Dr. Judith Smith
- Preliminary report on the phase II randomized, double-blind, placebo-controlled evaluation of AHCC
For the eradication of HPV infections in woman with HPV positive pap smears
Dr. Judith A. Smith is an Associate Professor in the Department of Obstetrics, Gynecology and Reproductive Sciences at UTHealth McGovern Medical School and Director of the Women’s Health Integrative Medicine Program. She received a Bachelor of Science in Pharmacy and Doctor of Pharmacy from Union University Albany College of Pharmacy. She completed residency in Pharmacy Practice and Oncology Pharmacy Practice at NIH followed by a fellowship in Clinical Pharmacology at UT M.D. Anderson Cancer Center(UTMDACC). Previously she Faculty in the Department of Gynecologic Oncology at UTMDACC. She has been Board Certified in Oncology Pharmacy and Certified Professional in Healthcare Quality. Her research mission is to advance the progress of the safe and effective use of nutritional and herbal supplements with pharmacologic modalities as it relates to women’s health and cancer through innovative thinking, systematic methodology and collaborative interactions throughout the UTHealth System and global research community
Preliminary Report on the Phase II randomized, double-blind, placebo-controlled evaluation of
AHCC for the eradication of HPV Infections in women with HPV positive pap smears
○Judith A. Smith 1,2,3, Anjali Gaikwad 1,Barbara Rech 1, Jonathan P. Faro, M.D., PhD.4, Joseph A. Lucci, III, M.D.1,2;Yu Bai, M.D.1; Randall J. Olsen, M.D., Ph.D.5, Teresa T. Byrd, M.D.1
1 UTHealth McGovern Medical School, Houston, TX
2 UTHealth-Memorial Hermann Cancer Center- TMC, Houston TX
3 Memorial Hermann Hospital- TMC, Houston, TX
4Specialists in Obstetrics & Gynecology, Houston, TX
5Institute for Academic Medicine, Houston Methodist Research Institute, Houston, TX.
Purpose: Evaluate the efficacy AHCC 3 grams by mouth once daily to eradicate HPV infections in womenwith HPV positive PAP smears. Observe the durability of response to AHCC. Define the adverse effects ofAHCC compared to placebo.
Methods This is an ongoing NIH funded phase II study (NCT02405533) reviewed and approved by the University of Texas Health Sciences Center at Houston IRB to evaluate AHCC 3 grams in a randomized, double-blinded placebo controlled study. Patients will be randomized to first receive either ARM A: AHCC 3000 mg (taken as six 500 mg capsules) by mouth once daily on an empty stomach for 6 months OR ARM B: placebo (six capsules) by mouth once daily on an empty stomach for six to 12 months. HRHPVDNA status and the immune panel were monitored at each visit. Power analysis was based on expected 10% eradication in the absence of treatment and 50% eradication with treatment. At a 0.05 confidence level, we summarize below sample size and its associated statistical power. In this analysis, a planned sample of maximum of 50 patients (N=25 per group), which leads to 94.5% power to detect the hypothesized effect size.
Results: A total of 50 patients have been enrolled onto the phase II study. A total of 46 patients completed study at time of analysis with remaining planned to conclude in September 2018. Preliminary analysis confirmed a 62.5% clearance of HPV infections after six months of AHCC including 70% that have had confirmed eradication for greater than 12 months. Only one patient on placebo cleared HPV infection over 12 month study duration. Data to date also confirmed use of AHCC supplementation modulates of the expression and signaling of IFNβ that is known to be elevated in chronic viral infections, such as HPV, to levels below 25pg/mL. This was associated with correlative increase in IFN and eradication of HPV infections.
Conclusion: Preliminary results confirmed data observed in pilot studies that AHCC supplementation for at least six months is associated with over 60% successful elimination of HPV infections. The optimal duration of AHCC supplementation required after the first negative result still needs more evaluation in future clinical studies.