Dieses Lehrbuch

Teut, Michael; Dahler, Jörn; Lucae, Christian; Koch, Ulrich

doi:10.1016/b978-343757630-0.50002-9

Cited by 12 publications

(21 citation statements)

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“…The intervention was added to a naturalistic setting; we intended to include all patients living in the apartments to avoid selection. It is important to understand that the intervention was not designed to evaluate specific effects of homeopathic drugs, but to test a holistic geriatric treatment approach that included homeopathic treatment philosophy with lifestyle change 9. As this was a complex intervention consisting of several treatment modules, it is not possible to relate effects to single parts of the intervention (eg, exercise, reduction of conventional medication, naturopathic care, homeopathic treatment, or additional care offerings in general).…”

Section: Discussionmentioning

confidence: 99%

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Effects and feasibility of an Integrative Medicine program for geriatric patients– a cluster-randomized pilot study

Teut¹,

Schnabel²,

Baur³

et al. 2013

CIA

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BackgroundOlder adults often use complementary medicine; however, very few interventional studies have focused on them. The aim of this study was to evaluate the feasibility and to obtain preliminary data on effectiveness of an Integrative Medicine (IM) program compared to usual medical care.MethodsThe study consisted of older adults living in shared apartment communities including caregiving. The shared apartments were cluster-randomized to the IM program or Usual Care (UC). IM consisted of additional lifestyle modification (exercise and diet), external naturopathic applications, homeopathic treatment, and modification of conventional drug therapy for 12 months. The UC group received conventional care alone. The following outcomes were used: Nurses Observation Scale for Geriatric Patients (NOSGER); Assessment of Motor and Process Skills; Barthel Index; Qualidem; Profile of Wellbeing; and Mini-mental State Examination. Exploratory effect sizes (Cohen’s d, means adjusted for differences of baseline values) were calculated to analyze group differences.ResultsA total of eight shared apartment communities were included; four were allocated to IM (29 patients, median seven patients; [mean ± standard deviation] 82.7 ± 8.6 years) and four to UC (29 patients, median eight patients; 76.0 ± 12.8 years of age). After 12 months, effect sizes ≥0.3 were observed for activities of daily living on the NOSGER-Activities of Daily Living subscale (0.53), Barthel Index (0.30), Qualidem total sum score (0.39), Profile of Wellbeing (0.36), NOSGER-Impaired Social Behavior (0.47), and NOSGER-Depressed Mood subscales (0.40). Smaller or no effects were observed for all other outcomes. The intervention itself was found to be feasible, but elaborate and time consuming.DiscussionThis exploratory pilot study showed that for a full-scale trial, the outcomes of Activities of Daily Living and Quality of Life seem to be the most promising. The results have to be interpreted with care; larger confirmatory trials are necessary to validate the effects.

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Section: Discussionmentioning

confidence: 99%

“…The complex IM program was designed with the aim to support self-healing and included lifestyle-changing elements, naturopathic care, and homeopathic treatment 9,10…”

Section: Methodsmentioning

confidence: 99%

Effects and feasibility of an Integrative Medicine program for geriatric patients– a cluster-randomized pilot study

Teut¹,

Schnabel²,

Baur³

et al. 2013

CIA

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“…Homöopathische Arzneimittelprüfungen (HAMPs) werden seit über 200 Jahren von homöopathischen Ärzten durchgeführt und stellen eine traditionell in der homöopathischen Ärzteschaft verankerte Form des Arzneimittelselbstversuches dar [1]. Sie dienen, neben toxikologischen Daten, der qualitativen Ausformulierung eines homöopathischen Arzneimittelbildes: Symptomprofile, die eine homöopathische Arznei am gesunden Probanden hervorruft, sollen als Leitfaden verwendet werden, um beim kranken Patienten die passende homöopathische Arznei auf der Basis der Überein-stimmung charakteristischer Symptome zu identifizieren («similia similibus curantur»: Ähnliches möge durch Ähnliches behandelt werden).…”

Section: Hintergrundunclassified

Arzneirechtlicher Status und Organisation homöopathischer Arzneimittelprüfungen in Deutschland

Teut

Hirschberg²,

Elies³

et al. 2011

Forsch Komplementmed

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Homöopathische Arzneimittelprüfungen (HAMPs) werden seit über 200 Jahren von homöopathischen Ärzten durchgeführt und stellen eine traditionell in der homöopathischen Ärzteschaft verankerte Form des Arzneimittelselbstversuches dar. Nach Einschätzung durch die Bundesbehörden handelt es sich bei der homöopathischen Arzneimittelprüfung um eine klinische Prüfung Phase I, für die das Arzneimittelgesetz anzuwenden ist. Die Adaptation eines 200 Jahre alten, primär qualitativen Studiendesigns an das moderne Arzneimittelgesetz und die Good Clinical Practice Guidelines führt zu einer Reihe von Schwierigkeiten, die primär Verblindung, «informed consent» und die Einordnung unerwünschter Ereignisse betreffen. Heilpraktiker sind von der Leitung einer HAMP ausgeschlossen. Darüber hinaus steigen Kosten und organisatorischer Aufwand einer HAMP enorm. Der Artikel diskutiert Folgen und Konsequenzen für die Zukunft.

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“…Homeopaths and researchers have developed a variety of study protocols for HDP and incorporated a variety of modern standards in the last few years [2,3,12-16]. …”

Section: Introductionmentioning

confidence: 99%

Protocol for a phase 1 homeopathic drug proving trial

Teut

Hirschberg

Luedtke

et al. 2010

Trials

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BackgroundThis study protocol adapts the traditional homeopathic drug proving methodology to a modern clinical trial design.MethodMulti-centre, randomised, double-blind, placebo-controlled phase 1 trial with 30 healthy volunteers. The study consists of a seven day run-in period, a five day intervention period and a 16 day post-intervention observation period. Subjects, investigators and the statisticians are blinded from the allocation to the study arm and from the identity of the homeopathic drug. The intervention is a highly diluted homeopathic drug (potency C12 = 1024), Dose: 5 globules taken 5 times per day over a maximum period of 5 days. The placebo consists of an optically identical carrier substance (sucrose globules). Subjects document the symptoms they experience in a semi-structured online diary. The primary outcome parameter is the number of specific symptoms that characterise the intervention compared to the placebo after a period of three weeks. Secondary outcome parameters are qualitative differences in profiles of characteristic and proving symptoms and the total number of all proving symptoms. The number of symptoms will be quantitatively analysed on an intention-to-treat basis using ANCOVA with the subject's expectation and baseline values as covariates. Content analysis according to Mayring is adapted to suit the homeopathic qualitative analysis procedure.DiscussionHomeopathic drug proving trials using the terminology of clinical trials according GCP and fulfilling current requirements for research under the current drug regulations is feasible. However, within the current regulations, homeopathic drug proving trials are classified as phase 1 trials, although their aim is not to explore the safety and pharmacological dynamics of the drug, but rather to find clinical indications according to the theory of homeopathy. To avoid bias, it is necessary that neither the subjects nor the investigators know the identity of the drug. This requires a modification to the informed consent process and blinded study materials. Because it is impossible to distinguish between adverse events and proving symptoms, both must be documented together.Trial registrationClinicalTrials.gov identifier: NCT01061229.

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Dieses Lehrbuch

Cited by 12 publications

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Effects and feasibility of an Integrative Medicine program for geriatric patients– a cluster-randomized pilot study

Effects and feasibility of an Integrative Medicine program for geriatric patients– a cluster-randomized pilot study

Arzneirechtlicher Status und Organisation homöopathischer Arzneimittelprüfungen in Deutschland

Protocol for a phase 1 homeopathic drug proving trial

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Dieses Lehrbuch

Cited by 12 publications

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Effects and feasibility of an Integrative Medicine program for geriatric patients&ndash; a cluster-randomized pilot study

Effects and feasibility of an Integrative Medicine program for geriatric patients&ndash; a cluster-randomized pilot study

Arzneirechtlicher Status und Organisation homöopathischer Arzneimittelprüfungen in Deutschland

Protocol for a phase 1 homeopathic drug proving trial

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Effects and feasibility of an Integrative Medicine program for geriatric patients– a cluster-randomized pilot study

Effects and feasibility of an Integrative Medicine program for geriatric patients– a cluster-randomized pilot study