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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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