Changes in fatigue,autonomic functions,and blood biomarkers due to sitting isometric yoga in patients with chronic fatigue syndrome

Background

In a previous randomized controlled trial, we found that sitting isometric yoga improves fatigue in patients with chronic fatigue syndrome (CFS) who are resistant to conventional therapy. The aim of this study was to investigate possible mechanisms behind this finding, focusing on the short-term fatigue-relieving effect, by comparing autonomic nervous function and blood biomarkers before and after a session of isometric yoga.

Methods

Fifteen patients with CFS who remained symptomatic despite at least 6 months of conventional therapy practiced sitting isometric yoga (biweekly 20 min practice with a yoga instructor and daily home practice) for eight weeks. Acute effects of sitting isometric yoga on fatigue, autonomic function, and blood biomarkers were investigated after the final session with an instructor. The effect of a single session of sitting isometric yoga on fatigue was assessed by the Profile of Mood Status (POMS) questionnaire immediately before and after the session. Autonomic nervous function (heart rate (HR) variability) and blood biomarkers (cortisol, DHEA-S, TNF-α, IL-6, IFN-γ, IFN-α, prolactin, carnitine, TGF-β1, BDNF, MHPG, and HVA) were compared before and after the session.

Results

Sitting isometric yoga significantly reduced the POMS fatigue score (p?<?0.01) and increased the vigor score (p?<?0.01). It also reduced HR (p?<?0.05) and increased the high frequency power (p?<?0.05) of HR variability. Sitting isometric yoga increased serum levels of DHEA-S (p?<?0.05), reduced levels of cortisol (p?<?0.05) and TNF-α (p?<?0.05), and had a tendency to reduce serum levels of prolactin (p?<?0.1). Decreases in fatigue scores correlated with changes in plasma levels of TGF-β1 and BDNF. In contrast, increased vigor positively correlated with HVA.

Conclusions

A single session of sitting isometric yoga reduced fatigue and increased vigor in patients with CFS. Yoga also increased vagal nerve function and changed blood biomarkers in a pattern that suggested anti-stress and anti-inflammatory effects. These changes appear to be related to the short-term fatigue-relieving effect of sitting isometric yoga in patients with CFS. Furthermore, dopaminergic nervous system activation might account for sitting isometric yoga-induced increases in energy in this patient population.

Trial registration

University Hospital Medical Information Network (UMIN CTR) UMIN000009646. Registered Dec 27, 2012.

     

Isometric yoga improves the fatigue and pain of patients with chronic fatigue syndrome who are resistant to conventional therapy: a randomized,controlled trial

Background

Patients with chronic fatigue syndrome (CFS) often complain of persistent fatigue even after conventional therapies such as pharmacotherapy, cognitive behavioral therapy, or graded exercise therapy. The aim of this study was to investigate in a randomized, controlled trial the feasibility and efficacy of isometric yoga in patients with CFS who are resistant to conventional treatments.

Methods

This trial enrolled 30 patients with CFS who did not have satisfactory improvement after receiving conventional therapy for at least six months. They were randomly divided into two groups and were treated with either conventional pharmacotherapy (control group, n?=?15) or conventional therapy together with isometric yoga practice that consisted of biweekly, 20-minute sessions with a yoga instructor and daily in-home sessions (yoga group, n?=?15) for approximately two months. The short-term effect of isometric yoga on fatigue was assessed by administration of the Profile of Mood Status (POMS) questionnaire immediately before and after the final 20-minute session with the instructor. The long-term effect of isometric yoga on fatigue was assessed by administration of the Chalder’s Fatigue Scale (FS) questionnaire to both groups before and after the intervention. Adverse events and changes in subjective symptoms were recorded for subjects in the yoga group.

Results

All subjects completed the intervention. The mean POMS fatigue score decreased significantly (from 21.9?±?7.7 to 13.8?±?6.7, P?<?0.001) after a yoga session. The Chalder’s FS score decreased significantly (from 25.9?±?6.1 to 19.2?±?7.5, P?=?0.002) in the yoga group, but not in the control group. In addition to the improvement of fatigue, two patients with CFS and fibromyalgia syndrome in the yoga group also reported pain relief. Furthermore, many subjects reported that their bodies became warmer and lighter after practicing isometric yoga. Although there were no serious adverse events in the yoga group, two patients complained of tiredness and one of dizziness after the first yoga session with the instructor.

Conclusions

Isometric yoga as an add-on therapy is both feasible and successful at relieving the fatigue and pain of a subset of therapy-resistant patients with CFS.

Trial registration

University Hospital Medical Information Network (UMIN CTR) UMIN 000009646.

     

Design and development of adapters for electromagnetic trackers to perform navigated laparoscopic radiofrequency ablation

Background

Psychological factors play a role in a variety of gastrointestinal illness, including gastroesophageal reflux disease (GERD). Their impact on the surgical outcomes of antireflux surgery is unknown.

Methods

This is a single institution prospective controlled trial, comparing patients undergoing a laparoscopic Nissen fundoplication for GERD (LNF Group, n = 17) to patients undergoing an elective laparoscopic cholecystectomy for biliary colic (Control Group, n = 10). All patients had a psychological assessment before surgery, at 3 months and 6 months after surgery (i.e. Symptom CheckList-90-R somatization subset (SCL-90-R), Depression Anxiety Stress Scales, Anxiety sensitivity index, Illness attitude scale and Beck Depression Inventory II). GERD symptoms were recorded in the LNF Group using a standardized questionnaire (score 0–60). Patients with post-operative GERD symptoms score above 12 at 6 months were evaluated specifically. Statistical analysis was performed using a Student T test, and statistical significance was set at 0.05.

Results

There was no significant difference in preoperative and postoperative psychological assessment between the two groups. In the LNF Group, 7 patients had persisting GERD symptoms at 6 months (GERD score greater than 12). The preoperative SCL-90-R score was also significantly higher in this subgroup, when compared to the rest of the LNF Group (18.2 versus 8.3, p < 0.05) and to the Control Group (18.2 versus 7.9, p < 0.05). There was no significant difference for the other psychological tests.

Conclusion

The SCL-90-R Somatization Subset, reflecting the level of somatization in a patient, may be useful to predict poor outcomes after antireflux surgery. Cognisance of psychological disorders could improve the selection of an optimal treatment for GERD and help reduce the rate of ongoing symptoms after LNF.     

Pre-referral rectal artesunate in severe malaria: flawed trial

Introduction

Irritable bowel syndrome affects as many as 14% of high school-aged students. Symptoms include discomfort in the abdomen, along with diarrhea and/or constipation and other gastroenterological symptoms that can significantly impact quality of life and daily functioning. Emotional stress appears to exacerbate irritable bowel syndrome symptoms suggesting that mind-body interventions reducing arousal may prove beneficial. For many sufferers, symptoms can be traced to childhood and adolescence, making the early manifestation of irritable bowel syndrome important to understand. The current study will focus on young people aged 14-26 years with irritable bowel syndrome. The study will test the potential benefits of Iyengar yoga on clinical symptoms, psychospiritual functioning and visceral sensitivity. Yoga is thought to bring physical, psychological and spiritual benefits to practitioners and has been associated with reduced stress and pain. Through its focus on restoration and use of props, Iyengar yoga is especially designed to decrease arousal and promote psychospiritual resources in physically compromised individuals. An extensive and standardized teacher-training program support Iyengar yoga's reliability and safety. It is hypothesized that yoga will be feasible with less than 20% attrition; and the yoga group will demonstrate significantly improved outcomes compared to controls, with physiological and psychospiritual mechanisms contributing to improvements.

Methods/Design

Sixty irritable bowel syndrome patients aged 14-26 will be randomly assigned to a standardized 6-week twice weekly Iyengar yoga group-based program or a wait-list usual care control group. The groups will be compared on the primary clinical outcomes of irritable bowel syndrome symptoms, quality of life and global improvement at post-treatment and 2-month follow-up. Secondary outcomes will include visceral pain sensitivity assessed with a standardized laboratory task (water load task), functional disability and psychospiritual variables including catastrophizing, self-efficacy, mood, acceptance and mindfulness. Mechanisms of action involved in the proposed beneficial effects of yoga upon clinical outcomes will be explored, and include the mediating effects of visceral sensitivity, increased psychospiritual resources, regulated autonomic nervous system responses and regulated hormonal stress response assessed via salivary cortisol.

Trial registration

ClinicalTrials.gov NCT01107977.     

Sodium pentosan polysulfate resulted in cartilage improvement in knee osteoarthritis - An open clinical trial-

Background

Pentosan polysulfate sodium (pentosan) is a semi-synthetic drug manufactured from beech-wood hemicellulose by sulfate esterification of the xylopyranose hydroxyl groups. From in vitro and animal model studies, pentosan has been proposed as a disease modifying osteoarthritis drug (DMOAD). The objective of this study was to assess the efficacy, safety, and patient satisfaction in patients with mild radiographic knee osteoarthritis (OA) findings and OA-associated symptoms and signs.

Methods

Twenty patients were assessed clinically at Nagasaki University Hospital. The radiographic indications of OA were grade 1 to 3 using the Kellgren-Lawrence Grading System (K/L grade). Pentosan used in this study was manufactured and supplied in sterile injectable vials (100 mg/ml) by bene GmbH, Munich, Germany. The study was a single-center, open-label trial. Treatment consisted of 6 weekly subcutaneous injections (sc) of pentosan (2 mg/kg). Patients were clinically assessed at entry and 1 to 8, 11, 15, 24 & 52 weeks post treatment. The results were analyzed using one way ANOVA and Dunnett's method.

Results

Hydrarthroses were reduced quickly in all cases. The clinical assessments, i.e., knee flexion, pain while walking, pain after climbing up and down stairs, etc, were improved significantly and these clinical improvements continued for almost one year. The dose used in this study affected the blood coagulation test, but was within safe levels. Slightly abnormal findings were noted in serum triglycerides.

Conclusions

Pentosan treatment in twenty patients with mild knee OA seemed to provide improvements in clinical assessments and C2C level of cartilage metabolism.

Trial Registration

UMIN Clinical Trials Registry (UMIN-CTR) UMIN000002790     

Clinical features of outpatients with somatization symptoms treated at a Japanese psychosomatic medicine clinic

Background

Somatization is produced due to the summation of psychological factors, irrespective of the presence or absence of physical factors. A group of diseases with severe pain and other disorders exhibit so-called Medically Unexplained Symptoms (MUS), and the characteristics of patients with MUS are largely unexplained. In this paper, the characteristics of a series of new patients with somatization treated in a Japanese university hospital are discussed.

Method

The subjects were 871 patients who newly visited the Department of Psychosomatic Medicine, Toho University Omori Medical Center between January and December of 2015. Under the assumption that the definition of somatization is same as that of MUS, the correlation between somatization and the age, sex, academic background, chief complaints, reasons for visiting the medical center, diagnosis, symptoms, presence or absence of a referral form, continued treatment after the first visit, and marital status of these patients at the time of their respective examinations were evaluated.

Results

Of the patients studied, 68% suffered from somatization. Among them, 11% met the definition of Functional Somatic Symptoms (FSS) and 74% had somatization associated with mood disorder or anxiety disorder. Digestive symptoms were reported by 33%, headaches by 24%, and unusual sensations by 21%. Whereas no correlation was found between somatization symptoms and the patients’ academic background, marital history, or medical history after the first visit, a positive correlation (p < 0.05) was found between somatization and patients who had been referred by their doctor.

Conclusion

Many of the studied patients who suffered from somatization, regardless of age and sex, were referred to us by doctors from other hospitals. It was concluded that many patients difficult to diagnose or deal with are referred the Department of Psychosomatic Medicine of Japanese university hospitals, thus these hospitals must assume great responsibility for preventing mistaken diagnoses by conducting effective psychological treatment and thorough medical examinations.

     

Exercise rehabilitation on home-dwelling patients with Alzheimer's disease - a randomized, controlled trial. Study protocol

Background

The Turkish population living in the Netherlands has a high prevalence of psychological complaints and has a high threshold for seeking professional help for these problems. Seeking help through the Internet can overcome these barriers. This project aims to evaluate the effectiveness of a guided self-help problem-solving intervention for depressed Turkish migrants that is culturally adapted and web-based.

Methods

This study is a randomized controlled trial with two arms: an experimental condition group and a wait list control group. The experimental condition obtains direct access to the guided web-based self-help intervention, which is based on Problem Solving Treatment (PST) and takes 6 weeks to complete. Turkish adults with mild to moderate depressive symptoms will be recruited from the general population and the participants can choose between a Turkish and a Dutch version. The primary outcome measure is the reduction of depressive symptoms, the secondary outcome measures are somatic symptoms, anxiety, acculturation, quality of life and satisfaction. Participants are assessed at baseline, post-test (6 weeks), and 4 months after baseline. Analysis will be conducted on the intention-to-treat sample.

Discussion

This study evaluates the effectiveness of a guided problem-solving intervention for Turkish adults living in the Netherlands that is culturally adapted and web-based.

Trial Registration

Nederlands Trial Register: NTR2303     

Psychological health and religious coping of Ghanaian women with infertility

Background

Infertility has been shown to have considerable psychological effects on the well-being of couples, especially women. Religion has been found as a resource used by infertile women to cope with their distress. Little research has examined the influence of religious coping on psychological distress among infertile women in Ghana. This study examines the relationship between positive and negative religious coping and psychological health for women with infertility problems in Ghana.

Methods

One hundred and fifty married women who were receiving assisted reproduction care in two specialized clinics were recruited for this study. Participants were administered with the Brief Symptom Inventory and Brief Religious Coping Scale to assess psychological health associated with infertility and religious coping respectively. A hierarchical regression was performed to examine the relative contribution of the domains of psychological health (i.e. somatization, anxiety and depression) in predicting negative religious coping and positive religious.

Results

The results showed that negative religious coping was significant and positively correlated with somatization, depression and anxiety. Furthermore, a positive relationship also existed between positive religious coping and somatization and anxiety but not depression. After controlling for age and duration of infertility, somatization and anxiety predicted positive religious coping whilst all the domains of psychological health (somatization, anxiety and depression) precited negative religious coping.

Conclusions

This study expanded on the existing literature by examining positive and negative religious coping with psychological distress associated with infertility for women. These results underscore the need for health professionals providing therapies for women with infertility to acknowledge and consider their religious beliefs as this influences their mental health.

     

Brief internet-based cognitive behavior therapy program with a supplement drink improved anxiety and somatic symptoms in Japanese workers

Background

Self-help cognitive behavior therapy (CBT) is a useful approach for the treatment of psychological problems. Recent research on the effectiveness of self-help internet-based CBT (ICBT) indicates that the paradigm moderately improves psychological problems. Furthermore, previous studies have shown that food and drinks containing supplements improve various health conditions. We investigated the effect of a brief self-help ICBT administered with a supplement drink on psychological well-being and somatic symptoms.

Methods

In total, 101 healthy workers were enrolled in the 4-week ICBT program, which consisted of psychoeducation on stress management, behavior activation, and cognitive restructuring. The supplement soft drink was taken every day during the program. The participants were instructed to watch on-demand video clips and read the self-help guidebook and supporting comic strip weekly on the Internet or smartphone. The Japanese version of the Profile of Mood States (POMS) was administered before and after completion of the program. Scores on the POMS tension-anxiety (POMS-TA), depression (POMS-D), and fatigue (POMS-F) subscales were used to assess the effect of the program. Somatic symptoms were assessed using the Brief Job Stress Questionnaire.

Results

In total, 75 participants continued the program for 4 weeks; however, of those, 27 failed to complete all weekly tasks or meet the post-assessment deadlines. Therefore, the data of 48 participants were included in the analysis. Pre-post intervention comparisons using paired t-tests revealed significant improvement on the POMS-TA, but not the POMS-D or POMS-F subscales. Moreover, participants reported a significant reduction in the severity of low back pain.

Conclusion

Our brief intervention moderately improved anxiety levels and the symptom of low back pain. These findings suggest that the brief ICBT program is effective in non-patient populations. Future directions for brief ICBT are discussed.

Trial registration

This study was registered on February 10, 2016 at UMIN. The registration number is UMIN000020962.

     

Maraviroc, a chemokine receptor-5 antagonist, fails to demonstrate efficacy in the treatment of patients with rheumatoid arthritis in a randomized, double-blind placebo-controlled trial

Introduction

The purpose of this study was to determine whether maraviroc, a human CC chemokine receptor 5 (CCR5) antagonist, is safe and effective in the treatment of active rheumatoid arthritis (RA) in patients on background methotrexate (MTX).

Methods

This phase IIa study comprised two distinct components: an open-label safety study of the pharmacokinetics (PK) of MTX in the presence of maraviroc, and a randomized, double-blind, placebo-controlled, proof-of-concept (POC) component. In the PK component, patients were randomized 1:1 to receive maraviroc 150 or 300 mg twice daily (BID) for four weeks. In the POC component, patients were randomized 2:1 to receive maraviroc 300 mg BID or placebo for 12 weeks. Patients were not eligible for inclusion in both components.

Results

Sixteen patients were treated in the safety/PK component. Maraviroc was well tolerated and there was no evidence of drug-drug interaction with MTX. One hundred ten patients were treated in the POC component. The study was terminated after the planned interim futility analysis due to lack of efficacy, at which time 59 patients (38 maraviroc; 21 placebo) had completed their week 12 visit. There was no significant difference in the number of ACR20 responders between the maraviroc (23.7%) and placebo (23.8%) groups (treatment difference -0.13%; 90% CI -20.45, 17.70; P = 0.504). The most common all-causality treatment-emergent adverse events in the maraviroc group were constipation (7.8%), nausea (5.2%), and fatigue (3.9%).

Conclusions

Maraviroc was generally well tolerated over 12 weeks; however, selective antagonism of CCR5 with maraviroc 300 mg BID failed to improve signs and symptoms in patients with active RA on background MTX.

Trial Registration

ClinicalTrials.gov: NCT00427934     

Comparison of the efficacy and safety of tocilizumab for colchicine-resistant or colchicine-intolerant familial Mediterranean fever: study protocol for an investigator-initiated,multicenter, randomized,double-blind,placebo-controlled trial

Background

Familial Mediterranean fever (FMF) is an inherited disorder caused by a number of mutations of the Mediterranean fever (MEFV) gene, coding a protein named pyrin that acts as a major regulatory component of the inflammasome. The first-line drug for FMF treatment is colchicine, but 10% of patients with FMF do not respond well to colchicine. Although the efficacy of tocilizumab (TCZ), which is a recombinant, humanized, antihuman interleukin 6 (IL-6) receptor monoclonal antibody, has been reported to prevent FMF attacks, the effects of TCZ on individuals with colchicine-resistant or colchicine-intolerant FMF have not been evaluated in a randomized clinical trial.

Methods/design

In this phase III, investigator-initiated, multicenter, double-blind, randomized, parallel-group trial, the efficacy and safety of TCZ will be compared with placebo in patients with colchicine-resistant or colchicine-intolerant FMF. The study will be conducted in nine centers in Japan. Participants (n =?24) will be randomly assigned to receive 162?mg of TCZ (n =?12) or placebo (n =?12) administered subcutaneously once weekly for 24?weeks. Rescue treatment will be allowed if rescue criteria are met. A primary endpoint is the number of fever attacks until 24?weeks. Secondary endpoints include the number of occurrences of accompanying symptoms during attacks; the time until a fever attack occurs; the duration of fever attacks; serum C-reactive protein and serum amyloid A; 36-item Short Form Health Survey; general evaluation by a physician (100-mm visual analogue scale); body temperature; the percentage of subjects who achieve FMF 50 at 12?weeks and 24?weeks; and pharmacodynamic assessment, including the measurement of serum TCZ level and soluble IL-6 receptor.

Discussion

The study is expected to produce evidence regarding the efficacy of a potential new therapeutic agent, TCZ, in improving the clinical course and outcome for patients with colchicine-resistant or colchicine-intolerant FMF.

Trial registration

University Hospital Medical Information Network Clinical Trials Registry, UMIN000028010. Registered on 7 July 2017.

     

A randomised sham controlled trial of vertebroplasty for painful acute osteoporotic vertebral fractures (VERTOS IV)

Background

Combination of erlotinib and bevacizumab is a promising regimen in advanced non-squamous non-small-cell lung cancer (NSCLC). We are conducting a single arm phase II trial which aims to evaluate the efficacy and safety of this regime as a second- or third-line chemotherapy.

Methods

Key eligibility criteria were histologically or cytologically confirmed non-squamous NSCLC, stage III/IV or recurrent NSCLC not indicated radical chemoradiation, prior one or two regimen of chemotherapy, age 20 years or more, and performance status of two or less. The primary endpoint is objective response rate. The secondary endpoints include overall survival, progression-free survival, disease control rate and incidence of adverse events. This trial plans to accrue 80 patients based on a two-stage design employing a binomial distribution with an alternative hypothesis response rate of 35% and a null hypothesis threshold response rate of 20%. A subset analysis according to EGFR mutation status is planned.

Discussion

We have presented the design of a single arm phase II trial to evaluate the efficacy and safety of combination of bevacizumab and erlotinib in advanced non-squamous NSCLC patients. In particular we are interested in determining the merit of further development of this regimen and whether prospective patient selection using EGFR gene is necessary in future trials.

Trial registration

This trial was registered at the UMIN Clinical Trials Registry as UMIN000004255 (http://www.umin.ac.jp/ctr/index.htm).     

The effect for Japanese workers of a self-help computerized cognitive behaviour therapy program with a supplement soft drink

Background

Computerized cognitive behaviour therapy (CCBT) programs can provide a useful self-help approach to the treatment of psychological problems. Previous studies have shown that CCBT has moderate effects on depression, insomnia, and anxiety. The present study investigated whether a supplement drink that includes L-carnosine enhances the effect of CCBT on psychological well-being.

Methods

Eighty-seven participants were randomly allocated to a control group, CCBT, or CCBT with supplement drink. The CCBT and CCBT with supplement drink groups received six weekly self-help CCBT program instalments, which consisted of psycho-education about stress management and coping, behaviour activation, and cognitive restructuring. The CCBT group consumed a bottle of the supplement soft drink every morning through the 6 weeks. This program was delivered by an e-learning system on demand and also included a self-help guidebook. Seventy-two participants completed the program or were assess at the end of the study.

Results

ANOVA revealed that there were significant interactions (times × groups) for POMS tension-anxiety and fatigue. The CCBT group showed significantly improved tension-anxiety scores, whereas the CCBT with drink group showed significant improvements on fatigue.

Conclusion

The self-help CCBT program reduced the subjective experience of tension-anxiety in this group of workers. The addition of a supplement drink enhanced the effect of CCBT on fatigue, providing one possible approach to enhancement of such programs.

Trial registration

This study was registered on September 2, 2016 at UMIN. The registration number is UMIN000023903.

     

Investigator experiences with financial conflicts of interest in clinical trials

Background

Sub-threshold depression is common, impairs functioning, and increases the risk of developing major depression. Although psychological treatments have been investigated for sub-threshold depression, they are costly. A less costly alternative could be an educational health promotion campaign about effective self-help for depression symptoms. The aim of the study is to test the efficacy of a low-cost email-based mental health promotion campaign in changing self-help behaviour and preventing more severe depression in adults with sub-threshold depression.

Methods/Design

The project is a randomised controlled trial of an automated preventive email-intervention aimed at people with sub-threshold depression. Adults aged 18+ with sub-threshold depression (as measured with the Patient Health Questionnaire-9), who are not already receiving professional treatment for depression, are eligible for admission to the study. Internet users will sign up via the study website http://www.moodmemos.com and be randomly allocated to receive emails twice weekly for six weeks containing either self-help coping advice or general information about depression as a control. Outcomes will be assessed at the start, midpoint, and end of the intervention, as well as six months later. Outcomes assessed include symptoms, incidence of major depression, psychological distress, social and occupational functioning, coping strategies, and coping self-efficacy. The primary hypothesis is that the Mood Memo emails containing coping strategies will reduce depression symptoms and be better at preventing major depression than the control emails that contain general information about depression.

Discussion

Promotion of actions an individual can take to prevent physical disease is a technique often used in public health. This study applies this approach to mental health, and explores whether a low-cost, easily disseminated email-based campaign can improve self-help coping behaviour and prevent depression in adults with sub-threshold depression.

Trial Registration

Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12609000925246     

Diagnostic d'une anéjaculation: à propos de 72 patients

Introduction

Anejaculation is the inability to ejaculate through the urethral meatus despite the presence of adequate erection and sexual stimulation.

Material and Methods

From January 1997 to July 2002, 72 patients (age: 17 to 72 years, mean age: 43 years, 65% under the age of 50) consulted the same urologist because of anejaculation.

Results

Forty seven patients (65%) were unable to achieve orgasm (anorgasmia). Twenty five patients were able to achieve orgasm: retrograde ejaculation (9 cases) or dry ejaculation (7 cases) (depending on the presence or absence spermatozoa in the urine after orgasm), indeterminate anejaculation (7 cases) and sluggish ejaculation (2 cases). Psychological risk factors were detected in 30 patients (42%), neurological risk factors were detected in 34 patients (47%) (especially peripheral neuropathy after pelvic or retroperitoneal surgery or diabetes mellitus) and pharmacological risk factors were detected in 16 patients (22%) (especially selective serotonin reuptake inhibitors). Men with anorgasmia presented psychological risk factors in 57% of cases, neurological risk factors in 36% of cases and pharmacological risk factors in 34% of cases. The percentages of these risk factors in patients with other forms of anejaculation were 12%, 68% and 0%, respectively. Twenty five patients (35%) presented several risk factors with a psychological predominance in 14 of them. No risk factors were detected in 11 patients (5 with retrograde ejaculation and 6 with anorgasmia), but a psychological aetiology appeared likely in 6 patients with anorgasmia, as they were able to achieve orgasm during masturbation. 70% of cases of anorgasmia therefore presented psychological risk factors or aetiologies (primary anorgasmia: 100%, secondary anorgasmia: 63%) versus 12% of patients with other forms of anejaculation.

Conclusion

1. The diagnosis of anejaculation must include the type of anejaculation.
2. The aetiological diagnosis is based on clinical interview.
3. Risk factors and aetiologies are often psychological, but sometimes neurological or pharmacological in patients with anorgasmia, and often neurological in other forms of anejaculation.
4. The term “psychological anejaculation” should be reserved for cases of primary anorgasmia.
5. Anorgasmia requires psychological assessment.

     

Plasma matrix metalloproteinases, low density lipoprotein oxidisability and soluble adhesion molecules after a glucose load in Type 2 diabetes

Background

Type 2 diabetes mellitus (DM-2) is one of the most prevalent chronic diseases of the aged and contributes to a significant amount of cardiovascular disease morbidity and mortality. Exercise training may be beneficial in attenuating the cardiovascular maladaptations associated with DM-2. The purpose of this study was to examine the effects of exercise training on left ventricular (LV) and vascular function in a sample of postmenopausal women with DM-2.

Methods

Twenty-eight postmenopausal women with DM-2 (age: 59 ± 7 yrs) were assigned to either an exercise training (ET) (n = 17) or control group (CT) (n = 7). Cardiorespiratory fitness ( ), LV filling dynamics and arterial compliance were assessed at baseline in all participants. The ET group performed a supervised aerobic and resistance training intervention three days per week for a period of 10 weeks, while the CT group continued normal activities of daily living.

Results

Body mass index, , age and duration of diabetes were similar between the ET and CT groups at baseline. (21.3 ± 3.3 to 24.5 ± 4.2 ml·kg^-1·min^-1, p < 0.05) and large artery compliance (1.0 ± 0.4 to 1.2 ± 0.4 mL·mmHg^-1, p < 0.05), increased significantly in the ET group following training despite no change in LV filling dynamics, blood pressure, lipid profile or insulin sensitivity. All variables remained unchanged in the CT group.

Conclusions

Exercise training improves large artery compliance and cardiorespiratory fitness in postmenopausal women with DM-2, without any appreciable changes in LV filling dynamics or conventional risk factors for cardiovascular disease.     

Sustained remission of symptoms and improved health-related quality of life in patients with cryopyrin-associated periodic syndrome treated with canakinumab: results of a double-blind placebo-controlled randomized withdrawal study

Introduction

To assess the effect of canakinumab, a fully human anti-interleukin-1β antibody, on symptoms and health-related quality of life (HRQoL) in patients with cryopyrin-associated periodic syndrome (CAPS).

Methods

In this 48-week, phase 3 study, patients with CAPS received canakinumab 150 mg subcutaneously at 8-week intervals. All patients (n = 35) received canakinumab during weeks 1 through 8; weeks 9 through 24 constituted a double-blind placebo-controlled withdrawal phase, and weeks 24 through 48 constituted an open-label phase in which all patients received canakinumab. Patient and physician assessments of symptoms, levels of inflammatory markers, and HRQoL were performed.

Results

Rapid symptom remission was achieved, with 89% of patients having no or minimal disease activity on day 8. Responses were sustained in patients receiving 8-weekly canakinumab. Responses were lost during the placebo-controlled phase in the placebo group and were regained on resuming canakinumab therapy in the open-label phase. Clinical responses were accompanied by decreases in serum levels of C-reactive protein, serum amyloid A protein, and interleukin-6. HRQoL scores at baseline were considerably below those of the general population. Improvements in all 36-item Short-Form Health Survey (SF-36) domain scores were evident by day 8. Scores approached or exceeded those of the general U.S. population by week 8 and remained stable during canakinumab therapy. Improvements in bodily pain and role-physical were particularly marked, increasing by more than 25 points from baseline to week 8. Therapy was generally well tolerated.

Conclusions

Canakinumab, 150 mg, 8-weekly, induced rapid and sustained remission of symptoms in patients with CAPS, accompanied by substantial improvements in HRQoL.

Trial registration

Clintrials.gov NCT00465985     

GITR signaling potentiates airway hyperresponsiveness by enhancing Th2 cell activity in a mouse model of asthma

Background

Anxiety and depression are common and treatable risk factors for re-hospitalisation and death in patients with COPD. The degree of lung function impairment does not sufficiently explain anxiety and depression. The BODE index allows a functional classification of COPD beyond FEV₁. The aim of this cross-sectional study was (1) to test whether the BODE index is superior to the GOLD classification for explaining anxious and depressive symptoms; and (2) to assess which components of the BODE index are associated with these psychological aspects of COPD.

Methods

COPD was classified according to the GOLD stages based on FEV_1%predicted in 122 stable patients with COPD. An additional four stage classification was constructed based on the quartiles of the BODE index. The hospital anxiety and depression scale was used to assess anxious and depressive symptoms.

Results

The overall prevalence of anxious and depressive symptoms was 49% and 52%, respectively. The prevalence of anxious symptoms increased with increasing BODE stages but not with increasing GOLD stages. The prevalence of depressive symptoms increased with both increasing GOLD and BODE stages. The BODE index was superior to FEV_1%predicted for explaining anxious and depressive symptoms. Anxious symptoms were explained by dyspnoea. Depressive symptoms were explained by both dyspnoea and reduced exercise capacity.

Conclusion

The BODE index is superior to the GOLD classification for explaining anxious and depressive symptoms in COPD patients. These psychological consequences of the disease may play a role in future classification systems of COPD.     

Heart rate variability in non-apneic snorers and controls before and after continuous positive airway pressure

Background

The effects of changes in cooling temperature on biomarker levels in exhaled breath condensate have been little investigated. The aim of the study was to test the effect of condensation temperature on the parameters of exhaled breath condensate and the levels of selected biomarkers.

Methods

Exhaled breath condensate was collected from 24 healthy subjects at temperatures of -10, -5, 0 and +5 C degrees. Selected parameters (condensed volume and conductivity) and biomarkers (hydrogen peroxide, malondialdehyde) were measured.

Results

There was a progressive increase in hydrogen peroxide and malondialdehyde concentrations, and condensate conductivity as the cooling temperature increased; total condensate volume increased as the cooling temperature decreased.

Conclusion

The cooling temperature of exhaled breath condensate collection influenced selected biomarkers and potential normalizing factors (particularly conductivity) in different ways ex vivo. The temperature of exhaled breath condensate collection should be controlled and reported.