Diethylstilbestrol usage was questioned by WJ Dieckmann in 1953
A strictly controlled clinical trial of the therapeutic value of diethylstilbestrol administered to patients during pregnancy in reducing the hazards of some of the late complications of pregnancy for mothers and babies has been reported.
The various complications were studied in the total unselected group of patients divided into primigravidas, primiparas, and multiparas. Then the groups were again studied after all groups were corrected to compare with the Smiths’.
The results of the administration of diethylstilbestrol in graduated amounts to 840 patients according to a schedule suggested by the Smiths were compared with the results of an identical placebo tablet given to 806 patients. Stilbestrol did not reduce the incidence of abortion, prematurity, or postmaturity. Premature babies of stilbestrol-treated mothers were no longer nor more mature for their gestational ages than comparable prematures in the control group of placebo-treated mothers. It did not decrease the incidence of perinatal mortality. It did not decrease the frequency of the toxemias of pregnancy.
“We too are disappointed, and apologetic., because we were instrumental in putting them to so much trouble in acquiring results that are still inconclusive.
“We also wish we had given a placebo to our controls.”
“We omitted from our analyses all patients who aborted prior to viability and did not accept those who had threatened to abort at any time early in pregnancy or include such cases in our control series.”
DR. GEORGE van S. SMITH, Brookline, Mass.
“We have never said that it should be given to all during pregnancies.”
“We do not recommend stilbestrol for pregnancy complications, …”
DR. OLIVE W. SMITH, Brookline, Mass.
“The one general conclusion to be drawn from this very painstaking study of Dieckmann and co-workers must be obvious to each of us; stilbestrol is no panacea.”
“We have a similar study in progress. At the present time 350 patients have completed their pregnancies. Treatment was begun prior to the sixteenth week. There seems no need to give the details of the results. The material was analyzed in much the same manner as that of Dieckmann and the results were virtually identical. In short, there was no difference in size of newborn infants, duration of pregnancy, occurrence of premature labor or of toxemia in the two groups. This short series gave the same results as the much longer series. It would seem to me, therefore, that these results indicate that stilbestrol for routine use has little value.
DR. WILLARD ALLEN, St. Louis, Mo
“We have followed Dr. Olive Smith’s work very carefully.
This experiment was designed in an attempt to learn whether diethylstilbestrol has therapeutic value. Our problem was to find out whether it is worth the time and effort and money to administer the drug to large segments of our population in an attempt to cut flown on the hazards of some of these pregnancy complications.
We have not proved that it is of value. All of om data are filed on IBM cards. These are available to any of you who wish to examine them. Concerning the length of time that the drug was taken by the patients, 15 weeks is the average time and 5 weeks i~ the minimum period.
We think that the number of patients studied and the methods useJ showed that stilbestrol has no therapeutic value in pregnancy. It is possible that that answer may not he correct, but it will take at least as many more patients just as carefully controlled to prove that stilbestrol administered prophylactically to normal or abnormal pregnant patients has any value in the prevention of the specific complications of pregnancy.”
DR. DAVIS (Closing)
- American Journal of Obstetrics and Gynecology, Volume 66, Issue 5 Pages 1062–1081, November 1953. Free full text available via sci-hub.
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