Pages

Sub-Saharan African randomised clinical trials into male circumcision and HIV transmission: methodological, ethical and legal concerns.



Sub-Saharan African randomised clinical trials into male circumcision and HIV transmission: methodological, ethical and legal concerns.


Abstract


In 2007, WHO/UNAIDS recommended male circumcision as an HIV-preventive measure based on three sub-Saharan African randomised clinical trials (RCTs) into female-to-male sexual transmission. A related RCT investigated male-to-female transmission. However, the trials were compromised by inadequate equipoise; selection bias; inadequate blinding; problematic randomisation; trials stopped early with exaggerated treatment effects; and not investigating non-sexual transmission. Several questions remain unanswered. Why were the trials carried out in countries where more intact men were HIV-positive than in those where more circumcised men were HIV-positive? Why were men sampled from specific ethnic subgroups? Why were so many participants lost to follow-up? Why did men in the male circumcision groups receive additional counselling on safe sex practices? While the absolute reduction in HIV transmission associated with male circumcision across the three female-to-male trials was only about 1.3%, relative reduction was reported as 60%, but, after correction for lead-time bias, averaged 49%. In the Kenyan trial, male circumcision appears to have been associated with four new incident infections. In the Ugandan male-to-female trial, there appears to have been a 61% relative increase in HIV infection among female partners of HIV-positive circumcised men. Since male circumcision diverts resources from known preventive measures and increases risk-taking behaviours, any long-term benefit in reducing HIV transmission remains uncertain.

Flawed Studies Used to Claim Circumcision Reduces HIV Infection


Shared with permission.

"... Unfortunately, it appears that this compulsion continues to drive some professionals and authorities to promote circumcision without proper critical analysis."

Baby
Medical research indicates that circumcision does not stem or control the flow of HIV and AIDS.
(BOSTON) - An article in the December Journal of Law and Medicine cites numerous flaws in three African studies that claim male circumcision reduces transmission of HIV. (see: the article here)
According to the article, the studies, which are being used to promote the circumcision of up to 38 million men in Africa, had selection bias, inadequate blinding, problematic randomization, experimenter bias, lead time bias, supportive bias, participant expectation bias, time-out discrepancy, and lack of investigating of non-sexual HIV transmission among other confounding factors and problems.
The absolute reduction in HIV transmission associated with male circumcision for the three studies was only about 1.3%. The African studies had cited the relative reduction in HIV transmission, a misleading figure. Reports in the popular press have been even more misleading. Furthermore, there are at least 17 observational studies that have not found any benefit from male circumcision in reducing HIV transmission. Since condom use after male circumcision is essential to prevent sexual transmission of HIV, circumcision does not have any additional value.
Ronald Goldman, Ph.D, executive director of the Circumcision Resouce Center and author of Circumcision: The Hidden Trauma, stated, "This article is another serious, critical analysis of flawed research that is being used to promote circumcision. We have seen such claims about the 'preventive benefits' of circumcision for over 100 years. They have all been refuted. No other normal, healthy body part is cut off for supposed 'preventive benefits.' From our psychological work, we know that there is a compulsion on the part of some circumcised men to have others circumcised.
Unfortunately, it appears that this compulsion continues to drive some professionals and authorities to promote circumcision without proper critical analysis. They also ignore the serious sexual and psychological harm caused by circumcision."
The article, which also discusses ethical and legal concerns about circumcision, concludes that a recommendation for mass circumcision programs in Africa is not justified. "Male circumcision is a dangerous distraction and waste of scare resources that should be used for known preventive measures."

Related Posts Plugin for WordPress, Blogger...