title: Mucosal disruption due to use of a widely-distributed commercial vaginal product: potential to facilitate HIV transmission.
abstract: OBJECTIVE
  Policresulen vaginal suppositories are a condensation product of metacresolsulfonic acid and formaldehyde. We investigated their use by female commercial sex workers (CSW) and whether such use could facilitate HIV transmission.
  
  
  METHODS
  We interviewed female CSW in Thailand about use of the product, and we directly observed the effects of self-administration of a single suppository by each of six women.
  
  
  RESULTS
  Of 200 CSW interviewed, 32% had used policresulen vaginal suppositories in the preceding year and 46% had used them at some time. Many used them for reasons not listed on the package insert, such as improving their male partners' sexual pleasure, and most did not abstain from vaginal sex following use. Among 36 brothel-based and 67 non-brothel-based CSW with known HIV infection, the use of the product was not associated with HIV-1 infection (adjusted relative risk 1.0, 95% confidence interval, 0.5-2.0). Exfoliation of the vaginal and cervical mucosa was observed in all six CSW 1 day after product use, and, although it could have been the result of repeated examinations, an increase in genital HIV-1 RNA shedding was also detected in all three HIV-seropositive women.
  
  
  CONCLUSIONS
  Although there was no epidemiological association with HIV infection, policresulen vaginal suppository use did disrupt the genital mucosa and therefore may have the potential to facilitate HIV transmission. Drug licensing authorities may wish to reassess the safety of this product. If the product continues to be distributed, steps should be taken to limit its use to the specific conditions for which it is indicated and to ensure that women abstain from vaginal sex following its use.
authors.affiliation: Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
authors.forename: P H
authors.initials: PH
authors.lastname: Kilmarx
authors.forename: K
authors.initials: K
authors.lastname: Limpakarnjanarat
authors.forename: S
authors.initials: S
authors.lastname: Supawitkul
authors.forename: S
authors.initials: S
authors.lastname: Korattana
authors.forename: N L
authors.initials: NL
authors.lastname: Young
authors.forename: B S
authors.initials: BS
authors.lastname: Parekh
authors.forename: R A
authors.initials: RA
authors.lastname: Respess
authors.forename: T D
authors.initials: TD
authors.lastname: Mastro
authors.forename: M E
authors.initials: ME
authors.lastname: St Louis
mesh_terms: D000282:Administration, Intravaginal; D000328:Adult; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000494:pharmacology*; D003127:Colposcopy; D003408:Cresols / Q000008:administration & dosage / Q000494:pharmacology*; D004338:Drug Combinations; D005260:Female; D005557:Formaldehyde / Q000008:administration & dosage / Q000494:pharmacology*; D015658:HIV Infections / Q000635:transmission*; D006801:Humans; D009092:Mucous Membrane / Q000187:drug effects / Q000473:pathology; D011446:Prospective Studies; D012306:Risk; D011477:Sex Work; D013488:Suppositories; D014621:Vagina / Q000187:drug effects* / Q000473:pathology; D014627:Vaginitis / Q000517:prevention & control
chemical_list: D000890:Anti-Infective Agents; D003408:Cresols; D004338:Drug Combinations; D013488:Suppositories; D005557:Formaldehyde; C001716:formaldehyde, meta-cresolsulfonic acid drug combination