Health Care Professional Information
Clinical Summary
Avlimil is a dietary supplement that is being promoted to help alleviate symptoms associated with female sexual dysfunction. It consists of sage leaf, red raspberry leaf, kudzu root extract, red clover extract, capsicum pepper, licorice root, bayberry fruit, damiana leaf, valerian root, ginger root, and black cohosh root. Sexual dysfunction may involve loss of sexual desire, difficulty in maintaining arousal, painful intercourse, or difficulty in achieving orgasm. It may result from factors such as stress, hormonal imbalances, cancer treatment involving surgery, radiation, chemotherapy or hormone therapy, use of antidepressants, or menopause. Avlimil is thought to enhance sexual satisfaction by increasing blood flow and by promoting muscle relaxation. Some of the components may improve circulation.
Results from in vitro and in vivo assays showed that Avlimil exhibits both estrogenic (at low concentration) and antiestrogenic (at higher concentrations) effects in a dose dependent manner (4). A small unpublished clinical trial involving 49 women found Avlimil to have a positive effect on sexual response (1). However, the ingredients in the commercial product are different from those used in the study (3).
Avlimil has not been studied in cancer patients. Since this product contains botanical ingredients that have estrogenic effects, it is not appropriate for patients with hormone sensitive cancers.
Purported Uses
- Female sexual dysfunction
Constituents
- Sage leaf (Salvia officinalis)
- Red raspberry leaf (Rubus idaeus)
- Kudzu root extract (Pueraria montana)
- Red clover extract (Trifolium pratense)
- Capsicum pepper (Capsicum annuum)
- Licorice root (Glycyrrhiza glabra)
- Bayberry fruit (Morella cerifera)
- Damiana leaf (Turnera diffusa)
- Valerian root (Valeriana officinalis)
- Ginger root (Zingiber officinale)
- Black cohosh root (Actaea racemosa)
Mechanism of Action
Sage, kudzu, red clover, licorice, and black cohosh have estrogenic effects and have been used for menopausal symptoms. Damiana leaf is purported to be an aphrodisiac but scientific proof is lacking. Capsaicin, a component of capsicum, can cause depolarization of C-fiber polymodal nociceptors and release of substance P which can heighten sensitivity (2). Manufacturers of Avlimil claim that the herbal components improve circulation that leads to increased blood flow to the genital tissue and also help muscle relaxation.
Warnings
Sexual dysfunction could be a result of other complex underlying physical, biological, or psychological disorders. Patients should consult and be monitored by a physician when using this product.
The Federal Trade Commission charged the marketers of Avlimil in making false and unsubstantiated claims. Avlimil's ingredients are substantially different from the formula used in the clinical trial cited in the advertisements (3).
Contraindications
Since this product exhibits estrogenic effects, it may not be appropriate for patients who have hormonal sensitive cancers.
Adverse Reactions
- Following ingestion of Avlimil, minor irritations including stomach upset have been reported (1).
Herb-Drug Interactions
Sage, kudzu, red clover, licorice, and black cohosh may have estrogenic effects. They can potentially interfere with action of tamoxifen and other products containing estrogen.
Literature Summary and Critique
Warner Health Care. Executive summary: Prospective, randomized, double-blind, placebo-based, parallel-group study. 2004
Forty-nine women, ages 25-65, were randomized in this study to receive two tablets of Avlimil daily or placebo for three months. Changes in arousal, lubrication, satisfaction, and pain were assessed by the Female Sexual Function Index (FSFI), which is a 19-question self-report form. Researchers claim that there were significant improvements for questions that involved sexual desire, arousal, and orgasm in assessments at 2 months and 3 months. However, this study is limited by small sample size. Large, well-designed clinical trials are warranted. Also, the dosage of Avlimil used in the study was one tablet twice a day while the recommended dose is one tablet a day. It is unclear if the lower dose would have similar effects. This study has not been published in a peer-reviewed journal.
Consumer Information
How It Works
Bottom Line: Avlimil has been shown in a small unpublished study to improve sexual function in normal women.
Avlimil is a dietary supplement that contains sage leaf, red raspberry leaf, kudzu root extract, red clover extract, capsicum pepper, licorice root, bayberry fruit, damiana leaf,valerian root, ginger root, and black cohosh root. It is being promoted to relieve symptoms of female sexual dysfunction. Sexual dysfunction may involve loss of sexual desire, arousal, difficulty in maintaining arousal, painful intercourse, or difficulty in achieving orgasm. This may result from factors such as stress, hormonal imbalances, use of antidepressants, menopause, and cancer treatments. The manufacturer claims that use of Avlimil results in improved sexual response. The herbal components of Avlimil are thought to enhance sexual satisfaction by increasing blood flow to the sex organs and by promoting muscle relaxation. A small unpublished study showed that Avlimil had a positive effect on sexual response in normal women.
Avlimil has not been studied in cancer patients.
Purported Uses
Female Sexual Dysfunction:
One unpublished study showed that Avlimil can improve sexual function in women when compared to placebo.
Research Evidence
Female Sexual Dysfunction
In this study, 49 women, ages 25-65, were given either one tablet of Avlimil twice daily or placebo for a three month period. The Female Sexual Function Index (FSFI) which consists of a 19 question self-report form was used to determine the changes in sexual function. Researchers claim that there were significant improvements in sexual desire, arousal, and orgasm in assessments done at 2 months and 3 months. However, the ingredients in the commercial product may differ from the formula used in the study.
Patient Warnings
Sexual dysfunction could be a result of other complex underlying physical, biological, or psychological disorders. Patients should consult and be monitored by a physician when using this product..
The Federal Trade Commission charged the marketers of Avlimil in making false and unsubstantiated claims. Avlimil's ingredients are not the same as the formula used in the clinical study cited in the advertisements (5).
Do Not Take If
Some of the ingredients such as sage, kudzu, red clover, licorice, and black cohosh in Avlimil may have estrogenic effects. They can potentially interfere with the action of tamoxifen and other products containing estrogen. Patients who have hormonal sensitive cancers should therefore avoid this product.
Side Effects
- Minor irritation
- Stomach upset
Last updated: December 21, 2011
arousal (uh-ROW-zul)
The state of being alert and ready to respond, or waking from sleep.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)biological (BY-oh-LAH-jih-kul)
Pertaining to biology or to life and living things. In medicine, refers to a substance made from a living organism or its products. Biologicals may be used to prevent, diagnose, treat or relieve of symptoms of a disease. For example, antibodies, interleukins, and vaccines are biologicals. Biological also refers to parents and children who are related by blood.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)black cohosh (blak KOH-osh)
An eastern North American perennial herb. A substance obtained from the root of the plant has been used in some cultures to treat a number of medical problems. It is being studied in the treatment of hot flashes and other symptoms of menopause. The scientific name is Also called black snakeroot, bugbane, bugwort, and rattlesnake root.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)blood (blud)
A tissue with red blood cells, white blood cells, platelets, and other substances suspended in fluid called plasma. Blood takes oxygen and nutrients to the tissues, and carries away wastes.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)botanical (buh-TA-nih-kul)
Having to do with, or derived from, plants.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)cancer (KAN-ser)
A term for diseases in which abnormal cells divide without control and can invade nearby tissues. Cancer cells can also spread to other parts of the body through the blood and lymph systems. There are several main types of cancer. Carcinoma is a cancer that begins in the skin or in tissues that line or cover internal organs. Sarcoma is a cancer that begins in bone, cartilage, fat, muscle, blood vessels, or other connective or supportive tissue. Leukemia is a cancer that starts in blood-forming tissue such as the bone marrow, and causes large numbers of abnormal blood cells to be produced and enter the blood. Lymphoma and multiple myeloma are cancers that begin in the cells of the immune system. Central nervous system cancers are cancers that begin in the tissues of the brain and spinal cord. Also called malignancy.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)capsaicin (kap-SAY-ih-sin)
A component of certain plants, including cayenne and red pepper, used topically for peripheral nerve pain. It is also being studied for controlling mucositis pain after chemotherapy and radiation therapy.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)chemotherapy (KEE-moh-THAYR-uh-pee)
Treatment with drugs that kill cancer cells.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)circulation (ser-kyoo-LAY-shun)
In the body, the flow of blood through the heart and blood vessels, and the flow of lymph through the lymph vessels.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)clinical (KLIH-nih-kul)
Having to do with the examination and treatment of patients.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)clinical trial (KLIH-nih-kul TRY-ul)
A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease. Also called clinical study.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)dose (dose)
The amount of medicine taken, or radiation given, at one time.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)dysfunction (dis-FUNK-shun)
A state of not functioning normally.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)estrogen (ES-truh-jin)
A type of hormone made by the body that helps develop and maintain female sex characteristics and the growth of long bones. Estrogens can also be made in the laboratory. They may be used as a type of birth control and to treat symptoms of menopause, menstrual disorders, osteoporosis, and other conditions.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)extract (EK-strakt)
In medicine, a preparation of a substance obtained from plants, animals, or bacteria and used as a drug or in drugs.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)genital (JEH-nih-tul)
Refers to the genitalia (external and internal sex organs and glands).
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)ginger (JIN-jer)
An herb with a root that has been used in cooking, and by some cultures to treat nausea, vomiting, and certain other medical conditions. It is being studied in the treatment of nausea and vomiting caused by cancer chemotherapy. The scientific name is .
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)herbal (ER-bul)
Having to do with plants.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)hormone (HOR-mone)
One of many chemicals made by glands in the body. Hormones circulate in the bloodstream and control the actions of certain cells or organs. Some hormones can also be made in the laboratory.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)in vitro (in VEE-troh)
In the laboratory (outside the body). The opposite of in vivo (in the body).
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)in vivo (in VEE-voh)
In the body. The opposite of in vitro (outside the body or in the laboratory).
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)ingestion (in-JES-chun)
Taking into the body by mouth.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)menopause (MEH-nuh-pawz)
The time of life when a woman’s ovaries stop producing hormones and menstrual periods stop. Natural menopause usually occurs around age 50. A woman is said to be in menopause when she hasn’t had a period for 12 months in a row. Symptoms of menopause include hot flashes, mood swings, night sweats, vaginal dryness, trouble concentrating, and infertility.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)orgasm (OR-ga-zum)
The final part of the sex act, which involves contraction of sexual organs and a sudden release of endorphins, leading to a feeling of pleasure. In males, orgasm usually occurs with release of semen.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)physician (fih-ZIH-shun)
Medical doctor.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)placebo (pluh-SEE-boh)
An inactive substance or treatment that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)prospective (pruh-SPEK-tiv)
In medicine, a study or clinical trial in which participants are identified and then followed forward in time.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)psychological (SY-koh-LAH-jih-kul)
Having to do with how the mind works and how thoughts and feelings affect behavior.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)radiation (RAY-dee-AY-shun)
Energy released in the form of particle or electromagnetic waves. Common sources of radiation include radon gas, cosmic rays from outer space, medical x-rays, and energy given off by a radioisotope (unstable form of a chemical element that releases radiation as it breaks down and becomes more stable).
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)randomized
Describes an experiment or clinical trial in which animal or human subjects are assigned by chance to separate groups that compare different treatments.
(http://www.cancer.gov/dictionary)red clover (red KLOH-ver)
Trifolium pratense. A plant with flowers that has been used in some cultures to treat certain medical problems. It is being studied in the relief of menopausal symptoms and may have anticancer effects. Also called purple clover, Trifolium pratense, and wild clover.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)response (reh-SPONTS)
In medicine, an improvement related to treatment.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)sensitivity (SEN-sih-TIH-vih-tee)
When referring to a medical test, sensitivity refers to the percentage of people who test positive for a specific disease among a group of people who have the disease. No test has 100% sensitivity because some people who have the disease will test negative for it (false negatives).
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)significant (sig-NIH-fih-kunt)
In statistics, describes a mathematical measure of difference between groups. The difference is said to be significant if it is greater than what might be expected to happen by chance alone. Also called statistically significant.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)stomach (STUH-muk)
An organ that is part of the digestive system. The stomach helps digest food by mixing it with digestive juices and churning it into a thin liquid.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)stress (stres)
The response of the body to physical, mental, or emotional pressure. This may make a person feel frustrated, angry, or anxious, and may cause unhealthy chemical changes in the body. Untreated, long-term stress may lead to many types of mental and physical health problems.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)surgery (SER-juh-ree)
A procedure to remove or repair a part of the body or to find out whether disease is present. An operation.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)tamoxifen (tuh-MOK-sih-FEN)
A drug used to treat certain types of breast cancer in women and men. It is also used to prevent breast cancer in women who have had ductal carcinoma in situ (abnormal cells in the ducts of the breast) and in women who are at a high risk of developing breast cancer. Tamoxifen is also being studied in the treatment of other types of cancer. It blocks the effects of the hormone estrogen in the breast. Tamoxifen is a type of antiestrogen. Also called tamoxifen citrate.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)therapy (THAYR-uh-pee)
Treatment.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)tissue (TIH-shoo)
A group or layer of cells that work together to perform a specific function.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)valerian (vuh-LEER-ee-un)
A plant whose roots are used as a sedative and to treat certain medical conditions. It is being studied as a way to improve sleep in cancer patients undergoing treatment. Also called garden heliotrope, garden valerian, Indian valerian, Mexican valerian, Pacific valerian, Valeriana officinalis, and Valerianae radix.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)
