Document Detail


Oral diindolylmethane (DIM): pilot evaluation of a nonsurgical treatment for cervical dysplasia.
MedLine Citation:
PMID:  19939441     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: Standard surgical treatment for CIN may impair fertility generating a need for alternative treatment options. We tested the efficacy and toxicity of oral DIM in the treatment of CIN 2 or 3 lesions. METHODS: Patients with biopsy-proven cervical intraepithelial neoplasia (CIN) 2 or 3 scheduled for loop electrosurgical excision procedure (LEEP) were randomized 2:1 to receive diindolylmethane (DIM) (BioResponse-DIM, BioResponse, Boulder, CO) orally at approximately 2 mg/kg/day for 12 weeks or placebo (defatted rice bran, BioResponse). Subjects were evaluated every 3-4 months for 1 year. Analysis of data up to 1 year was assessed including Pap smear, HPV, colposcopy, biopsy and physical examination were performed at follow-up. Central pathology review confirmed all histology diagnoses. RESULTS: To date, 64 subjects (mean age 28 years, range 18-61) have been enrolled (45 in the DIM arm, 19 in the placebo arm), with 60 available for analysis. Average follow-up was 6 months. At enrollment, 58% were diagnosed with CIN 2 and 42% with CIN 3, 57% of subjects were Caucasian, 15% African American, 12% Hispanic and 17% Asian. During treatment 2 subjects (3%) complained of nausea (grade 2) at the 3- to 4-month visit. No systemic toxicities were observed (normal CBC, LFTs, comprehensive metabolic). Forty-six subjects had biopsies at first follow-up (77%). Twenty-one subjects (47%) in the DIM group had improved CIN with a decrease by 1-2 grades or a normal result. Median time to improvement was 5 months. Improved Pap smear was seen in 49% (22/45) with either a less severe abnormality or normal result. Colposcopy improved in twenty-five subjects in the DIM group (56%). Of these 25 subjects, 21 (84%) had improved colposcopic impression, 13 (52%) had a decrease in involved quadrants and 18 (72%) had a decrease in lesion number. Complete colposcopic response was observed in 4 subjects (9%). Stratifying by level of dysplasia, age, race, HPV status, tobacco use, contraceptive used did not alter the results. At median follow-up of 6 months, 85% of subjects have not required LEEP based on routine clinical triage of improving global assessment. There was no statistically significant difference in any outcome between the DIM and placebo group. CONCLUSION: Oral DIM at 2 mg/kg/day is well tolerated with no significant toxicity. We observed a high rate of clinically significant improvement in confirmed CIN 2 or 3 lesions among both treatment groups in this randomized clinical trial.
Authors:
Giuseppe Del Priore; Deleep Kumar Gudipudi; Nadine Montemarano; Antonella M Restivo; Jeanetta Malanowska-Stega; Alan A Arslan
Publication Detail:
Type:  Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2009-11-24
Journal Detail:
Title:  Gynecologic oncology     Volume:  116     ISSN:  1095-6859     ISO Abbreviation:  Gynecol. Oncol.     Publication Date:  2010 Mar 
Date Detail:
Created Date:  2010-02-15     Completed Date:  2010-03-10     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0365304     Medline TA:  Gynecol Oncol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  464-7     Citation Subset:  IM    
Affiliation:
Indiana University School of Medicine, Dept of Ob-Gyn, Div Gyn Oncology, Indianapolis, IN 46202-5149, USA. gdelprio@iupui.ed
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MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Adult
Cervical Intraepithelial Neoplasia / drug therapy*,  pathology
Double-Blind Method
Female
Humans
Indoles / administration & dosage*
Pilot Projects
Placebos
Uterine Cervical Neoplasms / drug therapy*,  pathology
Chemical
Reg. No./Substance:
0/Indoles; 0/Placebos; 0/diindolylmethane

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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