Natures Health Diva II

Uses

Evening primrose oil is used as part of over-the-counter dietary supplements.

It is also used for the treatment of systemic inflammatory diseases and for women's health conditions such as cyclical mastalgia. These indications do not have sufficient evidence of their effectiveness. It was used for the treatment of atopic dermatitis in the United Kingdom but it is currently withdrawn due to lack of evidence of effectiveness.

Effective for:

• Vitamin A deficiency. Taking vitamin A by mouth is effective for preventing and treating symptoms of vitamin A deficiency. Vitamin A deficiency can occur in people with protein deficiency, diabetes, over-active thyroid, fever, liver disease, cystic fibrosis, or an inherited disorder called abetalipoproteinemia.

Possibly Effective for:

• Breast cancer. Premenopausal women with a family history of breast cancer who consume high levels of vitamin A in their diet seem to have reduced risk of developing breast cancer. It is not known if taking vitamin A supplements has the same benefit.
• Cataracts. Research suggests that high intake of vitamin A in the diet is linked to a lower risk of developing cataracts.
• Diarrhea related to HIV. Taking vitamin A along with conventional medicines seems to decrease the risk of death from diarrhea in HIV-positive children with vitamin A deficiency.
• Malaria. Taking vitamin A by mouth seems to decrease malaria symptoms in children less than 3 years-old living in areas where malaria is common.
• Measles. Taking vitamin A by mouth seems to reduce the risk of measles complications or death in children with measles and vitamin A deficiency.
• Precancerous lesions in the mouth (oral leukoplakia). Research suggests that taking vitamin A can help treat precancerous lesions in the mouth.
• Recovery from laser eye surgery (photoreactive keratectomy). Taking vitamin A by mouth along with vitamin E seems to improve healing after laser eye surgery.
• Complications after pregnancy. Taking vitamin A seems to reduce the risk of diarrhea and fever after pregnancy in malnourished women.
• Complications during pregnancy. Taking vitamin A by mouth seems to reduce the risk of death and night blindness during pregnancy in malnourished women.
• Eye disease affecting the retina (retinitis pigmentosa). Research suggests that taking vitamin A can slow the progression of an eye disease that causes damage to the retina.

Natures Health Diva II is also used to associated treatment for these conditions: Dietary supplementationDeficiency, Vitamin A, Deficiency, Vitamin D, Degenerative Retinal Disorders, Disorder of the Epithelium, Disorder of the Mesoderm, Inner ear disorder, Vitamin Deficiency, Vitamin E Deficiency, Nutritional supplementation

How Natures Health Diva II works

Evening primrose oil presents a content of 74% Linolenic acid and 9% Gamolenic acid from which the later seems to be the key active ingredient of this oil. These major essential fatty acids are required for the normal structure of cell membranes and they are not synthesized endogenously. The therapeutic activity of evening primrose oil is attributed to the direct action of its essential fatty acids on immune cells as well as to an indirect effect on the synthesis of eicosanoids. The actions of highly unsaturated fatty acids in tissues and eicosanoids are thought to be implicated in inflammatory and immunologic pathogeneses.

The essential fatty acids found in evening primrose oil are involved in the biosynthesis of prostaglandin. For this activity, the main involved component is the Gamolenic acid. The presence of this essential fatty acid allows the synthesis of anti-inflammatory substances such as 15-hydroxy-eicosatrienoic acid and prostaglandin E1.

Vision:Vitamin A (all-trans retinol) is converted in the retina to the 11-cis-isomer of retinaldehyde or 11-cis-retinal. 11-cis-retinal functions in the retina in the transduction of light into the neural signals necessary for vision. 11-cis-retinal, while attached to opsin in rhodopsin is isomerized to all-trans-retinal by light. This is the event that triggers the nerve impulse to the brain which allows for the perception of light. All-trans-retinal is then released from opsin and reduced to all-trans-retinol. All-trans-retinol is isomerized to 11-cis-retinol in the dark, and then oxidized to 11-cis-retinal. 11-cis-retinal recombines with opsin to re-form rhodopsin. Night blindness or defective vision at low illumination results from a failure to re-synthesize 11-cis retinal rapidly.
Epithelial differentiation: The role of Vitamin A in epithelial differentiation, as well as in other physiological processes, involves the binding of Vitamin A to two families of nuclear retinoid receptors (retinoic acid receptors, RARs; and retinoid-X receptors, RXRs). These receptors function as ligand-activated transcription factors that modulate gene transcription. When there is not enough Vitamin A to bind these receptors, natural cell differentiation and growth are interrupted.

Dosage

Natures Health Diva II dosage

Vitamin A deficiency For severe deficiency with corneal changes: 500,000 unit/day for 3 days, followed by 50,000 unit/day for 2 wk and then 10,000-20,000 unit/day for 2 mth as follow-up therapy.

For cases without corneal changes: 10,000-25,000 unit/day until clinical improvement occurs (usually 1 -2 wk).

Side Effects

Hypervitaminosis A characterised by fatigue, irritability, anorexia, weight loss, vomiting and other Gl disturbances, low-grade fever, hepatosplenomegaly, skin changes, alopoecia, dry hair, cracking and bleeding lips, SC swelling, nocturia, pains in bones and joints.

Toxicity

Evening primrose oil seems to have little toxicological effect in humans. The reported LD50 values in the mouse are 3.12 x 10^4 mcg/kg. The toxicological effects are very minimal and it has proven to not have an effect on tumor incidence nor to present effects on fertility studies.

Acute toxicity to vitamin A can occur when adults or children ingest >100x or >20x the RDA, respectively, over a period of hours or a few days. The RDA for vitamin A differs depending on age and sex and can range from 300 - 900 μg retinol activity equivalents (RAE) per day. Symptoms of acute systemic toxicity generally include mucocutaneous involvement (e.g. xerosis, cheilitis, skin peeling) and may involve mental status changes. Children are typically more susceptible to acute vitamin A toxicity - daily intakes of as little as 1500 IU/kg have been observed to result in toxicity.

Chronic vitamin A toxicity can develop following the long-term ingestion of high vitamin A doses. While there is a wide variation in the lowest toxic vitamin A dose, the ingestion of >25 000 IU daily for 6 years or 100,000 IU daily for 6 months is considered to be toxic. Chronic vitamin A toxicity can affect many organ systems and can lead to the development of osteoporosis and CNS effects (e.g. headaches).

Precaution

Cholestatic jaundice; fat-malabsorption conditions. Monitor patients closely for toxicity. Liver impairment and children.

Interaction

Decreased absorption with neomycin. Increased risk of hypervitaminosis A with synthetic retinoids eg, acitretin, isotretinoin and tretinoin. Increased risk of toxicity when used with alcohol.

Volume of Distribution

No pharmacokinetic data available.

Elimination Route

The pharmacokinetics of evening primrose oil is mainly studied by analyzing its active ingredient Gamolenic acid. After administration, Gamolenic acid is rapidly absorbed and converted directly to Dihomo-gamma-linolenic acid and other precursors. When orally administered, the tmax was directly dependent to the time of administration, being of 2.7 hours in the evening and 4.4 hours in the morning. The Cmax and AUC were registered to be approximately 21 mcg/ml and 274 mcg.h/ml. The bioavailability of Gamolenic acid acid is influenced by triglyceride composition, cellular kinetics of phospholipases and acyltransferases.

Readily absorbed from the normal gastrointestinal tract

Half Life

No pharmacokinetic data available.

1.9 hours

Clearance

No pharmacokinetic data available.

Elimination Route

The major components of the primrose oil are highly metabolized and the majority of the generated metabolites are excreted in the urine.

Pregnancy & Breastfeeding use

Pregnancy Category A. Adequate and well-controlled human studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).

Contraindication

Hypervitaminosis A; pregnancy (dose exceeding RDA).

Innovators Monograph

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