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PubMed2005

Acute treatment of moderate to severe depression with hypericum extract WS 5570 (St John's wort): randomised controlled double blind non-inferiority trial versus paroxetine.

OBJECTIVE: To investigate the efficacy of hypericum extract WS 5570 (St John's wort) compared with paroxetine in patients with moderate to severe major depression. DESIGN: Randomised double blind, double dummy, reference controlled, multicentre non-inferiority trial. SETTING: 21 psychiatric primary care practices in Germany. PARTICIPANTS: 251 adult outpatients with acute major depression with total score > or = 22 on the 17 item Hamilton depression scale. INTERVENTIONS: 900 mg/day hypericum extract WS 5570 three times a day or 20 mg paroxetine once a day for six weeks. In initial non-responders doses were increased to 1800 mg/day hypericum or 40 mg/day paroxetine after two weeks. MAIN OUTCOME MEASURES: Change in score on Hamilton depression scale from baseline to day 42 (primary outcome). Secondary measures were change in scores on Montgomery-Asberg depression rating scale, clinical global impressions, and Beck depression inventory. RESULTS: The Hamilton depression total score decreased by mean 14.4 (SD 8.8) points, corresponding to 56.6% (SD 34.3%) of the baseline value, in the hypericum group and by 11.4 (SD 8.6) points (44.8% (SD 33.5%) of baseline value) in the paroxetine group (intention to treat analysis; similar results were observed in the per protocol analysis). The intention to treat analysis (lower one sided 97.5% confidence limit 1.5 points for the difference hypericum minus paroxetine) and the per protocol analysis (lower confidence limit 0.7 points) showed non-inferiority of hypericum and statistical superiority over paroxetine. The lower limits in both cases exceeded the pre-specified non-inferiority margin of -2.5 points and the superiority margin of 0. The incidence of adverse events was 0.035 and 0.060 events per day of exposure for hypericum and paroxetine, respectively. CONCLUSIONS: In the treatment of moderate to severe major depression, hypericum extract WS 5570 is at least as effective as paroxetine and is better tolerated.

Antidepressive Agents, Second-Generation↗
PubMed2002

[Initial findings with pulsar perimetry in patients with ocular hypertension].

PURPOSE: To evaluate our first results with Pulsar perimetry in patients with ocular hypertension and compare them with normal individuals. METHODS: We studied 34 eyes of patients with ocular hypertension and normal G1 Octopus perimetry (mean age: 57.29 S.D. 10.55) and 41 eyes of normal individuals (mean age: 48.34 S.D. 13.71). A complete ophthalmologic examination, including Dr. González de la Rosa's Pulsar perimetry with TOP strategy, was performed for all patients. EXCLUSION CRITERIA: visual acuity <0.8, refractive defect 3 spheric dp or 1.5 astigmatic dp, pupil size <3 mm, ocular surgery or pathologies, non-controlled diabetes or neurological diseases. They all had previous perimetric experience. Results were analyzed with student t - test. RESULTS: For normal individuals, mean sensitivity (MS) for Pulsar perimetry was 21,25 src (spatial resolution and contrast units) with an S.D. of 2,70. Mean defect (MD) was 0,93 src S.D. 1,80 and loss variance (LV) was 6,11 src S.D. 4,30. For patients with ocular hypertension: MS was 18,65 src S.D. 2,79; MD was 2,73 src S.D. 2,30 and LV was 8,46 src S.D. 5,01. LV differences between the two groups were statistically significant (p<0.05) with 95% confidence limits of (-4.49; -0.20), and MS and MD differences, highly significant (p<0.01), with 99% confidence limits of (+0.92; +4.28;) and (-3.05; -0.54) respectively. CONCLUSIONS: Pulsar perimetry may have greater sensibility for the detection of early defects in patients with ocular hypertension than conventional perimetry.

Adolescent↗
PubMed2004

Comparative study on schizontocidal activity of recrystallized or crude daphnetin against malaria parasites.

OBJECTIVE: To compare the schizontocidal activity of recrystallized or crude daphnetin against malaria parasites in vivo. METHODS: Schizontocidal activity of recrystallized or crude daphnetin at various dosages was assessed in mice infected with Plasmodium berghei ANKA using a "4-day suppress assay". RESULTS: The comparison of the reduction rate of parasitemia caused by either recrystallized or crude dephnetin showed that ED(50) of crude daphnetin was 18.36 mg/kg, with 95% confidence limit of 5.96-56.54 mg/kg while ED50 of recrystallized daphnetin was 11.46 mg/kg, with 95% confidence limit of 8.63-15.22 mg/kg. CONCLUSION: The results indicate that the efficacy of recrystallized daphnetin is 37.6% higher than that of crude daphnetin.

Animals↗
PubMed1991

Risk of cataract and history of severe diarrheal disease in southern India.

A case-control study was carried out in the state of Tamil Nadu, southern India, to examine the association between the risk of visually disabling cataract and a lifetime history of severe diarrhea (including cholera). A series of 421 subjects, aged 35 to 65 years, meeting case (n = 181) and control (n = 240) eligibility criteria were enrolled from 19 rural cataract-screening camps. Ninety case-control pairs were postmatched for (reported) age (+/- 2 years), sex, and area of residence. A history of diarrhea was obtained by using an algorithm developed by other investigators in India who have reported a strong association between cataract and diarrhea. An odds ratio of 0.8 (95% confidence limits: 0.0, 3.2) was obtained from matched pairs analysis, and an odds ratio of 1.3 (95% confidence limit: 0.6, 2.7) was obtained among all subjects (n = 392) from a logistic analysis that adjusted for age, sex, occupation, area of residence, and caste. Findings of this study do not support the hypothesis of an increased risk of visually disabling cataract in persons with a positive history of severe diarrhea.

Adult↗
PubMedDate not supplied

Correlation between concentrations of n-hexane and toluene in exhaled and environmental air in an occupationally exposed population.

We determined the correlations between the concentrations of n-hexane and toluene in exhaled and environmental air in the shoe manufacturing industry. Data were collected in 1988 and in 1992 from a total of 265 subjects. Environmental air samples were collected with personal diffusive samplers by adsorption on activated charcoal during exposure and from end-expired air (alveolar air) on cartridges of activated charcoal after exposure. Both compounds were desorbed with carbon disulphide and analysed by gas chromatography. Linear regression analyses showed a good correlation between environmental and end-expired air concentrations (r = 0.82 for n-hexane and r = 0.81 for toluene). These correlations allowed us to calculate the concentrations in expired air corresponding to current environmental limit values. The calculated concentrations in end-expired air that correspond to current environmental threshold limit values of 176 mg m-3 for n-hexane and 377 mg m-3 for toluene are 28 mg m-3 (95% confidence limit, 27-29 mg m-3) and 40 mg m-3 (95% confidence limit, 39-41 mg m-3), respectively. Similar correlations were found when the data from the two study periods were analysed separately.

Adolescent↗
PubMed1987

Mitoxantrone in the treatment of acute leukemia.

Forty-six patients with acute leukemia were treated with mitoxantrone as a single agent. Twenty-nine patients had relapsed and/or refractory acute leukemia. Seventeen patients with acute non-lymphatic leukemia had received no prior treatment. Twelve mg/m2 of mitoxantrone was given intravenous on five consecutive days. Treatment related side effects included bone marrow suppression, mucositis, alopecia, nausea, vomiting and infection. Cardiotoxicity was documented in 7 patients. This study reconfirms that mitoxantrone is an active agent in acute leukemia with complete response documented in 10 of 29 patients with relapsed and/or refractory acute leukemia (34% response rate, 95% confidence limits 18-53%) and complete response documented in 11 of 17 patients (65% response rate, 95% confidence limits 38-87%) with previously untreated acute nonlymphatic leukemia.

Adolescent↗
PubMed1990

Screening hospital admissions from the emergency department for occult carbon monoxide poisoning.

Because cases of unrecognized carbon monoxide (CO) poisoning have been described among patients admitted to the hospital with other diagnoses, screening hospital admissions with carboxyhemoglobin testing has the potential for preventing morbidity among patients as well as among their cohabitants. Carboxyhemoglobin levels were obtained on 753 patients admitted to the hospital from the emergency department over a 3-month period during the winter. Patients in whom CO poisoning was diagnosed in the emergency department prior to admission were excluded. The mean carboxyhemoglobin level was 2.52% +/- 1.85%; there was no significant difference in mean carboxyhemoglobin among patients with medical, surgical, neurological, and psychiatric admission diagnoses (F = 1.17; df = 3,746; P = .32). Two patients (0.3%; 95% confidence limits, 0.04% to 1.1%) from the entire admission cohort, and one of 20 patients (5%; 95% confidence limits, 0.3% to 26.9%) admitted with seizures, had carboxyhemoglobin levels greater than 10%. The carboxyhemoglobin levels of the two patients were only marginally elevated, with levels of 10.9% and 11.3%. The cost of the carboxyhemoglobin screening program was $2.26 per patient result, or approximately $2,100 over a 3-month winter heating season. A program for screening emergency department admissions with carboxyhemoglobin testing, although feasible in terms of cost, detected few cases of unrecognized CO poisoning.

Adolescent↗
PubMed1985

Reproductive patterns and the risk of gestational trophoblastic disease.

The relation between reproductive pattern and the risk of gestational trophoblastic disease was evaluated in a case-control study conducted in Northern Italy on 310 women with histologically confirmed gestational trophoblastic disease and two control groups consisting of 290 obstetric subjects and 394 patients in hospital for acute, nonobstetric, nongynecologic conditions. Compared to that for nulliparous women, the estimated age-adjusted relative risk of trophoblastic disease for parous women was 0.6 (90% confidence limit = 0.4 to 0.9) when obstetric controls were used as a comparison group and 0.4 (95% confidence limit = 0.2 to 0.6) compared with other controls. Conversely, a history of spontaneous abortions was associated with elevated risk of gestational trophoblastic disease, and the risk increased significantly with increasing number of spontaneous abortions. When the combined effect of parity and spontaneous abortions was considered, the major factor influencing the risk of gestational trophoblastic disease was the existence of one or more previous term pregnancies.

Abortion, Habitual↗
PubMed1985

History of convulsions and use of pertussis vaccine.

Data on 2062 reports from the Monitoring System for Adverse Events Following Immunization, Centers for Disease Control (CDC), were analyzed to compare the risk of a personal or family history of convulsions in children who had a neurologic adverse event after receipt of diphtheria-tetanus-pertussis (DTP) vaccine with those who had a nonneurologic adverse event. Children with a neurologic event after DTP vaccine had a 7.2 times higher risk for personal history of convulsions (95% confidence limits 4.5 to 11.5) and a 4.5 times higher risk for family history of convulsions (95% confidence limits 3.1 to 6.7) than did children with an adverse event that did not affect the nervous system. Children with either a febrile or nonfebrile convulsion after receipt of DTP were significantly more likely to have a personal history of convulsions than children with a nonneurologic adverse event (P less than 0.0001). Children with a febrile convulsion after receipt of DTP but not children with nonfebrile convulsions were significantly more likely to have a family history of convulsions than those with a nonneurologic adverse event. It is recommended that pertussis vaccination be deferred in children with a personal history of a convulsion until it can be determined that an evolving neurologic disorder is not present. If such disorders are found, these children should be given the combined pediatric diphtheria and tetanus toxoids (DT) vaccine to complete the series.

Child↗
PubMed1997

The Spacehaler for delivery of salbutamol: a comparison with the standard metered-dose inhaler plus Volumatic spacer device.

The Spacehaler is a new, compact, pressurized aerosol device that uses the same canister as a conventional metered-dose inhaler (MDI). Its design, however, reduces the velocity of the aerosol cloud that emerges from the inhaler, thereby reducing the amount of the non-respirable fraction of the drug delivered to the patient. Large volume spacers achieve a similar effect, but they are bulky and therefore inconvenient to use and carry around. This study compared the bronchodilator effect of 200 micrograms salbutamol delivered by the Spacehaler to that of an MDI used with a Volumatic spacer (MDI plus spacer) in patients with reversible obstructive airways disease. Twenty-five patients with asthma, having a forced expiratory volume in 1 s (FEV1) between 50 and 90% predicted and a reversibility of > or = 15% to 200 micrograms salbutamol given by the conventional (standard) MDI entered the study. On two separate study days, they inhaled 200 micrograms salbutamol either via the Spacehaler or the MDI plus spacer. To maintain blinding, they received placebo on both study days via the alternate device. Their FEV1, forced vital capacity (FVC) and peak expiratory flow (PEF) were measured before and at regular intervals for 6 h after inhalation. Assessment of equivalence between the two devices was based on whether the 90% confidence interval for the difference between the weighted mean FEV1 was within +/- 0.25 1. Patient preference was assessed by a questionnaire at the end of the second study day. Twenty-four patients completed the study. Both devices produced a significant improvement in FEV1 (P < 0.02). The upper and lower 90% confidence limits for the difference in weighted mean FEV1 between the devices was +/- 0.041, and the 99% confidence limits were +0.061 and -0.071. The weighted means for FVC and PEF, and the duration of effect and peak responses for FEV1, FVC and PEF also showed no difference between the two devices. Patients found no difficulty in using the Spacehaler, and 20 out of 24 patients (83.3%) preferred it to the MDI plus spacer. The bronchodilator effect of 200 micrograms salbutamol administered by a Spacehaler was equivalent to that produced by an MDI plus spacer in this group of patients with reversible airways obstruction. The majority of patients preferred it to a large volume spacer.

Adult↗
PubMed2005

The development of position-specific performance indicators in professional rugby union.

The aim of this study was to construct a valid and reliable methodology for the analysis of performance profiles of individual playing positions within rugby union. Twenty-two matches were sampled from the domestic season of a professional male rugby union team. Key performance indicators for individual positions were developed and notated using a computerized behavioural analysis system. Performance profiles of playing positions containing data from one or more individuals were then constructed to compare intra-positional differences. Significant differences (chi-square) were observed between individuals within all the tested playing positions for the principal performance indicators (passing, carrying and tackling for the forward positions, and passing, carrying, tackling and kicking for the backs). For example, the difference between the two outside-halves in the study (P < 0.001) was illustrated by one of the players having a median of 6 successful carries for the season (95% confidence limits of 13 and 3), whereas the other had a median of 2 successful carries (95% confidence limits of 5 and 1). The findings suggest that while general positional performance profiles appear to exist, intra-positional differences may occur due to variations in an individual's style of play, the decision-making demands of the position and the effects of potential confounding variables. Multiple profiles may therefore be necessary for some playing positions to account for variation in factors such as playing conditions and the strength of the opposition.

Adult↗
PubMed1990

Total i.v. anaesthesia with propofol and alfentanil: dose requirements for propofol and the effect of premedication with clonidine.

We determined in 51 healthy patients undergoing body surface surgery the dose requirements for propofol, as part of a total i.v. anaesthesia technique with an alfentanil infusion. After premedication with temazepam, patients received alfentanil 50 micrograms kg-1 followed by an infusion of 50 micrograms kg-1 h-1. Patients were anaesthetized with a loading dose of propofol followed by a three-stage infusion designed to reach one of five preselected blood concentrations of propofol. The motor response to the initial surgical incision was noted and probit analysis was used to derive the ED50 (2.94 mg kg-1 h-1; 95% confidence limits: 2.35-3.37 mg kg-1 h-1) and ED95 (4.98 mg kg-1 h-1; 95% limits: 4.13-8.8 mg kg-1 h-1) for the final propotol infusion rate under these conditions. Whole blood concentration!of propofol at the time of the incision was related linearly to the inf!sion rate and the EC50 and EC95 (probit analysis) were derived as !.44 (95% confidence limits 0.62-1.87) and 4.05 (95% confidence lim!ts 2.78-30.5) micrograms ml-1, respectively. Post-operative recovery was!rapid, uncomplicated and uneventful. In a subgroup of eight patients,!the addition of clonidine 0.6 mg to the premedication significantly decreased the requirement for propofol (P less than 0.05) during surgery, but resulted in prolonged recovery times.

Administration, Oral↗
PubMed1992

Sighs and their effect on the breathing of patients anaesthetized with infusions of propofol.

Twenty-one spontaneous sighs were analysed from records of the breathing of 10 patients anaesthetized for 22-42 (mean 28.7) min with propofol infusions. Sighs occurred in eight patients, the rate varying between once in 29 min and four times in 26 min. There was no pattern in breaths preceding sighs, but the succeeding breaths were altered. On the first succeeding breath, tidal volume was reduced by a mean of 32% (95% confidence limits 19-44%; P less than 0.01) and inspiratory time by a mean of 15% (95% confidence limits 8-22%; P less than 0.01) of the means of the preceding breaths. These effects lasted on average at least 10 breaths. Expiratory time was usually slightly prolonged after a sigh, but this effect was less clear, less consistent and less prolonged. Sighs in patients anaesthetized with propofol reduce the ventilatory drive (in terms of mean inspiratory flow), and alter the timing, of succeeding breaths.

Adult↗
PubMed1994

Risk of other cancers following Kaposi's sarcoma: relation to acquired immunodeficiency syndrome.

To evaluate the risk of another cancer among persons who initially developed Kaposi's sarcoma, the authors used data from the Surveillance, Epidemiology, and End Results (SEER) program of the National Cancer Institute for the years 1973-1990. In persons under 70 years of age, 4,946 cases of Kaposi's sarcoma were observed during the period 1980-1990 (6,217 person-years of follow-up). On the basis of rates seen during the period prior to the epidemic of acquired immunodeficiency syndrome (AIDS), 169 cases were expected. Therefore, cases of Kaposi's sarcoma in this group were assumed to be AIDS-related, while cases occurring in older persons or during the 1970s were assumed to be non-AIDS-related. Rates were compared with the numbers of cases expected overall and by site on the basis of age-, sex-, and calendar year-specific rates from the SEER data. Among the 4,946 persons with AIDS-related Kaposi's sarcoma, the risk of developing non-Hodgkin's lymphoma through 1990 was increased 198-fold (95% confidence interval 169-232). However, the risk of all other cancers was only marginally increased (1.5-fold; 95% confidence interval 0.95-2.3), a risk that was probably biased upward because of ascertainment and misclassification. Among 491 persons with non-AIDS-related Kaposi's sarcoma, the relative risk of all cancers, including non-Hodgkin's lymphoma, was 0.9 (upper 95% confidence limit 1.2), and the risk of non-Hodgkin's lymphoma alone was 0.6 (upper 95% confidence limit 3.3). As of 1990, the risk of having another cancer following Kaposi's sarcoma was increased only in persons infected with human immunodeficiency virus, who were at high risk of non-Hodgkin's lymphoma but probably not of other cancers as a whole.

Acquired Immunodeficiency Syndrome↗
PubMed1999

Study of luminance effects on pinhole test results for visually impaired patients.

PURPOSE: The visual acuity of visually impaired patients has been reported to improve after a refraction, despite pinhole test results that show a decline or no change in acuity. Our aim was to investigate whether the pinhole-induced reduction in retinal illuminance accounted for these unreliable predictions of best-corrected acuity. METHODS: Participants were 64 adult patients referred for low-vision rehabilitation. Neutral density filters reproduced the pinhole-induced luminance loss, allowing pinhole test and postrefraction acuities to be measured at essentially equivalent levels of retinal illuminance. The following data were collected in random order from each subject's better eye: (1) habitual visual acuity, (2) habitual visual acuity with filter, (3) habitual visual acuity with pinhole, (4) best-corrected/postrefraction visual acuity, (5) postrefraction visual acuity with filter. RESULTS: On average, the pinhole test under-estimated postrefraction visual acuity by six letters (95% confidence limits = +/- 20). The pinhole test underestimated postrefraction visual acuity with the filter by two letters (95% confidence limits = +/- 16). Among subjects whose acuity improved with the pinhole test (N = 24), 83% experienced better postrefraction visual acuity. Among subjects whose acuity declined or remained unchanged with the pinhole test (N = 40), 50% achieved better postrefraction visual acuity. CONCLUSIONS: The pinhole-induced luminance loss contributed to inadequate predictions of postrefraction visual acuity. Pinhole test results were enormously variable, underestimating and overestimating postrefraction visual acuity. The pinhole test was less reliable when improvements in postrefraction visual acuity were small. Visually impaired patients deserve periodic refractions, and the pinhole test result should not be used as a dichotomizer for clinical decisions regarding the need for a refraction.

Adult↗
PubMed1999

Cancer risk in collagenous colitis.

Collagenous colitis is a recently described form of chronic inflammatory bowel disease. Other inflammatory bowel disorders are associated with increased risk of colorectal and extracolonic malignancies, but this has not been evaluated in collagenous colitis. Colorectal and extracolonic malignancies were identified in 117 patients with collagenous colitis from the Johns Hopkins Registry. The incidence rates of identified tumors, overall incidence rate of tumors, and overall mortality were then compared with general population through person year analysis with adjustment for population. No cases of colorectal cancer were found in collagenous colitis patients during a mean follow-up period of 7.0 years (range 2-12 years) after the diagnosis of colitis. Two patients developed colorectal cancer prior to the diagnosis of colitis, but no increase in life-time relative risk of colorectal cancer was found (relative risk 0.52; 95% confidence limits 0.05-1.5). An increased relative risk of lung cancer in women (relative risk 3.7; 95% confidence limits 1.0-9.6; p = 0.048) was noted. The relative risk of overall malignancy and overall mortality was not different than the general population. In collagenous colitis patients the life-time relative risk of colorectal cancer and the relative risk after the diagnosis of colitis with a mean observation period of 7 years was not increased. An increase in relative risk of lung cancer in women with collagenous colitis argues for further investigation of the role of smoking and other factors in this disorder.

Age Distribution↗
PubMed1986

Investigation of patients with abnormal response to warfarin.

In 55 patients in whom warfarin control had been satisfactory for at least 4 months, warfarin dose, plasma warfarin concentration and plasma clearance were measured. The mean dose to maintain the BCR (INR) between 2.3 and 3.3 was 5.1 +/- 2 mg day-1 (range 1.5-10 mg). Plasma warfarin concentrations and warfarin clearance were log-normally distributed with 95% confidence limits between 0.8 and 2.4 mg l-1 and 2.5 and 8.71 day-1 respectively. These confidence limits were used to construct algorithms which correctly predicted the cause of abnormal warfarin sensitivity in two patients and resistance in two further patients. These algorithms should help to identify the cause of abnormal warfarin responsiveness in the clinical setting.

Adolescent↗
PubMed1997

Measurement of airborne flour exposure with a monoclonal antibody-based immunoassay.

BACKGROUND: The development of simple and standardised methods to measure airborne levels of workplace biological allergens is an important step in reducing the incidence of occupational asthma. Such a method would be useful for measuring wheat flour allergens which cause asthma in bakers. Measurement of allergen per se rather than total dust enables exposure to be better defined. METHODS: Monoclonal antibodies were produced, their specificity analysed by immunoblotting and then used to affinity-purify a putative flour allergen. The importance of this protein as an allergen was tested by RAST using sera from allergic bakers and it was identified by N-terminal sequencing. Suitable monoclonal antibodies were chosen to develop an enzyme-linked immunosorbent assay. Commercial baking flours and personal airborne dust samples were analysed using the immunoassay. RESULTS: A sensitive and specific monoclonal antibody-based enzyme-linked immunosorbent assay was developed to measure a wheat alpha-amylase inhibitor. The wheat alpha-amylase inhibitor content of bulk wheat flours was 0.124% (95% confidence limits 0.083-0.164%) and airborne levels in bakeries had a geometric mean of 744 ng/m3 (95% confidence limits 371-1,496 ng/m3). CONCLUSION: This assay is suitable for widespread use as the monoclonal antibodies and standards are well defined and potentially infinitely available. The assay therefore offers distinct advantages over those exposure assessment methods currently in use. Comparable results would be obtained by different investigators over a prolonged time period. The assessment of flour allergen exposure and the relationship with clinical response could then be investigated using a multi-centered approach.

Air Pollutants, Occupational↗