QS NEWSLETTER ARCHIVE -

Quinacrine Non-surgical Method of Voluntary Female Sterilization: Current News

QS NEWSLETTER ARCHIVE

Published in the Quinacrine Newsletter 2000
*Award to Developer of QS* Dr. Jaime Zipper was one of thirty-two honored by the 10th World Congress on Human Reproduction and the International Academy of Human Reproduction for their outstanding contributions to this field of Medicine. The congress was held at the Bahia Convention Center, Salvador, Bahia, Brazil, May 4-8, 1999. The following is the text from the Award Ceremony Program referring to Dr. Zipper. Jaime Zipper - Chile Jaime Zipper graduated in Medicine from the University of Chile in 1953. He received postgraduate training in Reproductive Physiology at the Worcester Foundation for experimental Biology in the United States from 1961 to 1962. He became Associate Professor of Physiology of the Department of Physiology and Biophysics, University of Chile in 1963 and became Full Professor of Physiology in 1971. Between 1967 and 1969, Professor Zipper was a Medical Officer in the World Health Organization's Human Reproduction Program in Geneva, Switzerland. Professor Zipper was the 1983 recipient of the Ernst Grafenberg Award, Münster, Germany. Professor Zipper is best known for his discovery of the action of copper on gametes and the subsequent use of copper to improve the contraceptive efficacy of intrauterine devices. Professor Zipper was also one of the leading figures in the development of quinacrine non-surgical female sterilization. Special Session on the Quinacrine Method at 10th World Congress on Human Reproduction Reports on Continuing Studies by Experts from South America 10th World Congress on Human Reproduction May 4-8, 1999 Salvador, Bahia, Brazil Special Session on Quinacrine Sterilization Chairperson Sally Epstein Presentations Quinacrine Sterilization: An Update Elton Kessel Department of Public Health and Preventive Medicine, Oregon Health Sciences University, Portland, Oregon, USA Quinacrine sterilization: Toxicological issues Gianni Pinardi Pharmacology, Faculty of Medicine, University of Chile Observed and expected endometrial and other cancers after 20 years of follow-up of a cohort of women sterilized by intrauterine quinacrine and by tubal ligation Jaime Zipper Sotero del Rio Hospital, Area Sur Oriente, Santiago, Chile Quinacrine non-surgical female sterilization: Experience in Chile Valentin Trujillo San Jose Hospital, University of Chile, Santiago, Chile A preliminary report of female sterilization with a single dose of quinacrine pellets Sergio Guzman Department of Obstetrics and Gynecology, Universidad Austral, Valdivia, Chile Quinacrine Sterilization: Laparo-hysteroscopic monitoring of the procedure Laritza M. Rodriguez V. Fetal and Maternal Medicine, Gynecology and Obstetrics, Universidad Del Rosario, Santafe De Bogotá D.C. Colombia Endometrial assessment by vaginal ultrasonography after quinacrine method of non-surgical sterilization Cláudia Ramos C. Ferreira Department of Obstetrics and Gynecology, Universidade Federal de Minas Gerais, Belo Horizonte - MG, Brazil Sponsored by International Federation for Family Health Xango Auditorium 8:00 am - 10:00 am Saturday, May 8
Quinacrine Sterilization: An Update Elton Kessel Department of Public Health and Preventive Medicine, Oregon Health Sciences University, Portland, Oregon 97201, USA
Quinacrine sterilization (QS) involves transcervical insertion of quinacrine pellets using a modified Copper T IUD inserter. Pellets are placed at the fundus in the proliferative phase of two consecutive menstrual cycles. Efficacy is presently estimated at 1 pregnancy failure per 100 women at 2 years. Early complications are lower for QS than surgical sterilization and this is also true for risk of ectopic pregnancy with newer insertion protocols. The risk of birth defects is very low, when estimated from a model with reasonable assumptions for probability of insertion in a pregnant uterus or within 30 days of conception, probability of such exposed pregnancy being carried to term, and probability of quinacrine exposure to the fetus causing a birth defect. Although quinacrine is a mutagen it is unlikely to be a carcinogen. Concentrations of quinacrine in the uterus after transcervical insertion are higher than for oral administration for only a matter of a few hours, although this brief exposure is adequate to cause injury to the tubal epithelium, leading to inflammation and an occluding scar. Each site of use of QS must make its own risk/benefit assessment.
Quinacrine sterilization: Toxicological issues Gianni Pinardi Pharmacology, Faculty of Medicine, University of Chile
Controversial issues are reviewed. Although quinacrine is a mutagen in some in vitro screening tests, it is unlikely to be a carcinogen. The quinacrine molecule interculcates between adjacent bases of a DNA molecule. This bonding to DNA is in a noncovalent way, but covalent bonding is required for carcinogenicity. Most positive tests for mutagenicity in organic nitrogen compounds, of which quinacrine is an example, are false positives. There is actually evidence of anticarcinogenicity of quinacrine in experimental animals. Long-term follow-up of women sterilized with quinacrine shows no evidence of increased cancer risk. There is a suggestion of a protective effect against endometrial cancer. The extensive use of quinacrine orally has resulted in no reports of increased risk of cancer. The risk of birth defects among quinacrine sterilization pregnancy failures is not definitely known but must be low as it requires accidental insertion in a pregnant uterus, injury to the fetus and the pregnancy being carried to term. Toxicology studies in mice and monkeys showed no genetic damage to the fetus. Approved uses of quinacrine require many repeated doses which raise tissue concentrations higher than that of quinacrine sterilization, except for a few hours post insertion. This transient high intrauterine concentration of quinacrine injures the epithelium of the proximal tube, resulting in inflammation and an occlusive scar.
Observed and expected endometrial and other cancers after 20 years of follow-up of a cohort of women sterilized by intrauterine quinacrine and by tubal ligation Jaime Zipper Sotero del Rio Hospital, Area Sur Oriente, Santiago, Chile Valentin Trujillo San Jose Hospital, University of Chile, Santiago, Chile Alfredo Dabancens Faculty of Medicine, University of Chile, Santiago, Chile Rene Guzman-Serani Regional Hospital of Valdivia, Valdivia, Chile
The incidence of endometrial cancer in 3 different Chilean Hospitals during the period 1990-1995 was 175 cases. For women submitted to surgical sterilization by tubal ligation (TL), the incidence was 21 cases in this same period. For the cohort of 1545 women sterilized by the intrauterine quinacrine method, no cases of endometrial cancer were detected. The mean age of the 175 women at the time of cancer diagnosis was 63.9 years. However, the mean age was reduced to 53 years in the 21 patients sterilized by TL. The remaining 154 cases showed a mean age of 66.8 years. TL seems to be a factor which significantly anticipates the onset of endometrial cancer by a mean of 13.8 years. The incidence of all cancers observed in different organs in quinacrine-sterilized women during the period 1977-1996 was 25 cases; the expected incidence was 21.9 (ratio: 1.14, 95% CL: 0.74-1.68), a non significant statistical difference. During the period 1996-1998, an additional 25 endometrial cancer cases were detected at Sotero del Rio Hospital, but not one in the quinacrine cohort.
Quinacrine non-surgical female sterilization: Experience in Chile Valentin Trujillo San Jose Hospital, University of Chile, Santiago, Chile Jaime Zipper Sotero del Rio Hospital, Area Sur Oriente, Santiago, Chile Alfredo Dabancens Faculty of Medicine, University of Chile, Santiago, Chile Rene Guzman-Serani Regional Hospital of Valdivia, Valdivia, Chile
Intrauterine quinacrine sterilization was performed in 2880 Chilean women at three different hospitals between 1977 to 1998. The total number of pregnancies was 199 (4.13%). No birth defects or uterine lesions were detected in the pregnancies carried to term. Most pregnancies occurred during the first 24 months after insertion of quinacrine and few were added the following years. Nine ectopic pregnancies (0.31%) were detected, which is not different from IUD users and lower than for surgical sterilization. Mild and transitory side effects like: headache, lower abdominal pain, vaginal bleeding and amenorrhea were reported (12%). No deaths or life-threatening complications occurred. Review of other Chilean studies demonstrated an antitumoral activity of quinacrine in transplantable tumors in mice and epidemiologic studies showed no increased risk of gynecologic or any other type of cancer in quinacrine-sterilized women.
A preliminary report of female sterilization with a single dose of quinacrine pellets Sergio Guzman Rene Guzman-Serani Department of Obstetrics and Gynecology, Universidad Austral, Valdivia, Chile
Since 1979 we have been working on non-surgical female voluntary sterilization with intrauterine quinacrine pellets (252 mg) inserted transcervically in 2 or 3 consecutive menstrual cycles. The experience at the Department of Obstetrics and Gynecology of the Universidad Austral de Chile has been excellent since only 9 failures have been reported in a cohort of 151 women treated in 1979 after completing long-term follow-up of 78.520 woman/months. Since 1996, we have been exploring the use of a single dose of quinacrine pellets (288 mg) inserted among 25 women previously injected with depomedroxyprogesterone 21 to 30 days before. This paper is a preliminary report. The authors are aware of the small size of the series and that drawing a conclusion may be premature.
Quinacrine Sterilization: Laparo-hysteroscopic monitoring of the procedure Laritza M. Rodriguez V. Fetal and Maternal Medicine, Gynecology and Obstetrics, Universidad Del Rosario, Santafe De Bogotá D.C. Colombia
Quinacrine, a chemical structure derived from acridine, was originally introduced as treatment and prophylaxis for malaria. It has also been used in many countries for non-surgical female sterilization. The purpose of this study was to describe the use of this method in 40 women volunteers, to establish the rate of efficacy, complications and secondary effects. An efficacy of 95 %, confirmed by laparoscopy-histeroscopy, was found. The method is easy to apply, low cost and safe, as shown by the low number of complications (1 case of infection, out of 40 , that is, 2.5%; and one case of perforation, 2.5%). The most frequent secondary effects were: vaginal discharge (28 cases; 70%), abdominal pain (20 cases; 50%), and vaginal irritation (10 cases; 25%). It was not possible to find significant associations by the statistical Chi square test; only a tendency of association (p = 0.07) between abdominal pain and application of the method early in menstrual cycle (first ten days) was noted.
Endometrial assessment by vaginal ultrasonography after quinacrine method of non-surgical sterilization Cláudia Ramos C. Ferreira Marília Zicker Hanan Deborah Randazzo B. Magalhăes Department of Obstetrics and Gynecology, Universidade Federal de Minas Geraia, Belo Horizonte - MG, Brazil
Quinacrine non-surgical sterilization can be done quickly and without the risks of the surgical method. The aim of this study is to determine the safety and effectiveness of a method of non-surgical female sterilization. Additional studies to confirm the lack of increased cancer risk and inflammatory diseases should be done. Clinical evaluation and ultrasound will be made before and after transcervical administration of quinacrine pellets in order to detect side effects and to study the endometrium. The vaginal ultrasound studies can also show changes in the endometrium in 87% of carcinoma and hyperplasia cases. A group of 150 selected women to receive 2 monthly insertions of 250 mg of quinacrine will be examined before and (1, 3, 6 and 12 months) after the second dose, all of them during the proliferative phase of the menstrual cycle. Increased endometrial thickness, heterogeneous aspect and air or fluid collections will require detailed study to investigate their possible causes (endometriosis, endometrial carcinoma, endometrial hyperplasia, hematometra, pyometra, endometrial polyps and early intrauterine pregnancy). In these cases, the patients will be submitted to hysteroendosonography in order to confirm the aspect of the endometrium.
POPULATION: Group Seeks Ruling on New Sterilisation Drug. By Thalif Deen UNITED NATIONS, Mar 29 (IPS) - Population planning experts want the World Health Organisation (WHO) and the US Food and Drug Administration to determine whether a controversial new drug can be safely used as a method of family planning in the world's poorer nations. The Washington-based Population Institute says that if quinacrine hydrochloride is proved to be both safe and effective, it could be one of the cheapest female sterilisation agents in the market - costing only about 15 cents. ''With our planet's human numbers expected to reach six billion later this year - and 97 percent of that growth occurring in the developing world - it is obvious that there is an urgent need for economical, safe and effective contraceptives,'' says Werner Fornos, president of the Institute. Fornos told WHO Director-General Gro Harlem Brundtland and FDA Commissioner Jane Henney that successful clinical studies on the drug would have a significant bearing on family planning services provided to developing nations. Since both WHO and FDA expressed safety concerns, the Institute formally requested both institutions ''to resolve once and for all'' questions relating to the sterilisation agent. If quinacrine hydrochloride is given a clean bill of health, ''we would have a low-cost, non-surgical sterilisation method - with no operating room, no anesthesia, no expensive equipment - that is long term and does not require lengthy training,'' Fornos added. ''But if scientific evidence shows that quinacrine is dangerous, ineffective, or both, then there is a responsibility and an obligation to prevent its use.'' According to the Institute, the drug was used as an anti- malarial, helvetica agent in the 1930s, and administered orally to millions of US soldiers and sailors serving in the South Pacific during the Second World War. A Chilean researcher, Jaime Zipper, first used quinacrine for sterilisation in the early 1970s, and claims to have sterilised about 4,000 women with no deleterious effects. The drug has also been tested on some 1,800 Vietnamese women. To sterilise women, pellets of the drug are inserted into the uterus near the fallopian tubes. The chemical dissolves, burns the tubes' lining, and blockage from the resulting scar tissue prevents pregnancy, according to the Institute. Failure rate of the drug has been variously estimated at between one in 10 and one in 20. Fornos said that if appropiate testing concludes that the sterilisation agent is both safe and effective, ''it could go a long way toward ensuring that population stabilisation will be achieved in time to save our planet from perhaps irreparable environmental damage and millions of people from hunger, malnutrition, disease and unnecessary infant, child and maternal mortality.'' Jack Lippes, Professor of Gynecology and Obstetrics at the State University of New York, said that more than three million US servicemen took quinacrine to prevent malaria and other parasitic diseases. ''They took 100 milligrams daily for years. Since the end of the great war and with more than a 50 year follow-up, no clusters of cancer have been attributed to quinacrine,'' he said. Lippes said that an estimated 100 million people have taken quinacrine and no serious side effects have been reported. To this day, he said, the drug is used to treat several diseases, including lupus and rheumatoid arthritis, with no reports of significant harm. He said that ''a well designed and carefully administered American study would answer any questions the doubters may have.'' Among the issues under discussion at a weeklong meeting on population is contraception and fertility rates. The meeting, which is scheduled to end Thursday, is reviewing the successes and failures in implementing a Plan of Action adopted at the 1994 International Conference on Population and Development (ICPD) in Cairo. Robin Chandler Duke, of Population Action International, told reporters last week that about 60 percent of the world's fertile couples had access to family planning services and the use of contraception today, compared with 10 percent at the inception of the UN Population Fund (UNFPA) 30 years ago. She said it was essential to eliminate the more than 500,000 preventable maternal deaths occurring every year, and to advocate education and meaningful employment opportunities for women and girls. In a report released last week, the United Nations said that over the past five years, there have been increases in contraceptive use in all regions of the world. The average level of contraceptive use is estimated at 70 percent in rich countries and about 55 percent in poorer nations. Between 1988 and 1998, prevalence rose from 27 to 39 percent in Kenya, from 32 to 49 percent in Bangladesh, and from 36 to 46 percent in the Philippines. ''However, despite the sustained rise in contraceptive use, effective control over fertility has eluded a sizeable number of couples,'' the report said. The gap between stated desires to prevent or delay a birth and the actual use of contraception to achieve those goals is considerable in many countries, and the full range of modern family planning methods still remains unavailable to large numbers of couples worldwide, the study noted. [c] 1999, InterPress Third World News Agency (IPS) All rights reserved May not be reproduced, reprinted or posted to any system or service outside of the APC networks, without specific permission from IPS. Conference Schedule 1998-1999 QS experts have been invited to participate in medical conferences and meetings of reproduction rights organizations around the world. Look for the QS booth and talk to the health care professionals experienced with the method. IFFS '98 - the 16^th World Congress on Fertility & Sterility and American Society for Reproductive Medicine 54^th Annual Meeting, San Francisco, California, October 3-9, 1999. National Family Planning & Reproductive Health Association (NFPRHA) 27^th Annual Meeting, Washington, DC, February 15-17, 1999. Contraceptive Technology Conference Washington, DC, March 25-26, 1999. National Abortion Federation (NAF) 23^rd Annual Meeting, Atlanta, Georgia April 25-26, 1999. 10^th World Congress on Human Reproduction, Salvador, Brazil, May 4-8, 1999. American College of Obstetrics and Gynecology (ACOG) 47^th Annual Meeting Philadelphia, Pennsylvania, May 15-19, 1999. National Abortion Federation (NAF) Risk Management Seminar Ambulatory OB/GYN Nursing Conference San Francisco, California, September 23-24, 1999. American Society for Reproductive Medicine (ASRM), Toronto, Canada, September 27-29, 1999. National Association of Nurse Practitioners in Reproductive Health (NANPRH), New Orleans, Louisiana, October 14-16, 1999. Contraceptive Technology 2000 Conferences, Washington, DC, March 15-18, 2000 and San Francisco, California, March 29-April 1, 2000. National Abortion Federation (NAF) 24^th Annual Meeting American College of Obstetrics and Gynecology (ACOG) 48^th Annual Meeting, San Francisco, California and ACOG Regional Meetings 1999. XVI FIGO World Congress of Gynecology & Obstetrics, Washington, DC, September 3-8, 2000.

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