The use of two estrogen preparations (a combined contraceptive pill versus conjugated estrogen cream) intravaginally to treat urogenital symptoms in postmenopausal Thai women: a comparative study.

OBJECTIVE: To determine whether the combined contraceptive pill used intravaginally was as effective as the standard conjugated estrogen cream for the treatment of urogenital symptoms in postmenopausal Thai women. SUBJECTS AND METHODS: In a randomized clinical trial, 40 postmenopausal women with urogenital symptoms were randomly allocated to two treatment groups for 8 weeks. The first group (n = 20) received a combined contraceptive pill by the vaginal route, one tablet per week at bedtime for 8 weeks. Each tablet contained 250 microg levonorgestrel plus 30 microg ethinyl estradiol. The second group (n = 20) was given 1 gm of an intravaginal conjugated estrogen cream at bedtime, three times in the first week, twice in the second week, and then once a week for the next 6 weeks (1 gram of conjugated estrogen cream contained 0.625 mg conjugated equine estrogens). Subjects were questioned about their urogenital symptoms, and vaginal cytologic smears, vaginal bacterial cultures, and urine cultures were performed before treatment and after 2, 4, and 8 weeks of therapy. RESULTS: The vaginal pH and the proportion of the fecal type bacteria decreased in both groups, with no statistically significant difference between the groups. The karyopyknotic index and the maturation index were improved during treatment in both groups. An increase in the proportion of lactobacilli were recorded in both groups after therapy, with no significant difference between the two groups. No significant changes were observed in urinary bacteria. The therapy (combined contraceptive pill and estrogen cream) had a marked effect on urogenital symptoms (vaginal dryness, dyspareunia, urinary frequency, and urinary urgency), with impressive improvement comparably in both groups. CONCLUSIONS: A combined contraceptive tablet administered vaginally once a week can alleviate urogenital symptoms in Thai postmenopausal women as effectively as the vaginal estrogen cream. However, the pills are much less expensive and are easily obtained in developing countries.

PIP: A randomized clinical trial conducted in Bangkok, Thailand, investigated whether intravaginal use of a combined oral contraceptive (OC) is as effective for the treatment of urogenital symptoms in postmenopausal women as the standard regimen of conjugated estrogen cream. 40 postmenopausal women (mean age, 54 years) with urogenital symptoms related to estrogen deficiency were allocated to one of two treatment groups for 8 weeks. The first 20 women received one OC (250 mcg of levonorgestrel and 30 mcg of ethinyl estradiol) per week; the remaining 20 women were given estrogen cream (0.625 mg conjugated equine estrogens) at bedtime 3 times in the 1st week, twice in the 2nd week, and weekly for the last 6 weeks. Vaginal pH and the proportion of fecal-type bacteria decreased, the karyopyknotic and maturation indices improved, and the proportion of vaginal colonization with lactobacilli increased in both groups, with no significant differences between treatments. Also recorded in both groups were impressive improvements in vaginal dryness, dyspareunia, urinary frequency, and urinary urgency. No significant changes were observed in urinary bacteria. Combined OCs are less expensive than vaginal estrogen cream and more readily available in developing countries. Since they are as effective as the cream at alleviating urogenital symptoms in postmenopausal women, their use for this purpose merits consideration.

Long term efficacy of hepatitis B vaccine in infants born to hepatitis B e antigen-positive mothers.

The long term protective efficacy of recombinant hepatitis B vaccine, administered alone or concomitantly with hepatitis B immunoglobulin, was assessed in 263 healthy neonates of hepatitis B e antigen-positive mothers. Infants received the first dose of vaccine at birth; additional doses were given at either Months 1, 2 and 12 or Months 1 and 6. During the follow-up period, which ranged from 2 to 4 years, protective titers (> or = 10 mIU/ml) of anti-hepatitis B surface antibodies were found in virtually all infants who had responded to the primary course of vaccination. "Natural boosts," without persistent infection, were observed in only a small number of children. All children who were shown to have become chronic carriers were infected within the first year of life. No statistical difference in long term protective efficacy could be shown between the two vaccination schedules used or between the use of vaccine alone or vaccine plus hepatitis B immunoglobulin for either schedule.

Itraconazole in the treatment of acute vaginal candidosis.

An open non-comparative multicenter study of Itraconazole (Sporal) 400 mg as a single day therapy for vaginal candidosis was carried out at Siriraj Hospital and Chulalongkorn Hospital from 1st November 1988 to 31st August, 1989. Fifty-nine female out patients with vaginal candidosis were included in the study after excluding pregnancy, lactation, mixed vaginal infection and prior antimycotic therapy. Two capsules of 100 mg Itraconazole were given b.i.d. as a single day 400 mg dose. The patients were evaluated at the beginning prior to treatment for physical signs and symptoms, direct microscopic examination, and culture of vaginal fluid. The first and second follow-up were arranged at the end of one week and one month after therapy. The evaluations were the same as in the first visit. The clinical cure rate was 89 and 90 per cent at first and second follow-up respectively. The mycological cure rates were 83.3 and 69.57 per cent at the first and second follow-up respectively. There was one case of Torulopsis glabarta at the second follow-up.

Development and validation of a simple device to estimate birthweight and screen for low birthweight in developing countries.

Low birthweight (less than 2500 g) is the major factor associated with the death of infants within the first 4 weeks of life. The mean birthweight of newborn babies of a certain geographic area reflects the quality of maternal and child health care service as well as the degree of socioeconomic development of that particular region. Hence, birthweight is being used increasingly as an indicator for health and socioeconomic planning. However, in a developing country such as Thailand, two-fifths of the babies are delivered at home and are not weighed because scales are not available. To solve this problem in rural areas, a circular nomographic chart was developed with which the birthweight can be computed from a newborn baby's chest and mid-arm circumferences. Preliminary trials comparing these charts with standard baby scales showed a high degree of accuracy with sufficient sensitivity and specificity.

Adverse skin reactions to transdermal oestradiol in tropical climate. A comparative study of skin tolerance after using oestradiol patch and gel in Thai postmenopausal women.

A crossover randomized comparison between two different transdermal oestradiol delivery systems has been performed in post-menopausal women of the Bangkok area. Clinical benefits were identical with the use of either a gel, applied once/day on 800 cm2 of skin and which totally evaporated within 3 min, or a patch applied for 3-5 days on 20 cm2 of skin. There was no evidence of pharmacokinetic advantage with the patch, and the day to day intra-individual variations were even greater with patch than with gel. There were no cutaneous side effects with the gel, but unacceptable skin reactions, including itching, vesicular rash and residual pigmentation, were present in 58% of patients during patch use. Therefore a combination, in a small skin area, of adhesive, occlusive effect and high oestradiol concentration does not appear appropriate in hot and humid climate.

Comparison of a recombinant DNA hepatitis B vaccine alone or in combination with hepatitis B immune globulin for the prevention of perinatal acquisition of hepatitis B carriage.

The protective efficacy of a recombinant DNA yeast-derived hepatitis B vaccine was assessed alone or in combination with hepatitis B immune globulin (HBIg) in neonates born to surface antigen (HBsAg)-positive and e antigen (HBeAg)-positive mothers. Neonates received either a 10 micrograms dose of vaccine alone or the same dose of vaccine plus 0.5 ml HBIg within 12 h of birth. All infants subsequently received 10 micrograms of vaccine at 1, 2 and 12 months. Only two of the 58 (3.4%) newborns of HBsAg-positive/HBeAg-positive mothers receiving vaccine alone became chronically infected with hepatitis B virus (HBV) while all infants administered vaccine + HBIg were protected. These results indicate that although the administration of HBIg can increase the protection rate, the use of vaccine without concomitant administration of HBIg according to the above schedule could considerably reduce the risk of perinatal HBV transmission.

Protective efficacy of a recombinant DNA hepatitis B vaccine in neonates of HBe antigen-positive mothers.

We have assessed the protective efficacy of a recombinant DNA hepatitis B vaccine alone in infants of women who were positive for the surface antigen and the e antigen. The infants received a 10-micrograms dose of the vaccine within 12 hours of birth and additional doses 1, 2, and 12 months later. No significant adverse reactions to vaccination were observed and the vaccine was highly immunogenic. Only 2 (3.6%) of the 55 infants followed up to 13 months became chronically infected with the hepatitis B virus, as evidenced by the persistent presence of hepatitis B surface antigen in serum samples. Without immunoprophylaxis, 65% to 90% of such infants would become chronic carriers. Immunization with a recombinant vaccine without concomitant administration of hepatitis B immunoglobulin, therefore, considerably decreased the incidence of the carrier state.