Effects of comorbidities on quality of life in Filipino people with tuberculosis.

BACKGROUND: We investigated health-related quality of life (HrQoL) in Filipino people undergoing TB treatment, and whether HrQoL was negatively impacted by comorbidity with undernutrition, diabetes (DM) and anaemia.METHODS: Adult participants were enrolled in public facilities in Metro Manila (three sites) and Negros Occidental (two sites). Multivariate linear regression was used to model the four correlated domain scores from a WHOQOL-BREF questionnaire (physical, psychological, social, environmental). A forward-stepwise approach was used to select a final multivariable model with inclusion based on global tests of significance at P < 0.1.RESULTS: In 446 people on drug-susceptible TB treatment, DM and moderate/severe anaemia were not associated with HrQoL. After adjustment for age, sex, education, food insecurity, treatment adherence, inflammation, Category I or II TB treatment, treatment phase, current side effects and inhibited ability to work, moderate/severe undernutrition (body mass index < 17 kg/m²) was associated with lower HrQoL (P = 0.003) with reduced psychological (coefficient: -1.02, 95% CI -1.54 to -0.51), physical (-0.62, 95% CI -1.14 to -0.09) and environmental domain scores (-0.45, 95% CI -0.88 to -0.01). In 225 patients with known HIV status in Metro Manila, HIV was associated with modestly reduced HrQoL (P = 0.014).CONCLUSION: Nutritional status and food insecurity represent modifiable risk factors for poor HrQoL that may be alleviated through interventions.

Analysis of the bleeding pattern in assisted reproduction cycles with luteal phase supplementation using vaginal micronized progesterone.

This study was designed to determine the effects of a vaginal micronized progesterone preparation on bleeding patterns and pregnancy outcomes after in-vitro fertilization and intracytoplasmic sperm injection (IVF-ICSI). The study population consisted of 149 consecutive women who had undergone IVF-ICSI using 'long-protocol' stimulation with buserelin-human menopausal gonadotrophin (HMG). A retrospective chart analysis of computerized medical records was undertaken. Vaginal progesterone (200 mg three times daily) was begun the day before oocyte retrieval and continued for a minimum of 16-19 days following human chorionic gonadotrophin (HCG) administration. Occurrence of bleeding following HCG injection, pregnancy rate and outcomes, and serum concentrations of oestradiol were measured. Women undergoing IVF and embryo transfer with ICSI and using vaginal progesterone for luteal support had normal luteal phase lengths (day of HCG minus day of onset of bleeding). In the absence of pregnancy, bleeding occurred after 19.2 +/- 3.9 days (mean +/- SD). Out of the pregnant group only three women bled within 19 days of HCG administration: two had biochemical pregnancies which spontaneously vanished and one evolved to term. The results reflect the normal bleeding pattern to be expected when vaginal progesterone is used for luteal support in IVF and embryo transfer, an approach whose efficacy has been amply proven. No shortened luteal phases were observed using vaginally administered progesterone.

Induction of amenorrhea during hormone replacement therapy: optimal micronized progesterone dose. A multicenter study.

The effects of oral micronized progesterone on the endometrium and bleeding pattern have been assessed in a multicenter study of 101 postmenopausal patients. During a minimum of 6 cycles, the participants received either percutaneous 17 beta-estradiol (1.5 mg/day) associated with micronized progesterone (100 mg/day), given at bedtime for 21/28 days or 25 days/calendar month (n = 98) [1], or E2 (3 mg/day) for 25 days associated with progesterone (300 mg/day), from day 16 to day 25 (n = 3) [2], according to their willingness to induce, or not, cyclic withdrawal bleeding. Each endometrial biopsy performed at 6-month minimum was assessed by two independent pathologists: results showed 61% quiescent without mitosis, 23% mildly active with very rare mitoses and 8% partial secretory endometrium. The remaining biopsies showed inadequate tissue (4%) or a sub-atrophy (4%). No hyperplasia was found by any pathologist. In the case of inadequate material, the mean thickness of endometrial mucosa measured by ultrasonography was 3.9 mm. Amenorrhea incidence was 93.3 and 91.6% at the 3rd and 6th month of therapy, respectively. No bleeding occurred in more than 80% of women. The results show that a low dose of oral progesterone (100 mg/day), given during 25 days, efficiently protects the endometrium by fully inhibiting mitoses and induces amenorrhea in the majority of postmenopausal women, allowing better compliance to long-term therapy.

[A "no-bleeding" substitute hormone treatment with an oral microdose progesterone. A prospective multicenter study]. / Recherche d'un traitement hormonal substitutif "sans règles" avec la progestérone micronisée orale. Etude multicentrique prospective.

AIMS: Study of influence of different sequences of oral micronized progesterone (Pg) on endometrial morphology and the incidence of bleeding. DESIGN: Prospective comparative multicentric study conducted in 101 post-menopausal patients. PATIENTS AND METHODS: 98 patients who did not wish any regular withdrawal bleeding were given percutaneous oestradiol 17-beta (E2) (1.5 mg/d) associated with micronized Pg (100 mg/d) at bedtime during either 21 out of 28 days (group I), or 25 days per calendar month (group III), during a minimum of 6 months. For those wishing withdrawal bleeding (n = 3), E2 (3 mg/d) during 25 days was associated with Pg (300 mg/d) from the 16th to the 25th day of the month (group III). Endometrial biopsies were performed after 6 months of the same treatment and blindly analysed; transvaginal ultrasonography (measurement of endometrial mucosa thickness) was done in case of insufficient amount of tissue. RESULTS: Groups I and II: 61% of the endometrium were quiescent without mitosis, 23% were slightly active with rare mitoses, 8% partly secretory and 4% subatrophic. Sampling was inadequate in the remaining 4%. Mitotic activity of glands was low on the overall samplings (average < 0.53/1,000 cells). The average mucosa thickness was at 3.9 mm. No bleeding (spotting or withdrawal bleeding) occurred in 73.3% and 82.1% of cycles at the 3rd and 6th months of administration, respectively. Group III: endometrium were quiescent or slightly active and combined with frequent withdrawal bleeding. CONCLUSIONS: A relatively low dose of oral progesterone (100 mg/d) combined with E2 during 21d/28d or 25 d/month efficiently controls proliferation, induces a very low endometrial cyclic activity--while reducing spottings--and maintains an amenorrhea in the majority of women. This simple treatment is likely to improve compliance.

[Amenorrhea during menopausal hormone replacement therapy with a percutaneous estradiol and oral micronized progesterone combination]. / Aménorrhée lors du traitement hormonal substitutif de la ménopause par l'association d'estradiol percutané et de progestérone orale micronisée.

The effects of oral micronized progesterone-administered at a low dose-on the endometrium and on bleeding pattern have been evaluated during a multicenter study in which 101 patients were involved. For a minimum of 6 months, patients who did not wish to have withdrawal bleeding (98) received the association of 17 beta-percutaneous estradiol (1.5 mg/d) and oral micronized progesterone (100 mg/d, at bedtime) during 25 days per month (or 21 d/28). The few women (3) who wished regular bleeding were given progesterone (300 mg/d) with estradiol (3 mg/d), from the 16th to the 25th of the month. No hyperplasia was observed among the endometrial biopsies performed after 6 months minimum of treatment. 8% of the endometria were partially secretory, 4% were sub-atrophic, 23% were mildly active with rare mitoses and 61% were quiescent without mitoses. The remaining 4% were considered inadequate. Mitotic activity of the glands was minimal in all samplings (mean < 0.53/1,000 cells). The average thickness of the mucosa was measured by ultrasonography at 3.9 mm, in the cases of insufficient samplings. No bleeding (or spotting, or cyclic bleeding) occurred in 73.3% and 80.9% of the cycles, in the 3rd and 6th month of therapy. Therefore a low dose of oral Pg (100 mg/d) combined with E2 during 25 days/month efficiently controls endometrial proliferation, while allowing a very weak cyclic activity. This situation makes it possible to minimize spottings and to maintain an amenorrhea in the majority of patients, thus letting us hoping for an improvement in the observance of this simplified therapy.

[The endometrium under the effects of hormone replacement therapy in menopause with percutaneous estradiol and low-dose micronized progesterone]. / L'endomètre sous traitement hormonal substitutif de la ménopause par estradiol percutané et progestérone micronisée à faible dose.

AIM: The aim of our study is to evaluate the effects of a new combined association of percutaneous estradiol with oral micronized progesterone during 25 days/month and to confirm that a low dose of progesterone (100 mg/day) can adequately counteract endometrial proliferation induced by estradiol. METHODS: 78 endometrial tissue samples were obtained in a multicenter study on the effects of hormonal replacement therapy of the menopause. Endometrial biopsies were performed on average at the 6.6 month of the hormonal substitution (range: 5-13 months) after 12 days minimum exposure to progesterone. The morphological evaluation was performed blindly. RESULTS: All endometria are only slightly developed, without hyperplasia. Four groups were individualized: subatrophic endometrium (3), quiescent endometrium (48), slightly active endometrium (18), and endometrium with marginal secretion (6). Rare mitosis images have only been found in slightly active endometria. Their number is always very much below the normal proliferative phase with only 3 cases between less than 3 and 6 mitoses per 1000 glandular epithelial cells. CONCLUSION: A low micronized progesterone dose (100 mg/day) over a long period (25 days per month) allows to efficiently control the estrogen-induced endometrial proliferation. This adequate endometrial response is responsible for a high incidence of amenorrhea, often asked by patients, and for rare spottings.

[A randomized prospective study comparing supplementation of the luteal phase and early pregnancy by natural progesterone administered by intramuscular or vaginal route]. / Etude prospective randomisée comparant la supplémentation de la phase lutéale et de la grossesse débutante par la progestérone naturelle administrée par voie intra-musculaire ou vaginale.

Deficiency in the luteal phase has been shown during stimulated cycles using a protocol involving a GnRH agonist. The authors undertook a randomised prospective trial of supplementation by progesterone of the luteal phase and of early pregnancy in two hundred and seventy two patients requiring fertilisation in vitro (FIV), gamete inter-fallopian transfer (GIFT) or zygote inter-fallopian transfer (ZIFT). Either progesterone in solution in oil (50 mg/day) administered by intramuscular injection or micronized progesterone administered intra-vaginally (600 mg/d) were used as support for the luteal phase. Administration of progesterone in association with estradiol valerate was started on the day prior to oocyte puncture and was continued until the 12th week of pregnancy. The implantation rate was very close to the threshold of significance (P = 0.07) in favour of the patients given vaginal progesterone. There was a higher rate of clinical pregnancies (33.6 versus 26.7 p. cent) in the latter group, though this was not significant. While plasma progesterone (Pg) levels were lower in patients using vaginal progesterone, the abortion rate during the first three months was lower in this group (P < 0.05). Micronized progesterone administered vaginally was well tolerated by all patients. During stimulated cycles, notably by GnRHa, it thus proved to be more effective than Pg administered by intramuscular injection with regard to implantation and abortion rates.

A prospective randomized comparison of intramuscular or intravaginal natural progesterone as a luteal phase and early pregnancy supplement.

A luteal phase defect has been demonstrated in cycles stimulated using a protocol including a gonadotrophin releasing hormone agonist (GnRHa). We have conducted a randomized prospective study of luteal and early pregnancy supplementation in 262 women selected for in-vitro fertilization (IVF), gamete intra-Fallopian transfer (GIFT) or zygote intra-Fallopian transfer (ZIFT). Either intramuscular progesterone in oil (50 mg/day) or intravaginal micronized progesterone (600 mg/day) was used as luteal supplement. In association with oestradiol valerate, progesterone administration was initiated from the day before oocyte retrieval until the 12th week of pregnancy. The implantation rate just failed to reach statistical significance (P = 0.07) in favour of the group receiving intravaginal progesterone. In the latter group, we observed a higher clinical pregnancy rate (33.6 versus 26.7%, not significant). Despite lower plasma progesterone levels, a lower first trimester abortion rate (P less than 0.05) was found in the intravaginally treated group. Intravaginal micronized progesterone was well tolerated by all patients and appeared more effective than intramuscular progesterone in improving the implantation rate, and in decreasing the incidence of abortions in stimulated cycles including GnRHa.

[The administration of micronized progesterone in the treatment of threatened premature labor]. / L'administration de progestérone micronisée au cours du traitement de la menace d'accouchement prématuré.

A randomised double-blind placebo-controlled trial concerning the treatment of threatened premature labour was undertaken using the following methodology: beta-mimetics were given intravenously to all patients (44) and micronised progesterone or the placebo were prescribed orally after randomisation (22 patients in each group). The mean index of prolongation of pregnancy was similar in both groups. However, the mean duration of the intravenous infusion and the mean dose of beta-mimetics administered intravenously were significantly lower in the oral progesterone group (p less than 0.01). Similarly, there was a significant (less than 0.05) decrease in the mean duration of hospitalisation. The cost and risks of treatment are thus significantly reduced when beta-mimetics and oral progesterone are used in combination.

[Effects of deprivation and replacement by percutaneous 17 beta estradiol and oral progesterone on blood pressure and metabolic parameters in menopause patients with non-insulin-dependent diabetes]. / Effets de la substitution par 17 beta estradiol percutané et progestérone orale sur la pression artérielle et les paramètres métaboliques chez des patientes ménopausées diabétiques non insulinodépendantes.

The main purpose of this randomized controlled study was to assess the effects of postmenopausal estrogen replacement therapy on blood pressure (BP) and plasma renin substrate (PRS) in non insulin-dependent diabetic patients (DNID). We randomized 32 postmenopausal DNID (mean age: 55.3 +/- 4.2 years) into two groups: 16 women were untreated, and 16 received percutaneous estradiol (E2) 17 beta and natural progesterone for 6 months. Systolic (SBP) and diastolic (DBP) blood pressure were monitored by an automatic device at inclusion and on the 1st, 3rd and 6th months of therapy. Treatment efficacy was proven by significant E2 plasma increase to 92.2 +/- 13.4 pg/ml in the treated group, which is a sufficient level for preventing postmenopausal osteoporosis. No significant inter or or intra-individual variation in SBP or DBP was observed in either group. The same stability was noted for plasma renin substrate. No significant difference was noted between the two groups in terms of body weight, fructosamine and glycosylated hemoglobin A1c after 1, 3 and 6 months. There was also no change in plasma levels of total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides and apolipoproteins A1 and B. All the patients who received replacement therapy wished to continue treatment. We conclude that the association of percutaneous E2 17 beta and natural progesterone had no deleterious effects, in diabetic patients, on BP, carbohydrate and lipoprotein metabolism. Thus this postmenopausal replacement therapy appears preferable in this vascular high risk population, particularly since estrogens via the parenteral route may have an antiatherogenic effect by direct action on the vessel walls.

The use of micronized progesterone in the treatment of menace of preterm delivery.

The results of a study concerning the treatment of acute menace of preterm labor are given: beta-mimetics were administered intravenously in all cases (44) and micronized progesterone or placebo was administered orally after classical double-blind randomization (22 cases in each group). The mean index of pregnancy prolongation was the same in both groups. However the mean duration of the intravenous perfusion and the mean quantity of beta-mimetics administered intravenously were significantly reduced in the progesterone group (P less than 0.01). The mean duration of hospital stay was also significantly reduced (P less than 0.05). Cost and risks are finally significantly lessened.

[Value of a percutaneous estrogen solution in stopping lactation]. / Intérêt d'une solution oestrogénique percutanée pour le blocage de la lactation.

An open trial involving 121 women was carried out to compare the efficacy and safety of a percutaneous estrogen solution and of an anti-prolactin solution. The complete inhibition of the let-down of milk was slightly less frequently obtained with the Percutacrine Oestrogénique that with Parlodel. The efficacy of Percutacrine Oestrogénique was linked to two conditions of administration: administration soon after delivery and compliance with the dosage, which was less frequently achieved than with Parlodel. In contrast, the clinical safety of Percutacrine Oestrogénique was excellent, and significantly better than that of Parlodel, notably with regard to dizziness (p less than 0.001 for the first 5 days of treatment). The incidence of the depressive tendency commonly observed post-partum was lower in the group of women receiving Percutacrine Oestrogénique, and reached the level of significance after 10 days of treatment.

Contraceptive practice in 209 diabetic women regularly attending a specialized diabetes clinic.

In order to determine their contraceptive practice, 209 diabetic women, aged 16-50 years, regularly attending the diabetic clinic of a University Hospital in Paris, France, were interviewed. 134 (64%) were current-users of contraception. Contraceptive use was significantly lower among patients with NIDDM compared to patients with IDDM (46% vs 70%, p less than 0.01). Methods used were: intra-uterine devices (IUD) (32% of users), hormonal compounds (27%, almost exclusively low-dose progestogen only pill), occlusive and natural methods (27%), and tubal ligation (14%). The major gynaecological side-effects were associated with the use of low-dose progestogens (39% with amenorrhoea vs 14% for other methods, p less than 0.01). A subsample (n = 165, age-range 20-44 years) of this diabetic population was compared with a representative sample of 8,899 French women of the same age. The proportion of current-users of contraception in this diabetic population was lower than in the French population (63.5% vs 72.2%, p less than 0.02). The diabetic patients tended to use more efficient methods of contraception (pill, IUD and tubal ligation), but 11% of them used no contraception without a stated reason, compared to 4% of the French population. It is suggested that contraceptive guidance should be reinforced in diabetic women, particularly with NIDDM, in order to promote family planning, since tight glycaemic control before and during pregnancy is now recommended.

[Conception and contraception in diabetics]. / Conception et contraception chez les diabétiques.

PIP: Pregnancy in the diabetic women must be well-planned since it is crucial that the conception coincide with a period of perfect glycemic equilibrium. Contraception should be suspended only when the decision to conceive is made and the metabolic control is obtained. Currently, the mechanical and hormonal means of contraception (low-dose progestogen only) are the ones most commonly used. The child of a diabetic mother is open to risk for malformations, the result of hyperglycemia in the early stages of embryonic development. Impotence can plague the diabetic male's sex life. This is seen especially in autonomic diabetic neuropathy, in particular when there are severe urinary disorders. However, nonspecific causes for impotence are frequent in the diabetic male population and should be systematically investigated. (author's modified)^ieng

[Contraceptive methods used by female diabetic patients]. / Les methodes contraceptives actuelles utilisees par nos patientes diabetiques.

PIP: A questionnaire was used to study the contraceptive habits of ambulatory diabetic patients ages 16-50 (n=209) who were followed in the diabetology department of the Hotel-Dieu Hospital in Paris from June 1982 to December 1983. 64% of the patients were using contraceptives; 23% used none despite regular sexual intercourse and 13% had abandoned contraceptive use beforehand. This distribution was correlated to the type of diabetes and the parity. Microprogestagens and IUD were used most often (26% and 32%, respectively). The comparison with results of the broad study by the INED-INSEE in 1978 underscored the near absence of estroprogestagens and the lower percentage of microprogestagens used by diabetics than that compared with combined pills by the female French population. This is probably due to the poor gynecological tolerance which characterized this group. Microprogestagen users revealed the greatest incidence of amenorrhea (39%) and of menstrual disorders (33%). 19 contraceptive failures were noted, 6 of them with an IUD. 1/3 of the women did not use the method they chose initially, but 3/4 of them were generally satisfied. In conclusion, the frequent absence of effective contraception should be pointed out, particularly among the nulliparous, and the high percentage of IUDs inserted in these patients. Contraceptive advice is essential for diabetics in view of the importance of spacing each pregnancy. (author's modified)^ieng