[External validity of clinical trials for treatment of dementia with ginkgo biloba extracts]. / Die Rolle der externen Validität bei der Beurteilung klinischer Studien zur Demenzbehandlung mit Ginkgo-biloba-Extrakten.

OBJECTIVES: Ginkgo bilobaextracts have been applied in the treatment of dementia of vascular origin and Alzheimer disease for a long time. However, in the most elaborated systematic review to date, Birks and colleagues drew quite a moderate conclusion in spite of the overall positive results. The reason for such a moderate interpretation often lies in the preference of internal validity such as randomisation and blinding, sometimes at the expense of external validity (conditions of everyday practice). Because of this, we analysed the clinical trials evaluated by Birks et al. in the light of the following questions: 1) To what extent are criteria of external validity considered? 2) Does the additional evaluation of external validity lead to differences in the estimation of efficacy? 3) What are the results of our analysis in regard to the efficacy of ginkgo biloba extract? MATERIAL AND METHODS: The selection of the clinical trials was based upon those included in the review carried out by Birks et al. (2002). The criteria for evaluating external validity were developed by consulting physicians specialised in geriatrics, experts in herbal pharmaceutics and affected/ related individuals (patients and relatives). RESULTS: We analysed 34 placebo-controlled clinical trials with a total of 37 comparisons. 21 trials showed significant results in favour of the ginkgo application in more than 50% of investigated outcome parameters, eight were significant for less than 50% of the parameters, four showed a trend in favour of ginkgo, and only two studies (with 4 comparisons) found no advantage for ginkgo. One of these negative studies used daily doses far below the usual dose range [corrected] We found no evidence for publication bias. None of the studies considered all criteria of external validity. Out of the seven studies with relatively high external validity and good overall quality, five showed a significant result in more than 50% of parameters, two in < or = 50%. Severe adverse effects were not mentioned in the studies. DISCUSSION AND CONCLUSIONS: 1) In the clinical studies analysed external validity was taken into account only moderately, especially with respect to additional non-pharmaceutical interventions and selection of participants. 2) The evaluation according to external validity led to a different selection of studies that were used for estimation of the ginkgo efficacy without effects on the overall result. 3) Sufficient evidence of the efficacy of ginkgo bilobaextracts in the treatment of dementia of vascular origin and Alzheimer disease is provided in spite of methodological limitations. Further studies should focus on effectiveness, ginkgo-sensitive subgroups, more individualised therapeutic goals and corresponding outcome measurements.

[Pilot study for the development of a questionnaire for the measuring of the patients' attitude towards spirituality and religiosity and their coping with disease(SpREUK)]. / Pilotstudie zur Entwicklung eines Fragebogens zur Erfassung der spirituellen und religiosen Einstellung und des Umgangs mit Krankheit (SpREUK).

OBJECTIVE: Life-threatening diseases are the standard situations which confront patients with spirituality and religiosity. Although both are wellknown factors in disease coping, their measurability and operationability remains a basic problem due to the variety of different meanings and interpretations of these terms. In this paper we describe the development of a questionnaire for the measuring of the patients' attitudes towards spirituality and religiosity and their disease coping (SpREUK). MATERIAL AND METHODS: For a first evaluation, 129 patients with a mean age of 54 years (SD 14.3) completed the questionnaire. 67% of them were women. 76% had a Christian denomination, 19% no denomination, and only 4% reported other religious traditions. 45% of the patients suffered from cancer, 18% from multiple sclerosis, 22% from other chronic diseases, and 15% from acute diseases. The questionnaire comprises 29 five-stage likert-scaled items. Apart from a descriptive analysis of the single items, reliability (Cronbach's alpha) and validity analysis (factor analysis) of the questionnaire was performed. RESULTS: Factor analysis resulted in four dimensions: (1) 'Search for meaningful support', (2) 'Guidance, control and message of disease', (A) 'Support in relations with the external through spirituality/religiosity', and (B) 'Stabilization of the inner condition through spirituality/religiosity'. The reliability of the four scales of the SpREUK questionnaire is high: Cronbach's alpha 0.82, 0.62, 0.89, resp. 0.74. Women had significantly higher SpREUK scores for scales 1 and 2 than male patients. Non-denominational patients had significantly lower scores in all four scales than those with a Christian denomination. The scores did not correlate with disease or duration of disease; however, there might be a positive correlation between age and the score of scale 2. DISCUSSION: The impact of spirituality and religiosity on the course of disease, coping skills, and health-related quality of life is broadly discussed not only in complementary medicine. With the SpREUK questionnaire we present a reliable and valid instrument to measure the patients' search for meaningful support through spirituality/religiosity in terms of disease coping and health restoration. Further evaluation of this instrument is planned with a focus on hospitals which are affiliated with a specific denomination, as a reasonable extension of quality management and concept development.

[Evaluation of inpatient naturopathic treatment--the Blankenstein model. Part II: Effective strength and health status of patients over the course of time]. / Evaluation stationärer Naturheilkunde - das Blankensteiner Modell. Teil II: Effektstärken und Gesundheitsstatus der Patienten im zeitlichen Verlauf.

BACKGROUND: In order to check the possibilities and limits of naturopathic treatment within the field of inpatient care, in January 1997 a model department of naturopathy was established at the Hospital Blankenstein, Hattingen. For a period of 3 years (starting on July 1,1999) it has been scientifically accompanied by the Chair of Medical Theory and Complementary Medicine at the University of Witten/ Herdecke. AIM: The scientific evaluation focuses on the following question: How does a 3-week inpatient treatment with naturopathic methods effect different outcome parameters regarding a pre-post comparison and a half-year follow-up? METHODS: A prospective observation study with 4 defined times of measurement (hospitalization, discharge, 3 and 6 months after the end of the inhospital stay) and an analysis of the subgroups of patients with rheumatic diseases. The data of 1026 patients of the department of naturopathy were considered, who have been treated because of rheumatic diseases, metabolic diseases, chronic-bronchial diseases and allergic discomforts from July 1, 1999 to December 13, 2000. The mean value of age was 57.3 years, the median 58.5 years. 69.4% of the patients were capable of gainful employment (17-65 years). The patients were treated with classical naturopathic methods (hydrotherapy, phytotherapy), individually adapted to the patient's situation. Outcome parameters were quality of life (measured with the HLQ and the SF-36), mood (measured with the Bf-S), physical complaints (measured with the GBB24) and pain perception (measured with the SES) of the patient. RESULTS: All subscales as well as the total scores of the psychometric test instruments showed highly significant changes (t test, p < 0.01) between the time 'hospitalization' and 'discharge'. Within the follow-up these values were stabilized on a level significantly higher than the initial level. Patients with rheumatic diseases showed a profile different from that of patients with similar diseases. CONCLUSION: The results show a stabilization of the patients within the follow-up, which proves the long-lasting effect of naturopathic treatment. This is of special importance for the section of naturopathy, where the temporal dimension of treatment plays an important role and it is often asserted that therapeutical effects can above all be recognized in the long term.

[Changes in quality of life during acute inpatient naturopathic treatment--results of the Blankenstein model]. / Veränderung der Lebensqualität unter akutstationärer naturheilkundlicher Behandlung--Ergebnisse aus dem Blankensteiner Modell.

AIM OF THE STUDY: To check the possibilities and limitations of naturopathic treatment in in-patient care, a department of naturopathy was set up as a model project at the Hospital Blankenstein, Hattingen, in January 1997. In accordance with the plans and concepts of the Ministry For Women, Young People, Family And Health of the land North-Rhine Westphalia and the Federation of Statutory Health Insurance bodies, the department of naturopathy is designed to receive scientific support by the Chair of Medicine Theory for a total of three years, starting July 1, 1999. Focus is on the following question: How will a three-week in-patient treatment with naturopathic methods affect the quality of life of patients, based on a prepost-comparison and a follow-up over 6 months? METHODS: A prospective observation study with 4 defined times of measurement (hospitalisation, discharge, 3 and 6 months after the end of the in-hospital stay) and an analysis of the subgroups of patients with rheumatic diseases was carried out. The study comprised 618 patients of the department of naturopathy who were treated for rheumatic diseases, metabolic diseases, chronic bronchial diseases and allergic complaints between July 1, 1999 and June 13, 1999. The average age was 57.3 years and the median was 58 years. 71.3% of the patients were of gainful employment age, i.e. between 17 and 65 years old. The therapy consisted of serial treatments with classical naturopathic methods (hydrotherapy, phytotherapy etc.) adapted to the patients' individual needs. The aim parameter was the quality of life of the patient, measured by SF-36 and HLQ. RESULTS: All subscales as well as the total scores of life quality showed highly significant improvements (t-test, p < 0.01) between the times of 'hospitalisation' and 'discharge'. During follow-up these values stabilised on a level significantly higher than the initial level. Patients with rheumatic diseases showed a different profile compared to patients with similar diseases. CONCLUSION: Results show a stabilisation of patients during follow-up, demonstrating the long-term effect of the applied treatment. This is of special importance of naturopathy, as the temporal dimension of treatment is important in this context, and as it is often asserted that a manifestation of a therapeutical success is obvious mainly on a long-term basis.

[Evaluation of in-hospital treatment with naturopathic methods - the 'Blankenstein model'. Part I: Patients and therapeutic concepts]. / Evaluation stationärer Naturheilkunde - Das Blankensteiner Modell. Teil I: Patientenklientel und therapeutische Konzepte.

BACKGROUND: In January 1997 the department for naturopathy with 60 beds has been established at the Catholic Hospital St. Elisabeth, Blankenstein, and was taken into consideration in Northrhine-Westphalia's plan of hospital budgets. AIM: The establishment of this department was connected to a scientific evaluation, which was performed to check the diagnostic and therapeutic possibilities and limits of naturopathic methods applied within the field of inpatient treatment according to section sign 39 SGB V. PATIENTS AND METHODS: Besides sociodemographic surveys, questions about the ranges of indication and results of treatments as well as the analysis of the cost-benefit relation were part of the evaluation. Additionally, a subject of the current check was the delimitation towards means of rehabilitation or towards ambulant treatments. In order to initiate or to continue an open dialog with other model projects on this field, at first the therapeutical concept of the department was presented in excerpts. RESULTS: The mean age of the patients treated was 57.3 years. In total, 440 of the 618 patients (71.3%) were capable of gainful employment, which means they were between 17 and 65 years old. In three fourths of all examined patients their place of residence was in the areas of Essen, Dortmund, and Hagen. Every patient had a therapy time of 4.1 h per day in the hospital. In total, 8.7 medicines per patient were taken, with an average quantity of 12.9 single doses per day. 97.3% of the patients had a second diagnosis, and 91.8% of the patients had 3 or more diagnoses. 60% of the patients suffered from rheumatic diseases. In 84.7% of these patients the first diagnosis was 'disease of the skeleton and the muscles'. Concerning the diagnostic means, electrocardiograms and X-ray examinations as well as in-house councils about these means can be named as being characteristic. By means of patient groups that have been differentiated by the tracer diagnosis, the corresponding therapy standards are explained. These standards have been worked out with classical naturopathic treatments, especially in regard to rheumatic diseases. DISCUSSION: The application of naturopathic methods within the field of inpatient treatment is especially distinguished by the regular use of classical naturopathic treatments (especially hydrotherapy), with a high therapy density. By establishing standardized therapy concepts, comparisons with the ambulant care of chronically ill patients as well as with the results of model projects within the field of rehabilitation are made possible.