PMA - Zeolite (Clinoptilolite) in the Management of Irritable Bowel Syndrome - a Non-Interventional Study.

In clinical practice, the treatment of patients with irritable bowel syndrome (IBS) can be very challenging. The aims of the present non-interventional study (NIS) were to investigate the tolerability and efficacy of PMA-zeolite under everyday conditions in patients with diarrheic IBS type (IBS-D) or constipated type (IBS-C) or mixed type (IBS-M). METHODS: To document prospective data on tolerability and symptom frequency in the frame of a nationwide NIS, we recruited 204 IBS patients. The study focused on the IBS-related quality of life (measured by the SF-36 questionnaire) and improvements of IBS-related symptoms according to specific ROM-III criteria and stool consistency (Bristol stool scale). The participants documented their abdominal pain, bloating, number of bowel movements, and stool consistency through a web-based internet platform (initial and exit questionnaires) and daily diary entries over the period of intake (8 weeks). RESULTS: A total of 82.2% of the recruited patients had filled in the questionnaires before and after the 8-week treatment with PMA-zeolite. Seven of the eight subscales of the SF-36 improved significantly (p<0,001); the reduction in abdominal pain was especially significant (p<0,001). The diary entries confirmed the reduction in abdominal pain and revealed a significant reduction in days with bloating (p<0,001). The Bristol-stool-scale analysis showed improvements; particularly, patients with IBS-D benefited from the treatment (p<0,001). CONCLUSION: The treatment duration of 8 weeks was well tolerated by most patients. Under everyday life conditions, PMA-zeolite alleviated the global IBS-related symptoms and raised the quality of life (QOL). The PMA-zeolite, thus, may represent a good adjuvant therapeutic option for patients with irritable bowel syndrome.

Predictors of Functional Outcome in Patients With Bipolar Disorder: Effects of Cognitive Psychoeducational Group Therapy After 12 Months.

Background: Cognitive deficits are known as a core feature in bipolar disorder. Persisting neurocognitive impairment is associated with low psychosocial functioning. The aim of this study was to identify potential cognitive, clinical and treatment-dependent predictors for functional impairment, symptom severity and early recurrence in bipolar patients, as well as to analyze neurocognitive performance compared to healthy controls. Methods: Forty three remitted bipolar patients and 40 healthy controls were assessed with a neurocognitive battery testing specifically attention, memory, verbal fluency and executive functions. In a randomized controlled trial, remitted patients were assigned to two treatment conditions as add-on to state-of-the-art pharmacotherapy: cognitive psychoeducational group therapy over 14 weeks or treatment-as-usual. At 12 months after therapy, functional impairment and severity of symptoms were assessed. Results: Compared to healthy controls, bipolar patients showed lower performance in executive function (perseverative errors p < 0.01, categories correct p < 0.001), sustained attention (total hits p < 0.001), verbal learning (delayed recall p < 0.001) and verbal fluency (p-words p < 0.002). Cognitive psychoeducational group therapy and attention predicted occupational functioning with a hit ratio of 87.5%. Verbal memory recall was found to be a predictor for symptom severity (hit ratio 86.8%). Recurrence in the follow-up period was predicted by premorbid IQ and by years of education (hit ratio 77.8%). Limitations: Limitations of the present study result mainly from a small sample size. The extent of cognitive impairment appears to impact occupational disability, clinical outcome as well as recurrence rate. This result must be interpreted with caution because statistical analysis failed to show higher significance. Conclusions: Bipolar patients benefit from cognitive psychoeducational group therapy in the domain of occupational life. Deficits in sustained attention have an impact on occupational impairment. Implications for treatment strategies are discussed. Further evaluation in larger studies is needed.

Awareness of olfactory dysfunction in Parkinson's disease.

OBJECTIVE: Olfactory impairment is a very common symptom in Parkinson's disease (PD). However, individuals often overestimate their ability to smell. Hyposmia and metacognitive errors are also related to aging, depression, male gender and cognitive impairment. The current study investigated the awareness of olfactory functioning in PD and the influence of additional factors. METHOD: A sample of 124 nondemented PD patients and 154 elderly controls was assessed with the Sniffin' Sticks Odor Identification Test (OIT) and the Subjective Olfactory Capability (SOC) domain of the Assessment of Self-Reported Olfactory Functioning and Olfaction-Related Quality of Life, additional to measures of depressive symptoms, verbal memory and executive functioning. Olfactory awareness groups were formed by means of the cut-offs of the OIT and the SOC. RESULTS: Significant correlations between the OIT and the SOC were moderate in participants with PD and small in controls. Of all PD patients, 52% overrated their sense of smell while 27% correctly identified themselves as being hyposmic, as opposed to corresponding 6% and 1% of healthy elderly. Overrating and aware of being hyposmic participants with PD showed worse executive functions than PD patients who were objectively and subjectively normosmic. CONCLUSIONS: The findings imply that, although people with PD are aware of hyposmia to some extent, the majority is affected by overestimation of the ability to smell, making self-reported functioning an unreliable source of information. Moreover, reduced odor identification and impaired executive functioning might underlie the same pathological changes within the brain and could serve as a marker for cognitive impairment in PD. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Perception of aesthetics and personality traits in orthognathic surgery patients: A comparison of still and moving images.

It is common in practicing orthognathic surgery to evaluate faces with retruded or protruded chins (dysgnathic faces) using photographs. Because motion may alter how the face is perceived, we investigated the perception of faces presented via photographs and videos. Two hundred naïve raters (lay persons, without maxillo facial surgery background) evaluated 12 subjects with varying chin anatomy [so-called skeletal Class I (normal chin), Class II (retruded chin), and Class III (protruded chin)]. Starting from eight traits, with Factor analysis we found a two-Factor solution, i.e. an "aesthetics associated traits cluster" and a Factor "personality traits cluster" which appeared to be uncorrelated. Internal consistency of the Factors found for photographs and videos was excellent. Generally, female raters delivered better ratings than males, but the effect sizes were small. We analyzed differences and the respective effect magnitude between photograph and video perception. For each skeletal class the aesthetics associated dimensions were rated similarly between photographs and video clips. In contrast, specific personality traits were rated differently. Differences in the class-specific personality traits seen on photographs were "smoothed" in the assessment of videos, which implies that photos enhance stereotypes commonly attributed to a retruded or protruded chin.

Facial esthetics and the assignment of personality traits before and after orthognathic surgery rated on video clips.

Typically, before and after surgical correction faces are assessed on still images by surgeons, orthodontists, the patients, and family members. We hypothesized that judgment of faces in motion and by naïve raters may closer reflect the impact on patients' real life, and the treatment impact on e.g. career chances. Therefore we assessed faces from dysgnathic patients (Class II, III and Laterognathia) on video clips. Class I faces served as anchor and controls. Each patient's face was assessed twice before and after treatment in changing sequence, by 155 naïve raters with similar age to the patients. The raters provided independent estimates on aesthetic trait pairs like ugly /beautiful, and personality trait pairs like dominant /flexible. Furthermore the perception of attractiveness, intelligence, health, the persons' erotic aura, faithfulness, and five additional items were rated. We estimated the significance of the perceived treatment related differences and the respective effect size by general linear models for repeated measures. The obtained results were comparable to our previous rating on still images. There was an overall trend, that faces in video clips are rated along common stereotypes to a lesser extent than photographs. We observed significant class differences and treatment related changes of most aesthetic traits (e.g. beauty, attractiveness), these were comparable to intelligence, erotic aura and to some extend healthy appearance. While some personality traits (e.g. faithfulness) did not differ between the classes and between baseline and after treatment, we found that the intervention significantly and effectively altered the perception of the personality trait self-confidence. The effect size was highest in Class III patients, smallest in Class II patients, and in between for patients with Laterognathia. All dysgnathic patients benefitted from orthognathic surgery. We conclude that motion can mitigate marked stereotypes but does not entirely offset the mostly negative perception of dysgnathic faces.

Child abuse and neglect in institutional settings, cumulative lifetime traumatization, and psychopathological long-term correlates in adult survivors: The Vienna Institutional Abuse Study.

Child maltreatment (CM) in foster care settings (i.e., institutional abuse, IA) is known to have negative effects on adult survivor's mental health. This study examines and compares the extent of CM (physical, emotional, and sexual abuse; physical and emotional neglect) and lifetime traumatization with regard to current adult mental health in a group of survivors of IA and a comparison group from the community. Participants in the foster care group (n = 220) were adult survivors of IA in Viennese foster care institutions, the comparison group (n = 234) consisted of persons from the Viennese population. The comparison group included persons who were exposed to CM within their families. Participants completed the Childhood Trauma Questionnaire, the Life Events Checklist for DSM-5, the PTSD Checklist for DSM-5, the International Trauma Questionnaire for ICD-11, and the Brief Symptom Inventory-18 and completed a structured clinical interview. Participants in the foster care group showed higher scores in all types of CM than the comparison group and 57.7% reported exposure to all types of CM. The foster care group had significantly higher prevalence rates in almost all mental disorders including personality disorders and suffered from higher symptom distress in all dimensional measures of psychopathology including depression, anxiety, somatization, dissociation, and the symptom dimensions of PTSD. In both groups, adult life events and some but not all forms of CM predicted PTSD and adult life events partly mediated the association of PTSD and CM. Explanations for the severe consequences of CM and IA are discussed.

Emotion regulation and mental well-being before and six months after bariatric surgery.

PURPOSE: According to the current state of research, mental health improves due to bariatric surgery. However, improvements in weight and psychosocial aspects often show a gradual decline with time. As emotion regulation (ER) appears to be a key variable in the successful outcome of weight loss treatments, the present study aimed at investigating ER-strategies applied by bariatric surgery candidates pre- and post-surgery and examining interactions between ER, depressive symptoms, health-related quality of life (HrQoL), and post-surgical weight loss. METHODS: Prior to and 6 months after bariatric surgery, 45 patients (76% women) completed self-report questionnaires assessing depressive symptoms (Beck Depression Inventory-II), HrQoL (Short Form-36 Health Survey), and ER-strategies (Emotion Regulation Inventory for Negative Emotions). RESULTS: Six months post-surgery, the patients reported significant improvements in depressive symptomatology, HrQoL, and satisfaction with ER compared to pre-surgery. Groups differing in their course of ER-satisfaction also differed in psychosocial dimensions pre- to post-surgery, increased satisfaction being related to less impairment and enhanced communication of negative emotions as a form of an adaptive regulation. Patients with higher weight loss applied the strategy of controlled expression more frequently post-surgery than pre-surgery and compared to patients with lower weight loss. CONCLUSIONS: Postoperative weight loss leads to improvements in ER-satisfaction and mental well-being. As satisfaction with ER seems to be associated with less impaired mental well-being among bariatric surgery candidates, presumably even more positive psychosocial outcomes could be obtained post-surgery by implementing trainings explicitly encouraging the use of adaptive ER-strategies.

Assessment of nasalance and nasality in patients with a repaired cleft palate.

In patients with a repaired cleft palate, nasality is typically diagnosed by speech language pathologists. In addition, there are various instruments to objectively diagnose nasalance. To explore the potential of nasalance measurements after cleft palate repair by NasalView®, we correlated perceptual nasality and instrumentally measured nasalance of eight speech items and determined the relationship between sensitivity and specificity of the nasalance measures by receiver-operating characteristics (ROC) analyses and AUC (area under the curve) computation for each single test item and specific item groups. We recruited patients with a primarily repaired cleft palate receiving speech therapy during follow-up. During a single day visit, perceptive and instrumental assessments were obtained in 36 patients and analyzed. The individual perceptual nasality was assigned to one of four categories; the corresponding instrumental nasalance measures for the eight specific speech items were expressed on a metric scale (1-100). With reference to the perceptual diagnoses, we observed 3 nasal and one oral test item with high sensitivity. However, the specificity of the nasality indicating measures was rather low. The four best speech items with the highest sensitivity provided scores ranging from 96.43 to 100%, while the averaged sensitivity of all eight items was below 90%. We conclude that perceptive evaluation of nasality remains state of the art. For clinical follow-up, instrumental nasalance assessment can objectively document subtle changes by analysis of four speech items only. Further studies are warranted to determine the applicability of instrumental nasalance measures in the clinical routine, using discriminative items only.

Opioid Maintenance Treatment--A Call for a Joint European Quality Care Approach.

AIMS: The aim of this exploratory analysis of European Quality Audit of Opioid Treatment data was to identify areas of improvement for current opioid maintenance treatment (OMT) approaches. METHODS: Factors facilitating treatment entry, retention and refusal were compared between 8 European countries and between OMT patient (OMT-P) and active opioid user (AOU) sample groups. Both groups were divided into those who had never had OMT before (un-experienced OMT-P (n = 573) and AOU (n = 360)) and those who had been maintained at least once prior to this investigation (experienced OMT-P (n = 746) and AOU (n = 377)). RESULTS: The European comparison showed that motives for starting OMT vary distinctly between countries (p ≤ 0.001). Transnationally, experienced AOU reported concerns about their ability to follow treatment rules and negative treatment experiences as decisive reasons for staying out of OMT. Greater flexibility, less pressure to reduce their treatment dose and greater treatment structure were ranked significantly higher by experienced compared to un-experienced OMT-P as factors that might facilitate treatment retention (p ≤ 0.05). CONCLUSION: Increasing awareness of potential shortcomings of OMT delivery systems is crucial to optimally match treatment approaches to patient needs and also to reduce the considerable economic burden of addiction to society.

Aspects of social support and disclosure in the context of institutional abuse - long-term impact on mental health.

BACKGROUND: The psychological sequelae of institutionalized abuse and its long-term consequences has not been systematically documented in existing literature in regarding social support once disclosure has been made. Reporting abuse is crucial, in particular for adult victims of childhood IA within the Catholic Church. Nevertheless, there is ongoing controversy about the benefits of disclosure. Our study examines the interaction of disclosure and subsequent social support in relation to mental health. We look into the times of disclosure, the behaviour during the disclosure to a commission as adults, different level of perceived social support, and the effect on mental health. METHODS: The data were collected in a sample of financially compensated adult survivors who experienced institutionalized abuse during their childhood, using instruments to measure perceived social support, reaction to disclosure, PTSD, and further symptoms. RESULTS: High levels of perceived social support after early disclosure result in a higher level of mental health and contribute to less emotionally reactive behaviour during disclosure of past institutionalized abuse. Highly perceived levels of social support seem to play a crucial role in mental health, but this inference may be weakened by a possible interference of a lasting competence in looking for social support versus social influences. CONCLUSION: Future research should thus disentangle perceived social support into the competence of looking for social support versus socially influenced factors to provide more clarity about the positive association of perceived social support and mental health.

Information preferences regarding cure rates and prognosis of Austrian patients with advanced lung cancer.

INTRODUCTION: Due to concerns about patients' wellbeing, open end-of-life communication is associated with reservation. Furthermore, sociocultural differences must be considered. The objective of this pilot study was therefore to investigate the information preferences of Austrian patients regarding cure rates and prognosis. PATIENTS AND METHODS: The information preferences of 50 advanced lung cancer patients were assessed at their first visit to the Department of Radiation Oncology, Medical University of Vienna. Preferences in terms of content (cure rates and/or prognosis) and depth of the information (additional quantitative estimates) were addressed. After the individually adapted medical consultation, patients' satisfaction with the consultation and the emotional responses to the information were evaluated. RESULTS: The majority of patients (76 %) requested information about cure rates and/or prognosis; nearly half of these (47 %) wanted additional quantitative estimates. Neither sociodemographic variables, disease characteristics, nor time since diagnosis had an impact on the information preferences. The individually adapted medical information showed no overall negative influence on the emotional responses; only patients receiving prognostic information had significantly higher distress scores after the consultation. High satisfaction with the individually adapted medical consultation was reported by 92 % of patients. CONCLUSION: Austrian physicians may offer end-of-life communication and directly ask patients about their information preferences, since patients seem able to decide whether or not prognostic information would overwhelm their emotional capacity and therefore to accept or reject the invitation. The disclosure of cure rates and/or prognosis with or without quantitative estimates-according to the patients' preferences-shows overall no negative impact on emotional reactions. The individually adapted consultation results in high patient satisfaction. Nevertheless, prognostic information may lead to higher distress.

Resilience and mental health in adult survivors of child abuse associated with the institution of the Austrian Catholic Church.

In recent years, reports of institutional abuse within the Catholic Church have emerged and research on the consequences on mental health is in its beginnings. In this study, we report findings on current mental health and resilience in a sample of adult survivors of institutional abuse (N = 185). We compared 3 groups of survivors that differed regarding their current mental health to investigate aspects of resilience, coping, and disclosure. The majority of the sample was male (76.2%), the mean age was 56.28 (SD = 9.46) years, and more than 50.0% of the sample was cohabiting/married. Most of the survivors reported severe mental health problems. Known protective factors (education, social support, age) were not associated with mental health in our sample. Our findings corroborate that institutional abuse has long-term effects on mental health. We found that fewer emotional reactions during disclosure, task-oriented coping, and optimism were associated with better mental health. The study was limited by a cross-sectional design, but we conclude that the kind of institutional abuse reported is especially adverse, and thus typical protective factors for mental health do not apply. Future research should focus on intrapersonal factors and institutional dynamics to improve treatment for persons affected by institutional abuse.

Institutional abuse of children in the Austrian Catholic Church: types of abuse and impact on adult survivors' current mental health.

The aim of this study was to explore the nature and dimensions of institutional child abuse (IA) by the Austrian Catholic Church and to investigate the current mental health of adult survivors. Data were collected in two steps. First, documents of 448 adult survivors of IA (M=55.1 years, 75.7% men) who had disclosed their abuse history to a victim protection commission were collected. Different types of abuse, perpetrator characteristics, and family related risk factors were investigated. Second, a sample of 185 adult survivors completed the Posttraumatic Stress Disorder Checklist (PCL-C) and the Brief Symptom Inventory (BSI). Participants reported an enormous diversity of acts of violent physical, sexual, and emotional abuse that had occurred in their childhood. The majority of adult survivors (83.3%) experienced emotional abuse. Rates of sexual (68.8%) and physical abuse (68.3%) were almost equally high. The prevalence of PTSD was 48.6% and 84.9% showed clinically relevant symptoms in at least one 1 of 10 symptom dimensions (9 BSI subscales and PTSD). No specific pre-IA influence was found to influence the development of PTSD in later life (e.g. poverty, domestic violence). However, survivors with PTSD reported a significantly higher total number of family related risk factors (d=0.33). We conclude that childhood IA includes a wide spectrum of violent acts, and has a massive negative impact on the current mental health of adult survivors. We address the long-term effects of these traumatic experiences in addition to trauma re-activation in adulthood as both bear great challenges for professionals working with survivors.

Lessons learned from a comparison of evidence-based research in pregnant opioid-dependent women.

OBJECTIVES: Lessons learned in research and treatment of opioid dependence demonstrate the need to include pregnant women in clinical trials. METHODS: Two double-blind, double-dummy, randomized controlled trials (Pilot study, European sample(†) of MOTHER-trial) comparing buprenorphine and methadone in opioid-dependent pregnant women were conducted. In both studies, participants received voucher-based incentives for attendance and completion of study assessments. In the MOTHER trial, participants additionally received escalating voucher incentives for drug-free urine samples. Neonatal abstinence syndrome was treated with oral morphine solution based on standardized modified Finnegan scores. RESULTS: After a mean treatment period of 13.79 weeks in the Pilot study (PS, n = 18) and 20.78 weeks in the MOTHER-trial (MT, n = 41), respectively (p < 0.001), PS patients delivered at mean doses of 14.00 mg buprenorphine/52.50 mg methadone and MT participants at 13.44 mg buprenorphine/63.68 mg methadone. Nonsignificant differences regarding dropout rates were found (22% in PS versus 10% in MT), but dropout was significantly earlier in the MT (p = 0.013). Significantly higher rates of concomitant consumption of opioids and benzodiazepines occurred in the PS compared with the MT (p < 0.001), however, with no significant differences in neonatal data between both settings. CONCLUSIONS: Early treatment enrolment combined with contingency management contributes to reduced illicit drug use throughout pregnancy, surprisingly without influencing neonatal outcome parameters.

Influence of site differences between urban and rural American and Central European opioid-dependent pregnant women and neonatal outcome characteristics.

BACKGROUND: Multi-center trials enable the recruitment of larger study samples, although results might be influenced by site-specific factors. METHODS: Site differences of a multi-center prospective double-blind, double-dummy randomized controlled trial (7 centers: Central Europe (Vienna)/USA (3 urban/3 rural centers)) comparing safety and efficacy of methadone and buprenorphine in pregnant opioid-dependent women and their neonates. RESULTS: Urban US women had the highest rate of concomitant opioid (p = 0.050) and cocaine consumption (p = 0.003), the highest dropout rate (p = 0.001), and received the lowest voucher sums (p = 0.001). Viennese neonates had significantly higher Apgar scores 1 min (p = 0.001) and 5 min after birth (p < 0.001) and were more often born by cesarean section (p = 0.024). Rural US newborns had a significantly shorter neonatal abstinence syndrome treatment duration compared to Viennese and urban US sites (p = 0.006), in addition to other site-specific differences, suggesting a more severely affected group of women in the urban US sites. CONCLUSION: This clinical trial represents a role model for pharmacological treatment in this unique sample of pregnant women and demonstrates the clinical importance of considering site-specific factors in research and clinical practice.

Are male neonates more vulnerable to neonatal abstinence syndrome than female neonates?

BACKGROUND: Prior studies have shown an increased vulnerability among males to adverse outcomes during the postnatal period. Most children exposed to opioids and other medications in utero develop neonatal abstinence syndrome (NAS), yet individual predisposition for NAS is poorly understood. OBJECTIVE: This investigation examined the role of neonatal sex in the postnatal period for neonates exposed to standardized opioid maintenance treatment in utero with a focus on NAS regarding severity, medication requirements, and duration. METHODS: This was a secondary analysis of data collected in a prospective randomized, double-blind, double-dummy, multicenter trial (MOTHER study) that examined the comparative safety and efficacy of methadone and buprenorphine during pregnancy. A total of 131 neonates born to opioid-dependent women randomized at 6 US sites (n = 74) and 1 European site (n = 37) were analyzed. Sex-based differences in birth weight, length, head circumference, NAS duration, NAS severity, and treatment parameters of full-term neonates were assessed. RESULTS: Males had a significantly higher birth weight (P = 0.027) and head circumference (P = 0.017) compared with females, with no significant sex difference in rates of preterm delivery. No significant sex-related differences were found for NAS development, severity, or duration, or medication administered, and there were no significant differences in concomitant drug consumption during pregnancy (P = 0.959). CONCLUSIONS: This unique prospective study shows similar postnatal vulnerability for both sexes, suggesting that factors other than sex are the major determinants of clinically significant NAS. ClinicalTrials.gov identifier: NCT 00271219.

Impact of treatment approach on maternal and neonatal outcome in pregnant opioid-maintained women.

OBJECTIVE: The objective of this study is to compare maternal and neonatal outcome of opioid-dependent women maintained on buprenorphine or methadone throughout pregnancy in a randomized double-blind double-dummy clinical trial (CT) with a comparison group undergoing a structured standard protocol (SP) at the Medical University of Vienna, Austria. METHODS: One hundred and fourteen subjects were included in the analysis, with 77 in SP (n = 51 methadone, n = 26 buprenorphine), and 37 in CT (n = 19 methadone, n = 18 buprenorphine), comparing maternal concomitant consumption during third trimester, demographic birth data, duration of treatment for neonatal abstinence syndrome (NAS), morphine dose for NAS treatment and length of hospital stay (LOS). RESULTS: Both study groups yielded healthy neonates with no significant demographic differences and equivalently low rates of positive maternal urine toxicologies. However, NAS parameters were significantly better in CT regarding total medication dose administered to neonates (p = 0.014) and LOS (p = 0.015). Superior results were achieved in buprenorphine compared with methadone-exposed neonates regarding gestational age at birth (p = 0.003), birth weight (p = 0.011), total morphine dose administered (p = 0.008), NAS treatment duration (p = 0.008) and LOS (p = 0.001). CONCLUSIONS: Comparably favorable outcome for mothers and infants and efficacy and safety of opioid medications were shown in both treatment approaches. Neonatal care could benefit from transferring successful CT procedures into clinical practice.

Randomized controlled trials in pregnancy: scientific and ethical aspects. Exposure to different opioid medications during pregnancy in an intra-individual comparison.

BACKGROUND: Chronic medical conditions such as opioid dependence require evidence-based treatment recommendations. However, pregnant women are under-represented in clinical trials. We describe the first within-subject comparison of maternal and neonatal outcomes for methadone- versus buprenorphine-exposed pregnancies. Although methadone is the established treatment of pregnant opioid-dependent women, recent investigations have shown a trend for a milder neonatal abstinence syndrome (NAS) under buprenorphine. However, it is not only the choice of maintenance medication that determines the occurrence of NAS; other factors such as maternal metabolism, illicit substance abuse and nicotine consumption also influence its severity and duration and represent confounding factors in the assessment of randomized clinical trials. CASE SERIES DESCRIPTION: Three women who were part of the European cohort of a randomized, double-blind multi-center trial with a contingency management tool [the Maternal Opioid Treatment: Human Experimental Research (MOTHER) study], each had two consecutive pregnancies and were maintained on either methadone or buprenorphine for their first and then the respective opposite, still-blinded medication for their second pregnancy. Birth measurements, the total neonatal abstinence score, the total amounts of medication used to treat NAS and the days of NAS treatment duration were assessed. RESULTS: Both medications were effective and safe in reducing illicit opioid relapse and avoiding preterm labor. Methadone maintenance yielded to a significantly higher neonatal birth weight. Data patterns suggest that buprenorphine exposure was associated with lower neonatal abstinence syndrome (NAS) scores. Findings from this unique case series are consistent with earlier reports using between-group analyses. CONCLUSIONS: Buprenorphine has the potential to become an established treatment alternative to methadone for pregnant opioid-dependent women. Under special consideration of ethical boundaries, psychopharmacological treatment during pregnancy must be addressed as an integral part of clinical research projects in order to optimize treatment for women and neonates.

Association between prenatal tobacco exposure and outcome of neonates born to opioid-maintained mothers. Implications for treatment.

BACKGROUND: Prenatal nicotine exposure is associated with increased neonatal mortality, low birth weight, and smaller head circumference. Opioid-dependent pregnant women show a particularly high prevalence of tobacco smoking and are at greater risk for additional adverse events. However, little is known about the impact of tobacco smoking on opioid-maintained pregnant women and neonatal outcomes. PATIENTS AND METHODS: This study examined the effect of cigarette smoking on 139 opioid-maintained pregnant women and their neonates. Forty-five percent of the participants were maintained on slow-release oral morphine (SROM), 39% received methadone maintenance, and 16% received buprenorphine. Participants were divided into two groups: (1) women who reported a low cigarette consumption of < or =10 cigarettes/day (56.8%) and (2) those reporting heavy consumption of > or =20 cigarettes/day (43.2%). Neonatal outcome measures were assessed, and a standardized Finnegan score was applied to determine the neonatal abstinence syndrome (NAS). RESULTS: Fifty-two percent of the newborns did not require treatment for NAS (54% of neonates born to methadone-maintained mothers, 30% born to SROM-maintained mothers, and 95% born to buprenorphine-maintained mothers; p < 0.001). Heavy cigarette consumption was associated with significantly lower neonatal birth weight (p < 0.001), smaller birth length (p = 0.017) as well as with the severity of NAS (p = 0.03). With regard to concomitant consumption of opioids (p = 0.54), cocaine (p = 0.25), amphetamines (p = 0.90) or benzodiazepines (p = 0.09), no significant differences between heavy or low nicotine consumption were noted. CONCLUSION: Heavy tobacco smoking in opioid-maintained pregnant women is associated with adverse medical and developmental consequences for the newborn. Future treatment programs for this target group should focus on an individualized approach to opioid maintenance therapy in addition to offering specially tailored counseling for smoking cessation.

[The relationship between tinnitus, personality, and depression]. / Der Zusammenhang von Tinnitus, Persönlichkeit und Depression.

OBJECTIVE: This study examines the relationship between personality characteristics, depression symptoms, demographic profile, and the amount of the tinnitus-related distress experienced. METHOD: 121 patients suffering from tinnitus were examined by unique testing in a tinnitus-practice via three questionnaires over a period of 22 months. RESULTS: A relationship between the severity of tinnitus-related distress and demographic profile as well as a relationship between depression symptoms and the severity of the tinnitus-related distress could be shown. Also, significant results were observed within the personality range in the areas of "impulsiveness," "aggressiveness," "demands," "physical discomfort," "health worries," und "emotionality." DISCUSSION: Patients suffering severely from tinnitus represent a clinically relevant group for psychotherapeutic treatment. Especially persons with comorbid symptoms of depression should be screened regularly and offered additional psychotherapeutic or psychiatric treatment.