The Alliance for Microbicide Development in
its April 7 2006 News Digest
(click here for transcript..)
claims that new data suggest safety concerns regarding the
use of lemon and lime juice.
The following response has been provided by Malcolm Potts,MB,BChir,PhD,
Fred H.Bixby Endowed Chair,School of Public Health, University
of California, Berkeley, California:
Most microbicides in high concentration could have the potential
of damaging the vaginal epithelium.
Once it was known that lime juice was being widely used by
thousands of women in Nigeria, there was an obvious need to
study possible adverse effects.
Sadly, those who control most resources in microbicide development
did not choose to respond fast to this clear need. After a delay
of at least two years, two research groups finally started to
look into the matter.
The University of California Berkeley managed to raise limited
funds to implement a safety study using 20% lime juice. This
study showed no significant adverse effects up to a 20% dilution
and it is now in the publishing pipeline.
Limited data is now also available on the second study conducted
by CONRAD using higher concentrations of lime juice (including
25%, 50% and 100%). Their preliminary analysis suggests a fair
degree of damage seen in the colposcopies of their lime users
in all concentrations used, but it also found a very high rate
of adverse events in a control group. These findings are impossible
to interpret in advance of a full discussion of all the
available data on lime juice at all the tested concentrations.
We have seen the preliminary results of CONRAD but it was
not possible to discuss these results at the Alliance meeting.
Unfortunately the Alliance for Microbicide Development has
circulated its conclusions unilaterally, based on preliminary
on colposcopies and adverse effects (not on biomarkers etc.)
and without consulting with the Berkeley researchers. Those
reading the Alliance statement would be wise to not give it
too much weight until a more objective complete analysis of
all the data has been completed.
It may be useful at this stage to spell out the possible range
of outcomes of research on lime juice and their implications.
a. Lime juice in clinical trials on human volunteers
may be shown to be harmful at certain concentrations, in which
case there will be an ethical imperative to study the Nigerian
women in more detail, both from the viewpoint of genital health
and the acquisition of HIV in exposed women. If women are indeed
at a greater risk then an education campaign will need to be
mounted to inform women of the risk.
b. The different outcomes between the Berkeley and
the CONRAD may be due to methodological flaws in one or both
studies.
c. Lime juice may be safe at low concentration but
damage the epithelium at a high concentration.
d. Research is needed to determine the concentration
of lime juice need to kill HIV in vivo after normal intercourse.
e. A discussion is needed whether a complete buffering
of semen is needed (as maybe for the use of lime juice before
intercourse) or whether a douche immediately after intercourse
could already greatly reduce the volume of effective semen by
washing it out.
This important schedule of work and decision making needs
to be conducted with a transparent sharing of data and in a
collegial manner, and without excluding any research group from
the decision making.
Malcolm Potts Bixby Professor, University California,
Berkeley. April 10. 2006
Malcolm Potts, MB, BChir, PhD
Fred H. Bixby Endowed Chair
School of Public Health
314 Warren Hall #7360
University of California
Berkeley, Calfornia 94720-7360
Tel 510 642 6915
Fax 510 524 4418
http://bixby.berkeley.edu
