Comment
laparoscopic and open resection except for patients with stage III disease, who, in Lacy’s study, had improved survival for unknown reasons. This long-term endpoint was not reported in CLASICC, but it will be important to see whether CLASICC’s results support those of the COST and Lacy trials. Until recently, because of the concerns about oncological effects, surgeons have agreed to offer laparoscopic colon resection in colorectal cancer only to patients enrolled in a clinical trial. CLASICC, with the COST1 and Lacy12 trials, shows that patients with colorectal cancer can be offered laparoscopic-assisted resection. These studies provide data supporting the safety of laparoscopic colectomy for colorectal cancer for complications and survival, while offering moderate advantages in terms of recovery. It is important that the surgeons are well trained both in advanced laparoscopic techniques and in oncological surgical principles. Preoperative work-up should focus on identifying patients who are at high risk for conversion. Because of the increased operative times, length of stay, and complications seen in these patients, serious thought should be given to doing the operation in an open fashion. In appropriately selected patients who are operated on by experienced surgeons, laparoscopic surgery for colorectal cancer may be the new gold standard.
Myriam J Curet Minimally Invasive Surgery Program, Department of Surgery, Stanford University, Stanford, CA 94305, USA
[email protected] I declare that I have no conflict of interest. 1 2 3 4 5
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COST. A comparison of laparoscopically assisted and open colectomy for colon cancer. N Engl J Med 2004; 350: 2050–59. Curet MJ. Port site metastases: a review. Am J Surg 2004; 187: 705–12. Berends FJ, Kazemier G, Bonjer HJ, Lange JF. Subcutaneous metastases after laparoscopic colectomy. Lancet 1994; 344: 58. Kieran JA, Curet MJ. Laparoscopic colon resection for colon cancer. J Surg Res 2004; 117: 79–91. Stage JG, Schulze S, Moller P, et al. Prospective randomized study of laparoscopic versus open colonic resection for adenocarcinoma. Br J Surg 1997; 84: 391–96. Milsom JW, Böhm B, Hammerhofer KA, et al. A prospective, randomized trial comparing laparoscopic versus conventional techniques in colorectal cancer surgery: a preliminary report. J Am Coll Surg 1998; 187: 46–54. Hasegawa H, Kabeshima Y, Watanabe M, et al. Randomized controlled trial of laparoscopic versus open colectomy for advanced colorectal cancer. Surg Endosc 2003; 17: 636–40. Lezoche E, Feliciotti F, Paganini AM, et al. Laparoscopic vs open hemicolectomy for colon cancer. Surg Endosc 2002; 16: 596–602. Franklin ME, Rosenthal D, Abrego-Medina D, et al. Prospective comparison of open vs. laparoscopic colon surgery for carcinoma: five-year results. Dis Colon Rectum 1996; 39 (suppl): S35–46. The COLOR Study Group. COLOR: a randomized clinical trial comparing laparoscopic and open resection for colon cancer. Dig Surg 2000; 17: 617–22. Hazebroek EJ, COLOR Study Group. COLOR: a randomized clinical trial comparing laparoscopic and open resection for colon cancer. Surg Endosc 2002; 16: 949–53. Lacy AM, García-Valdecasas JC, Delgado S, et al. Laparoscopy-assisted colectomy versus open colectomy for treatment of non-metastatic colon cancer: a randomized trial. Lancet 2002; 359: 2224–29. Weeks JC, Nelson H, Gelber S, for the Clinical Outcomes of Surgical Therapy (COST) Study Group. Short-term quality-of-life outcomes following laparoscopic-assisted colectomy vs open colectomy for colon cancer: a randomized trial. JAMA 2002; 287: 321–28.
Enhanced access to emergency contraception See Comment page 1670 See World Report page 1677
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Despite its undisputed safety and efficacy, enhancing women’s access to emergency contraception has been controversial.1,2 Some of this controversy is related to the anomalous position of emergency contraception in the family-planning repertoire: anomalous because it is used after sex.3 At the same time, some developments in emergency contraception, aimed at combating teenage and unwanted pregnancy, have been reported in particularly lurid terms by the mass media, conflating concerns about sexual morality, inappropriate use of contraception, and the spread of sexually transmitted infections.2 Against this background, it is interesting to note the findings from a recent study providing evidence of the broader effects of emergency contraception on key public-health issues.4 Tina Raine and colleagues4 randomly assigned 2117 young women
aged 15–24 years to either pharmacy access to emergency contraception without a prescription, advance provision of emergency contraception, or usual care (requiring a visit to a clinic). Over the 6-month follow-up, the authors report that women in the advance provision group were almost twice as likely to use emergency contraception (37·4%) than those who had pharmacy access (24·2%) or usual care (21%). Interestingly, pregnancy rates and rates of new sexually transmitted infections were similar in all the groups. Furthermore, easier access to emergency contraception did not appear to affect regular contraceptive use or risky sexual behaviours. Like Litt,5 we believe this is important new evidence. Data from a recent study in Scotland reached similar conclusions.6 In that study, women aged 16–29 years www.thelancet.com Vol 365 May 14, 2005
Comment
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were provided with five courses of emergency contraception to keep at home (advance supply), which they obtained when accessing general practices, familyplanning clinics, or accident and emergency departments. The study concluded that advance supply was viewed positively by women and that concerns about repeated use of emergency contraception, as well as links between easier access to such contraception and risky sex or changed contraceptive behaviours, appear to be unfounded. Clearly, both studies should reassure those worried about these issues. On the other hand, the authors of the Scottish study6 reported no decrease in abortion rates (the stated aim of the project). They suggest that one of the reasons for no decrease was that the project “deepened rather than widened access to emergency contraception, that is advance supplies did not reach those most at risk of unwanted pregnancy’’. We believe this point to be a central issue and urgently needs to be addressed in subsequent research. Our concern is that in concentrating on links between easier access to emergency contraception and contraceptive behaviours or sexually transmitted infections (although clearly important), researchers may have overlooked the need to address www.thelancet.com Vol 365 May 14, 2005
whether the current configuration of emergency contraception services are appropriate for all women. As Litt5 points out, we know that younger women are at highest risk of unprotected intercourse and unwanted pregnancy. In the UK, research into teenage and unwanted pregnancies has focused on women from lower socioeconomic groups and identified a disparity in conception rates by socioeconomic status.7 Research needs to explore whether new routes of supply (both pharmacy-supplied emergency contraception and that provided in advance) meet the needs of younger women and those from lower socioeconomic groups. From our research in Greater Manchester, UK, free supplies of emergency contraception distributed through community pharmacies were mainly sought by women aged over 20, and the perception of participating pharmacists was that use was mainly confined to women from higher socioeconomic groups.8,9 How do younger women and women from lower socioeconomic groups perceive emergency contraception and what role does this method play in their contraceptive repertoires? To what extent is advanced provision (via various routes) appropriate to women from these groups? Ziebland et al6 make the point that women in their study of advance provision viewed not having to undergo the embarrassment of seeking emergency contraception from a health professional as a positive development. However, women clearly have to access a health professional in the first place to obtain advance supplies. To what extent does having to contact a health professional deter younger women and those from lower socioeconomic groups from seeking emergency contraception? Understanding these issues might shed important light on the appropriateness of services and their use by those most at risk of unwanted pregnancy. Of course, in researching these issues, we might obtain data that raise concerns about the state of a nation’s sexual morality. However, if we are to address the important public-health issues that are stake, we will need to do so. Returning to the issues we began with, as the chair of the Independent Advisory Group for Sexual Health and HIV in England remarked: ‘’Some believe sexual health issues to be a kind of Pandora’s box of sins unleashed on a permissive society. It’s time to de-stigmatise sexual health and properly deal with what is and will continue to be a very real consideration for public health.’’10 1669
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*Paul Bissell, Claire Anderson Centre for Pharmacy, Health and Society, School of Pharmacy, University of Nottingham, Nottingham NG7 2RD, UK
[email protected] We declare that we have no conflict of interest. 1 2 3 4
Stammers T. Emergency contraception from pharmacists misses opportunity. BMJ 2001; 322: 1245. Marsh B, Finney S. Morning after pill fuels the epidemic of sexual diseases. Daily Mail Oct 18, 2003. Ziebland S. Emergency contraception: an anomalous position in the family planning repertoire? Soc Sci Med 1999; 49: 1409–17. Raine TR, Harper CC, Rocca CH, et al. Direct access to emergency contraception through pharmacies and effect on unintended pregnancy and STIs: a randomised controlled trial. JAMA 2005; 293: 54–62.
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Litt IF. Placing emergency contraception in the hands of women. JAMA 2005; 293: 98–99. Ziebland S, Wyke S, Seaman P, et al. What happened when Scottish women were given advance supplies of emergency contraception? A survey and qualitative study of women’s views and experiences. Soc Sci Med 2005; 60: 1767–79. McLeod A. Changing patterns of teenage pregnancy: population based study of small areas. BMJ 2001; 323: 199–203. Bissell P, Anderson C. Supplying emergency contraception via community pharmacies in the UK: reflections on the experiences of users and providers. Soc Sci Med 2003; 57: 428–33. Anderson C, Bissell P, Sahram S, Sharma R. Manchester, Salford and Trafford Health Action Zone: report into the provision of emergency hormonal contraception by community pharmacies via patient group directions. Nottingham, University of Nottingham, 2001. Independent Advisory Group For Sexual Health and HIV. Annual report 2003/2004. London: Department of Health, 2004.
Missed contraceptive pills and the critical pill-free interval See Comment page 1668
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The UK Faculty of Family Planning and Reproductive Health Care has just issued new guidance on what to advise when combined oral contraceptive pills are missed.1 This new guidance is part of a continuing series produced by the Faculty’s Clinical Effectiveness Unit and is based on WHO publications. These publications include Medical Eligibility Criteria for Contraceptive Use and Selected Practice Recommendations for Contraceptive Use.2,3 The WHO recommendations were produced by an expert working group who reviewed all available evidence. The Clinical Effectiveness Unit has adapted them for practice in a developed country, in this case the UK. Health professionals have generally welcomed these clear and simplified messages,2,3 as a means of ensuring uniformity and quality in contraceptive provision. It must be remembered, however, that the initial WHO recommendations were developed to improve and extend contraceptive provision in developing countries, where maternal and perinatal mortality and morbidity are high and the balance of contraceptive risk might be quite different.4 Reducing unplanned pregnancies is also important in affluent countries, but the Clinical Effectiveness Unit has followed WHO guidance in relaxing some of the more cautious rules, resulting in a potential increased risk of pregnancy for a small number of women. Has the Unit gone too far this time? The new recommendations for missed contraceptive pills aim to simplify the previous rules that were overcautious in their advice about use of back-up contraception, such as condoms, for much of the contraceptive pill cycle.5 The previous rules were also
confusing, contradictory, and fairly complex for some women. What do the new recommendations say? There are several consensus principles agreed by the authors (panel).1 All health professionals will concur with the statements that pill dose does indeed matter, cycle regimen is important, and the key to oral contraceptive success hinges on the pill-free interval. So why is there controversy with these new rules that state no back-up contraception or emergency contraception is required until three or more 30–35 g ethinyloestradiol pills have been forgotten or two or more 20 g or less ethinyloestradiol pills? And what about triphasic regimens? Women often report that they are taking a mini or low-dose contraceptive pill but are unsure if it contains oestrogen and rarely know the amount of Panel: Clinical Effectiveness Unit consensus principles about missed contraceptive pills1 It is important to take an active (hormonal) pill as soon as possible when pills have been missed. If pills are missed, the chance that pregnancy will occur depends not only on how many pills were missed but also when the pills were missed. Evidence for recommendations about missed pills is mainly derived from studies of women using 30–35 g ethinyloestradiol pills. Limited evidence on 20 g ethinyloestradiol pills suggests there could be a higher risk of pregnancy when missing such pills than when missing 30–35 g pills. A more cautious approach is recommended after missing 20 g ethinyloestradiol pills. Field experience highlights the need for simple guidelines about missed pills.
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