A comparison of two regimens of intravaginal misoprostol for termination of second trimester pregnancy: a randomized comparative trial.
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A prospective randomized trial was conducted in 148 women to compare the efficacy of two regimens of vaginal misoprostol for termination of second trimester pregnancy. Women aged 16-40 years requesting termination of second trimester pregnancy were randomized into two groups. Women in group 1 were given vaginal misoprostol 400 microg every 3 h for a maximum of five doses in 24 h. Women in group 2 were given vaginal misoprostol 400 microg every 6 h for a maximum of three doses in 24 h. If women did not abort in 24 h, the same regimen was repeated. The median induction-abortion interval in group 1 (15.2 h) was significantly shorter (P < 0.01) than that in the group 2 (19.0 h). The percentage of women who achieved successful abortion within 48 h in group 1 (90.5%) was also significantly higher (P < 0.02) than that in group 2 (75.7%). The incidence of fever was more common in group 1 (P = 0.01). It is concluded that the regimen of vaginal misoprostol 400 microg every 3 h with maximum of five doses in 24 h was more effective than the regimen of misoprostol every 6 h in termination of second trimester pregnancy. (+info)
Gastrointestinal health care resource use and costs associated with nonsteroidal antiinflammatory drugs versus acetaminophen: retrospective cohort study of an elderly population.
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OBJECTIVE: To estimate gastrointestinal (GI) health care resource use and direct costs associated with prescription nonsteroidal antiinflammatory drugs (NSAIDs) in an elderly population. METHODS: Using the Government of Quebec's health insurance database, we obtained the medical, pharmaceutical, and demographic records of 73,850 senior citizens who, between 1993 and 1997, had either an NSAID or an acetaminophen prescription dispensed. The date of their first dispensed prescription for an NSAID or acetaminophen was termed their index date. Patients who were not taking oral corticosteroids or anticoagulants at their index date, were not diagnosed with cancer at their index date, and were not hospitalized and did not have any GI events during the year prior to their index date were included in the study. Patients who had a dispensed NSAID prescription at their index date formed the NSAID cohort; the others formed the acetaminophen cohort. All patients were followed up for 2 years. The daily direct costs of GI events incurred during NSAID therapy by the NSAID cohort were compared with those incurred during a similar followup period by the acetaminophen cohort. The difference in these average daily costs was attributed to NSAID use. RESULTS: The NSAID cohort included 5,268 senior citizens and the acetaminophen cohort 2,245. More GI adverse events were observed in the NSAID cohort (odds ratio 2.48, 95% confidence interval 2.06, 3.00). The average daily direct cost of GI events for a day of NSAID therapy attributed to the NSAIDs was $0.84 (Canadian). On average, for each Canadian dollar spent on NSAIDs, an additional $0.66 was spent on their side effects. CONCLUSION: Safer alternatives to NSAIDs would significantly reduce medical care costs for patients in need of NSAID therapy. (+info)
Vaginal misoprostol alone for medical abortion up to 9 weeks of gestation: efficacy and acceptability.
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Misoprostol and mifepristone have been shown to be effective for medical abortion up to 9 weeks of gestation. When used alone, the successful complete abortion rate dropped to approximately 60%. It has been demonstrated that by adding water to misoprostol, the success rate rose to 92%. This is the first randomized study to investigate the efficacy of misoprostol and water versus misoprostol alone for first trimester medical abortion in women at +info)
Low-dose misoprostol for the prevention of low-dose aspirin-induced gastroduodenal injury.
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INTRODUCTION: The harmful effects of non-steroidal anti-inflammatory drugs (NSAIDs) on the gastric mucosa and the prophylactic effects of misoprostol are both dose-dependent. AIM: To investigate whether a low-dose of misoprostol is sufficient to prevent gastric mucosal injury caused by low-dose aspirin. METHODS: We conducted a double-blind placebo controlled parallel group endoscopic study in 32 evaluable volunteers. The main outcome measure was erosive injury (ulcers and superficial erosions) in the gastric mucosa over 28 days. RESULTS: Most subjects developed erosions on aspirin 300 mg daily. This was significantly reduced by misoprostol 100 microg daily. (Odds ratio 0.18, 95% CI: 0.07-0.48). There were no drug-related or gastrointestinal adverse events in subjects receiving misoprostol. CONCLUSION: Misoprostol 100 microg daily can prevent low-dose aspirin induced gastric mucosal injury without causing identifiable adverse effects. (+info)
Determining minimally important changes in generic and disease-specific health-related quality of life questionnaires in clinical trials of rheumatoid arthritis.
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OBJECTIVE: To define clinically meaningful changes in 2 widely used health-related quality of life (HQL) instruments in studies of patients with rheumatoid arthritis (RA). METHODS: Patients with RA (n = 693) who were enrolled in 2 double-blind, placebo-controlled clinical trials completed the Short Form 36 (SF-36) modified health survey and the Health Assessment Questionnaire (HAQ) disability index at baseline and 6-week followup assessments. Data on 5 RA severity measures were also collected at baseline and at 6 weeks (patient and physician global assessments, joint swelling and tenderness counts, and global pain assessment). Comparison of changes in the SF-36 scales and HAQ scores was made between groups of patients known to differ in the level of change on each RA severity measure. RESULTS: With few exceptions, changes in the SF-36 and HAQ scores were different between patients who differed in the level of change on each RA severity measure. Changes in the SF-36 and HAQ scores were more strongly related to changes in the patient and physician global assessments and patient pain assessment than to changes in the joint swelling and tenderness counts. CONCLUSION: Based on these results, minimally important changes in the SF-36 scales and HAQ disability scores were determined, which will be useful in interpreting HQL results in clinical trials. (+info)
Systematic review of the cost effectiveness of prophylactic treatments in the prevention of gastropathy in patients with rheumatoid arthritis or osteoarthritis taking non-steroidal anti-inflammatory drugs.
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A systematic review on the cost effectiveness of prophylactic treatments of non-steroidal anti-inflammatory drug (NSAID) induced gastropathy in patients with osteoarthritis or rheumatoid arthritis was conducted. Two reviewers conducted the literature search and the review. Both full and partial economic evaluations published in English, Dutch, or German were included. The criteria list published in the textbook of Drummond was used to determine the quality of the economic evaluations. The methodological quality of three randomised controlled trials (RCTs) in which the economic evaluations obtained probability estimates of NSAID induced gastropathy and adverse events was assessed by a list of internal validity criteria. The conclusions were based on a rating system consisting of four levels of evidence. Ten economic evaluations were included; three were based on RCTs. All evaluations studied misoprostol as prophylactic treatment: in one evaluation misoprostol was studied as a fixed component in a combination with diclofenac (Arthrotec). All economic evaluations comprised analytical studies containing a decision tree. The three trials were of high methodological quality. Nine economic evaluations were considered high quality and one economic evaluation was considered of low methodological quality. There is strong evidence (level "A") that the use of misoprostol for the prevention of NSAID induced gastropathy is cost effective, and limited evidence (level "C") that the use of Arthrotec is cost effective. Although the levels of evidence used in this review are arbitrary, it is believed that a qualitative analysis is useful: quantitative analyses in this field are hampered by the heterogeneity of economic evaluations. Existing criteria to evaluate the methodological quality of economic evaluations may need refinement for use in systematic reviews. (+info)
Randomized comparison of vaginal (200 microg every 3 h) and oral (400 microg every 3 h) misoprostol when combined with mifepristone in termination of second trimester pregnancy.
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It is known that when misoprostol is given at 200 microg every 3 h after mifepristone pretreatment, the vaginal route is more effective than the oral route. However, women prefer the oral route. This randomized study was to test our hypothesis that oral misoprostol 400 microg is as effective as vaginal misoprostol 200 microg when given every 3 h in termination of second trimester pregnancy after priming with mifepristone. A total of 142 patients was randomly assigned to group 1 (200 mg mifepristone + 400 microg oral misoprostol every 3 h up to five doses) or group 2 (200 mg mifepristone + 200 microg vaginal misoprostol every 3 h up to five doses). The incidence of side-effects and the preference study were assessed through a standardized questionnaire during and after the abortion. For the oral group, both the incidence of diarrhoea (40.0 versus 23.2%, P = 0.03) and the amount of drug used (1734 compared with 812 microg, P < 0.0001) were significantly higher than that of the vaginal group but the incidence of fever appeared to be lower (not significant). There was no significant difference in complete abortion rate: 81.4% in the oral group and 75.4% in the vaginal group. The median induction-abortion interval was similar in the two groups (10.4 versus 10.0 h). The percentage of women who aborted in 24 h was also similar: 57/70 (81.4%) in the oral group and 58/69 (87.0%) in the vaginal group. Overall, 82.0% of women preferred the oral route. Oral misoprostol (400 microg) given every 3 h up to five doses, when combined with mifepristone, was as effective as the vaginal (200 microg) route in second trimester termination of pregnancy. This regimen could also be offered to those women who found repeated vaginal administration unacceptable. (+info)
Preparation of the cervix for surgical termination of pregnancy in the first trimester.
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Worldwide, surgical vacuum aspiration is the method of choice of terminating first trimester unwanted pregnancy. Cervical priming prior to surgical evacuation reduces the risks of cervical injury by making the cervix softer and easier to dilate. Over the years, a number of effective methods of cervical priming have became available: osmotic dilators; antiprogesterone and prostaglandins. Of these, prostaglandins remain the most widely used method of cervical preparation. However many of the natural and synthetic analogues of prostaglandins are either expensive or associated with troublesome side-effects. More recently, misoprostol, a synthetic 15-deoxy-16 hydroxy 16-methyl analogue of naturally occurring prostaglandin E, used in the management of peptic ulcers, has established a lead for cervical priming in terms of availability, ease of administration, cost and effectiveness. In fact it appears that both oral and vaginal misoprostol given at dosages of 400 microg are effective for cervical priming when administered 3 h prior to surgical vacuum aspiration. Now that the use of misoprostol for cervical priming has been validated, its widespread use in gynaecological practice is expected. (+info)