Natural extract used for venous hypertensive microangiopathy : Twenty-two individuals with venous hypertensive microangiopathy (VHM, high pressure in the veins) were included in this randomized, placebo-controlled study investigating the benefits of Essaven gel (EG). Results show that compared with placebo, EG significantly improved microcirculation in patients with VHM, even with a single application. (12)
A natural combination treatment for chronic venous insufficiency (CVI):
A double-blind, placebo-controlled trial for plant extract, vitamin, and flavonoid combination for chronic venous insufficiency (CVI): A venotropic agent containing (per capsule)16.5 mg Ruscus aculeatus, an evergreen shrub otherwise known as butcher’s broom (RAES), 75 mg hesperidin, and 50 mg ascorbic acid was found to be better than a placebo for treating chronic venous insufficiency (CVI) of the lower limbs in this double-blind trial (n=40). The trial involved 2 periods of treatment lasting 2 months with participants receiving 2 capsules or placebo administered 3 times daily. Symptoms and measures of plethysmograph circulatory capacity was significantly better in response to RAES treatment. RAES was also well tolerated. (13)
A meta-analysis for a plant extract, vitamin, and flavonoid combination for chronic venous insufficiency (CVI):
Cyclo 3 Fort in the treatment of chronic venous insufficiency: In a meta-analysis of 25 studies (n=10,246) of patients with chronic venous insufficiency (CVI), Cyclo 3 Fort (each capsule contains 150 mg Ruscus aculeatus, 150 mg hesperidin methyl chalcone, and 100 mg ascorbic acid) was found to be superior to placebo. Compared to placebo, Cyclo 3 Fort significantly reduced severity of pain (0.44 points on 4 point scale), cramps (0.26 points), heaviness (0.53 points), paraesthesia or tingling/burning/numbness of a person’s skin (0.29 points), and venous capacity (0.70 ml/100 ml). Swelling (edema), calf and ankle circumference were also significantly better among patients receiving Cyclo 3 Fort versus placebo. (14)
Endotelon in chronic venous insufficiency (CVI):
Endotelon is a brand name product produced from grapeseed, and procyanidolic oligomers, (Sanofi-Labaz Laboratories, Sanofi Winthrop). This agent was evaluated in a study including 50 females during pregnancy for response to chronic venous insufficiency with Endotelon® dosed at 150 mg per day and diosmine (semi-synthetic flavonoid) dosed 450mg per day for 30 days. The randomized, double-blind, equivalence trial found that Endotelon compared to the diosmine faired better for heaviness, sluggishness, cramps and swelling. Over 65% of the patients responded to Endotelon verses 45% for diosmine. After stopping Endotelon, the treatment effect lasted for 15 days. Diosmine treatment related effects lasted for 10 days. This is statistically significant. Endotelon therapy was found to show consistent benefit for treatment of venous insufficiency in this study. (15)
Assessment and Plan: Chronic Venous Insufficiency and Varicose Veins
- Daflon, a widely available natural flavonoid agent containing 90% diosmin and 10% hesperidin has had excellent results in treatment of chronic venous insufficiency (CVI):
- In two randomized, double-blind, 2-month studies, Daflon 500 mg twice daily significantly decreased ankle and calf circumferences, discomfort (nocturnal cramps and sensations of leg heaviness, swelling, or heat), and more leg ulcers were healed in patients with chronic venous insufficiency (CVI) compared to placebo or standard care alone (1).
- Compression therapy with either Daflon 500 mg (two tablets daily) or placebo for 8 weeks showed during an 8-week period significantly shorter time to complete healing in the Daflon 500 mg group (32%) compared with placebo (13%)(2).
- Horse chestnut for chronic venous insufficiency (CVI):
- Seven clinical trials and concluded that horse chestnut seed extract was effective for CVI, reduced leg pain and was safe without severe adverse effects vs. placebo including a study reviewed by the author showing it to be as effective as compression stockings (3).
- Another review of 13 randomized controlled trials showed that horse chestnut seed extract compared to placebo reduced leg volume by 46.4 ml, increased the chances of improving leg pain by 4.5 times, edema/swelling by 1.5 times, and itching by 1.7 times without serious side-effects (4).
- Compared to placebo, horse chestnut extract, escin at a dose of 75 mg oral twice daily, significantly reduced edema (5).
- Aescin (contains horse chestnut) combined with essential phospholipids (AEPL) topical gel for chronic venous insufficiency (CVI): Treatment with AEPL in areas of diseased blood vessels improved skin perfusion and appeared to prevent venous ulcerations (6).
- Pycnogenol for chronic venous insufficiency (CVI):
- Swelling (edema), leg ‘heaviness’, and pressure in the veins were significantly reduced in a study with 40 patients after the use of Pycnogenol at a dose of 100 mg, 2-3 times per day for 2 months and no side-effects were reported (7).
- Pycnogenol 100 mg oral 3 times daily or placebo for 3 months showed that 60% of subjects had disappearance of swelling/pain, almost all had less leg heaviness, and 33% had resolved leg heaviness compared to placebo (8).
- Pycnogenol appeared to protect against deep vein thrombosis (DVT) and superficial vein thrombosis (SVT) on flights over 8 hour average time after a dose of 200 mg 2-3 hours before flying, 200 mg six hours later and 100 mg the day after flying (10). No subjects on pycnogenol developed thrombosis vs. 5.15% of placebo patients (10).
- Pycnogenol vs. Venostasin (horse chestnut seed extract) for chronic venous insufficiency (CVI): A 4-week study compared Venostasin (horse chestnut seed extract) at 600 mg oral daily against Pycnogenol (pine bark extract) at 360 mg oral daily both treated groups showed improvement, but Pycnogenol was more effective for CVI and improved the lipid profile over Venostatin (9).
- Essaven gel (EG) used for superficial vein thrombosis and venous hypertensive microangiopathy:
- For superficial vein thrombosis: Authors investigated the effect of Essaven gel (EG) with the active ingredient, aescin, (or escin) a horse chesnut extract in comparison with placebo over 8-weeks which found that reductions in the signs and symptoms of SVT were significantly greater in the EG treatment group and no serious side-effects were reported (11).
- For venous hypertensive microangiopathy : A randomized, placebo-controlled study with Essaven gel (EG) showed that compared with placebo, EG significantly improved microcirculation in patients with VHM, even with a single application (12).
- Ruscus aculeatus (extract of an evergreen shrub also known as butcher’s broom), hesperidin (citrus flavonoid), and ascorbic acid (vitamin C) combination for the treatment of chronic venous insufficiency (CVI):
- A double-blind, placebo-controlled trial using 16.5 mg Ruscus aculeatus, 75 mg hesperidin, and 50 mg ascorbic acid, 2 capsules or placebo administered 3 times daily was better than a placebo for treating CVI in both symptoms and measures of plethysmograph circulatory capacity, and treatment was well tolerated (13).
- Cyclo 3 Fort (each capsule contains 150 mg Ruscus aculeatus, 150 mg hesperidin methyl chalcone, and 100 mg ascorbic acid) was found to be superior to placebo in reducing severity of pain, cramps, heaviness, paraesthesias, swelling, and leg circumference (14).
- Endotelon®, (A brand name product produced from grapeseed containing Procyanidolic Oligomers, Sanofi-Labaz Laboratories, Sanofi Winthrop) used for chronic venous insufficiency: 50 females were treated with either Endotelon® dosed at 150 mg per day or diosmine (semi-synthetic flavonoid) dosed at 450mg per day for 30 days. Endotelon faired better than diosmine for heaviness, sluggishness, cramps and swelling with 65% of the patients responding to Endotelon vs. 45% for diosmine with 15 days of extended treatment effect (15).