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Arborizations in cervical smears
Volume
79
Correspondence
Number2
the computation, effective observation of the remaining group began with the twelfth month rather than with the date of prescription. It is necessary, therefore, to deduct 11 months for each of the 176 patients (1,936 months in all) from the reported total of 3,354 months of exposure. This correction reduces the aggregate exposure to 1,418 months and increases the pregnancy rate to 13.5 per 100 years of exposure. Although the above procedure is correct arithmetically, the resulting pregnancy rate is not comparable to rates published by other authors which, in general, include all months of exposure with use of a prescribed contraceptive method. Drs. Finkelstein and Goldberg kindly provided me with a complete tabulation by months of use and pregnancy status of all 366 patients who accepted the cream-jel. According to the table, the total exposure of the 366 patients amounted to 4,381 months during which 87 unplanned pregnancies occurred. Computed on this basis, the pregnancy rate is 23.8 per 100 years of exposure, a rate typical of those found among clinic patients using a jelly or cream without diaphragm. Aggregate exposure of all 366 patients during the first year of observation totaled 2,963 months with 71 pregnancies, corresponding to a pregnancy rate of 28.8 per 100 years of exposure. The higher level of this rate, compared with the period from the twelfth month onward (13.5 per 100 years of exposure), reflects the greater risk of conception in the earlier period during which the least skillful and least interested couples tend to fall by the wayside. Owing to the greater risk of pregnancy in the early months of use, limitation of the study to patients who remain under obsrrvation for 12 months or more results in a spuriously low pregnancy rate, even when the first 11 months of exposure are correctly deductcd. The authors cite a recommendation by the Council on Pharmacy and Chemistry to the effect that “each case reported should be observed for at least 12 months.” Since this formula assures a minimum of 11 pregnancy-free months in each case, it is statistically unsound and should never be used in the computation of pregnancy rates. t\ joint subcommittee of the Margaret Sanger Research Bureau and the Planned Parenthood Federation of America is now working on a new set of criteria for the approval of chemical contracrptives. One of the recommendations agreed upon by this subcommittee stipulates that “the averngr period of observation during which the
413
material was used should be at least one year.” Replacement of the Council’s recommendation by the proposed new formula will help to avoid misleading results, such as those presented in the report by Drs. Finkelstein and Goldberg. Christopher Tie&-, M.D. Director of Research National Committee on Maternal Health, Inc. 2 East 103 Street New York 29, New Sept. 28, 1959
York
Arborizations
cervical
To
in
smears
the Editors:
The article by Drs. Schwalenberg and Efstation appearing on page 860 of the October issue of the JOURNAL includes a sweeping statement which, to a reader not fully informed of all the data on the subject of the mucus fern phenomenon, might be misleading. The authors, referring to Ullery and Shabanah,l state, “they did not believe that arborization in the cervical mucus was an indication of progesterone deficiency.” It has always been argued by many obstetricians who took interest in the subject that some of their pregnant patients showed arborizations in their cervical smears at various stages of pregnancy and yet they were delivered normally at term. We were the first to draw attention to the significance of this type of arborization as that depicted in the authors’ Fig. 1, A-the atypical fern pattern.lm3 This pattern occurs in about 30 per cent of nonpregnant women in the progestational phase and in some pregnant women who are apparently normal. We were, and still are, of opinion that this is the pattern to be seen in cervical smears when there is a dual activity by both estrogens and progesterone reflected in the smear. The poorer the pattern of arborizations the more dominant will progesterone be, and the opposite also holds true. Based on these observations and other clinical data, we concluded (paragraph 3, page 239) that “the presence of a fern reaction in the cervical smear during pregnancy does not necessarily mean placental insufficiency.“l A cervical mucus smear which cxhibits plentiful mucoid material and abundant exfoliation denotes apparent progestational domi-
414
Correspondence
nanct:. Some of these smears will show, in addition, this pattern of poor arborization or atypical ferning. When this is the case, the patient is in no danger of progesterone deficiency. But when the proportion of ferning increases and continues to do so, placental insufficiency becoming irrrversible, the mucoid material and exfoliation inevitably diminish, and the picture becomes that of clear heavy ferns, as depicted in Fig. 7 of out article (page 238) .I The authors’ statement ,Iparagraph la page 86’2) that “All patients who repeatedly rhowed heavy arborizations of the cervical mucus were treated with progesteronr.” ~tc., speaks for itself as simply a confirmation of our findings and is basically similar to our statement. In thp authors’ series of 200 patients, 6.5 per cent had abortions. a similar finding to our 6.6 per cent.’ The fact that the other patients who did not have abortions showed unusual symptoms which vanished with reversal of the cervical mucus findings is not a unique experience. If the authors would revise the smears taken from these patients, using the index-of-refraction liquids-a test for the detection of electrolyte imbalance adopted to clinical usage by myself*---they will find that there was an imbalance between sodium and potassium chloride, the latter being in escess of the normal. .4 good, reliable nontoxic diuretic would have rclie\red thesr patients of their symptoms without c-hanging the ferning reaction quantitatively but only qualitatively. It is less expensive and rnor(’ convenient and is easy to handle.
all pregnant patients show arborization in vary ing amounts in all stages of pregnancy”; (B> “The prcsenre of arborization does not necessarily mean placental insufficiency.” We believe these statements are misleading. We recognize the difference between ‘typical” arid ‘“atypical” arborization. Our studies2 have indicated that the positive smear may, at certain arcas of pregnancy, be so common as to be conxidered normal, but is not more common than 11.6 per cent. This we found to be true in 200 1~3tients with over 2,000 carefully studied and .mnoted slides, and is uow true of more than 500 patients wirh over 5,000 smears. Our incidence of positive smears agrees morr closely with Zondek’s ~c+ss of 226 cases with an inq.idence of 12 per c-ent arborization in pregnancy. Wr will happily retract the statement that l)r. Shabanah dors not believe arborization of pregnant cervical mucus is an indication of progesterone deficiency. particularly so if this will impress upon the minds of the readers that. such a condition may exist. The aforernentioned article” was offered to cbrnphasize thr importance of c.ervical mucus studies in pregnancy 1.0 the average obstetrician. No one can at. present determine which patient \\,ill continue IO show arborization and which will progress to an irreversible deficiency. For thrsfs reasons we emphasize, with Dr. Shabanah, that a repeatedly positive cervical mucus must br reverted by treatment with progesterone to .i negative smear REFERENCES
REFERENCES
1. Ullery, J. C., and Shabanah, E. H.: Obst. & Gynec. 10: 233, 1957. 2. Davis, M. E., and Abou-Shabanah, E. H.: Fertil. & Steril. 9: 344, 1958. 3. Ullery, J. C., Livingston, N., and AbouShabanah, E. H.: Obst. & Gynec. Surv. 14: 1, 1959. 4. Abou-Shabanah, E. H., Boutselis, J. G., Frajola, W. J., and Ullery, J. C.: .4111. J. OBST. & GYNEC. 76: 1248, 1958. E. H. Shabanah,
To
the
by Drs. Schwalenberg
R. R. Schwalenberg, T. D. E/station. M.D, Tifiin, Ohio November,
M.D.
1959
M.D.
1002 Central Ave. Saskatoon, Saskatchewan Oct. 15, 1959
Reply
1. Ullery, J. C., and Shabanah, E. H.: Obst. & Gynec. 10: 233, 1957. 2. Schwalenberg, R. R., and Efstation, T. D.: AM. J. OBST. & GYNEC. 78: 860, 1959. 3. Zondek, B., Forman, I., and Cooper, K. L.: Fertil. PC Steril. 6: 523. 1955.
Index-of-refraction
liquids
7’0 thP Editarc:
and
Efstation
Editors:
Dr. Shabanah states in his original article’ in a study of 95 cases: (A] “Thirty per cent of
The article entitled “The Nasal Mucus Smear in Toxemias of Pregnancy,” which appeared in thft December, 1958, issue of the JOURNAL (page I 2481. describes a simple procedure for the drtcction of rlectrolyte imbalance.
79
Correspondence
Number2
the computation, effective observation of the remaining group began with the twelfth month rather than with the date of prescription. It is necessary, therefore, to deduct 11 months for each of the 176 patients (1,936 months in all) from the reported total of 3,354 months of exposure. This correction reduces the aggregate exposure to 1,418 months and increases the pregnancy rate to 13.5 per 100 years of exposure. Although the above procedure is correct arithmetically, the resulting pregnancy rate is not comparable to rates published by other authors which, in general, include all months of exposure with use of a prescribed contraceptive method. Drs. Finkelstein and Goldberg kindly provided me with a complete tabulation by months of use and pregnancy status of all 366 patients who accepted the cream-jel. According to the table, the total exposure of the 366 patients amounted to 4,381 months during which 87 unplanned pregnancies occurred. Computed on this basis, the pregnancy rate is 23.8 per 100 years of exposure, a rate typical of those found among clinic patients using a jelly or cream without diaphragm. Aggregate exposure of all 366 patients during the first year of observation totaled 2,963 months with 71 pregnancies, corresponding to a pregnancy rate of 28.8 per 100 years of exposure. The higher level of this rate, compared with the period from the twelfth month onward (13.5 per 100 years of exposure), reflects the greater risk of conception in the earlier period during which the least skillful and least interested couples tend to fall by the wayside. Owing to the greater risk of pregnancy in the early months of use, limitation of the study to patients who remain under obsrrvation for 12 months or more results in a spuriously low pregnancy rate, even when the first 11 months of exposure are correctly deductcd. The authors cite a recommendation by the Council on Pharmacy and Chemistry to the effect that “each case reported should be observed for at least 12 months.” Since this formula assures a minimum of 11 pregnancy-free months in each case, it is statistically unsound and should never be used in the computation of pregnancy rates. t\ joint subcommittee of the Margaret Sanger Research Bureau and the Planned Parenthood Federation of America is now working on a new set of criteria for the approval of chemical contracrptives. One of the recommendations agreed upon by this subcommittee stipulates that “the averngr period of observation during which the
413
material was used should be at least one year.” Replacement of the Council’s recommendation by the proposed new formula will help to avoid misleading results, such as those presented in the report by Drs. Finkelstein and Goldberg. Christopher Tie&-, M.D. Director of Research National Committee on Maternal Health, Inc. 2 East 103 Street New York 29, New Sept. 28, 1959
York
Arborizations
cervical
To
in
smears
the Editors:
The article by Drs. Schwalenberg and Efstation appearing on page 860 of the October issue of the JOURNAL includes a sweeping statement which, to a reader not fully informed of all the data on the subject of the mucus fern phenomenon, might be misleading. The authors, referring to Ullery and Shabanah,l state, “they did not believe that arborization in the cervical mucus was an indication of progesterone deficiency.” It has always been argued by many obstetricians who took interest in the subject that some of their pregnant patients showed arborizations in their cervical smears at various stages of pregnancy and yet they were delivered normally at term. We were the first to draw attention to the significance of this type of arborization as that depicted in the authors’ Fig. 1, A-the atypical fern pattern.lm3 This pattern occurs in about 30 per cent of nonpregnant women in the progestational phase and in some pregnant women who are apparently normal. We were, and still are, of opinion that this is the pattern to be seen in cervical smears when there is a dual activity by both estrogens and progesterone reflected in the smear. The poorer the pattern of arborizations the more dominant will progesterone be, and the opposite also holds true. Based on these observations and other clinical data, we concluded (paragraph 3, page 239) that “the presence of a fern reaction in the cervical smear during pregnancy does not necessarily mean placental insufficiency.“l A cervical mucus smear which cxhibits plentiful mucoid material and abundant exfoliation denotes apparent progestational domi-
414
Correspondence
nanct:. Some of these smears will show, in addition, this pattern of poor arborization or atypical ferning. When this is the case, the patient is in no danger of progesterone deficiency. But when the proportion of ferning increases and continues to do so, placental insufficiency becoming irrrversible, the mucoid material and exfoliation inevitably diminish, and the picture becomes that of clear heavy ferns, as depicted in Fig. 7 of out article (page 238) .I The authors’ statement ,Iparagraph la page 86’2) that “All patients who repeatedly rhowed heavy arborizations of the cervical mucus were treated with progesteronr.” ~tc., speaks for itself as simply a confirmation of our findings and is basically similar to our statement. In thp authors’ series of 200 patients, 6.5 per cent had abortions. a similar finding to our 6.6 per cent.’ The fact that the other patients who did not have abortions showed unusual symptoms which vanished with reversal of the cervical mucus findings is not a unique experience. If the authors would revise the smears taken from these patients, using the index-of-refraction liquids-a test for the detection of electrolyte imbalance adopted to clinical usage by myself*---they will find that there was an imbalance between sodium and potassium chloride, the latter being in escess of the normal. .4 good, reliable nontoxic diuretic would have rclie\red thesr patients of their symptoms without c-hanging the ferning reaction quantitatively but only qualitatively. It is less expensive and rnor(’ convenient and is easy to handle.
all pregnant patients show arborization in vary ing amounts in all stages of pregnancy”; (B> “The prcsenre of arborization does not necessarily mean placental insufficiency.” We believe these statements are misleading. We recognize the difference between ‘typical” arid ‘“atypical” arborization. Our studies2 have indicated that the positive smear may, at certain arcas of pregnancy, be so common as to be conxidered normal, but is not more common than 11.6 per cent. This we found to be true in 200 1~3tients with over 2,000 carefully studied and .mnoted slides, and is uow true of more than 500 patients wirh over 5,000 smears. Our incidence of positive smears agrees morr closely with Zondek’s ~c+ss of 226 cases with an inq.idence of 12 per c-ent arborization in pregnancy. Wr will happily retract the statement that l)r. Shabanah dors not believe arborization of pregnant cervical mucus is an indication of progesterone deficiency. particularly so if this will impress upon the minds of the readers that. such a condition may exist. The aforernentioned article” was offered to cbrnphasize thr importance of c.ervical mucus studies in pregnancy 1.0 the average obstetrician. No one can at. present determine which patient \\,ill continue IO show arborization and which will progress to an irreversible deficiency. For thrsfs reasons we emphasize, with Dr. Shabanah, that a repeatedly positive cervical mucus must br reverted by treatment with progesterone to .i negative smear REFERENCES
REFERENCES
1. Ullery, J. C., and Shabanah, E. H.: Obst. & Gynec. 10: 233, 1957. 2. Davis, M. E., and Abou-Shabanah, E. H.: Fertil. & Steril. 9: 344, 1958. 3. Ullery, J. C., Livingston, N., and AbouShabanah, E. H.: Obst. & Gynec. Surv. 14: 1, 1959. 4. Abou-Shabanah, E. H., Boutselis, J. G., Frajola, W. J., and Ullery, J. C.: .4111. J. OBST. & GYNEC. 76: 1248, 1958. E. H. Shabanah,
To
the
by Drs. Schwalenberg
R. R. Schwalenberg, T. D. E/station. M.D, Tifiin, Ohio November,
M.D.
1959
M.D.
1002 Central Ave. Saskatoon, Saskatchewan Oct. 15, 1959
Reply
1. Ullery, J. C., and Shabanah, E. H.: Obst. & Gynec. 10: 233, 1957. 2. Schwalenberg, R. R., and Efstation, T. D.: AM. J. OBST. & GYNEC. 78: 860, 1959. 3. Zondek, B., Forman, I., and Cooper, K. L.: Fertil. PC Steril. 6: 523. 1955.
Index-of-refraction
liquids
7’0 thP Editarc:
and
Efstation
Editors:
Dr. Shabanah states in his original article’ in a study of 95 cases: (A] “Thirty per cent of
The article entitled “The Nasal Mucus Smear in Toxemias of Pregnancy,” which appeared in thft December, 1958, issue of the JOURNAL (page I 2481. describes a simple procedure for the drtcction of rlectrolyte imbalance.