Forschende Komplementärmedizin und klassische Naturheilkunde = Research in complementary and natural classical medicine
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Forsch Komplementarmed Klass Naturheilkd · Aug 2005
Randomized Controlled Trial Clinical TrialEffectiveness of balneotherapy in chronic low back pain -- a randomized single-blind controlled follow-up study.
Balneotherapy, a domain of medical science, focuses on utilizing the beneficial effects of medicinal waters. Low back pain is among the most prevalent musculoskeletal disorders affecting a large proportion of the population during their lifetime. Although small in number, all controlled studies published on this subject have demonstrated the benefits of balneotherapy. This present study was undertaken to compare the effects of hydrotherapy with mineral water vs. tap water on low back pain. ⋯ Balneotherapy in itself can alleviate low back pain. As demonstrated by this study, the analgesic efficacy and improvement of mobility accomplished by the use of mineral water is significantly superior to that afforded by hydrotherapy with tap water. Our results clearly establish the beneficial effects of mineral water. Moreover, it is a valuable adjunct to other forms of physical treatment as well as to pharmacotherapy.
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Forsch Komplementarmed Klass Naturheilkd · Dec 2004
[Acupuncture in the treatment of pain--hypothesis to adaptive effects].
A basic principle in conventional pain therapy is that the treatment should be tailored to the pathological mechanism of the disease. This is based on the knowledge of the effector mechanisms of the applied treatment modalities. Although for acupuncture the mode of action still remains elusive in many parts, evidence about its mechanisms in pain treatment is growing. ⋯ Possible mechanisms are differentiated in local and systemic effects and the question of point specificity is discussed. Additionally a comprehensive hypothesis is set up for the long-term effects of acupuncture in the treatment of chronic pain. In this context acupuncture is considered as a mode of repetitive, nociceptive stimulation, which induces adaptive processes on different physiological levels leading to an improved ability of the nociceptive system to cope with painful stimuli.
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Forsch Komplementarmed Klass Naturheilkd · Aug 2004
Randomized Controlled Trial Multicenter Study Clinical TrialRetrolective, comparative, epidemiological cohort study with parallel groups design for evaluation of efficacy and safety of drugs with "well-established use".
The randomized controlled clinical trial (RCT) is accepted as the "golden standard" for the evaluation of efficacy and safety of new drugs. In contrast, to demonstrate efficacy and safety of drugs with "well-established use" that have been on the European Community market for long time, observational comparative epidemiological studies can be used according to the European drug regulation directive. However, because comparative epidemiological cohort studies can share some risk of bias with other nonrandomized observational study designs, there is a need for an approach that could effectively reduce the bias risk in this type of studies. ⋯ Complementary therapy of patients with primary, non-metastatic breast carcinoma with the mistletoe extract Iscador was safe and in comparison to the control group within the same study cohort showed considerably fewer ADRs attributed to concurrent conventional therapy, reduced disease symptoms, and suggested a significant improvement of survival. Despite some methodical limitations that require careful study planning and conduction as well as critical interpretation, the applied study design seems suitable to evaluate the efficacy and safety of drugs with "well-established use", particularly in oncology.
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Forsch Komplementarmed Klass Naturheilkd · Aug 2004
A framework for classifying study designs to evaluate health care interventions.
Researchers who are trained in epidemiology recognise and use the standard range of designs, i. e. retrospective and prospective cohort studies and case control studies, for studying aetiological questions. The application of study designs to health care interventions is more complex. Researchers may modify familiar designs, in response to specific problems posed by the interventions being evaluated, and an unambiguous nomenclature has not been established. ⋯ Evidence of associations between features of study designs, specific biases and their consistent influence on effect estimates is lacking. A framework for classifying study design will be proposed, based on key features of study designs, i. e. what researchers actually did. This framework may (a) help to reduce the ambiguity about study design labels, and uncertainty about how a study was actually carried out, and (b) help methodological researchers to gather evidence about associations between different study design features and susceptibility to bias.
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Forsch Komplementarmed Klass Naturheilkd · Jun 2004
[Problems of randomized studies in complementary medicine demonstrated in a study on mistletoe treatment of patients with breast cancer].
Prospective randomized studies on mistletoe therapy repeatedly demonstrated that there is a basic problem in the matter of enrolling the appropriate number of patients within a reasonable amount of time. Most studies have to face this problem. However, recent experience suggests that this problem is more pronounced in the case of mistletoe treatment of cancer patients. ⋯ This confirms our suspicion that the difficulties of enrollment and randomization in the case of mistletoe studies exceed those of studies conducted in conventional oncology. The reasons for this dramatic effect and the possibility of alternative study designs are discussed.