Phlogenzym® in Patients With Acute Thrombophlebitis - Efficacy and Tolerance

Enzymes are absorbed in the small intestine and taken up into the bloodstream, at least to some extent. There, they act in an anti-inflammatory manner, as was first described for the serine protease trypsin. Similarly, the cysteine protease bromelain, extracted from the stems of pineapples, is an effective phytotherapeutical drug with anti-inflammatory properties.Proteases have also been indicated to show a certain improvement of the fluidity of the blood. An additional component of the oral enzyme combination can be rutoside, or rutin, a flavonoid known to have cytoprotective and anti-inflammatory properties.

• Phlogenzym (Drug), also known as Wobenzym plus: Bromelain / Trypsin / Rutoside
• Placebo (Other)

Primary outcomes

• Difference of pain at rest between values day 0 (baseline) and day 7 [Change day 0 until day 7]: Patients were asked to evaluate resting pain on day 0 (baseline) as well as day 7 on a 10-cm VAS (Visual Analogue Scale), with the left end (0 cm) indicating "no pain" and the right end (10 cm) "unbearable pain". The distance from the left end was recorded.
• Responders [day 14]: Number of responders (pain value smaller or equal to 1 cm on visual analogue scale for pain (VAS, eft end (0 cm) indicating "no pain" and the right end (10 cm) "unbearable pain") on day 14

Other outcomes

• Pain under Pressure [0, 4, 7, 14 days]: Meyer's pressure points at the lateral side of the tibia and Krieger's pressure point in the popliteal space, 4-point rating scale ranging from 0 (no pain) to 3 (severe pain)
• Symptoms [0, 4, 7, 14 days]: skin redness, hyperthermia, palpable/visible phlebitic cords, heaviness, tenseness
• Sum Score of Symptoms [0, 4, 7, 14 days]: Sum score of all described symptoms (skin redness, hyperthermia, palpable/visible phlebitic cords, heaviness, tenseness)

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* male ог female patients with thrombophlebitis in the upper extremities (with ог without varicosis);
* age \~ 18 years;
* acute thrombophlebitis in the lower leg
* moderate to severe pain as monitored on a visual analog scale (VAS, value ≥ 3 cm)
* pain under pressure
* presence of at least three of the following symptoms: skin redness, hyperthermia, phlebitic cords, feeling of heaviness and tenseness.

Exclusion Criteria:

* known deep phlebothrombosis
* flourishing ulcus cruris
* arterial occlusive disease
* peripheral neuropathy
* malignant disease
* concomitant concomitant treatment ог а therapy which ended less than 7 days before baseline with corticosteroids, diuretics, anticoagulative agents, platelet aggregation inhibitors and systemic/topical use of anti-inflammatory agents, other preparations for veins and analgesics;
* known intolerance against the active ог the inactive ingredients of the study medication (especially lactose);
* pregnancy
* lactation,
* known alcohol or drug abuse
* participation in another clinical study

• Marcel Baumueller, MD, Principal investigator, Private Practice
• Gerhard Stauder, Dr, Study director, Mucos Pharma GmbH & Co. KG (EX)