosteroid dose. High-resolution computed tomographic scans from baseline to 5 years after BT showed no structural abnormalities that could be attributed to BT. CONCLUSIONS: These data demonstrate the 5-year durability of the benefits of BT with regard to both asthma control (based on maintained reduction in severe exacerbations and ED visits for respiratory symptoms) and safety. BT has become an important addition to our treatment armamentarium and should be considered for patients with severe persistent asthma who remain symptomatic despite taking inhaled corticosteroids and long-acting ß2-agonists.

Biologic lung volume reduction in advanced upper lobe emphysema: phase 2 results.

RATIONALE: Biologic lung volume reduction (BioLVR) is a new endobronchial treatment for advanced emphysema that reduces lung volume through tissue remodeling. OBJECTIVES: Assess the safety and therapeutic dose of BioLVR hydrogel in upper lobe predominant emphysema. METHODS: Open-labeled, multicenter phase 2 dose-ranging studies were performed with BioLVR hydrogel administered to eight subsegmental sites (four in each upper lobe) involving: (1) low-dose treatment (n = 28) with 10 ml per site (LD); and (2) high-dose treatment (n = 22) with 20 ml per site (HD). Safety was assessed by the incidence of serious medical complications. Efficacy was assessed by change from baseline in pulmonary function tests, dyspnea score, 6-minute walk distance, and health-related quality of life. MEASUREMENTS AND MAIN RESULTS: After treatment there were no deaths and four serious treatment-related complications. A reduction in residual volume to TLC ratio at 12 weeks (primary efficacy outcome) was achieved with both LD (-6.4 +/- 9.3%; P = 0.002) and HD (-5.5 +/- 9.4%; P = 0.028) treatments. Improvements in pulmonary function in HD (6 mo: DeltaFEV(1) = +15.6%; P = 0.002; DeltaFVC = +9.1%; P = 0.034) were greater than in LD patients (6 mo: DeltaFEV(1) = +6.7%; P = 0.021; DeltaFVC = +5.1%; P = 0.139). LD- and HD-treated groups both demonstrated improved symptom scores and health-related quality of life. CONCLUSIONS: BioLVR improves physiology and functional outcomes up to 6 months with an acceptable safety profile in upper lobe predominant emphysema. Overall improvement was greater and responses more durable with 20 ml per site than 10 ml per site dosing. Clinical trial registered with www.clinicaltrials.gov (NCT 00435253 and NCT 00515164).

Emotional Regulation in Women with Chronic Fatigue Syndrome and Depression: Internal Representations and Adaptive Defenses.

Chronic fatigue syndrome (CFS) presents challenges in differential diagnosis and treatment. Complicating diagnosis is that its symptoms overlap with those of depression. This study applies psychoanalytic concepts to understand emotional regulation (ER) in women with CFS and/or depression. One hundred eighty-six women were assigned to four groups and compared: (a) CFS plus high er depression (CFS-HD); (b) CFS plus lower depression (CFS-LD); (c) depressive disorder (DD); and (d) healthy controls (HC). ER was operationalized by measures of capacity to form internal representations and adaptive defenses. The study's premise was that difficulties metabolizing emotions psychologically would be associated with their greater somatic expression. Some support was found for the hypothesis that CFS participants would exhibit more impairment in representing emotions and in adaptive defenses compared to the DD and HC groups, but this held only for the CFS-HD group. Although CFS-LD participants were expected to be more purely somatizing than the CFS-HD group, they instead showed more sophisticated capacities for ER than that group and recalled less distressing early relationships, revealing more resilience. Still, however, we found support for somatization in some CFS sufferers: Within both the CFS-HD and the CFS-LD groups, weaknesses in representing emotions and in defensive functioning were associated with more severe physical symptoms. Clinically, the heterogeneity of CFS and those who suffer from it indicates the need for individual assessment and depression treatment.

Telehealth services to improve nonadherence: A placebo-controlled study.

The objective of this study was to test whether a telehealth intervention could improve the compliance with continuous positive airway pressure (CPAP) by patients with sleep apnea. These patients had been nonadherent for the initial 3 months of therapy even after receiving the initial standard and then supplemental audiotaped/videotaped patient education for adhering to CPAP nightly. The materials and methods included a randomized testing of experimental and placebo interventions. Interventions were delivered by nurses to two groups in their homes by telehealth over a 12-week period. The placebo intervention was used to control for Hawthorne effect, time and attention influences and the novelty of having telehealth in the home. Results following the telehealth interventions were that significantly more patients in the experimental group 1 (n = 10) than the placebo group 2 (n = 9) were adhering nightly to CPAP (chi 2 = 4.55, p = 0.033). Group 1 patients reported greater satisfaction with their intervention. However, both groups rated telehealth delivery positively. The mean cost of each 20-minute telehealth visit was 30 dollars while the total cost of the telehealth intervention for each patient was 420 dollars. These costs included telehealth equipment, initial installation, longdistance telephone charges, nurse salary, and intervention materials. Conclusions are that telehealth interventions are a potentially cost-effective service for increasing adherence to prescribed medical treatments. Replication studies with large samples and in other clinical groups are recommended.