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BACKGROUND: Padma 28 is an herbal formula from Tibetan Medicine, which since 35 years has been registered in Switzerland as a drug for the symptoms of circulatory disorders. Over this time, a large body of scientific literature has accumulated. The aim of this article was to give an overview of the clinical studies.METHODS: A systematic literature search was done in PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials (CCRCT). The clinical trials found were assessed regarding fields of application, efficacy, and safety, as well as methodological quality and level of evidence.
RESULTS: 29 trials (1 meta-analysis, 21 controlled trials, 7 open trials) and 3 retrospective case studies were found. They deal with different indications and include a total of 1,704 verum (of these, 697 children), 333 placebo, and 394 untreated or healthy patients. Dropouts and withdrawals were 2.5 and 3.5 times higher in the placebo than in the verum group, respectively. The highest level of evidence for the use of Padma 28 was found in the indication of intermittent claudication (11 trials). Indications of efficacy were also found in other vascular (6 trials) and different inflammatory diseases (12 trials).
CONCLUSIONS: The results suggest a favorable safety profile for Padma 28, also in the children examined (41% of the study population). Furthermore, the results show a broad field of applications. According to clinical evidence, Padma 28 has shown to be a safe and effective symptomatic treatment option for atherosclerosis-related diseases such as intermittent claudication. It also seems to have a potential for application in certain chronic inflammatory diseases such as recurrent respiratory tract infections, viral hepatitis, and multiple sclerosis. However, further randomized controlled trials (RCT) are needed to confirm these findings.
BACKGROUND: Atherosclerosis is a systemic disease. Its association with the metabolic syndrome requires a multimodal therapy setting, to alleviate symptoms and for primary and secondary prevention. In the planning of the therapy, information about evidence of the interventions and a rationale for reasonable combinations are important.METHOD: For compiling a meta-narrative review (MNR) on the evidence of complementary and conventional pharmaco-therapy in peripheral arterial occlusive disease (PAOD), the literature was searched for meta-analyses of randomized controlled trials (RCTs). These were evaluated taking into account network-pharmacological aspects and research parameters.
RESULTS: 4 suitable meta-analyses were found. In comparison to placebo, treatments with verum showed a significant improvement of the maximum walking distance of 63.5 m (95% confidence interval (CI) 27.11-99.91 m; Padma 28, Tibetan Formula), 41.3 m (95% CI -7.1-89.7 m; cilostazol, phosphodiesterase IIl inhibitor), 43.8 m (95% CI 14.1-73.6 m; pentoxifylline, rheological drug), and 71.2 m (95% CI 13.3-129.0 m; naftidrofuryl, rheological drug). Only for Padma 28, clinical relevance, defined as an increase of the maximum walking distance by >100 m, was analyzed and reached by 18.2% of the verum and 2.1% of the placebo patients (odds ratio 10; 95% CI 3.03-33.33). 1 conventional and 1 complementary drug additionally showed to have significant pleiotropic effects (Padma 28 and cilostazol (e.g. reduction of triglycerides)).
CONCLUSIONS: According to meta-analytic evidence, naftidrofuryl and Padma 28 show clinically relevant efficacy for the treatment of early stages of PAOD. The extent to which the theoretically possible combination of different drugs contributes to improve the systemic disease under a network-pharmacological rationale remains to be shown in a multi-armed RCT.
The spreading of Tibetan Buddhism and with it the Tibetan medicine in the region east of Lake Baikal, goes back to the 17th century. At the beginning of the 18th century, German speaking scholars were among the first to undertake scientific expeditions through Siberia. As such they were amongst the first scientists of the modern era who encountered the traditions, concepts, and therapeutic methods of Tibetan medicine. The aim of this article is to describe and analyze these first encounters with Tibetan medicine by the example of selected men of science of the 18th and 19th century. This work is based on extensive studies of sources in archives and libraries in Russia and Switzerland. We found documents related to the following scientists: Daniel Gottlieb Messerschmidt (1685-1735), Johann Georg Gmelin (1709-1755), Erik Laxmann (1737-1796), Friedrich Adelung (1768-1843), and Joseph Rehmann (1779-1831). They mentioned the distribution of Tibetan medicine within Russia, the use of medicinal plants and formulas as well as therapeutic techniques. For the scientific community of the time these first encounters of Europeans with practitioners of Tibetan medicine could not lift Tibetan medicine out of other exotic context in the field of ethnography. For today's researchers, these encounters are an important evidence for more than 300 years of development of Tibetan medicine on the vast territory of Siberia. The practice and the scientific examination of Tibetan medicine in Siberia is an active endeavor until today. The present work shows that it is possible and rewarding to follow up the historic and cultural connections from Europe to Asia via the Siberian link.
BACKGROUND: The multicompound herbal drug Padma 28 is based on a formula from Tibetan Medicine and has been used in Switzerland for over 30 years in the symptomatic treatment of circulatory disorders including intermittent claudication.OBJECTIVE: What is the current evidence regarding the clinical efficacy and safety of this drug in patients with peripheral arterial occlusive disease(PAOD)?
MATERIALS AND METHODS: Electronic databases were searched (each from inception to fall 2005) as well as the reference lists of the relevant articles.
RESULTS: 14 articles were found including 6 published studies, 1 un-published study, 6 double publications and 1 meta-analysis. Six studies analyzed maximum walking distance, 5 of these showed a significant increase. The pooled data of the meta-analysis confirmed a significant and clinically relevant increase of the maximum walking distance by more than 100 m in about 1 out of 5 patients. Serious adverse events were not related to verum, non-serious adverse events were equally frequent as under placebo.
CONCLUSIONS: The evidence available shows that the multi-target therapy with Padma 28 provides statistically significant and clinically relevant relief from PAOD-related symptoms, i.e. an increased walking distance.
In the context of the network model of the organism, multimorbid states (≥ 2 chronic diseases at the same time) can be considered as a complex disease pattern which can be mapped as characteristic signatures. From the perspective of system theory, living systems such as the human body are viewed as networks of interacting parts. These in turn can themselves be subnetworks assigned to different complexity levels. They range, e.g., from the gene to the transcriptome, proteome, metabolome, and epigenome up to the network of the entire molecular interactions, the so-called interactome. In multimorbidity, the disease signature affects different networks at all levels, e.g., cell systems, organs, and functional systems. Based on this semiotics, certain signatures of effectiveness and profiles of action can be assigned to each drug. A drug signature represents the physicochemical stimuli that cause a reaction by the system, as well as the cross-links by which the entire connected system is affected at all levels. Phytotherapeutics, which chemically represent multi-component mixtures, have especially complex signatures. As multi-target medicines with a pleiotropic effect profile, they therapeutically affect different levels of the network, which is why they are also referred to as network medicines. Herbal formulas from traditional medicine systems such as Tibetan Medicine are an example for phytotherapeutics with a particularly complex pleiotropic signature. Also from the traditional point of view, a disease signature is set in relation with a corresponding drug signature. However, in this case, it is based on the traditional energetic understanding of diseases. Modern research results clearly indicate a widely diversified signature range of Tibetan Medicines and thus provide a rationale for their use in integrative treatment approaches for diseases with complex signatures, e.g. in multimorbidity. The system-theoretical approach discussed here represents a method to enable a connectivity of traditional methods from complementary and alternative medicine to the other disciplines of modern medicine.
Herbal drugs are being increasingly used in medical practice, often without appropriate scrutiny of their safety and efficacy. The medicinal product Padma 28 is a fixed combination with Tibetan origin, used in Europe since the 1960s for the symptomatic treatment of circulatory disorders, including those of peripheral arterial occlusive disease (PAOD). We have conducted an analysis of all available data on this herbal drug from published literature as well as from original data we obtained from contacting the authors of published papers, reports and the manufacturer. A total of 19 trials have reported on 2084 patients to date, 444 of whom were in six controlled clinical studies on PAOD. A meta-analysis of five trials showed Padma 28 to increase walking distance by >100m in 18.2% of the patients with verum, versus 2.1% with placebo (P<0.001; odds ratio: 10 [95% CI 3.03, 33.33]; RR: 0.12; number needed to treat=6.2). The safety profile appears to be favourable. Available evidence shows that Padma 28 provides significant relief from PAOD-related symptoms (i.e. walking distance), probably of the same order of magnitude as other employed medications. However, larger confirmatory RCTs are desirable.