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PubMed2006

Safety and efficacy of the cyclooxygenase-2 inhibitors parecoxib and valdecoxib after noncardiac surgery.

BACKGROUND: Valdecoxib and its intravenous prodrug parecoxib are reported to increase thromboembolic risk after coronary artery bypass grafting. The authors conducted a randomized trial to examine their safety and analgesic efficacy in patients recovering from major noncardiac surgical procedures. METHODS: The trial was randomized and double-blind, with 10 days of treatment and 30 days of follow-up. Patients (n = 1,062) received either parenteral parecoxib for 3 days and oral valdecoxib for the rest of the treatment period or placebo medications throughout. The frequency of predefined adjudicated postrandomization adverse events, including cardiovascular thromboembolism, renal dysfunction, gastroduodenal ulceration, and wound-healing complications, was assessed in each group. Secondary efficacy endpoints included patients' pain ratings, opioid analgesic consumption (recorded as morphine equivalents), and reports of opioid-related adverse effects. RESULTS: Predefined adjudicated adverse events had similar frequencies among patients who received parecoxib and valdecoxib (2.7%) and placebo patients (3.2%) (P = 0.58), including cardiovascular thromboembolic events (1.0% in each group; P = 1.0). Placebo patients consumed more morphine equivalents (66.2 +/- 92.4 mg) than did patients receiving parecoxib and valdecoxib (43.2 +/- 65.7 mg) (P < 0.001). Placebo patients had higher mean pain ratings on each of study days 2-10 (P < 0.01) and reported more opioid-related symptom distress on days 2-6 (P < 0.01). CONCLUSIONS: Parecoxib and valdecoxib are useful adjuncts to opioids for the treatment of postoperative pain in noncardiac surgical patients. Further study will be required to determine the safety profile of parecoxib and valdecoxib administered to patients with known atherosclerotic disease after noncardiac surgery.

Adult↗
PubMed2005

Beta-endorphin prevents collagen induced arthritis by neuroimmuno-regulation pathway.

OBJECTIVE: To observe the effects and mechanisms of beta-endorphin (beta-END) preventing collagen induced arthritis (CIA) by neuroimmuno-regulating pathway. METHODS: Female wistar (Ws) rats were used in this study. CIA was induced by Native bovine type II collagen emulsified with complete Freund's adjuvant (CFA). Beta-END was administered i.p. to CIA rats every other day from the 14th day (secondary immunization) to the 35th day after primary immunization. Clinical assessments were performed by two independent, blinded examiners every other day. Pathological and radiological observations were taken on the 35th day after the primary immunization. Tumor necrosis factor-alpha (TNF-alpha), interleukin-1beta (IL-1beta), interleukin-6 (IL-6), regulated upon activation, normal T-cell expressed and secreted (RANTES), inducible NO syntheses (iNOS), matrix metalloproteinase-2 (MMP-2) and MMP-9 mRNA expression of synovium tissues of CIA rats was estimated by quantitative RT-PCR. The frequency of spleen Th1 and Th2 cells were assessed by fluorescence activated cell sorter (FACS) assay. RESULTS: Clinical manifestation of rats with CIA were significantly abrogated or ameliorated by treatment with beta-END. Beta-END treatment in vivo could down-regulate mRNA expression of several pro-inflammatory cytokines, chemokines and MMPs in CIA synovial, and polarize Th1/Th2 balance to Th2. CONCLUSION: Beta-END alleviates CIA through both depressing Th1 responses and down-regulating proinflammatory and other rheumatic factors, suggesting beta-END is a promising anti-inflammatory and anti-rheumatic agent in treating CIA.

Analysis of Variance↗
PubMed1990

Efficacy of once-a-day terazosin in benign prostatic hyperplasia: a randomized, double-blind placebo-controlled clinical trial.

This randomized, placebo-controlled, double-blind study was performed to evaluate the efficacy and safety of once-a-day terazosin (10 mg/day) in ambulatory patients (n = 57) with benign prostatic hyperplasia (BPH). After a 4-week placebo lead-in and a 24-week treatment period with terazosin (both single-blind), 30 patients who responded to terazosin were randomly assigned to either the terazosin or placebo treatment group for 12 weeks. During the single-blind treatment period, the peak urine flow rate increased 54% from a baseline average of 7.76 ml/sec to 11.92 ml/sec after terazosin; the mean flow rate increased 55% from a baseline of 4.90 ml/sec to 7.59 ml/sec; and the residual volume decreased 56% from 93.1 ml to 40.7 ml. The mean obstructive symptom score, irritative symptom score and physician's global assessment score improved by 68%, 34% and 27%, respectively. All these changes were significant (P less than 0.05) when compared to baseline values. During the double-blind period, the improvement in all the variables was sustained in the terazosin group but not in the placebo group. Peak and mean urinary flow rates, and physician's global assessment showed significant (P less than or equal to 0.05) differences at the end of the double-blind period. Adverse events occurred only during the single-blind period. The most frequent were headache (n = 6), asthenia (n = 3), and hypotension (n = 3). In summary, terazosin administered once-a-day improved the obstructive and irritative symptoms of BPH, urine flow rates and residual volume. Terazosin was well tolerated.

Adrenergic alpha-Antagonists↗
PubMed1992

Clinical efficacy of a triclosan/copolymer pre-brush rinse.

A five-day, double-blind parallel clinical study was conducted to determine the effect on plaque removal of a pre-brush rinse containing 0.03 triclosan (Irgacare MP, Ciba-Geigy Corp.) and 0.125% of a copolymer of methoxyethylene and maleic acid (Gantrez, GAF Corp.), as compared to a matching placebo pre-brush rinse. One hundred eleven subjects were stratified into two balanced groups according to baseline Quigley-Hein Plaque Index scores. Each group was randomly assigned to use either the triclosan/copolymer pre-brush rinse or the matching placebo pre-brush rinse. In order to determine plaque removal efficacy of the pre-brush rinses, subjects rinsed their mouths twice daily (mornings and evenings) for one minute with 15 ml of their assigned pre-brush rinse. Immediately after rinsing, subjects brushed their teeth for 30 seconds with a commercially available dentifrice containing 0.76% sodium monofluorophosphate and a soft-bristled toothbrush. The morning rinsing/brushing procedure was done under supervision at the clinical facility. The evening rinsing/brushing procedure was done at home. After five days' use of their assigned pre-brush rinse and toothbrushing, subjects were evaluated by the dental examiner for residual plaque using the modified Quigley-Hein Plaque Index scoring procedure. When mean five-day Quigley-Hein Plaque Index scores were compared for both groups, the triclosan/copolymer pre-brush rinse removed 22.54% more plaque from all surfaces of the teeth than the matching placebo pre-brush rinse. When mean Quigley-Hein Plaque Index decrements (the difference between baseline and five-day Quigley-Hein Plaque Index scores) were compared for both groups, the triclosan/copolymer pre-brush rinse removed more than twice as much plaque from all surfaces of the teeth than the matching placebo pre-brush rinse (33.99% efficacy versus 15.19% efficacy). When mean five-day Plaque Severity Index scores were compared for both groups, the triclosan/copolymer pre-brush rinse removed 46.15% more plaque from the "more difficult to brush" surfaces of the teeth than the matching placebo pre-brush rinse. rinse.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed2000

Acute antidepressant effects of intravenous hydrocortisone and CRH in depressed patients: a double-blind, placebo-controlled study.

OBJECTIVE: The primary objective of this investigation was to examine the acute antidepressant effects of intravenous hydrocortisone and ovine corticotropin releasing hormone (CRH) infusions in patients with major depression. METHOD: Twenty-two patients who met DSM-III-R criteria for nonpsychotic major depression were randomly assigned to receive intravenously 1 mg/kg of ovine CRH, 15 mg of hydrocortisone, or saline under double-blind conditions on day 1. Standard depression rating scales were completed on day 1 before the study medications were administered and again the following day (day 2). RESULTS: Patients treated with hydrocortisone demonstrated a significantly greater reduction in total 21-item Hamilton Depression Rating Scale scores (mean reduction=8.4 points or 37%) than patients given ovine CRH (mean=1.2 points) or placebo (mean=1.3 points). CONCLUSIONS: Acute hydrocortisone infusion is associated with a rapid and robust reduction in depressive symptoms. The authors discuss the therapeutic implications of these findings.

Adult↗
PubMed1998

Optic neuritis with residual tunnel vision in perchloroethylene toxicity.

CASE REPORT: In a 57-year-old female owner of a dry-cleaning shop, we describe the association of severe bilateral optic neuritis with unexpectedly high concentrations of perchloroethylene/metabolites in the blood and of chloroform in urine. Visual disturbances consisted of complete blindness for 9 days in the left eye, for 11 days in the right eye, with bright phosphenes and pain on eye rotation. Only central (2-3 degrees radius) vision recovered in the following months. CONCLUSION: Although environmental concentrations of perchloroethylene were within normal limits, we measured five-fold increases in vapors emitted when ironing freshly dry-cleaned fabrics, and suggest that inhalation of perchloroethylene vapors was the cause of this case of ocular nerve toxicity, recapitulating a previous report of major perchloroethylene toxicity.

Blindness↗
PubMed1995

Comparative staining in vitro and plaque inhibitory properties in vivo of 0.12% and 0.2% chlorhexidine mouthrinses.

The mere incorporation of an active ingredient in an oral hygiene product does not necessarily guarantee efficacy. As new formulations appear, it would seem prudent to at least screen for activity by comparison with an established product. The aim of this study was to compare a new 0.12% chlorhexidine containing rinse with a well researched 0.2% chlorhexidine rinse product. The rinses were firstly compared in vitro for dietary staining effects and in vivo for plaque inhibition. Both formulations in vitro produced progressive staining of acrylic specimens with increasing passages through a standard tea solution. The clinical investigation was a 3-treatment, randomised, double blind, crossover, 4-day plaque regrowth study, balanced for 1st and 2nd order residual effects and involving 24 volunteers. From a zero plaque baseline, volunteers suspended oral hygiene and rinsed 2 x per day with the allocated rinse. The chlorhexidine doses were 18 mg and 20 mg per rinse for the 0.12% and 0.2% formulations, respectively. Plaque was scored by area and index on day 5. The results showed that the 2 chlorhexidine rinses were similar in efficacy by comparison with the control rinse. These studies in vitro and in vivo indicate that the chlorhexidine in the new preparation is available and active and the product could find use in those preventive applications suggested for other chlorhexidine formulations.

Acrylic Resins↗
PubMed2006

[Transoral resection of locally advanced squamous cell carcinoma of the lateral oropharynx: combination of CO2 laser microsurgery with flap reconstruction].

INTRODUCTION: Transoral laser microsurgery of locally advanced carcinomas of the lateral pharynx often results in exposure of major vessels of the neck and is accompanied by a substantial risk of intra- and postoperative bleeding. We therefore only perform these operations after external protection of neck vessels, if necessary combined with flap reconstruction. PATIENTS AND METHODS: Between October 2001 and December 2004, 11 locally advanced squamous cell carcinomas of the lateral oropharynx that reached the major vessels of the neck were treated as follows: after ipsilateral neck dissection with temporary protection of the jugular vein and carotid arteries, the neck remained open while transoral laser surgery of the primary tumor was performed. Pharyngeal defects were subsequently closed by either primary suture or a platysma myofascial flap. All patients underwent adjuvant radiotherapy. RESULTS: All primary tumors were completely resected. None of the patients required tracheotomy or placement of a percutaneous endoscopic gastrostomy tube. The mean duration of nasogastric feeding tubes was 12.7 days. In one case, the routine radiological contrast study revealed a blind cervical fistula 10 days after surgery. This healed spontaneously within 7 days. One mild postoperative hemorrhage had to be stopped by endoscopic coagulation under general anesthesia. During a mean follow-up of 19.4 months, none of the patients developed a local and/or regional recurrence. CONCLUSION: The surgical procedure described ensures sufficient protection of neck vessels during and after the transoral resection of advanced carcinomas of the pharynx. It successfully combines the advantages of minimally invasive laser microsurgery with those of flap reconstruction known from traditional surgery.

Carbon Dioxide↗
PubMed1993

Retinal and other manifestations of incontinentia pigmenti (Bloch-Sulzberger syndrome).

BACKGROUND: One of the largest series of patients with incontinentia pigmenti who have undergone detailed ophthalmologic examination is reported here, including previously unrecognized findings with visually disabling consequences. METHODS: Thirteen females with incontinentia pigmenti from eight unrelated families were evaluated. The diagnosis of incontinentia pigmenti had been established previously by a referring pediatrician or dermatologist in 12 patients and by the authors in one other patient on the basis of retinal findings and history of characteristic skin manifestations. RESULTS: Abnormalities of the eye, central nervous system, skeleton, teeth, and hair develop in a majority of patients. The authors describe the evolution of retinal vascular abnormalities, and, for the first time, document foveal hypoplasia (in 4 of their 13 patients). The authors also provide the first report of a child with a normal brain shown on computed tomographic scan at 3 days old, which evolved to devastating cerebral ischemia, edema, and cortical blindness beginning at 6 days old. CONCLUSIONS: Incontinentia pigmenti should be included in the differential diagnosis of patients with peripheral retinal vascular nonperfusion, preretinal neovascularization, infantile retinal detachment, or foveal hypoplasia, particularly if there is evidence of characteristic dermatologic or other systemic manifestations. In infants with incontinentia pigmenti, retinal vascular anomalies are best detected by examination under anesthesia using fluorescein angiography.

Adolescent↗
PubMed2001

Role of sulfite additives in wine induced asthma: single dose and cumulative dose studies.

BACKGROUND: Wine appears to be a significant trigger for asthma. Although sulfite additives have been implicated as a major cause of wine induced asthma, direct evidence is limited. Two studies were undertaken to assess sulfite reactivity in wine sensitive asthmatics. The first study assessed sensitivity to sulfites in wine using a single dose sulfited wine challenge protocol followed by a double blind, placebo controlled challenge. In the second study a cumulative dose sulfited wine challenge protocol was employed to establish if wine sensitive asthmatics as a group have an increased sensitivity to sulfites. METHODS: In study 1, 24 asthmatic patients with a strong history of wine induced asthma were screened. Subjects showing positive responses to single blind high sulfite (300 ppm) wine challenge were rechallenged on separate days in a double blind, placebo controlled fashion with wines of varying sulfite levels to characterise their responses to these drinks. In study 2, wine sensitive asthmatic patients (n=12) and control asthmatics (n=6) were challenged cumulatively with wine containing increasing concentrations of sulfite in order to characterise further their sensitivity to sulfites in wine. RESULTS: Four of the 24 self-reporting wine sensitive asthmatic patients were found to respond to sulfite additives in wine when challenged in a single dose fashion (study 1). In the double blind dose-response study all four had a significant fall in forced expiratory volume in one second (FEV(1)) (>15% from baseline) following exposure to wine containing 300 ppm sulfite, but did not respond to wines containing 20, 75 or 150 ppm sulfite. Responses were maximal at 5 minutes (mean (SD) maximal decline in FEV(1) 28.7 (13)%) and took 15-60 minutes to return to baseline levels. In the cumulative dose-response study (study 2) no significant difference was observed in any of the lung function parameters measured (FEV(1), peak expiratory flow (PEF), mid phase forced expiratory flow (FEF(25-75))) between wine sensitive and normal asthmatic subjects. CONCLUSIONS: Only a small number of wine sensitive asthmatic patients responded to a single dose challenge with sulfited wine under laboratory conditions. This may suggest that the role of sulfites and/or wine in triggering asthmatic responses has been overestimated. Alternatively, cofactors or other components in wine may play an important role in wine induced asthma. Cumulative sulfite dose challenges did not detect an increased sensitivity to sulfite in wine sensitive asthmatics and an alternative approach to identifying sulfite/wine sensitive asthma may be required.

Adult↗
PubMed1992

Antiplaque efficacy of a triclosan/copolymer prebrush rinse: a plaque prevention clinical study.

A 5-day, double-blind parallel clinical study was conducted to determine the antiplaque efficacy of a pre-brush rinse containing 0.03% triclosan and 0.125% of a copolymer of polyvinyl methyl ether maleic acid as compared to a matching matching placebo pre-brush rinse. A total of 114 subjects were stratified into two balanced groups according to baseline Quigley-Hein Plaque Index scores. Each group was randomly assigned to use either the triclosan/copolymer pre-brush rinse or the placebo pre-brush rinse. All subjects received a thorough oral prophylaxis at the start of the study. They rinsed their mouths twice daily (mornings and evenings) for 1 minute with 15 cc of their assigned pre-brush rinse. Immediately after rinsing, subjects brushed their teeth for 30 seconds with a commercially-available dentifrice containing 0.76% sodium monofluorophosphate and a soft-bristled toothbrush. The morning rinsing/brushing procedure was done under supervision at the clinical facility. The evening rinsing/brushing procedure was done at home. After 5 days' use of their assigned pre-brush rinse, subjects were evaluated for plaque formation using the modified Quigley-Hein Plaque Index scoring system. As compared to the matching placebo pre-brush rinse, the results showed: 1) The triclosan/copolymer pre-brush rinse provided a 28.15% reduction in plaque formation on all surfaces of the teeth. This reduction was statistically significant (P less than 0.001); 2) The triclosan/copolymer pre-brush rinse provided a 50% reduction in plaque formation on the "more difficult to brush" surfaces of the teeth.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed2001

The effect of chewing sugar-free gum on plaque regrowth at smooth and occlusal surfaces.

BACKGROUND AND AIM: Chewing gum has the potential to provide oral health benefits including plaque control. The aim of this study was to determine the effects of chewing sugar free gum on plaque regrowth at buccal, lingual and occlusal surfaces of teeth. METHOD AND MATERIALS: 11 healthy and dentally-fit dental hygiene students participated in this randomised, single-blind crossover 4-day plaque regrowth study. From a zero plaque score on day 1, subjects suspended oral hygiene measures and either chewed gum or did not chew gum over 4 days. Gum chewing was one piece chewed for 30 min 4 x per day. On day 4, subjects were scored for plaque after disclosing from buccal, lingual and unrestored occlusal surfaces. RESULTS: There was no significant difference in smooth surface plaque scores between the treatments but significantly less plaque accumulated (44%) at occlusal surfaces during gum chewing compared to no gum chewing. CONCLUSION: Chewing gum can reduce plaque accumulation at sites of predilection for caries but has little or no effect at sites of predilection for gingivitis.

Adult↗
PubMed1994

Benzyl-benzoate foam: effects on mite allergens in mattress, serum and nasal secretory IgE to Dermatophagoides pteronyssinus, and bronchial hyperreactivity in children with allergic asthma.

Home mattresses of 24 asthmatic children with house dust mite allergy were sprayed with either benzyl-benzoate foam or placebo in a double blind fashion, 10 days before the children left the residential house for asthmatic children Istituto Pio XII (located in the Italian Alps in an environment free of mites) and went back to their own home for the Christmas and Easter holidays. A further group of 8 children, whose mattresses received no treatment, was kept as an absolute control. Two days after spraying, benzyl-benzoate or placebo were vacuumed from the mattresses. Acarex test was performed immediately before spraying and at the end of each holiday period of 20 and 10 days, respectively. Bronchial hyperreactivity as well as serum and nasal secretory specific IgE for Dermatophagoides pteronyssinus were assessed in all children immediately before leaving and within 48 hr after returning to the residential house. The results of the study show that sprayed benzyl-benzoate foam was no more effective than placebo in reducing the level of house dust mite recovered from patients' mattresses, or in reducing bronchial hyperreactivity and IgE concentration in serum and nasal secretions.

Adolescent↗
PubMed1992

Do patients with moderately impaired gastrointestinal function requiring enteral nutrition need a predigested nitrogen source? A prospective crossover controlled clinical trial.

This prospective double blind randomised seven day crossover controlled clinical trial was carried out to determine whether enterally fed patients with moderately impaired gastrointestinal function require a predigested nitrogen (N) source compared with whole protein. Twelve malnourished patients with varying gastrointestinal abnormalities, who required enteral feeding, received 2.25 l of one of two isocaloric isonitrogenous enteral diets (1 kcal/ml, 4.8 g nitrogen/l) containing either predominantly medium chain peptides (tetra or higher peptides) or whole protein as the nitrogen source. Nitrogen absorption and balance were calculated from dietary intake and analysis of 24 hour total urinary and faecal nitrogen for the last five days of each study period. There was no significant difference in either stool weight (110 (SEM) (49) v 111 (32) g/d), nitrogen absorption (91 (2) v 89 (2)%) or nitrogen balance (+1.0 (1.3) v +0.6 (1.4) g nitrogen/d) between the peptide and whole protein nitrogen sources when all patients are considered. There was, however, evidence to suggest a nutritional advantage from administering an enteral diet whose nitrogen source comprises oligopeptides, rather than whole protein, to a subgroup of patients with small bowel disease.

Dietary Proteins↗
PubMed1991

Systemic or local treatment of erythrasma? A comparison between erythromycin tablets and Fucidin cream in general practice.

In a Danish multi-practice study the efficacy of erythromycin tablets (Abboticin 500 mg tablets), fusidic acid cream (Fucidin cream), and placebo was compared in 86 patients (71 men and 15 women) with erythrasma. The patients were treated 'double-blind' for 14 days with either active tablets + placebo cream, placebo tablets + active cream, or placebo tablets + placebo cream. The signs of erythrasma, i.e. colour intensity, demarcation, and scaling of the affected area, as well as degree of fluorescence under Wood's light, were recorded before treatment, after one and two weeks, and at follow-up four weeks later. Cure/improvement was obtained in 77% of the cases in the erythromycin group, 87% in the fusidic acid group, and 42% in the placebo group. There was no difference between the active preparations, whereas both were significantly better than placebo, P = 0.01.

Adolescent↗
PubMed1990

Effect of a mouthrinse containing triclosan and a copolymer on plaque formation in a normal oral hygiene regimen.

A 6-day, double-blind parallel clinical study was conducted to determine the effect on plaque formation of a mouthrinse containing 0.03% [corrected] triclosan (Irgacare MP) and 0.25% of a copolymer of methoxyethylene and maleic acid (Gantrez), as compared to a flavored/colored water placebo mouthrinse. A total of 47 subjects were stratified into two balanced groups using their pre-prophylaxis plaque score. All subjects received a thorough oral prophylaxis at the start of the study. Each group was randomly assigned to the use of either the water placebo mouthrinse or the mouthrinse containing triclosan/copolymer. Subjects rinsed their mouths twice daily (mornings and evenings) for 1 minute with 15 cc of their assigned mouthrinse. Immediately after rinsing, the subjects brushed their teeth for 30 seconds with a commercially available dentifrice containing 0.76% sodium monofluorophosphate in a silica base and a soft-bristled toothbrush. The morning rinsing/brushing procedure was conducted under supervision at the clinical facility. The evening rinsing/brushing procedure was performed at home. After 5 days' use of their assigned mouthrinse, subjects were evaluated by the dental examiner for plaque formation using the modified Quigley-Hein scoring procedure. The results indicated that the triclosan/copolymer mouthrinse provided a 31.03% reduction in plaque formation as compared to the water placebo mouthrinse. This reduction was statistically significant at the 99% level of confidence.

Adult↗
PubMed1990

Clinical study of a pre-brush rinse and a triclosan/copolymer mouthrinse: effect on plaque formation.

A 6-day, double-blind parallel clinical study was conducted to determine the effect on plaque formation of a mouthrinse containing 0.03% triclosan (Irgacare MP) and 0.25% of a copolymer of methoxyethylene and maleic acid (Gantrez), as compared to a flavored/colored water placebo mouthrinse and Plax antiplaque pre-brushing dental rinse. A total of 60 subjects were stratified into three balanced groups using their pre-prophylaxis Plaque Index score. All subjects received a thorough oral prophylaxis at the start of the study. Each group was randomly assigned to the use of either the water placebo mouthrinse, the Plax mouthrinse or the mouthrinse containing triclosan/copolymer. Subjects rinsed twice daily (mornings and evenings) for 1 minute with 15 cc of their assigned mouthrinse. Immediately after rinsing, subjects brushed their teeth for 30 seconds with a commercially available dentifrice containing 0.76% sodium monofluorophosphate in a silica base and a soft-bristled toothbrush. The morning rinsing/brushing procedure was performed under the supervision at the clinical facility. The evening rinsing/brushing procedure was conducted at home. After 5 days' use of their assigned mouthrinse, subjects were evaluated by the dental examiner for plaque formation. The results indicated that the triclosan/copolymer mouthrinse, when used as a pre-brush rinse prior to regular toothbrushing, provided statistically significant reductions in supragingival plaque formation, when compared to both a pre-brush water placebo mouthrinse (-39.83%) or Plax antiplaque prebrushing dental rinse (-37.30%).

Adult↗
PubMed2000

Natural progesterone, but not medroxyprogesterone acetate, enhances the beneficial effect of estrogen on exercise-induced myocardial ischemia in postmenopausal women.

OBJECTIVES: We sought to compare the effects of estrogen/transvaginal progesterone gel with estrogen/medroxyprogesterone acetate (MPA) on exercise-induced myocardial ischemia in postmenopausal women with coronary artery disease or previous myocardial infarction, or both. BACKGROUND: Estrogen therapy beneficially affects exercise-induced myocardial ischemia in postmenopausal women; however, women with an intact uterus also take progestin to protect against uterine malignancies. The effects of combination estrogen/progestin therapy on myocardial ischemia are unknown. METHODS: Eighteen postmenopausal women (mean +/- SD age 59+/-7 years) were given 17-beta-estradiol in single-blinded manner for four weeks (1 mg/day for three weeks then 2 mg/day for one week). Estradiol (2 mg/day) was then continued, and the patients were randomized (double-blind) for 12 days to either transvaginal progesterone gel (90 mg on alternate days) and oral MPA placebo (10 mg/day), or vice versa. After another two weeks on estradiol alone, the patients crossed over to progestin treatment and repeated the protocol on the opposite treatment. Patients underwent treadmill exercise testing after each estradiol phase and at day 10 of each progestin phase. RESULTS: Exercise time to myocardial ischemia increased after the first estrogen phase as compared with baseline (mean difference with 95% confidence interval [CI]: 72 s [34 to 110], p = 0.001), and was increased by combination estradiol/progesterone therapy as compared with estradiol/MPA therapy (92 s [35 to 149], p = 0.001)). Two patients (11%) were withdrawn while taking estradiol/MPA owing to unstable angina. CONCLUSIONS: Combination estrogen/transvaginal progesterone gel increases exercise time to myocardial ischemia, as compared with estrogen/MPA. These results imply that the choice of progestin in women at higher cardiovascular risk requires careful consideration.

Cross-Over Studies↗