Safety and effectiveness of large-volume enema solutions

Schmelzer, Marilee; Schiller, Lawrence R.; Meyer, Richard W.; Rugari, Susan M.; Case, P.L.

doi:10.1016/j.apnr.2004.09.010

Cited by 35 publications

(54 citation statements)

References 17 publications

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“…Most of the studies were correlational, speculating that douching had deleterious effects on the rectum, but evidence was lacking until Schmelzer et al (2004) published the results of their work. In a doubleblind, repeated-measures study comparing three types of enema solutions (soapsuds, tap water, and polyethylene glycol-electrolyte solution-PEG-ES) in 24 healthy volunteers, rectal biopsies showed surface epithelium loss after soapsuds and tap water enemas, but not for PEG-ES enemas.…”

Section: Introductionmentioning

confidence: 96%

The Use of Rectal Douches among HIV-uninfected and Infected Men who Have Unprotected Receptive Anal Intercourse: Implications for Rectal Microbicides

et al. 2007

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Although some rectal douches result in surface epithelium loss and potential increase of HIV transmission, men who have sex with men (MSM) continue to use them. We describe the prevalence of this practice among MSM engaging in unprotected receptive anal intercourse (URAI) in risky circumstances. A multiethnic sample with overrepresentation of HIV-negative MSM who had URAI in the previous year was recruited exclusively through the Internet. Participants were 105 MSM (78 HIV-negative, 27 HIV-positive). A total of 53% of HIV-negative and 96% of HIV-positive men douched in preparation for sex, most of them frequently or always, mainly for hygienic purposes. 27% of HIV-negative and 44% of HIV-positive douched after sex, partly believing douching protected from infections. Douching practices started around age 25. Regression analyses found the association between HIV status and douching occasions persisted after controlling for demographic characteristics and number of URAI occasions. Rectal douching in preparation for sex is common among men who practice URAI. This population could benefit from alternatives to condoms, such as rectal microbicides. Given the popularity of pre-coital douching and its frequency, a harmless rectal douche that could deliver a rectal microbicide could have great acceptability.

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Section: Introductionmentioning

confidence: 96%

The Use of Rectal Douches among HIV-uninfected and Infected Men who Have Unprotected Receptive Anal Intercourse: Implications for Rectal Microbicides

et al. 2007

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“…35 As in other studies documenting the popularity of rectal douching among MSM, 25,26,37 such behavior was fairly prevalent (18-53% among Black participants). Unfortunately, several common forms of rectal douching (soapsuds, tap water) have been reported to damage the surface epithelium of the colon or rectum in human 29 and animal 38 studies, thereby potentially enhancing vulnerability to HIV and other STIs. However, research to date is limited and there is promise that other douching products (e.g., polyethylene glycol electrolyte solution) cause significantly less epithelial damage.…”

Section: Calabrese Et Almentioning

confidence: 99%

“…However, research to date is limited and there is promise that other douching products (e.g., polyethylene glycol electrolyte solution) cause significantly less epithelial damage. 29 Given the variety of douching methods reported, 26 further information regarding the least harmful solutions, equipment, and techniques would be helpful.…”

Section: Calabrese Et Almentioning

confidence: 99%

“…18 Moreover, documentation of condom use often relies on aggregate retrospective self-reports, which have proven vulnerable to distortion, with MSM more commonly underestimating than overestimating unprotected PAI. 19 Additionally, Black MSM's participation in other behavioral practices known or suspected to influence vulnerability to HIV and other STIs, including lubricant use [20][21][22][23][24] and precoital rectal douching or enema use, [25][26][27][28][29][30] has received insufficient attention in the literature.…”

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confidence: 99%

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An Event-Level Comparison of Risk-Related Sexual Practices Between Black and Other-Race Men Who Have Sex with Men: Condoms, Semen, Lubricant, and Rectal Douching

Calabrese

Rosenberger

Schick

et al. 2013

AIDS Patient Care and STDs

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Black men who have sex with men (MSM) living in the U.S. are disproportionately affected by HIV/AIDS. An online survey of sexual behavior was completed by Black, White, Hispanic/Latino, Asian/Pacific Islander, and other-race MSM (n = 11,766) ages 18-87 years. Complete condom use, semen exposure, pre-coital rectal douching (enema use), and lubricant use at last male-partnered sexual event were compared by race, controlling for relevant sociodemographic variables and stratifying by sexual position (receptive, insertive, or both). Across sexual positions, 55-62% of Black MSM reported condom use, 5-8% reported semen exposure, 18-53% reported douching, and 33-43% reported lubricant use. Reported behavioral profiles were not significantly different from other races, except that Black MSM reported greater condom use than White MSM in the insertive position. Although findings argue against disproportionate rates of risk behavior accounting for racial disparities in HIV prevalence, they nonetheless highlight a need for continued behavioral intervention.

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“…20,21 A large proportion of users simply use tap water (a hypoosmolar formulation) due to easy availability; however, epithelial loss has also been reported after its use. 22 Whether any of these types of enema are suitable for drug delivery as PrEP is unstudied.…”

mentioning

confidence: 99%

Isoosmolar Enemas Demonstrate Preferential Gastrointestinal Distribution, Safety, and Acceptability Compared with Hyperosmolar and Hypoosmolar Enemas as a Potential Delivery Vehicle for Rectal Microbicides

Leyva

Bakshi

Fuchs

et al. 2013

AIDS Research and Human Retroviruses

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Rectally applied antiretroviral microbicides for preexposure prophylaxis (PrEP) of HIV infection are currently in development. Since enemas (rectal douches) are commonly used by men who have sex with men prior to receptive anal intercourse, a microbicide enema could enhance PrEP adherence by fitting seamlessly within the usual sexual practices. We assessed the distribution, safety, and acceptability of three enema types-hyperosmolar (Fleet), hypoosmolar (distilled water), and isoosmolar (Normosol-R)-in a crossover design. Nine men received each enema type in random order. Enemas were radiolabeled [ 99m Tc-diethylene triamine pentaacetic acid (DTPA)] to assess enema distribution in the colon using single photon emission computed tomography/ computed tomography (SPECT/CT) imaging. Plasma 99m Tc-DTPA indicated mucosal permeability. Sigmoidoscopic colon tissue biopsies were taken to assess injury as well as tissue penetration of the 99m Tc-DTPA. Acceptability was assessed after each product use and at the end of the study. SPECT/CT imaging showed that the isoosmolar enema had greater proximal colonic distribution (up to the splenic flexure) and greater luminal and colon tissue concentrations of 99m Tc-DTPA when compared to the other enemas ( p < 0.01). Colon biopsies also showed that only the hyperosmolar enema caused sloughing of the colonic epithelium ( p < 0.05). In permeability testing, the hypoosmolar enema had higher plasma 99m Tc-DTPA 24-h area under the concentration-time curve and peak concentration compared to the hyperosmolar and isoosmolar enemas, respectively. Acceptability was generally good with no clear preferences among the three enema types. The isoosmolar enema was superior or similar to the other enemas in all categories and is a good candidate for further development as a rectal microbicide vehicle.

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Safety and effectiveness of large-volume enema solutions

Cited by 35 publications

References 17 publications

The Use of Rectal Douches among HIV-uninfected and Infected Men who Have Unprotected Receptive Anal Intercourse: Implications for Rectal Microbicides

The Use of Rectal Douches among HIV-uninfected and Infected Men who Have Unprotected Receptive Anal Intercourse: Implications for Rectal Microbicides

An Event-Level Comparison of Risk-Related Sexual Practices Between Black and Other-Race Men Who Have Sex with Men: Condoms, Semen, Lubricant, and Rectal Douching

Isoosmolar Enemas Demonstrate Preferential Gastrointestinal Distribution, Safety, and Acceptability Compared with Hyperosmolar and Hypoosmolar Enemas as a Potential Delivery Vehicle for Rectal Microbicides

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