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| Title: |
Efficacy and safety of Padma 28 in peripheral arterial occlusive disease |
| Author(s): |
Melzer J, Brignoli R, Saller R. |
| 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. |
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The Use of B Vitamin Supplements and Peripheral Arterial Disease Risk in Men Are Inversely Related. |
| Author(s): |
Merchant AT, Hu FB, Spiegelman D, Willett WC, Rimm EB, Ascherio A. |
| Peripheral arterial disease (PAD) causes morbidity and is associated with mortality. B vitamin intake has been inversely associated with coronary heart disease, but their effects on PAD are not known. We examined prospectively the relationships between dietary folate, vitamin B-6 and B-12 and PAD risk in 51,529 male U.S. health professionals, aged 40 to 75 y, who answered a detailed 131-item questionnaire to assess diet and vitamin supplement use. The study population consisted of 46,036 men free of PAD, cardiovascular disease and diabetes at baseline followed for 12 y during which we documented 308 incident PAD cases. For every 400 micro g/d increment of folate intake, the multivariate adjusted PAD risk decreased by 21% [relative risk (RR) = 0.79, 95% CI 0.64-0.96]. Men in the top category of folate intake (median = 840 micro g) were at 33% lower risk of PAD than men in the bottom category (median = 244 micro g) (RR = 0.67, 95% CI 0.45-0.96, P-value, test for trend = 0.03) after multivariate adjustment. There were weak inverse associations between intake of vitamin B-6 and PAD risk (RR = 0.70, 95% CI 0.48-1.02, P-value, test for trend = 0.06) and B-12 (RR = 0.77, 95% CI 0.54-1.11, P-value, test for trend = 0.12). These results suggest that higher consumption of folate may contribute to the prevention of PAD. |
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Optimal diets for prevention of coronary heart disease. |
| Author(s): |
Hu FB, Willett WC. |
| CONTEXT: Coronary heart disease (CHD) remains the leading cause of mortality in industrialized countries and is rapidly becoming a primary cause of death worldwide. Thus, identification of the dietary changes that most effectively prevent CHD is critical. OBJECTIVE: To review metabolic, epidemiologic, and clinical trial evidence regarding diet and CHD prevention. DATA SOURCES AND STUDY SELECTION: We searched MEDLINE through May 2002 for epidemiologic and clinical investigations of major dietary factors (fat, cholesterol, omega-3 fatty acids, trans-fatty acids, carbohydrates, glycemic index, fiber, folate, specific foods, and dietary patterns) and CHD. We selected 147 original investigations and reviews of metabolic studies, epidemiologic studies, and dietary intervention trials of diet and CHD. DATA EXTRACTION: Data were examined for relevance and quality and extracted by 1 of the authors. DATA SYNTHESIS: Compelling evidence from metabolic studies, prospective cohort studies, and clinical trials in the past several decades indicates that at least 3 dietary strategies are effective in preventing CHD: substitute nonhydrogenated unsaturated fats for saturated and trans-fats; increase consumption of omega-3 fatty acids from fish, fish oil supplements, or plant sources; and consume a diet high in fruits, vegetables, nuts, and whole grains and low in refined grain products. However, simply lowering the percentage of energy from total fat in the diet is unlikely to improve lipid profile or reduce CHD incidence. Many issues remain unsettled, including the optimal amounts of monounsaturated and polyunsaturated fats, the optimal balance between omega-3 and omega-6 polyunsaturated fats, the amount and sources of protein, and the effects of individual phytochemicals, antioxidant vitamins, and minerals. CONCLUSIONS: Substantial evidence indicates that diets using nonhydrogenated unsaturated fats as the predominant form of dietary fat, whole grains as the main form of carbohydrates, an abundance of fruits and vegetables, and adequate omega-3 fatty acids can offer significant protection against CHD. Such diets, together with regular physical activity, avoidance of smoking, and maintenance of a healthy body weight, may prevent the majority of cardiovascular disease in Western populations. |
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Peripheral arterial disease detection, awareness, and treatment in primary care. |
| Author(s): |
Hirsch AT, Criqui MH, Treat-Jacobson D, Regensteiner JG, Creager MA, Olin JW, Krook SH, Hunninghake DB, Comerota AJ, Walsh ME, McDermott MM, Hiatt WR. |
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Placebo-controlled double-blind study to investigate the efficacy of the Tibetan plant preparation Padma 28 in the treatment of intermittent claudication. |
| Author(s): |
Smulski HS, Wojcicki J |
| Objective To determine the efficacy of the Tibetan plant preparation Padma 28 for intermittent claudication. Design Randomized, placebo-controlled, double-blind trial of 16 weeks’ duration. PatientsOf 100 patients between the ages of 35 and 65 with pre-established diagnosis of intermittent claudication, 93 completed the study. Inclusion criteria were a typical anamnesis, positive physical examination, maximum walking distance of less than 250 m and a minimum 6 months’ duration of the disease. Exclusion criteria were peripheral arterial occlusive disease, diseases affecting walking ability, or missing steady state. Intervention Padma 28 (380 mg) 2 capsules twice daily (n=50) or placebo (n=50) for 16 weeks. ResultsPatients receiving Padma 28 exhibited on standardized ergometry an increase of maximum walking distance from 87.5 to 187.7 m. The patients receiving placebo showed a non-significant increase of 12.5 m. The increase in walking distance of the group receiving Padma 28 compared with placebo was highly significant after 12 and 16 weeks. Conclusions Padma 28 shows clinically relevant effectiveness in peripheral arterial occlusive disease of the lower extremities, Fontaine II with intermittent claudication. |
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Padma 28, a Botanical Compound, Decreases The Oxidative Burst Reaction of Monocytes and Improves Fibrinolysis in Patients with Stable Intermittent Claudication. |
| Author(s): |
Winther K, Kharazmi A, Himmelstrup H, Drabaek H, Mehlsen J |
| Thirty-six patients with a median age of sixty-seven years and a median duration of stable intermittent claudication of five years were randomized to either active treatment with Padma 28 or placebo for four months. The group randomized to active therapy received twice daily two tablets, each tablet containing 340 mg of a dried herbal mixture composed according to an ancient lamaistic preparation. The group randomized to placebo received inactive tablets of indistinguishable taste, colour and size. Platelet aggregation in vitro by ADP or collagen was not significantly changed by Padma 28, but three statistically significant findings during active drug treatment were: the “oxidative burst” of monocytes, as measured by chemiluminescence, decreased from 75.6 mVolt to 53.5 mVolt; euglobulin clot lysis time was shortened by approximately 40%, signifying a sharp increase in fibrinolytic activity, and PAI-1 activity decreased from 14.6 to 10.1 IU/ml (p<0.05). Patients on placebo showed no significant changes in any of these parameters. The possible relevance of these biochemical changes to the clinical benefit obtained from Padma 28 therapy is discussed. |
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Title:
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A botanical compound, Padma 28, increases walking distance in stable intermittent claudication. |
| Author(s): |
Drabaek H, Mehlsen J, Himmelstrup H, Winther K. |
| 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 painfree 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. |
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Padma 28 modifies immunological functions in experimental atherosclerosis in rabbits. |
| Author(s): |
Gieldanowski J, Dutkiewicz T, Samochowiec L, Wojcicki J. |
| The effect of Padma 28 on selected parameters of humoral and cellular immune reactions in rabbits subjected to experimental atherosclerosis was studied. The drug significantly reduced the size of atherosclerotic plaques in the aorta and restored to a varying extent the immune functions studied. The possible mechanism by which Padma 28 may exert its anti-atherosclerotic action is discussed in the scope of the immunological theory of atherosclerosis. |
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Treatment of chronic ischemia of the lower extremities with complex herbal preparation |
| Author(s): |
Smulski HS. |
| Chronic ischemia of the lower extremities with atherosclerosis background is being manifested by intermittent claudication. For treating the intermittent claudication many drugs are used, which may give rise to therapeutical side effects. In 50 patients with diagnosed arteriosclerosis affecting the lower extremities in II stage according to Fontain, a vegetable preparation PADMA-28 was applied for 16 weeks. A marked, statistically significant elongation of the claudication distance was achieved. That was measured, under standardized condition, on an ergometer-treadmill. Moreover, there was also a decrease in the index of blood platelets aggregation, a drop in the level of cholesterol, triglycerides, total lipids, beta lipoproteins, and an increase in ++alpha lipoproteins. Also 50 patients were receiving placebo for 16 weeks, but no positive results were observed in comparison with preparation PADMA-28. The studies were carried out by the method of double blind test, the latter was accomplished by randomized method. Observation, the performed biochemical examinations did not reveal any undesirable effect. Drug tolerance was excellent. The positive influence of the drug may result from summed action of components contained in the preparation namely: bioflavonoides, salicylates, valepotriates, tannins, phenol acids, ethereal oils and esters of acids. PADMA-28 may be a useful adjuvant to therapeutic methods with regard to chronic ischemia of the lower extremities in II stage, according to Fontain. |
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Title:
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Effects of the Tibetan herbal preparation Padma 28 in intermittent claudication |
| Author(s): |
Schrader R, Nachbur B, Mahler F. |
| 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. |
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