Clinical acceptability, use-patterns and use-effectiveness of the vaginal contraceptive sponge and Neo Sampoon tablets--an international multi-center randomized clinical trial

This paper describes the results from a randomized clinical trial comparing the Collatex vaginal contraceptive sponge (a predecessor of the Today sponge) and Neo Sampoon foaming vaginal contraceptive tablets; the trial was conducted from 1979 to 1983 in four centers located in three countries (two in Yugoslavia and one each in Taiwan and Bangladesh). The sponge was associated with more insertion and retention problems than the tablet, especially in the two Asian centers. More Neo Sampoon users complained of a burning or stinging sensation. This complaint, however, seemed to be well-tolerated and was not a frequent reason for irregular use and/or discontinuation of use of the tablets. Clinically significant medical complications were rarely reported for either method. Sponge users were more likely to report irregular use than tablet users, primarily due to inconvenience of use. Rates of discontinuation at six months of use were also consistently higher among sponge users than Neo Sampoon users in the four centers. Life-table pregnancy rates at 12 months of use ranged from 3.8 to 18.2 per 100 sponge users and 6.2 to 29.9 per 100 Neo Sampoon users, based on data from the two Yugoslavian centers and the Taiwan center (data from the Bangladesh center were excluded from analysis of pregnancy rates). Practical implications of these findings are discussed.     

Association of vegetable, fruit, and grain intakes with colorectal cancer: the Multiethnic Cohort Study

BACKGROUND: It is uncertain whether or not vegetables, fruit, or grains protect against colorectal cancer. OBJECTIVE: In a large prospective study, we investigated the association of vegetable, fruit, and grain intakes with colorectal cancer risk. DESIGN: Between 1993 and 1996, 85 903 men and 105 108 women completed a quantitative food-frequency questionnaire that included approximately 180 foods and beverages in the Multiethnic Cohort Study. A diagnosis of colorectal cancer was made in 1138 men and 972 women after an average follow-up of 7.3 y. Cox proportional hazards models were used to calculate multivariate-adjusted relative risks and 95% CIs for colorectal cancer. RESULTS: In men, multivariate adjustment for energy intake, dietary, and nondietary variables resulted in relative risks in the highest quintile group of 0.74 (95% CI: 0.59, 0.93; P for trend = 0.02) for vegetables and fruit combined, 0.80 (95% CI: 0.64, 0.99; P for trend = 0.09) for fruit alone, and 0.85 (95% CI: 0.69, 1.05; P for trend = 0.05) for vegetables alone. When colon and rectal cases were separated among men, the inverse associations were stronger for colon than for rectal cancer. In women, none of the associations with vegetables, fruit, or vegetables and fruit combined were significant. Grain intake was not associated with colorectal cancer for either men or women. CONCLUSION: The intake of vegetables and fruit was inversely related to colorectal cancer risk among men but not among women. The association appears stronger for colon than for rectal cancer.     

Genetic polymorphisms in the estrogen receptor beta (ESR2) gene and the risk of epithelial ovarian carcinoma

Ovarian cancer is influenced by exogenous and endogenous estrogens as suggested by experimental and epidemiological evidence. Estrogen receptor beta is a predominant estrogen receptor in the normal ovary. Polymorphisms in the estrogen receptor beta gene (ESR2) might influence epithelial ovarian risk through regulation of cell proliferation and apoptosis. This population-based case–control study included 313 women with epithelial ovarian carcinoma and 574 controls, frequency-matched on age and ethnicity. Unconditional logistic regression was used to test associations of rs1271572, rs1256030, rs1256031, and rs3020450 ESR2 genotypes with ovarian cancer risk. Compared to homozygous common allele carriers, homozygous carriers of variant alleles for rs1271572 [odds ratio (OR) = 1.79, 95% confidence interval (CI):1.15–2.79, p global = 0.01] and rs1256030 [OR = 1.67, CI: 1.08–2.59, p global = 0.04], and women with haplotypes, including variant alleles of rs1271572, rs1256030, and rs1256031 SNPs [OR = 1.75, CI: 1.17–2.63, p global = 0.007], had significantly increased risk of ovarian carcinoma. The association of the rs1271572 genotype was strongest among women who had never used contraceptive steroids (p for interaction = 0.04). Our data suggest that ESR2 might be a susceptibility marker for epithelial ovarian cancer.     

Rare events associated with tubal sterilizations: an international experience

The results from previous analyses of an international data set collected by Family Health International are reviewed in relation to the incidence, severity, risk factors, and outcomes of rare events associated with tubal sterilization. The rare events included for review, by sequence of their relationship to the tubal sterilization procedure are: luteal phase pregnancy, intraoperative complications (uterine perforation, unintended laparotomy required for completion of the laparoscopic procedure, and technical failure in tubal ring sterilization), deaths, early readmission following laparoscopic sterilization, hysterectomy after laparoscopic sterilization, and pregnancy (intrauterine and ectopic) conceived after tubal sterilization. The widespread use of this method of contraception has important public health implications, and awareness of these events will help clinicians minimize such incidences and better deal with them when they arise.     

Detection of karyotype changes in interphase cells: oligonucleotide-primed in situ labelling versus fluorescence in situ hybridization

Interphase cytogenetics is a rapidly developing technique which is usually performed by fluorescence in situ hybridization (FISH). Recently, oligonucleotide-primed in situ synthesis (PRINS) has become established as a method of labelling centromeric regions of chromosomes in metaphase spreads. We tested the suitability of PRINS in detecting the exact copy number of chromosomes 1, 3, 7 and 8 in intact interphase cells of 17 cytological preparations derived from normal and neoplastic tissues. Control procedures consisted in preparation of metaphase spreads of lymphocytes of healthy donors, conventional cytogenetics in some of the specimens, and omission of the primers or Taq polymerase from the reaction mixture. All specimens were additionally examined by FISH and analysed blind by two experienced observers. Both PRINS and FISH revealed a corresponding distribution of hybridization signals for all chromosomes examined in specimens of normal bone marrow (n = 5), normal liver cells (n = 5), three samples of acute nonlymphocytic leukaemia in which conventional chromosome analyses had shown monosomy 7 or trisomy 8, and in four hepatocellular carcinomas that displayed trisomy 1. Overall, statistical analysis revealed no significant difference in the signal distribution between the two techniques. Our results demonstrate that PRINS is as reliable as FISH for detecting chromosome copy numbers in interphase nuclei of intact cells. The PRINS method, however, is easier to perform, faster and less expensive, holding great potential for future applications in diagnostic pathology.     

Reproductive risks in a community-based distribution program of oral contraceptives, Matamoros, Mexico

A Reproductive Risk Factors Survey was carried out in 1982 in conjunction with a community-based distribution (CBD) program in Matamoros, Mexico, to determine whether the distribution of oral contraceptives to women through CBD programs exposes any demonstrable group of users to more health risks than if the program had not been put in place. The methodology involved interviews by nurses of program pill users and non-program pill users. Health indicators related to cardiovascular accidents were the main focus of comparison between the groups. The data indicate that respondents were well informed about their own health status, and, in terms of the conditions studied, program users were found to be similar in health status to non-program pill users whether or not they were ever examined for contraindications to pill use. The study indicates that this CBD program has not increased the risks associated with pill use for its clients and has, in fact, given protection from pregnancy to women who may otherwise not have had access to oral contraceptives.     

Salmonella bloodstream infection in Ghanaian children

Objective: To examine the frequency of community-acquired salmonella bloodstream infection in Ghanaian children and the occurrence of antibiotic resistance in salmonellae.
Methods: The study comprised 472 patients with a blood culture obtained within 48 h of admission to the pediatric department of Korle Bu Teaching Hospital in Accra, Ghana, over a 3-month period. All Salmonella isolates from blood cultures were speciated and antibiotic susceptibility tests were performed. Clinical data of children with salmonella bloodstream infection were compared to those of controls. Two control groups were identified: all children enrolled in the study without salmonella bloodstream infection (group 1), and those with bloodstream infection due to other organisms (group 2).
Results: A pathogen was isolated from 111 children (23.5%), and salmonellae were among the most common isolates ( n =24; 21.6%). Among Salmonella strains, S. enteritidis ( n =14;59%) predominated over S. typhi ( n =6;25%). Resistance to several antibiotics was only found in S. enteritidis isolates ( n =8;57%). Children with salmonella bloodstream infection presented more often than controls with severe anemia, jaundice, abdominal pain and distension as well as hepatomegaly and splenomegaly. They were also hospitalized for a significantly longer period, but the case-fatality rate was similar.
Conclusions: Salmonella bloodstream infection, especially due to non-typhoidal strains, is a potential health problem for Ghanaian children and may be complicated by resistance to the commonly available antibiotics.     

Cervical dilatation in interval insertion of an IUD. Who requires it and does it lead to a high expulsion rate?

Cervical dilatation is occasionally performed to facilitate IUD insertions in difficult-to-insert cases. Patient characteristics associated with the need for dilation and whether dilation is associated with an increased risk of early expulsion of the IUD have rarely been studied. This analysis, using the extensive international IUD data base developed and maintained by Family Health International, is intended to answer these questions. This case-control analysis revealed that nulliparous women as well as women who had used oral contraceptives or an IUD in the previous month were more likely to require cervical dilatation at IUD insertion. Breastfeeding women, on the other hand, were less likely to require cervical dilatation to facilitate IUD insertion. Hypotheses are generated from this analysis that need to be tested in future studies. The six- and 12-month gross cumulative life-table expulsion rates and other pertinent termination event rates (e.g., accidental pregnancies and removals due to bleeding and pain) were not found to be higher for women with cervical dilatation than for women without.     

Expulsions in immediate postpartum insertions of Lippes Loop D and Copper T IUDs and their counterpart Delta devices--an epidemiological analysis

In this paper, an epidemiological analysis was performed, using an international data set, exclusively on the expulsion problem associated with postpartum IUD insertions. The inserter's experience in postplacental insertions is probably an important determining factor for IUD expulsions. Immediate insertions (within 10 minutes after placental delivery) are possibly associated with lower expulsion rates than later insertions (eg. two to 72 hours after placental delivery) during the woman's postpartum hospitalization. No significant differences were detected between the standard Lippes Loop D and Copper T IUDs and their counterpart Delta devices specifically designed for postpartum use, between the two types of Delta device or between the hand and inserter methods. A case-control analysis also did not detect any significant association between IUD expulsions and mild complications occurring or management performed during the third stage of labor and delivery. The practical implications of these findings, the methodologic problems of this analysis and future research strategies are also discussed.