Risk of bleeding related to selective and non-selective serotonergic antidepressants: a case/non-case approach using data from two pharmacovigilance databases.

INTRODUCTION: There is increasing evidence for an association between treatment with selective serotonin reuptake inhibitors (SSRI) and an increased risk of bleeding events. The most important underlying mechanism appears to be inhibition of serotonin uptake in platelets, an effect that is also present in antidepressants with non-selective serotonin-reuptake inhibition (NSRI). Accordingly, also NSRI may be associated with an increased risk of bleeding. However, there is little data in this regard. METHODS: Based on data (spontaneous reports of adverse drug reactions) from 2 pharmacovigilance databases (WHO-database/Vigibase™; BfArM/AkdÄ-database in Germany) we used a case/non-case approach and calculated reporting odds ratios (ROR) as measures for disproportionality regarding the association of treatment with an agent of the group SSRI/NSRI and haemorrhages. RESULTS: Whereas both positive control agents (ASS and diclofenac) were statistically associated with haemorrhages in both databases (ASS: BfArM/AkdÄ, ROR 13.62 [95% CI 12.76-14.53]/WHO, ROR 12.96 [95% CI 12.75-13.16]; diclofenac: BfArM/AkdÄ, ROR 3.01 [95% CI 2.71-3.21]/WHO, ROR 2.11 [95% CI 2.05-2.16]), none of the agents of the group SSRI (ROR<1) was associated with haemorrhages. In group NSRI, only St. John's wort/hypericum was associated with haemorrhages (WHO-database, ROR 1.31 [95% CI 1.06-1.63]). DISCUSSION: Signal detectioning in 2 pharmacovigilance databases suggest that serotonin reuptake inhibition is not associated with an increased risk of bleeding. However, underreporting may have accounted for the evaluated absent associations, particularly concerning SSRI. Regarding the detected increased risk of bleeding associated with hypericum, pharmacokinetic drug-drug interactions may be relevant independent of serotonin reuptake inhibition.

Psychologic disorder and sexual dysfunction in elders.

These data, in combination with the literature reviewed above, demonstrate several important points for those who work in clinics where elders with sexual problems are seen: 1. The currently available literature on the relation of sexual dysfunction to psychiatric disorder in the elderly is not extensive, and much of the literature is limited by methodologic flaws. There is a clear need for improved research methods and a broader data base. Nonetheless, the existing studies indicate that psychologic disorders are found in conjunction with sexual dysfunction commonly enough that clinicians must regularly assess for their presence. 2. The cause of sexual problems is seldom simple or entirely clear. Diagnoses of psychologic concerns and disorders that might relate to sexual dysfunction are common, and most older patients' sexual dysfunction will have a mixed cause, with both medical and psychologic factors playing an important role in the development and maintenance of sexual dysfunction. In our series of patients, 52.8% had diagnosable psychologic difficulties that were assumed to be related to the sexual difficulties. Another large group (39.9%) had psychologic factors (although not diagnosable disorders) that were assumed to contribute to the current manifestation of sexual dysfunction. Thus, it should not be assumed, as it was in years past, that when one likely causative factor is identified (e.g, diabetes, performance anxiety, or depression), the cause of the dysfunction has been identified. 3. The types of psychopathology seen in sex clinics are typically fairly limited, with the largest proportions by far being alcohol abuse or depression (50.1% and 62.1%, respectively, of all psychologic diagnoses in our clinic). Major psychopathology is relatively underrepresented. We suspect this underrepresentation does not reflect a true population characteristic but, rather, a selection difference; patients with major psychopathology such as schizophrenia either do not complain of sexual dysfunction to their therapists or are not referred for treatment by their therapists. 4. The presenting complaints of patients with a psychologic disorder do not differ significantly from those of patients without a psychologic disorder in a general sexual dysfunction clinic. 5. Treatment outcome, especially the rate of successful treatment, does not differ between those with and those without psychologic diagnoses when physicians and psychologists work together on an interdisciplinary team to offer treatment.(ABSTRACT TRUNCATED AT 400 WORDS)

The buddy system: a method for generalized reduction of inappropriate interpersonal behaviour of retarded-psychiatric patients.

Previous research has suggested a strategy for training social skills in chronic retarded-psychotic patients, but has not demonstrated extensive generalization or maintenance of gains. This study varied the standard training procedure (e.g. Bellack et al., 1976) in an attempt to improve generalization and maintenance. First, training involved instructions, modelling, role-playing, and feedback with daily problem situations rather than preselected, pre-written scenes. Second, each of the two patients treated served as a partner for the other; each patient monitored the other's behaviour and provided reinforcement, information and feedback to the 'buddy' (directly in the living environment). The procedure was effective in teaching appropriate social behaviours on the ward as well as in therapy sessions. Post-checks, taken 6 weeks after the conclusion of the treatment, indicated that improvements were maintained.

PTSD 40 years later: incidence and person-situation correlates in former POWs.

A statewide sample of WWII ex-POWs (N = 442) responded to questionnaires that sampled current and past difficulties with PTSD-related symptoms; an incidence of serious difficulties with these symptoms of 56% was revealed. Retrospective reports of temporal patterns revealed no consistent patterns of symptom occurrence, but, rather, a waxing and waning of difficulties over the 40-year period. Unexpectedly, measures of severity of the POW experiences did not predict current symptomatology. Rank at time of capture, however, was consistently and strongly predictive of PTSD. It is suggested that PTSD is a highly persistent phenomenon and that both situation and person variables contribute to the development and maintenance of PTSD.

Treatment for premature ejaculation through male-only groups.

A report on the treatment of premature ejaculation in a group format is provided. In this format only males attended group therapy sessions, but they were expected to relay all information on the group meetings to their regular sexual partners. The women then participated in structured retraining exercises with their male partners. This approach was both cost effective and successful for most couples. It is argued, though, that group treatments are not likely to be as effective as the Masters and Johnson strategy and that clinics should, therfore, remain flexible enough to provide more individualized treatment for those couples who do not succeed with group approaches. Therapists are also encouraged to ensure that treatment gains are well established before terminating therapy.

Case studies on remediating memory deficits in brain-damaged individuals.

Two case reports illustrate the application of mnemonic techniques for the remediation of memory problems common to brain-damaged patients. A clinical paradigm for such work that includes general and specific assessment; laboratory evaluation of intervention strategies, and finally in-vitro application is described.

A comparison of social skills training and contingent attention to improve behavioural deficits of chronic psychiatric patients.

Twelve chronic psychiatric patients were treated with either social skills training or contingent attention to improve behavioural assets or deficits noted on the ward by independently trained raters blind to experimental conditions. Treatment was applied across groups using a multiple-baseline format. Inspection of the data revealed that clinically significant improvements in socially appropriate assets and deficits observed on the ward resulted with social skills training but no substantiative change accrued due to the contingent attention. The behaviours selected for treatment were those which staff were most willing to reinforce. This variable may account, in part at least, for the generalization of treatment effects to the natural environment with persons who received social skills training.

Dangerousness commitments: indices of future violence potential?

This study examines the accuracy of long-term clinical predictions of dangerousness among psychiatric inpatients and explores factors influencing the levels of such accuracy. Hospital and state criminal history records of all psychiatric patients (N = 31) for whom, during a four-year period, treatment staff pursued extended civil commitments based on dangerousness under the Postcertification for the imminently Dangerous statute (California Welfare and Institutions Code section 5300) were reviewed. A matched control group consisted of 31 patients who had been placed on 14-Day Certifications for Dangerousness to Others, but who were not subsequently placed on 180-Day Postcertifications. Sixty-one percent of patients in the postcertification group engaged in documented physically assaultive behavior during the extended one- to five-year follow-up period, compared with 26 percent of patients in the matched control group, suggesting that inclusion in the extended commitment group was indicative of greater long-term potential for assault. Differences in assaultiveness did not emerge during the first year of followup, but became clear and significant over subsequent years. Accuracy of prediction differed as a function of patient ethnic group.

Endogeneity and reactivity as orthogonal dimensions in depression.

Endogeneity and reactivity have long been considered polar opposites of a major dimension of depression. The present factor analytic study examines 35 distinct depressive symptoms in three depressed samples and supports the conceptualization of D. F. Klein (Endomorphic depression. Arch. Gen. Psychiatry, 31:447-454, 1974) that endogeneity and reactivity can be construed as orthogonal, independent dimensions. Symptoms consistently loading on an endogeneity factor are: 1) lacking in reactivity to environmental changes; 2)showing no interest in life; 3) retarded (slow, feeling tired, etc.); 4) feeling unable to act; 5) considering self lazy; 6) feeling helpless and powerless; and 7) perceiving depression as qualitatively different from ordinary sadness. Symptoms consistently loading on a reactivity factor are: 1) feeling that he or she is bearing troubles; 2) presence of precipitating stress; 3) crediting problems to excessive family and/or job responsiblitiies; 4) expressing concern for welfare of family and friends; 5) visceral symptoms; 6) feeling at "end of rope"; 7) having middle-of-the-night insomnia; and 8) showing self-pity. The results suggest a methodology for identifying depressives who are high-high, low-high, high-low, and low-low on the endogeneity and reactivity factors.

Comparison of polymerized and unpolymerized antigen E for immunotherapy of ragweed allergy.

Polymerization of ragweed antigen into high-molecular-weight polymers could improve immunotherapy for ragweed pollinosis by reducing side effects while retaining immunogenicity. To study this thesis, 23 ragweed-sensitive patients were treated with either ordinary ragweed antigen E or ragweed antingen E polymerized by glutaraldehyde. Four patients received the polymerized antigen, and six controls ordinary antigen according to the standard immunotherapy schedule; two groups of three patients received either form by a "doubling-dose" schedule. Seven subjects received the polymerized antigen by a schedule in which each successive dose was tripled. Serum antigen E binding capacity (blocking antibody) increased significantly in all subjects (P less than 0.001 by Student-test). Patients treated with polymerized antigen had fewer local and generalized reactions than those receiving the monomeric preparation. Polymerized ragweed antigen permits more rapid immunization of atopic persons, with fewer side effects than standard monomeric preparations.