NOTE: The blend of herbs in Heartrol. is the same as that in the Tibetan formula called .PADMA 28. (which is the focus of the studies below).

 

Atherosclerosis 2006 Nov;189(1):39-46. Epub 2006 Apr 4.

Treating intermittent claudication with Tibetan medicine Padma 28: does it work?

Melzer J et al

Department of Internal Medicine, Complementary Medicine, University Hospital Zurich, Raemistrasse 100, 8091 Zurich, Switzerland. joerg.melzer@usz.ch

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 favorable. 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.

PMID: 16600251

 

Forsch Komplementarmed. 2006 Feb;13 Suppl 1:28-30. Epub 2006 Feb 17.

Padma 28 in the treatment of chronic dental pulpitis: an observational case study in 49 patients

[Article in German]

Fullermann F.

BACKGROUND: In the case of pulpitis the dentist has to differentiate between a reversible and therefore treatable pulpal inflammation and an irreversible damage of the pulpa, accord-ing to the clinical symptoms. From these one cannot draw conclusions about the effective histological condition of the pulpa. Early stages of pulpitis cannot be recognized by X-rayeither. OBJECTIVES: By means of case studies in the course of daily dental practice the following questions are addressed:Is dental pulpitis an indication for the use of the Tibetan remedy Padma 28? Can a root canal treatment be prevented by administering Padma 28? What dosage is appropriate in this indication? PATIENTS AND METHODS: 53 patients with symptoms of chronic dental pulpitis but without clear indication for an im-mediate root canal treatment were prescribed 2 x 2 tablets Padma 28 daily, for 15 days. 49 patients took the preparation,and the course of symptoms was recorded and analyzed according to a simple scheme. RESULTS: 27 of these patients(55%) were free of pain within 1 month. A total of 40 patients(81%) reached a pain-free state after a longer period. By now, in most cases observations have been made for a period of 2-3 years (maximum: 5.5 years). 12 patients (24%) remained without relapse so far for more than 3 years. These experiences allow to deduce possible indications and clinical symptoms for the use of Padma 28. CONCLUSIONS: These results encourage the use of Padma 28 as a complementary preparation with little side effects, in unclear cases of pulpitis. The clinical development can be observed without further treatment if the patient does not need pain medication. Most patients (>80%) showed a complete remission, positively affect-ed and expedited by Padma 28; root canal treatments or ex-tractions could be prevented. In many cases the improvement has sustained over observation periods of >3 years. Criteria for therapeutic decisions are proposed.

PMID: 16582561

Forsch Komplementarmed. 2006 Feb;13 Suppl 1:23-7. Epub 2006 Feb 17.

Efficacy and safety of Padma 28 in peripheral arterial occlusive disease

[Article in German]

Melzer J et al

 

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.

PMID: 16582560

Forsch Komplementarmed. 2006 Feb;13 Suppl 1:13-7. Epub 2006 Feb 17.

Anti-inflammatory mechanisms of the Tibetan herbal preparation Padma 28 in the vessel wall.

Exner M,Raith M, et al

BACKGROUND: The Tibetan herbal preparation Padma 28 has been shown to act as an anti-atherosclerotic agent in advanced peripheral arterial occlusive disease. We tested the effect of aqueous Padma 28 extracts on both the Creactive protein (CRP) induced expression of the pro-inflammatory cell adhesion molecule E-selectin and the anti-atherosclerotic protective enzyme heme oxygenase- 1 (HO-1) in human aortic endothelial cells. METHODS AND RESULTS: According to FACS analysis, quantitative RT-PCR and Western blot, CRP-induced E-selectin expression was completely prevented by aqueous Padma 28 extracts. Additionally, Padma 28 mediated an up to 60-fold upregulation of HO-1 mRNA as measured by quantitative RT-PCR. This upregulation could also be demonstrated on the protein level. CONCLUSION: Aqueous extracts of the Tibetan herbal preparation Padma 28 inhibit CRP-induced expression of the inflammatory cell adhesion molecule E-selectin and lead to upregulation of the vascular protective enzyme HO-1 in human aortic endothelial cells. These properties may be responsible for its anti-atherosclerotic effects in peripheral arterial occlusive disease.

PMID: 16582558

Forsch Komplementarmed. 2006 Feb;13 Suppl 1:7-12. Epub 2006 Feb 17.

Anti-inflammatory potential of Padma 28--review of experimental data on the antiatherogenic activity and discussion of the multi-component principle

[Article in German]

Ueberall F, et al

BACKGROUND: The Tibetan remedy Padma 28 has been used in Europe for decades and has proved to be effective in inflammatory and atherosclerotic conditions. Beyond clinical trials, a large number of in vitro and ex vivo studies report various properties and biochemical activities of this complex herbal multicompound. OBJECTIVE: To give an overview of the complex efficacy profile of Padma 28, to review available data, to relate findings to the development of atherosclerosis and thus to discuss the antiatherogenic potential of Padma 28. METHODS: Published non-clinical original papers on Padma 28 were collected and classified according to the studied mechanisms of action. Results were correlated to the briefly described sequences of atherogenesis and various mechanisms of action were elaborated, laying particular emphasis on more recent articles. RESULTS: The complex activity profile of Padma 28 spans mainly direct and indirect anti-inflammatory proper-ties as well as further categories of biochemical actions. These can be related to the complex processes of atherogenesis. CONCLUSIONS: The described mechanisms support the therapeutic field of application of Padma 28, i.e. peripheral circulatory disorders as well as chronic inflammatory disorders. Moreover, the numerous effects as well as the diversity of sites of action allow to draw first conclusions on the conceptual design of this multicomponent formula.

Vasa. 2005 Feb;34(1):11-7.

Comment in:

Vasa. 2005 August;34(3):211-1;author reply 212-2

Effects of the Tibetan herbal preparation PADMA 28 on blood lipids and lipid oxidisability in subjects with mild hypercholesterolaemia.

Brunner-La Rocaa HP et al

BACKGROUND: Previous studies showed an anti-atherosclerotic effect of PADMA 28, an herbal formula based on Tibetan medicine. As the mechanisms of action are not fully understood, we investigated whether PADMA 28 may lower blood lipids and lipid oxidisability, and affect early endothelial dysfunction. PATIENTS AND METHODS: Sixty otherwise healthy subjects with total cholesterol > or = 5.2 mmol/l and < 8.0 mmol/l were randomly assigned to placebo or PADMA 28, 3 x 2 capsules daily, for 4 weeks (double-blind). Blood lipids (total, LDL-, and HDL-cholesterol, triglycerides, Apo-lipoprotein A1 and B) and ex vivo lipid oxidisability were measured before and after treatment. In a subset of 24 subjects, endothelial function was assessed using venous occlusion plethysmography with intraarterial infusion of acetylcholine. Isolated LDL and plasma both untreated and pre-treated with PADMA 28 extract were oxidised by the radical generator AAPH. Conjugated diene formation was measured at 245 nm. RESULTS: Blood lipids did not change during the study in both groups. In contrast to previous reports in mild hypercholesterolaemia, no endothelial dysfunction was seen and, consequently, was not influenced by therapy. Ex vivo blood lipid oxidisability was significantly reduced with PADMA 28 (area undercurve: 5.29 +/- 1.62 to 4.99 +/- 1.46, p = 0.01), and remained unchanged in the placebo group (5.33 +/- 1.88 to 5.18 +/- 1.78, p > 0. 1). This effect persisted one week after cessation of medication. In vitro experiments confirmed the prevention of lipid peroxidation in the presence of PADMA 28 extracts. Persistent protection was also seen for LDL isolated from PADMA 28-pretreated blood after being subjected to rigorous purification. CONCLUSIONS: This study suggests that the inhibition of blood lipid oxidisability by PADMA 28 may play a role in its anti-atherosclerotic effect.

Eur. Cytokine Network 2004 Jul-Sep;15(3):203-9.

PADMA-28, a Tibetan herbal preparation is an inhibitor of inflammatory cytokine production.

Barak V, Kalickman I, et al

BACKGROUND: Previous studies have shown that PADMA-28, a multicomponent, traditional Tibetan herbal plant preparation possesses a variety of beneficial effects on several experimental models of inflammatory and immune processes, including autoimmune diabetes and autoimmune encephalomyelitis. In humans, PADMA-28 attenuated the symptoms associated with intermittent claudications in atherosclerotic patients. OBJECTIVE: To assess the effect of PADMA 28 on the immune system, e.g. cytokine (interleukins) production. DESIGN: Cytokine production by human blood monocytes (derived from 12 healthy donors) stimulated in vitro, either by endotoxin (LPS) from Salmonella typhi or by lipoteichoic acid (LTA) from group A Streptococci was modulated by PADMA-28. RESULTS: The present study showed that an aqueous extract of PADMA-28 strongly decreased the production of the inflammatory cytokines IL-1beta, IL-6, IL-8 and TNF-alpha, and more moderately, also decreased the anti-inflammatory cytokine IL-10 induced by LPS. However, the LTA - induced IL-10 production was [not significantly] increased by the low dose PADMA-28, while not effected at all by the higher dose of PADMA-28. CONCLUSIONS: The data from these finding suggest a possible clinical efficacy of PADMA-28 either in autoimmune and in inflammatory conditions or in post-inflammatory sequelae, as previously shown in in vivo and human studies, probably by decreasing inflammatory cytokines.

Forsch Komplementarmed Klass Naturalheilkd 2002 Dec;9(6):346-51.

Comparative investigation of the antimicrobial activity of PADMA 28 and selected European herbal drugs.

Weseler A, Saller R, Reichling J.

OBJECTIVE: PADMA 28 is a multicompound preparation of 20 herbs, calcium sulphate, and camphor, derived from Tibetan medicine. It is usually used in the treatment of peripheral circulatory disorders, accompanied by the symptoms tingling, formication, heaviness and tenseness in arms and legs, numbness in hands and feet, and cramps in the calf. Recently, the question of whether appropriate preparations of PADMA 28 also exhibit antibacterial and antimycotic activity has often been raised. As there are as yet no experimental findings that answer this question, an in vitro study was carried out. In a parallel survey we investigated the antimicrobial properties of 5 herbal drugs which are commonly used in the traditional European folk medicine for the topical treatment of mild skin infections, wounds and eczematous skin lesions. METHODS: The minimum inhibitory concentrations (MIC) and the minimum bactericidal concentrations (MBC) of alcohol-based (tinctures) and aqueous (teas) herbal drug preparations were determined in vitro by a broth microdilution method for 5 Gram-positive and 5 Gram-negative bacteria, as well as the yeast Candida albicans. RESULTS: The aqueous and alcohol-based PADMA 28 preparations as well as the corresponding preparations of the European herbal drugs showed an antibacterial effect against Gram-positive bacteria in vitro. These bacteria revealed a somewhat higher sensitivity to the teas prepared from the European herbal drugs (MIC: 1.3-20.0 mg/ml) than to the aqueous preparations of PADMA 28 (MIC: 5.0-40.0 mg/ml). The better antibacterial activity of the European herbal drugs is probably based on their relatively high amount of tanning agents. On the other hand, all tested plant preparations inhibited not at all or only insufficiently the growth of the Gram-negative bacteria tested and that of Candida albicans. The ethanolic PADMA 28 tinctures showed an improved inhibitory effect on the Gram-positive bacteria (MIC: 0.38-1.51% tincture or 0.38-1.51 mg PADMA 28/ml) compared with the aqueous preparations; this effect is comparable to the ethanolic tinctures of the tested European herbal drugs (MIC: 0.4-1.6/3.2% tincture or 0.4-1.6/3.2 mg herbal drug/ml). CONCLUSION: All tested tea preparations and alcoholic tinctures of PADMA 28 as well as those of the selected European herbal drugs exhibited evident antibacterial effects against Gram-positive bacteria in vitro. On the other hand, except for Klebsiella pneumoniae, all Gram-negative bacteria tested and the yeast Candida albicans were insensitive against the different aqueous and alcohol-based plant extracts.

PMID: 12618552

Ugeskr Laeger 1994 Oct 17;156(42):6207-9.

 

Padma-28, a herbal preparation, increases walking distance in patients with intermittent claudication

 

[Article in Danish]

Drabaek H, Mehlsen J, et al

Frederiksberg Hospital

Thirty-six patients with stable intermittent claudication were randomized in a doubleblind study either to treatment with two tablets of Padma-28 twice daily (containing 340 mg dried herbal mixture composed according to an ancient lamaistic prescription) or placebo for four months. Effect of treatment was quantified by measurements of systemic and peripheral systolic blood pressures, and pain-free and maximal walking distances on a tread-mill. The actively treated group attained a significant increase in pain-free walking distance from 115 m (72-218) to 227 m (73- >1000, p < 0.05). The placebo group did not show significant changes in either pain-free or maximal walking distance. Significant changes in systemic or peripheral blood pressures could not be demonstrated in any of the groups. In conclusion, our study has shown that treatment with Padma-28 over a four month period significantly increases the walking distance in patients with stable intermittent claudication of long duration.

PMID: 7998359

 

Angiology, 1993 Nov;44(11):863-7.

A botanical compound, Padma 28, increases walking distance in stable intermittent claudication.

Drabaek H, Mehlsen J, et al

Department of Clinical Physiology, Frederiksberg Hospital, Denmark.

Thirty-six patients with a median age of sixty-seven years and a median duration of intermittent claudication of five years were randomized to either active treatment with Padma 28 or placebo. The effect of treatment was quantified by measurements of systemic and peripheral systolic blood pressures and by measurements of the pain-free and the maximal walking distance on a treadmill. The ankle pressure index (ankle systolic pressure/arm systolic pressure) was calculated. The group randomized to active treatment received two tablets bid containing 340 mg of a dried herbal mixture composed according to an ancient lamaistic preparation (Padma 28). After active treatments, administered over a period of four months in a double-blinded, randomized design, the patients allocated to this group attained a significant increase in the pain-free walking distance from 52 m (20-106) to 86 m (24-164; P < 0.05) and in the maximal walking distance from 115 m (72-218) to 227 m (73- > 1,000; P < 0.05). The patient-group receiving placebo treatments did not show any significant changes in either the pain-free or the maximal walking distance. The authors could not demonstrate any significant changes in the ankle pressure index either during active or during placebo treatment. In conclusion, this study has shown that treatment with Padma 28 over a period of four months significantly increased the walking distance in patients with stable, intermittent claudication of long duration.

PMID: 8239057

Schweiz Med Wochenschr 1985 Jun 1;115(22):752-6.

Effects of the Tibetan herbal preparation Padma 28 in intermittent claudication

[Article in German]

Schrader R, Nachbur B, et al

In a placebo-controlled double blind study the effect of Padma 28, a Tibetan herbal prescription, on patients with intermittent claudication was investigated. After two weeks without vasoactive therapy 23 patients were treated by Padma 28 and 20 by placebo. The patients had a disease history of at least 8 months, a steady state for symptoms (maximum walking distance below 250 m), and were distributed randomly in the two groups. After 16 weeks the patients treated with Padma 28 exhibited on standardized ergometry an increase of some 100% (p less than 0.01) in the maximum as well as painfree walking distance. The control patients showed increases of 21% in maximum (p less than 0.05 as compared to Padma 28), and 46% in painfree walking distance. The drug was well tolerated and no drop-out ensued because of side effects.

PMID: 3892663

 

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