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 A small unpublished clinical trial involving 49 women found Avlimil to have a positive effect on sexual response (1).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
E-mail your questions and comments to aboutherbs@mskcc.org.