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Episiotomy would be a candidate. We thought we we doing such good, now it appears that we may have been increasing the chance of tears rather than decreasing.
eg (not quite an RCT?)
Midline episiotomy and anal incontinence: retrospective cohort study
Lisa B Signorello, Bernard L Harlow, Amy K Chekos, and John T Repke
BMJ 2000; 320: 86-90.
_________________________________________________________________________
Dr Gary Jackson, Manager Clinical Planning Rm 307 Support Building
South Auckland Health, Private Bag 93311, Otahuhu, Auckland
ph 64-9-276 0044 ext 2512 fax 64-9-276 0191 mobile 025 286 1815
email [log in to unmask]
-----Original Message-----
From: Djulbegovic, Benjamin [SMTP:[log in to unmask]]
Sent: Wednesday, February 02, 2000 5:25 AM
To: 'Evidence-based discussion group'
Subject: RCTs that changed medical practice....
Dear all,
I am trying to compile a list of examples where randomized trials have been
shown to dramatically alter medical practice (by proving that treatment that
has been established in medical practice for years was actually more
detrimental or clearly inferior to alternative approach). We are not
looking for the trials that showed no difference in effect, or resulted in
conclusion that one may use either treatment A or B. We are more interested
in the examples that:
a) show reversal of effect
b) potentially harmful treatment, very toxic, expensive or complicated
medical treatments (e.g. surgery, high-dose chemotherapy, etc) were shown
not to be superior to less harmful and less-complicated treatments
c) randomized trials demonstrated dramatic beneficial effect (e.g.
having relative-risk reduction >30%)
Perhaps, such a list has already been compiled. In that case, I would
appreciate it if someone can provide me with details on the source. If not,
I am inviting you to join me in compiling such a list, or catalog of a sort
(which I will gladly share with the members of the discussion list).
Immediate examples of dramatic changes in the practice that come to my mind
are:
- use of DES to prevent miscarriages in pregnant women (later shown
in RCTs that outcomes were worse in DES treated group compared to control)
-prophylactic use of lidocaine during myocardial infarction (again
shown to be more harmful than placebo)
-gastric freezing as a treatment for peptic ulcer (dramatic results
were obtained in uncontrolled studies, later to be shown not to be any more
successful than less aggressive medical treatment)
-ligation of int. mammary artery as a treatment for coronary artery
disease (shown in RCT that it was no better than sham surgery, with small
incision in the chest)
-surgery vs. surgery+adjuvant chemoRx in treatment of osteosarcoma
(dramatic beneficial effect of adjuvant chemoRx)
-melphalan+prednisone vs. colchicine (reversal of effect; M+P
superior to colchicine that was earlier, in non-RCT trial, was shown to be
superior to M+P)
-high-dose chemotherapy (transplant) vs. chemoRx as adjuvant
treatment in high-risk breast cancer (abstracts published last year showed
no difference)
Admittedly, there will be some judgement calls in deciding whether a given
study would qualify as the one that dramatically changed medical practice,
or as an "example of the danger of applying pathophysiologic reasoning to
therapeutic actions without first testing the hypothesis by means of
adequately designed trials".
Please, don't forget to include the full bibliographic details on the
examples that you consider would meet our provisional definition of "RCTs
that altered medical practice".
I look forward to compiling this exciting list.
Thank you for your cooperation.
With best wishes
Ben Djulbegovic
Benjamin Djulbegovic, MD
Associate Professor of Medicine
H. Lee Moffitt Cancer Center & Research Institute
at the University of South Florida
Division of Blood and Bone Marrow Transplant
12902 Magnolia Drive
Tampa, FL 33612
Editor: Evidence-based Oncology
e-mail:[log in to unmask]
http://www.hsc.usf.edu/~bdjulbeg/
phone:(813)979-7202
fax:(813)979-3071