Publications by authors named "Thomas Ostermann"

139 Publications

The INTREST registry: protocol of a multicenter prospective cohort study of predictors of women's response to integrative breast cancer treatment.

BMC Cancer 2021 Jun 23;21(1):724. Epub 2021 Jun 23.

Department of Psychology, Chair of Research Methodology and Statistics in Psychology, Witten / Herdecke University, Witten, Germany.

Background: Cancer registries usually assess data of conventional treatments and/or patient survival. Beyond that, little is known about the influence of other predictors of treatment response related to the use of complementary therapies (CM) and lifestyle factors affecting patients' quality and quantity of life.

Methods: INTREST is a prospective cohort study collecting register data at multiple German certified cancer centers, which provide individualized, integrative, in- and outpatient breast cancer care. Patient-reported outcomes and clinical cancer data of anticipated N = 715 women with pTNM stage I-III breast cancer are collected using standardized case report forms at the time of diagnosis, after completing neo-/adjuvant chemotherapy, after completing adjuvant therapy (with the exception of endocrine therapy) as well as 1, 2, 5, and 10 years after baseline. Endpoints for multivariable prediction models are quality of life, fatigue, treatment adherence, and progression-based outcomes/survival. Predictors include the study center, sociodemographic characteristics, histologic cancer and comorbidity data, performance status, stress perception, depression, anxiety, sleep quality, spirituality, social support, physical activity, diet behavior, type of conventional treatments, use of and belief in CM treatments, and participation in a clinical trial. Safety is recorded following the Common Terminology Criteria for Adverse Events.

Discussion: This trial is currently recruiting participants. Future analyses will allow to identify predictors of short- and long-term response to integrative breast cancer treatment in women, which, in turn, may improve cancer care as well as quality and quantity of life with cancer.

Trial Registration: German Clinical Trial Register DRKS00014852 . Retrospectively registered at July 4th, 2018.
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http://dx.doi.org/10.1186/s12885-021-08468-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8220783PMC
June 2021

Expert consensus-based clinical recommendation for an integrative anthroposophic treatment of acute bronchitis in children: A Delphi survey.

Complement Ther Med 2021 Aug 28;60:102736. Epub 2021 May 28.

Department of Pediatrics, Gemeinschaftskrankenhaus Herdecke, Gerhard-Kienle-Weg 4, 58313, Herdecke, Germany; Department of Pediatric Oncology and Hematology, University of Duisburg-Essen, Hufelandstr.55, 45147, Essen, Germany.

Background: Acute bronchitis is one of the most common pediatric diseases. In addition to conventional therapies, a frequent use of complementary and alternative medicine (CAM) has been stated. Anthroposophic medicine (AM) is one of the most practiced complementary and integrative medicine (CIM) approaches in Central Europe but hitherto no consensus-based clinical recommendations or guidelines are available. Therefore, a consensus-based recommendation leading to an informed and reasonable use of AM in the treatment of acute bronchitis in pediatrics was developed.

Methods: A total of 61 physicians in Germany with expertise in the field of anthroposophic pediatrics was invited to complete an online multistep Delphi process. Two independent reviewers quantitatively and qualitatively evaluated the results. The survey was completed when >75 % consensus was achieved.

Results: The clinical recommendation comprises 15 subitems related to treatment as well as clinical and psychosocial aspects. All items reached strong consensus (>90 %; N = 9) or consensus (75-90 %; N = 6).

Conclusion: The comprehensive clinical recommendation creates a scientific base for the anthroposophic integrative treatment of acute bronchitis in children in Germany. It will make the anthroposophic approach more applicable, understandable and comparable to a wider public of physicians and other health professionals in Germany.
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http://dx.doi.org/10.1016/j.ctim.2021.102736DOI Listing
August 2021

IU - A Digital Application for the Graphical Examination of Interpersonal Attachment.

Stud Health Technol Inform 2021 May;278:180-186

Department for Psychology and Psychotherapy, Witten/Herdecke University, Germany.

Human attachment describes the establishment of contact between two or more people leading to a closer interpersonal relationship. For measuring attachment, the use of nonverbal assessments tools including art and drawing tasks has been shown to be an alternative to conventional assessment approaches. The present study aims at evaluating the internal criterion validity of a new digital drawing tool for measuring interpersonal attachment. 68 participants took part in this pilot study and were separated in groups of two. After completion of a 10-item subscale of Social Orientation (SO) they were asked to sit opposite to the other and to hold eye contact during a three minute drawing period. Moving the pen to the upper section near the partner stood for thoughts about the other, while moving to the lower section closest to the subject implicated thoughts about oneself. The mean distance of the resulting time series of the two subjects were calculated, using the mean Euclidean distance, and compared with the difference in the SO values via linear regression. Taking all differences together a moderate correlation of r = 0.298 was observed, which however slightly missed the level of significance (p = 0.09). We were able to find small evidence for the criterion validity of IU digital drawing tool. For future studies, other measures of similarity in the time series, i.e. the Manhattan Distance are discussed as an extension to foster the present results.
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http://dx.doi.org/10.3233/SHTI210067DOI Listing
May 2021

Yoga, Eurythmy Therapy and Standard Physiotherapy (YES-Trial) for Patients With Chronic Non-specific Low Back Pain: A Three-Armed Randomized Controlled Trial.

J Pain 2021 Apr 20. Epub 2021 Apr 20.

Institute of Integrative Medicine, Witten/Herdecke University, Germany.

We aimed to evaluate the effects of yoga and eurythmy therapy compared to conventional physiotherapy exercises in patients with chronic low back pain. In a three-armed, multicentre, randomized controlled trial, patients with chronic low back pain were treated for 8 weeks in group sessions (75 minutes once per week). Primary outcome was patients' physical disability (measured by RMDQ) from baseline to week 8. Secondary outcome variables were pain intensity and pain-related bothersomeness (VAS), health-related quality of life (SF-12) and life satisfaction (BMLSS). Outcomes were assessed at baseline, after the intervention at 8 weeks and at a 16-week follow up. Data of 274 participants were used for statistical analyses. There were no significant differences between the three groups for the primary and all secondary outcomes. In all groups, RMDQ decreased comparably at 8 weeks, but did not reach clinical meaningfulness. Pain intensity and pain-related bothersomeness decreased, while quality of life increased in all 3 groups. In explorative general linear models for the SF-12's mental health component participants in the eurythmy arm benefitted significantly more compared to physiotherapy and yoga. Furthermore, within-group analyses showed improvements of SF-12 mental score for yoga and eurythmy therapy only. All interventions were safe. Clinical Trials Register: DRKS-ID: DRKS00004651 Perspective: This article presents the results of a multicentre three-armed randomized controlled trial on the clinical effects of three 8-week programs in patients with chronic low back pain. Compared to the 'gold standard' of conventional physiotherapeutic exercises, eurythmy therapy and yoga therapy lead to comparable symptomatic improvements in patients with chronic low back pain. However, the within-group effect sizes were small to moderate and did not reach clinical meaningfulness on patients' physical disability (RMDQ).
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http://dx.doi.org/10.1016/j.jpain.2021.03.154DOI Listing
April 2021

Antecedents of Individuals' Concerns Regarding Hospital Hygiene and Surgery Postponement During the COVID-19 Pandemic: Cross-sectional, Web-Based Survey Study.

J Med Internet Res 2021 03 11;23(3):e24804. Epub 2021 Mar 11.

Health Psychology and Applied Diagnostics, University of Wuppertal, Wuppertal, Germany.

Background: The COVID-19 pandemic poses a major challenge to people's everyday lives. In the context of hospitalization, the pandemic is expected to have a strong influence on affective reactions and preventive behaviors. Research is needed to develop evidence-driven strategies for coping with the challenges of the pandemic. Therefore, this survey study investigates the effects that personality traits, risk-taking behaviors, and anxiety have on medical service-related affective reactions and anticipated behaviors during the COVID-19 pandemic.

Objective: The aim of this study was to identify key factors that are associated with individuals' concerns about hygiene in hospitals and the postponement of surgeries.

Methods: We conducted a cross-sectional, web-based survey of 929 residents in Germany (women: 792/929, 85.3%; age: mean 35.2 years, SD 12.9 years). Hypotheses were tested by conducting a saturated path analysis.

Results: We found that anxiety had a direct effect on people's concerns about safety (β=-.12, 95% CI -.20 to -.05) and hygiene in hospitals (β=.16, 95% CI .08 to .23). Risk-taking behaviors and personality traits were not associated with concerns about safety and hygiene in hospitals or anticipated behaviors.

Conclusions: Our findings suggest that distinct interventions and information campaigns are not necessary for individuals with different personality traits or different levels of risk-taking behavior. However, we recommend that health care workers should carefully address anxiety when interacting with patients.
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http://dx.doi.org/10.2196/24804DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7954115PMC
March 2021

Selection procedure human medicine and psychology at the University of Witten/Herdecke: adaptation to the virtual zoom room.

GMS J Med Educ 2020 3;37(7):Doc70. Epub 2020 Dec 3.

Witten/Herdecke University, Faculty of Health, Didactics and Educational Research in Health Science, Witten, Germany.

For the selection of students for the winter semester 2020/21, the established selection procedure of the University of Witten/Herdecke (UW/H) was adapted to the virtual space in view of the current contact ban and recommended keeping of distance. The three stations in the second step of the procedure, the biographical one-on-one interview, presentation and discussion on a subject-specific topic as well as multiple mini interviews (MMI) on the social skills of the applicants were audiovisual and in real time in zoom meetings. The medical, psychological and student reviewers were prepared for the virtual selection procedure in training sessions. Three weeks before the selection days, the applicants received information on the technical requirements for the interviews and on data protection for the persons affected by the collection of personal data. The evaluation of the virtual selection procedure was carried out by the reviewers using an online questionnaire with 8 socio-demographic, 5 organizational, 8 content and 3 open questions. The 108 reviewers conducted selection interviews in tandems (medical/psychological and student reviewers) with 178 applicants for human medicine and 105 applicants for psychology. The online evaluation by 58 reviewers (response rate 53.7%) showed a positive agreement with the virtual selection procedure, with a more favorable assessment of organization and content by the medical and psychological reviewers compared to the student reviewers. The adequate adaptation of the selection procedure of the UW/H to the virtual zoom room as well as its acceptance are confirmed by the successful execution of the selection days for the students for the winter semester 2020/21 and the evaluation of the reviewers. The results and analysis of this exceptional situation will be used to also conduct the upcoming selection procedure for the summer semester 2021 in the virtual space. A valid assessment for the future use of a virtual selection procedure as a possible supplement to the personal selection interviews at the University of Witten/Herdecke remains to be made.
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http://dx.doi.org/10.3205/zma001363DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7740028PMC
December 2020

Comparative analysis of resource utilization in integrative anthroposophic and all German pediatric inpatient departments.

BMC Health Serv Res 2020 Oct 12;20(1):939. Epub 2020 Oct 12.

Department of Psychology, Chair of Research Methodology and Statistics in Psychology, Witten/Herdecke University, Alfred-Herrhausen-Straße 50, 58448, Witten, Germany.

Background: Integrative Medicine (IM) combines conventional and complementary therapies. It aims to address biological, psychological, social, spiritual and environmental aspects of patients' health. During the past 20 years, the use and request of IM in children and adults has grown. Anthroposophic Medicine (AM) is an IM approach frequently used in children in Germany. From both public health and health economic perspectives, it is relevant to investigate whether there are differences in the resource utilization between integrative pediatric departments (IPD) and the entirety of all pediatric departments.

Methods: Standard ward documentation data from all German integrative anthroposophic pediatric departments (2005-2016; N = 29,956) is investigated and systematically compared to data of the entirety of all pediatric departments in Germany derived from the Institute for the Hospital Reimbursement System (2005-2016, N = 8,645,173). The analyses focus on: length of stay, Diagnosis Related Groups (DRG), Major Diagnosis Categories (MDC), and effective Case Mix Index (CMI).

Results: The length of stay in the IPD (M = 5.38 ± 7.31) was significantly shorter than the DRG defined length of stay (M = 5.8 ± 4.71; p < .001; d = - 0.07) and did not exceed or undercut the DRG covered length of stay. Compared to the entirety of all pediatric departments (M = 4.74 ± 6.23) the length of stay was significantly longer in the in the IPD (p <. 001; d = 0.12). The effective CMI in IPD and all pediatric departments were identical (M = 0.76). The frequencies of DRG and MDC differed between IPD and all pediatric departments, with higher frequencies of DRGs and MDCs associated with chronic and severe illnesses in the IPD.

Conclusions: Treatment within integrative anthroposophic pediatric departments fits well in terms of the DRG defined conditions concerning length of stay, even though integrative pediatric patients has an increased length of stay of averagely 1 day, which is most likely associated to time consuming, complex integrative treatment approaches and to a certain extend to higher amount of chronic and severe diseases.
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http://dx.doi.org/10.1186/s12913-020-05782-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7552368PMC
October 2020

Postprandial dynamics of splenic volume in healthy volunteers.

Physiol Rep 2020 01;8(2):e14319

Institute for Integrative Medicine, Faculty of Health, Witten/Herdecke University, Herdecke, Germany.

Throughout the history of medicine, many functions have been attributed to the spleen and numerous researchers have focused on a postulated digestive function. Beginning in 1825, systematic animal studies showed evidence for a postprandial increase in splenic volume (SV) with a peak 30 min to five hours after food intake. Since the introduction of imaging techniques, two studies have been conducted on humans, revealing a decrease in SV 30 to 45 min postprandially. The aim of this study was to examine possible postprandial changes in SV over a period of seven hours. The ethics-approved, randomized crossover study included 10 healthy volunteers, who received a standardized meal (3,600 kJ) on one study day and fasted on the other. Sonographic measurements were obtained at six measurement points on each day. Thirty minutes after the meal, SV increased significantly by 38.2 ± 51.2 cm (17.3%; p = .04) compared to the baseline measurement and decreased gradually afterward. In males, SV 30 min after the meal was 70.2 ± 21.6 cm higher (p = .002) compared to the fasting condition and 60 min later it was still significantly increased. The apparent SV increase after food intake is discussed in relation to hemodynamic changes in the splanchnic region. It seems plausible that the spleen has a rhythmic and regulative function within the portal system, something which warrants further research and should be taken more into account in nutritional physiology.
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http://dx.doi.org/10.14814/phy2.14319DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6981305PMC
January 2020

A Systematic Review and Meta-Analysis on the Survival of Cancer Patients Treated with a Fermented Viscum album L. Extract (Iscador): An Update of Findings.

Complement Med Res 2020 10;27(4):260-271. Epub 2020 Jan 10.

Institute of Integrative Medicine, Faculty of Health, Witten/Herdecke University, Herdecke, Germany,

Purpose: We aimed at updating the evidence found in controlled studies addressing general and event-free survival of cancer patients treated with the fermented mistletoe extract Iscador.

Methods: The databases Embase, PubMed, CAMbase, Scopus, AMED and Cochrane were searched for clinical studies on cancer patients treated with Iscador. Quality of studies and risk of bias were evaluated according to the Cochrane guidelines and the Newcastle Ottawa Scale. Outcome data were expressed as hazard ratios (HR) and the respective 95% confidence intervals (CI). Meta-analysis was carried out using a random-effects model.

Results: Eighty-two controlled studies met the inclusion criteria, of which 32 with 55 strata provided data for extracting HR and CI. The overall HR was 0.59 (95% CI: [0.53; 0.65], p < 0.0001) in favour of Iscador treatment. Heterogeneity of study results was moderate (I2 = 50.9%; p < 0.0001, τ2 = 0.053). Meta-regression did not reveal significant effects of sample size or study design. However, significant differences were found between cancer entities (p < 0.01), with most pronounced effects in cervical (HR = 0.43) and less pronounced effects in lung cancer (HR = 0.84).

Conclusions: We found almost identical effects on cancer survival based on a broader database of higher quality. However, none of the studies was blinded and, therefore, there might be risk of performance bias. Implications for cancer survivors are as follows: findings indicate that adjuvant treatment of cancer patients with Iscador can be associated with a better survival.
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http://dx.doi.org/10.1159/000505202DOI Listing
April 2021

Do patients of integrative anthroposophic pediatric inpatient departments differ? Comparative analysis to all pediatric inpatients in Germany considering demographic and clinical characteristics.

BMC Public Health 2019 Dec 3;19(1):1623. Epub 2019 Dec 3.

Department of Pediatrics, Gemeinschaftskrankenhaus Herdecke, Gerhard-Kienle-Weg 4, 58313, Herdecke, Germany.

Background: Integrative medicine (IM) is a patient-centered, evidence-based, therapeutic paradigm which combines conventional and complementary approaches. The use of IM in pediatrics has increased in the past two decades and parents' demand for it is growing. An IM whole systems approach is anthroposophic medicine. Considering the growing demand for integrative approaches in children, it is relevant from a public health perspective to find out which kind of children use IM in Germany and whether they differ from the entirety of pediatric inpatients in Germany. Moreover, it would be interesting to known, whether these patients are willing to travel a longer distance to gain integrative treatment.

Methods: The present study investigates the standard ward documentation datasets of 29,956 patients of all German integrative anthroposophic pediatric inpatient wards from 2005 to 2016 and compares them systematically to collect data of the entirety of all pediatric inpatient wards in Germany. Apart from patients' age and gender, and the ICD-10 admission diagnoses, the geographical catchment area of the hospitals were analyzed.

Results: Sociodemographic characteristics of pediatric inpatients in the integrative anthroposophic departments (IAH) did not differ from the entirety of all pediatric inpatients. Regarding clinical characteristics, higher frequencies were found for endocrine, nutritional and metabolic diseases (IAH: 7.24% vs. 2.98%); mental, behavioral, and neurodevelopmental disorders (IAH: 9.83% vs. 3.78%) and nervous diseases (IAH: 8.82% vs. 5.16%) and lower frequencies for general pediatric diseases such as respiratory diseases (IAH: 17.06% vs. 19.83%), digestive diseases (IAH: 3.90% vs. 6.25%), and infectious and parasitic diseases (IAH: 12.88% vs. 14.82%) in comparison to the entirety of all pediatric inpatients in Germany. The IAH showed a broad catchment area, with most patients being from former, Western federal republic of Germany. Large catchment areas (> 100 km) for the IAH are merely covered by severe and chronic diseases.

Conclusion: Pediatric inpatients of IAH do not differ from the entirety of pediatric inpatients in Germany regarding sociodemographic characteristics but show differences regarding clinical characteristics. Parents are willing to travel further distance to get specialized integrative anthroposophic medical care for children with severe and chronic diseases.
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http://dx.doi.org/10.1186/s12889-019-7972-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6889203PMC
December 2019

The prevalence of young carers - a standardised survey amongst school students (KiFam-study).

Scand J Caring Sci 2020 Jun 27;34(2):501-513. Epub 2019 Oct 27.

School of Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany.

Background: Children and adolescents who provide care, assistance or support for a chronically ill family member are called young carers. While there is a growing body of research about their specific situation, needs and impact of caring, only very few studies provide information on prevalence rates.

Objectives: The aim was to provide prevalence data for young carers in Germany, and to describe and quantify the nature and extent of their help.

Design: A cross-sectional study.

Settings: Data collection took place between 2016 and 2017 in 44 secondary schools (fifth to 13th grade) in North Rhine-Westphalia, Germany.

Participants: A total of 6313 students aged from 10 to 22 years participated in this study. They represent 0.5% of the basic population.

Methods: Based on the results of a preliminary qualitative study, a standardised electronic questionnaire was developed, which comprised four subject areas: socio-demographic information, general daily aids, health-related quality of life and chronic illness within the family. Statistical analyses included chi-square tests for nominal data and univariate analyses of variance for metrical data together with 95% confidence intervals.

Results: 19.6% (n = 1238) of all respondents state that someone in their family needs help due to a chronic illness. Nevertheless, not all of them are involved in caring activities. The prevalence of those defined as young carers in this study is 6.1% (n = 383), 64% are girls. They take on a wide range of activities. In addition to domestic work, they help their ill relatives with mobility, dressing and undressing, medication, feeding, personal hygiene and with intimate care.

Conclusions: The data provide a good insight into the situation of young carers. The prevalence rate is higher than expected. It refers to the social relevance of this topic and the need for further investigations.
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http://dx.doi.org/10.1111/scs.12754DOI Listing
June 2020

Effects of yoga on eating disorders-A systematic review.

Complement Ther Med 2019 Oct 31;46:73-80. Epub 2019 Jul 31.

Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany. Electronic address:

Background: The question of whether yoga practice ameliorates or even aggravates eating disorders is currently under debate. The aim of this review was to systematically assess and the effectiveness and safety of yoga in patients with eating disorders.

Methods: Medline/PubMed, PsycINFO, and the Psychological and Behavioral Science Collection were screened through July 2018 for randomized controlled trials, non-randomized controlled trials and longitudinal observational studies on yoga for patients with eating disorders and other individuals with disordered eating and/or body dissatisfaction. Risk of bias was assessed using the Cochrane risk of bias tool and the Newcastle-Ottawa Quality Assessment Scale.

Results: Eight randomized trials and four uncontrolled trials involving a total of 495 participants were included. Risk of bias was mixed. Comparing yoga to untreated control groups, effect sizes ranged from negligible effects of d = 0.02 to very large effects of d = 2.15. However, most effects were small to moderately sized and in most cases not significant. No safety-related data were reported.

Conclusions: There is limited evidence on the effectiveness and safety of yoga in patients with eating disorders. Yoga can be preliminarily considered as an additional treatment option in multimodal psychiatric treatment programs.
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http://dx.doi.org/10.1016/j.ctim.2019.07.021DOI Listing
October 2019

Differential Item Functioning for Boys and Girls in a Screening Instrument for Attention Deficit Hyperactivity Disorder.

Stud Health Technol Inform 2019 Sep;267:3-8

Department for Psychology and Psychotherapy, Witten/Herdecke University, Germany.

Differential item functioning (DIF) indicates differential response probabilities of items for different subgroups. While there is a vast amount of research and literature on DIF in the field of educational screening and career assessment, DIF analysis has hardly been applied in the field of clinical assessment. This paper aims at analyzing the presence of gender related DIF in a cross-sectional survey of children assessed by a structured questionnaire containing items on attention deficit and hyperactivity. A total of 1449 children (mean age: 1.94 ± 0.14 years; 51.2% male) were included. Almost no significant variations in parameters were found between boys and girls. Results based on a Partial Credit Model indicate an absence of DIF in eight out of nine items. Consistent with other studies in attention deficit hyperactivity disorder (ADHD) our results imply that the same level of rating for a symptom has the same meaning for boys and girls.
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http://dx.doi.org/10.3233/SHTI190797DOI Listing
September 2019

Effects of occlusal splint therapy in patients with migraine or tension-type headache and comorbid temporomandibular disorder: A randomized controlled trial.

Medicine (Baltimore) 2019 Aug;98(33):e16805

Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Essen.

Background: Migraine and tension-type headache often occur comorbid with temporomandibular disorder; occlusal splint therapy is the most common treatment for temporomandibular disorder. The aim of this study was to assess the effects of occlusal splint therapy on headache symptoms in patients with migraine and/or tension-type headache comorbid with temporomandibular disorder.

Methods: Sixty adult patients with migraine and/or tension-type headache and comorbid temporomandibular disorder were randomly assigned to individualized occlusal splint therapy applied during day- and nighttime plus usual care (n = 30) or usual care alone (n = 30). Primary outcome was the change in current pain intensity on a 100 mm visual analogue scale from week 1 to week 12. Secondary outcomes included changes in headache days and headache hours assessed by headache diaries over a 2-week period, health-related quality of life (SF-36), and adverse events from week 1 to week 12 and (in the occlusal splint plus usual care group only) to week 24.

Results: No group differences in changes in pain intensity from week 1 to week 12 were found. The number needed to treat was 3.8. Physical quality of life reduced stronger in the usual care group than in the occlusal splint plus usual care group. In the occlusal splint plus usual care group, headache intensity significantly decreased and physical quality of life significantly increased from week 1 to week 12 and to week 24 (all P < .001). No adverse events were reported.

Conclusions: A day- and night-time occlusal splint therapy in addition to usual care was not superior to usual care alone in patients with chronic headache and comorbid TMD. Four patients need to be treated to induce a minimal clinically relevant improvement in one patient. The small sample size and lack of power limit these findings.
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http://dx.doi.org/10.1097/MD.0000000000016805DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6831110PMC
August 2019

Effectiveness of a homeopathic complex medicine in infantile colic: A randomized multicenter study.

Complement Ther Med 2019 Aug 1;45:136-141. Epub 2019 Jun 1.

Chair of Research Methodology and Statistics in Psychology, Witten/Herdecke University, Witten, Germany.

Objectives: Infantile colic is a common benign disease occurring in early infancy that may have a great impact on family life. In the present study, the effectiveness and safety of the complex homeopathic medicine Enterokind was compared with Simethicone for treating infantile colic.

Design And Setting: Current data were drawn from a prospective, multicenter, randomized, open-label, controlled clinical trial that was conducted in 2009 in 3 Russian outpatient clinics. Children received either Enterokind (Chamomilla D6, Cina D6, Colocynthis D6, Lac defloratum D6 and Magnesium chloratum D6) or Simethicone. Data from infants ≤ 6 months with infantile colic are presented here.

Main Outcome Measures: The main outcomes assessments were the change of total complaints score (maximum 17 points) and total objective symptoms score (maximum 22 points) after 10 days of treatment.

Results: Data from 125 infants ≤ 6 months with infantile colic were analyzed. The differences in total complaints and objective symptoms scores between baseline and day 10, estimated from the ANCOVA model, were found to be highly significant (p < 0.0001; ITT) in favor of Enterokind, both for complaints (Δ=-2.38; 95% confidence interval (CI): [-2.87; -1.89]) and for objective symptoms (Δ=-2.07; 95% CI: [-2.65; -1.49]). 1 adverse event (AE), vomiting, occurred under Enterokind and was rated to be unlikely related to it; 4 AEs occurred under Simethicone. All AEs were non-serious.

Conclusions: The current study indicates that Enterokind is an effective and safe homeopathic treatment for functional intestinal colic in infants ≤ 6 months.
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http://dx.doi.org/10.1016/j.ctim.2019.05.026DOI Listing
August 2019

A Randomized Controlled Trial to Investigate the Impact of Tango Argentino versus Tai Chi on Quality of Life in Patients with Parkinson Disease: A Short Report.

Complement Med Res 2019 2;26(6):398-403. Epub 2019 Jul 2.

Quality of Life, Spirituality and Coping, Institute of Integrative Medicine, Faculty of Health, Witten/Herdecke University, Herdecke, Germany,

Objectives: Parkinson disease (PD) is a neurodegenerative disorder with increasing impairments in disease progression. The aim of the pilot study was to investigate the influence of Tango argentino on the quality of life of people with PD compared to Tai Chi. Design, Setting, Interventions: In the two-arm, randomized controlled pilot study, patients with PD received a 10-week Tango argentino or Tai Chi intervention (once per week, 60 min each).

Main Outcome Measures: The outcome parameters were assessed at three time points (after the 1st course, after the 5th course, and after the 10th course) using standardized instruments, i.e., Parkinson's Disease Questionnaire-39 (PDQ-39), Brief Multidimensional Life Satisfaction Scale (BMLSS), Inner Congruence with Practices (ICPH).

Results: Overall, 14 patients and their partners received Tango argentino (9 male, 5 female; mean age: 69 ± 8 years) and 15 received Tai Chi (3 male, 12 female; mean age: 69 ± 11 years). Four patients in each group were lost during the trial. No improvements were found in both groups for all outcomes. Patients in the tango group reported better emotional well-being (p = 0.039) after 10 weeks of intervention compared to the Tai Chi group.

Conclusions: Further studies are needed taking into account findings from this study to improve recruitment and attrition of patients during the trial and to justify the potential implementation of Tango argentino into clinical care.
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http://dx.doi.org/10.1159/000500070DOI Listing
April 2020

[Immunologische Ex-vivo-Untersuchung zur Wirkung potenzierter Substanzen bei parodontaler Entzündung unter Verwendung der Durchflusszytometrie].

Complement Med Res 2019 2;26(6):410-420. Epub 2019 Jul 2.

Department für Zahn-, Mund- und Kieferheilkunde, Abteilung für Parodontologie, Fakultät für Gesundheit, Universität Witten/Herdecke, Witten, Deutschland.

Hintergrund: Bei der Behandlung parodontaler Entzündungen werden in der Versorgungspraxis auch homöopathische Mittel eingesetzt. Noch ist weniger über deren grundlegende Wirkprinzipien bekannt. Ziel dieser Arbeit war es daher, die Auswirkungen potenzierter Substanzen bei parodonta-ler Entzündung mittels Durchflusszytometrie zu untersuchen. Material und Methoden: Lymphozyten aus Blutproben von drei Parodontitis-Patienten und drei gematchten gesunden Probanden wurden extrahiert und mit stark verdünnten wässrigen Extrakten (D12 und C200) aus Mercurius solubilis, Silicea, Sulphur, Tuberculinum oder Placebo inkubiert. Um die Lymphozytenexpression zu untersuchen, wurde die Durchflusszytometrie für CD45R0- und CD25-Antikörper angewandt. Die statistische Analyse wurde unter Verwendung von Histogramm- und bivariaten Dot-Plot-Analysen durchgeführt. Ergebnisse: Veränderungen der Expression von CD25 und CD45R0 wurden bei Mercurius C200, Mercurius D12, Silicea D12 und Sulphur D12 beobachtet. Mit 36,47% zeigte Sulphur D12 die höchsten Veränderungen in der CD45R0-Expression zwischen Verum und Placebo bei den Parodontitis-Patienten. Die CD25-Expression war in Mercurius D12 mit 18,68% am höchsten. Aufgrund der hohen Variabilität konnten die Ergebnisse jedoch nicht durch statistische Analysen untermauert werden. Diskussion: Diese Studie konnte zeigen, wie Effekte hoch verdünnter Substanzen mit modernen immunologischen Methoden analysiert werden können. Obwohl die Schlussfolgerungen aufgrund der hohen Variabilität der Lymphozytenexpression begrenzt sind, könnten die Ergebnisse dieser Pilotstu-die weitere Untersuchungen anregen.

Background: Several homeopathic remedies are applied in the treatment of periodontal inflammation. Still, little is known about their basic working principles. We therefore aimed at investigating the effects of homeopathic drugs in periodontal inflammation by flow cytometry.

Material And Methods: Lymphocytes from blood samples of three periodontitis patients and three matched healthy volunteers were extracted and incubated with highly diluted (D12 and C200) aqueous extracts from Mercurius solubilis, Silicea, Sulphur, Tuberculinum, or placebo. To investigate lymphocyte expression, flow cytometry was applied for CD45R0 and CD25 antibodies. Statistical analysis was performed using histogram and bivariate dot-plot analysis.

Results: Changes in CD25 and CD45R0 expression were observed in Mercurius C200, Mercurius D12, Silicea D12, and Sulfur D12. With 36.47%, Sulfur D12 showed the highest differences in CD45R0 expression in periodontitis patients between verum and placebo. CD25 expression was highest in Mercurius D12 with 18.68%. Due to high variability, the results could, however, not be underpinned by statistical analyses.

Conclusion: This study demonstrated how effects of highly diluted substances can be analyzed using modern immunological methods. Although conclusions are limited due to high variability in lymphocyte expression, results from our pilot study might encourage further investigations.
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http://dx.doi.org/10.1159/000501056DOI Listing
April 2020

The Digital Tree Drawing Test for Screening of Early Dementia: An Explorative Study Comparing Healthy Controls, Patients with Mild Cognitive Impairment, and Patients with Early Dementia of the Alzheimer Type.

J Alzheimers Dis 2019 ;68(4):1561-1574

Nürtingen-Geislingen University (HfWU), Institute of Research and Development in Art Therapies, Nürtingen, Germany.

The digital tree drawing test (dTDT) is a newly developed screening tool for the early detection of Alzheimer's disease. It is performed with a digitizing pen, recording each pen stroke with temporal and spatial precision. It was hypothesized that movement characteristics recorded during the painting process contribute to the identification of patients with mild cognitive impairment (MCI) and early dementia of the Alzheimer type (eDAT). The study population consisted of 187 participants (67 healthy controls, 64 MCI, and 56 eDAT patients) with a mean age of 68.6±10.6 years. Between-group comparisons of the dTDT-variables were conducted with analysis of variance. The diagnostic power of dTDT variables was analyzed with stepwise logistic regressions and areas under curve (AUC) of receiver operating control curves. Cognitively impaired persons used less colors and line widths and changed them less often than healthy subjects (p-values ≤0.05). Compared to control, eDAT patients had larger not-painting periods, were slower, and their pictures had less contrast, image size, and complexity (p-values ≤0.01). Logistic regression models of stepwise selected dTDT variables resulted in an AUC of 0.84 (95% confidence interval (CI) [0.79, 0.90], sensitivity = 0.78, specificity = 0.77) for discriminating healthy subjects from all cognitive impaired, an AUC of 0.77. (95% CI [0.69; 0.85], sensitivity = 0.56, specificity = 0.83) for discriminating healthy controls from MCI patients and an AUC of 0.90 (95% CI [0.84, 0.96], sensitivity = 0.86, specificity = 0.82) for discriminating controls from eDAT patients. The results suggest that digital recording of pen-stroke data during the drawing process can contribute to the screening of cognitive impaired patients.
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http://dx.doi.org/10.3233/JAD-181029DOI Listing
August 2020

A proof-of-concept trial of HELIOX with different fractions of helium in a human study modeling upper airway obstruction.

Eur J Appl Physiol 2019 May 8;119(5):1253-1260. Epub 2019 Mar 8.

Philipp Klee-Institute for Clinical Pharmacology, HELIOS Clinic Wuppertal, Wuppertal, Germany.

Background: Helium in oxygen (HELIOX) can relieve airway obstruction and lower the work of breathing because it increases the threshold at which turbulent gas flow is induced. Less turbulent and more laminar flow lowers the work of breathing. According to guidelines, the fraction of Helium in HELIOX should be maximized (e.g. to 79%). Here, we investigate whether HELIOX with less than 60% of Helium is able to relieve the sensation of dyspnea in healthy volunteers.

Methods: 44 volunteers underwent resistive loading breathing different gases (medical air and HELIOX with a fraction of 25%, 50% or 75% helium in oxygen) in a double-blinded crossover design. Subjects rated their degree of dyspnea (primary outcome parameter) and the variability of noninvasively measured systolic blood pressure was assessed.

Results: Dyspnea was significantly reduced by HELIOX-containing mixtures with a fraction of helium of 25% or more. Similarly, blood pressure variability was reduced significantly even with helium 25% during respiratory loading with the higher load, whereas with the smaller load an effect could only be obtained with the highest helium fraction of 75%.

Conclusion: In this clinical trial, HELIOX with less than 60% of helium in oxygen decreased the sensation of dyspnea and blood pressure variability, a surrogate parameter for airway obstruction. Therefore, higher oxygen fractions might be applied without losing the helium-related benefits for the treatment of upper airway obstruction.

Trial Registration: Registration with clinical trials (NCT00788788) and EMA (EudraCT number: 2006-005289-37).
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http://dx.doi.org/10.1007/s00421-019-04116-7DOI Listing
May 2019

Digital Integrative Medicine - Just Knocking on Wood or a Bit More?

Authors:
Thomas Ostermann

Complement Med Res 2019;26(1):1-2. Epub 2019 Feb 18.

Department of Psychology and Psychotherapy, Witten/Herdecke University, Witten, Germany,

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http://dx.doi.org/10.1159/000497050DOI Listing
September 2019

Gua Sha therapy for chronic low back pain: A randomized controlled trial.

Complement Ther Clin Pract 2019 Feb 10;34:64-69. Epub 2018 Nov 10.

Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany; Australian Research Centre in Complementary and Integrative Medicine (ARCCIM), Faculty of Health, University of Technology Sydney, Sydney, Australia.

Objective: To test the efficacy of Gua Sha therapy in patients with chronic low back pain.

Methods: 50 patients with chronic low back pain (78% female, 49.7 ± 10.0 years) were randomized to two Gua Sha treatments (n = 25) or waitlist control (n = 25). Primary outcome was current pain intensity (100-mm visual analog scale); secondary outcome measures included function (Oswestry Disability Index), pain on movement (Pain on Movement Questionnaire), perceived change in health status, pressure pain threshold, mechanical detection threshold, and vibration detection threshold.

Results: After treatment, patients in the Gua Sha group reported lower pain intensity (p < 0.001) and better overall health status (p = 0.002) compared to the waitlist group. No further group differences were found. No serious adverse events occurred.

Conclusions: Gua Sha appears to be an acceptable, safe, and effective treatment for patients with chronic low back pain. Further rigorous studies are needed to confirm and extend these results.
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http://dx.doi.org/10.1016/j.ctcp.2018.11.002DOI Listing
February 2019

Effectiveness of yoga in eating disorders - A case report.

Complement Ther Med 2019 Feb 13;42:145-148. Epub 2018 Nov 13.

Department of Internal and Integrative Medicine, Faculty of Medicine, University of Duisburg-Essen, 45276 Essen, Germany.

Eating disorders are among the most common psychosomatic diseases and are often associated with negative health consequences. The use of yoga as a treatment method in eating disorders is controversial discussed. The interviewee was a 38 year old female patient suffering on anorexia nervosa and various psychosomatic-psychiatric diagnoses in her medical history. The patient reported that yoga recovered the soul contact which she lost and she had learned to perceive and feel herself again. She stated that yoga helped her to find access to her body and its needs and to cope with her traumatic experiences. She also reported that attitudes have changed in relation to her stomach in the treatment of her anorexia. The case report confirmed the positive effect of yoga on eating disorders. Research should pay particular attention to taking into account the influence of individual's co-morbidities, as eating disorders usually occur in association with co-morbidities.
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http://dx.doi.org/10.1016/j.ctim.2018.11.014DOI Listing
February 2019

The Effectiveness of Leech Therapy in Chronic Low Back Pain.

Dtsch Arztebl Int 2018 11;115(47):785-792

Charité - University Medicine Berlin, corporate member of the Free University Berlin, Humboldt University of Berlin, and Berlin Institute of Health, Institute of Social Medicine, Epidemiology and Health Economics, Foundation Chair of Clinical Naturopathy; Department of Internal Medicine, Division of Naturopathy, Immanuel Hospital Berlin; Department of Psychology, Faculty of Health, Witten/Herdecke University; KPW Garbsen, Center for Physiotherapy.

Background: Leech therapy has been found to be effective in the treatment of a number of chronic musculoskeletal pain syndromes. Leeches are also often used empirically to treat chronic low back pain, but data from clinical trials have been lacking to date. We therefore conducted the first randomized trial of leech therapy for chronic low back pain.

Methods: Patients with chronic low back pain were randomized to receive either a single session of local treatment with 4-7 leeches or four weekly sessions of exercise therapy (1 hour each) led by a physical therapist. The primary endpoint was a change in average back pain intensity, as measured using a 100-mm visual analog scale (VAS), after 28 days. Secondary end- points included functional impairment (Roland-Morris Disability Questionnaire, Hannover Functional Ability Questionnaire), quality of life (Short-Form Health Questionnaire [SF 36]), pain perception (pain perception scale = Schmerzempfindungsskala [SES]), depressivity (Center for Epidemiological Studies Depression Scale [CES-D]), and analgesic consumption (questionnaire/ diary). Trial visits took place before treatment and on days 28 ± 3 and 56 ± 5 after the start of treatment; the overall duration of the trial was 56 ± 5 days.

Results: The mean low back pain score improved from 61.2 ± 15.6 before treatment to 33.1 ± 22.4 on day 28 in the leech ther- apy group (n = 25) and from 61.6 ± 14.8 to 59.8 ± 16.7 in the exercise therapy group (n = 19) (group difference -25.2; 95% con- fidence interval [-41.0; -9.45]; p = 0.0018). Significant benefits of leech therapy were also found at both time points with respect to physical impairment and function as well as physical quality of life. The patients' expectations from treatment were higher in the leech therapy group but did not significantly affect the findings.

Conclusion: A single session of leech therapy is more effective over the short term in lowering the intensity of pain over the short term and in improving physical function and quality of life over the intermediate term (4 weeks and 8 weeks, respectively). The limitations of this trial are the lack of blinding and the small number of patients. Leech therapy appears to be an effective treat- ment for chronic low back pain.
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http://dx.doi.org/10.3238/arztebl.2018.0785DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6334223PMC
November 2018

[Correction: Motivation for Specialisation in General Practice - A Quantitative Study of NRW's Medical Students in Support of Targeted Recruitment].

Gesundheitswesen 2019 Jan 3. Epub 2019 Jan 3.

Institut für Allgemeinmedizin und Familienmedizin, Universität Witten/Herdecke, Witten.

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http://dx.doi.org/10.1055/a-0824-0226DOI Listing
January 2019

[Motivation for Specialisation in General Practice - A Quantitative Study of NRW's Medical Students in Support of Targeted Recruitment].

Gesundheitswesen 2020 Jun 5;82(6):520-526. Epub 2018 Dec 5.

Institut für Allgemeinmedizin und Familienmedizin, Universität Witten/Herdecke, Witten.

Aim Of Study: Due to forecasted shortage of general practitioners, we conducted an online survey of all medical students in North-Rhine-Westphalia to identify and quantify determinants in medical students' decision to specialize in general practice (GP).

Methodology: To identify the motives driving the choice of GP as a career, responses of 3976 participants (22.6% of medical students invited) were subjected to factor analysis. Relationships between extracted factors and career choice were ascertained via regression analysis adjusted for population characteristics. All participants who had positioned themselves distinctly for/against GP were included in regression analysis (n=2862).

Results: Four of five identified factors were significantly associated with the intended choice of GP. "Comprehensive patient contact" (OR 4.02; 95% CI [3.5-4.6]), and "flexible working hours" (OR 1.35; 95% CI [1.2-1.5]) represent factors associated with choosing GP despite the perception of "superior career opportunities, income and status in other specializations" (OR 1.14; 95% CI [1.0-1.3]). Meanwhile, preference for "specialization, research and teamwork in other disciplines" (OR 0.55; 95% CI [0.5-0.6]) obstructs the intended choice of GP.

Conclusion: GP recruitment can profit from focused sponsorship of students' interest in patient contact within GP clerkships, appropriate GP teaching structure at the universities, enhanced research and teamwork opportunities, and increased flexibility of working hours.
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http://dx.doi.org/10.1055/a-0777-1782DOI Listing
June 2020

On the preference for linear regression models in children: Results of a field study in elementary school children.

J Exp Child Psychol 2019 02 12;178:30-40. Epub 2018 Oct 12.

Department of Psychology and Psychotherapy, Witten/Herdecke University, 58448 Witten, Germany. Electronic address:

We aimed at showing that children are able to identify and draw a line of best fit through a cloud of points according to the concept of linear regression. A sample of 72 children in third and fourth primary school grades were given two different tasks. In a first task, 10 different sheets with three illustrations of the same scatterplot with different lines of regression to choose from were presented. In a second task, scatterplots were given and children were asked to draw a line of best fit with pencil and ruler. In the first task bisector regression was preferred (χ = 15.21, df = 4, p = .004), whereas in the second conventional regression ordinary least squares (X|Y) was favored (χ = 27.14, df = 4, p < .001). In summary, the preference of the traditional regression model using a minimization in the vertical dimension was only partly supported by our data.
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http://dx.doi.org/10.1016/j.jecp.2018.09.009DOI Listing
February 2019

Anthroposophic medicine in the treatment of pediatric pseudocroup: A systematic review.

Complement Ther Med 2018 Oct 4;40:185-190. Epub 2017 Sep 4.

Department of Pediatrics, Gemeinschaftskrankenhaus Herdecke, Gerhard-Kienle-Weg 4, 58313 Herdecke, Germany; Department of Pediatric Oncology and Hematology, University Hospital Essen, Hufelandstr. 55, 45147 Essen, Germany. Electronic address:

Background: In Europe only few integrative pediatric wards exists and there are two German hospitals focusing on anthroposophic medicine as part of complementary and alternative medicine (CAM). Whilst the most common pediatric diseases are treated here, pseudocroup patients make up a large group in these hospitals, receiving conventional as well as anthroposophic therapies. However, effectiveness of these therapy concepts mostly based on physicians' experiences but clinical studies are hitherto missing.

Methods: A systematic literature search identifying therapy approaches for pseudocroup in children was conducted in general electronic databases (Cochrane Library, PubMed, OVID) and in CAM-specific databases (CAMbase, CAM-QUEST, Anthromedics). Search results were screened for anthroposophic therapy options. In addition, anthroposophic guidebooks were handsearched for relevant information.

Results: Among 157 articles fulfilling search criteria one retrospective study, and five experience reports describing anthroposophic treatments were identified. Several medications for the treatment of pseudocroup were mentioned such as Aconitum, Apis, Bryonia, Hepar sulfuris, Lavender, Pyrit, Sambucus and Spongia. During appropriate use no adverse effects were reported.

Conclusion: Anthroposophic medicine harbors a broad spectrum of remedies for the treatment of pseudocroup in children. In particular, Aconitum, Bryonia and Spongia are frequently recommended; however, clinical trials investigating the effectiveness are sparse. Therefore, development and validation of therapy strategies are required.
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http://dx.doi.org/10.1016/j.ctim.2017.09.001DOI Listing
October 2018

Verbal Probabilities: Linear or Logistic? - A Regression Analysis Approach.

Stud Health Technol Inform 2018 ;253:117-121

Department for Psychology and Psychotherapy, Witten/Herdecke University, Alfred Herrhausen-Straße 50, 58448 Witten, Germany.

Verbal probability expressions are quite intuitive and used in a variety of clinical important issues like adverse drug causality appraisal. However, there is insufficient evidence of their numerical meaning and whether they have a linear or logistic relationship with them. We aimed at contributing to answering these questions by means of a comparative regression analysis based on a sample of N=683 participants between 10 and 82 years (mean age 20.33±11.77; median: 18 years) who were asked to numerically rate a given set of sixteen verbal probability phrases on a visual analogue scale. With respect to the explained variance, we found an R2 for the linear model of 0.574 while R2 for the logistic model was only 0.392 indicating a superiority of linear model compared to the logistic model. Although we were able to show that ranked verbal phrases are more likely to behave in a linear that in a logistic way other regression options like the double logistic model should be taken into consideration for further research.
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November 2018

[Management of Acute Gastroenteritis in Children: A Systematic Review of Anthroposophic Therapies].

Complement Med Res 2018 25;25(5):321-330. Epub 2018 Jul 25.

Background: Acute gastroenteritis in children accounts for about 10% of hospital admissions and is still one of the major causes of death worldwide. As many children are treated with complementary and alternative medicine (CAM) and anthroposophic medicine, respectively, especially in Europe, the aim of this review was to descriptively present published anthroposophic therapies applied for the treatment of acute gastroenteritis in childhood.

Methods: A complex search strategy recording a broad spectrum of CAM therapies was developed to identify anthroposophic therapy options for the treatment of gastroenteritis in children. The search was conducted in 4 general scientific as well as 3 CAM-specific databases.

Results: In total, 3,086 articles were identified and screened for anthroposophic related content. The majority of hits deal with nutritional/dietary therapies. Articles considering anthroposophic approaches constitute only 3.1% (7/227) of all CAM-related articles. Among these articles 2 observational studies, 3 experience reports and 2 reviews were identified. In the experience reports, a variety of anthroposophic remedies was recommended but mostly unsupported by scientific evidence. However, observational studies for the anthroposophic medications, Bolus alba comp. and Gentiana comp., were detected. Additionally, studies investigating the efficacy and safety of Chamomilla, Ipecacuanha, Podophyllum or Tormentilla preparations in homeopathy and phytomedicine, respectively, were presented.

Conclusions: Most CAM-associated therapies for gastroenteritis in childhood comprise dietary recommendations. Studies concerning anthroposophic approaches and medications, respectively, are deficient. The results of this study underline that effort is needed to evaluate anthroposophic therapies in a clinical setting.
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http://dx.doi.org/10.1159/000488317DOI Listing
September 2019

Evaluation of the palliative symptom burden score (PSBS) in a specialised palliative care unit of a university medical centre - a longitudinal study.

BMC Palliat Care 2018 Jul 7;17(1):92. Epub 2018 Jul 7.

Institute of Psychiatry, Psychology and Neuroscience; Department of Psychological Medicine, King's College London, London, UK.

Background: The implementation of standardised, valid and reliable measurements in palliative care is subject to practical and methodological challenges. One aspect of ongoing discussion is the value of systematic proxy-based assessment of symptom burden in palliative care. In 2011, an expert-developed proxy-based instrument for the assessment of symptom burden in palliative patients, the Palliative Symptom Burden Score (PSBS), was implemented at the Specialised Palliative Care Unit of the University Medical Centre in Dusseldorf, Germany. The present study investigated its feasibility, acceptance and psychometric properties.

Methods: The PSBS was rated by nursing staff three times a day over 5 years (N = 820 patients). Feasibility and nurses' acceptance of PSBS were analysed. Structural validity was investigated by principal component analysis. Construct validity was examined via cross-validation with the Hospice and Palliative Care Evaluation checklist. Discriminative validity of the PSBS was analysed by means of Kruskal-Wallis test of patients' performance score. Reliability of the PSBS was evaluated by internal consistency analysis, test-retest and split-half-reliability. Inter-rater reliability was investigated by observer agreement of nurses' ratings of symptom burden within a day. Sensitivity to change was analysed by Wilcoxon test with repeated measures of the PSBS before and after palliative complex treatment.

Results: A high degree of acceptance and the feasibility of a high-frequency proxy-based symptom burden assessment approach were demonstrated. There were low rates of missing values and no indications of the adoption of prior ratings. PSBS in its present form demonstrates good structural and construct validity (r = .27-.79, p's < .001) and high sensitivity to changes in symptom burden (p's < .01, except sweating), but unsatisfactory reliability (α = .41-.67; test-retest: r .30-.88; p's < .001; split-half: r = .69; p < .001; inter-rater: n.s.).

Conclusions: The study presents a framework for the post hoc validation of an already existing documentation tool in palliative care. This study supports the notion that PSBS might not be reflective of an overall construct and will therefore require further development and critical comparison to other already established symptom burden instruments in palliative care.
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http://dx.doi.org/10.1186/s12904-018-0342-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6035799PMC
July 2018
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