EcoSun Pass: A tool to evaluate the ecofriendliness of UV filters used in sunscreen products.

OBJECTIVE: Sunscreens play a major role in the EU sun protection strategy in order to prevent humans from UV light-induced skin damage. In recent years, the demand for high-quality sunscreen products including aspects of broad range and photostability of the UV protection, showing good spreadability onto human skin and excellent sensorial properties during and after application has increased. Environmental aspects are considered. Sunscreens are complex compositions, with UV filters being the key element in the formulations reaching up to about 30% in content in the final product. Some of these ingredients, however, may be regarded as hazardous for the aquatic environment. Nevertheless, the aquatic ecosystem represents only a single environmental compartment, which may be impacted by UV filters. Therefore, the EcoSun Pass (ESP) tool was developed in order to assess the overall environmental impact of UV filters in combination with its efficacy (Sun Protection Factor, SPF and UVA Protection Factor, UVA-PF). METHODS: For that purpose, at first 24 of the EU-approved UV filters for sunscreen applications were evaluated for their environmental hazard profiles. Nine example UV filter compositions representing both SPF 30 and 50 were evaluated for ecofriendliness using the ESP tool. RESULTS: The results revealed that two out of four SPF 30 compositions are considered as ecofriendly. Likewise, from the SPF 50 two out of five did meet the criteria for ecofriendliness. Furthermore, the results showed that most ecofriendly example formulations have also the lowest overall UV filter content in the product, based on the use of highly innovative and least hazardous UV filters. CONCLUSION: These results demonstrate that the tool is applicable to various formulations being present on the market and thus allows for a selection of most ecofriendly and efficient UV filters to be used in sunscreens.

OBJECTIF: les écrans solaires jouent un rôle majeur dans la stratégie de protection solaire de l'UE, afin de protéger les êtres humains contre les lésions cutanées causées par les rayons ultraviolets. Au cours des dernières années, la demande pour des écrans solaires de haute qualité a augmenté, notamment ceux ayant une bonne capacité d'étalement sur la peau humaine, d'excellentes propriétés sensorielles pendant et après l'application, une plage large et démontrant la photostabilité de la protection anti-UV. Les aspects environnementaux sont pris en compte. Les écrans solaires ont des compositions complexes, les filtres UV étant l'élément clé des formulations, avec une présence jusqu'à près de 30 % dans le contenu du produit final. Toutefois, certains de ces ingrédients peuvent être considérés comme dangereux pour l'environnement aquatique. Néanmoins, l'écosystème aquatique ne représente qu'un seul compartiment environnemental pouvant être affecté par les filtres UV. Par conséquent, l'outil EcoSun Pass (ESP) a été développé afin d'évaluer l'impact environnemental global des filtres UV, ainsi que leur efficacité (facteur de protection solaire, FPS et facteur de protection UV-A, UVAPF). MÉTHODES: dans ce but, les profils de risque environnemental de 24 des filtres UV approuvés dans l'UE, pour les applications d'écran solaire, ont d'abord été évalués. Le respect de l'environnement de neuf exemples de compositions de filtres UV, représentant les FPS 30 et 50, a été évalué à l'aide de l'outil ESP. RÉSULTATS: les résultats ont révélé que deux des quatre compositions de FPS 30 sont considérées comme écologiques. De même, deux écrans solaires sur cinq ayant un indice FPS 50 répondaient aux critères de respect de l'environnement. De plus, les résultats ont montré que la plupart des exemples de formulations écologiques contiennent également la plus faible teneur globale en filtres UV ; elles sont basées sur l'utilisation de filtres UV hautement innovants et les moins dangereux. CONCLUSION: ces résultats démontrent que l'outil est applicable à diverses formulations présentes sur le marché, et qu'il permet donc d'utiliser une sélection des filtres UV les plus écologiques et efficaces dans les écrans solaires.

Inhibitory effect of acetylsalicylic acid on human platelet function in normal volunteers and in women using a combined oral contraceptive regime.

Six parameters related to the release reaction were measured simultaneously in 10 human volunteers prior to the intake of one single dose of 1 g acetylsalicylic acid and 1, 4, 5, 6 and 7 days alter: deltaE5 with diluted collagen, deltaE10 with Thrombofax and the serotonin-14C release by undiluted and diluted collagen, by Thrombofax and by bovine plasma. The duration of the inhibitory effect varied according to the test used. It was the most prolonged (through the 7th day) if serotonin-14C release by diluted collagen was measured. A systematic investigation of the platelet release reaction in women taking a combined oral contraceptive was also performed. There were no statistically significant differences from a control group. No difference in acetylsalicylic acid sensitivity, measured 24 hours after intake of 1 g of aspirin, could be demonstrated.

Intrauterine contraception in adolescent women. The GyneFix intrauterine implant.

Pregnancy rates among adolescents have not decreased over the last 10 years, despite numerous efforts. To solve this important health problem, the major strategy recommended is to encourage contraceptive use among sexually active teenagers. An important means of obtaining this is by promoting methods that are not dependent on daily administration in order to avoid noncompliance. One such method (Norplant) has already shown to be much more effective than the combination pill in preventing pregnancy in adolescent women. The frameless intrauterine implant system (fixed, frameless, and completely flexible) has been studied since 1985 in women between 14 and 50 years of age. The results in young nulligravid women confirm its very high effectiveness (cumulative pregnancy rate at 36 months: 1.4%), its low expulsion rate (cumulative rate at 36 months: 0.9%) and its optimal tolerance (cumulative removal rate for medical reasons at 36 months: 2.4%), resulting in a high acceptance of the implant and a high continued use. The system (GyneFix) offers long-term protection (5 years), and its insertion, with or without anesthetic, is easily accomplished in the office. The GyneFix should therefore be recommended as an excellent alternative for birth control pills for young women with low risk for STDs, especially when compliance is a problem, without an increased risk for complications and without systemic side effects. Removal of the device is accomplished by traction on the tail. It can also be used for emergency contraception and for insertion immediately after termination of pregnancy.

The cesarean delivery rate can be safely reduced in a developing country.

In an attempt to reduce the cesarean rate without adverse effect on outcome, new guidelines for the management of dystocia, previous cesarean delivery, fetal distress, and breech presentation were introduced in September 1984 in a provincial hospital in Zimbabwe, Africa. Comparison of the 2-year periods before and after September 1984 showed that the cesarean rate had dropped from 16.8 to 8.0%, the maternal mortality rate from 202 to 57 per 100,000 births, and the perinatal mortality rate from 71.9 to 56.2 per 1000 births. During the latter period, use of oxytocin increased from 3.4 to 17.4%. These findings suggest that the adoption of strict guidelines can lead to a decrease in the cesarean rate and an improvement in obstetric outcome.

Bromocriptine in an injectable retard form for puerperal lactation suppression: comparison with Estandron prolongatum.

Intramuscular injection of a single 50-mg dose of long-acting bromocriptine microspheres was compared with a single intramuscular dose of an estradiol/testosterone ester combination in a single-blind, randomized study of 54 subjects. Bromocriptine was significantly more effective than the steroid drug in preventing milk flow, and rebound lactation was not observed in any bromocriptine-treated patients. Neither group showed deleterious side effects or significant biologic changes in coagulation parameters. There were no blood pressure or electrocardiographic alterations. Postpartum prolactin suppression was more intense after bromocriptine administration than after steroid therapy.

Plasma sex steroid and gonadotropin levels in control and silastic vaginal medroxyprogesterone acetate-impregnated ring cycles.

The concentrations of sex steroid hormones in plasma were determined daily in 14 young adult women, during both a control cycle and a treatment cycle. During the latter a Silastic ring into which 100 or 200 mg of medroxyprogesterone acetate (Provera) had been incorporated was worn intravaginally. During the treatment cycles, plasma levels of estradiol, progesterone, and 17-hydroxyprogesterone remained within the range observed during the early follicular phase. Testosterone and androstenedione levels did not show any cyclic variation during the treatment cycle; however, the mean levels were decreased by about 25% compared with the over-all plasma levels of the control cycle, whereas dehydroepiandrosterone levels were decreased by about 15%. It is concluded that these Provera-containing Silastic intravaginal rings inhibit ovulation and decrease androgen secretion by the ovaries significantly.

A double-blind trial of single-dose ciramadol for the treatment of post-episiotomy pain.

A randomized double-blind trial was carried out in 54 women to evaluate the effectiveness of ciramadol in a single (60 or 30 mg) oral dose regimen, compared with 60 mg codeine and placebo, in the treatment of post-episiotomy pain. Ciramadol gave a significantly better analgesic effect, at both 2 and 6 hours, and produced negligible side-effects. Codeine did less well than placebo in this study.

The multisleeved copper T model TCu220C: effect of long-term use on corrosion and dissolution of copper.

Corrosion and dissolution of copper were studied in 136 multisleeved TCu220C models used for up to 158 months. Surface alterations were examined at low magnification. Topography and depth of copper corrosion were evaluated microscopically in cross-sections of the TCu220C devices. Amounts of residual copper were determined by X-ray fluorescence spectrometry. Sleeve and wire corrosion differ in two respects: edge corrosion is typical for tubular copper and the corrosion process is more pronounced in the upper part of multisleeved devices. Despite considerable individual variation, maximum corrosion depth in relation to duration of IUD use is topographically similar for copper sleeves and copper wire. Calcareous deposits reduce both the dissolution and the corrosion of copper but not the contraceptive effectiveness of the TCu220C. Up to 125 months, the loss of copper from deposit-bearing devices amounts on average to 8 micrograms/day as against 23 micrograms/day for TCu220C models without visible coating.

Corrosion of filamentous intra-uterine copper. The MLCu250 and the MLCu375.

Although the effective life span of an IUD provided with filamentous copper is, calculated on the basis of the rate of dissolution of copper, several years, corrosion may lead to breakage of the wire after a shorter period of use. When copper wire with a diameter of 0.20 to 0.25 mm is used, the proportion of IUDs with broken wires increases with time after three years of use. It was not known whether this disadvantage could be reduced or eliminated by the use of a thicker wire. In this study the corrosion behaviour was observed in MLCu250 and MLCu375 devices, which have copper wire with a diameter of 0.30 and 0.40 mm, respectively. The earliest breakage was observed after 8 months of use for 0.30 mm wire and after 9 months of use for 0.40 mm wire. In IUDs with 0.30 mm wire the proportion with broken wires increased after 3 years of use. Since examples of the MLCu375 with 0.40 mm wire used for more than 3 years were few, it was impossible to make definite conclusions in this respect. In general, the corrosion behaviour in copper diameter range of 0.3 to 0.4 mm is the same as indicated in previous studies for diameter range of 0.2 to 0.25.

Metabolic effects of the triphasic oral contraceptive Trigynon.

Effects of Trigynon, a triphase low-dose oral contraceptive, containing ethinylestradiol and l-norgestrel in various proportions, on testosterone binding globulin, transcortin, thyroxine, free testosterone, free cortisol and free thyroxine as well as on plasma lipids and glucose tolerance were studied in 12 normal women treated for 3-6 months. Trigynon appears to have dominant estrogenic effects as evidenced from the increase in transport proteins and the decrease in free testosterone concentration. Plasma lipids were not significantly influenced; glucose tolerance was slightly, but not significantly decreased.

Effect of long-term hormonal contraception on plasma lipids.

Serum lipid and apoprotein levels were determined in fasting women after long-term use (5-12 years) of Depo Provera, Orgametril, Ortho Novum SQ, Binordiol, Microgynon-50, and Ministat. Compared with matched controls, pure progestogens (Depo Provera and Orgametril) caused a moderate decrease of TG, HDL chol, and Apo A1, whereas estrogen-dominant oral contraceptives (Ortho Novum SQ) increased the same parameters. The effects of long-term use of hormonal contraception on lipids did not differ from those predicted from short-term (6 months) studies.

PIP: Serum lipid and apoprotein levels were determined in fasting women after longterm use (5-12 years) of Depo-Provera, Orgametril, Ortho Novum SQ, Binordiol, Microgynon-50, and Ministat. Compared with matched controls, pure progestogens (Depo-Provera and Orgametril) caused a moderate decrease of triglycerides (TG), HDL cholesterol, and Apo Al, whereas estrogen-dominant oral contraceptives (Ortho Novum SQ) increased the same parameters. The effects of longterm use of hormonal contraception on lipids did not differ from those predicted from short-term (6 months) studies.

Copper loss from the copper T model TCu22OC.

The effect of mineral deposits on the copper dissolution rate of the Copper T Model TCu22OC was examined. 118 Copper T22OC devices removed from subjects for various medical and personal reasons after 12 to 72 months in utero were examined and graded based on the proportion of the total copper area covered with mineral deposits. The deposits increased in average size during the first three years of IUD use and then remained relatively constant. Seventeen percent of the devices were in situ for four or more years. Copper analysis was performed on 30 Copper T 22OC devices from selected periods of use : 12-14, 22-26, 36-39 and 48-72 months of use. The mean daily copper loss was 29.4 micrograms and the range, 7.3 to 62.1 micrograms. An inverse correlation between the amount of mineral deposit on the copper surface and the rate of copper loss was observed.

Plasma levels of ethinylestradiol (EE) during cyclic treatment with combined oral contraceptives.

The purpose of the present study was to extend the still limited data concerning ethinylestradiol (EE) plasma levels after repeated daily ingestion of a combination pill during the course of classical cyclic treatment. Plasma EE levels were followed in 13 volunteers throughout, in total, 19 treatment cycles with either a 50 ug EE (+ 125ug d-norgestrel) or a 30 ug (+ 150ug d-norgestrel) containing oral contraceptive. In addition, single plasma EE determinations were performed in 110 chronic oral contraceptive users. Whereas different patterns in plasma EE levels (sampling 24 hours following last pill ingestion) were observed among the different volunteers, the mean levels increased progressively during treatment and reflected closely the differences in dosage. The values obtained in the volunteers at the end of the treatment cycle showed important interindividual variations. The findings during a first treatment cycle or during the following ones were similar and for different treatment cycles in the same patient, the patterns in plasma EE levels were consistent. The results for single plasma determinations in chronic contraceptive users (sampling between 8th and 21st day of treatment cycle, 9 to 24 hours since last pill ingestion) showed more pronounced interindividual variations, the individual EE levels being not correlated to parameters such as body weight, body surface, months of oral contraception prior to the study, sex hormone binding capacity or day of the cycle. However, significant differences in mean plasma EE levels were noticed for patients treated with different commercial preparations with identical EE content, suggesting the existence of differences in bioavailability. The relevancy of plasma EE determinations is discussed and from the results of the present study, it is concluded that a strictly standardized time of sampling is an absolute condition for obtaining interpretable results.

Immediate post-placental IUD insertion: the expulsion problem.

This paper reports an evaluation of immediate post-placental insertion of a non-copper (Lippes Loop D) and several copper-bearing IUD models (TCu200, TCu220C, MLCu375, MLCu250, Nova T-PP, DimélysR). Based on the analysis of a total of 2,646 insertions and 55,794 woman-months of experience, we conclude that placement of an IUD within ten minutes of delivery of the placenta is a valuable alternative to interval insertion, because this method is safe and effective. Effectiveness was significantly lower for the Lippes Loop D than for the T- and ML-IUD models tested, the latter showing roughly comparable pertinent event rates. Pertinent event rates for copper IUDs were influenced by the skill of the operator; age of the recipient only had a significant effect on effectiveness, whereas parity had no significant effect on pertinent event rates. The single and still unsolved problem associated with immediate postpartum insertion is the greater likelihood of expulsion compared with interval insertion, and this hazard is significantly much greater for the Loop than for the copper-bearing devices assessed. The evolution of the expulsion rates shows a constant time-relationship. This pattern makes it obvious why follow-up of recipients, at least during the first trimester following insertion, is mandatory if immediate post-placental IUD insertion is to be optimally effective.

Cytogenetic evaluation of patients in relation to the use of oral contraception.

PIP: Chromosome damage was studied, in vivo and in vitro, in women using or having used oral contraceptives. Compared with those from a control group, no significant increase of numerical or structural abnormalities of metaphase chromosomes (n=149,599) was detected in phytohemoglutinin-stimulated lymphocytes after 72 hours of culturing. Limitations of the experimental method in this and other chromosome studies are discussed in detail.^ieng

Immediate postplacental insertion and fixation of the CuFix postpartum implant system.

Since promising results were obtained with the CuFix interval implant system in international clinical trials conducted worldwide, a modification of the device adapting it for immediate postplacental insertion and fixation (IPPIF) seemed a logical approach to solve the expulsion problem of IUDs inserted at that particular time. Seventy-three insertions were performed at three university centers, during 1990 and 1991, both by skilled and unskilled investigators. The results of this multicenter study show the excellent retainability of the modified IUD supporting the validity of the anchoring principle. The insertion procedure is easy, requiring minimal training, and the insertion technique appeared to be safe.

PIP: Physicians inserted the CuFix postpartum (CuFixPP) implant system, an IUD, to a depth of 1.3 cm in the fundal myometrium in 73 healthy women soon after vaginal delivery (10-30 minutes) at either the University Hospital in Gent, Belgium; the University Medical School in Debrecen, Hungary; or Alexandra Hospital of the University of Athens in Greece. Since previous international clinical trials showed unacceptably high rates of expulsion of CuFixPP, researchers conducted this trial to test the IUD after having it modified for immediate postplacental insertion and fixation. None of the physicians had received training in the insertion procedure of this experimental IUD. The cumulative expulsion rate at 12 and 18 months was 3.1. The cumulative pregnancy rate at 12 and 18 months stood at 1.5. The sole reasons for removal at 12 and 18 months were bleeding/pain and planned pregnancy (7.4 at 12 and months and 10.8 at 18 months; 9 at 12 months and 12.2 at 18 months, respectively). Physicians experienced difficulty removing the IUD in 4 cases. The removals did not cause noticeable bleeding. No complications occurred. These findings revealed that, with further modifications, the CuFixPP IUD holds considerable promise as a simple and effective method of postpartum contraception, which can easily be inserted by nurses or midwives, especially in developing countries.

Immediate postplacental IUD insertion: a randomized trial of sutured (Lippes Loop and TCu22OC) and non-sutured (TCu22OC) models.

A randomized clinical trial concerning immediate post-placental insertion (IPPI) of the Delta Lippes Loop, Delta TCu22OC, and TCu22OC was undertaken to assess the effect of the addition of catgut strands on IUD performance. A total of 906 devices were inserted and the subjects followed for 20 months, at which time 14,136 woman-months experience had been accumulated. The Delta Loop constantly had inadmissibly high expulsion and pregnancy rates. The two T-IUD models had significantly lower rates of expulsion and pregnancy, and these rates were similar for the sutured and the non-sutured TCu22OC. Immediate postplacental insertion of the three IUD models was totally safe in terms of infection and perforation. Due to the difficulty of insertion and high expellability, the Delta Loop is considered unfit for IPPI. Performance of the TCu22OC was good but the results did not indicate that "suturing" improved the retainability of this IUD model significantly.

Intrauterine contraception: from silver ring to intrauterine contraceptive implant.

Gräfenberg introduced his silver ring in 1928 and by his classic paper, published in 1931, provided intrauterine contraception with a scientific basis. For largely non-medical reasons, the Gräfenberg ring vanished from the scene a few years later, and it took almost 30 years before the method was rehabilitated as a result of a change in mental attitude toward birth control, the awareness of world population explosion, and the introduction of improved intrauterine devices (IUDs). The United States became the epicenter of IUD research in the 1960s but, due to adverse publicity and the threat of litigation, the pendulum swung and European investigators took over the job of improving the IUD. Proceeding from Dr Gräfenberg's classic paper, the major steps in the evolution of the intrauterine devices are retraced with focus on the scientists who were innovative in the field.

Battey's operation: an exercise in surgical frustration.

Robert Battey (1828-1895) introduced bilateral oophorectomy for the treatment of non-ovarian conditions in 1872, coining the term "normal ovariotomy" for the operation. Normal ovariotomy - a contradictio in terminis - was practised widely for several decades. Alfred Hegar (1830-1914), among many other gynaecologists, extended the indications of Battey's operation to include the treatment of various ovarian conditions as well, e.g., small tumors. Better insight into female physiology and ovarian function finally pushed the sinister operation of Robert Battey from the scene.