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PubMed1981

Controlled trial of speech therapy versus oxprenolol for stammering.

In a controlled trial of treatment for stammering under stress oxprenolol (40 mg) compared with placebo was assessed in a double-blind manner over two days, six weeks apart, in 31 stammerers before and after speech therapy. The trial design also allowed six weeks of intensive speech therapy, using a slowed-speech and relaxation technique, to be compared with not treatment and assessed single-blind. Oxprenolol produced a significant fall in pulse rate and systolic blood pressure but no overall change in performance either before or after speech therapy. Intensive speech therapy produced a highly significant improvement in the global performance of untrained subjects (p less than 0.001) and a significant reduction in the number (p less than 0.001) and duration (p less than 0.001) of blocks. Maintenance speech therapy tended to produce further improvement in trained subjects. Speech therapy is apparently an effective treatment for stammering, whereas oxprenolol appears to be of no value when given routinely; oxprenolol may be of value, however, in very stressful conditions.

Adolescent↗

PubMedDate not supplied

Prevention of intraperitoneal adhesions by intraperitoneal lavage and intraperitoneal 5-fluorouracil: experimental studies.

Postoperative adhesions remain the leading cause of small bowel obstruction. Peritoneal adhesions were induced in 180 rats by scraping the cecum and burning the adjacent parietal peritoneum by electrocoagulation. The adhesions were scored 14 days later in a blinded manner. All four types of intraperitoneal instillations significantly reduced the extension and the severity of the adhesions, at both schedules, when compared to the control group. The use of 5-fluorouracil at 20 mg/kg in peritoneal dialysis solution during 5 days significantly decreased the global score (P = 0.04), the extension (P = 0.04), and the severity (P = 0.04) of adhesions when compared to the 5-day instillation of peritoneal dialysis alone. Lavage of the abdomen with peritoneal dialysis solution or hetastarch decreased the formation of adhesions. Instillation of 5-fluorouracil in a large volume of peritoneal dialysis solution could be novel and promising treatments for prevention of postoperative adhesions.

Animals↗

PubMed1988

Episodic twice-daily treatment for recurrent genital herpes.

A new dosage regimen of orally administered acyclovir, 800 mg twice daily for five days, for the treatment of recurrent genital herpes was compared with the standard dosage of 200 mg given five times per day. A double-blind study of 157 patients was used to evaluate the safety and efficacy of both regimens. The new regimen was well tolerated, more convenient, and as effective as the standard dosage. In male patients, the new regimen may be more effective than the standard regimen of 200 mg given five times per day to treat lesions that are already present.

Acyclovir↗

PubMed1989

MK-801, an excitatory amino acid antagonist, does not improve neurologic outcome following cardiac arrest in cats.

The excitatory amino antagonist MK-801 was administered to cats following resuscitation from cardiac arrest to evaluate its effect on neurologic and neuropathologic outcome in a clinically relevant model of complete cerebral ischemia. In 29 cats studied, cardiac arrest (ventricular fibrillation) was maintained for 18 min and resuscitation was successfully performed in 21 cats. Four animals underwent a sham arrest. MK-801 or placebo was administered in a blinded, randomized manner. Beginning at 5 min post resuscitation (PR), MK-801 330 micrograms/kg over 2 min followed by 73 micrograms/kg/h for 10 h or the same volume of placebo was administered. Resuscitated animals remained paralyzed and sedated in an intensive care setting for 24-30 h PR. Neurologic examinations were performed at 2, 4, and 7 days PR by observers blinded to the treatment groups. Seventeen cats were entered into data analysis (nine MK-801-treated and eight placebo-treated). MK-801-treated animals had a significantly greater neurologic deficit score (NDS) rank (0 = normal, 100 = brain death) 2 days PR (mean rank 12.1 vs. 5.6; p = 0.008). This difference is most likely due to ongoing sedative actions of MK-801. There were no significant differences in NDS rank at 4 (10.3, MK-801 vs. 7.5, placebo) and 7 (9.6, MK-801 vs. 8.3, placebo) days PR. There were no significant differences in frontal cortex, hippocampus, occipital cortex, or cerebellar neuropathology between groups. Sham-arrested cats had normal neurologic and neuropathologic evaluations. In the circumstance of complete cerebral ischemia as employed in the current study, MK-801 had no beneficial effect upon neurologic or neuropathologic outcome.

Animals↗

PubMed1992

Comparison of the effects of loratadine and astemizole in the treatment of children with seasonal allergic rhinoconjunctivitis.

The efficacy and safety of a once-daily dose of loratadine 10 mg (5 mg in patients whose body weight was less than or equal to 30 kg) and astemizole 2 mg/10 kg body weight o.d. were compared in a 14-day third-party blind study. Forty-one children (30 boys and 11 girls, aged 6-14 years) with seasonal allergic rhinoconjunctivitis entered the study. The pollen count was monitored throughout the study. A significant improvement (p less than 0.01) in allergy symptoms was observed from the third day for both drugs; there was no significant difference between drugs, although loratadine led to a greater reduction in symptoms. In the astemizole group, the apparently rapid onset of drug action might by explained by reduced pollen exposure. Therapeutic response was excellent/good in 83.3% and 58.8% of the loratadine and astemizole groups, respectively. The results reported by the patients/parents were similar. Nine of the children on astemizole and four children on loratadine complained of side effects; three patients in the astemizole group were withdrawn from treatment because of adverse effects. No abnormal changes in lab values were observed in either group.

Adolescent↗

PubMed1994

[Evaluation of the analgesic effect of naftidrofuryl in permanent ischemia in patients with arterial diseases. Double-blind versus placebo study].

Ischemic rest pain, with or without trophic disorders and occurring very frequently at night, is responsible for insomnia and complications such as positional oedema. The pathophysiological mechanisms underlying the analgesic effect of naftidrofuryl led us to evaluate the efficacy of this treatment. 37 selected patients were given 2 daily infusions of 400 mg of naftidrofuryl for 8 days, under double-blind conditions. Evaluation criteria were pain assessment using a visual analogue scale, analgesic consumption considering both the power (WHO scale: level I paracetamol, level II dextropropoxyphene, level III morphine) and the dosage of the analgesic used (analgesic score), index of therapeutic success including the level of pain reduction and the absence of analgesic use. The results showed a significant difference in favour of naftidrofuryl for: reduction of pain, difference in the course of the analgesic score, the distribution of the population according to the index of therapeutic success. Three patients discontinued treatment due to inefficacy, but all 3 belonged to the placebo group. This study demonstrates the benefit of naftidrofuryl in pain reduction which was assessed, in particular, by the reduction of analgesic consumption.

Aged↗

PubMed2000

Efficacy of daily and alternate-day dosing regimens with the combination buprenorphine-naloxone tablet.

This study evaluated the efficacy of a combination tablet formulation of buprenorphine containing 8 mg of buprenorphine and 2 mg of naloxone for every other day treatment and whether increasing the daily maintenance dose was essential for maintaining an efficacious alternate-day treatment. Twenty-six opioid-dependent outpatients completing a 16-day baseline entered a double-blind, placebo-controlled, triple crossover trial. Twenty-one days of daily combination tablet administration were compared to two different 21-day periods of alternate-day buprenorphine administration where subjects received either 8 or 16 mg of the combination tablet every other day with placebo on the interposed day. Fifty-four percent (14/26) of subjects completed the study, but only two subjects dropped out during the 16-mg alternate-day condition. Rates of medication compliance, illicit opioid use and subject- and observer-rated measures of opioid effects did not distinguish daily from alternate-day treatments in subjects completing the study. However, pupillary diameter was significantly increased during 8-mg alternate-day compared to the 8-mg daily or 16-mg alternate-day treatment. These data replicate earlier findings describing the acceptability of alternate-day buprenorphine treatment using multiples of the daily maintenance dose and extend these findings by establishing the clinical efficacy of daily and alternate-day dosing regimens with the combination buprenorphine naloxone tablet. This study also suggests slightly improved outcomes during alternate-day treatment using multiples of the daily dose.

Adult↗

PubMed2004

Establishing the dosage equivalency of oxymorphone extended release and oxycodone controlled release in patients with cancer pain: a randomized controlled study.

OBJECTIVE: To compare the analgesic efficacy and safety of oxymorphone extended release (ER) and oxycodone controlled release (CR) in patients with moderate to severe cancer pain. RESEARCH DESIGN AND METHODS: This randomized, multicenter, double-blind, 2-period crossover study included adult outpatients (>or= 18 years of age) with moderate or severe cancer pain who were first titrated for 3-10 days with open-label oxymorphone or oxycodone to achieve a stable dose that provided and other efficacy parameters were comparable for adequate analgesia with tolerable adverse events and no requirement for more than 2 doses of rescue medication per day. The subsequent double-blind treatment phase was a 7- to 10-day period of oxycodone CR or oxymorphone ER treatment followed by crossing over to the alternate medication for another 7-10 days. During the treatment phase, up to 2 doses per day of morphine sulfate 15-mg tablets were allowed as rescue. MAIN OUTCOMES AND MEASURES: Assessments included the Brief Pain Inventory, global evaluations, Karnofsky performance status, and clinical laboratory evaluations (serum chemistry profile, complete blood count, urinalysis). Efficacy variables were analyzed using a mixed-effects model with treatment, sequence, and period as fixed effects and subject as a random effect. RESULTS: Forty-seven patients entered the titration/stabilization phase, 44 received at least 1 dose of study drug, 42 completed the first double-blind phase, and 40 completed the second double-blind phase. Mean pain intensity scores the 2 groups. The mean daily dosage of oxycodone CR (91.9 mg) was twice that of oxymorphone ER (45.9 mg), an equianalgesic dose ratio of 2:1. Rescue medication use was low in both groups (approximately 1 tablet of morphine sulfate 15 mg/day). No significant differences in opioid adverse events were observed between the groups. CONCLUSIONS: Adult patients with cancer who were taking oxycodone CR were readily converted to oxymorphone ER and required half the milligram dose to stabilize their pain. Within 72 h, most patients achieved a stable dose that provided adequate relief with similar opioid adverse events.

Adult↗

PubMed1989

The effect of cisapride on defaecation in normal human subjects--lack of effect on faecal excretion of water, fat, and bile acids.

In order to elucidate whether or not the increased stool frequency that occurs during cisapride treatment is a result of malabsorption of water, fat, and bile acids, 12 healthy volunteers were dosed with either tablets of placebo q.d.s. or tablets of 10 mg cisapride q.d.s. during two periods of 5 days in a double-blind, crossover study. Stool frequency, stool consistency, and side-effects were recorded each day. Total faecal mass, faecal water content, and faecal excretion of fat and bile acids were determined during the last 72 h of each study period. Mean daily stool frequency was 18.8% higher during cisapride [1.68 +/- 0.12 (S.E.M.)] administration than during placebo (1.42 +/- 0.12); P = 0.038. The stool consistency score increased by 11.8% towards softer stools during cisapride dosing (N.S.). There were no significant differences in total faecal mass (placebo 399.4 g/72 h; cisapride; 414.5 g/72 h), faecal water content (placebo; 75.6%: cisapride 76.2%), or faecal excretion of fat (placebo; 12.7 g/72 h: cisapride; 11.6 g/72 h) and total bile acids (placebo; 2212 mumol/72 h: cisapride; 2261 mumol/72 h). The side-effects reported during placebo were constipation (n = 3), and during cisapride meteorism (n = 4) and increased appetite (n = 2). The increased stool frequency during cisapride treatment is not caused by malabsorption of water, fat, or bile acids, but seems to be the consequence of a direct motor effect.

Adult↗

PubMed1995

[Treatment of diversion colitis with short-chain fatty acids. Bacteriological study].

OBJECTIVES: Bacterial imbalance may be involved in the pathogenesis of diversion colitis, via diminished production of short chain fatty acids. The aim of the study was to evaluate the effectiveness of short chain fatty acids on microbial flora of patients with diversion colitis and to compare this flora to the microbial flora of controls. METHODS: We prospectively evaluated the effectiveness of short chain fatty acids irrigation on bacterial flora of the excluded colon in 13 patients (8 males, 5 females; mean age: 43.7 years). The causes of diversion were inflammatory bowel disease (n = 4) colonic cancer (n = 2) sigmoid diverticulitis with perforation (n = 3) ischio-rectal abscess (n = 2) and miscellaneous (n = 2). Patients were given, twice a day for 14 days in a double blind manner, a 60 mL enema containing either short chain fatty acids (acetate: 60 mmol/L; propionate: 30 mmol/L; and n-butyrate: 40 mmol/L) (group 1; n = 7) or isotonic NaCl (group 2; n = 6). Bacteriological studies were carried on before starting the trial (D1) and 14 days later (D14). RESULTS: Before and after treatment, there was no difference between group 1 and group 2 concerning bacterial counts and species. Bacterial flora of patients with diversion colitis was characterized by: a) an increase of the count of aerobic bacteria; b) an increase of aerobic and aeroanaerobic species; c) the presence of black pigmented Gram negative anaerobic rods such as Prevotella intermedia and Porphyromonas asaccharolytica which were not found in rectal flora of the control group (16 volunteers, mean age: 27 years). CONCLUSIONS: These data suggest that: a) enema with short chain fatty acids does not induce significant changes in the composition of the microbial flora in patients with diversion colitis; b) bacterial dysbiosis may be involved in pathogenesis of diversion colitis without involving the action of short chain fatty acids.

Adult↗

PubMed1983

Effect of a combination of orphenadrine/paracetamol tablets ('Norgesic') on myalgia: a double-blind comparison with placebo in general practice.

The clinical efficacy and tolerability of a combination preparation ('Norgesic') of 35 mg orphenadrine plus 450 mg paracetamol was compared with that of placebo in a controlled double-blind, parallel group, 7-day study comprising 44 patients suffering from pain due to tension of the cervical and upper thoracic musculature. The patients were allocated at random into two homogeneous groups, stratified by sex and initial pain intensity. One group received the combination, the other placebo. The dosage used was 1 tablet 3-times daily. The effect of treatment of pain was assessed daily using a visual analogue scale. Despite the low dosage used, orphenadrine/paracetamol produced statistically significant pain relief from initial levels by and from the second day of the study. Comparison between the groups showed that the analgesic efficacy of the combination was significantly superior to that of placebo from the third day of treatment. These results confirm the efficacy of a combination of orphenadrine/paracetamol in patients suffering from myalgia nuchae.

Acetaminophen↗

PubMed2006

A post hoc subgroup analysis of an 18-day randomized controlled trial comparing the tolerability and efficacy of mixed amphetamine salts extended release and atomoxetine in school-age girls with attention-deficit/hyperactivity disorder.

BACKGROUND: Because the scientific literature on the pharmacotherapy of attention-deficit/hyperactivity disorder (ADHD) is almost entirely based on the results of studies in samples consisting primarily of boys, much is unknown about the treatment response in girls. OBJECTIVE: This post hoc analysis compared the efficacy, tolerability, and time course of the effect of mixed amphetamine salts extended release (MAS XR) and atomoxetine in school-age girls with ADHD. METHODS: This was an intent-to-treat subanalysis of the data from girls enrolled in a multicenter, 18-day, randomized, double-blind, parallel-group, forced dose-titration, laboratory school study enrolling boys and girls aged 6 to 12 years with ADHD. The study compared the efficacy, tolerability, and time course of the effect of increasing doses of MAS XR (10, 20, and 30 mg/d) and atomoxetine (0.5 and 1.2 mg/kg per day). The laboratory school sessions were organized in cycles to include 12 hours of observation. Efficacy measures included the SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham) deportment rating subscale, the SKAMP attention rating subscale, and academic testing (number of math problems attempted and answered correctly). Adverse events were assessed throughout the study period. Tolerability and efficacy measures were assessed during laboratory school visits on days 7, 14, and 21. RESULTS: This subanalysis included 57 girls (median age, 9 years; 49.1% white, 22.8% black, 17.5% Hispanic) with a diagnosis of ADHD, combined subtype. Twenty-six girls were randomized to receive MAS XR and 31 were randomized to receive atomoxetine. Mean SKAMP deportment and attention subscale scores in the 2 groups were similar at baseline. Mean changes from baseline were significantly greater for MAS XR compared with atomoxetine on the SKAMP deportment score (-0.48 vs -0.04, respectively; P<0.001) and SKAMP attention score (-0.45 vs -0.05; P<0.001). The time course of medication effect, based on change from baseline in SKAMP deportment scores, indicated 12-hour efficacy for MAS XR at hours 2, 4.5, 7, 9.5, and 12 (all time points, P<0.01 vs baseline) but not for atomoxetine. At the end of the study, both treatment groups had a significant increase from baseline in the mean number of math problems attempted and answered correctly (P<0.001). Girls who received MAS XR attempted significantly greater numbers of problems compared with those who received atomoxetine (P=0.04). Both MAS XR and atomoxetine were well tolerated. The most frequently occurring treatment-related adverse events in girls receiving MAS XR were decreased appetite (40.7%), upper abdominal pain (29.6%), insomnia (25.9%), and headache (14.8%). The most frequently occurring treatment-related adverse events in girls receiving atomoxetine were somnolence (28.1%), upper abdominal pain (15.6%), vomiting (15.6%), nausea (12.5%), and decreased appetite (12.5%). CONCLUSION: This post hoc analysis in a subpopulation of girls with ADHD, combined subtype, found that 18-day treatment with MAS XR was significantly more effective than atomoxetine in terms of ratings of classroom behavior, attention, and academic productivity.

Adrenergic Uptake Inhibitors↗

PubMed2003

Prospective randomized clinical trial comparing patient-controlled intravenous analgesia with patient-controlled epidural analgesia after lumbar spinal fusion.

STUDY DESIGN: A prospective, randomized, double-blind clinical trial was conducted. OBJECTIVE: To compare the efficacy of patient-controlled analgesia (PCA) with that of patient-controlled epidural analgesia (PCEA) in terms of overall patient satisfaction with postoperative pain management after lumbar spine fusion. SUMMARY OF BACKGROUND DATA: In numerous surgical disciplines, PCEA and PCA have proved to be effective methods of postoperative pain control. The literature states that with PCEA, less opioid use is required during the immediate postoperative period to maintain equivalent pain control compared to PCA. Continuous epidural infusion has been assessed in spine fusion patients, but PCEA has not been evaluated. Furthermore, this is the first prospective randomized clinical trial to assess overall patient satisfaction while stratifying patients for both anxiety level and preoperative opioid use. METHODS: For this study, 74 patients were assigned randomly to one of two treatment groups, with PCA and PCEA administered in a double-blind manner for a 3-day postoperative course. All the patients received both PCA and PCEA delivery systems. Assessment was by a blinded, independent observer. Overall patient satisfaction with pain management was assessed by a visual analog scale at the end of postoperative day 3. Secondary measures included: three scales from the Functional Independence Measure instrument; opioid quantity; side effects; and length of hospital stay. RESULTS: Thirty-eight patients were randomized to PCA, and 36 were randomized to PCEA. No baseline variable differences between the groups were observed. The results showed no difference between the groups on the following measures: overall patient satisfaction with pain management, ambulation, and length of stay. The PCA patients used significantly more opioid than the PCEA patients. CONCLUSIONS: Both postoperative analgesic regimens provided good overall patient satisfaction. The only clinical advantage of PCEA over PCA for spine fusion patients was the lower amount of opioid consumed, although the PCEA group experienced significantly more side effects than the PCA group. There were no other significant differences. Therefore, patient or physician preference could select either postoperative pain management delivery system.

Analgesia, Epidural↗

PubMedDate not supplied

A randomized controlled clinical trial assessing the effect of betamethasone valerate 0.12% foam on the short-term treatment of stasis dermatitis.

BACKGROUND: There are no published studies examining either the effectiveness of topical steroids in the treatment of stasis dermatitis or indicating what steroid strength or duration of treatment is optimal to treat this common condition. OBJECTIVE: To investigate the efficacy of twice-daily application of the topical steroid betamethasone valerate 0.12% foam for the treatment of stasis dermatitis. DESIGN: 42-day randomized, double-blinded, vehicle-controlled, pilot study. SETTINGS: Outpatient dermatology clinic at a university-affiliated clinic. SUBJECTS: 19 subjects, mean age of 73, with mild to moderate bilateral stasis dermatitis. INTERVENTION: Twice-daily application of betamethasone valerate 0.12% foam versus vehicle foam to bilateral randomly assigned lower legs for 28 days with follow-up to day 42. MAIN OUTCOME MEASURES: The primary clinical endpoints were the mean change in erythema, scale, swelling, petechiae, post-inflammatory hyperpigmentation, and self-reported pruritus, assessed on a 5-point Likert scale (0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe). Secondary endpoints were changes in health related quality of life (HRQL) using the EuroQol-5D (EQ-5D) utility score and visual analog scale (VAS) and the Dermatology Life Quality Index (DLQI). RESULTS: Although there was no overall difference between the foam and vehicle-treated leg at days 14 and 28, the steroid-treated leg, but not the vehicle-treated leg, showed statistical improvement over baseline. Improvement in the steroid-treated leg was statistically better than vehicle at days 14 and 28 in terms of erythema (P < .05) and petechiae (P < .05). Improvement in VAS was notable at days 14 (7.1%), 28 (9.7%), and 42 (9.6%) (P < .001). Similarly, there was a statistically significant improvement in the DLQI compared to baseline on visit days 14 (188.9%) and 28 (126.1%) (P < .001). CONCLUSIONS: This study suggests that betamethasone valerate 0.12% foam is an effective and well-tolerated short-term treatment of stasis dermatitis, but that higher potency steroids may be needed to achieve better efficacy. Furthermore, these results are the first to suggest that the application of effective topical anti-inflammatory therapy can lead to improvement in HRQL.

Administration, Topical↗

PubMed1993

Quantitative electroencephalographic correlates of steroid administration in man.

Elevated levels of circulating corticosteroids are frequently associated with behavioral alterations in man, although the mechanisms by which corticosteroids may affect behavior are poorly understood. To evaluate possible effects of exogenous corticosteroids on brain electrophysiological functioning and the relationship of such effects to behavioral and biochemical changes, we administered prednisone (80 mg p.o. daily for 5 days) in a double-blind manner to 11 medically healthy volunteers. Quantitative electroencephalogram analysis was performed following 4 days of prednisone administration and during the preceding and ensuing placebo administration periods. Central theta wave brain electrical activity significantly increased following prednisone administration and returned to baseline following prednisone withdrawal. This effect was directly correlated with prednisone-induced increases in subjective sadness ratings and with decreases in self-rated energy and well-being. Prednisone-induced reductions in peak alpha wave activity were also directly correlated with increases in subjective sadness and Symptom Checklist-90 ratings and with decreases in self-rated 'hypomanic' symptoms. Further, prednisone-induced increases in theta activity were significantly correlated with prednisone-induced decreases in CSF levels of somatostatin-like immunoreactivity, and prednisone-induced decreases in peak alpha activity were significantly correlated with decreases in CSF levels of norepinephrine and with relative increases (or lesser decreases) in CSF levels of beta-endorphin and beta-lipotropic hormone. This preliminary report of the concomitant development of prednisone-induced changes in brain electrical activity, neurochemistry and behavior highlights areas for future exploration in the study of corticosteroid effects on behavior in man.

Adult↗

PubMed1997

Rapid benefit of intravenous pulse loading of clomipramine in obsessive-compulsive disorder.

OBJECTIVE: The authors conducted a randomized, double-blind, placebo-controlled trial of intravenous versus oral pulse loading of clomipramine in patients with obsessive-compulsive disorder to test two hypotheses: 1) intravenous pulse loading will cause greater immediate improvement than oral pulse loading and 2) patients who respond to pulse loading will continue to improve during 8 weeks of oral clomipramine treatment. METHOD: Fifteen patients with DSM-III-R obsessive-compulsive disorder of at least 1 year's duration and baseline Yale-Brown Obsessive Compulsive Scale scores of 17 or higher were enrolled in the study. Yale-Brown scale ratings were made 4.5 days after double-blind oral or intravenous pulse loading of clomipramine, and patients were then given 150 mg/day of oral clomipramine with increases of 25 mg every 4 days to 250 mg/day as tolerated or, in two cases, other selective serotonin reuptake inhibitors (SSRIs). RESULTS: The first hypothesis was confirmed: 4.5 days after the second pulse-loaded dose, six of seven patients given intravenous clomipramine but only one of eight given oral medication responded to the drug. After 8 weeks of oral clomipramine, the results partially supported the second hypothesis: four of six patients who had responded to intravenous clomipramine continued their improvement, but those who had responded to pulse loading did not improve statistically significantly more than those who had not. CONCLUSIONS: Intravenous pulse loading of clomipramine may be a valuable new treatment for obsessive-compulsive disorder, particularly for patients who have failed oral treatment trials.

Administration, Oral↗

PubMed1999

A randomized, prospective study to evaluate the efficacy and acceptance of three bowel preparations for colonoscopy in children.

OBJECTIVE: We performed a prospective, randomized, single-blind study in children undergoing colonoscopy to evaluate the acceptance and efficacy of three different bowel preparations. METHODS: Seventy patients (ages 3-20 yr, 38 males) were randomly assigned to one of the three study preparations: Magnesium citrate with X-prep and clear liquid diet for 2 days (group A); Dulcolax for 2 days and Fleet enema without dietary restriction (group B); and Golytely 20 ml/kg (up to 1 L) per hour for 4 h with clear liquid diet for 1 day (group C). Endoscopists blinded to bowel preparation graded the adequacy of colon cleansing. The preparations were rated by patients for tolerance, willingness to retake them, adverse effects, and compliance. RESULTS: Data analysis using Fisher exact test and trend test showed that colon cleansing in groups A and C was superior to that in group B (p < 0.0001) and better in group C than A (p < 0.075). Overall tolerance and compliance were significantly better for groups A and B than group C (p < 0.003), but not different between A and B. More of group B patients were willing to retake the preparation than in group C (p < 0.002) and group A (p < 0.05), but this was not different between groups A and C. Adverse effects were reported more frequently by patients in group C than in groups A and B (p < 0.01). CONCLUSIONS: Although the least well tolerated, Golytely provided the best cleansing. Dulcolax without dietary restriction provided unsatisfactory colon cleansing. Magnesium citrate with X-prep was acceptable and provided good cleansing.

Adolescent↗

PubMed1985

Treatment of mild to moderate essential hypertension with muzolimine. Two years of follow-up.

This study was carried out in association with medical practitioners who were responsible for observing the patients. In a first phase, 58 subjects younger than 70 years with moderate essential hypertension were allotted at random to treatment with either indapamide (2.5 mg per day) or muzolimine (20 mg per day). The double blind-double dummy study lasted for six months and demonstrated that the two drugs were similar in efficacy and tolerance. At the end of this phase 42 patients whose supine diastolic blood pressure fell to below 100 mmHg were selected to continue the trial with 20 mg per day muzolimine in an open long-term study. The survey comprised two periods: the first lasted for six months, the patients being examined every two months, and the second lasted for one year and patients were seen quarterly. However, 8 subjects entered directly into the second period. At each examination standing and supine blood pressure, heart rate and body weight were noted; blood was sampled to allow measurements of serum plasma parameters. Thus 15 patients were treated with muzolimine over two years and 15 over 18 months. Clinically the fall in blood pressure observed initially was maintained throughout the rest of the trial; but 3 patients needed another drug, i.e. central hypotensor (2 cases) and beta-blocker (1 case). Two subjects complained of transitory cramps, but 3 other complications not imputable to the treatment were observed: one myocardial infarction and 2 strokes. Biologically there was no change in mean plasma potassium level, but 3 patients received a potassium supplement.(ABSTRACT TRUNCATED AT 250 WORDS)

Blood Pressure↗