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Biomedical subjects

T R Einarson

Publications and source records attributed to T R Einarson.

At least 19 recordsLinked to original sources
PubMed2000

Child care center staff contribute to physician visits and pressure for antibiotic prescription.

OBJECTIVE: To determine whether child care center (CCC) providers contribute to unnecessary physician referrals and antibiotic prescriptions in young children with upper respiratory tract infections. DESIGN: A survey using a structured telephone questionnaire between May 3, 1998, and July 27, 1998. PARTICIPANTS: Child care center providers from randomly selected licensed Ontario CCCs accepting diapered children. MAIN OUTCOME MEASURES: Knowledge, attitudes, and practices concerning physician referral; exclusion; and antibiotic use for children with upper respiratory tract infections. Indications for exclusion were compared with published Canadian guidelines. RESULTS: Contact was made with 42 eligible CCCs to obtain the requisite number of 36 participants (participation rate, 86%). Of the 36 centers, staff reported advising that children visit a physician for colored nasal discharge in 28 (78%), for productive cough in 23 (64%), and for unusual behavior in 9 (25%). Also of the 36 centers, staff reported excluding children for colored nasal discharge in 20 (56%), for productive cough in 16 (44%), and for unusual behavior in 15 (42%). Antibiotics were thought useful for nonspecific upper respiratory tract infections to prevent the spread of infection in 9 (26%), to speed up recovery in 7 (21%), and to prevent bacterial infection in 13 (38%) of 34 centers. In the previous 6 months, 25 (69%) of 36 staff members reported making an exception to exclusion because a child had an antibiotic prescription. CONCLUSIONS: Many children are referred by CCC staff to physicians contrary to established guidelines. As staff must act on behalf of parents, a low threshold for referral is not unreasonable. However, this survey confirms that CCC staff recommend children to receive antibiotics and exclude children inappropriately. These practices are based on incomplete knowledge. Research on appropriate management of upper respiratory tract infections by CCC staff is needed. Education to correct specific knowledge deficits should be initiated.

Anti-Bacterial Agents↗
PubMed2000

Can we use anxiolytics during pregnancy without anxiety?

QUESTIONOne of my patients suffers from anxiety and was using lorazepam to treat it. When she became pregnant, she stopped the medication immediately, but now she is worried about the potential effect on the baby because she was using the drug just after conception. Is this class of drugs safe during pregnancy? What should she do if she needs antianxiety treatment during the rest of her pregnancy?ANSWEREvidence to date from cohort studies did not identify a notable association between use of benzodiazepines and increased risk of major malformations, including oral cleft. In contrast, data from case-control studies show a slightly increased risk of oral cleft. Hence, level 2 ultrasonography is recommended to rule out visible forms of cleft lip. Using benzodiazepines late in pregnancy could cause withdrawal syndrome in newborns.

Anti-Anxiety Agents↗
PubMed1999

Meta-analytic review of the clinical effectiveness of oral deferiprone (L1).

OBJECTIVE: To summarize efficacy and effectiveness in iron overloaded patients treated with the orally active iron chelator deferiprone also known as L1 or, using meta-analysis of the literature. METHODS: We reviewed the literature, searching Medline and Embase databases, as well as reviews and other literature on the topic. Inclusion criteria were: original clinical trials reporting results for serum ferritin concentration (SF), hepatic iron concentration or urinary iron excretion (UIE). Efficacy data had to have been reported after > or =3 months of treatment. Data were combined using a random effects model (Cochrane) modified for use with single groups to produce a point estimate and a 95% confidence interval. To summarize the clinical effectiveness, overall proportion of patients where deferiprone was able to reduce serum ferritin was calculated. We also examined average (mg x l(-1)) serum ferritin levels over the reported time (mean) and absolute decrease from the baseline after therapy. To summarize efficacy, success was defined as the proportion of patients who achieved UIE of 25 mg per day or 0.5 mg x kg(-1) x day(-1), which equals the average amount received from monthly blood transfusions. We also calculated the overall average level (mg per day) of UIE over the reported time of therapy (mean). As part of a sensitivity analysis, data were analyzed for two ranges of deferiprone dosage: < or = 50 mg x kg(-1) x day(-1) and > or =75 mg x kg(-1) x day(-1). RESULTS: Of 83 identified references, nine clinical trials met our inclusion criteria, providing data for 129 iron overloaded patients. After a mean of 16 months of therapy (range 6.4 36 months) with 66.4 mg x kg(-1) x day(-1) (mean) of deferiprone, 75.5% of highly iron overloaded patients had a decrease in serum ferritin from baseline. The average drop in serum ferritin of 0.8 mg x l(-1) was 23.5% from baseline. The overall average UIE for therapy was 28.8 mg per day in patients receiving > or = 75 mg x kg(-1) x day(-1) over 8.5 months of therapy. At the same dosage, more than half of the patients (51.8%) achieved negative iron balance. When studies with patients receiving lower dosage (< or = 50 mg x k(-1) x day(-1)) were included, the success rate was 45.1%. CONCLUSION: Overall, deferiprone has clinical efficacy in achieving negative iron balance and reducing body iron burden in highly iron overloaded patients. After an average of 16 months of deferiprone in doses > or = 75 mg x kg(-1) x day(-1), most patients had a decrease in ferritine concentration.

Administration, Oral↗
PubMed1999

Comparison of extended-release venlafaxine, selective serotonin reuptake inhibitors, and tricyclic antidepressants in the treatment of depression: a meta-analysis of randomized controlled trials.

The purpose of this study was to summarize and compare the clinical success rates of extended-release venlafaxine, some selective serotonin reuptake inhibitors (SSRIs), and certain tricyclic antidepressants (TCAs). A meta-analytic approach was used to synthesize outcomes from published randomized controlled trials involving patients scoring > or =15 on the Hamilton Rating Scale for Depression (HAM-D) or > or =18 on the Montgomery-Asberg Depression Rating Scale (MADRS). Searches of the MEDLINE, EMBASE, and International Pharmaceutical Abstracts databases were performed, as were searches of references from retrieved articles and reviews. Drugs included in the comparison were extended-release venlafaxine (venlafaxine-XR); the SSRIs citalopram, fluoxetine, fluvoxamine, paroxetine, and sertraline; and the TCAs amitriptyline, imipramine, desipramine, and nortriptyline. Therapeutic success was defined as a 50% decrease in the HAM-D or MADRS score. Data were extracted by 2 independent evaluators, with differences resolved through consensus discussions. Weighted mean success rates were calculated for each drug class, using a random-effects model. The resulting data represent 44 trials with 63 study arms and 4033 patients with depression. Venlafaxine-XR demonstrated a 73.7% success rate, which was statistically significantly greater than that of the studied SSRIs (61.1%) and TCAs (57.9%) (P<0.001). Thus this meta-analysis of randomized controlled studies of patients with depression suggests that venlafaxine-XR is clinically superior in efficacy to SSRIs and TCAs. Venlafaxine-XR also had universally lower, though nonsignificant, dropout rates.

Antidepressive Agents, Second-Generation↗
PubMed1999

Antibiotic prescribing for Canadian preschool children: evidence of overprescribing for viral respiratory infections.

Antibiotic resistance is associated with prior receipt of antibiotics. An analysis of linked computerized databases for physician visits and antibiotic prescriptions was used to examine antibiotic prescribing for different respiratory infections in preschool children in Canada. In 1995, 64% of 61,165 children aged <5 years made 140,892 visits (mean, 3.6 visits per child) for respiratory infections; 74% of children who made visits received antibiotic prescriptions. Antibiotics were prescribed to 49% of children with upper respiratory tract infection, 18% with nasopharyngitis, 78% with pharyngitis or tonsillitis, 32% with serous otitis media, 80% with acute otitis media, 61% with sinusitis, 44% with acute laryngitis or tracheitis, and 24% with influenza. Acute otitis media accounted for 33% of all visits and 39% of all antibiotic prescriptions. The estimated Canadian-dollar cost of overprescribing was $423,693, or 49% of the total cost of antibiotics ($859,893) used in this group. This population-based study confirms antibiotic overprescribing in Canada.

Anti-Bacterial Agents↗
PubMed1999

Reproducibility of medical information obtained via the telephone vs personal interview.

The Motherisk [corrected] Program, a teratogenic information service, conducts patient interviews over the telephone as well as in a clinic setting. In both instances, medical information and exposure history is obtained from the patient, including such items as pregnancy history, drug exposure, alcohol and smoking habits. It occurred on several occasions that the clinic interviewer remarked that the same patient had volunteered information to them, that differed from the information documented on the intake telephone form. The objective of the study was to establish the levels of agreement in the documentation, between these two forms of interviews. Two groups of 100 paired telephone and clinic forms were randomly selected from our data base, 1990-1991 and 1996-1997. These two groups were chosen to assess if there were any differences over a five year time period. Statistical calculations were performed using the Kappa statistic, a method that measures agreement. Kappa scores indicated high reproducibility for both pregnancy and smoking history, good reproducibility for medical history, marginal-good for exposures (although excellent agreement was found for the primary drug of concern) and marginal-good for alcohol information. Overall, agreement was superior in the 1990-1991 group. There were marked differences in consistency, between the information recorded on the telephone form and the clinic form, most specifically relating to secondary exposures and alcohol history. It suggests that a person to person interview yields a more complete medical history than a telephone interview.

Alcohol Drinking↗
PubMed1998

Benzodiazepine use in pregnancy and major malformations or oral cleft: meta-analysis of cohort and case-control studies.

OBJECTIVE: To determine if exposure to benzodiazepines during the first trimester of pregnancy increases risk of major malformations or cleft lip or palate. DESIGN: Meta-analysis. SETTING: Studies from 1966 to present. SUBJECTS: Studies were located with Medline, Embase, Reprotox, and from references of textbooks, reviews, and included articles. Included studies were original, concurrently controlled studies in any language. INTERVENTIONS: Data extraction and quality assessment were done independently and in duplicate. MAIN OUTCOME MEASURES: Maternal exposure to benzodiazepines in at least the first trimester; incidence of major malformations or oral cleft alone, measured as odds ratios and 95% confidence intervals with a random effects model. RESULTS: Of over 1400 studies reviewed, 74 were retrieved and 23 included. In the analysis of cohort studies fetal exposure to benzodiazepine was not associated with major malformations (odds ratio 0.90; 95% confidence interval 0.61 to 1. 35) or oral cleft (1.19; 0.34 to 4.15). Analysis of case-control studies showed an association between exposure to benzodiazepines and development of major malformations (3.01; 1.32 to 6.84) or oral cleft alone (1.79; 1.13 to 2.82). CONCLUSIONS: Pooled data from cohort studies showed no association between fetal exposure to benzodiazepines and the risk of major malformations or oral cleft. On the basis of pooled data from case-control studies, however, there was a significant increased risk for major malformations or oral cleft alone. Until more research is reported, level 2 ultrasonography should be used to rule out visible forms of cleft lip.

Abnormalities, Drug-Induced↗
PubMed1998

Pregnancy outcome following maternal organic solvent exposure: a meta-analysis of epidemiologic studies.

BACKGROUND: Evidence of fetal damage or demise from occupational organic solvent levels that are not toxic to the pregnant woman is inconsistent in the medical literature. The risk for major malformations and spontaneous abortion from maternal inhalation of organic solvent exposure during pregnancy was summarized using meta-analysis. METHODS: Medline, Toxline, and Dissertation Abstracts databases were searched to locate all research papers published in any language from 1996 to 1994. Included were studies that were case-control or cohort in design and indicated first trimester (or up to 20 weeks gestation for spontaneous abortion) maternal solvent exposure. A summary odds ratio (ORs) with 95% confidence intervals (CI) was calculated from research results combined by the Mantel-Haenszel method. RESULTS: In total, 559 studies were obtained from the literature search. Five studies for each outcome of interest qualified for inclusion in the analysis. The ORs for major malformations from five studies (n = 7,036 patients) was 1.64 (CI 1.16-2.30) and for spontaneous abortion from five studies (n = 2,899 patients) was 1.25 (CI 0.99-1.58). CONCLUSIONS: Maternal occupational exposure to organic solvents is associated with a tendency toward an increased risk for spontaneous abortion and additional studies may affect the trend. There is a statistically significant association with major malformations which warrants further investigation.

Abnormalities, Drug-Induced↗
PubMed1998

Drug utilization 90%--a simple method for assessing the quality of drug prescribing.

OBJECTIVES: To describe a simple method for assessing the quality of drug prescribing. METHODS: We tested the idea that the number of drugs accounting for 90% of drug use--drug utilization 90% (DU90%)--may serve as an indicator of the quality of drug prescribing. We ranked the drugs by volume of defined daily doses (DDD) and determined how many drugs accounted for the DU90% segment. We also compared this segment with the pharmacotherapeutic guidelines issued by the Regional (local) Drug Committee to determine the adherence to its recommendations (index of adherence). The cost per DDD within the DU90% segment and for the remaining 10% was also calculated. The utilization of drugs based on prescriptions purchased during April 1995 was determined for 24 primary health care (PHC) centres in southwestern Stockholm. RESULTS: The number of different products, defined as all products marketed under a single brand name within an ATC (anatomic therapeutic chemical) category, in the DU90% segment varied twofold (81-164) between the 24 PHC centres. Differences in the number of GPs per PHC centre accounted for a third of this variation. The compliance with the Drug Committee recommendations varied between 54% and 78%. There was no relationship between the number of products accounting for the DU90% segment and the adherence to local prescription guidelines, i.e. prescribing more products did not increase the adherence. The costs for the DU90% drugs varied from 2.26 SEK/DDD in one PHC centre to 3.75 in another one, with an average cost of 2.87 SEK/DDD, while for the remaining 10% it was the double (6:54 SEK/DDD). In all, the DU90% drugs made up 80.8% of the total cost as compared with 19.2% for the remaining 10%. In the DU90% segment, there was no clear relationship between adherence to the guidelines and the cost/DDD, i.e. following the evidence-based guidelines appeared to provide a higher quality of prescribing rather than cheaper prescribing. CONCLUSIONS: The DU90% is an inexpensive, flexible, and simple method for assessing the quality of drug prescribing in routine health care. The number of products in the DU90% segment and adherence to prescription guidelines may serve as general quality indicators. The method may be adapted to provide comparative data between PHC centres, hospitals, regions etc. that may be cross-sectional and longitudinal. Other quality criteria, specific for each class of drugs, should complement these general indicators.

Catchment Area, Health↗
PubMed1998

Pharmacoeconomic analysis of topical treatments for tinea infections.

BACKGROUND: A payor-perspective economic analysis of the topical creams ciclopirox, clotrimazole, ketoconazole, miconazole, and terbinafine (TER) used to treat dermatophytosis has been made. This pharmacoeconomic evaluation was conducted in Austria, Germany, and Switzerland. METHODS: A four-phase approach was used. Phase 1: experts were assembled to identify the standard approach for management of fungal infections and a decision tree was constructed to model the process. Phase 2: meta-analysis was used to determine success, failure, and relapse rates. Phase 3: economic analyses performed included cost of regimen, total expected cost, and cost-effectiveness. Phase 4: sensitivity analyses (robustness analysis) were also executed to determine the validity of the assumptions. RESULTS: In the total expected cost analysis, TER demonstrated the lowest overall cost of treating patients. Terbinafine also provided the highest number of disease-free days during the analytic time horizon and, consequently, the lowest cost per disease-free day. Sensitivity analyses suggest that TER is the most cost-effective topical product for treating dermatophytosis in Austria, Germany, and Switzerland. CONCLUSIONS: All analytic scenarios suggest that TER therapy demonstrates lower expected costs and generates more DFDs when compared with the fungistatic topical therapies included in this pharmacoeconomic analysis. Terbinafine is expected to be the most cost-effective choice in Austria, Germany, and Switzerland for treatment of dermatophytosis minor.

Administration, Topical↗
PubMed1998

Critical analysis of the pharmaceutical care research literature.

OBJECTIVE: To describe and evaluate published pharmaceutical care research and make recommendations to improve the quality of the literature. DATA SOURCES: MEDLINE and International Pharmaceutical Abstracts using the key word "pharmaceutical care," limited to research articles published January 1988-December 1996. STUDY SELECTION: Articles that evaluated the provision of pharmaceutical care in a defined population. DATA EXTRACTION: Citations (title and abstract) identified were reviewed. Articles potentially meeting the inclusion criteria were screened and scored according to the Pharmaceutical Care Research Checklist for the presence of criteria including pharmaceutical care process, methodology, and measures/outcomes. RESULTS: A total of 979 citations were identified. Of 57 abstracts identified as potentially meeting the inclusion criteria, 43 articles were eliminated, 2 were rejected, and 12 were accepted for analysis. Deficiencies identified included: a lack of research in community practice (n = 2), randomized controlled trials (n = 3), workload measurement (n = 6), and patient satisfaction (n = 1). Scoring according to the Pharmaceutical Care Research Checklist also identified the following deficiencies (maximum Composite Criterion Score [CCS] of 24): description of population sample (CCS 17), dropouts (CCS 13), informed consent (CCS 8), pharmacist training/qualifications (CCS 9), instrument validity (CCS 10), structure criteria (CCS 4), patient outcomes (CCS 11), and economic outcomes (CCS 12). The mean total checklist score was 37 of 50 (range 31-46). CONCLUSIONS: Few research studies have evaluated the provision of pharmaceutical care in a defined population. Deficiencies identified by low CCSs demonstrated the need for quality research design and a clear description of the pharmaceutical care process to evaluate the impact of pharmaceutical care. Recommendations for improvement in research design were made.

Humans↗
PubMed1998

A systematic review of lidocaine-prilocaine cream (EMLA) in the treatment of acute pain in neonates.

OBJECTIVE: Neonates routinely undergo painful cutaneous procedures as part of their medical treatment. Lidocaine-prilocaine 5% cream (EMLA) is a topical anesthetic that may be useful for diminishing the pain from these procedures. EMLA is routinely used in children and adults. There is substantial apprehension about its use in neonates because of concerns that it may cause methemoglobinemia. The objective of this review was to determine the efficacy and safety of EMLA as an analgesic for procedural pain treatment in neonates and provide evidence-based recommendations for clinical practice. METHODS: Systematic review techniques were used. Studies were identified using manual and computer-aided searches (Medline, EMBASE, Reference Update, personal files, scientific meeting proceedings). Behavioral (eg, facial action, crying) and physiologic (eg, heart rate, oxygen saturation, blood pressure, respiratory rate) outcome data from prospective nonrandomized controlled studies and randomized controlled trials in full-term and preterm neonates were accepted for inclusion to establish efficacy of EMLA. The risk of methemoglobinemia (defined as methemoglobin concentration >5% and requiring medical intervention) was estimated from all prospective studies. RESULTS: Eleven studies of the efficacy of EMLA were included in the analysis. Infant gestational age at the time of delivery ranged from 26 weeks to full-term. Two studies included data from both neonates and older infants. The following procedures were studied: circumcision (n = 3), heel lancing (n = 4), venipuncture (n = 1), venipuncture and arterial puncture (n = 1), lumbar puncture (n = 1), and percutaneous venous catheter placement (n = 1). Nine studies were randomized controlled trials. The total sample size for each study ranged from 13 to 110 neonates. The dose of EMLA used was 0.5 g to 2 g in 9 studies, and was not specified in the others. The duration of application ranged from 10 minutes to 3 hours. The three studies that investigated the efficacy of EMLA for decreasing the pain of circumcision used a randomized controlled trial design. All of them demonstrated significantly reduced crying time during the procedure in the infants in the EMLA group compared with the infants in the control group. Facial grimacing, assessed in two of the studies, was also significantly lower in the EMLA group. Using meta-analytic techniques, the heart rate outcome data for two studies was summarized. Increases in heart rate compared with baseline values were 12 to 27 beats per minute less for the EMLA group than in the placebo group during various stages of the surgical procedure. Three studies that investigated the pain from heel lancing were randomized controlled trials; the other was a nonrandomized controlled study. None demonstrated a significant benefit of EMLA for any of the outcome measures used to assess pain (ie, behavioral pain scores, infant crying, heart rate, blood pressure, respiratory rate, oxygenation parameters). One randomized controlled study of the pain from venipuncture showed that infants treated with EMLA had significantly lower heart rates and cry duration compared with infants treated with a placebo. In one nonrandomized study, a significantly lower behavioral pain score was observed for infants treated with EMLA compared with the control group. Infant heart rate, however, did not differ between the groups. In one randomized controlled study of pain from percutaneous venous catheter placement, EMLA resulted in a significantly lower increase in heart rate and respiratory rate. Behavioral pain scores were significantly lower during arterial puncture in one nonrandomized controlled study. EMLA did not reduce physiologic changes or behavioral pain scores in one randomized controlled trial in infants undergoing lumbar puncture. Meta-analytic techniques revealed that methemoglobin concentrations did not differ between EMLA-treated and placebo-treated infants (weighted mean di

Acute Disease↗
PubMed1998

An overview of topical antifungal therapy in dermatomycoses. A North American perspective.

Dermatophytes cause fungal infections of keratinised tissues, e.g. skin, hair and nails. The organisms belong to 3 genera, Trichophyton, Epidermophyton and Microsporum. Dermatophytes may be grouped into 3 categories based on host preference and natural habitat. Anthropophilic species predominantly infect humans, geophilic species are soil based and may infect both humans and animals, zoophilic species generally infect non-human mammals. It is important to confirm mycologically the clinical diagnosis of onychomycosis and other tinea infections prior to commencing therapy. The identity of the fungal organism may provide guidance about the appropriateness of a given topical antifungal agent. Special techniques may be required to obtain the best yield of fungal organisms from a given site, especially the scalp and nails. It is also important to realise the limitations of certain diagnostic aids e.g., Wood's light examination is positive in tinea capitis due to M. canis and M. audouinii (ectothrix organisms); however, Wood's light examination is negative in T. tonsurans (endothrix organism). Similarly, it is important to be aware that cicloheximide in culture medium will inhibit growth of non-dermatophytes. Appropriate media are therefore required to evaluate the growth of some significant non-dermatophyte moulds. For tinea infections other than tinea capitis and tinea unguium, topical antifungals may be considered. For effective therapy of tinea capitis an oral antifungal is generally necessary. Similarly, oral antifungals are the therapy of choice, especially if onychomycosis is moderate to severe. Furthermore, where the tinea infection involves a large area, in an immunocompromised host or if infection is recurrent with poor response to topical agents, then oral antifungal therapy may be necessary. Topical antifungal agents may be broadly divided into specific and nonspecific agents. The former group includes the polyenes, azoles, allylamines, amorolfine, ciclopirox and butenafine. Generally the topical agent is available as a cream, sometimes for use intravaginally. Less commonly, the formulation may be in the form of a powder, lacquer, spray, gel or solution. Many of these agents have a broad spectrum of activity, being effective against dermatophytes, yeasts and Malassezia furfur. For the treatment of tinea corporis, tinea cruris tinea versicolor and cutaneous candidosis, once or twice daily application may be required, the most common duration of therapy being 2 to 4 weeks. For tinea pedis the most common treatment duration is 4 to 6 weeks.

Administration, Topical↗
PubMed1998

Efficacy and safety of neuroleptics in behavioral disorders associated with dementia.

BACKGROUND: Neuroleptics are commonly used to treat behavioral disorders associated with dementia. However, their safety and efficacy have not been well established in these patients. METHOD: A meta-analysis of randomized, controlled (either placebo or active drug), double-blind trials published since 1966 (N = 16; 499 treated, 112 active controls, and 123 placebo) was conducted. Data were collected on proportion of patients with clinically significant improvement, significant side effects, and dropout rates. RESULTS: Pooled mean percentages of patients who improved (95% CI): all neuroleptics, 64% (54% to 74%); low potency, 63% (54% to 72%); moderate potency, 70% (56% to 85%); moderate-high potency, 62% (49% to 75%); and high potency, 69% (49% to 90%). Thus, no differences in efficacy existed between different potencies of neuroleptics. Therapeutic effect (neuroleptic minus placebo) was only 26% (14% to 38%). Treatment-emergent side effects were more common for neuroleptics vs. placebo (mean difference = 25%, 13% to 37%), but pooled mean dropout rates were not different (mean difference = 4%, -7% to 14%). Neither weighting by clinical trial quality (3 raters; weighted agreement, 83% to 92%) nor exclusion of poor quality trials changed the results. CONCLUSION: Neuroleptics have small but significant efficacy over placebo in this population, and the efficacy rate is equivalent to the side effect rate. Comparing different neuroleptics shows they have similar efficacy, side effects, and dropout rates. Further study to determine more specific drug-responsive behaviors is needed to maximize benefits of these drugs.

Antipsychotic Agents↗
PubMed1997

Efficacy of pentosan polysulfate in the treatment of interstitial cystitis: a meta-analysis.

OBJECTIVES: To determine the efficacy of pentosan polysulfate (Elmiron) compared to placebo in the treatment of interstitial cystitis. METHODS: The data sources used were MEDLINE, Excerpta Medica, and International Pharmaceutical Abstracts databases, and the manufacturer. Bibliographies of articles obtained were reviewed. The keywords used were pentosanpolysulfate, pentosanpolysulfate sodium, and pentosan. Inclusion criteria were blinded selection of English language, prospective, randomized, placebo-controlled comparative trials; > or = 8 weeks' duration; > or = 300 mg daily; adult humans with > or = 1 symptoms including pain, urgency, frequency, and nocturia; symptoms for > or = 12 months; normal urinalysis; negative findings for urine culture and cytology. Exclusion criteria were hemorrhagic cystitis; drug-, microbial-, or radiation-induced cystitis; carcinoma in situ; other influencing diseases. The outcome of success was defined as a > or = 50% decrease in pain, urgency, frequency, and nocturia. The number of successes was extracted by blinded investigators, treating withdrawals as failures. The percentage difference in success rates of pentosan polysulfate and placebo, and the number needed to treat (NNT) were determined for each variable; P values and 95% confidence intervals (CIs) were determined for combined data. Homogeneity of effect was determined by calculating Q (chi-squared). Article quality was assessed using the Chalmers scale to determine if quality affected outcome. Effective inter-rater reliability was determined using Rosenthal's method. Significance was set at P < 0.05. RESULTS: Four studies were included. Data were extracted from all four studies for pain (n = 398), three for urgency (n = 306), two for frequency (n = 160), and one study for nocturia (n = 106). The differences (95% confidence limits) were pain: 16.6% (95% CI 8%, 25%), NNT = 7; urgency: 13.0% (1.0%, 25%), NNT = 7.5; frequency: 16.7% (2.3%, 31.1%), NNT = 6; nocturia: -1% (-19.8%, 21.8%). P values from homogeneity tests were not significant. Mean quality scores were 63.8%, 48.1%, 50.4%, and 65.6%, respectively, in the four studies; the effective inter-rater reliability was 0.96. Results did not differ when weighted by quality score. CONCLUSIONS: Pentosan polysulfate is more efficacious than placebo in the treatment of pain, urgency, and frequency associated with interstitial cystitis. Pentosan polysulfate is not significantly different from placebo in treating nocturia associated with interstitial cystitis.

Adult↗
PubMed1997

The efficacy, safety and tolerability of antidepressants in late life depression: a meta-analysis.

BACKGROUND: To determine the efficacy, safety and tolerability of antidepressants in depressed elderly patients. METHODS: Search for randomized controlled double-blind studies evaluating atypical antidepressants (ATYPs), reversible inhibitors of monoamine oxidase-A, selective serotonin reuptake inhibitors (SSRIs) and tricyclic antidepressants in moderate/severe depressed patients > or = 60 years for > or = four weeks. The random effects model (single-arm; comparative) was used to aggregate efficacy, safety and dropout. RESULTS: No difference in single-arm aggregation of outcomes for four antidepressant classes. Comparative analyses showed no statistical difference between outcomes, except SSRIs had a higher response rate than ATYPs. CONCLUSION: Elderly show no differences in antidepressant class outcomes. LIMITATIONS: Heterogeneity and lack of power. CLINICAL RELEVANCE: There is little advantage for antidepressant classes over another in the aged.

Age Factors↗
PubMed1997

Quality assessment of pharmacoeconomic abstracts of original research articles in selected journals.

OBJECTIVE: To assess and compare the quality of pharmacoeconomic abstracts of cost-minimization analyses, cost-effectiveness analyses, cost-utility analyses, and cost-benefit analyses of original research articles in selected medical, pharmacy, and health economics journals. METHODS: MEDLINE was used to identify articles in selected medical, pharmacy, and health economics journals using the MeSH word "economic" and text words "cost" and "pharmacoeconomic"; the journal PharmacoEconomics was searched manually. All retrieved abstracts were evaluated. Original, comparative (at least one drug comparator) research articles (1990-1994) reporting both costs and clinical outcomes were included in the quality analysis. Abstract quality was assessed as a percentage by using a checklist with 29 objective criteria. Group consensus produced interrater reliability greater than 0.8. RESULTS: One thousand two published abstracts labeled with the above key words were identified. Of these, 951 were excluded from quality assessment because they were not original research (18%), were not pharmacoeconomic research (47%), lacked a drug comparator (35%), or did not report a clinical outcome (0.5%). Thus, the quality of 51 (5% of the total) remaining abstracts was assessed. Overall scores were 56% in 1990 and 58% in 1994 (p = 0.094). Medical articles scored highest (61.5%; n = 25), pharmacy articles were next (54.3%; n = 5), and health economics articles were lowest (53.4%; n = 21) (p = 0.091); structured abstracts scored significantly higher (62.5%; n = 20) than unstructured (53.3%; n = 31) (p = 0.003). CONCLUSIONS: Abstract quality was generally poor, with no significant change in quality over time. Medical journals scored highest, probably because they use structured abstracts. Guidelines for structured pharmacoeconomic abstracts may assist in improving quality.

Abstracting and Indexing↗