The Anthroposophic Artistic Movement Assessment for Eurythmy Therapy (AART-ASSESS-EuMove). A validation study.

OBJECTIVE: Eurythmy Therapy (ET) is a mindfulness oriented therapy developed in the context of anthroposophic medicine. Despite commonly used in practice, it remains unclear whether active participation (Inner Correspondence) during ET can be observed in eurythmy gestures (EGest). So far, no validated peer-report instrument to evaluate EGest exists. METHOD: To validate an 83-item ET peer-report scale, a nested study on a sample of n = 82 breast cancer survivors with cancer-related fatigue was conducted. EGest were evaluated twice, at baseline and at 10-week follow-up, by peer-reports from two separate therapists. Interrater-reliability (IRR) was estimated by Cohen's weighted kappa (κw) across all items. Additionally, reliability-(RA) and principal component analyses (PCA) were conducted. Patients completed two self-report scales: Satisfaction with ET (SET) and Inner Correspondence with the Movement Therapy (ICPH). RESULTS: IRR was greater than or equal (κw ≥ 0.25) for 41 items (49.3%) with a mean weighted kappa of κ̅w = 0.40 (SD = 0.17, range = 0.25-0.85). RA resulted in the exclusion of 25 items with insufficient item-total correlations < 0.40. A PCA with 16 items revealed 3 subscales: 1. Mindfulness in Movement (8 items), 2. Motor Skills (5 items), 3. Walking Pattern (3items) explaining 63.86% of total variance. Internal consistency (Cronbach's alpha) was high for the sum score with α = 0.89 and for the subscales with α = 0.88, 0.86 and 0.84 respectively. Significant small to moderate subscale correlations were found ranging from r = 0.29-0.63 (all p < 0.01). Mindfulness in Movement correlated with Inner Correspondence (r = 0.32) and with Satisfaction with ET (r = - 0.25, both p < 0.05). CONCLUSIONS: The new AART-ASSESS-EuMove is the first consistent and reliable peer-report instrument to evaluate EGest. It shows associations between peer-reported Mindful Movement and patients' self-reported ICPH and SET.

Four-year follow-up on fatigue and sleep quality of a three-armed partly randomized controlled study in breast cancer survivors with cancer-related fatigue.

Cancer-related fatigue (CRF) is a frequent long-term symptom in non-metastasized breast cancer patients (BC). This 4-year follow-up intended to compare the long-term effects of a 10-week multimodal therapy (MT: sleep education, psychoeducation, eurythmy- and painting therapy) and combination therapy [CT: MT plus aerobic training (AT)] to AT-control. BC-patients were randomized or allocated by preference to three arms in a comprehensive cohort study. Primary outcome was a composite score including Pittsburgh Sleep Quality Index (PSQI) and Cancer Fatigue Scale (CFS-D), captured at baseline, after 10 weeks of intervention (T1), 6 months later (T2), and after 4 years (T3). We exploratively tested for superiority of MT and CT versus AT after 4 years (T3) based on the statistical model of the main analysis. Of 126 (65 randomized) BC-patients included, 105 started treatments and 79 were re-assessed for long-term effects (T3). MT and CT were superior over AT after 4 years regarding PSQI/CFS-D and PSQI sum-score, respectively (all p < 0.05), but not for CFS-D. The multimodal and combination treatment for breast cancer patients with CRF indicates sustainable long-term superiority over aerobic training for the outcomes sleep quality and combined sleep quality/fatigue. A confirmative randomized controlled trial is warranted.

The Anthroposophic Art Therapy Assessment Paint (AART-ASSESS-P): A peer-report instrument to assess patients' pictorial expression during Anthroposophic Painting Therapy.

OBJECTIVE: Anthroposophic painting therapy (APT) is a specific form of art therapy that aims to activate self-healing capacities through painting aquarelles. METHODS: The Anthroposophic Art Therapy Assessment-Paint' (AART-ASSESS-P) was developed to measure pictorial expression and validated in the framework of a comprehensive cohort design study. The validation study examined 68 breast cancer patients with fatigue. Art therapists made pre- and post-assessments of spontaneously drawn water-color paintings with a preliminary version of the AART-ASSESS-P (58 items). Inter-rater reliability (IRR) for the items was examined with Cohen's weighted Kappa (κw). Additionally, a reliability- and factor analysis (FA) were conducted. Convergence criteria were patients' self-report measures: the Satisfaction with Painting Therapy, Inner Correspondence with Painting Therapy and the Self-Regulation Questionnaire. RESULTS: IRR for the items was heterogeneous (κw= 0.09-0.89, Mean κw= 0.40, SD = 0.17). Thirty-six items were excluded due to insufficient IRR and item-total correlation (κw= < 0.30, ρitem-total< 0.30). A FA with 22 items revealed 5 subscales: Shape Development (6 items), Shape Arrangement (6 items), Order and Symmetry (5 items), Color Application (3 items), and Color Quality (2 items) explaining 61% of total variance. Psychometric properties for the AART-ASSESS-P were satisfying with Cronbach's alpha coefficients (rα = 0.60-0.81) across subscales. Due to weak inter-subscale correlations (r = 0.18-0.48, p < 0.05) and the ambiguity of face validity a sum-score was not formed. Correlations between subscales and self-reports were small (all p < 0.05). CONCLUSION: The AART-ASSESS-P is the first reliable instrument to measure pictorial expression during APT.

Reliability and first validity of the inner correspondence questionnaire for painting therapy (ICPTh) in a sample of breast cancer patients.

Objectives Art therapy (ArT) such as mindfulness-oriented painting therapy is increasingly used in psychosomatic, oncological integrative and rehabilitative medicine. Though it remains unknown how ArT works, we hypothesize that an engaged participation with painting ('Inner-Correspondence') contributes to improved symptom scores. In the context of a comprehensive cohort study for breast cancer survivors with cancer-related fatigue, we developed a patient-reported outcome measure to assess 'Inner Correspondence' with painting therapy and conducted a first validation study. Design A 24-item questionnaire on 'Inner Correspondence' (ICPTh) was administered after ten weeks of intervention and at six month followup together with concurrent scales (Inner Correspondence and Peaceful Harmony, Cancer Fatigue Scale, Hospital Anxiety and Depression Scale, Internal Coherence Scale). Statistical assessment included reliability- and factor analyses. Results A total of n = 68 BC (mean age, 58.2 years, SD = 8.7) participated in the preliminary validation study. Exploratory factor analysis revealed a robust 22-item scale with an unambiguous four-factor solution explaining 78% of total variance and the following subsales: 1) therapy congruence and relaxation (11 items), 2) inner development and mood (6 items), 3) artistic skill (3 items) and 4) task congruence (2 items). The 22-item ICPTh yielded high reliability (Cronbach's alpha = .966, item-total correlation = .497 - .883, test-retest reliability = .888). Conclusions We present a reliable instrument to measure 'Inner Correspondence' with painting therapy. Due to the small sample size and sample selection further validation studies are indicated.

Do we have predictors of therapy responsiveness for a multimodal therapy concept and aerobic training in breast cancer survivors with chronic cancer-related fatigue?

Cancer-related fatigue (CRF) is a burdensome symptom for breast cancer (BC) patients. In this pilot study, we tested several questionnaires as predictors for treatment responsiveness, along with the implementation of a multimodal therapy concept consisting of sleep, psycho-education, eurythmy, painting therapy and standard aerobic training. At the Community Hospital Havelhöhe and the Hannover Medical School, 31 BC patients suffering from CRF could be evaluated in a 10-week intervention study. CRF was assessed by the Cancer Fatigue Scale (CFS-D). Further questionnaires were the Pittsburgh Sleep Quality Index, the autonomic regulation scale, Self-Regulation Scale (SRS), the Internal Coherence Scale (ICS) and the European Organization of Research and Treatment Health-Related Quality of Life Core Questionnaire scale. We estimated the regression coefficients of all scales on CFS-D by simple and multiple linear regression analyses and compared regression slopes and variances between the different questionnaires on CFS-D at the end of treatment. We found a significant impact of SRS and ICS at baseline on CFS-D at the end of the intervention [absolute standardised multiple regression coefficient values ranging from 0.319 (SRS) to 0.269 (ICS)] but not for the other questionnaires. In conclusion, this study supports the hypothesis that the SRS or ICS measuring adaptive capacities could be more appropriate as outcome predictors than classical questionnaire measures in complex interventions studies.

Impact of autonomic and self-regulation on cancer-related fatigue and distress in breast cancer patients--a prospective observational study.

PURPOSE: Cancer-related fatigue (CRF) has a major impact on the quality of life in breast cancer patients (BC). So far, only a few prospective studies have investigated the effect of adaptive salutogenic mechanisms on CRF. The aim of our study was to evaluate the possible prospective influence of autonomic Regulation (aR) and self-regulation (SR) on CRF and distress in long-term survivors. METHODS: 95 BC and 80 healthy female controls (C) had been included in the observational study between 2000 and 2001 and completed the questionnaires on aR, SR and Hospital Anxiety and Depression Scale (HADS). Of these, 62 BC, and 58 C participated in the re-evaluation 6.6 years later: 16 participants were deceased (14 BC and 2 C). During follow-up, participants were requested to answer questions involving (Cancer Fatigue Scales) CFS-D, aR, SR and HADS. Multiple regression analysis was used to evaluate the influence of aR, SR, age, Charlson co-morbidity-index and diagnosis on CFS-D and HADS, and to select further potentially relevant factors. RESULTS: High aR values showed significant effects, namely inverse relationships with CFS-D, cognitive fatigue, anxiety and depression. SR showed a reduced influence on anxiety and depression (all p < 0.05). CONCLUSIONS: Autonomic regulation might have an independent, reductive influence on global fatigue, cognitive fatigue and--together with self-regulation--it seems to have a protective influence on anxiety and depression. The connection between these parameters is still unclear and awaits further evaluation. IMPLICATION FOR CANCER SURVIVORS: AR seems to be a prognostic factor in breast cancer survivors, capable of reducing cancer-related fatigue and self-regulation distress as well. Further research is necessary in order to show how aR can be improved by therapeutic interventions.

Viscum album [L.] extract therapy in patients with locally advanced or metastatic pancreatic cancer: a randomised clinical trial on overall survival.

BACKGROUND: The unfavourable side-effects of late-stage pancreatic cancer treatments call for non-toxic and effective therapeutic approaches. We compared the overall survival (OS) of patients receiving an extract of Viscum album [L.] (VaL) or no antineoplastic therapy. METHODS: This is a prospective, parallel, open label, monocentre, group-sequential, randomised phase III study. Patients with locally advanced or metastatic cancer of the pancreas were stratified according to a binary prognosis index, composed of tumour stage, age and performance status; and were evenly randomised to subcutaneous injections of VaL extracts or no antineoplastic therapy (control). VaL was applied in a dose-escalating manner from 0.01 mg up to 10mg three times per week. Patients in both groups received best supportive care. The primary end-point was 12-month OS, assessed in a group-sequential analysis. FINDINGS: We present the first interim analysis, including data from 220 patients. Baseline characteristics were well balanced between the study arms. Median OS was 4.8 for VaL and 2.7 months for control patients (prognosis-adjusted hazard ratio, HR=0.49; p<0.0001). Within the 'good' prognosis subgroup, median OS was 6.6 versus 3.2 months (HR=0.43; p<0.0001), within the 'poor' prognosis subgroup, it was 3.4 versus 2.0 months respectively (HR=0.55; p=0.0031). No VaL-related adverse events were observed. CONCLUSION: VaL therapy showed a significant and clinically relevant prolongation of OS. The study findings suggest VaL to be a non-toxic and effective second-line therapy that offers a prolongation of OS as well as less disease-related symptoms for patients with locally advanced or metastatic pancreatic cancer.

Validation of the State Version Questionnaire on Autonomic Regulation (State-aR) for cancer patients.

OBJECTIVES: Current quality of life inventories used in oncology mainly measure the effects of chemo- or radiotherapy alongside functional and role scales. A new approach is to measure the autonomic state of regulation with the trait-inventory of autonomic regulation (Trait-aR). Loss of Trait-aR has been shown in different medical conditions such as breast cancer (BC) but not in colorectal cancer patients (CRC). In this paper we report the validation of a new state autonomic regulation scale (State-aR) of the last week. METHODS: Study 1 included 114 participants: (41 women/16 men with cancer and 57 age- and gender-matched healthy people) to conduct a reliability-, factor- and validity-analysis. Concurrent and convergent validity was evaluated with Trait-aR, Fatigue-Numerical-Scale, Hospital Anxiety and Depression Scale (HADS-D) and the self-regulation scale, 65 participants were retested. Study 2 completed 42 participants: 17 with BC and 25 with CRC receiving chemotherapy. The State-aR was administered prior, during and after chemotherapy for measuring responsiveness. RESULTS: The factor analysis loaded to four subscales of State-aR (rest-activity, orthostatic-circulatory, thermo-sweating and digestive regulation) with a: Cronbach-α r(α) = 0.77?0.83 and a test-retest-reliability r(rt) = 0.60?0.80. The sum- and subscales correlated with their concurrent subscales in the Trait-aR (0.48?0.74) and with the sum-scale moderately with all convergent criteria (r = 0.41?-0.44; p <0.001). During chemotherapy the State-aR-sum and rest-activity-scale decreased significantly compared to the change in the Trait-aR (p <0.05). CONCLUSIONS: These findings support that the state autonomic regulation scale has satisfactory to good reliability, good validity and acceptable responsiveness in the context of chemotherapy treatment.

Calling 911 in response to stroke: no change following a four-year educational campaign.

BACKGROUND: Public awareness campaigns are conducted to increase stroke awareness, yet evidence of their long-term effectiveness is limited. Since 2006, the Czech Stroke Society has conducted an educational campaign throughout the Czech Republic (CR) to increase awareness about stroke. This report evaluates the effectiveness of this campaign by comparing the results of a nationwide survey on stroke awareness in 2009 with the results from 2005. METHODS: In 2009, a nationwide survey was conducted throughout the CR using the same methodology as in 2005 and employing a 3-stage random sampling method (area, household, and household member sampling). Participants >40 years of age were personally interviewed via a structured questionnaire concerning their knowledge and ability to correctly respond to stroke as assessed by the validated Stroke Action Test (STAT). The primary outcome measure was the difference in a STAT score >50% (i.e. respondents chose to call 911 for >50% of stroke symptoms) between 2005 and 2009. Campaign intensity was characterized by a systematic search for media messages about stroke in the CR. RESULTS: A total of 601 interviews were obtained (90% response rate) in 2009 (592 people were interviewed in 2005). A STAT score >50% was achieved by 18% of the respondents both in 2005 and 2009 (p = 0.89). There was no increase in the knowledge of risk factors or warning signs between 2005 and 2009. Respondents who noticed the campaign (19%) had better STAT scores than respondents who did not (25 vs. 17%; p = 0.038). A systematic search revealed that the campaign had reasonable intensity because there were 978 media reports about stroke between 2006 and 2008. CONCLUSIONS: A medium-intensity educational campaign, based on donated advertising media, failed to increase stroke awareness. However, if the campaign had reached more people, it might have been effective. Therefore, in the future, paid advertising media should accompany free media, although such approach would require a substantially larger budget. Awareness campaigns should be constantly evaluated for their effectiveness to develop more successful strategies.

Safety of performing CT angiography in stroke patients treated with intravenous thrombolysis.

OBJECTIVE: Exposure to contrast agents may cause nephrotoxicity. The safety of performing CT angiography without having knowledge of the baseline creatinine level in stroke patients treated with tissue plasminogen activator (tPA) has not been established. METHODS: This is an observational cohort study, with a historical control group to evaluate the safety of CT angiography performed before tPA treatment given within 3 h of symptom onset. The CT angiography group represents all patients treated with tPA between September/2003 and November/2007 who had CT angiography. The control group consists of all patients treated with tPA between January 1999 and August 2003 when CT angiography was not performed. The primary outcome was a creatinine increase in 24-72 h compared with baseline; the secondary outcome was a creatinine increase by > or = 44 micromol/l in 24-72 h and the incidence of symptomatic intracerebral haemorrhage (sICH). RESULTS: Baseline parameters between the CT angiography group (164 patients, age 70+/-11; 91 male) and the control group (77 patients, age 67+/-11; 45 male) were similar. In the CT angiography group, the mean creatinine increase was -0.89 mmol/l and in the control group 2.2 mmol/l (p=0.42). A creatinine increase of > or = 44 micromol/l occurred in five patients (3%) in the CT angiography group and in three patients (4%) in the control group (p=0.50). Also, in the CT angiography group, eight patients (5%) had sICH as compared with three patients (4%) in the control group (p=0.73). CONCLUSION: Contrast agents given for CT angiography, performed in patients with normal and abnormal creatinine level, neither caused renal injury nor interfered with the safety of tPA treatment.

Validation of a questionnaire measuring the regulation of autonomic function.

BACKGROUND: To broaden the range of outcomes that we can measure for patients undergoing treatment for oncological and other chronic conditions, we aimed to validate a questionnaire measuring self-reported autonomic regulation (aR), i.e. to characterise a subject's autonomic functioning by questions on sleeping and waking, vertigo, morningness-eveningness, thermoregulation, perspiration, bowel movements and digestion. METHODS: We administered the questionnaire to 440 participants (female symbol: N = 316, male symbol: N = 124): 95 patients with breast cancer, 49 with colorectal cancer, 60 with diabetes mellitus, 39 with coronary heart disease, 28 with rheumatological conditions, 32 with Hashimoto's disease, 22 with multiple morbidities and 115 healthy people. We administered the questionnaire a second time to 50.2% of the participants. External convergence criteria included the German version of the Hospital Anxiety and Depression Scale (HADS-D), a short questionnaire on morningness-eveningness, the Herdecke Quality of Life Questionnaire (HLQ) and a short version questionnaire on self-regulation. RESULTS: A principal component analysis yielded a three dimensional 18-item inventory of aR. The subscales orthostatic-circulatory, rest/activity and digestive regulation had internal consistency (Cronbach-alpha: ralpha = 0.65 - 0.75) and test-retest reliability (rrt = 0.70 - 85). AR was negatively associated with anxiety, depression, and dysmenorrhoea but positively correlated to HLQ, self-regulation and in part to morningness (except digestive aR) (0.49 - 0.13, all p < 0.05). CONCLUSION: An internal validation of the long-version scale of aR yielded consistent relationships with health versus illness, quality of life and personality. Further studies are required to clarify the issues of external validity, clinical and physiological relevance.

Validation of the German version of the Cancer Fatigue Scale (CFS-D).

Fatigue is a very important factor determining the quality of life in patients with malignancies. Cancer fatigue occurs with anaemia, during and after chemo- or radiotherapy and in patients with advanced tumours. The Cancer Fatigue Scale (CFS) is a three-dimensional inventory with 15 items which was originally developed in Japan. We present the results of a validation study of the German version (CFS-D) of this instrument. The CFS-D was administered to 114 participants in a matched-pair study. In total, 57 (41 women) of the participants had malignant conditions, and 57 (41 women) were healthy volunteers. The Fatigue Numerical Scale was used to test convergence. The physical and performance status of the cancer patients was assessed by the Karnofsky-Index. Criteria for testing multidimensionality were the Hospital Anxiety and Depression Scale, and the questionnaire on autonomic regulation. We generated a three-dimensional inventory of the CFS-D with the subscales physical fatigue/vitality, cognitive and affective fatigue. The reliability results for the complete scale: Cronbach's alpha: r(alpha) = 0.94, retest reliability: r(rt) = 0.82. The convergence criteria correlate between r = 0.44-0.65 (all P < 0.001). The CFS-D is highly reliable and has construct validity in relation to other measures.

Caregivers' perception of HIV-infected Dominican children's behaviour.

Caregivers (mothers and non-mothers) of HIV children face many challenges related to both physical demands and emotional well-being. The perception of caregivers in the Dominican Republic, a country greatly impacted by HIV/AIDS, in regard to their children's behaviour, has not been investigated to date. To extend understanding of the potential behavioural issues involved in providing care to children without access to antiretroviral therapy, the Child Behaviour Checklist was administered to 52 caregivers of HIV Dominican children (2-8 years old). Both mothers and non-mothers perceived significant pathological internalizing behavioural symptoms in immunosuppressed children, compared to children with less disease progression. Analyses of gender comparisons revealed that older female children were perceived as withdrawn/depressed by their caregivers. These findings suggest that children's disease status may be an important contributor to caregiver perception in mothers, as well as non-mothers and indicate that gender-specific relationships warrant further study.

Behavioural symptoms of children with HIV infection living in the Dominican Republic.

OBJECTIVE: The purpose of this report is to describe behavioural problems encountered in a group of Dominican children living with Human Immunodeficency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS) in the Dominican Republic. They were not receiving antiretroviral treatment. METHOD: The participants were 43 children with HIV infection (2 to 8 years of age) who were attending an immunology clinic in the largest paediatric hospital in the Dominican Republic. All of the participants were vertically infected with the HIV virus (mother-to-child transmission) and had a very low socio-economic status. The children's caregivers were administered the Child Behavioural Checklist (CBCL) by trained psychologists to determine the caregivers 'perception of the children's behavioural problems. Behavioural findings were examined according to the CBCL age format: younger children (under 5 years of age) and older children (over 6 years of age). RESULTS: Descriptive statistics revealed a high proportion of the children, both younger (approximately 40%) and older (46%) scored in the borderline/clinical ranges for internalizing problems, including anxiety, withdrawn-depressed and somatic complaints. In addition, 46% of the older children were perceived as having externalizing problems (rule breaking and aggressive behaviour). CONCLUSION: These findings suggest that a high incidence of behavioural and mood problems may be prevalent among Dominican children with HIV Thefindings are discussed in terms of future research to examine other risk factors that might contribute to the high rate of maladaptive behaviours observed in the present report, including the contribution of socio-economic status, caregiver illness, caregiver education and parental loss.

Caregivers' perception of HIV-infected Dominican children's behaviour / La percepción de los encargados del cuidado de la salud en relación con la Conducta de niños dominicanos infestados por vih

Caregivers (mothers and non-mothers) of HIV children face many challenges related to both physical demands and emotional well-being. The perception of caregivers in the Dominican Republic, a country greatly impacted by HIV/AIDS, in regard to their children's behaviour, has not been investigated to date. To extend understanding of the potential behavioural issues involved in providing care to children without access to antiretroviral therapy, the Child Behaviour Checklist was administered to 52 caregivers of HIV Dominican children (2-8 years old). Both mothers and non-mothers perceived significant pathological internalizing behavioural symptoms in immunosuppressed children, compared to children with less disease progression. Analyses of gender comparisons revealed that older female children were perceived as withdrawn/depressed by their caregivers. These findings suggest that children's disease status may be an important contributor to caregiver perception in mothers, as well as non-mothers and indicate that gender-specific relationships warrant further study.

Los encargados del cuidado de la salud (madres y no madres) de niños HIV+ enfrentan muchos retos, tanto en relación con las exigencias físicas cuanto con respecto al estado emocional de los niños. La percepción de los encargados del cuidado de la salud en República Dominicana ­ un país muy impactado por el VIH/SIDA ­ con respecto a la conducta de sus niños, no se ha investigado hasta hoy. A fin de extender la comprensión de los problemas potenciales de comportamiento implícitos en ofrecer cuidado a niños sin acceso a terapia antiretroviral, se administró la Lista de Conductas Infantiles ­ conocida en inglés como Chile Behaviour Checklist ­ a los encargados del cuidado de la salud de los niños dominicanos VIH+ (2 ­ 8 años de edad). Tanto las madres como las no madres percibieron síntomas significativos de conducta de interiorización patológica en los niños inmunodeprimidos, en comparación con los niños con la enfermedad menos avanzada. Los análisis de las comparaciones de género revelaron que las niñas de más edad, pero no los varones, eran percibidas como retraídas/ deprimidas por los encargados del cuidado. Estos hallazgos sugieren que el estatus de la enfermedad de los niños, puede ser un factor que contribuye de forma importante a la percepción de los encargados del cuidado de la salud, ya sean o no madres, e indioan que las relaciones específicas de género merece más estudio

Behavioural symptoms of children with HIV infection living in the Dominican Republic / Síntomas de conducta de los niños infectados por vih en la república dominicana

OBJECTIVE: The purpose of this report is to describe behavioural problems encountered in a group of Dominican children living with Human Immunodeficency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS) in the Dominican Republic. They were not receiving antiretroviral treatment. METHOD: The participants were 43 children with HIV infection (2 to 8 years of age) who were attending an immunology clinic in the largest paediatric hospital in the Dominican Republic. All of the participants were vertically infected with the HIV virus (mother-to-child transmission) and had a very low socio-economic status. The children's caregivers were administered the Child Behavioural Checklist (CBCL) by trained psychologists to determine the caregivers 'perception of the children's behavioural problems. Behavioural findings were examined according to the CBCL age format: younger children (under 5 years of age) and older children (over 6 years of age). RESULTS: Descriptive statistics revealed a high proportion of the children, both younger (approximately 40) and older (46) scored in the borderline/clinical ranges for internalizing problems, including anxiety, withdrawn-depressed and somatic complaints. In addition, 46of the older children were perceived as having externalizing problems (rule breaking and aggressive behaviour). CONCLUSION: These findings suggest that a high incidence of behavioural and mood problems may be prevalent among Dominican children with HIV Thefindings are discussed in terms of future research to examine other risk factors that might contribute to the high rate of maladaptive behaviours observed in the present report, including the contribution of socio-economic status, caregiver illness, caregiver education and parental loss.

Objetivo. El propósito de este reporte es describir los problemas conductuales hallados en un grupo de niños dominicanos que viven con el virus de la inmunodeficiencia humana/síndrome de la inmunodeficiencia humana adquirida (VIH/AIDS) en República Dominicana, sin recibir tratamiento antiretroviral. Método. Los participantes fueron 43 niños (de 2 a 8 años de edad) infectados por el VIH, que asistían a una clínica inmunológica en el mayor hospital pediátrico de la República Dominicana. Todos los participantes estaban verticalmente infectados por el virus del VIH (transmisión de madre a hijo), y tenían un estatus socioeconómico bajo. Con el propósito de determinar la percepción que los encargados del cuidado de los niños tenían de los problemas conductuales de estos, psicólogos profesionales aplicaron a los cuidadores infantiles el instrumento conocido como la Lista de Control de la Conducta del Niño (CBCL). Los hallazgos conductuales fueron examinados de conformidad con el formato de edad de la CBCL: niños menores (por debajo de los 5 años de edad) y niños mayores (más de 6 años de edad) Resultados. Las estadísticas descriptivas revelaron que una alta proporción de niños, tanto menores (aproximadamente 40%) como mayores (46%), alcanzaron puntuaciones en los rangos clínicos/límites de problemas de internalización, incluyendo ansiedad, depresión con retraimiento, y quejas somáticas. Además, del 46% de los niños mayores se tuvo la percepción de que tenían problemas de externalización (rompimiento de las reglas y comportamiento agresivo). Conclusión. Estos hallazgos sugieren que prevalece una alta incidencia de problemas conductuales y anímicos entre los niños dominicanos con VIH. Los hallazgos se discuten en término de una investigación futura a fin de examinar otros factores de riesgo que podrían estar contribuyendo a la alta tasa de comportamientos maladaptativos observados en el reporte presente, incluyendo la contribución del estatus socioeconómico, la enfermedad de los propios cuidadores, la educación de los cuidadores y la pérdida de los padres.

A pilot study on systemic thrombolysis followed by low molecular weight heparin in ischemic stroke.

Low molecular weight heparin (LMWH) administered immediately after intravenous thrombolysis (IT) may reduce the risk of arterial re-occlusion. Its benefit, however, may not outweigh the risk of intracranial hemorrhage (ICH). We sought preliminary data regarding safety of this combined therapy in an open-label, non-randomized study. The patients received either a standard anticoagulation (AC) starting 24 h after IT (the standard AC group) or AC with 2850 IU of nadroparin, given every 12 h immediately after IT (the early AC group). Sixty patients received IT treatment: 25 in the standard AC group [mean age 66, median National Institutes of Health Stroke Scale (NIHSS) 13, 64% men] and 35 in the early AC group (mean age 68, median NIHSS 13, 69% men). Symptomatic ICH occurred in one patient (4%) in the standard AC group and three patients (8.6%) in the early AC group [odds ratio (OR) 1.8; 95%CI 0.2-12.8]. At 3 months, nine patients in the standard AC group (36%) and 16 patients in the early AC group (45.7%) achieved a modified Rankin scale 0 or 1 (OR 1.2; 95%CI 0.5-3.2). Our study suggests that treatment with LMWH could be associated with higher odds of ICH, although it may not necessarily lead to a worse outcome. This justifies larger clinical trials.

Efficacy, safety and tolerability of an orally administered cannabis extract in the treatment of spasticity in patients with multiple sclerosis: a randomized, double-blind, placebo-controlled, crossover study.

OBJECTIVE: Cannabis may alleviate some symptoms associated with multiple sclerosis (MS). This study investigated the effect of an orally administered standardized Cannabis sativa plant extract in MS patients with poorly controlled spasticity. METHODS: During their inpatient rehabilitation programme, 57 patients were enrolled in a prospective, randomized, double-blind, placebo-controlled crossover study of cannabis-extract capsules standardized to 2.5 mg tetrahydrocannabinol (THC) and 0.9 mg cannabidiol (CBD) each. Patients in group A started with a drug escalation phase from 15 to maximally 30 mg THC by 5 mg per day if well tolerated, being on active medication for 14 days before starting placebo. Patients in group B started with placebo for seven days, crossed to the active period (14 days) and closed with a three-day placebo period (active drug dose escalation and placebo sham escalation as in group A). Measures used included daily self-report of spasm frequency and symptoms, Ashworth Scale, Rivermead Mobility Index, 10-m timed walk, nine-hole peg test, paced auditory serial addition test (PASAT), and the digit span test. RESULTS: In the 50 patients included into the intention-to-treat analysis set, there were no statistically significant differences associated with active treatment compared to placebo, but trends in favour of active treatment were seen for spasm frequency, mobility and getting to sleep. In the 37 patients (per-protocol set) who received at least 90% of their prescribed dose, improvements in spasm frequency (P = 0.013) and mobility after excluding a patient who fell and stopped walking were seen (P = 0.01). Minor adverse events were slightly more frequent and severe during active treatment, and toxicity symptoms, which were generally mild, were more pronounced in the active phase. CONCLUSION: A standardized Cannabis sativa plant extract might lower spasm frequency and increase mobility with tolerable side effects in MS patients with persistent spasticity not responding to other drugs.

Massage therapy effects on depressed pregnant women.

Eighty-four depressed pregnant women were recruited during the second trimester of pregnancy and randomly assigned to a massage therapy group, a progressive muscle relaxation group or a control group that received standard prenatal care alone. These groups were compared to each other and to a non-depressed group at the end of pregnancy. The massage therapy group participants received two 20 min therapy sessions by their significant others each week for 16 weeks of pregnancy, starting during the second trimester. The relaxation group provided themselves with progressive muscle relaxation sessions on the same time schedule. Immediately after the massage therapy sessions on the first and last days of the 16-week period the women reported lower levels of anxiety and depressed mood and less leg and back pain. By the end of the study the massage group had higher dopamine and serotonin levels and lower levels of cortisol and norepinephrine. These changes may have contributed to the reduced fetal activity and the better neonatal outcome for the massage group (i.e. lesser incidence of prematurity and low birthweight), as well as their better performance on the Brazelton Neonatal Behavior Assessment. The data suggest that depressed pregnant women and their offspring can benefit from massage therapy.

Immunomodulatory effects of orally administered cannabinoids in multiple sclerosis.

Cannabinoids can modulate the function of immune cells. We here present the first human in vivo study measuring immune function in 16 MS patients treated with oral cannabinoids. A modest increase of TNF-alpha in LPS-stimulated whole blood was found during cannabis plant-extract treatment (p=0.037), with no change in other cytokines. In the subgroup of patients with high adverse event scores, we found an increase in plasma IL-12p40 (p=0.002). The results suggest pro-inflammatory disease-modifying potential of cannabinoids in MS.