title: Clinical studies on the efficacy and safety of Padma 28, a complex herbal formulation from Tibetan medicine: an overview.
abstract: 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.
authors.affiliation: Scientific Medical Division, Padma Inc., Hinwil, Switzerland.
authors.forename: Cecile
authors.initials: C
authors.lastname: Vennos
authors.forename: Jörg
authors.initials: J
authors.lastname: Melzer
authors.forename: Reinhard
authors.initials: R
authors.lastname: Saller
mesh_terms: D000328:Adult; D001157:Arterial Occlusive Diseases / Q000188:drug therapy*; D050197:Atherosclerosis / Q000188:drug therapy; D002648:Child; D018849:Controlled Clinical Trials as Topic; D019317:Evidence-Based Medicine; D006801:Humans; D007383:Intermittent Claudication / Q000188:drug therapy; D038861:Medicine, Tibetan Traditional; D008517:Phytotherapy; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D010936:Plant Extracts; C066069:Padma 28