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CARDIOVASCULAR JOURNAL OF AFRICA • Volume 27, No 6, November/December 2016
AFRICA
337
intra-pericardial fibrinolytic therapy to facilitate pericardial
drainage is one such technique,
8,9
which has been touted as
potentially effective at reducing constriction by breaking up
fibrous adhesions, and will be tested in the soon-to-be-launched
second investigation into the management of pericarditis trial
(IMPI-2). Angiotensin convertase enzyme inhibitors are capable
of activating anti-fibrotic cytokines within the pericardium and
may also hold promise.
10,11
Finally, we should also applaud the
on-going attempts to better understand the pathobiology of
tuberculous pericarditis and its complications through high-
quality basic science research that will hopefully identify new
targets for adjuvant therapies.
12-14
Secondly, it is also important to emphasise that, strictly
speaking, this study by Liebenberg
et al
. is by no means a
negative study. Small pilot or vanguard studies such as this are
not designed to provide definitive answers on efficacy; in fact, if
they do, it’s likely that there is a type II or similar error. The main
objectives of such studies, even if unstated, are actually to make
sure that important design, method and safety issues necessary
to successfully conduct an appropriately sized study are in place.
Important questions that often need addressing include: is the
recruitment rate achieved in the pilot study adequate to reach
calculated sample sizes in a reasonable time frame if a definitive
study is conducted; is the investigational drug free of harmful
side effects and safe enough in this unique condition to be tested
on hundreds or thousands of patients; is the infrastructure
and set up required to not lose any patients during follow up
adequate; are the tools such as those for data collection and
storage adequate; and finally, are the resources available and
allocated for conducting a full study appropriate to ensure
success? To this end the authors have gone some way in providing
at least some of the required answers. On the face of it, a large,
simple, randomised trial that is feasible and safe, and that would
require multiple collaborating sites and mitigation strategies to
prevent loss to follow up and completion within acceptable time
frames is possible.
In conclusion, the authors should be congratulated for
continuing to fight the good fight and demonstrating that we
in the developing world must never lose sight of the principle
that where there are unresolved clinical conditions unique to
our environment, if we who face the problem do not try to find
the solutions, no one else will do it for us. They have reminded
us that it is imperative for us to continue to believe that there
is no reason why with hard work, dedication and application,
we cannot find appropriate solutions to improve the lot of our
patients. We hope their demonstrated perseverance remains,
and look forward to the news of a full-scale, large, randomised,
controlled trial with them at the helm.
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