- Email: [email protected]
Facing the facts on advance provision of emergency contraception
Contraception 82 (2010) 579 – 582
Letters to the Editor
Finding the right face for advanced provision of emergency contraception To the Editor: We appreciate the comments from Polis et al. with regard to the controversy surrounding advanced supply of emergency contraception (EC) use, and the part our article [1] plays in the current body of literature. It appears that our interpretation of the state of the evidence is similar, however different our opinions are about future research directions. Polis et al. state that our interpretation that the lack of statistical significance regarding the difference in the pregnancy rates in the two arms of our trial may be due to small sample size is â overly optimistic particularly in light of the relatively low use of EC in this study.â We submit that the use of EC in our study was relatively high (40%), especially when compared to the rates of EC use in the author's Cochrane review on advanced supply of EC [2], and we maintain that since our study was designed primarily as a feasibility study without a large enough sample size to prove a difference in pregnancy rates, the relative risk of pregnancy of 0.57 in the intervention arm certainly suggests a trend towards efficacy, but of course is not definitive. Despite the disappointing effectiveness data of advance supply of EC on a population- based level, we know that levonorgestrel is biologically efficacious, and we know that its use as a postcoital contraceptive is time-sensitive [3,4]. It is therefore important to identify subgroups of the population for whom advanced supply may be of value, especially when these are the very populations for whom proactive contracepting has proven particularly challenging, and who do not have access to over-the-counter EC. The highly vulnerable population of postpartum teens still could benefit from advancing the cause of advanced supply of EC. Courtney A. Schreiber Obstetrics and Gynecology University of Pennsylvania School of Medicine Philadelphia, PA 19104, USA E-mail address: [email protected] 0010-7824/$ – see front matter © 2010 Elsevier Inc. All rights reserved.
Sarah Ratcliffe Center for Clinical Epidemiology and Biostatistics University of Pennsylvania School of Medicine Philadelphia, PA 19104, USA Kurt T. Barnhart Obstetrics and Gynecology Center for Clinical Epidemiology and Biostatistics University of Pennsylvania School of Medicine Philadelphia, PA 19104, USA doi:10.1016/j.contraception.2010.04.014 References [1] Schreiber CA, Ratcliffe SJ, Barnhart KT. A randomized controlled trial of the effect of advanced supply of emergency contraception in postpartum teens: a feasibility study. Contraception 2010;81:435–40. [2] Polis CB, Schaffer K, Blanchard K, Glasier A, Harper CC, Grimes DA. Advance provision of emergency contraception for pregnancy prevention. (full review)Cochrane Database Syst Rev 2007(2):CD005497. [3] Arowojolu AO, Okewole LA, Adekunle AO. Comparative evaluation of the effectiveness and safety of two regimens of levonorgestrel for emergency contraception in Nigerians. Contraception 2002;66:269–73. [4] Task Force on Postovulatory Methods of Fertility Regulation. Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception. Lancet 1998;352:428–33.
Facing the facts on advance provision of emergency contraception To the Editor: For over a decade, studies have assessed the effect of advance provision of emergency contraception (EC) on pregnancy rates. This research has shown uniformly disappointing results. A Cochrane review of 11 randomized trials updated in 2010 [1] found no evidence of reduced pregnancy rates due to advance provision of EC, either in individual trials or in a meta-analysis of the pooled data of over 7000 women. A systematic literature review which also included observational studies reached the same conclusion [2].
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Letters to the Editor / Contraception 82 (2010) 579–582
A small randomized controlled trial (n=50) recently reported by Schreiber et al. [3] provides no evidence to the contrary. The authors interpret a relative risk of 0.57 to suggest that advance provision “halved the risk of pregnancy” in postpartum adolescents, stating that the lack of statistical significance (p=.23) is “because of the small sample size.” However, this interpretation seems overly optimistic, particularly in light of the relatively low use of EC in this study, as well as the consistent lack of benefit of advance EC provision in all prior studies, including a trial of teen mothers [4], and three other trials in adolescents [5–7]. We wholeheartedly support the provision of EC to individual women who will use it. However, at this point, we submit that the family planning community must accept the unwelcome conclusion that as a public health measure, advance EC provision alone will not likely result in a measurable population-level benefit. Additional trials of this issue are unlikely to be useful. We need to spend our limited valuable resources on more promising approaches for using EC to reduce unintended pregnancy rates. Chelsea B. Polis Johns Hopkins Bloomberg School of Public Health 615 North Wolfe Street, Baltimore, MD 21205, USA E-mail address: [email protected] Elizabeth G. Raymond Family Health International Research Triangle Park, NC 27709, USA James Trussell Princeton University Office of Population Research Princeton, NJ 08540, USA doi:10.1016/j.contraception.2010.04.015 References [1] Polis CB, Grimes DA, Schaffer K, Blanchard K, Glasier A, Harper CC. Advance provision of emergency contraception for pregnancy prevention. Cochrane Database of Systematic Reviews 2007, Issue 2. Art. No.: CD005497. DOI: 10.1002/14651858.CD005497.pub2. [2] Raymond EG, Trussell J, Polis CB. Population effect of increased access to emergency contraceptive pills: a systematic review. Obstet Gynecol 2007;109:181–8. [3] Schreiber CA, Ratcliffe SJ, Barnhart KT. A randomized controlled trial of the effect of advanced supply of emergency contraception in postpartum teens: a feasibility study. Contraception 2010;81(5):435–40. [4] Belzer M, Sanchez K, Olson J, Jacobs AM, Tucker D. Advance supply of emergency contraception: a randomized trial in adolescent mothers. J Pediatr Adolesc Gynecol 2005;18:347–54. [5] Raine TR, Harper CC, Rocca CH, Fischer R, et al. Direct access to emergency contraception through pharmacies and effect on unintended pregnancy and STIs: a randomized controlled trial. JAMA 2005;293:54–62. [6] Raymond EG, Stewart F, Weaver M, Monteith C, Van Der PB. Impact of increased access to emergency contraceptive pills: a randomized controlled trial. Obstet Gynecol 2006;108:1098–106.
[7] Gold MA, Wolford JE, Smith KA, Parker AM. The effects of advance provision of emergency contraception on adolescent women's sexual and contraceptive behaviors. J Pediatr Adolesc Gynecol 2004; 17:87–96.
Letter to the Editor To the Editor: We would like to thank Dr. Wiebe for her interesting comments on our article “The EVAPIL scale” recently published in this journal [1]. Dr. Wiebe suggests that the sexual question in EVAPIL does not capture the relevant characteristics of sexual side effects arguing that a question focusing on sexual desire would be more relevant than a question evaluating “enjoyment during intercourse,” which involves the quality in the relationship more than adverse effects of hormonal contraception. We agree with this remark. During the EVAPIL scale building process, sexual side effects were firstly evaluated by two separate questions regarding sexual desire and sexual pleasure. However, validation steps conducted in a population of oral contraception users demonstrated that there was a very strong correlation (r=0.92, pb.0001) between the answers obtained to these two questions and that the difference between desire and pleasure was not evident for most women. In order to limit the number of questions and not to oversize the weight of the sexual side effects, we decided to delete the question on sexual desire and to maintain the only question on sexual pleasure which clearly included information on sexual desire, at least for our sample of French women. In addition, the EVAPIL scale was written and validated in French, and the English translation of this question might have been confusing. The literal translation of the French term is: Since I have been taking the pill: x I have not had a partner 0 I have the same degree of sexual pleasure than before 1 I have a lesser degree of sexual pleasure than before 2 I rarely experience sexual pleasure 3 I never experience sexual pleasure It is possible that further validation processes in other languages than French will demonstrate the importance of the distinction between sexual desire and sexual pleasure as suggested by Dr. Wiebe. Olivier Graesslin Centre Hospitalier Universitaire Institut Mère Enfant Alix de Champagne Service de Gynécologie-Obstétrique 45 rue Cognacq-Jay F-51092 Reims, France E-mail address: [email protected]
Letters to the Editor
Finding the right face for advanced provision of emergency contraception To the Editor: We appreciate the comments from Polis et al. with regard to the controversy surrounding advanced supply of emergency contraception (EC) use, and the part our article [1] plays in the current body of literature. It appears that our interpretation of the state of the evidence is similar, however different our opinions are about future research directions. Polis et al. state that our interpretation that the lack of statistical significance regarding the difference in the pregnancy rates in the two arms of our trial may be due to small sample size is â overly optimistic particularly in light of the relatively low use of EC in this study.â We submit that the use of EC in our study was relatively high (40%), especially when compared to the rates of EC use in the author's Cochrane review on advanced supply of EC [2], and we maintain that since our study was designed primarily as a feasibility study without a large enough sample size to prove a difference in pregnancy rates, the relative risk of pregnancy of 0.57 in the intervention arm certainly suggests a trend towards efficacy, but of course is not definitive. Despite the disappointing effectiveness data of advance supply of EC on a population- based level, we know that levonorgestrel is biologically efficacious, and we know that its use as a postcoital contraceptive is time-sensitive [3,4]. It is therefore important to identify subgroups of the population for whom advanced supply may be of value, especially when these are the very populations for whom proactive contracepting has proven particularly challenging, and who do not have access to over-the-counter EC. The highly vulnerable population of postpartum teens still could benefit from advancing the cause of advanced supply of EC. Courtney A. Schreiber Obstetrics and Gynecology University of Pennsylvania School of Medicine Philadelphia, PA 19104, USA E-mail address: [email protected] 0010-7824/$ – see front matter © 2010 Elsevier Inc. All rights reserved.
Sarah Ratcliffe Center for Clinical Epidemiology and Biostatistics University of Pennsylvania School of Medicine Philadelphia, PA 19104, USA Kurt T. Barnhart Obstetrics and Gynecology Center for Clinical Epidemiology and Biostatistics University of Pennsylvania School of Medicine Philadelphia, PA 19104, USA doi:10.1016/j.contraception.2010.04.014 References [1] Schreiber CA, Ratcliffe SJ, Barnhart KT. A randomized controlled trial of the effect of advanced supply of emergency contraception in postpartum teens: a feasibility study. Contraception 2010;81:435–40. [2] Polis CB, Schaffer K, Blanchard K, Glasier A, Harper CC, Grimes DA. Advance provision of emergency contraception for pregnancy prevention. (full review)Cochrane Database Syst Rev 2007(2):CD005497. [3] Arowojolu AO, Okewole LA, Adekunle AO. Comparative evaluation of the effectiveness and safety of two regimens of levonorgestrel for emergency contraception in Nigerians. Contraception 2002;66:269–73. [4] Task Force on Postovulatory Methods of Fertility Regulation. Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception. Lancet 1998;352:428–33.
Facing the facts on advance provision of emergency contraception To the Editor: For over a decade, studies have assessed the effect of advance provision of emergency contraception (EC) on pregnancy rates. This research has shown uniformly disappointing results. A Cochrane review of 11 randomized trials updated in 2010 [1] found no evidence of reduced pregnancy rates due to advance provision of EC, either in individual trials or in a meta-analysis of the pooled data of over 7000 women. A systematic literature review which also included observational studies reached the same conclusion [2].
580
Letters to the Editor / Contraception 82 (2010) 579–582
A small randomized controlled trial (n=50) recently reported by Schreiber et al. [3] provides no evidence to the contrary. The authors interpret a relative risk of 0.57 to suggest that advance provision “halved the risk of pregnancy” in postpartum adolescents, stating that the lack of statistical significance (p=.23) is “because of the small sample size.” However, this interpretation seems overly optimistic, particularly in light of the relatively low use of EC in this study, as well as the consistent lack of benefit of advance EC provision in all prior studies, including a trial of teen mothers [4], and three other trials in adolescents [5–7]. We wholeheartedly support the provision of EC to individual women who will use it. However, at this point, we submit that the family planning community must accept the unwelcome conclusion that as a public health measure, advance EC provision alone will not likely result in a measurable population-level benefit. Additional trials of this issue are unlikely to be useful. We need to spend our limited valuable resources on more promising approaches for using EC to reduce unintended pregnancy rates. Chelsea B. Polis Johns Hopkins Bloomberg School of Public Health 615 North Wolfe Street, Baltimore, MD 21205, USA E-mail address: [email protected] Elizabeth G. Raymond Family Health International Research Triangle Park, NC 27709, USA James Trussell Princeton University Office of Population Research Princeton, NJ 08540, USA doi:10.1016/j.contraception.2010.04.015 References [1] Polis CB, Grimes DA, Schaffer K, Blanchard K, Glasier A, Harper CC. Advance provision of emergency contraception for pregnancy prevention. Cochrane Database of Systematic Reviews 2007, Issue 2. Art. No.: CD005497. DOI: 10.1002/14651858.CD005497.pub2. [2] Raymond EG, Trussell J, Polis CB. Population effect of increased access to emergency contraceptive pills: a systematic review. Obstet Gynecol 2007;109:181–8. [3] Schreiber CA, Ratcliffe SJ, Barnhart KT. A randomized controlled trial of the effect of advanced supply of emergency contraception in postpartum teens: a feasibility study. Contraception 2010;81(5):435–40. [4] Belzer M, Sanchez K, Olson J, Jacobs AM, Tucker D. Advance supply of emergency contraception: a randomized trial in adolescent mothers. J Pediatr Adolesc Gynecol 2005;18:347–54. [5] Raine TR, Harper CC, Rocca CH, Fischer R, et al. Direct access to emergency contraception through pharmacies and effect on unintended pregnancy and STIs: a randomized controlled trial. JAMA 2005;293:54–62. [6] Raymond EG, Stewart F, Weaver M, Monteith C, Van Der PB. Impact of increased access to emergency contraceptive pills: a randomized controlled trial. Obstet Gynecol 2006;108:1098–106.
[7] Gold MA, Wolford JE, Smith KA, Parker AM. The effects of advance provision of emergency contraception on adolescent women's sexual and contraceptive behaviors. J Pediatr Adolesc Gynecol 2004; 17:87–96.
Letter to the Editor To the Editor: We would like to thank Dr. Wiebe for her interesting comments on our article “The EVAPIL scale” recently published in this journal [1]. Dr. Wiebe suggests that the sexual question in EVAPIL does not capture the relevant characteristics of sexual side effects arguing that a question focusing on sexual desire would be more relevant than a question evaluating “enjoyment during intercourse,” which involves the quality in the relationship more than adverse effects of hormonal contraception. We agree with this remark. During the EVAPIL scale building process, sexual side effects were firstly evaluated by two separate questions regarding sexual desire and sexual pleasure. However, validation steps conducted in a population of oral contraception users demonstrated that there was a very strong correlation (r=0.92, pb.0001) between the answers obtained to these two questions and that the difference between desire and pleasure was not evident for most women. In order to limit the number of questions and not to oversize the weight of the sexual side effects, we decided to delete the question on sexual desire and to maintain the only question on sexual pleasure which clearly included information on sexual desire, at least for our sample of French women. In addition, the EVAPIL scale was written and validated in French, and the English translation of this question might have been confusing. The literal translation of the French term is: Since I have been taking the pill: x I have not had a partner 0 I have the same degree of sexual pleasure than before 1 I have a lesser degree of sexual pleasure than before 2 I rarely experience sexual pleasure 3 I never experience sexual pleasure It is possible that further validation processes in other languages than French will demonstrate the importance of the distinction between sexual desire and sexual pleasure as suggested by Dr. Wiebe. Olivier Graesslin Centre Hospitalier Universitaire Institut Mère Enfant Alix de Champagne Service de Gynécologie-Obstétrique 45 rue Cognacq-Jay F-51092 Reims, France E-mail address: [email protected]