This study aimed to determine whether AHCC supplementation for six months supported the host immune system’s ability to clear high-risk human papillomavirus infections (HPV).

Human papillomaviruses are classified as non-enveloped, double-stranded DNA viruses that typically infect epithelial cells, including those on the skin and mucosa, and can cause benign warts, carcinoma in situ, and malignant lesions.

Humans contain more than 100 HPV strains, including 40 low-risk strains associated with genital warts/lesions and fifteen high-risk strains associated with cancer. Therefore, over time, a patient with HR-HPV infection is more likely to develop cancer.

It is imperative to note, however, that persistent high-risk HPV infections do not cause cancer by themselves; rather, they are co-factors in the risk of cancer development when combined with other insults such as poor nutrition, smoking, physiological stress, or immune dysfunction/suppression.

In the United States, persistent high-risk HPV infections cause 85,890 cancer cases annually, and 79 million Americans have an HPV infection.

What is AHCC?

The compound AHCC is a proprietary, standardized extract developed in Japan in 1992 from cultured Lentinula edodes mycelia (Shiitake Mushroom). It is primarily composed of α-glucan components.

The therapeutic effects of AHCC have been reported in several animal and human studies, including antioxidants and anti-cancer effects, as well as modulation of the immune system, to prevent viral and bacterial infections (9–14). In addition, clinical studies have demonstrated that AHCC reduces infection risk and eases symptoms associated with existing illnesses.

What Did The Research Reveal?

There were 50 women over 30 years old who had persistent high-risk HPV infections for at least two years in this randomized, double-blind, placebo-controlled study. The patients were randomized to a placebo once daily for 12 months (N = 25) or AHCC 3-g capsules once daily on an empty stomach for six months, followed by AHCC 3-g capsules for six months.

Each patient was evaluated every three months for HPV DNA and HPV RNA levels, along with a blood sample used to assess interferon-alpha, interferon-beta, interferon-gamma, IgG1, T lymphocyte levels, and natural killer (NK) cells.

AHCC supplementation was offered unblinded to placebo patients for six months after the 12-month study ended with the same follow-up appointments and testing as the intervention arm.

Among fifty women with high-risk HPV, 41 completed the study. After six months of AHCC supplementation, 14 of the 22 patients were HPV RNA/HPV DNA negative, whereas 64.3% (9/14) achieved a durable response defined as being HPV RNA/HPV DNA negative after six months.

After six months of AHCC supplementation, six of the twelve placebo arm patients were HPV RNA/HPV DNA negative after six months of the unblinded study.

Thirty-four patients (22 blinded and 12 unblinded) received AHCC supplementation with an overall response rate of 58.8%, clearing persistent HPV infections at the end of the study.

According to these phase II results, AHCC 3g once daily was effective in supporting the host immune system to eradicate persistent HPV infections and was well tolerated with no significant adverse effects.

Further evaluation is needed to determine how long AHCC supplementation should last beyond the first negative result for durable outcomes. In addition, in those with HPV infections, suppression of IFN-β level to less than 20 pg/ml correlates with clearance of infection. It deserves further investigation as a clinical monitoring tool.

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