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Thrombophlebitis

A common disease that affects veins is thrombophlebitis – which is an inflammation of the veins due to blood clotting. A number of studies show that Wobenzym® is very effective in decreasing the pain, edema and throphic ulcers often seen in thrombophlebitis and post-thrombophlebitis syndrome. The studies show improvement of blood flow with increased blood fibrinolytic activity and inhibited platelet function.
In a randomized double blind phase III clinical trial they noted that after 15 days of treatment, there was a significant difference in favor of the enzyme treatment when pain, redness, swelling and induration ( a hardening of the tissue due to swelling and inflammation). We see the same improvement in lymphedema.
                                           From FREQUENTLY ASKED QUESTIONS, with answers by Joseph J Collins, RN, ND
                                           Read the special section: :
CARVIOVASCULAR AND LYMPHATIC SYSTEMS & WOBENZYM®

What the literature says about Systemic Enzyme Support and:

Thrombophlebitis
& Postthrombophlebitic Syndrome

Application of Wobenzym and Phlogenzym to the angiology and vascular surgery.  

Kopadze, T.Sh., Natsvlishvili, G.A., Tvaladze, M.G., Avazashvili, D.N. Application of Wobenzym and Phlogenzym to the angiology and vascular surgery. Georgian Medical News 2001, No. 2, (serial No.71), pp. 27 – 29. Department of Vascular and Urgent microsurgery of the Tbilisi State Medical Academy for Post-Diploma Education [Abstract in Russian]  

In 1997-99 enzymotherapy was used in complex treatment of the 150 patients, that were admitted to the clinic of Vascular and Urgent microsurgery of the Tbilisi First City Hospital. 83 of these patients had disease of venous system, including acute thrombophlebitis and postthrombophlebitic syndrome. We had used enzymotherapy with Wobenzym and Phlogenzym in such cases and observe decrease of pain, reduction of edema and throphic ulcers. The same drugs were used in the treatment of arterial pathology (in 25 patients) with positive clinical outcomes.
We also used enzymotherapy in treatment of 42 patients with different traumas of the hand. After application of enzymes in such cases, decrease of pain, reduction of edema and improvement of microcirculation of the injured site were observed.
Basing on our experience we conclude, that enzymes, as medical means with high efficacy and practical absence of adverse reactions, must be widely used in the complex treatment of vascular and traumatic disorders.
Key words: enzymotherapy, Wobenzym, Phlogenzym, vascular and traumatic disorders.
Poster Reference Number 46.  

Systemic enzyme therapy of lower limb postphlebitic syndrome.  

Koshkin V.M., Kirienko A.I., Leontjev S.G., Agafonov V.F. Systemic enzyme therapy of lower limb postphlebitic syndrome.  Angiology and vascular surgery 2000, Vol. 6, No. 2, pp. 61 – 64. Department of Faculty Surgery, Russian State Medical University, Moscow, Russia [  Abstract in Russian and Czech]  

Large clinical material (66 patients) and modern diagnostic modalities were used for comparative study of systemic enzyme therapy (Phlogenzym, 2 dragees per 3 times per day for 3 months) and conventional combined therapy of lower limb postphlebitic syndrome. Clinical effect of systemic enzyme therapy was more pronounced (84% for systemic enzyme therapy vs 73% for conventional therapy). Better outcome was provided by significant changes in hemostasis and blood rheological parameters, especially by increased blood fibrinolytic activity and inhibited platelet function. These resulted in facilitation of venous outflow from affected extremity and clinical regression of chronic venous insufficiency.
Key words: systemic & enzyme therapy, postphlebitic syndrome, hemostasis, blood rheology, venous outflow.
Poster Reference Number 47.  

Wobenzym in the treatment of Thrombophlebitis.  

Džupina A.1, Džupinová M.2 Wobenzym in the treatment of Thrombophlebitis. Praktická flebologie 1998, Roè. 7, è. 1, str. 28-30 (17-12-3) 1 Internal Department, City Hospital and Clinic, Bardejov, Slovakia; 2 Immunology and Alergology Clinic, City Hospital and Clinic, Bardejov, Slovakia [Czech abstract]  

Summary: We would like to emphasize, that Wobenzym therapy of 46 deep vein thrombosis patients treated for one year led to a disappearing of followed subjective troubles and to the improvement in objective duplex ultrasound findings . These facts allowed us to omit the anticoagulation therapy in 20 patients. In the rest of 26 patients the therapy led to a reduction of the leg edema and to the better centripetal stream monitored by duplex ultrasound as well as to a reduction or vanishing of the subjective troubles of patients. This means better quality of patient`s life. Therapy by proteolytic enzyme preparations in this indication is, in our opinion, very suitable. Its effect is to be verified by more extensive trials with more patients.
Poster Reference Number 48.  

Wobenzym® in the Treatment of Acute Thrombophlebitis (MU-693204)

 Valery M. Koshkin, M.D., D.M.Sci.Wobenzym® in the Treatment of Acute Thrombophlebitis. PharmaScript, Kathi-Kobus-Steig 1, D-82515 Wolfratshausen, Germany  

Summary: In a randomised double blind clinical trial phase III (acc. to German Drug Law) with two parallel groups, it should be demonstrated in patients with thrombo- or varicophlebitis whether the enzyme preparation Wobenzym® reduces pain and edema earlier than a placebo treatment.
119 patients with clinically verified acute thrombophlebitis or varicophlebitis of a superficial vein of the lower extremity were taken into this study. 60 patients received the enzyme preparation and 59 placebo. The data of all patients was evaluable.
Primary investigator was Prof. Valery M. Koshkin, M.D., D.M.Sci., Angiology Laboratory, Department of Surgery, State Medical University of Russia, Leninsky prospect, 8 Ia, Moscow, 117049 - Russia.
The patients received 10 tablets t.i.d. (= 30 tablets per day). The therapy lasted 15 days.
At baseline the patients were comparable with regard to age, sex, height, weight and the symptoms pain, redness, induration, swelling, sum score of the symptoms, length of the inflammatory vascular process and time for refilling of the veins (p > 0.05, Wilcoxon-Mann-Whitney-U-test).
The main endpoint for statistical evaluation was the sum score of the symptoms pain, redness, induration and swelling.
As secondary criteria the other parameters for evaluation of the efficacy like pain, redness, induration, swelling, length of the inflammatory vascular process, smallest circumference supramalleolar, largest calf circumference, knee circumference, circumference 15 cm above the knee, time for refilling the veins (by light-reflexion-rheography), the result of therapy and the subjective judgement of efficacy by the physician and the patients were evaluated. Other secondary criteria were the laboratory parameters (ESR, white blood cells, platelets, AST, ALT, g-GT), the subjective judgement of tolerante, and adverse events caused by the study therapy.
The main endpoint - the sum score of pain, redness, induration and swelling - showed a statistically significant difference on the 5% level (p = 0.033) after 15 days of treatment in favor of the enzyme treatment.
The judgement of the secondary criteria showed statistically significant differences in favor of the enzyme treatment with pain (p = 0.033), the length of the inflammatory vascular process (p = 0.005) and the time for refilling the veins of the affected leg (p = 0.005).
The result of therapy in the enzyme group was on average 2.6 ("good" to "moderate") and therefore some better than in the placebo group with 3.0 ("moderate"), but the difference was not statistically significant (p > 0.05).The efficacy of the drug was judged by the physician at the end of therapy in the enzyme group with 2.6 ("good" to "moderate") and in the placebo group with 2.9 ("moderate"). The patients judged the efficacy as 2.6 ("good" to "moderate") in the enzyme group and es 2.8 ("moderate") in the placebo group. The differente between the groups was not statistically significant (p > 0.05).
The tolerance of the therapy was judged by the physician in the enzyme group as 1.8 ("good") and in the place- bo group as 1.7 ("very good" to "good"). The judgement by the patients was similar: 1.9 ("good") in the enzyme group and 1.8 ("good") in the placebo group. There was no significant difference between the groups (p > 0.05).
Adverse events occurred in either group. Three were documented in the enzyme group and four in the placebo group. The difference between the groups was not statistically significant (p > 0.05). In the enzyme group there was one thrombosis on the contralateral leg, one deep vein thrombosis of the lower extremity and one acute ileofemoral thrombosis. The onset was on average after 7.0 days and they lasted for 7.3 days. The severity of all adverse events was "moderate" and the cause judged as "unknown". In all three patients the study therapy was stopped and twice a symptomatic therapy of the adverse events with heparin was necessary. In two patients residual complaints did not arise and the patient's outcome was without damage. In one patient residual complaints without specification were seen, there was a transitory damage. In the placebo group there were dysphagia, nausea and headache. They started on average after 6.8 days, the duration was one day, and they were "moderate". They were caused in one patient by the study drug, and in three cases the cause was unknown. In one patient the therapy was stopped, in one patient no measures were taken, and in two patients a symptomatic therapy of the adverse event with analgesics was necessary. No residual complaints were seen in any case, and all patients' outcome was without damage.
Poster Reference Numb 49.