Clinical Evidence

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A systematic review and meta-analysis summarise the evidence from clinical trials performed with Padma 28. They revealed that 19 clinical studies are available with regard to this herbal preparation [92]. While most studies examined the efficacy in patients with PAOD, that is to say claudicatio intermittens, individual studies were performed in other diseases (e.g. angina pectoris, hepatitis B, respiratory infections) but are not discussed here.

From the studies on PAOD (stage II according to Fontain) seven controlled trials were included in the systematic review. Six of them examined the same primary outcome (i.e. maximum walking distance), and one examined ankle pressure. The authors of the meta-analysis received the raw data of the single trials and therefore were able to perform a thorough re-analysis on an ITT basis. The re-analysis revealed non-comparability in the baseline data in one trial. Finally, the raw data of five trials could be pooled for meta-analysis thanks to the homogeneity of the data (272 patients: 155 verum, 117 placebo). The general analysis showed that the treatment with two tablets twice or three times a day for 16 weeks resulted in a significant prolongation of the maximal walking distance compared to placebo. To understand the clinical relevance of this finding, the authors chose the criterion for prolonging the maximum walking distance of more than 100 m. This criterion was significant as well and fulfilled by 18.2% of the patients under verum and by only 2.1% under placebo (P < 0.001; odds ratio: 10 [95% CI 3.03, 33.33]; number needed to treat: 6.2; RR: 0.12) [92]. In addition, as a secondary result a small but significant reduction in the blood levels of triglycerides and blood sugar as well as in systolic and diastolic blood pressure was observed in the patients of the verum group compared to placebo.

As regards safety, not only were the data of the 5 trials on PAOD analysed but all the available safety data from all 19 trials reporting on adverse events were as well (555 patients: 371 verum, 184 placebo). Serious adverse events (verum 2.4%, placebo 3.3%) were not associated with the treatment. Non-serious adverse events associated with the treatment were comparable in both treatment groups (verum 3.2%, placebo 2.7%; the most frequent were gastrointestinal side effects).

Data on other safety aspects are limited [70]: no studies have been done on the effects on responsiveness (ability to drive, use of machines). No risk potential was seen in experimental studies on animals concerning acute or chronic toxicity or in in vitro studies on gentoxicity. No human data are available on the use of Padma 28 during pregnancy. However, the hypersensibility to one of the compounds of Padma 28 should be regarded as a contraindication [70].

8.3.5 Summary

The current evidence shows that treatment with Padma 28 (two tablets twice or three times daily for 16 weeks) results in a statistically significant and clinically relevant increase in the maximum walking distance by more than 100 m. Following a clear improvement in symptoms, a reduction in the daily dosage is possible to two tablets a day as stated in the package insert.

According to a meta-analysis, the efficacy of Padma 28 in the symptomatic treatment of PAOD is greater than that of pentoxifylline [93] or Ginkgo [94-97] and at least comparable with naftidrofuryl [93]. The product is well tolerated and safe.

In view of the experimental effects and clinical data, the use of the complex herbal preparation can be regarded as an example of a multitarget [98] approach in herbal medicine. With this in mind the mostly small dosages of its herbal drugs could be seen as additional or synergetic in terms of biological effects and efficacy, while possible side effects are limited because of the small amounts of the individual herbal drugs (maybe because certain enzyme systems or receptors are only partly affected) [99]. If one considers PAOD as a kind of marker for systemic atherosclerosis [100] and if one keeps in mind that patients with PAOD often suffer from other chronic diseases (e.g. metabolic syndrome, diabetes, high blood pressure) [101], such an approach seems rewarding. Moreover it would partly be in concordance with theories in Tibetan Medicine [68] as well as latest research in pharmacology [98].

If the anti-oxidative properties of the preparation play a prominent role needs to be evaluated in robust studies.

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