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PubMed1997

Comparison of effects of albendazole sulfoxide on in vitro produced bovine embryos and rat embryos.

OBJECTIVE: To evaluate and compare effects of albendazole sulfoxide (ABZSO) on rat embryos and bovine embryos produced in vitro. ANIMALS: In vitro produced bovine embryos. Rat embryos recovered from naturally bred Sprague-Dawley rats. PROCEDURE: 4- and 8-cell bovine embryos were randomly allocated to ABZSO or vehicle control groups. After 48 hours, embryos were evaluated for cell number and blastomere morphology. Rat embryos of similar stages, flushed from the uterine tube on gestational day 2-5, were randomly allocated to treatment or control groups. After 24 hours, embryos were evaluated as described previously. RESULTS: 44% of control bovine embryos divided in culture (> or = 16-cell stage). Fifteen percent of the controls had morphologic abnormalities, including disparity in blastomere size and cytoplasmic vacuoles and stippling. Treated (> or = 1 microgram of ABZSO/ml) bovine embryos differed (P < 0.0001) from controls, with 4% development and 93% abnormal morphology. Forty-five percent of control rat embryos divided in culture. Treated (> or = 500 ng of ABZSO/ml) rat embryos differed (P < 0.0003) from controls with regard to ability to divide. There were no consistent morphologic abnormalities in rat embryos. CONCLUSIONS: In vitro produced bovine embryos were susceptible to ABZSO at a concentration > or = 1 microgram/ ml, resulting in decreased ability to divide and presence of gross morphologic abnormalities. Rat embryos produced in vivo and exposed in vitro to ABZSO at a concentration > or = 500 ng/ml had decreased ability to divide in culture. CLINICAL RELEVANCE: Despite severe effects of ABZSO (> or = 1 microgram/ml) on bovine embryo development in vitro, it is beyond the scope of this study to speculate whether a therapeutic dosage of albendazole (10 mg/kg of body weight) would result in necessary concentrations of ABZSO in vivo to disrupt embryogenesis.

Abnormalities, Drug-Induced↗

PubMed1994

Comparative trial of quinapril versus captopril in mild to moderate congestive heart failure. Quinapril/Captopril Congestive Heart Failure Study Group.

OBJECTIVE: To compare the efficacy and safety of captopril twice a day with quinapril once a day for the treatment of mild to moderate congestive heart failure in a multicentre, double-blind, randomly allocated, parallel-group, 12-week study. METHODS: Exercise capacity, M-mode echocardiographic left ventricular measurements and clinical signs and symptoms were evaluated. After a 2-week, single-blind, placebo washout period, the patients were randomly allocated to double-blind treatment with either captopril twice a day or quinapril once a day; the initial doses of 12.5 and 5 mg, respectively, were increased to 25 and 10 mg, respectively, in the first month, and 50 and 20 mg in the second and third months, as required to achieve adequate blood pressure control. Baseline diuretic and/or digitalis therapy was allowed during the study, so that the patients were maintained in a stable condition. RESULTS: Data from 70 captopril- and 76 quinapril-treated patients were analysed. Both angiotensin converting enzyme inhibitors displayed comparable efficacy. Both drugs were well tolerated, with a low drop-out rate (11.4% for captopril and 10.5% for quinapril). CONCLUSION: Treatment with 20 mg quinapril once a day was as effective and safe for the treatment of congestive heart failure as 100 mg captopril administered twice a day.

Aged↗

PubMed1998

Persistence of the activity of topical ivermectin against biting lice (Bovicola bovis).

To assess the persistence of the activity of topical ivermectin against a natural challenge with biting lice (Bovicola bovis), 90 mixed-breed cattle that had been treated to remove lice, were blocked by bodyweight within sex and randomly allocated to three treatments: untreated control, doramectin at 200 micrograms/kg by subcutaneous injection, and ivermectin at 500 micrograms/kg by topical application. Forty-five pens were blocked into three groups of 15, and the blocks of pens were randomly allocated to three 14-day challenge periods starting 21, 28 and 35 days after treatment. There were five pens per treatment for each challenge period, and one B bovis-infested donor calf was introduced into each pen containing two principal calves at the start of the challenge period for that block of pens. The calves were examined thoroughly for B bovis seven, 14 and 21 days after the introduction of the donors. There were no significant differences between the control and doramectin groups for the numbers of animals infested, or the geometric mean louse counts at the final examination for any of the challenge periods. At the final examination for each challenge period, the louse counts of the cattle treated with topical ivermectin were all zero, and significantly (P < 0.05) fewer cattle treated with topical ivermectin were infested than either the controls or cattle treated with doramectin.

Animals↗

PubMed1999

Reducing myoclonus after etomidate.

BACKGROUND: The authors hypothesized that myoclonus after etomidate is dose-related, could be suppressed when small doses of etomidate were administered before induction, and is unassociated with seizure-like activity on electroencephalogram (EEG). METHODS: Three studies were performed. In the first study, 36 men were randomly assigned to receive 0.025, 0.050, 0.075, 0.100, 0.200, or 0.300 mg/kg of etomidate. In a second crossover study, eight men were randomly allocated to receive either a pretreatment dose of 0.050 mg/kg etomidate or placebo 50 s before 0.300 mg/kg etomidate was injected. EEG was recorded for subjects in the first two studies. In a third study, 60 patients were randomly allocated to one of three pretreatment doses of etomidate: 0.030, 0.050, or 0.075 mg/kg before 0.300 mg/kg was given. RESULTS: In Study 1, myoclonus was not observed after 0.025 or 0.050 mg/kg etomidate. One volunteer had myoclonus after 0.075 mg/kg and another after 0.100 mg/kg etomidate; three had myoclonus after 0.200 mg/kg; and five after 0.300 mg/kg. Incidence of myoclonus was dose-related (P < or = 0.01). In Study 2, two volunteers (25%) with etomidate pretreatment had mild myoclonus compared to six (75%) with placebo pretreatment (P < or = 0.05). EEG changes, other than delta waves, were not seen during myoclonic epochs. In Study 3, myoclonus was less likely after the small pretreatment doses (0.030 or 0.050 mg/kg) than after the large dose (0.075 mg/kg, P < or = 0.01). CONCLUSIONS: Incidence and intensity of myoclonus after induction with etomidate are dose-related, suppressed by pretreatment, and unassociated with seizure-like EEG activity.

Adult↗

PubMed1990

A comparison of seven-point and visual analogue scales. Data from a randomized trial.

Many controlled trials rely on subjective measures of symptoms or quality of life as primary outcomes. The relative merits of different response options for these instruments is an important issue. Therefore, we compared the responsiveness and validity of seven-point versus visual analogue scales (VAS) in a questionnaire measuring quality of life in chronic heart failure in a double-masked crossover trial of digoxin versus placebo. The VAS and seven-point scale versions of the questionnaire were administered to 20 patients during 7 weeks on digoxin and 7 weeks on placebo. The order of administration of the questionnaires was determined by random allocation. The ability of the two methods to distinguish digoxin and placebo, and their correlation with other measures, were comparable. We conclude that the two methods of presenting response options show comparable responsiveness and validity in a randomized trial setting. The ease of administration and interpretation of the seven-point scale recommend its use.

Humans↗

PubMed1995

Continuity of care by a midwife team versus routine care during pregnancy and birth: a randomised trial.

OBJECTIVE: To compare continuity of care from a midwife team with routine care from a variety of doctors and midwives. DESIGN: A stratified, randomised controlled trial. PARTICIPANTS AND SETTING: 814 women attending the antenatal clinic of a tertiary referral, university hospital. INTERVENTION: Women were randomly allocated to team care from a team of six midwives, or routine care from a variety of doctors and midwives. MAIN OUTCOME MEASURES: Antenatal, intrapartum and neonatal events; maternal satisfaction; and cost of treatment. RESULTS: 405 women were randomly allocated to team care and 409 to routine care; they delivered 385 and 386 babies, respectively. Team care women were more likely to attend antenatal classes (OR, 1.73; 95% CI, 1.23-2.42); less likely to use pethidine during labour (OR, 0.32; 95% CI, 0.22-0.46); and more likely to labour and deliver without intervention (OR, 1.73; 95% CI, 1.28-2.34). Babies of team care mothers received less neonatal resuscitation (OR, 0.59; 95% CI, 0.41-0.86), although there was no difference in Apgar scores at five minutes (OR, 0.86; 95% CI, 0.29-2.57). The stillbirth and neonatal death rate was the same for both groups of mothers with a singleton pregnancy (three deaths), but there were three deaths (birthweights of 600 g, 660 g, 1340 g) in twin pregnancies in the group receiving team care. Team care was rated better than routine care for all measures of maternal satisfaction. Team care meant a cost reduction of 4.5%. CONCLUSION: Continuity of care provided by a small team of midwives resulted in a more satisfying birth experience at less cost than routine care and fewer adverse maternal and neonatal outcomes. Although a much larger study would be required to provide adequate power to detect rare outcomes, our study found that continuity of care by a midwife team was as safe as routine care.

Adult↗

PubMed1991

UK Prospective Diabetes Study (UKPDS). VIII. Study design, progress and performance.

The UK Prospective Diabetes Study (UKPDS) is a multi-centre, prospective, randomised, intervention trial of 5100 newly-diagnosed patients with Type 2 (non-insulin-dependent) diabetes mellitus which aims to determine whether improved blood glucose control will prevent complications and reduce the associated morbidity and mortality. Newly presenting Type 2 diabetic patients aged 25-65 years inclusive, median age 53 years, median body mass index 28 kg/m2 and median fasting plasma glucose 11.3 mmol/l, were recruited and treated initially by diet. Ninety five percent remained hyperglycaemic (fasting plasma glucose greater than 6 mmol/l) and were randomly allocated to different therapies. In the main randomisation, those who were asymptomatic and had fasting plasma glucose under 15 mmol/l were allocated either to diet policy, or to active policy with either insulin or sulphonylurea aiming to reduce the fasting plasma glucose to under 6 mmol/l. Over 3 years, the median fasting plasma glucose in those allocated to diet policy was 8.9 mmol/l compared with 7.0 mmol/l in those allocated to active policy. The Hypertension in Diabetes Study has been included in a factorial design to assess whether improved blood pressure control will be advantageous. Patients with blood pressure greater than or equal to 160/90 mm Hg were randomly allocated to tight control aiming for less than 150/85 mm Hg with either an angiotensin-converting enzyme inhibitor or a Beta-blocker or to less tight control aiming for less than 200/105 mm Hg. The endpoints of the studies are major clinical events which affect the life and well-being of patients, such as heart attacks, angina, strokes, amputations, blindness and renal failure. To date, 728 patients have had at least one clinical endpoint. Surrogate endpoints include indices of macrovascular and microvascular disease detected by ECG with Minnesota Coding, retinal colour photography and microalbuminuria. The studies also aim to evaluate potential risk factors for the development of diabetic complications such as smoking, obesity, central adiposity, plasma LDL- and HDL-cholesterol, triglyceride, insulin, urate and other biochemical variables. The studies are planned to terminate in 1994, with a median follow-up of 9 years (range 3-16 years) for the glucose study and 5 years (range 2-6 years) for the hypertension study.

Adult↗

PubMed2002

Acute diarrhea during adjuvant therapy for rectal cancer: a detailed analysis from a randomized intergroup trial.

PURPOSE: During adjuvant radiotherapy (RT) for rectal cancer, patients receiving 5-fluorouracil (5-FU) by protracted venous infusion have a higher risk of diarrhea than have patients receiving bolus 5-FU. Toxicity from a previously reported randomized clinical trial was analyzed to quantify the difference in this risk. Additionally, the persistence of diarrhea after RT was analyzed. METHODS AND MATERIALS: A total of 656 patients were eligible. Patients with T3-4 N0-2 M0 or T1-2 N1-2 M0 resected, high-risk rectal cancer were randomly allocated to receive 5-FU by either protracted venous infusion or bolus during RT (50.4-54.0 Gy). Two cycles of bolus 5-FU were given before and after RT. One-half of the first 445 patients were also randomly allocated to receive lomustine in conjunction with the bolus 5-FU. The incidence and severity of diarrhea in relation to patient and treatment characteristics were evaluated. RESULTS: The rate of diarrhea was significantly greater in patients receiving 5-FU by protracted venous infusion than in patients receiving bolus 5-FU; the difference was most pronounced for Grade 3 (severe) diarrhea (21% versus 13%, p = 0.007). The incidence and magnitude of diarrhea before and after RT were similar. Patients treated with an anterior resection had a higher rate of severe or life-threatening diarrhea than did patients treated with an abdominoperineal resection (31% vs. 12%, p < 0.001). CONCLUSIONS: During pelvic RT, patients who receive 5-FU by protracted venous infusion rather than by bolus have a higher risk of severe or life-threatening diarrhea during RT. This risk does not appear to persist during chemotherapy after completion of pelvic RT.

Acute Disease↗

PubMed1996

Exercise and weight control in sedentary overweight men: effects on clinic and ambulatory blood pressure.

OBJECTIVE: To examine whether restriction of caloric intake and exercise of vigorous intensity can independently and additively influence clinic and ambulatory blood pressures in sedentary overweight men. DESIGN: Sixty subjects aged 20-50 years were randomly allocated either to continue their normal caloric intake or to restrict it by 4186-6279 kl/day, with 15% provided by protein, 30% by fat and 55% by carbohydrate, for 16 weeks. Within each of these groups subjects were further randomly allocated either to a control light intensity programme of exercise or to a vigorous intensity programme of exercise for 30 min three times a week. The light exercise group performed stationary cycling against no resistance, flexibility exercises and slow walking. The vigorous intensity group cycled on an ergometer at 60-70% of maximum their workload. RESULTS: Fifty-one subjects completed the study. Their maximal oxygen uptake was increased by approximately 24% with vigorous exercise but did not change with light exercise. Caloric intake restriction led to a significant loss of body mass of 9.5 kg (95% confidence interval 7.6-11.3), whereas vigorous exercise had no effect. Restriction of caloric intake reduced supine clinic systolic and diastolic blood pressures significantly by 5.6 (2.3-8.9) and 2.4 mmHg (0.4-4.2), respectively. Relative to the control light exercise group, exercise of vigorous intensity exercise had no significant effect on clinic blood pressure. In contrast, time series analysis revealed that both caloric intake restriction and vigorous exercise were associated with lower daytime ambulatory systolic blood pressure, the reduction in systolic blood pressure being sustained throughout the 24 h period when vigorous exercise and caloric intake restriction were combined. CONCLUSION: Compared with the effects of caloric intake restriction, the effects of a vigorous exercise programme on blood pressure are inconsistent, there being no influence on clinic blood pressure but a reduction in daytime ambulatory blood pressure. However, when combined with caloric intake restriction, regular vigorous exercise exhibits a synergistic effect in reducing ambulatory blood pressure throughout a 24 h period.

Adult↗

PubMed2003

Intraoperative fluorouracil in endonasal laser dacryocystorhinostomy.

BACKGROUND: Although endonasal laser dacryocystorhinostomy (ELDCR) offers many advantages compared with conventional techniques, postoperative scarring leading to occlusion of the rhinostomy is more common with ELDCR. OBJECTIVE: To investigate whether fluorouracil applied to the rhinostomy site intraoperatively has an effect on the outcome. PARTICIPANTS: We randomly allocated 155 consecutive patients (201 procedures) to a control group and a fluorouracil group. Patients and investigators were masked to the choice of treatment. METHODS: All patients underwent ELDCR. A pledget soaked in isotonic sodium chloride solution or 0.5-mg/mL fluorouracil, randomly allocated by the pharmacy, was applied to the rhinostomy site for 5 minutes at the time of surgery. Patients were followed up for 12 months and their symptoms were assessed at each visit. RESULTS: Among patients followed up for 12 months or longer, ELDCR procedures performed with topical application of fluorouracil to the rhinostomy site were successful in 65 (76%), compared with 52 (63%) for the control group. This was not statistically significant when patients who failed to attend follow-up at or after 12 months were not counted as successfully treated (P =.21, chi(2) test). Even if those who failed to attend for follow-up were counted as successes, the effect of fluorouracil did not reach significance at the.05 level (P =.08, chi(2) test). CONCLUSION: The topical application of fluorouracil failed to increase the patency rates in ELDCR.

Administration, Topical↗

PubMed2002

Acarbose for prevention of type 2 diabetes mellitus: the STOP-NIDDM randomised trial.

BACKGROUND: The worldwide increase in type 2 diabetes mellitus is becoming a major health concern. We aimed to assess the effect of acarbose in preventing or delaying conversion of impaired glucose tolerance to type 2 diabetes. METHODS: In a multicentre, placebo-controlled randomised trial, we randomly allocated patients with impaired glucose tolerance to 100 mg acarbose or placebo three times daily. The primary endpoint was development of diabetes on the basis of a yearly oral glucose tolerance test (OGTT). Analyses were by intention to treat. FINDINGS: We randomly allocated 714 patients with impaired glucose tolerance to acarbose and 715 to placebo. We excluded 61 (4%) patients because they did not have impaired glucose tolerance or had no postrandomisation data. 211 (31%) of 682 patients in the acarbose group and 130 (19%) of 686 on placebo discontinued treatment early. 221 (32%) patients randomised to acarbose and 285 (42%) randomised to placebo developed diabetes (relative hazard 0.75 [95% CI 0.63-0.90]; p=0.0015). Furthermore, acarbose significantly increased reversion of impaired glucose tolerance to normal glucose tolerance (p<0.0001). At the end of the study, treatment with placebo for 3 months was associated with an increase in conversion of impaired glucose tolerance to diabetes. The most frequent side-effects to acarbose treatment were flatulence and diarrhoea. INTERPRETATION: Acarbose could be used, either as an alternative or in addition to changes in lifestyle, to delay development of type 2 diabetes in patients with impaired glucose tolerance.

Acarbose↗

PubMed1983

Evaluation of mezlocillin in elective gastrointestinal surgery.

We report the interim results of two trials to evaluate the place of mezlocillin in elective intestinal operations. Sixty-four operations for gastro-oesophageal disease have been performed where patients were randomly allocated to mezlocillin or cefuroxime. Wound sepsis occurred in 19% of the mezlocillin patients compared with 3% of those receiving cefuroxime. Seventy-three operations have been performed for colorectal cancer in whom three doses of antibiotic were used for prophylaxis. Patients were randomly allocated to mezlocillin and metronidazole or cefuroxime and metronidazole. The rates of abdominal wound sepsis in the groups were 15% and 12% respectively. Post-operative Clostridium difficile colitis occurred in four of the cefuroxime patients, compared with none of those receiving mezlocillin. Mezlocillin appears to be a safe and effective antibiotic when used in combination with metronidazole in colorectal resections for cancer.

Cefuroxime↗

PubMed2003

Practice makes perfect: the critical role of mixed practice in the acquisition of ECG interpretation skills.

PURPOSE: To examine the effect of instructional format on medical students' learning of ECG diagnosis. METHOD: Two experiments employed different learning and practice methods. In the first, students were randomly allocated to one of two instructional approaches, one organized around features (e.g., QRS voltage) and the other around diagnostic categories (e.g., bundle branch blocks), followed by a practice phase. In the second experiment, the instruction was standardized, and students were randomly allocated to one of two practice phases, either "contrastive" where examples from various categories are mixed together, or "non-contrastive" where all the examples in a single category are practiced in a single block. RESULTS: In the first experiment, there was no significant differences in students' diagnostic accuracy on novel ECG examples. In the second experiment, students exposed to the contrastive approach in the practice phase had superior diagnostic accuracy (46%) compared to 30% accuracy for the non-contrastive session, p < 0.05). CONCLUSION: These experiments highlight two important features in the design of instructional materials. First, learning around the features of the problem (analogous to problem-based learning) may have no advantages over learning the category. Second, the design and organization of deliberate practice can result in significant learning gain.

Canada↗

PubMed2002

Effect of indomethacin on the antihypertensive efficacy of valsartan and lisinopril: a multicentre study.

OBJECTIVE: To compare the effect on antihypertensive efficacy produced by the addition of indomethacin to the angiotensin II (Ang II) antagonist, valsartan, or to the angiotensin-converting enzyme inhibitor, lisinopril, in hypertensive patients with chronic osteoarthritis. SUBJECTS AND METHODS: One hundred and twenty-eight patients (52 men and 76 women) aged 25-82 years (mean age 55.7 years), with diastolic blood pressure (DBP) > 100 mmHg at the end of a 2-week placebo washout period were allocated randomly to groups to receive valsartan (80-160 mg once daily) or lisinopril (10-20 mg once daily). At the end of 10 weeks of treatment, patients with DBP < 90 mmHg, while continuing to receive valsartan or lisinopril treatment, were allocated randomly to groups to receive either indomethacin (50 mg three times a day) or the corresponding placebo for 2 weeks, with a 1-week washout period between the two treatments, according to a double-blind, crossover design. After the initial washout period, patients were examined at the end of the 4th, 8th and 10th weeks of randomized treatment with valsartan and lisinopril, at the end of the first crossover period and then at the beginning and at the end of the second crossover period. At each visit, sitting and standing blood pressure were measured by standard mercury sphygmomanometer. RESULTS: The addition of indomethacin blunted the blood pressure-decreasing effect of both antihypertensive drugs. Although indomethacin produced greater increases in both systolic and DBP values in the lisinopril-treated patients (5.45/3.22 mmHg) than in the valsartan-treated ones (2.12/1.87 mmHg), no significant difference between the two drugs was found. CONCLUSIONS: From a theoretical standpoint, these findings suggest that prostaglandins may play a part in the antihypertensive action of Ang II antagonists. From a practical standpoint, hypertensive patients treated with valsartan or with lisinopril should be monitored to detect changes in blood pressure control while receiving indomethacin.

Adult↗

PubMed2003

The use of postal reminders to reduce non-attendance at an orthodontic clinic: a randomised controlled trial.

OBJECTIVES: To evaluate the effect of issuing a patient reminder plus a confirmation slip on the attendance of orthodontic new patients. SETTING: Department of Orthodontics, University Dental Hospital of Manchester. DESIGN: A randomised controlled trial. METHODS: New patients were randomly allocated to:receive a reminder letter and return a confirmation slip ornot receive a reminder. OUTCOME MEASURES: Patient attendance at the clinic. RESULTS: A total of 232 patients were entered into the study between June 18, 2001 and August 29, 2001. These were randomly allocated to 115 (49.8%) in the reminder group and 116 (50.2%) in the no reminder group. If the patient received a reminder and returned the confirmation they were less likely to fail the appointment than if they did not receive a reminder (OR 0.4, 95% CI 0.2 to 0.96) There was an effect of social deprivation, if the patients lived in an area of high social deprivation they were 2.7 (95% CI 1.1 to 6.5) times more likely to fail to attend an appointment than people who were more affluent. CONCLUSIONS: The use of postal reminders for orthodontic consultation appointments appears to result in a useful increase of appointments that are kept or cancelled in advance.

Appointments and Schedules↗

PubMed2002

Interventions led by nurse continence advisers in the management of urinary incontinence: a randomized controlled trial.

BACKGROUND: The short-term efficacy of combined lifestyle and behavioural interventions led by nurses in the management of urinary incontinence has not been rigorously evaluated by randomized controlled trial. We conducted a 6-month randomized controlled trial to determine whether a model of service delivery that included lifestyle and behavioural interventions led by "nurse continence advisers" in collaboration with a physician with expertise in continence management could reduce urinary incontinence and pad use in an outpatient population. We also aimed to evaluate the impact of this approach on subjects' knowledge about incontinence and their quality of life. METHODS: We used advertising in the mainstream media, newsletters to family physicians and community information sessions in 1991 to invite volunteers who were 26 years of age or older and suffered from incontinence to participate in a randomized controlled trial. Men and women who met the eligibility criteria were randomly allocated to receive either counselling from specialized nurses to manage incontinence using behavioural and lifestyle modification sessions every 4 weeks for 25 weeks or usual care. Symptoms of incontinence and the use of incontinence pads were the primary outcome measures. RESULTS: Using sealed envelopes, 421 patients were randomly allocated to the treatment or control groups. On average, patients in the treatment group experienced 2.1 "incontinent events" per 24 hours before treatment and 1.0 incontinent event per 24 hours at the end of the study. Control patients had an average of 2.4 incontinent events per 24 hours before the study and 2.2 incontinent events per 24 hours at the end of the study. The mean decrease in events in the treatment group was 1.2 and in the control group 0.2 (p = 0.001). Pad use declined from a mean of 2.2 per 24 hours before randomization in the treatment group to 1.2 per 24 hours at the end of the study, compared with 2.6 pads per 24 hours in the control group at the start of the study and 2.4 per 24 hours at the end. Pad use per 24 hours decreased on average by 0.9 pads in the treatment group and 0.1 in the control group (p = 0.021). INTERPRETATION: Behavioural and lifestyle counselling provided by specialized nurses with training in managing incontinence reduces incontinent events and incontinence pad use.

Adult↗

PubMedDate not supplied

Comparison of efficacy, secondary failure rate, and complications of sulfonylureas.

The data from three clinical trials are presented, comparing the efficacy of different sulfonylureas in the treatment of type II diabetes. In a multicenter study, gliclazide improved control in 49% of patients who had failed on other drugs. When five groups of type II diabetic patients were treated concurrently with five randomly allocated different sulfonylureas over 1 year, the percentage of patients achieving normal HbA1 levels was best with gliclazide (80%) and glibenclamide (74%), when compared with chlorpropamide (17%), glipizide (40%), and gliquidone (40%). Secondary failure rate over 5 years was assessed in 248 type II diabetic patients randomly allocated to three different sulfonylureas and found to be lowest with gliclazide (7%) compared with glibenclamide (17.9%): p < 0.1) and glipizide (25.6%: p < 0.005). The incidence of hypoglycemia was significantly higher with glibenclamide than with gliclazide (p < 0.05). The differences in efficacy and secondary failure rate between sulfonylureas may be related to the mechanism of insulin release from the beta-cell and the more physiological action of gliclazide could partly explain this. These trials suggest that gliclazide is a potent sulfonylurea with a low rate of secondary failure and a low incidence of side effects and may be a better choice in long-term sulfonylurea therapy.

Clinical Trials as Topic↗

PubMed1997

Feasibility of the transparent cap-fitted colonoscope for screening and mucosal resection.

PURPOSE: A transparent plastic cap of 17 mm in outer diameter, 15 mm in inner diameter, and 10 mm in length can be easily attached to the tip of a colonoscope. By using the cap, a better view of the lesions hiding at the opposite side of the fold can be obtained. When a flat colonic lesion is found, a submucosal injection of saline solution is performed, the target mucosa is sucked inside the cap, snared under a full endoscopic suction, and resected by an electrical current. This procedure is called endoscopic mucosal resection using transparent cap-fitted endoscope (EMRC). Feasibility of the cap-fitted colonoscope for screening colonoscopic examination and mucosal resection was evaluated. MATERIALS AND METHODS: One hundred forty patients were randomly allocated for screening with a normal colonoscope (NCF) or that with the cap-fitted colonoscope (CCF). Average time for insertion up to the cecum, patients' discomfort during insertion expressed in 4 degrees, and average number of lesions found in one patient were compared. Thirty lesions randomly allocated for mucosal resection with conventional strip biopsy or EMRC were also evaluated. RESULTS: Time consumed for insertion up to the cecum with the CCF (12.4 +/- 6.6 minutes) was the same as that with the NCF (12.3 +/- 5.2 minutes), and there was no significant difference in patients' discomfort; however, the average number of lesions found in one patient was larger when using the CCF (0.86 +/- 0.96) than when using the NCF (0.58 +/- 0.81). For mucosal resection, 40 flat or wide-based lesions including 6 mucosal carcinomas were resected with EMRC. We experienced only one pinhole perforation of the ascending colon by heat damage, which was treated successfully by surgery. There was no other major complication or recurrence. CONCLUSION: The cap-fitted endoscope was equal in maneuverability, was excellent in sensitivity in comparison with the regular colonoscope, and was thought to be feasible both in screening and mucosal resection.

Aged↗