Barij EPO Soft Capsule

Adjuvant treatment for:

Diabetic neuropathy

Rheumatoid arthritis

Multiple Sclerosis (MS)

Premenstrual Syndrome (PMS) and premenstrual breast tenderness

Erectile dysfunction, especially caused by diabetes and microvascular abnormalities in diabetes

Several clinical trials have demonstrated the effectiveness of Evening Primrose Oil (EPO), as a source of GLA, in cases of diabetic neuropathy, hypertension, breast tenderness, premenstrual syndrome, osteoporosis and dementia. Evening primrose has anti-inflammatory effects, corrects deficiency of the essential fatty acid omega-6, improves the synthesis of vasodilator eicosanoids, rectifies defects in neural blood flow and the velocity of neural conduction in diabetic patients.  GLA is one of the essential fatty acids which the human body cannot synthesize and needs to be provided, like the vitamins, via nutrition and supplements. A share of the positive effects of this substance is due to an increase in production of prostaglandin E1 which possesses anti-inflammatory properties. In what follows, the results of some clinical trials are summarized.

During 17 years up to 1992 in Cardiff Mastalgia Clinic, 224 patients with cyclical and 90 patients with non-cyclical breast pain were administered different medications in various rounds of clinical trials. In patients who responded to treatment, danazol was the most efficient medicine (70%) and bromocriptine and evening primrose oil showed similar effects (about 45%). Also, patients who received evening primrose oil reported fewer adverse effects.

In parallel, random, double-blind, placebo-controlled clinical trials in 7 centers in England and Finland, 111 patients with mild diabetic neuropathy received either GLA (480 mg per day) or placebo for one year, and were evaluated using standard tests. In the test group, considerable positive change was observed in 13 parameters out of the 16 parameters of interest to the study, which was indicative of positive efficacy on the progression of mild diabetic neuropathy. Gender, age, type of diabetes, age of commencement or duration of diabetes had no significant effect on the outcome. However, the treatment was more effective in those patients whose diabetes was relatively managed. The patients could follow the treatment for another 12 months and to all those who participated in this phase GLA (dose unknown) was administered; further progress was also observed in this phase.(8)

To 22 patients with diabetic distal polyneuropathy who participated in a placebo-controlled double-blind study, either 360 mg GLA or placebo capsules were administered for 6 months. Patients in the treatment group showed significant improvement in the symptoms of diabetic distal polyneuropathy.

In a random, double-blind, placebo-controlled clinical trial, 37 patients with rheumatoid arthritis and active sinusitis received either 1.2 g GLA or placebo per day for 24 weeks. In comparison to the placebo group, in which the signs and symptoms of the disorders had not changed or had aggravated, treatment with GLA caused significant decrease in disease activity (p<0.05).

In a double-blind placebo-controlled clinical trial, 56 patients with active rheumatoid arthritis received either GLA (2.8 g per day) or placebo (sunflower oil) for 6 months. Afterwards, all patients were administered GLA for 6 months in a single-blind phase. Treatment with GLA caused significant reduction in signs and symptoms of disease activity. In comparison to 4 out of 19 patients in the placebo group, in most patients in the test group (12 out of 22 patients), at least 25% progress was registered with 3 test parameters. In the second 6-month period, both groups showed improvement in disease activity.

In a clinical trial carried out in a nursing home, 40 women with confirmed osteoporosis were divided into 4 groups and administered fish oil, EPO, fish oil plus EPO or olive oil (control) for 16 weeks. Serum alkaline phosphatase levels in the group receiving fish oil and the group receiving fish oil plus EPO decreased, which is indicative of an increase in bone mineral density. The amount of osteocalcin, which is an indicator of bone formation, increased in the group receiving fish oil and more significantly in the group receiving fish oil plus EPO. Although EPO did not have an effect on its own, it increased the effect of fish oil, probably due to a better balance in plasma fatty acids.

In a non-controlled clinical trial, 12 patients with hyperlipidemia received 3 g GLA per day for 4 months. After the treatment, plasma triglyceride decreased 48% (p<0.001), HDL increased 22% (p<0.01) and total cholesterol and LDL decreased significantly.

Twice a day, 1-2 soft capsules each time; or as prescribed by your physician.

Dosage Form

Soft Capsule

 

Packaging

1000 mg soft capsules in plastic container in cardboard box

Patient information leaflet inside

Ingredients

Evening Primrose Oil (Oenothera biennis L.)

Active Ingredients

gamma-linolenic acid

Contraindications and Cautions

  • Known allergic response to any of the product’s ingredients.
  • Contrary to primary reports in early 80s of the potential effects of evening primrose seed oil in decreasing seizure threshold and occurrence of temporal epilepsy, especially in schizophrenic and epileptic patients who take antiepileptic drugs, like phenothiazine, it has been demonstrated that taking linoleic acid and gamma-linolenic acid not only poses no risk in cases of epilepsy, but also long-term oral administration of linoleic acid and alpha-linolenic acid (with a ratio of 4 to 1) has shown to protect rats against seizure in 4 different models of epilepsy. Therefore, seizure is not among the adverse effects or contraindications of evening primrose oil.

 

Adverse Effects

No reported significant adverse effect.

 

Drug Interaction

No reported significant drug interaction.

 

Administration during Pregnancy and Lactation

Like all other medications, it is recommended to take with care during the first trimester of pregnancy. Administration is safe during lactation, as breast milk contains linoleic acid and gamma-linolenic acid.

 

Further Notes

  • Keep away from sight and reach of children.
  • Close the container tightly right after taking your medicine and keep it away from light and in 15-30°C.
  • In patients with mastalgia, cancer has to be ruled out before taking this medication.
  • It is recommended that physicians monitor their patients, who take anticonvulsant medication or have a history of seizures, while taking this medication.
  • Keep this leaflet; you may need to read it again.

Based on presence of 70-140 mg gamma-linolenic acid (GLA) per soft capsule.