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At least 1,135 records · Page 63Linked to original sources

PubMed1988

Treatment of bulimia with fenfluramine and desipramine.

Desipramine and fenfluramine were administered to bulimic patients in a 15-week study of double-blind, placebo-controlled, crossover design. The 22 patients in the study met DSM-III criteria for bulimia and were of normal weight. Twelve subjects were randomly allocated to the fenfluramine group, and 10 subjects received desipramine. Half the subjects in each group received the active drug in the first 6 weeks and half received placebo. There was a 3-week washout period, after which subjects were crossed over for the remaining 6 weeks. The Eating Disorder Inventory, profile of Mood States, bulimia symptom checklists, and Hopkins Symptom Checklist were administered at weeks 0, 2, 4, 6, 9, 11, 13, and 15. Subjects maintained a daily record of bingeing, vomiting, and laxative/diuretic abuse. Results indicated that both drugs had beneficial effects on bingeing and vomiting frequency, although a greater proportion of patients were identified who responded to fenfluramine than to desipramine. Fenfluramine and desipramine were also effective in reducing the psychological symptoms of bulimia, such as the urge to binge, and feelings of depression. Results suggest that direct alteration of central food intake regulatory centers can effectively control bulimia.

Adolescent↗

PubMed1979

Gradual reintroduction of full-strength milk after acute gastroenteritis in children.

46 children (26 boys and 20 girls) admitted with mild acute gastroenteritis were randomly allocated to a regimen of continuing on full-strength milk, or to one of taking clear fluids until the diarrhoea settled before full-strength milk was reintroduced either immediately, or gradually in quarter-strength steps. There was no difference in length of hospital stay between the three groups.

Acute Disease↗

PubMedDate not supplied

Controlled trial of suloctidil in intermittent claudication.

Forty-five patients with intermittent claudication were first treated with placebo tablets for 3 months and then randomly allocated to double-blind therapy with either suloctidil or placebo for 6 months. Walking distance improved significantly in both groups during the 3 months of placebo treatment. During the 6 months of double-blind treatment with a further significant improvement occurred only in the placebo group when all patients were analyzed. However, when patients who stopped for reasons unrelated to claudication such as angina and exhaustion during repeated walking tests were eliminated, only suloctidil-treated patients improved significantly. The evolution of leg flow and distal pressure was similar in the two treatment groups whether all legs or only legs with abnormal flow and pressure values were considered. By contrast, when the analysis was limited to legs with claudication pain, a significant improvement occurred only in the suloctidil-treated group. These findings suggest that suloctidil may improve the claudication symptoms of patients with chronic arterial obstructive disease and in particular the perfusion of legs experiencing claudication pain. However, the clinical significance of this improvement appears limited.

Clinical Trials as Topic↗

PubMed1983

Zopiclone to geriatric patients. A parallel double-blind dose-response clinical trial of zopiclone as a hypnotic to geriatric patients - a study in a geriatric hospital.

Zopiclone was given for 14 nights to 68 geriatric patients (mean age 81 years) with sleep problems. The patients were randomly allocated to four treatment groups: 3.75 mg, 5.0, 7.5, or 10.0 mg of zopiclone. Sleep quantity and quality, side effects, and influence on psychomotor performance (digit symbol substitution and letter cancellation test) were studied before treatment, during active treatment, and after withdrawal of the drug. All patients slept better on zopiclone compared to placebo. There were only slight differences between the different dose levels as regards quantity and quality. No influence on psychomotor performance could be shown. The side effects were mild. Zopiclone showed a good hypnotic efficacy, and 7.5 mg is probably the best dose for elderly patients.

Aged↗

PubMed1985

Pre- versus postoperative radiotherapy in rectal carcinoma: an interim report from a randomized multicentre trial.

Since October 1980 a randomized multicentre trial has been in progress among patients with rectal carcinoma, in whom high-dose fractionated pre-operative irradiation (total dose 25.5 Gy in 5-7 days) is being tested against postoperative irradiation to a high dose level using a conventional fractionation scheme (totally 60 Gy in 8 weeks) delivered only to a high-risk group of patients (Dukes' stages B and C). The primary aim of the trial is to investigate whether local recurrence rate differs between the two groups, and a secondary aim is to see whether 5-year survival will differ between the two groups of patients. Up to October 1984, 360 patients have been randomly allocated to these two groups. Locally curative surgery has been performed in 161 patients in the pre-operative irradiation group and in 152 patients in the postoperative irradiation group. Pre-operative irradiation was extremely well tolerated and there were no irradiation-related complications; 95 per cent of these patients received their treatment according to the intended schedule. However, 48 of the 161 patients had a tumour in Dukes' stage A. Pre-operative radiotherapy had no impact on postoperative mortality or the occurrence of anastomosis dehiscence, but significantly more patients with perineal wound sepsis after an abdominoperineal resection were found in the group of patients receiving pre-operative radiotherapy. This prolonged the stay in hospital after surgery. Postoperative radiotherapy was not so well tolerated as pre-operative treatment, and in a substantial number of patients the treatment could not be commenced until a relatively long time after surgery. To date, the local recurrence rate is acceptably low (approximately 10 per cent) in both treatment groups.

Clinical Trials as Topic↗

PubMed1986

The effectiveness of adenoidectomy in the treatment of glue ear: a randomized controlled trial.

One hundred children with glue ear, in whom surgical treatment was indicated, were randomly allocated to 1 of 4 treatment groups. Children in 2 of the groups underwent adenoidectomy plus various combinations of ear operations while in the other 2 groups surgery was confined to the ears. The effect of adenoidectomy was assessed 6 weeks, 6 months and 1 year after surgery by means of audiometry, impedance tympanometry and parental opinion. Improvements in hearing were greater in those children who underwent an adenoidectomy than in those who did not (4.0 dB at 6 weeks; 2.4 dB at 6 months; 0.7 dB at 1 year). However, these differences are of little clinical significance and were only statistically significant (P less than 0.05) 6 weeks after surgery. Middle ear function, measured by tympanometry, revealed a similar pattern of response to treatment. Despite this, 6 months after surgery a higher proportion of parents were satisfied with their child's condition if an adenoidectomy had been performed. Possible explanations of this discrepancy between clinical and parental assessments of outcome are discussed.

Acoustic Impedance Tests↗

PubMed1988

Antimicrobial prophylaxis for major head and neck surgery in cancer patients.

A total of 113 patients were randomly allocated to receive either ticarcillin plus clavulanic acid (total dose, 20.8 g) or clindamycin (total dose, 2.4 g) plus amikacin (total dose, 1 g) as perioperative antimicrobial prophylaxis for major head and neck surgery. The two groups were similar in age, prior antineoplastic treatment (surgery, chemotherapy, and radiotherapy) or tracheostomy, and the various types of surgery including radical neck dissection. The wound infection rate was 10% in the group of patients receiving clindamycin plus amikacin and 36% in the group receiving ticarcillin plus clavulanic acid (P less than 0.05). Initiation of systemic antibiotic therapy within 15 days of surgery was necessary for 20 and 45% of these patients, respectively (P less than 0.05). The distribution of microorganisms causing wound infections was comparable in both groups, except for anaerobes, which were isolated predominantly from patients who had received ticarcillin plus clavulanic acid.

Adult↗

PubMed1987

Menstrual regulation by intramuscular injections of 16-phenoxy-tetranor PGE2 methyl sulfonylamide or vacuum aspiration. A randomized multicentre study. World Health Organization Task Force on Post-ovulatory Methods for Fertility Regulation.

A multicentre trial was conducted to compare the efficacy and side-effects of an intramuscularly administered PGE2 analogue and vacuum aspiration in women with a delay of up to 21 days in the expected onset of menses. A total of 473 such women were randomly allocated to treatment with either 16-phenoxy-W-17, 18, 19, 20-tetranor PGE2 methyl sulfonylamide (three intramuscular injections of 0.5 mg at 3-h intervals) or vacuum aspiration, and the outcome of therapy assessed 1, 2 and 6-8 weeks later. Retrospective analysis of hCG levels indicated that 419 (88.6%) women had been pregnant at the time of treatment. With few exceptions, administration of the PGE2 analogue induced vaginal bleeding in both pregnant and non-pregnant women but the duration and subjectively perceived amount of bleeding were greater than after vacuum aspiration. Both treatments were equally effective. In pregnant women the overall frequency of complete abortion was 91% for prostaglandin treatment and 94% for vacuum aspirations. If non-pregnant women were included, the respective success rates (i.e. percentages of women not pregnant 2 weeks after treatment) were 92% and 95%. Gastrointestinal side-effects and lower abdominal pain requiring intramuscular analgesia were more common after prostaglandin therapy than following vacuum aspiration in both pregnant and non-pregnant women.

Abortifacient Agents↗

PubMed1988

Controlled plasma exchange trial in acute renal failure due to multiple myeloma.

We studied 29 patients affected by acute renal failure due to multiple myeloma with Bence-Jones proteinuria greater than 1 g/day to evaluate the effectiveness of plasma exchange in the treatment of severe myeloma nephropathy. Renal failure was severe enough to require dialysis in 24 cases, while the remaining 5 patients showed serum creatinine levels greater than 5 mg/dl. The patients were randomly allocated to Group I (15 patients undergoing plasma exchange together with corticosteroids, cytotoxic drug, hemodialysis only when needed) or to Group II (14 patients undergoing peritoneal dialysis together with corticosteroids and cytotoxic drug). In Group I Bence-Jones proteinuria decreased dramatically (P less than 0.01) with a significant increase in urine output (P less than 0.001), while Group II presented a slight reduction in Bence-Jones proteinuria without a significant increase in daily diuresis. Thirteen out the 15 Group I patients recovered renal function reaching serum creatinine levels less than or equal to 2.5 mg/dl in most cases. Only two patients in Group II improved renal failure well enough to stop dialysis. The one-year survival rate was significantly higher in Group I (66%) than in Group II (28%, P less than 0.01). We conclude that plasma exchange associated to chemotherapy rapidly removes large amounts of light chains, improves both renal function and long-term survival expectancies.

Acute Kidney Injury↗

PubMed1988

Comparison of delayed release 5 aminosalicylic acid (mesalazine) and sulphasalazine in the treatment of mild to moderate ulcerative colitis relapse.

Oral formulations of 5-aminosalicylic acid (mesalazine) appear less toxic than sulphasalazine. We have therefore compared sulphasalazine, low dose mesalazine and high dose mesalazine in the treatment of mild to moderate relapse of ulcerative colitis. Sixty one patients (32 men, aged 20-78 years) were randomly allocated to sulphasalazine 2 g daily, mesalazine 800 mg daily, or mesalazine 2.4 g daily in a double blind, double dummy, four week trial. Groups were comparable for age, sex, extent of disease, and pretrial sulphasalazine intake. Four patients were unable to complete the study because of treatment failure (two taking sulphasalazine and two high dose mesalazine). A further two patients taking sulphasalazine developed side effects necessitating withdrawal. Within treatment comparisons revealed significant improvement of: sigmoidoscopic grade in the sulphasalazine group; rectal bleeding, sigmoidoscopic and histological grade in the low dose mesalazine group; stool frequency, rectal bleeding and sigmoidoscopic grade in the high dose mesalazine group. Greater improvement in rectal bleeding (p less than 0.05) and sigmoidoscopic appearances (p less than 0.05) occurred in patients taking high dose mesalazine than in those taking sulphasalazine. In two patients taking high dose mesalazine minor rises of plasma creatinine concentrations occurred, suggesting the need to monitor renal function.

Adult↗

PubMed1987

Controlled trial of prednisolone as adjuvant in treatment of tuberculous constrictive pericarditis in Transkei.

In Transkei, 143 patients with active tuberculous constrictive pericarditis without significant pericardial effusion all received the same daily 6-month antituberculosis regimen of streptomycin, isoniazid, rifampicin, and pyrazinamide for 14 weeks followed by isoniazid and rifampicin. They were randomly allocated to receive in addition either prednisolone or placebo for the first 11 weeks; the comparison was double-blind throughout treatment and follow-up. In the 114 patients assessable up to 24 months, improvement was significantly more rapid in the prednisolone group, as shown by the rate of fall in the mean pulse rate and the rate at which jugular venous pressure and level of physical activity became normal. During follow-up, 2 (4%) of the 53 prednisolone and 7 (11%) of the 61 placebo patients died from pericarditis, and 11 (21%) and 18 (30%), respectively, required pericardiectomy. By 24 months 50 (94%) prednisolone and 52 (85%) placebo patients had a favourable status. 3 patients (1 prednisolone, 2 placebo) were normally active but were classified as not having achieved a favourable status. It is recommended that, in the absence of a specific contraindication, antituberculosis chemotherapy should be initially supplemented by steroids.

Adolescent↗

PubMed1987

Effects of long-term Org OD 14 administration on blood coagulation in climacteric women.

98 post-menopausal women were randomly allocated to either Org OD 14 [(7 alpha, 17 alpha)-17-hydroxy-7-methyl-19-norpregn-5(10)-en-20-yn-3-one] 2.5 mg/day or placebo. Treatment was continued for up to 6 yr. Any thromboembolic episode that occurred was recorded. Prothrombin time (PT), partial thromboplastin time (PTT), factor VII level and factor X level were measured prior to treatment and at yearly intervals. Antithrombin III level was measured in the last two yr of the study. There was one cerebrovascular accident after 3 months of placebo therapy but no other thromboembolic episodes. No significant difference was found between the effects of Org OD 14 and placebo with regard to any clotting factors at any time interval, although factor VII and factor X levels were consistently lower in the OD 14 group than in the placebo group. Antithrombin III levels measured after 5 and 6 yr were significantly higher (P less than 0.01) in the OD 14 group, suggesting a reduced risk of thrombosis in the treatment group.

Blood Coagulation↗

PubMed1991

Therapeutic effects of combined treatment using tetracycline-immobilized collagen film and root planing in periodontal furcation pockets.

46 upper and lower molars with furcation grade II involvement were selected from 16 patients with periodontal disease. The teeth were randomly allocated to the following groups according to treatment; (1) 4 consecutive administrations of tetracycline-immobilized cross-linked collagen film (TC film) at intervals of 1 week (TC group); (2) 1 root planing treatment (RP group); (3) combination treatment (TC + RP group); (4) no treatment (control group). The therapeutic effects of each treatment were compared both clinically and microbiologically. Records of plaque index, gingival index, bleeding on probing, probing depth, probing attachment level and microscopic counts were obtained at 0, 4, 6 and 8 weeks. The results showed marked decreases in probing depth and density of micro-organisms in both the RP and TC + RP groups. In particular, the TC + RP group was characterized by a decreased rate of bleeding on pocket probing and an increased probing attachment gain. The above findings demonstrated that root planning is effective in the treatment of furcation involvement and that the effects are enhanced by the local administration of TC films.

Collagen↗

PubMed1985

[A randomized trial of 3-drug combination chemotherapy in small cell lung cancer--CPA/ACNU/VCR vs ADR/ACNU/VCR].

From April 1981 to February 1983, 116 untreated patients (ECOG PS 0-3) with histologically or cytologically proven small cell lung cancer were randomly allocated to chemotherapy regimen using CPA.ACNU.VCR (CNV, n = 64) or ADR.ACNU.VCR (ANV, n = 52). The objective tumor response was 29.7% (19/53) for the CNV regimen and 48.1% (25/48) for the ANV regimen, but there was no statistically significant difference in these groups. Median survival time was 22.9 w for the CNV regimen (n = 64) and 42.4 w for the ANV (n = 52) regimen. The survival rate was statistically significantly higher for the ANV regimen compared to that of the CNV regimen (P greater than 5%). The toxicity showed no difference between these groups. Addition of ADR to ACNU + VCR was effective, but addition of CPA to these two drugs was not effective.

Aged↗

PubMed1990

Placebo-controlled trial of nimodipine in the treatment of acute ischemic cerebral infarction.

Nimodipine is a 1,4-dihydropyridine derivative that shows a preferential cerebrovascular activity in experimental animals. Clinical data suggest that nimodipine has a beneficial effect on the neurologic outcome of patients suffering an acute ischemic stroke. Our double-blind placebo-controlled multicenter trial was designed to assess the effects of oral nimodipine on the mortality rate and neurologic outcome of patients with an acute ischemic stroke. One hundred sixty-four patients were randomly allocated to receive either nimodipine tablets (30 mg q.i.d.) or identical placebo tablets for 28 days. Treatment was always started less than or equal to 48 hours after the acute event. The Mathew Scale, slightly modified by Gelmers et al, was used for neurologic assessment. Mortality rate and neurologic outcome after 28 days were used as evaluation criteria. We considered 123 patients to be valid for the analysis of efficacy. Mortality rates did not differ significantly between groups. Neurologic outcome after 28 days of therapy did not differ between groups. However, when only those patients most likely to benefit from any intervention (Mathew Scale sum score of less than or equal to 65 at baseline) were analyzed separately in post hoc-defined subgroups, the nimodipine-treated subgroups showed a significantly better neurologic outcome. This result suggests that some patients with acute ischemic stroke will benefit from treatment with nimodipine tablets.

Adult↗

PubMed1990

Effect of glucose tablets on craving for cigarettes.

Clients attending a smokers clinic were randomly allocated to two groups to assess the effects of glucose tablets in reducing craving for cigarettes. Smokers who had already been abstinent for 1 week were eligible to take part in the study. All subjects completed rating relating to urge to smoke and craving. Then subjects in one group were given packets of dextrose tablets and those in the other group were given packets of tablets containing sorbitol (a low calorie sweetener). Ratings of urges to smoke and craving were taken after 1 week, during which time the subjects had been asked to chew their tablets ad lib. Eight out of ten smokers in each group maintained abstinence. The remaining two smokers either did not abstain or did not turn up for the second measurement session. There was a significant reduction in ratings of urges to smoke and craving in the glucose group compared with the sorbitol group. These results support a theory postulating a link between glucoregulation and cigarette craving. If the results are replicated and it is shown that the reduction in craving translates into improved abstinence rates, oral glucose could be of assistance to smokers wishing to give up.

Female↗

PubMed1986

[A randomized controlled trial of surgical adjuvant therapy with mitomycin C, 5-fluorouracil and OK-432 in patients with gastric cancer].

The effect of postoperative immunochemotherapy with mitomycin C (MMC), 5-fluorouracil (5-FU) and OK-432 was evaluated as an adjuvant therapy after curative resection for gastric cancer. Immediately after surgery, patients were randomly allocated to the following three treatments: (A) chemotherapy with MMC and 5-FU (32 cases); (B) chemoimmunotherapy with MMC, 5-FU and OK-432 (33 cases); and (C) surgery alone as control (34 cases). There were no significant differences in the background factors influencing survival time among the groups, and there was no dose-distribution of chemotherapeutic agents between groups A and B. While the differences were not statistically significant, the survival rate and disease-free interval of group B were better than those of groups A or C. Side effects such as gastroenteric disorder, leukopenia (less than 3,000/mm3), thrombocytopenia (less than 7 X 10(4)/mm3) and increase of serum transaminase level (GPT greater than or equal to 100 units) were less frequently observed in group B than in group A. The results of the present study seemed to indicate that chemoimmunotherapy with OK-432 may be effective for surgical adjuvant therapy.

Aged↗

PubMed1981

Chenodiol (chenodeoxycholic acid) for dissolution of gallstones: the National Cooperative Gallstone Study. A controlled trial of efficacy and safety.

A double-masked study was conducted to determine the efficacy and safety of randomly allocated chenodiol (chenodeoxycholic acid, 750 mg/d or 350 mg/d) or placebo administered for 2 years to 916 patients for dissolution of radiolucent gallstones. There was confirmed complete dissolution in 13.5% of patients (750 mg/d), 5.2% (375 mg/d), and 0.8% (placebo), p less than 0.0001. Partial (over 50%) or complete dissolution (by validated roentgenographic metrology) occurred in 40.8% (750 mg/d), 23.6% (375 mg/d), and 11.0% (placebo), p less than 0.0001. Dissolution occurred more frequently in women, thin patients, or patients with small or floating gallstones or serum cholesterol greater than or equal to 227 mg/dL. Clinically significant hepatotoxicity occurred in 3% of patients (750 mg/d), 0.4% (375 mg/d), and 0.4% (placebo), p less than 0.007, and always was reversible biochemically. Elevations of 10% or more of serum cholesterol, mostly low-density lipoproteins, occurred in 85.2% of patients (750 mg/d), 82.8% (375 mg/d), and 67.0% (placebo), p less than 0.001. Chenodiol, 750 mg/d for up to 2 years, is appropriate therapy for dissolution of gallstones in selected patients who are informed of the risks and benefits.

Chemical and Drug Induced Liver Injury↗