Randomised trials in the South African Medical Journal, 1948-1997.
OBJECTIVE
To describe randomised controlled trials (RCTs) published in the South African Medical Journal (SAMJ) over a 50-year period from 1948 to 1997 with regard to number, topic and quality.


METHODS
We hand searched all issues of the SAMJ published during the study period to identify all published RCTs.


METHODS
Number, topic and quality of RCTs published from 1948 to 1997.


RESULTS
Eight hundred and fifty-eight clinical trials were published during the period reviewed. Eighty-four per cent of RCTs were published as full articles. During the 1980s the number of RCTs published increased rapidly, with a peak of 35 in 1985, but then declined to only 5 in 1997. The majority (92%) of RCTs were conducted in a hospital setting. A varied range of subjects was covered, with gastroenterology taking the lead and no trials in public health. The sample size in more than 50% of RCTs was smaller than 50 patients. Fifty-one per cent (435 trials) used random allocation and 49% (423) quasi-random methods of allocation. Concealment of treatment allocation was judged to be adequate in 46% of studies (N = 200), blinding of observers assessing outcomes was adequate in 28% (123), and all the allocated test subjects were included in the primary analysis in 28% (123). The follow-up period was more than 1 year in 4% (17) and less than 6 days in 16% (71).


CONCLUSIONS
Compared with other international journals the SAMJ is highly regarded in terms of the number of trials published. There are, however, a number of deficiencies in the quality of the trials.
Pienaar
E D
ED
South African Cochrane Centre, Medical Research Council, Tygerberg, W Cape.
Volmink
J
J
Zwarenstein
M
M
Swingler
G H
GH
D002985:Clinical Protocols / Q000592:standards; D006801:Humans; D018156:Journalism, Medical / Q000592:standards*; D018579:Patient Selection; D010506:Periodicals as Topic / Q000592:standards* / Q000706:statistics & numerical data*; D016032:Randomized Controlled Trials as Topic / Q000592:standards* / Q000706:statistics & numerical data*; D012107:Research Design / Q000592:standards / Q000706:statistics & numerical data; D013019:South Africa; D013997:Time Factors