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At least 361 records · Page 20Linked to original sources
PubMed2005

Botulinum toxin type A (BOTOX) for the prophylactic treatment of chronic daily headache: a randomized, double-blind, placebo-controlled trial.

OBJECTIVE: The objective of this study was to evaluate the safety and efficacy of botulinum toxin type A (BoNT-A; BOTOX, Allergan, Inc.) for the prophylactic treatment of chronic daily headache (CDH). BACKGROUND: Several open-label and small controlled trials suggest that BoNT-A may be effective in the prophylactic treatment of headache. DESIGN AND METHODS: This was an 11-month, randomized double-blind, placebo-controlled study of BoNT-A for the treatment of patients aged 18 to 65 years old with 16 or more headache days per 30 days conducted at 13 North American study centers. Following a 30-day screening period and a 30-day, single-blind, placebo-response period to identify placebo responders, eligible patients from both the placebo responder and placebo nonresponder groups were injected with BoNT-A or placebo every 90 days and assessed every 30 days for 9 months, a period encompassing three treatment cycles. The primary efficacy measure was the change from baseline in the frequency of headache-free days in a 30-day period for the placebo nonresponder group at day 180, the chosen efficacy time point. The secondary efficacy measure was the proportion of patients with a decrease from baseline of 50% or more in the frequency of headache days per 30-day period for the placebo nonresponder group at day 180. The change from baseline in the frequency of headaches (per 30-day period), the proportion of patients with a decrease from baseline of 50% or greater in the frequency of headaches per 30-day period, acute medication use, and adverse events were also assessed. RESULTS: Of 571 patients assessed over the baseline period, 355 (mean age, 43.5 years; 300/355 [84.5%] female) were enrolled and randomized. At the end of the placebo run-in period, 279 patients (79%) were classified as placebo nonresponders and 76 patients (21%) as placebo responders. Subsequently, patients were randomized within each group to receive either BoNT-A or placebo. In the placebo nonresponder stratum, the mean number of headache-free days at baseline was 5.8 (+/-4.7) for BoNT-A- versus 5.5 (+/-4.7) for placebo-treated patients. At day 180, placebo nonresponders treated with BoNT-A had an improved mean change from baseline of 6.7 headache-free days per 30-day period compared to a mean change from baseline of 5.2 headache-free days for placebo-treated patients. The between-group difference of 1.5 headache-free days favored BoNT-A treatment, although the difference between the groups was not statistically significant. However, a statistically significant difference was observed at day 180 endpoint for the secondary efficacy measure. A significantly higher percentage of BoNT-A patients had a decrease from baseline of 50% or greater in the frequency of headache days per 30-day period at day 180 (32.7% vs. 15.0%, P=.027). Also, the mean change from baseline in the frequency of headaches per 30-day period at day 180 was -6.1 for BoNT-A patients vs. -3.1 for the placebo patients (P=.013). Only 4 of 173 BoNT-A patients (2.3%) discontinued the study due to adverse events. The majority of treatment-related adverse events were transient and mild to moderate in severity. CONCLUSIONS: BoNT-A treatment resulted in patients having, on average, approximately seven more (1 week) headache-free days compared to baseline. Although at the primary time point (day 180) the BoNT-A treatment resulted in a 1.5 between-group difference compared to placebo, this difference was not statistically significant. The treatment met secondary efficacy outcome measures, including the percentage of patients experiencing a 50% or more decrease in the frequency of headache days, in addition to statistically significant reductions in headache frequency. BoNT-A was also well tolerated in patients with CDH.

Adolescent↗
PubMed1986

[Comparison of the effect of a selective and a nonselective beta receptor blocker on the ischemic ST segment, lung function and stress-induced decrease in blood glucose].

This study was designed to compare the antihypertensive and anti-ischemic effects of the newly developed cardioselective beta-blocking agent, betaxolol, with the non-selective agent, nadolol, both of which have hydrophilic long acting properties, over a period of 48 hours. Additionally, the study was intended to determine whether betaxolol exerts a lesser influence on pulmonary function and whether beta-1- and beta-2-adrenergic blocking agents also induce a decrease in blood glucose levels during standard bicycle ergometry for three to nine minutes, similar to that reported in association with exercise of longer duration and, if so, whether this effect can be circumvented by the use of a selective agent. Ten patients with angiographically documented CAD, stable exercise angina pectoris and reproducible ST-segment depression of at least 1 mm received on day 1, in a single blind fashion, one tablet of placebo, on day 2 and day 7, in a double-blind, randomized and cross-over fashion, 20 mg betaxolol or 80 mg nadolol, respectively. Bicycle ergometry was performed before, four, 24 and 48 hours after drug with fixed work loads, blood glucose determination before and after ergometry four hours after drug and airway resistance and maximal ventilatory capacity studies were carried out five hours after drug administration. As compared with placebo, betaxolol and nadolol led to reductions of ST-segment depression of 65% (p less than 0.01) and 74% (p less than 0.005) at four hours, of 53% (p less than 0.025) and 56% (p less than 0.01) at 24 hours and 41% (p less than 0.05) and 44% (p less than 0.05) at 48 hours.(ABSTRACT TRUNCATED AT 250 WORDS)

Adrenergic beta-Antagonists↗
PubMed1998

Double-blind randomized trial of tramadol for the treatment of the pain of diabetic neuropathy.

OBJECTIVE: The objective of this study was to evaluate the efficacy and safety of tramadol in treating the pain of diabetic neuropathy. BACKGROUND: The pain of diabetic neuropathy is a major cause of morbidity among these patients and treatment, as with other small-fiber neuropathies, is often unsatisfactory. Tramadol is a centrally acting analgesic for use in treating moderate to moderately severe pain. METHODS: This multicenter, outpatient, randomized, double-blind, placebo-controlled, parallel-group study consisted of a washout/screening phase, during which all analgesics were discontinued, and a 42-day double-blind treatment phase. A total of 131 patients with painful diabetic neuropathy were treated with tramadol (n=65) or placebo (n=66) tramadol, which were administered as identical capsules in divided doses four times daily. The primary efficacy analysis compared the mean pain intensity scores in the tramadol and placebo groups obtained at day 42 of the study or at the time of discontinuation. Secondary efficacy assessments were the pain relief rating scores and a quality of life evaluation based on daily activities and sleep characteristics. RESULTS: Tramadol, at an average dosage of 210 mg/day, was significantly (p < 0.001) more effective than placebo for treating the pain of diabetic neuropathy. Patients in the tramadol group scored significantly better in physical (p=0.02) and social functioning (p=0.04) ratings than patients in the placebo group. No statistically significant treatment effects on sleep were identified. The most frequently occurring adverse events with tramadol were nausea, constipation, headache, and somnolence. CONCLUSIONS: The results of this placebo-controlled trial showed that tramadol was effective and safe in treating the pain of diabetic neuropathy.

Activities of Daily Living↗
PubMed1985

Baclofen for the treatment of acute low-back syndrome. A double-blind comparison with placebo.

The efficacy and safety of baclofen (30-80 mg daily) for the treatment of acute low-back syndrome were evaluated in a 14-day, double-blind, randomized study of 200 patients (100 baclofen, 100 placebo). Patients with initially severe or extremely severe symptoms (as opposed to moderate symptoms) benefitted most from treatment with baclofen. The incidence of adverse effects was significantly higher in the baclofen group; however, most were mild to moderate and disappeared in all but two patients who required a reduction in dosage, without reduced drug efficacy. Baclofen was shown to be effective, safe, and well-tolerated for the treatment of patients with acute low-back syndrome.

Adolescent↗
PubMedDate not supplied

[Therapeutic effects of trazodone in the treatment of tremor. Multicentric double-blind study].

A 30 days therapeutical trial with trazodone has been performed in 47 patients suffering from different types of tremor. No significant improvement was detected in patients suffering from parkinsonian syndromes, multiple sclerosis, psycogenic tremor and hyperthyroidism. After the double-blind trial with trazodone, a significant improvement (p less than 0.025) was, instead, evident in 5 out of 6 patients with essential tremor, while the score did not change in the 3 patients with essential tremor who were treated with placebo.

Adult↗
PubMedDate not supplied

A double-blind comparative study of zolpidem versus zopiclone in the treatment of chronic primary insomnia.

Zolpidem (10 mg/day) and zopiclone (7.5 mg/day), administered at night, were compared in a 14-day, double-blind, equivalence trial on 479 chronic primary insomniacs (zolpidem, 231; zopiclone, 248) throughout Japan, with a 1-week follow-up to assess rebound. The primary endpoint was the investigators' rating of global improvement of sleep disorders. A total of 32 patients in the zolpidem group (13.9%) and 45 patients in the zopiclone group (18.1%) withdrew from the study before the end of the treatment. In the zolpidem group, 67.9% (142/209) of patients were rated at least 'moderately improved' versus 61.6% (135/219) with zopiclone, zolpidem being at least as effective as zopiclone (90% confidence interval: -1.7, 14.3). With zolpidem, sleep onset latency improved in significantly more patients (85.8% versus 77.5%) and significantly fewer patients showed aggravated sleep onset latency relative to baseline at follow-up (4.5% versus 15.4%). Significantly fewer patients receiving zolpidem experienced drug-related adverse events (31.3% versus 45.3%), with bitter taste representing 5.8% (six of 104) of such complaints with zolpidem compared with 39.9% (69/173) with zopiclone. In conclusion, zolpidem was at least as effective as zopiclone, showed significantly less rebound on discontinuation and was better tolerated.

Adult↗
PubMed1982

Routine subcultures shown to be unnecessary in radiometric detection of bacteremia using three media.

A study to determine the necessity of routine blind subcultures when using the radiometric BACTEC-460 instrument for detection of bacteremia was conducted. In the first phase, blind subcultures were performed on day 10 of incubation; in the second phase, blind subcultures were performed on day 4; in the final phase the subculture was performed on day one. During the study, 6,208 blood cultures from 2,455 patients were inoculated into three different culture media. There were 454 microbial isolates recovered, including 269 presumed pathogenic isolates. The single significant discrepancy between blind subculture and radiometric detection was a case of Staphylococcus epidermidis septicemia in which the organism was detected 48 hours earlier by blind subculture. There were no cultures in which significant bacterial isolates were detected by blind subcultures but not radiometrically. Thus, under the conditions of this study, routine blind subcultures are not necessary when using the BACTEC radiometric system for detection of bacteremia.

Adult↗
PubMed1979

Ovulation induction with luteinizing hormone--releasing hormone in amenorrheic, infertile women.

Thirteen women with infertility thought due to anovulation were treated with LRH. Etiologic diagnoses of amenorrhea included hypothalamic or "idiopathic" and PCOD. All patients had normal gonadotropins and otherwise normal endocrinologic and infertility evaluations; none had ovulated with clomiphene. Patients were studied for six 35 day cycles, single blind, and received LRH or placebo by subcutaneous injections for 28 days/cycle (LRH dosage 1.0 mg 2 or 3 times each day). Frequent assessments of physical status, cervical mucus, vaginal cytology, and serum LH, FSH, estrogen, and progesterone were performed. Ovulation was documented by basal temperature, serum progesterone and, on occasion, endometrial biopsy. Follow-up was continued for 6 months after therapy. Of the 13 patients treated, eight have ovulated and five have conceived. There were no complications of therapy.

Adult↗
PubMed1982

Double-blind evaluation of temazepam, flurazepam, and placebo in geriatric insomniacs.

The efficacy and safety of temazepam (30 mg) were compared with the efficacy and safety of flurazepam hydrochloride (30 mg) and placebo in a four-day, double-blind study in 75 geriatric convalescent-home patients with insomnia. The efficacy and safety profiles of the two active drugs were similar. Patients treated with temazepam, however, reported significantly less drug hangover both on awakening and during the entire day after each night of treatment than did patients receiving flurazepam or placebo. The difference between temazepam and flurazepam was probably due to the drugs' markedly different half-lives, temazepam's mean half-life being ten hours compared with 65.5 hours for the active metabolite of flurazepam. It is well recognized that the elderly may be especially sensitive to the adverse effects associated with the accumulation of the long-acting metabolite of flurazepam. Since temazepam has no active metabolites and minimal accumulation, it is a particularly appropriate hypnotic for use in geriatric patients.

Aged↗
PubMed1986

Double-blind comparison of ketoprofen and placebo in the treatment of sprains and strains.

Sixty patients (42 men and 18 women between the ages of 18 and 37 years) with grade 2 or grade 3 sprains or elongations participated in a seven-day double-blind study. By random determination, they were treated with either 100 mg of ketoprofen or placebo TID. Pain evaluation, vital signs, concomitant medication, and side effects were determined on days 1,3, and 7. Compared with placebo, ketoprofen produced statistically significant reductions (P less than 0.05) in investigator-rated pain at rest (day 3), on palpation (days 1, 3, and 7), on motion (days 1 and 3), and on the subject-rated analog scale (days 1 and 3). It also achieved a greater relief of pain (days 1 and 3) and greater overall efficacy, as expressed by the statistically significant improvements in the total pain scores on motion and on palpation, on the total pain relief score, on the total pain analog score, and on the sum of pain intensity differences for pain at rest, on palpation, and on motion. Tolerance to the seven-day ketoprofen treatment was excellent. Results from the study indicate that ketoprofen is efficacious in relieving pain following sprains and strains.

Acetaminophen↗
PubMed1998

Transcranial magnetic stimulation in mania: a controlled study.

OBJECTIVE: Left prefrontal transcranial magnetic stimulation has been reported to have ECT-like effects in depression; therefore, the authors planned a study of transcranial magnetic stimulation in mania. METHOD: Sixteen patients completed a 14-day double-blind, controlled trial of right versus left prefrontal transcranial magnetic stimulation at 20 Hz (2-second duration per train, 20 trains/day for 10 treatment days). Mania was evaluated with the Mania Scale, the Brief Psychiatric Rating Scale, and the Clinical Global Impression. RESULTS: Significantly more improvement was observed in patients treated with right than with left prefrontal transcranial magnetic stimulation. CONCLUSIONS: The therapeutic effect of transcranial magnetic stimulation in mania may show laterality opposite to its effect in depression.

Adult↗
PubMed1990

Efficacy of single-dose versus seven-day trimethoprim treatment of cystitis in women: a randomized double-blind study.

Single-dose trimethoprim treatment of cystitis was compared with 7-day treatment in a randomized double-blind study in primary health care. Consecutive female patients (613) with symptoms of lower urinary tract infection (UTI) and positive bacteriuria screening tests were enrolled. In 502 cases UTI was confirmed by urine culture. Follow-up was performed twice, after 2-3 and 5-6 weeks. Short-term efficacy could be evaluated in 425 cases and accumulated efficacy in 344. Short-term efficacy was 82% for single-dose and 94% for 7-day treatment (P less than .001). Accumulated efficacy was 71% for single-dose and 87% for 7-day therapy (P less than .001). Fewer adverse reactions were noted with single-dose therapy (not significant). The cure rate for UTI caused by P-fimbriated Escherichia coli was not different from that of other E. coli infections. Infections with Staphylococcus saprophyticus showed a lower cure rate than E. coli infections with the single-dose regimen (P less than .05 for short-term efficacy).

Adolescent↗
PubMed1980

Haloperidol for acute schizophrenic patients. An evaluation of three oral regimens.

The relative efficacy of three oral regimens of haloperidol was compared in a ten-day, double-blind study of 63 acutely ill schizophrenic patients newly admitted to the hospital. One group of patients received 20 mg of haloperidol on day 1, then increasing increments of 20 mg a day, reaching a maximum dosage of 100 mg daily on day 5. Another group received 10 mg of haloperidol on day 1, then increasing increments of 10 mg daily, reaching 100 mg daily on day 10. A third group of patients received a fixed dosage of 10 mg daily for ten days. Haloperidol was well tolerated by the patients; there were no serious adverse reactions. The data indicated that the regimens had similar therapeutic efficacy, suggesting that acutely ill schizophrenic patients respond to a wide range of doses of haloperidol but that onset of response and efficacy are not increased in most patients by providing a high initial loading dosage. Adequate, safe dosage must be determined in each case.

Acute Disease↗
PubMed1986

Thermogenesis in human skeletal muscle as measured by direct microcalorimetry and muscle contractile performance during beta-adrenoceptor blockade.

The influence of beta-adrenoceptor-blockade on skeletal muscle was studied in ten healthy males with propranolol, atenolol and pindolol randomly given for 8 days each in a cross-over double blind test. After 7 days on each drug, muscle function was tested by an isokinetic dynamometer. Thermogenesis in biopsy samples taken from vastus lateralis muscle after a low grade exercise was studied after 8 days on each drug by direct calorimetry with a perfusion microcalorimeter. Before drug administration, a median heat production rate of 0.67 mW/g of muscle was measured. This value was significantly reduced by 25% during propranolol, but no significant change was found during atenolol or pindolol administration. Peak torque decline during isokinetic endurance test changed significantly in knee flexor but not in extensor muscles, from 15% to 27% after propranolol and from 15% to 23% after pindolol. Maximum dynamic strength was unaltered. Our data suggest that blockade of sympathetic beta 2-receptors decreases thermogenesis in human skeletal muscle and impairs isokinetic endurance.

Adolescent↗
PubMed1980

An experimental model for assessing effects of anorectics on spontaneous food intake of obese subjects.

Ad libitum access to food by use of a platter service is a new method for studying spontaneous food intake in obese human subjects. The effect of diethylpropion on energy intake was evaluated by the platter-service method in 2 overweight adult male subjects hospitalized on a metabolic unit for 41 days. This double-blind experiment was divided into 12 consecutive 3-day study periods during each of which the subjects received either 25 mg diethylpropion or a matching placebo before each meal. In this design protocol the 12 study periods provided 6 consecutive drug-placebo trials for each subject. To encourage ad libitum ingestion, food was served "family style" from large platters and pitchers at meals, and snacks were always available. Subjects were not aware that their intake was being monitored. On diethylpropion administration both subjects had an average decrease in energy intake of 11% and 15% (p less than 0.005). The platter service model, which provides a near-natural eating situation under systematic control, appears to be a useful and sensitive method for assessing effects of anorectic drugs on spontaneous food intake.

Adult↗
PubMed1997

Ipratropium nasal spray in children with perennial rhinitis.

OBJECTIVE: To compare the efficacy and safety of ipratropium nasal spray and placebo administered twice each day for 4 weeks in pediatric patients with perennial rhinitis who had rhinorrhea as a major complaint. METHODS: This was a multicenter, double-blind, parallel group study. Patients aged 6 to 18 years with symptoms of perennial nonallergic (PNAR) or perennial allergic rhinitis (PAR) were randomized to receive ipratropium (42 micrograms per nostril) or placebo nasal spray, double-blind, twice each day for 4 weeks. Efficacy was evaluated by nasal symptoms, especially anterior rhinorrhea, and quality of life. Previous caregivers for rhinitis and medications used in the past were also evaluated. RESULTS: A total of 202 patients were empanelled, 162 with PAR, 40 with PNAR; of these 151 with mild-severe rhinorrhea were evaluated for efficacy. Treatment with ipratropium reduced symptoms of rhinorrhea primarily in patients with PNAR. In patients with PAR this response was less pronounced, and was seen as a modest decrease in the severity of rhinorrhea noted in the first 2 weeks of treatment. Quality of life assessments confirmed that rhinorrhea was bothersome to these pediatric patients, and suggested that treatment with ipratropium nasal spray was associated with an improvement, especially in the patients with PNAR. There were few adverse events; these were similar in the two treatment groups. CONCLUSIONS: Ipratropium nasal spray 0.03% administered at a dose of 42 micrograms/nostril bid is a safe and effective new therapy for control of anterior rhinorrhea in pediatric patients with PNAR. Twice daily administration is adequate for patients with PNAR, but patients with PAR might benefit from more frequent administration (e.g., tid).

Administration, Inhalation↗
PubMed2000

Efficacy on climacteric symptoms and safety of low dose estradiol transdermal matrix patches. A randomized, double-blind placebo-controlled study.

Two estradiol (E2) transdermal patches releasing 25 micrograms/day E2 (D-25) or 37.5 micrograms/day E2 (D-37.5) were compared to a placebo patch on 156 patients in natural or surgical menopause suffering from at least 5 hot flushes per day, randomly and blindly assigned to three parallel groups of 52 patients each, to be treated continuously for 12 weeks, without progestin opposition. "Responders" (patients with less than 3 hot flushes per day at the end of treatment), were 82% and 90% under D-25 or D-37.5, respectively, both significantly (p < 0.001) more than under placebo (44%). Comparable efficacy was observed on severity of hot flushes, Kupperman Index and on the self-rated efficacy. Systemic adverse events occurred in 10%, 10% and 8% of patients, respectively, under D-25, D-37.5 or placebo. Occasional mild and transient itching and/or erythema on the site of application was reported by few patients and did never require discontinuation of application. In conclusion D-25 and D-37.5 were significantly more effective than placebo in relieving climacteric symptoms and were systemically and locally as well tolerated as placebo. D-25 (Demestril 25) releasing 25 micrograms/day E2 can therefore be recommended for low-dosed estrogen replacement therapy.

Administration, Cutaneous↗