Frequency of reporting of adverse events in randomized controlled trials of psychotherapy vs. psychopharmacotherapy

Background

Psychopharmacology and psychotherapy are the two main therapies in mental health. It is common practice to consider adverse events (AEs) of medications, but it’s not clear this occurs with psychotherapy.

Aim

This study investigates the frequency with which reports of AEs occur in clinical trials using either psychopharmacology alone, psychotherapy alone, or combined approaches.

Methods

Forty-five articles of randomized trials published in high-impact journals were chosen from a Medline search, and separated into three groups of 15 articles: pharmacotherapy alone (M), psychotherapy alone (T) and combined studies that looked at the effect of both a psychotherapeutic (CT) and psychopharmacologic (CM) intervention. Criteria for what defines an AE were established and the papers were rated for mentions of AEs in papers as a whole and by each section.

Results

The χ²-analysis of AE mentions showed significant differences between the four study conditions in terms of each paper as a whole (χ²: 10.1, p < 0.018), and by section. Medication (M + CM) and psychotherapy papers (T + CT) were then combined into two groups to compare the odds that one was more likely to mention AEs than the other. Bivariate logistic regression yielded statistically significant odds ratios ranging from 9.33 to 20.99, with medications being far more likely to mention AEs.

Conclusion

We believe the difference in reports of AEs mirrors the attitudes researchers and providers. It’s critical to consider, and standardize the definition of, AEs in psychotherapy, and imperative to identify and address potential AEs in psychotherapy research.     

The antioxidant tempol decreases acute pulmonary thromboembolism-induced hemolysis and nitric oxide consumption

Introduction

Acute pulmonary thromboembolism (APT) is a critical condition associated with acute pulmonary hypertension. Recent studies suggest that oxidative stress and hemolysis contribute to APT-induced pulmonary hypertension, possibly as a result of increased nitric oxide (NO) consumption. We hypothesized that the antioxidant tempol could attenuate APT-induced hemolysis, and therefore attenuate APT-induced increases in plasma NO consumption.

Materials and Methods

APT was induced in anesthetized sheep with autologous blood clots. The hemodynamic effects of tempol infused at 1.0 mg/kg/min 30 min after APT were determined. Hemodynamic measurements were carried out every 15 min. To assess oxidative stress, serum 8-isoprostanes levels were measured by ELISA. Plasma cell-free hemoglobin concentrations and NO consumption by plasma samples were determined. An in vitro oxidative AAPH-induced hemolysis assay was used to further validate the in vivo effects of tempol.

Results

APT caused pulmonary hypertension, and increased pulmonary vascular resistance in proportion with the increases in 8-isoprostanes, plasma cell-free hemoglobin concentrations, and NO consumption by plasma (all P < 0.05). Tempol attenuated the hemodynamic alterations by approximately 15-20% and blunted APT-induced increases in 8-isoprostanes, in cell-free hemoglobin concentrations, and the increases in NO consumption by plasma (P < 0.05). Tempol dose-dependently attenuated AAPH-induced in vitro hemolysis (P < 0.05).

Conclusions

Our findings are consistent with the idea that antioxidant properties of tempol decrease APT-induced hemolysis and nitric oxide consumption, thus attenuating APT-induced pulmonary hypertension.     

Quality of life in bipolar and schizoaffective disorder — A naturalistic approach

Purpose

The aim of this study was to evaluate the health-related quality of life (HRQoL) in bipolar type I (BD I) and schizoaffective (SQA) patients during a 2-year period in a naturalistic study.

Methods

This study was based on the data generated by the Bipolar Comprehensive Outcome Study, a prospective, non-interventional, observational study of participants with BD I and SQA disorder. Mixed-Model Repeated Measures Analysis was used to analyze changes in the SF-36 and EQ-5D.

Results

Participants exhibited low health status at baseline with SF-36 mean scores of 46.7 ± 10.5 and 36.9 ± 12.9 (best imaginable health = 100, normal population ≈ 50) for physical and mental components, respectively. No significant differences were found between the ratings of the BD I and SQA patients on HRQoL. The SF-36 SMC improved significantly over 24 months although SPC scores remained consistent across the study. On the whole, the lowest SMC score was observed among the depressed patients (38.20), followed by the patients with a mixed state (39.01) and the manic patients (39.83).

Limitations

The observational design may have limited the causal relationships and the generalizability within the current findings.

Conclusions

HRQoL was significantly impaired in all stages of BD and SQA when compared to the general population. The impairment of HRQoL was most pronounced in the depressed state, followed by the mixed state and then the manic state. The euthymic patients showed the least impairment. In addition, patients showed a global improvement in their mental health satisfaction over the 2 years follow up period.     

Neuropsychological predictors of response to randomized treatment in obsessive–compulsive disorder

Objective

To identify neuropsychological predictors of treatment response to cognitive–behavioral therapy (CBT) and fluoxetine in treatment-naïve adults with obsessive–compulsive disorder (OCD).

Method

Thirty-eight adult outpatients with OCD underwent neuropsychological assessment, including tasks of intellectual function, executive functioning and visual and verbal memory, before randomization to a 12-week clinical trial of either CBT or fluoxetine. Neuropsychological measures were used to identify predictors of treatment response in OCD.

Results

Neuropsychological measures that predicted a better treatment response to either CBT or fluoxetine were higher verbal IQ (Wechsler Abbreviated Scale of Intelligence) (p = 0.008); higher verbal memory on the California Verbal Learning Test (p = 0.710); shorter time to complete part D (Dots) (p < 0.001), longer time to complete part W (Words) (p = 0.025) and less errors on part C (Colors) (p < 0.001) in the Victoria Stroop Test (VST). Fewer perseverations on the California Verbal Learning Test, a measure of mental flexibility, predicted better response to CBT, but worse response to fluoxetine (p = 0.002).

Conclusion

In general, OCD patients with better cognitive and executive abilities at baseline were more prone to respond to either CBT or fluoxetine. Our finding that neuropsychological measures of mental flexibility predicted response to treatment in opposite directions for CBT and fluoxetine suggests that OCD patients with different neuropsychological profiles may respond preferentially to one type of treatment versus the other. Further studies with larger samples of OCD patients are necessary to investigate the heuristic value of such findings in a clinical context.     

Alertness and psychomotor performance effects of the histamine-3 inverse agonist MK-0249 in obstructive sleep apnea patients on continuous positive airway pressure therapy with excessive daytime sleepiness: a randomized adaptive crossover study

Objectives

We aimed to evaluate the efficacy of the selective H3 receptor inverse agonist MK-0249 to treat excessive daytime sleepiness (EDS).

Methods

In this three-period, double-blind, crossover study, 125 patients (100 men, 25 women; mean age, 48.6 years) with obstructive sleep apnea receiving nasal continuous positive airway pressure therapy who had refractory EDS were randomized to 2 weeks each of daily MK-0249 (5, 8, 10, or 12 mg, adaptively assigned), modafinil 200 mg, and placebo. At baseline and after each treatment period, six maintenance of wakefulness tests (MWT) and Psychomotor Vigilance Tasks (PVT) were conducted at 2-h intervals, beginning 1 h postdose (∼09:00). The Epworth sleepiness scale (ESS), Clinical Global Impression of Severity (CGIS) and Digit Symbol Substitution Test (DSST) also were assessed. The primary end point was MWT sleep latency averaged over the first four time points (MWT-early).

Results

MWT-early mean change from baseline sleep latency at week 2 was 1.2 min for placebo, 2.1 min for MK-0249 (top two doses pooled; P > .05 vs placebo), and 5.9 min for modafinil (P ? .001 vs placebo). MK-0249 showed improvements vs placebo on secondary and exploratory end points of ESS, CGIS, PVT, and DSST. Insomnia adverse events (AEs) were greater for MK-0249 (combined doses, 17.5%) than for placebo (0.9%) or modafinil (1.8%).

Conclusion

MK-0249 did not significantly affect MWT sleep latency. However, the pattern of improvement on subjective ratings and psychomotor performance end points suggested that MK-0249 was associated with changes in aspects of cognition and performance not captured by the MWT.     

Safety and efficacy of edoxaban in patients undergoing hip fracture surgery

Introduction

Edoxaban is an oral, direct, once-daily factor Xa inhibitor. This study evaluated the safety and efficacy of edoxaban compared to subcutaneous enoxaparin in Japanese patients undergoing hip fracture surgery.

Materials and methods

In this multicenter, randomized, open-label, active-comparator, phase 3 trial, 92 patients were randomized 2:1 to receive edoxaban 30 mg once daily (n = 62) or enoxaparin sodium (enoxaparin) 2000 IU (equivalent to 20 mg) twice daily (n = 30) for 11 to 14 days. The primary endpoints were the incidence of major or clinically relevant non-major (CRNM) bleeding and incidence of any bleeding events (major, CRNM, or minor bleeding). Secondary efficacy endpoints included the incidence of thromboembolic events, venous thromboembolism-related deaths, and all-cause deaths. Additional adverse events were recorded throughout the study.

Results

In the edoxaban and enoxaparin treatment groups, the incidence of major or CRNM bleeding was 3.4% and 6.9%, respectively, while any bleeding event occurred in 25.4% and 17.2% of patients, respectively. The incidence of thromboembolic events was 6.5% in the edoxaban group and 3.7% in the enoxaparin group. All events were asymptomatic deep vein thrombosis. The incidence of adverse events was 72.9% and 82.8% in the edoxaban and enoxaparin groups, respectively.

Conclusions

Compared to subcutaneous enoxaparin 2000 IU twice daily, oral edoxaban 30 mg once daily demonstrated similar safety and efficacy in the prevention of thromboembolic events in Japanese patients undergoing hip fracture surgery.Clinical trials registration number: NCT01181141.     

The process of cognitive behaviour therapy for chronic fatigue syndrome: Which changes in perpetuating cognitions and behaviour are related to a reduction in fatigue?

Objective

Cognitive behaviour therapy (CBT) can significantly reduce fatigue in chronic fatigue syndrome (CFS), but little is known about the process of change taking place during CBT. Based on a recent treatment model (Wiborg et al. J Psych Res 2012), we examined how (changes in) cognitions and behaviour are related to the decrease in fatigue.

Methods

We included 183 patients meeting the US Centers for Disease Control criteria for CFS, aged 18 to 65 years, starting CBT. We measured fatigue and possible process variables before treatment; after 6, 12 and 18 weeks; and after treatment. Possible process variables were sense of control over fatigue, focusing on symptoms, self-reported physical functioning, perceived physical activity and objective (actigraphic) physical activity. We built multiple regression models, explaining levels of fatigue during therapy by (changes in) proposed process variables.

Results

We observed large individual variation in the patterns of change in fatigue and process variables during CBT for CFS. Increases in the sense of control over fatigue, perceived activity and self-reported physical functioning, and decreases in focusing on symptoms explained 20 to 46% of the variance in fatigue. An increase in objective activity was not a process variable.

Conclusion

A change in cognitive factors seems to be related to the decrease in fatigue during CBT for CFS. The pattern of change varies considerably between patients, but changes in process variables and fatigue occur mostly in the same period.     

Ascending beta oscillation from finger muscle to sensorimotor cortex contributes to enhanced steady-state isometric contraction in humans

Objective

β-Band corticomuscular coherence is suggested as an electrophysiological mechanism that contributes to sensorimotor functioning in the maintenance of steady-state contractions. Converging evidence suggests that not only the descending corticospinal pathway but the ascending sensory feedback pathway is involved in the generation of β-band corticomuscular coherence. The present study aimed to investigate which pathway, descending vs. ascending, contributes more to the stability of muscle contraction, especially for human intrinsic hand muscles.

Methods

In this study, we assessed directed transfer function (DTF) between magnetoencephalography signals over the sensorimotor cortex (SMC) and rectified electromyographic (EMG) signals recorded during steady-state isometric contraction of the right thumb muscle (flexor pollicis brevis, FPB) or right little finger muscle (flexor digiti minimi brevis, FDMB) in 15 right-handed healthy subjects.

Results

β-Band DTF was statistically significant in both descending (SMC → EMG) and ascending (EMG → SMC) directions, and mean phase delays for each direction were in agreement with the conduction time for the descending corticospinal and ascending sensory feedback pathways. The strengths of the β-band DTF (EMG → SMC direction) were greater in the FPB muscle than in the FDMB muscle, while the strengths of the β-band DTF (SMC → EMG direction) were not different between the two muscles. Moreover, the β-band DTF (EMG → SMC direction) was greater in the “Stable” period than in the “Less Stable” period within the FDMB muscle. Greater DTF (EMG → SMC direction) was positively associated with the stability of muscle contraction.

Conclusions

Our findings suggest that ascending β-band oscillatory activity may promote a steady-state isometric contraction by efficiently transmitting sensory feedback from finger muscles to the sensorimotor cortex.

Significance

The results show the differential contribution of the ascending part of the corticomuscular network depending on the functional organization.     

The effects of electromyography-controlled functional electrical stimulation on upper extremity function and cortical perfusion in stroke patients

Objective

The relation was investigated between hemiparetic arm function improvement and brain cortical perfusion (BCP) change during voluntary muscle contraction (VOL), EMG-controlled FES (EMG-FES) and simple electrical muscle stimulation (ES) before and after EMG-FES therapy in chronic stroke patients.

Methods

Sixteen chronic stroke patients with moderate residual hemiparesis underwent 5 months of task-orientated EMG-FES therapy of the paretic arm once or twice a week. Before and after treatment, arm function was clinically evaluated and BCP during VOL, ES and EMG-FES were assessed using multi-channel near-infrared spectroscopy.

Results

BCP in the ipsilesional sensory-motor cortex (SMC) was greater during EMG-FES than during VOL or ES; therefore, EMG-FES caused a shift in the dominant BCP from the contralesional to ipsilesional SMC. After EMG-FES therapy, arm function improved in most patients, with some individual variability, and there was significant improvement in Fugl–Meyer (FM) score and maximal grip strength (GS). Clinical improvement was accompanied by an increase in ipsilesional SMC activation during VOL and EMG-FES condition.

Conclusion

The EMG-FES may have more influence on ipsilesional BCP than VOL or ES alone.

Significance

The sensory motor integration during EMG-FES therapy might facilitate BCP of the ipsilesional SMC and result in functional improvement of hemiparetic upper extremity.     

Recent randomized controlled trials of psychological interventions in healthcare: A review of their quantity,scope, and characteristics

Objective

This study aimed to describe the quantity, scope, and fundamental characteristics of recently published randomized controlled trials (RCTs) of psychological interventions.

Methods

We queried two major databases (PsycINFO and PubMeD) for primary reports published in 2010 of RCTs of psychological interventions for participants with a medical condition. We collected data on the characteristics of the trials, participants, interventions, outcomes, and reports.

Results

Of 3696 retrieved reports 295 primary publications were included. About half (53%) of trials included participants with a mental disorder and more than half evaluated interventions based on a cognitive behavioral therapy (CBT) framework. A majority of trials recruited participants in North America and Europe (79%). A minority of the trials focused on children and adolescents (17%) or the elderly (8%). The median sample size of the intervention arm was n = 41. Thirty-nine percent of trials reported solely patient-reported outcomes. Only 5% of reports indicated funding from for-profit organizations. The median 2010 impact factor of the journals in which reports were published was 2.96.

Conclusion

This snapshot of the research on psychological interventions suggests that the evidence base for psychological interventions is expanding mainly for CBT interventions for adults in high-income countries. Although the restrictive inclusion criteria limit the generalizability of these results, researchers and funding agencies might be advised to strive for greater diversity regarding interventions, geographical/cultural settings and age groups. Regularly updated reviews of this research field, with gradually refined methodology and increased scope, may further inform funders and researchers.     

Cognitive behaviour therapy for low self-esteem: a preliminary randomized controlled trial in a primary care setting

Background and Objectives

Low self-esteem (LSE) is associated with psychiatric disorder, and is distressing and debilitating in its own right. Hence, it is frequent target for treatment in cognitive behavioural interventions, yet it has rarely been the primary focus for intervention. This paper reports on a preliminary randomized controlled trial of cognitive behaviour therapy (CBT) for LSE using Fennell’s (1997) cognitive conceptualisation and transdiagnostic treatment approach (25 and 27).

Methods

Twenty-two participants were randomly allocated to either immediate treatment (IT) (n = 11) or to a waitlist condition (WL) (n = 11). Treatment consisted of 10 sessions of individual CBT accompanied by workbooks. Participants allocated to the WL condition received the CBT intervention once the waitlist period was completed and all participants were followed up 11 weeks after completing CBT.

Results

The IT group showed significantly better functioning than the WL group on measures of LSE, overall functioning and depression and had fewer psychiatric diagnoses at the end of treatment. The WL group showed the same pattern of response to CBT as the group who had received CBT immediately. All treatment gains were maintained at follow-up assessment.

Limitations

The sample size is small and consists mainly of women with a high level of educational attainment and the follow-up period was relatively short.

Conclusions

These preliminary findings suggest that a focused, brief CBT intervention can be effective in treating LSE and associated symptoms and diagnoses in a clinically representative group of individuals with a range of different and co-morbid disorders.     

Assessing Bodily Preoccupations is sufficient: Clinically effective screening for hypochondriasis

Objective

Hypochondriasis is a persistent psychiatric disorder and is associated with increased utilisation of health care services. However, effective psychiatric consultation interventions and CBT treatments are available. In the present study, we provide evidence of clinically effective screening for hypochondriasis. We describe the clinically effective identification of patients with a high probability of suffering from hypochondriasis. This identification is achieved by means of two brief standardised screening instruments, namely the Bodily Preoccupation (BP) Scale with 3 items and the Whiteley-7 (WI-7) with 7 items.

Methods

Both the BP scale and the WI-7 were examined in a sample of 228 participants (72 with hypochondriasis, 80 with anxiety disorders and 76 healthy controls) in a large psychotherapy outpatients' unit, applying the DSM-IV criteria. Cut-off values for the BP scale and the WI-7 were computed to identify patients with a high probability of suffering from hypochondriasis. Additionally, other self-report symptom severity scales were completed in order to examine discriminant and convergent validity. Data was collected from June 2010 to March 2013.

Results

The BP scale and the WI-7 discriminated significantly between patients with hypochondriasis and those with an anxiety disorder (d = 2.42 and d = 2.34). Cut-off values for these two screening scales could be provided, thus identifying patients with a high probability of suffering from hypochondriasis.

Conclusions

In order to reduce costs, the BP scale or the WI-7 should be applied in medical or primary care settings, to screen for patients with a high probability of hypochondriasis and to transfer them to further assessment and effective treatment.     

Does neuropsychological test performance predict outcome of cognitive behavior therapy for Chronic Fatigue Syndrome and what is the role of underperformance?

Objective

A subgroup of patients with Chronic Fatigue Syndrome (CFS) has cognitive impairments, reflected by deviant neuropsychological test performance. However, abnormal test scores can also be caused by suboptimal effort. We hypothesized that worse neuropsychological test performance and underperformance were related to each other and to a smaller reduction in fatigue, functional impairments, physical limitations and higher dropout rates following cognitive behavior therapy (CBT) for CFS.

Methods

Data were drawn from a previous trial, in which CFS patients were randomized to two conditions; 1) guided self-instruction and additional CBT (n = 84) or 2) waiting period followed by regular CBT for CFS (n = 85). Underperformance was assessed using the Amsterdam Short Term Memory Test (< 84). To test neuropsychological test performance, the Symbol Digit Modalities Task, a simple reaction time task and a choice reaction time task were used. Interaction effects were determined between underperformance and neuropsychological test performance on therapy outcomes.

Results

Underperformance was associated to worse neuropsychological test performance, but there were no significant interaction effects of these two factors by therapy on fatigue severity, functional impairments and physical limitations, but there was a significant main effect of underperformance on functional impairments, physical limitations and dropout rates.

Conclusion

Underperformance or neuropsychological test performance was not related to the change in fatigue, functional impairments, and physical limitations following CBT for CFS. However, underperforming patients did drop out more often. Therapists should pay attention to beliefs and behavioral or environmental factors that might maintain underperformance and increase the risk of dropout.     

Safety and Efficacy of Edoxaban,an Oral Factor Xa Inhibitor,Versus Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty: The STARS E-3 Trial

Introduction

This phase 3 trial compared the safety and efficacy of edoxaban, an oral direct factor Xa inhibitor, with enoxaparin sodium (enoxaparin) for thromboprophylaxis after total knee arthroplasty (TKA) in patients in Japan and Taiwan.

Materials and methods

In this randomized, double-blind, double-dummy study, patients received oral edoxaban 30 mg once daily beginning 6 to 24 hours postsurgery or enoxaparin 2000 IU (equivalent to 20 mg) subcutaneously twice daily beginning 24 to 36 hours postsurgery for 11 to 14 days. The primary efficacy endpoint was the composite of symptomatic pulmonary embolism and symptomatic and asymptomatic deep vein thrombosis. Safety endpoints included the incidence of major bleeding, clinically relevant non-major (CRNM) bleeding, major bleeding or CRNM bleeding, all bleeding events, adverse events, and adverse drug reactions.

Results

Of 716 patients enrolled, 360 and 356 were randomized to receive edoxaban or enoxaparin, respectively. The primary efficacy outcome occurred in 22/299 (7.4%) and 41/295 (13.9%) patients in the edoxaban and enoxaparin groups, respectively (relative risk reduction = 46.8%), indicating non-inferiority (P < 0.001) and superiority (P = 0.010) of edoxaban versus enoxaparin. In the edoxaban and enoxaparin groups, major bleeding occurred in 4/354 (1.1%) versus 1/349 (0.3%) patients (P = 0.373); major or CRNM bleeding occurred in 22/354 (6.2%) versus 13/349 (3.7%) patients (P = 0.129), respectively.

Conclusions

Edoxaban 30 mg once daily was more effective for thromboprophylaxis than subcutaneous enoxaparin 2000 IU twice daily following TKA and demonstrated a similar incidence of bleeding events.     

Estudio postautorización de la eslicarbazepina en el tratamiento de epilepsias farmacorresistentes: resultados preliminares

Introduction

Eslicarbazepine acetate (ESL) is a new antiepileptic drug (AED) and an analogue to carbamazepine (CBZ) and oxcarbazepine (OXC). In this study, we evaluate initial therapeutic response to ESL and events in the change from CBZ and OXC.

Methods

We evaluated 61 patients with a broad spectrum of drug-resistant epilepsies in a cross-sectional study. The switch from CBZ and OXC to ESL was carried out in a single night at ratios of 1:1.3 and 1:1 mg respectively.

Results

The most common form of epilepsy was temporal lobe epilepsy (62.3%). The most common aetiology was mesial temporal sclerosis (26.2%). Mean follow-up time was 4.7±3.2 months. In 40 patients with a minimum follow-up period of 3 months, monthly median seizure frequency dropped by 63.6% (P<.001) and a reduction of 80% or more was recorded in 30%. Adverse events (AEs) occurred in 54%; all appeared during the titration phase. They were more frequent at doses in excess of 800 mg (73.9% vs. 47.4%; P=.042). The most common AE was dizziness (34.4%), which was commonly associated with VPA, LTG and/or LCS consumption (19.2% vs. 45.7%; P=.031). The retention rate at 3 months was 75.4%. A total of 25 patients replaced CBZ or OXC treatment with ESL; any AEs were transient (69.2% for CBZ and 33% for OXC; P=.073). At 3 months after the treatment change, median seizure frequency had decreased by 20% (P<.075).

Conclusions

ESL is effective in the treatment of focal epilepsies and its early retention rate is > 70%. AEs occurred during the titration phase and corresponded to associated AEDs. A rapid change from CBZ and OXC to ESL treatment can be safely performed.     

The metabolic costs of hostility in healthy adult men and women: Cross-sectional and prospective analyses

Background

Hostility is associated with altered metabolic activity but little research has examined sex and/or age differences using a global index of metabolic dysfunction or examined different aspects of hostility.

Methods

The moderating effect of sex and age on the associations between three aspects of hostility (cynical attitude, angry affect, quarrelsome behavior in daily living) and metabolic burden (number of metabolic parameters in the higher quartile) were evaluated in 188 healthy men and women (M_age = 41; SD = 11.34). Three years later, metabolic burden was measured again in 133 participants.

Results

At study onset, quarrelsome behavior was associated with greater metabolic burden in men and women (Beta = .144; p < .05). After 3 yrs, cynical hostility predicted increased metabolic burden among mid-age and older individuals (b = .013 and .046 respectively; p < .001).

Conclusion

The aspect of hostility that is most closely associated with metabolic burden depends on the age of the participants and whether measures are concurrent or prospective.     

Alexithymia and non-treatment: An Internet based study of 312 people with chronic anxiety

Background

Despite the availability of highly efficacious treatments, many individuals with anxiety disorders never receive adequate treatment. Alexithymic deficits, such as difficulties in recognizing feelings and focusing on emotional experiences, may contribute to low rates of help seeking.

Methods

Multiple Internet-based strategies (announcements of anxiety disorder websites, postings in online self-help forums, notices in anxiety chat rooms) were used to recruit a sample of 312 participants with chronic and clinically relevant anxiety symptoms. Those who had never received professional treatment (n = 49) were compared to those with current or previous treatment (n = 263) with regard to alexithymia, anxiety, depression and health-related quality of life.

Results

Logistic regression analysis revealed that the strongest predictor for belonging to the never treated group was the externally oriented thinking facet of alexithymia. In addition, substantially more participants in the never treated group (49%) were considered high-alexithymic (20-item Toronto Alexithymia Scale total score ≥61) compared to the treated group (35%).

Conclusions

The main finding was a strong relationship between the externally oriented thinking facet of alexithymia and the non-use of professional help for anxiety. Internet-based programs could be a promising first step in supporting this group of people to overcome their anxiety.     

An analysis of matching cognitive-behavior therapy techniques to learning styles

Background and objectives

To optimize the effectiveness of cognitive-behavior therapy (CBT) for each individual patient, it is important to discern whether different intervention techniques may be differentially effective. One factor influencing the differential effectiveness of CBT intervention techniques may be the patient's preferred learning style, and whether this is ‘matched’ to the intervention.

Method

The current study uses a retrospective analysis to examine whether the impact of two common CBT interventions (thought records and behavioral experiments) is greater when the intervention is either matched or mismatched to the individual's learning style.

Results

Results from this study give some indication that greater belief change is achieved when the intervention technique is matched to participants' learning style, than when intervention techniques are mismatched to learning style.

Limitations

Conclusions are limited by the retrospective nature of the analysis and the limited dose of the intervention in non-clinical participants.

Conclusions

Results suggest that further investigation of the impact of matching the patient's learning style to CBT intervention techniques is warranted, using clinical samples with higher dose interventions.     

Post-marketing surveillance of thrombomodulin alfa,a novel treatment of disseminated intravascular coagulation - Safety and efficacy in 1,032 patients with hematologic malignancy

Introduction

Post-marketing surveillance of thrombomodulin alfa (TM-α) was performed to evaluate safety and efficacy in patients with disseminated intravascular coagulation (DIC) with hematologic malignancy.

Materials and methods

All patients treated with TM-α from May 2008 to April 2010 in Japan were included. Information about baseline characteristics, safety, and efficacy were collected. The DIC resolution rate, survival rate on Day 28 after the last TM-α administration, and changes in DIC score and coagulation tests were evaluated.

Results

The underlying diseases associated with DIC were acute myeloid leukemia (except for acute promyelocytic leukemia, n = 350), lymphoma (n = 199), acute promyelocytic leukemia (n = 172), acute lymphoblastic leukemia (n = 156), myelodysplastic syndromes (n = 61), and other (n = 94). The incidence rates of bleeding-related adverse events and adverse drug reactions were 17.8% and 4.6%, respectively. In subjects with bleeding symptoms at baseline, 55.0% were assessed as disappeared or improved based on symptoms after TM-α treatment. The DIC resolution and survival rates were 55.9% and 70.7%, respectively. The DIC score and coagulation tests including thrombin-antithrombin complex (TAT) were significantly improved. Coagulation tests were significantly improved after TM-α treatment even in subjects whose clinical course of underlying disease was assessed as unchanged or exacerbated.

Conclusions

This surveillance confirmed the safety and efficacy of TM-α in clinical practice, thus TM-α may be an ideal treatment for patients with DIC based upon hematologic malignancy.