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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