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Two methods of natural family planning
Volume Number
136 5
symptom. In the ovulation method, proper understanding and teaching of the peak symptom are essential to the measurement of its effectiveness. Striking by its absence from the “interim report” is any discussion of the quality control procedures which were utilized to guarantee a high-quality educational service to the people entered into the study. While the authors claim that the methods were taught by “professional” teachers, such teachers were defined as “women who previously used the method and/or had formalized training in teaching the method.” Simple use of either of the methods certainly does not qualify an individual to be a teacher in natural family planning. For those who had “formalized training,” such training should have been outlined since no judgment on the effectiveness of the teaching can be made and such is essential to a proper analysis of the results. Finally, while the study claims to be a “use-effectiveness” study it is much more of a modified version of extended use-effectiveness. No objective definition of “user failure” is provided. One cannot ascertain how many pregnancies were related to poor teaching, nor can one tell how many pregnancies occurred as the result of the couples’ last-minute exercise of their freedom to choose to use their fertility. The use-effectiveness of the two methods under study as methods to achieve a pregnancy has been ignored. In doing so, the investigators have ignored use-effectiveness reality. Thomas W. Hilgers, M.D. Department of Obstetrics and Gynecology Creighton Uniuersity School of Medicine 601 North 30th Street Suite 4810 Omaha, Nebraska 68131
Reply to Dr. Hilgers To the Editors: The use of the term “maximal mucus secretion” was employed as a descriptive phrase to assist readers unfamiliar with the “ovulation method” terminology. Our volunteers were indeed taught that the peak symptom was the last day of clear, stretchy, lubricative mucus, without regard to the quantity of the mucus. In answer to Dr. Hilgers’ criticism of quality control of teacher education, it should be noted that there was no published or universally accepted methodology for teaching the “ovulation method” prior to the beginning of our study. All teachers had formalized group and individual training sessions. Our teaching criteria were developed from prior teacher experience, on-site consultation, and training conferences with several nationally as well as internationally known authorities on the “ovulation method,” including Drs. John and Lynn Billings. From the inception of this study, the Human Life Foundation representatives were involved in de-
Correspondence
697
veloping the teaching methodology. Periodically they observed and reviewed the teacher training, as well as individual volunteer instruction. Dr. Hilgers‘ personal visit to the study center was as an invited consultant. His suggestions led to a reappraisal of some aspects of the methodology. It is pertinent to note, however, that the pregnancy rate of the “ovulation method” volunteers remained unchanged after the implementation of these changes. It is true that the study protocol was not designed to investigate the use of natural family planning to achieve pregnancy. Therefore, couples expressing a desire to conceive were excluded from the project. After being enrolled in training or in the study, those couples who stated that they had changed their desire and would attempt pregnancy were terminated from the study. If a pregnancy occurred before the study personnel were notified, these pregnancies were then recorded as user failures. We found that it was extremely difficult, if not impossible, to establish whether an unplanned pregnancy occurred as a result of teaching, the ability of a volunteer to properly interpret mucus symptoms in a specific cycle, or a combination of both. Dr. Hilgers had the opportunity of questioning six volunteer couples who had experienced unplanned pregnancies. We questioned the reliability of his techniques in determining the objective and subjective circumstances surrounding the unplanned pregnancies in these “ovulation method” users. We have appreciated the constructive criticism and positive suggestions, but we feel the record should be set straight on the above-discussed matters. Maclyn E. Wade, M.D. Phyllis McCarthy, Ph.D. George S. Harris, M.D. Hal C. Danzer, M.D. Cedars-Sinai Medical Center 8700 Beverly Boulevard Los Angeles, California 90048
Two methods of natural family planning To the Editors: I would like to comment on “A randomized prospective study of the use-effectiveness of two methods of natural family planning: An interim report,” by Wade and associates, published in THE JOURNAL (134:628, 1979). My comments are directed particularly to the voluntary withdrawal rate, which was significantly higher for the ovulation method than the symptothermal method. In my view there were two errors in the minds of those who conceived this trial: (1) The ovulation method was tested as a contraceptive, which it is not; (2) there was attachment to the idea, supported neither by
696
March 1. 1980 Am. J. Obster. Gynecol.
Correspondence
logic nor by practical experience, that the combination of two or more methods of avoiding pregnancy will always give better results than the use of one method alone. Approximately 25%, of the couples recruited into the trial were unmarried. It is a matter of common experience that among unmarried couples who have a sexual relationship there will be a significant number whose partnership lacks a total commitment to each other and will be maintained only if coitus occurs frequently. NO natural family planning method preserves that kind of relationship, although the attempted application may transform it into something better. The choice to be made is not between different contraceptives but between contraception and abstiwence during the fertile phase. Abstinence will elevate communication above a genital level. 1t is reliably reported that a number of those persons engaged in the recruitment for this trial encouraged the couple to use barrier methods of contraception, at least during what they called “the learning phase.” The biological e1ements of the ovulation method are such that in the preovulatory phase of the cycle successive days are not used for coitus lest there be confusion by seminal fluid and vaginal transudates. Once the oculatory mucus pattern has commenced there must again be avoidance of genital contact until the fourth day after the peak symptom; competent teachers always make this teaching explicit. From the time the couples came under instruction they had to choose whether to give up barrier contraception in order to learn, properly or not. the ovulation method. The symptothermal variant which was taught to the other group was essentially temperature-rhythm, which does not include the same biological exigency for abstinence during the fertile phase. The temperature-rhythm teachers may have pointed out that abstinence during the fertile phase will ensure the avoidance of pregnancy whereas coitus with the use of barrier methods of contraception will not, but if any other advice were given against contraception it would have been based on moral and not biological grounds. All trials are able to teach us something, and it is the lessons to which I have drawn attention that should be thoroughly assimilated as the results of this study are assessed. J, J. Billings, M.D. 86 Wellington Parade East Melbourne, 3002, Australia
Rqqy to Dr. fwMngs To the Editors: This study was designed to compare the use-effcctiveness of two methods of natural family planning. The primary objective has always been to determine how effective each was in avoiding pregnancy. Unmarried couples with a stable “sexual relationship” were included as a matter of practical reality of the population studied in Southern California. Their commitment was an important area of our study. lnterestingly enough, our final report shows that the pregnancy rate and the volunteer dropout rate in married and unmarried couples were very similar. We are annoyed by the references of the critics of this study to the alleged recommended use of barrier methods and spermatocides by the volunteer couples. both in training and in the study. This is a fallacy. All volunteers were recruited with the explicit promise that no other methods except the natural family planning method randomly assigned to them would be used, both in training and in the study. During recruitment, potential volunteers were advised of the Food and Drug Administration warning of possible teratogenicity in fetuses of women who conceived immediately after stopping oral contraceptives. The use of any method of avoiding pregnancy for this reason or other reasons prior to training was left to individual discretion. However, according to the study protocol, these specific women could not start training until experiencing at least one spontaneous menses. Once training began, the volunteer had to follow all of the guidelines of the protocol. We should like to emphasize that the variant of the symptothermal method utilized in our study clearly included close observation of the changes in the mucus symptoms. Mac@ E. Wade, M.D. Mary Phyllis McCarthy Ph.D. George S. Hams, M.D. Hal C. Danzu, M.D. Cedars-Sinai Medical Center 8700 Beverly Boulevard Los Angeles, Calfomia 90048
136 5
symptom. In the ovulation method, proper understanding and teaching of the peak symptom are essential to the measurement of its effectiveness. Striking by its absence from the “interim report” is any discussion of the quality control procedures which were utilized to guarantee a high-quality educational service to the people entered into the study. While the authors claim that the methods were taught by “professional” teachers, such teachers were defined as “women who previously used the method and/or had formalized training in teaching the method.” Simple use of either of the methods certainly does not qualify an individual to be a teacher in natural family planning. For those who had “formalized training,” such training should have been outlined since no judgment on the effectiveness of the teaching can be made and such is essential to a proper analysis of the results. Finally, while the study claims to be a “use-effectiveness” study it is much more of a modified version of extended use-effectiveness. No objective definition of “user failure” is provided. One cannot ascertain how many pregnancies were related to poor teaching, nor can one tell how many pregnancies occurred as the result of the couples’ last-minute exercise of their freedom to choose to use their fertility. The use-effectiveness of the two methods under study as methods to achieve a pregnancy has been ignored. In doing so, the investigators have ignored use-effectiveness reality. Thomas W. Hilgers, M.D. Department of Obstetrics and Gynecology Creighton Uniuersity School of Medicine 601 North 30th Street Suite 4810 Omaha, Nebraska 68131
Reply to Dr. Hilgers To the Editors: The use of the term “maximal mucus secretion” was employed as a descriptive phrase to assist readers unfamiliar with the “ovulation method” terminology. Our volunteers were indeed taught that the peak symptom was the last day of clear, stretchy, lubricative mucus, without regard to the quantity of the mucus. In answer to Dr. Hilgers’ criticism of quality control of teacher education, it should be noted that there was no published or universally accepted methodology for teaching the “ovulation method” prior to the beginning of our study. All teachers had formalized group and individual training sessions. Our teaching criteria were developed from prior teacher experience, on-site consultation, and training conferences with several nationally as well as internationally known authorities on the “ovulation method,” including Drs. John and Lynn Billings. From the inception of this study, the Human Life Foundation representatives were involved in de-
Correspondence
697
veloping the teaching methodology. Periodically they observed and reviewed the teacher training, as well as individual volunteer instruction. Dr. Hilgers‘ personal visit to the study center was as an invited consultant. His suggestions led to a reappraisal of some aspects of the methodology. It is pertinent to note, however, that the pregnancy rate of the “ovulation method” volunteers remained unchanged after the implementation of these changes. It is true that the study protocol was not designed to investigate the use of natural family planning to achieve pregnancy. Therefore, couples expressing a desire to conceive were excluded from the project. After being enrolled in training or in the study, those couples who stated that they had changed their desire and would attempt pregnancy were terminated from the study. If a pregnancy occurred before the study personnel were notified, these pregnancies were then recorded as user failures. We found that it was extremely difficult, if not impossible, to establish whether an unplanned pregnancy occurred as a result of teaching, the ability of a volunteer to properly interpret mucus symptoms in a specific cycle, or a combination of both. Dr. Hilgers had the opportunity of questioning six volunteer couples who had experienced unplanned pregnancies. We questioned the reliability of his techniques in determining the objective and subjective circumstances surrounding the unplanned pregnancies in these “ovulation method” users. We have appreciated the constructive criticism and positive suggestions, but we feel the record should be set straight on the above-discussed matters. Maclyn E. Wade, M.D. Phyllis McCarthy, Ph.D. George S. Harris, M.D. Hal C. Danzer, M.D. Cedars-Sinai Medical Center 8700 Beverly Boulevard Los Angeles, California 90048
Two methods of natural family planning To the Editors: I would like to comment on “A randomized prospective study of the use-effectiveness of two methods of natural family planning: An interim report,” by Wade and associates, published in THE JOURNAL (134:628, 1979). My comments are directed particularly to the voluntary withdrawal rate, which was significantly higher for the ovulation method than the symptothermal method. In my view there were two errors in the minds of those who conceived this trial: (1) The ovulation method was tested as a contraceptive, which it is not; (2) there was attachment to the idea, supported neither by
696
March 1. 1980 Am. J. Obster. Gynecol.
Correspondence
logic nor by practical experience, that the combination of two or more methods of avoiding pregnancy will always give better results than the use of one method alone. Approximately 25%, of the couples recruited into the trial were unmarried. It is a matter of common experience that among unmarried couples who have a sexual relationship there will be a significant number whose partnership lacks a total commitment to each other and will be maintained only if coitus occurs frequently. NO natural family planning method preserves that kind of relationship, although the attempted application may transform it into something better. The choice to be made is not between different contraceptives but between contraception and abstiwence during the fertile phase. Abstinence will elevate communication above a genital level. 1t is reliably reported that a number of those persons engaged in the recruitment for this trial encouraged the couple to use barrier methods of contraception, at least during what they called “the learning phase.” The biological e1ements of the ovulation method are such that in the preovulatory phase of the cycle successive days are not used for coitus lest there be confusion by seminal fluid and vaginal transudates. Once the oculatory mucus pattern has commenced there must again be avoidance of genital contact until the fourth day after the peak symptom; competent teachers always make this teaching explicit. From the time the couples came under instruction they had to choose whether to give up barrier contraception in order to learn, properly or not. the ovulation method. The symptothermal variant which was taught to the other group was essentially temperature-rhythm, which does not include the same biological exigency for abstinence during the fertile phase. The temperature-rhythm teachers may have pointed out that abstinence during the fertile phase will ensure the avoidance of pregnancy whereas coitus with the use of barrier methods of contraception will not, but if any other advice were given against contraception it would have been based on moral and not biological grounds. All trials are able to teach us something, and it is the lessons to which I have drawn attention that should be thoroughly assimilated as the results of this study are assessed. J, J. Billings, M.D. 86 Wellington Parade East Melbourne, 3002, Australia
Rqqy to Dr. fwMngs To the Editors: This study was designed to compare the use-effcctiveness of two methods of natural family planning. The primary objective has always been to determine how effective each was in avoiding pregnancy. Unmarried couples with a stable “sexual relationship” were included as a matter of practical reality of the population studied in Southern California. Their commitment was an important area of our study. lnterestingly enough, our final report shows that the pregnancy rate and the volunteer dropout rate in married and unmarried couples were very similar. We are annoyed by the references of the critics of this study to the alleged recommended use of barrier methods and spermatocides by the volunteer couples. both in training and in the study. This is a fallacy. All volunteers were recruited with the explicit promise that no other methods except the natural family planning method randomly assigned to them would be used, both in training and in the study. During recruitment, potential volunteers were advised of the Food and Drug Administration warning of possible teratogenicity in fetuses of women who conceived immediately after stopping oral contraceptives. The use of any method of avoiding pregnancy for this reason or other reasons prior to training was left to individual discretion. However, according to the study protocol, these specific women could not start training until experiencing at least one spontaneous menses. Once training began, the volunteer had to follow all of the guidelines of the protocol. We should like to emphasize that the variant of the symptothermal method utilized in our study clearly included close observation of the changes in the mucus symptoms. Mac@ E. Wade, M.D. Mary Phyllis McCarthy Ph.D. George S. Hams, M.D. Hal C. Danzu, M.D. Cedars-Sinai Medical Center 8700 Beverly Boulevard Los Angeles, Calfomia 90048