- Email: [email protected]
ROUND-UP Research
Round-Up
Reproductive Health Matters, No 3, May 1994
RSSSASCS Review of recent IUD studies E V I E W o f a w i d e r a n g e of s t u d i e s o n IUDs u n d that: IUDs a r e n o t a b o r t i f a c i e n t s ; n e w e r 1UDs a r e h i g h l y effective a n d l o n g lasting; IUDs c a n b e u s e d safely b y m o s t l a c t a t i n g w o m e n , w i t h l o w e r r e m o v a l r a t e s a t t r i b u t a b l e to b l e e d i n g a n d / o r pain; i m m e d i a t e p o s t - p l a c e n t a l i n s e r t i o n r e d u c e s t h e risk of e x p u l s i o n usually a s s o c i a t e d w i t h p o s t p a r t u m i n s e r t i o n ; IUDs p e r se a r e n o t a s s o c i a t e d w i t h a n i n c r e a s e d risk of pelvic inflamm a t o r y d i s e a s e (PID), ectopic p r e g n a n c y o r subs e q u e n t infertility. R a t h e r t h e risk o f PID is s h o w n to b e linked to t h e risk of STDs generally. A W H O multicentre study found that infection was most likely to m a n i f e s t itself w i t h i n 20 d a y s of IUD insertion. I s s u e s i d e n t i f i e d as still c o n t r o v e r s i a l in s p i t e o f n u m e r o u s s t u d i e s are: s h o u l d c o n t r a - i n d i c a t i o n s f o r IUDs b e m o d i f i e d b a s e d o n n e w e r findi n g s ? Is t h e risk of u t e r i n e p e r f o r a t i o n g r e a t e r in l a c t a t i n g w o m e n ? D o IUD tails i n c r e a s e t h e risk o f PID? Do p r o p h y l a c t i c a n t i b i o t i c s at IUD i n s e r t i o n h e l p p r e v e n t p o s t - i n s e r t i o n PID? T h e lack o f epidemiological information on bacterial origins o f PID c o m p l i c a t e s a n s w e r i n g t h i s l a s t q u e s t i o n . issues that have been insufficiently addressed a n d r e q u i r e f u r t h e r e m p i r i c a l s t u d i e s are: effect o f p r o v i d e r skill o n IUD p e r f o r m a n c e ; IUD u s e in nulliparous women and women approaching m e n o p a u s e ; r e l a t i o n s h i p b e t w e e n IUD u s e a n d c h l a m y d i a ; l o n g - t e r m IUD u s e a n d safety. S o m e p r o g r a m m a t i c q u e s t i o n s r a i s e d are: S h o u l d s y s t e m a t i c IUD r e m o v a l b e i m p l e m e n t e d among women approaching or passing menop a u s e ? Is it a d v i s a b l e to i n s t i t u t e l a r g e p r o g r a m m e s to r e p l a c e less-effective, o l d e r IUDs w i t h n e w e r , m o r e effective o n e s ? 1 1. Chi, I-cheng, 1993. What have we learnt from recent IUD studies: a researcher's perspective. Contraception. 48(August):81-107.
hormonal contraceptive, they were flooded with n e a r l y 350 e n q u i r i e s . T h e trial, w h i c h is t e s t i n g t h e c o n t r a c e p t i v e efficacy o f a w e e k l y i n j e c t i o n o f t h e m a l e a n d r o g e n t e s t o s t e r o n e , is t h e s e c o n d o f t w o m u l t i c e n t r e trials c o o r d i n a t e d b y t h e W o r l d H e a l t h O r g a n i s a t i o n in p a r t i c i p a t i n g c e n t r e s in Australia, China, Finland, France, Hungary, S i n g a p o r e , S w e d e n , T h a i l a n d , UK a n d USA. The method works by gradually lowering the s p e r m c o u n t to t h e p o i n t w h e r e p r e g n a n c y bec o m e s virtually i m p o s s i b l e . This p r o c e s s t a k e s three months on average, during which time a n o t h e r c o n t r a c e p t i v e is n e e d e d . A f t e r t h a t t h e r e is a 1 2 - m o n t h efficacy p e r i o d f o r t h e i n j e c t a b l e o n its o w n , w i t h r e t u r n to n o r m a l s p e r m c o u n t w i t h i n six m o n t h s o f s t o p p i n g t h e i n j e c t i o n o n a v e r a g e . Side effects i n c l u d e a c h e a n d oilier skin in some men. Increased aggression does not a p p e a r to o c c u r as a r e s u l t o f t h e e x t r a t e s t o s t e r o n e . C u r r e n t trials will c o n t i n u e t o m o n i t o r f o r side effects a n d will look at v o l u n t e e r s ' m o t i v a t i o n f o r j o i n i n g t h e trial a n d s a t i s f a c t i o n with the method. S i n c e a w e e k l y i n j e c t i o n is n o t likely to b e acceptable, several avenues of research are being explored to develop formulations intended to last t h r e e to f o u r m o n t h s . T h e s e i n c l u d e u s i n g t e s t o s t e r o n e b u c i c l a t e o n its o w n , u s i n g t h e p r o gestogen DMPA combined with an androgen; and the progestogen levonorgestrel combined with testosterone buciclate. 1. Waites, GMH, 1993. Male fertility regulation: the challenges for the year 2000. British Medical Bulletin. 49(1):210-21. 2. Special Programme of Research, Development and Research Training in Human Reproduction Annual Technical Report 1992. World Health Organisation,
Geneva. 3. Press release, University of Manchester Press, 14 July 1993.
AZT reduces rate of maternal transmission of HIV
Support for research on male hormonal contraception When the University of Manchester put out a n e w s r e l e a s e t h a t t h e y w e r e s e e k i n g 30 m a l e v o l u n t e e r s 21 to 45 y e a r s old to t r y t h e first m a l e
P r e l i m i n a r y r e s u l t s o f a t r i a l b y t h e US N a t i o n a l Institute of Allergy and Infectious Diseases (NIAID) a n d t h e F r e n c h N a t i o n a l I n s t i t u t e o f Child Health and Human Development confirm a
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h i g h l y r e d u c e d risk o f HIV t r a n s m i s s i o n p r i o r to b i r t h w i t h u s e o f A Z T in p r e g n a n c y . T h e trial b e g a n in 1991. U p t o t h e e n d of 1993, 477 p r e g n a n t w o m e n w i t h HIV h a d e n r o l l e d , some of whom were randomly given AZT ( z i d o v u d i n e ) a n d o t h e r s a p l a c e b o , to d e t e r m i n e w h e t h e r A Z T c o u l d h e l p t o r e d u c e t h e risk o f HIV t r a n s m i s s i o n t o t h e i r i n f a n t s p r i o r to b i r t h . L e n g t h o f t r e a t m e n t r a n g e d f r o m 1 t o 29 weeks, depending on when the women were enrolled. T h e t r e a t m e n t w a s b e g u n n o e a r l i e r t h a n 14 w e e k s o f p r e g n a n c y a n d n o l a t e r t h a n 34 w e e k s . During labour, the women received a continuous i n t r a v e n o u s d o s e o f A Z T o r p l a c e b o . W i t h i n 24 h o u r s a f t e r b i r t h a n d f o r six w e e k s t h e r e a f t e r , i n f a n t s r e c e i v e d t h e s a m e t r e a t m e n t as t h e i r mothers (either AZT or placebo). O f 364 i n f a n t s f o r w h o m at l e a s t o n e HIV t e s t w a s a v a i l a b l e at t h e e n d o f 1993, 53 h a d HIV, o f w h i c h 13 w e r e b o r n to m o t h e r s r e c e i v i n g A Z T a n d 40 t o m o t h e r s o n p l a c e b o . T h e r a t e o f t r a n s m i s s i o n w a s 8.3 p e r c e n t w i t h A Z T as c o m p a r e d w i t h 25.5 p e r c e n t w i t h p l a c e b o . A s a result, A Z T t r e a t m e n t w a s o f f e r e d to all r e m a i n i n g p a r t i c i p a n t s o n p l a c e b o w h o w e r e still p r e g n a n t a n d to t h e i r i n f a n t s , s i n c e t h e r e s u l t s w e r e so d e a r . M o n i t o r i n g will c o n t i n u e . Preliminary analysis of the results shows that b o t h m o t h e r s a n d i n f a n t s t o l e r a t e d A Z T well w i t h n o s i g n i f i c a n t s h o r t - t e r m a d v e r s e effects o t h e r t h a n m i l d a n a e m i a in s o m e i n f a n t s , w h i c h resolved after AZT was stopped. Most of the w o m e n w e r e at a relatively e a r l y s t a g e o f HIV disease. C o n g e n i t a l a n o m a l i e s in t h e i n f a n t s did n o t differ f r o m w h a t w o u l d b e e x p e c t e d in t h e general population or between treatment and p l a c e b o g r o u p s . S e v e n i n f a n t s in e a c h g r o u p d i e d e i t h e r o f s e r i o u s a n o m a l i e s p r e s e n t at b i r t h o r from HIV-related disease. B e c a u s e l o n g - t e r m effects o f A Z T t h e r a p y o n the infants are currently unknown, no recomm e n d a t i o n s a b o u t t r e a t m e n t to p r e v e n t t r a n s m i s s i o n o f HIV d u r i n g p r e g n a n c y a n d d e l i v e r y are being made, pending development of consensus on the balance between known benefit a n d u n k n o w n risk.l -
1. AZT reduces rate of maternal transmission of HIV. Press release, questions and answers, and executive summary. NIAID News. 21 February 1994.
Spermicides, c o n d o m s and HIV In 1989-90 in C a m e r o o n , 273 w o m e n e x c h a n g i n g sex f o r m o n e y p a r t i c i p a t e d in a trial a i m e d at determining the association between low dose (100rag) s p e r m i c i d e a n d c o n d o m u s e a n d HIV t r a n s m i s s i o n risks. T h e w o m e n h a d a m e a n o f 3.2 p a r t n e r s p e r w e e k d u r i n g follow up. T h e y w e r e g i v e n r e g u l a r s u p p l i e s a n d c o u n s e l l e d to u s e b o t h m e t h o d s f o r all i n t e r c o u r s e . T h e y r e c o r d e d a c t u a l u s e o n p i c t o r i a l logs a n d v i s i t e d t h e clinic o n c e a m o n t h for a m e a n f o l l o w u p o f 8 m o n t h s . Their previous condom use had been sporadic a n d less t h a n 10 p e r c e n t h a d u s e d s p e r m i c i d e s previously. Reproductive tract infections were d i a g n o s e d a n d t r e a t e d at e n t r y a n d d u r i n g follow up. D u r i n g t h e f o l l o w u p p e r i o d , 33 p e r c e n t o f t h e w o m e n h a d v a g i n a l / c e r v i c a l l e s i o n s , 11 p e r c e n t i n d u c e d c e r v i c a l b l e e d i n g , 39 p e r c e n t g o n o r r h o e a , 59 p e r c e n t t r i c h o m o n i a s i s , 74 p e r c e n t c a n d i d i a s i s . O n l y 20 p e r c e n t o f t h e w o m e n reported no incident of unprotected intercourse d u r i n g f o l l o w up. Nineteen women seroconverted during the study period. Almost three-quarters reported one or more condom breakages. There were frequent reports of various discomforts with both methods, though no association with lesions was found. Both consistent condom use and consistent spermicide use were associated with lower incidences of gonorrhoea and genital ulcers. C o n s i s t e n t s p e r m i c i d e u s e r s g a i n e d s u b s t a n t i a l p r o t e c t i o n f r o m HIV, as d i d c o n s i s t e n t condom users who had had experience with c o n d o m s p r i o r to t h e study. T h e g r e a t e s t protection was found with consistent use of both m e t h o d s in w o m e n w i t h p r e v i o u s c o n d o m e x p e r i e n c e . Lack o f p r e v i o u s c o n d o m e x p e r i e n c e was associated with reduced protection; however, w i t h o u t i n f o r m a t i o n o n c l i e n t v a r i a b l e s , reasons for this finding could not be ascertained. This s t u d y e x a m i n e s s p e r m i c i d e u s e at l o w d o s e s a n d w i t h a l o w f r e q u e n c y o f use. It f i n d s a p r o t e c t i v e effect o f s p e r m i c i d e s a g a i n s t HIV w i t h c o n s i s t e n t use. B e c a u s e c o n d o m u s e is also i n v o l v e d , t h e i n d e p e n d e n t effect o f t h e t w o m e t h o d s c a n n o t b e m e a s u r e d directly. 1 T h e r e is e v i d e n c e t h a t s p e r m i c i d e s in h i g h e r d o s e s w i t h f r e q u e n t u s e in a h i g h risk p o p u l a t i o n c a n i n c r e a s e t h e risk o f HIV infection. 2 A large, r a n d o m i s e d clinical trial o f n o n o x y n o l - 9 s h o u l d b e a p r i o r i t y o f HIV p r e v e n t i o n r e s e a r c h s o t h a t
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t h e v a l u e o f s p e r m i c i d e s f o r HIV r i s k r e d u c t i o n can be determined. 1 1. Zekeng, Leopold; Feldblum, Paul J; Oliver, Regina M et al, 1993. Barrier contraceptive use and HIV infection among high-risk women in Cameroon. AIDS. 7(5):725-31. 2. Kreiss, Joan; Ngugi, Elizabeth; Holmes, King; et al, 1992. Efficacy of nonoxynol-9 contraceptive sponge use in preventing heterosexual acquisition of HIV in Nairobi prostitutes. J A M A . 268:477-82.
Costing HIV prevention strategies C a s e s t u d i e s o f six HIV p r e v e n t i o n s t r a t e g i e s in d e v e l o p i n g c o u n t r i e s , m a i n l y in L a t i n A m e r i c a , t h e C a r i b b e a n a n d Africa, w e r e d o n e in a n a t t e m p t to c a l c u l a t e t h e i r costs. T h e six s t r a t e g i e s were: mass media campaigns, peer education p r o g r a m m e s , STD t r e a t m e n t , c o n d o m social m a r k e t i n g , safe b l o o d p r o v i s i o n , a n d n e e d l e exchange/bleach provision programmes. Financial c o s t d a t a w e r e a b s t r a c t e d f r o m p u b l i s h e d s t u d i e s o r o b t a i n e d d i r e c t l y f r o m p r o j e c t coo r d i n a t o r s . A w i d e r a n g e of c o s t s f o r e a c h s t r a t e g y w a s f o u n d , e.g. p e e r e d u c a t i o n c o s t f r o m U S $0.15 to $12.59 p e r c o n t a c t . T h e m o n e t a r y c o s t o f a p r o g r a m m e is o n l y o n e a s p e c t o f m e a s u r i n g its e f f e c t i v e n e s s . W i t h o u t t a k i n g i n t o a c c o u n t s u c h f a c t o r s as e f f e c t i v e n e s s in r e d u c i n g risk-related practices, cheapness may mistakenly b e s e e n as t h e o n l y m e a s u r e . F u r t h e r , s t r a t e g i e s where some of the costs are displaced onto the r e c i p i e n t s , s u c h as socially m a r k e t e d c o n d o m s , a p p e a r c h e a p e r o n l y if m e a s u r e s o f c o s t inc l u d e t h o s e t o p r o v i d e r s only. T h e c o m p l e x i t y o f m e a s u r i n g c o s t - e f f e c t i v e n e s s well is m a d e clear. 1 1. SOderlund, N; Lavis; Broomberg, J; and Mills, A, 1993. The costs of HIV prevention strategies in developing countries. Bulletin of the WHO. 71(5):595-604.
Misoprostol for second trimester abortions Illegal a n d d a n g e r o u s a b o r t i o n s a r e a m a j o r c a u s e o f m a t e r n a l m o r t a l i t y a n d m o r b i d i t y in M o z a m b i q u e . To r e d u c e t h i s p r o b l e m , i n d u c e d a b o r t i o n is o f f e r e d o n r e q u e s t at t h e o b s t e t r i c / gynaecology department of Maputo Central Hospital, after evaluation and authorisation by a
medical committee. The use of extra-amniotic p r o s t a g l a n d i n (PG) f o r s e c o n d t r i m e s t e r a b o r t i o n s is p r e f e r r e d o v e r s u r g i c a l m e t h o d s . This s t u d y w a s to d e t e r m i n e w h e t h e r m i s o p r o s t o l (Cytotec, a n o r a l PG) a d m i n i s t e r e d i n t r a v a g i n a l l y w a s a safe a l t e r n a t i v e to m e e t a l a r g e d e m a n d f o r s e c o n d t r i m e s t e r a b o r t i o n s in M a p u t o . In 1992, 121 w o m e n w i t h a m e a n a g e o f 23 w e r e g i v e n f o u r 200 m c g t a b l e t s of m i s o p r o s t o l v a g i n a l l y in o n e dose. T h i s d o s e o c c a s i o n a l l y caused frequent and painful uterine contract i o n s , so t h e d o s e w a s r e d u c e d t o 600 m c g f o r t h e n e x t t e n w o m e n , t h e n t o 400 m c g f o r 28 w o m e n a n d t h e n 200 m c g f o r t e n w o m e n . A n y w o m a n w h o s h o w e d n o s i g n s o f a b o r t i o n in p r o g r e s s 24 h o u r s l a t e r w a s g i v e n a s e c o n d dose. If a f t e r 48 hours abortion was not advanced, the method w a s c o n s i d e r e d to h a v e failed a n d s u r g i c a l a b o r t i o n w a s c a r r i e d out. E i g h t y p e r c e n t w e r e 12-15 w e e k s p r e g n a n t ; t h e r e m a i n d e r w e r e 16-22 w e e k s p r e g n a n t . A b o r t i o n o c c u r r e d in 91 p e r c e n t o f t h e w o m e n . T e n w o m e n d i d n o t a b o r t w i t h i n 48 h o u r s a n d five w o m e n p r e f e r r e d t o s t o p w a i t i n g a f t e r 24 h o u r s . In all b u t o n e o f t h e s e cases, v a c u u m a s p i r a t i o n w a s c a r r i e d o u t successfully. F o r t h e remaining woman an infusion of prostaglandin was administered. Vomiting, diarrhoea, fever and sweating were n o t o b s e r v e d in a n y o f t h e w o m e n . Five w o m e n required stronger analgesics than paracetamol. No transfusions were needed and there were no deaths or major complications. None of the women presented for follow-up treatment subs e q u e n t l y . V a c u u m a s p i r a t i o n , d o n e as a safeguard that abortion was complete for the p u r p o s e s o f t h e study, d i d n o t a p p e a r to b e n e c e s s a r y in m o s t cases. T h e r e s u l t s a p p e a r e d t o b e at l e a s t as g o o d as w i t h o t h e r P G m e t h o d s b e t w e e n 12 a n d 22 w e e k s of pregnancy, with the added benefits of a very l o w i n c i d e n c e o f c o m p l i c a t i o n s , l o w cost a n d e a s y s t o r a g e o f t h i s m e t h o d . A n initial d o s e o f 400 m c g o r less f o r p r e g n a n c i e s o v e r 15 w e e k s is s u g g e s t e d . A d d i t i o n a l s t u d i e s to d e t e r m i n e t h e optimum dosage and ascertain whether second trimester abortions with misoprostol alone are indeed complete, are needed. 1 1. Bugalho, Antonio, Bique, Cassimo, Alemida, Luisa and FaOndes, Anibal, 1993. The effectiveness of intravaginal misoprostol (Cytotec) in inducing
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abortion after eleven weeks of pregnancy. Studies in Family Planning. 24(5):319-23.
B a c t e r i a l v a g i n o s i s , late miscarriage and preterm delivery P r e t e r m d e l i v e r y is t h e m o s t i m p o r t a n t c a u s e of perinatal mortality and morbidity. There a r e m a n y c a u s e s a n d it r e m a i n s i n c o m p l e t e l y u n d e r s t o o d . This s t u d y in t h e U K of 738 w o m e n s h o w e d t h a t late m i s c a r r i a g e a n d p r e t e r m d e l i v e r y w e r e a s s o c i a t e d w i t h t h e p r e s e n c e of b a c t e r i a l v a g i n o s i s in e a r l y p r e g n a n c y . This association was independent of other recognised risk f a c t o r s s u c h as p r e v i o u s p r e t e r m delivery. The researchers recommend screening and t r e a t m e n t f o r b a c t e r i a l v a g i n o s i s b e f o r e t h e 16th w e e k of p r e g n a n c y to h e l p t o p r e v e n t t h e s e outcomes. 1 1. Hay, Phillip E, Lamont, Ronald F, Taylor-Robinson, David et al, 1994. Abnormal bacterial colonisation of the genital tract and subsequent preterm delivery and late miscarriage. British Medical Journal. 308(29 January):295-98.
Evaluation of home-based maternal records T h i r t e e n c e n t r e s in e i g h t c o u n t r i e s (Egypt, India, P a k i s t a n , P h i l i p p i n e s , S e n e g a l , Sri Lanka, D e m o c r a t i c Y e m e n a n d Z a m b i a ) p a r t i c i p a t e d in a W H O c o l l a b o r a t i v e s t u d y to e v a l u a t e h o m e - b a s e d m a t e r n a l r e c o r d s . T h e six o b j e c t i v e s o f t h e s e r e c o r d s - to p r o m o t e c o n t i n u i t y o f care, e n c o u r a g e e a r l y r e c o g n i t i o n o f w o m e n a n d n e w b o r n s at risk a n d i n i t i a t e action, p r o m o t e r e f e r r a l t h a t meets women's needs, encourage appropriate c a r e a n d self-care, p r o v i d e a useful a n d p r a c t i c a l record, and provide a focus for health education - a r e e a c h e x a m i n e d . P r o b l e m s s u c h as o v e r s e l e c t i o n a n d r e f e r r a l o f w o m e n at risk a r e a d dressed and solutions suggested. W o m e n u s e r s s u g g e s t e d i m p r o v e m e n t s in t h e l a n g u a g e , i l l u s t r a t i o n s , layout, a n d c o n t e n t o f t h e records. Health workers using the records with w o m e n o f t e n felt m o r e t r a i n i n g a n d s u p p o r t w a s needed. They wanted guidelines for identifying risk f a c t o r s , s t a n d a r d s o f care, m a k i n g r e f e r r a l s and ensuring that referral units were equipped for emergencies. Although the impact of using the records on rates of maternal mortality and
morbidity could not be measured, the records c o n t r i b u t e d s u b s t a n t i a l l y t o i m p r o v e d quality and quantity of antenatal, postnatal and interpregnancy care of mothers and better neonatal care. 1 1. Shah, P M, Selwyn, B J, Shah, K, Kumar, V, et al, 1993. Evaluation of the home-based maternal record: a WHO collaborative study. Bulletin o f the WHO. 71(5):535-48.
B r e a s t s c r e e n i n g or mammography? W h i l e m o s t w o m e n w i t h b r e a s t c a n c e r in t h e U S A a r e o v e r a g e 50, in P a k i s t a n t h e a v e r a g e a g e is 45 a n d o n e in five w o m e n is u n d e r a g e 35. In Pakistan, few women do breast self-examination a n d t h e a v e r a g e size o f l u m p s at t h e t i m e o f d i a g n o s i s is o v e r 5 cms, w i t h p o o r p r o g n o s i s . 1 M a m m o g r a p h y is a c o m p l e x s c r e e n i n g test, t e c h n i c a l l y difficult t o p e r f o r m a n d i n t e r p r e t , a n d requires great expertise, staff training, quality c o n t r o l a n d e x p e n d i t u r e to s u c c e e d in r e d u c i n g m o r t a l i t y . W h i l e it also c o s t s m o n e y t o t r a i n surgeons, pathologists and nurse examiners to d o b r e a s t s c r e e n i n g b y p h y s i c a l e x a m i n a t i o n , it w o u l d c o s t c o n s i d e r a b l y less t h a n m a m m o graphy. The costs of physical examination could b e five to t e n t i m e s less t h a n f o r m a m m o g r a p h y , a n i m p o r t a n t c o n s i d e r a t i o n in a n e c o n o m i c recession when health care resources are scarce. This p a p e r p r o p o s e s critical e v a l u a t i o n in r a n d o m i s e d trials o f t h e efficacy of p h y s i c a l e x a m ination by trained health professionals, with and w i t h o u t b r e a s t s e l f - e x a m i n a t i o n b y w o m e n , as a n a l t e r n a t i v e to m a m m o g r a p h y . 2 1. Early age of onset: an outstanding feature of breast cancer in Pakistani women. National Health. January-March 1993, 73. 2. Mittra, I, 1994. Breast screening: the case for physical examination without mammography. Lancet. 343(5 February):342-44.
Effects o f t a m o x i f e n o n t h e endometrium L a r g e trials h a v e b e e n set u p to a s s e s s w h e t h e r t a m o x i f e n d e c r e a s e s t h e risk of b r e a s t c a n c e r in h e a l t h y w o m e n , so it is i m p o r t a n t to i n v e s t i g a t e t h e d r u g ' s p o t e n t i a l a d v e r s e effects, i n c l u d i n g t h e risk o f e n d o m e t r i a l c a n c e r . This c a s e - c o n t r o l
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t u d y in t h e N e t h e r l a n d s w a s of 98 w o m e n w h o a d e n d o m e t r i a l c a n c e r d i a g n o s e d at l e a s t t h r e e ~ o n t h s a f t e r a d i a g n o s i s of p r i m a r y b r e a s t a n c e r a n d 285 m a t c h e d c o n t r o l s . T a m o x i f e n h a d e e n u s e d b y 24 p e r c e n t o f w o m e n w i t h u b s e q u e n t e n d o m e t r i a l c a n c e r a n d 20 p e r c e n t f controls. Women who had used tamoxifen for ~ore t h a n t w o y e a r s h a d a 2.3 (0.9-5.9) t i m e s r e a t e r risk of e n d o m e t r i a l c a n c e r t h a n n e v e r sers. T h e r e w a s a s ! g n i f i c a n t t r e n d o f i n c r e a s i n g [sk o f e n d o m e t r i a l ~ c a n c e r w i t h d u r a t i o n o f ~moxifen u s e a n d c u m u l a t i v e dose. T h e s e t r e n d s / e r e s i m i l a r w i t h daily d o s e s o f 4 0 m g o r 3 0 m g o r ,~ss, t h o u g h f e w of t h e w o m e n in t h i s s t u d y e c e i v e d 3 0 m g o r less. In a D a n i s h study, t h e lightly i n c r e a s e d risk a m o n g w o m e n w h o t o o k 0 m g o r less w a s n o t s i g n i f i c a n t . T h e d o s e o f t m o x i f e n in t h e p r e v e n t i o n trials is 2 0 m g . These researchers conclude that physicians h o u l d b e a w a r e t h a t t h e i n c r e a s e d risk o f n d o m e t r i a l c a n c e r a f t e r t a m o x i f e n u s e will c a u s e o m e m o r b i d i t y in b r e a s t c a n c e r p a t i e n t s t r e a t e d /ith t h e d r u g . H o w e v e r , t h e p r o v e n clinial b e n e f i t f t a m o x i f e n in c o n t r o l l i n g b r e a s t c a n c e r clearly u t w e i g h s t h e m o d e s t i n c r e a s e in e n d o m e t r i a l a n c e r risk. E n d o m e t r i a l c a n c e r h a s a m o r e ~vourable p r o g n o s i s t h a n b r e a s t c a n c e r , so n o a t i e n t s h o u l d b e d e n i e d t a m o x i f e n b e c a u s e of o t e n t i a l a d v e r s e effects o n t h e e n d o m e t r i u m . W h e t h e r t a m o x i f e n s h o u l d b e u s e d to p r e v e n t r e a s t c a n c e r in h e a l t h y w o m e n will d e p e n d o n 1hether t h e d e c r e a s e in t h e i n c i d e n c e o f b r e a s t ancer outweighs the increased risk of n d o m e t r i a t c a n c e r , w h i c h c u r r e n t trials a r e ~eking to d e t e r m i n e . Risks o f t a m o x i f e n at 3 0 m g n d 2 0 r a g d o s e s o v e r l o n g e r p e r i o d s (five y e a r s r m o r e ) a n d r i s k s f o r e x - u s e r s r e m a i n to b e etermined. 1 van Leeuwen, Flora E, Benraadt, Jantien, Coebergh, Jan Willem W e t al, 1994. Risk of endometrial cancer after tamoxifen treatment of breast cancer. Lancet. 343(19 February):448-52.
Sanitary protection among poor Bangladeshi w o m e n This s t u d y e x a m i n e s t h e s a n i t a r y p r o t e c t i o n u s e d b y 80 p o o r w o m e n in u r b a n , p e r i - u r b a n a n d r u r a l areas of Dhaka, Sylhet and Noakhali. Most used r a g s f o r m e n s t r u a l m a n a g e m e n t ; only a f e w u s e d s a n i t a r y n a p k i n s . O t h e r s u s e d c o t t o n wool, panties or nothing. Many did not know about s a n i t a r y p r o t e c t i o n a n d o t h e r s said it w a s t o o e x p e n s i v e to c o n s i d e r b u y i n g it. T h e s t u d y l o o k e d at beliefs a b o u t m e n s t r u a t i o n , h o w w o m e n cleaned the rags they used, and whether they had m e n s t r u a t i o n - r e l a t e d h e a l t h p r o b l e m s . It f o u n d a high instance of reproductive tract infections l i n k e d to t h e u s e o f m e n s t r u a l r a g s w h i c h w e r e n o t b o i l e d a n d / o r d r i e d in w a y s t h a t w o u l d h a v e p r e v e n t e d infection. E d u c a t i o n in culturally a c c e p t a b l e a n d f e a s i b l e w a y s to c l e a n r e - u s e d menstrual rags and panties for women who cannot afford disposable means of sanitary p r o t e c t i o n is r e c o m m e n d e d . 1 1. Ahmed, Shanaz, Huq, Nasreen, Chowdhury, Panna et al, 1992. Investigation into the sanitary protection needs of poor w o m e n in Bangladesh. Intermediate Technology, Bangladesh, May.
Assisted conception and the quality of parenting A s t u d y in t h e UK c o m p a r e d 41 families w i t h a c h i l d c o n c e i v e d b y in v i t r o f e r t i l i s a t i o n a n d 45 with a child conceived by donor insemination w i t h 43 families w i t h a c h i l d c o n c e i v e d n a t u r a l l y a n d 55 w i t h a c h i l d a d o p t e d in e a r l y i n f a n c y . T h e c h i l d r e n w e r e a g e d 4-8, r o u g h l y h a l f b o y s a n d girls, a n d w i t h p a r e n t s m a t c h e d f o r a g e a n d class. T h e q u a l i t y o f p a r e n t i n g w a s a s s e s s e d t h r o u g h a r a n g e o f t e s t s w i t h the c h i l d r e n , interviews with the mothers and questionnaires filled o u t b y b o t h p a r e n t s a n d t h e c h i l d r e n ' s teachers. The results suggest that a strong desire f o r p a r e n t h o o d is m o r e i m p o r t a n t to quality of p a r e n t i n g t h a n g e n e t i c ties. 1 1. Golombok, Susan, Cook, Rachel, Bish, Alison, and Murray, Clare, 1994. Parents and their children happy with assisted conception [letter]. British Medical Journal. 308(5 March):658-59.
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RSSSASCS Review of recent IUD studies E V I E W o f a w i d e r a n g e of s t u d i e s o n IUDs u n d that: IUDs a r e n o t a b o r t i f a c i e n t s ; n e w e r 1UDs a r e h i g h l y effective a n d l o n g lasting; IUDs c a n b e u s e d safely b y m o s t l a c t a t i n g w o m e n , w i t h l o w e r r e m o v a l r a t e s a t t r i b u t a b l e to b l e e d i n g a n d / o r pain; i m m e d i a t e p o s t - p l a c e n t a l i n s e r t i o n r e d u c e s t h e risk of e x p u l s i o n usually a s s o c i a t e d w i t h p o s t p a r t u m i n s e r t i o n ; IUDs p e r se a r e n o t a s s o c i a t e d w i t h a n i n c r e a s e d risk of pelvic inflamm a t o r y d i s e a s e (PID), ectopic p r e g n a n c y o r subs e q u e n t infertility. R a t h e r t h e risk o f PID is s h o w n to b e linked to t h e risk of STDs generally. A W H O multicentre study found that infection was most likely to m a n i f e s t itself w i t h i n 20 d a y s of IUD insertion. I s s u e s i d e n t i f i e d as still c o n t r o v e r s i a l in s p i t e o f n u m e r o u s s t u d i e s are: s h o u l d c o n t r a - i n d i c a t i o n s f o r IUDs b e m o d i f i e d b a s e d o n n e w e r findi n g s ? Is t h e risk of u t e r i n e p e r f o r a t i o n g r e a t e r in l a c t a t i n g w o m e n ? D o IUD tails i n c r e a s e t h e risk o f PID? Do p r o p h y l a c t i c a n t i b i o t i c s at IUD i n s e r t i o n h e l p p r e v e n t p o s t - i n s e r t i o n PID? T h e lack o f epidemiological information on bacterial origins o f PID c o m p l i c a t e s a n s w e r i n g t h i s l a s t q u e s t i o n . issues that have been insufficiently addressed a n d r e q u i r e f u r t h e r e m p i r i c a l s t u d i e s are: effect o f p r o v i d e r skill o n IUD p e r f o r m a n c e ; IUD u s e in nulliparous women and women approaching m e n o p a u s e ; r e l a t i o n s h i p b e t w e e n IUD u s e a n d c h l a m y d i a ; l o n g - t e r m IUD u s e a n d safety. S o m e p r o g r a m m a t i c q u e s t i o n s r a i s e d are: S h o u l d s y s t e m a t i c IUD r e m o v a l b e i m p l e m e n t e d among women approaching or passing menop a u s e ? Is it a d v i s a b l e to i n s t i t u t e l a r g e p r o g r a m m e s to r e p l a c e less-effective, o l d e r IUDs w i t h n e w e r , m o r e effective o n e s ? 1 1. Chi, I-cheng, 1993. What have we learnt from recent IUD studies: a researcher's perspective. Contraception. 48(August):81-107.
hormonal contraceptive, they were flooded with n e a r l y 350 e n q u i r i e s . T h e trial, w h i c h is t e s t i n g t h e c o n t r a c e p t i v e efficacy o f a w e e k l y i n j e c t i o n o f t h e m a l e a n d r o g e n t e s t o s t e r o n e , is t h e s e c o n d o f t w o m u l t i c e n t r e trials c o o r d i n a t e d b y t h e W o r l d H e a l t h O r g a n i s a t i o n in p a r t i c i p a t i n g c e n t r e s in Australia, China, Finland, France, Hungary, S i n g a p o r e , S w e d e n , T h a i l a n d , UK a n d USA. The method works by gradually lowering the s p e r m c o u n t to t h e p o i n t w h e r e p r e g n a n c y bec o m e s virtually i m p o s s i b l e . This p r o c e s s t a k e s three months on average, during which time a n o t h e r c o n t r a c e p t i v e is n e e d e d . A f t e r t h a t t h e r e is a 1 2 - m o n t h efficacy p e r i o d f o r t h e i n j e c t a b l e o n its o w n , w i t h r e t u r n to n o r m a l s p e r m c o u n t w i t h i n six m o n t h s o f s t o p p i n g t h e i n j e c t i o n o n a v e r a g e . Side effects i n c l u d e a c h e a n d oilier skin in some men. Increased aggression does not a p p e a r to o c c u r as a r e s u l t o f t h e e x t r a t e s t o s t e r o n e . C u r r e n t trials will c o n t i n u e t o m o n i t o r f o r side effects a n d will look at v o l u n t e e r s ' m o t i v a t i o n f o r j o i n i n g t h e trial a n d s a t i s f a c t i o n with the method. S i n c e a w e e k l y i n j e c t i o n is n o t likely to b e acceptable, several avenues of research are being explored to develop formulations intended to last t h r e e to f o u r m o n t h s . T h e s e i n c l u d e u s i n g t e s t o s t e r o n e b u c i c l a t e o n its o w n , u s i n g t h e p r o gestogen DMPA combined with an androgen; and the progestogen levonorgestrel combined with testosterone buciclate. 1. Waites, GMH, 1993. Male fertility regulation: the challenges for the year 2000. British Medical Bulletin. 49(1):210-21. 2. Special Programme of Research, Development and Research Training in Human Reproduction Annual Technical Report 1992. World Health Organisation,
Geneva. 3. Press release, University of Manchester Press, 14 July 1993.
AZT reduces rate of maternal transmission of HIV
Support for research on male hormonal contraception When the University of Manchester put out a n e w s r e l e a s e t h a t t h e y w e r e s e e k i n g 30 m a l e v o l u n t e e r s 21 to 45 y e a r s old to t r y t h e first m a l e
P r e l i m i n a r y r e s u l t s o f a t r i a l b y t h e US N a t i o n a l Institute of Allergy and Infectious Diseases (NIAID) a n d t h e F r e n c h N a t i o n a l I n s t i t u t e o f Child Health and Human Development confirm a
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h i g h l y r e d u c e d risk o f HIV t r a n s m i s s i o n p r i o r to b i r t h w i t h u s e o f A Z T in p r e g n a n c y . T h e trial b e g a n in 1991. U p t o t h e e n d of 1993, 477 p r e g n a n t w o m e n w i t h HIV h a d e n r o l l e d , some of whom were randomly given AZT ( z i d o v u d i n e ) a n d o t h e r s a p l a c e b o , to d e t e r m i n e w h e t h e r A Z T c o u l d h e l p t o r e d u c e t h e risk o f HIV t r a n s m i s s i o n t o t h e i r i n f a n t s p r i o r to b i r t h . L e n g t h o f t r e a t m e n t r a n g e d f r o m 1 t o 29 weeks, depending on when the women were enrolled. T h e t r e a t m e n t w a s b e g u n n o e a r l i e r t h a n 14 w e e k s o f p r e g n a n c y a n d n o l a t e r t h a n 34 w e e k s . During labour, the women received a continuous i n t r a v e n o u s d o s e o f A Z T o r p l a c e b o . W i t h i n 24 h o u r s a f t e r b i r t h a n d f o r six w e e k s t h e r e a f t e r , i n f a n t s r e c e i v e d t h e s a m e t r e a t m e n t as t h e i r mothers (either AZT or placebo). O f 364 i n f a n t s f o r w h o m at l e a s t o n e HIV t e s t w a s a v a i l a b l e at t h e e n d o f 1993, 53 h a d HIV, o f w h i c h 13 w e r e b o r n to m o t h e r s r e c e i v i n g A Z T a n d 40 t o m o t h e r s o n p l a c e b o . T h e r a t e o f t r a n s m i s s i o n w a s 8.3 p e r c e n t w i t h A Z T as c o m p a r e d w i t h 25.5 p e r c e n t w i t h p l a c e b o . A s a result, A Z T t r e a t m e n t w a s o f f e r e d to all r e m a i n i n g p a r t i c i p a n t s o n p l a c e b o w h o w e r e still p r e g n a n t a n d to t h e i r i n f a n t s , s i n c e t h e r e s u l t s w e r e so d e a r . M o n i t o r i n g will c o n t i n u e . Preliminary analysis of the results shows that b o t h m o t h e r s a n d i n f a n t s t o l e r a t e d A Z T well w i t h n o s i g n i f i c a n t s h o r t - t e r m a d v e r s e effects o t h e r t h a n m i l d a n a e m i a in s o m e i n f a n t s , w h i c h resolved after AZT was stopped. Most of the w o m e n w e r e at a relatively e a r l y s t a g e o f HIV disease. C o n g e n i t a l a n o m a l i e s in t h e i n f a n t s did n o t differ f r o m w h a t w o u l d b e e x p e c t e d in t h e general population or between treatment and p l a c e b o g r o u p s . S e v e n i n f a n t s in e a c h g r o u p d i e d e i t h e r o f s e r i o u s a n o m a l i e s p r e s e n t at b i r t h o r from HIV-related disease. B e c a u s e l o n g - t e r m effects o f A Z T t h e r a p y o n the infants are currently unknown, no recomm e n d a t i o n s a b o u t t r e a t m e n t to p r e v e n t t r a n s m i s s i o n o f HIV d u r i n g p r e g n a n c y a n d d e l i v e r y are being made, pending development of consensus on the balance between known benefit a n d u n k n o w n risk.l -
1. AZT reduces rate of maternal transmission of HIV. Press release, questions and answers, and executive summary. NIAID News. 21 February 1994.
Spermicides, c o n d o m s and HIV In 1989-90 in C a m e r o o n , 273 w o m e n e x c h a n g i n g sex f o r m o n e y p a r t i c i p a t e d in a trial a i m e d at determining the association between low dose (100rag) s p e r m i c i d e a n d c o n d o m u s e a n d HIV t r a n s m i s s i o n risks. T h e w o m e n h a d a m e a n o f 3.2 p a r t n e r s p e r w e e k d u r i n g follow up. T h e y w e r e g i v e n r e g u l a r s u p p l i e s a n d c o u n s e l l e d to u s e b o t h m e t h o d s f o r all i n t e r c o u r s e . T h e y r e c o r d e d a c t u a l u s e o n p i c t o r i a l logs a n d v i s i t e d t h e clinic o n c e a m o n t h for a m e a n f o l l o w u p o f 8 m o n t h s . Their previous condom use had been sporadic a n d less t h a n 10 p e r c e n t h a d u s e d s p e r m i c i d e s previously. Reproductive tract infections were d i a g n o s e d a n d t r e a t e d at e n t r y a n d d u r i n g follow up. D u r i n g t h e f o l l o w u p p e r i o d , 33 p e r c e n t o f t h e w o m e n h a d v a g i n a l / c e r v i c a l l e s i o n s , 11 p e r c e n t i n d u c e d c e r v i c a l b l e e d i n g , 39 p e r c e n t g o n o r r h o e a , 59 p e r c e n t t r i c h o m o n i a s i s , 74 p e r c e n t c a n d i d i a s i s . O n l y 20 p e r c e n t o f t h e w o m e n reported no incident of unprotected intercourse d u r i n g f o l l o w up. Nineteen women seroconverted during the study period. Almost three-quarters reported one or more condom breakages. There were frequent reports of various discomforts with both methods, though no association with lesions was found. Both consistent condom use and consistent spermicide use were associated with lower incidences of gonorrhoea and genital ulcers. C o n s i s t e n t s p e r m i c i d e u s e r s g a i n e d s u b s t a n t i a l p r o t e c t i o n f r o m HIV, as d i d c o n s i s t e n t condom users who had had experience with c o n d o m s p r i o r to t h e study. T h e g r e a t e s t protection was found with consistent use of both m e t h o d s in w o m e n w i t h p r e v i o u s c o n d o m e x p e r i e n c e . Lack o f p r e v i o u s c o n d o m e x p e r i e n c e was associated with reduced protection; however, w i t h o u t i n f o r m a t i o n o n c l i e n t v a r i a b l e s , reasons for this finding could not be ascertained. This s t u d y e x a m i n e s s p e r m i c i d e u s e at l o w d o s e s a n d w i t h a l o w f r e q u e n c y o f use. It f i n d s a p r o t e c t i v e effect o f s p e r m i c i d e s a g a i n s t HIV w i t h c o n s i s t e n t use. B e c a u s e c o n d o m u s e is also i n v o l v e d , t h e i n d e p e n d e n t effect o f t h e t w o m e t h o d s c a n n o t b e m e a s u r e d directly. 1 T h e r e is e v i d e n c e t h a t s p e r m i c i d e s in h i g h e r d o s e s w i t h f r e q u e n t u s e in a h i g h risk p o p u l a t i o n c a n i n c r e a s e t h e risk o f HIV infection. 2 A large, r a n d o m i s e d clinical trial o f n o n o x y n o l - 9 s h o u l d b e a p r i o r i t y o f HIV p r e v e n t i o n r e s e a r c h s o t h a t
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t h e v a l u e o f s p e r m i c i d e s f o r HIV r i s k r e d u c t i o n can be determined. 1 1. Zekeng, Leopold; Feldblum, Paul J; Oliver, Regina M et al, 1993. Barrier contraceptive use and HIV infection among high-risk women in Cameroon. AIDS. 7(5):725-31. 2. Kreiss, Joan; Ngugi, Elizabeth; Holmes, King; et al, 1992. Efficacy of nonoxynol-9 contraceptive sponge use in preventing heterosexual acquisition of HIV in Nairobi prostitutes. J A M A . 268:477-82.
Costing HIV prevention strategies C a s e s t u d i e s o f six HIV p r e v e n t i o n s t r a t e g i e s in d e v e l o p i n g c o u n t r i e s , m a i n l y in L a t i n A m e r i c a , t h e C a r i b b e a n a n d Africa, w e r e d o n e in a n a t t e m p t to c a l c u l a t e t h e i r costs. T h e six s t r a t e g i e s were: mass media campaigns, peer education p r o g r a m m e s , STD t r e a t m e n t , c o n d o m social m a r k e t i n g , safe b l o o d p r o v i s i o n , a n d n e e d l e exchange/bleach provision programmes. Financial c o s t d a t a w e r e a b s t r a c t e d f r o m p u b l i s h e d s t u d i e s o r o b t a i n e d d i r e c t l y f r o m p r o j e c t coo r d i n a t o r s . A w i d e r a n g e of c o s t s f o r e a c h s t r a t e g y w a s f o u n d , e.g. p e e r e d u c a t i o n c o s t f r o m U S $0.15 to $12.59 p e r c o n t a c t . T h e m o n e t a r y c o s t o f a p r o g r a m m e is o n l y o n e a s p e c t o f m e a s u r i n g its e f f e c t i v e n e s s . W i t h o u t t a k i n g i n t o a c c o u n t s u c h f a c t o r s as e f f e c t i v e n e s s in r e d u c i n g risk-related practices, cheapness may mistakenly b e s e e n as t h e o n l y m e a s u r e . F u r t h e r , s t r a t e g i e s where some of the costs are displaced onto the r e c i p i e n t s , s u c h as socially m a r k e t e d c o n d o m s , a p p e a r c h e a p e r o n l y if m e a s u r e s o f c o s t inc l u d e t h o s e t o p r o v i d e r s only. T h e c o m p l e x i t y o f m e a s u r i n g c o s t - e f f e c t i v e n e s s well is m a d e clear. 1 1. SOderlund, N; Lavis; Broomberg, J; and Mills, A, 1993. The costs of HIV prevention strategies in developing countries. Bulletin of the WHO. 71(5):595-604.
Misoprostol for second trimester abortions Illegal a n d d a n g e r o u s a b o r t i o n s a r e a m a j o r c a u s e o f m a t e r n a l m o r t a l i t y a n d m o r b i d i t y in M o z a m b i q u e . To r e d u c e t h i s p r o b l e m , i n d u c e d a b o r t i o n is o f f e r e d o n r e q u e s t at t h e o b s t e t r i c / gynaecology department of Maputo Central Hospital, after evaluation and authorisation by a
medical committee. The use of extra-amniotic p r o s t a g l a n d i n (PG) f o r s e c o n d t r i m e s t e r a b o r t i o n s is p r e f e r r e d o v e r s u r g i c a l m e t h o d s . This s t u d y w a s to d e t e r m i n e w h e t h e r m i s o p r o s t o l (Cytotec, a n o r a l PG) a d m i n i s t e r e d i n t r a v a g i n a l l y w a s a safe a l t e r n a t i v e to m e e t a l a r g e d e m a n d f o r s e c o n d t r i m e s t e r a b o r t i o n s in M a p u t o . In 1992, 121 w o m e n w i t h a m e a n a g e o f 23 w e r e g i v e n f o u r 200 m c g t a b l e t s of m i s o p r o s t o l v a g i n a l l y in o n e dose. T h i s d o s e o c c a s i o n a l l y caused frequent and painful uterine contract i o n s , so t h e d o s e w a s r e d u c e d t o 600 m c g f o r t h e n e x t t e n w o m e n , t h e n t o 400 m c g f o r 28 w o m e n a n d t h e n 200 m c g f o r t e n w o m e n . A n y w o m a n w h o s h o w e d n o s i g n s o f a b o r t i o n in p r o g r e s s 24 h o u r s l a t e r w a s g i v e n a s e c o n d dose. If a f t e r 48 hours abortion was not advanced, the method w a s c o n s i d e r e d to h a v e failed a n d s u r g i c a l a b o r t i o n w a s c a r r i e d out. E i g h t y p e r c e n t w e r e 12-15 w e e k s p r e g n a n t ; t h e r e m a i n d e r w e r e 16-22 w e e k s p r e g n a n t . A b o r t i o n o c c u r r e d in 91 p e r c e n t o f t h e w o m e n . T e n w o m e n d i d n o t a b o r t w i t h i n 48 h o u r s a n d five w o m e n p r e f e r r e d t o s t o p w a i t i n g a f t e r 24 h o u r s . In all b u t o n e o f t h e s e cases, v a c u u m a s p i r a t i o n w a s c a r r i e d o u t successfully. F o r t h e remaining woman an infusion of prostaglandin was administered. Vomiting, diarrhoea, fever and sweating were n o t o b s e r v e d in a n y o f t h e w o m e n . Five w o m e n required stronger analgesics than paracetamol. No transfusions were needed and there were no deaths or major complications. None of the women presented for follow-up treatment subs e q u e n t l y . V a c u u m a s p i r a t i o n , d o n e as a safeguard that abortion was complete for the p u r p o s e s o f t h e study, d i d n o t a p p e a r to b e n e c e s s a r y in m o s t cases. T h e r e s u l t s a p p e a r e d t o b e at l e a s t as g o o d as w i t h o t h e r P G m e t h o d s b e t w e e n 12 a n d 22 w e e k s of pregnancy, with the added benefits of a very l o w i n c i d e n c e o f c o m p l i c a t i o n s , l o w cost a n d e a s y s t o r a g e o f t h i s m e t h o d . A n initial d o s e o f 400 m c g o r less f o r p r e g n a n c i e s o v e r 15 w e e k s is s u g g e s t e d . A d d i t i o n a l s t u d i e s to d e t e r m i n e t h e optimum dosage and ascertain whether second trimester abortions with misoprostol alone are indeed complete, are needed. 1 1. Bugalho, Antonio, Bique, Cassimo, Alemida, Luisa and FaOndes, Anibal, 1993. The effectiveness of intravaginal misoprostol (Cytotec) in inducing
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abortion after eleven weeks of pregnancy. Studies in Family Planning. 24(5):319-23.
B a c t e r i a l v a g i n o s i s , late miscarriage and preterm delivery P r e t e r m d e l i v e r y is t h e m o s t i m p o r t a n t c a u s e of perinatal mortality and morbidity. There a r e m a n y c a u s e s a n d it r e m a i n s i n c o m p l e t e l y u n d e r s t o o d . This s t u d y in t h e U K of 738 w o m e n s h o w e d t h a t late m i s c a r r i a g e a n d p r e t e r m d e l i v e r y w e r e a s s o c i a t e d w i t h t h e p r e s e n c e of b a c t e r i a l v a g i n o s i s in e a r l y p r e g n a n c y . This association was independent of other recognised risk f a c t o r s s u c h as p r e v i o u s p r e t e r m delivery. The researchers recommend screening and t r e a t m e n t f o r b a c t e r i a l v a g i n o s i s b e f o r e t h e 16th w e e k of p r e g n a n c y to h e l p t o p r e v e n t t h e s e outcomes. 1 1. Hay, Phillip E, Lamont, Ronald F, Taylor-Robinson, David et al, 1994. Abnormal bacterial colonisation of the genital tract and subsequent preterm delivery and late miscarriage. British Medical Journal. 308(29 January):295-98.
Evaluation of home-based maternal records T h i r t e e n c e n t r e s in e i g h t c o u n t r i e s (Egypt, India, P a k i s t a n , P h i l i p p i n e s , S e n e g a l , Sri Lanka, D e m o c r a t i c Y e m e n a n d Z a m b i a ) p a r t i c i p a t e d in a W H O c o l l a b o r a t i v e s t u d y to e v a l u a t e h o m e - b a s e d m a t e r n a l r e c o r d s . T h e six o b j e c t i v e s o f t h e s e r e c o r d s - to p r o m o t e c o n t i n u i t y o f care, e n c o u r a g e e a r l y r e c o g n i t i o n o f w o m e n a n d n e w b o r n s at risk a n d i n i t i a t e action, p r o m o t e r e f e r r a l t h a t meets women's needs, encourage appropriate c a r e a n d self-care, p r o v i d e a useful a n d p r a c t i c a l record, and provide a focus for health education - a r e e a c h e x a m i n e d . P r o b l e m s s u c h as o v e r s e l e c t i o n a n d r e f e r r a l o f w o m e n at risk a r e a d dressed and solutions suggested. W o m e n u s e r s s u g g e s t e d i m p r o v e m e n t s in t h e l a n g u a g e , i l l u s t r a t i o n s , layout, a n d c o n t e n t o f t h e records. Health workers using the records with w o m e n o f t e n felt m o r e t r a i n i n g a n d s u p p o r t w a s needed. They wanted guidelines for identifying risk f a c t o r s , s t a n d a r d s o f care, m a k i n g r e f e r r a l s and ensuring that referral units were equipped for emergencies. Although the impact of using the records on rates of maternal mortality and
morbidity could not be measured, the records c o n t r i b u t e d s u b s t a n t i a l l y t o i m p r o v e d quality and quantity of antenatal, postnatal and interpregnancy care of mothers and better neonatal care. 1 1. Shah, P M, Selwyn, B J, Shah, K, Kumar, V, et al, 1993. Evaluation of the home-based maternal record: a WHO collaborative study. Bulletin o f the WHO. 71(5):535-48.
B r e a s t s c r e e n i n g or mammography? W h i l e m o s t w o m e n w i t h b r e a s t c a n c e r in t h e U S A a r e o v e r a g e 50, in P a k i s t a n t h e a v e r a g e a g e is 45 a n d o n e in five w o m e n is u n d e r a g e 35. In Pakistan, few women do breast self-examination a n d t h e a v e r a g e size o f l u m p s at t h e t i m e o f d i a g n o s i s is o v e r 5 cms, w i t h p o o r p r o g n o s i s . 1 M a m m o g r a p h y is a c o m p l e x s c r e e n i n g test, t e c h n i c a l l y difficult t o p e r f o r m a n d i n t e r p r e t , a n d requires great expertise, staff training, quality c o n t r o l a n d e x p e n d i t u r e to s u c c e e d in r e d u c i n g m o r t a l i t y . W h i l e it also c o s t s m o n e y t o t r a i n surgeons, pathologists and nurse examiners to d o b r e a s t s c r e e n i n g b y p h y s i c a l e x a m i n a t i o n , it w o u l d c o s t c o n s i d e r a b l y less t h a n m a m m o graphy. The costs of physical examination could b e five to t e n t i m e s less t h a n f o r m a m m o g r a p h y , a n i m p o r t a n t c o n s i d e r a t i o n in a n e c o n o m i c recession when health care resources are scarce. This p a p e r p r o p o s e s critical e v a l u a t i o n in r a n d o m i s e d trials o f t h e efficacy of p h y s i c a l e x a m ination by trained health professionals, with and w i t h o u t b r e a s t s e l f - e x a m i n a t i o n b y w o m e n , as a n a l t e r n a t i v e to m a m m o g r a p h y . 2 1. Early age of onset: an outstanding feature of breast cancer in Pakistani women. National Health. January-March 1993, 73. 2. Mittra, I, 1994. Breast screening: the case for physical examination without mammography. Lancet. 343(5 February):342-44.
Effects o f t a m o x i f e n o n t h e endometrium L a r g e trials h a v e b e e n set u p to a s s e s s w h e t h e r t a m o x i f e n d e c r e a s e s t h e risk of b r e a s t c a n c e r in h e a l t h y w o m e n , so it is i m p o r t a n t to i n v e s t i g a t e t h e d r u g ' s p o t e n t i a l a d v e r s e effects, i n c l u d i n g t h e risk o f e n d o m e t r i a l c a n c e r . This c a s e - c o n t r o l
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t u d y in t h e N e t h e r l a n d s w a s of 98 w o m e n w h o a d e n d o m e t r i a l c a n c e r d i a g n o s e d at l e a s t t h r e e ~ o n t h s a f t e r a d i a g n o s i s of p r i m a r y b r e a s t a n c e r a n d 285 m a t c h e d c o n t r o l s . T a m o x i f e n h a d e e n u s e d b y 24 p e r c e n t o f w o m e n w i t h u b s e q u e n t e n d o m e t r i a l c a n c e r a n d 20 p e r c e n t f controls. Women who had used tamoxifen for ~ore t h a n t w o y e a r s h a d a 2.3 (0.9-5.9) t i m e s r e a t e r risk of e n d o m e t r i a l c a n c e r t h a n n e v e r sers. T h e r e w a s a s ! g n i f i c a n t t r e n d o f i n c r e a s i n g [sk o f e n d o m e t r i a l ~ c a n c e r w i t h d u r a t i o n o f ~moxifen u s e a n d c u m u l a t i v e dose. T h e s e t r e n d s / e r e s i m i l a r w i t h daily d o s e s o f 4 0 m g o r 3 0 m g o r ,~ss, t h o u g h f e w of t h e w o m e n in t h i s s t u d y e c e i v e d 3 0 m g o r less. In a D a n i s h study, t h e lightly i n c r e a s e d risk a m o n g w o m e n w h o t o o k 0 m g o r less w a s n o t s i g n i f i c a n t . T h e d o s e o f t m o x i f e n in t h e p r e v e n t i o n trials is 2 0 m g . These researchers conclude that physicians h o u l d b e a w a r e t h a t t h e i n c r e a s e d risk o f n d o m e t r i a l c a n c e r a f t e r t a m o x i f e n u s e will c a u s e o m e m o r b i d i t y in b r e a s t c a n c e r p a t i e n t s t r e a t e d /ith t h e d r u g . H o w e v e r , t h e p r o v e n clinial b e n e f i t f t a m o x i f e n in c o n t r o l l i n g b r e a s t c a n c e r clearly u t w e i g h s t h e m o d e s t i n c r e a s e in e n d o m e t r i a l a n c e r risk. E n d o m e t r i a l c a n c e r h a s a m o r e ~vourable p r o g n o s i s t h a n b r e a s t c a n c e r , so n o a t i e n t s h o u l d b e d e n i e d t a m o x i f e n b e c a u s e of o t e n t i a l a d v e r s e effects o n t h e e n d o m e t r i u m . W h e t h e r t a m o x i f e n s h o u l d b e u s e d to p r e v e n t r e a s t c a n c e r in h e a l t h y w o m e n will d e p e n d o n 1hether t h e d e c r e a s e in t h e i n c i d e n c e o f b r e a s t ancer outweighs the increased risk of n d o m e t r i a t c a n c e r , w h i c h c u r r e n t trials a r e ~eking to d e t e r m i n e . Risks o f t a m o x i f e n at 3 0 m g n d 2 0 r a g d o s e s o v e r l o n g e r p e r i o d s (five y e a r s r m o r e ) a n d r i s k s f o r e x - u s e r s r e m a i n to b e etermined. 1 van Leeuwen, Flora E, Benraadt, Jantien, Coebergh, Jan Willem W e t al, 1994. Risk of endometrial cancer after tamoxifen treatment of breast cancer. Lancet. 343(19 February):448-52.
Sanitary protection among poor Bangladeshi w o m e n This s t u d y e x a m i n e s t h e s a n i t a r y p r o t e c t i o n u s e d b y 80 p o o r w o m e n in u r b a n , p e r i - u r b a n a n d r u r a l areas of Dhaka, Sylhet and Noakhali. Most used r a g s f o r m e n s t r u a l m a n a g e m e n t ; only a f e w u s e d s a n i t a r y n a p k i n s . O t h e r s u s e d c o t t o n wool, panties or nothing. Many did not know about s a n i t a r y p r o t e c t i o n a n d o t h e r s said it w a s t o o e x p e n s i v e to c o n s i d e r b u y i n g it. T h e s t u d y l o o k e d at beliefs a b o u t m e n s t r u a t i o n , h o w w o m e n cleaned the rags they used, and whether they had m e n s t r u a t i o n - r e l a t e d h e a l t h p r o b l e m s . It f o u n d a high instance of reproductive tract infections l i n k e d to t h e u s e o f m e n s t r u a l r a g s w h i c h w e r e n o t b o i l e d a n d / o r d r i e d in w a y s t h a t w o u l d h a v e p r e v e n t e d infection. E d u c a t i o n in culturally a c c e p t a b l e a n d f e a s i b l e w a y s to c l e a n r e - u s e d menstrual rags and panties for women who cannot afford disposable means of sanitary p r o t e c t i o n is r e c o m m e n d e d . 1 1. Ahmed, Shanaz, Huq, Nasreen, Chowdhury, Panna et al, 1992. Investigation into the sanitary protection needs of poor w o m e n in Bangladesh. Intermediate Technology, Bangladesh, May.
Assisted conception and the quality of parenting A s t u d y in t h e UK c o m p a r e d 41 families w i t h a c h i l d c o n c e i v e d b y in v i t r o f e r t i l i s a t i o n a n d 45 with a child conceived by donor insemination w i t h 43 families w i t h a c h i l d c o n c e i v e d n a t u r a l l y a n d 55 w i t h a c h i l d a d o p t e d in e a r l y i n f a n c y . T h e c h i l d r e n w e r e a g e d 4-8, r o u g h l y h a l f b o y s a n d girls, a n d w i t h p a r e n t s m a t c h e d f o r a g e a n d class. T h e q u a l i t y o f p a r e n t i n g w a s a s s e s s e d t h r o u g h a r a n g e o f t e s t s w i t h the c h i l d r e n , interviews with the mothers and questionnaires filled o u t b y b o t h p a r e n t s a n d t h e c h i l d r e n ' s teachers. The results suggest that a strong desire f o r p a r e n t h o o d is m o r e i m p o r t a n t to quality of p a r e n t i n g t h a n g e n e t i c ties. 1 1. Golombok, Susan, Cook, Rachel, Bish, Alison, and Murray, Clare, 1994. Parents and their children happy with assisted conception [letter]. British Medical Journal. 308(5 March):658-59.
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