A Clinical Comparison of Triazolam with Placebo and with Secobarbital in Insomniac Patients

1978 ◽  
Vol 6 (4) ◽  
pp. 343-347 ◽  
Author(s):  
K Kay Okawa ◽  
George S Allen
Keyword(s):  
Side Effects ◽  
Sleep Duration ◽  
Sleep Onset ◽  
Questionnaire Data ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Sleep Questionnaire ◽  
Clinical Comparison ◽  
Hypnotic Efficacy ◽  
Better Than

Seventy-six out-patient insomniacs participated in three different two-night, double-blind crossover trials investigating the hypnotic efficacy and safety of triazolam. Triazolam 0.5 mg was compared to placebo in one trial conducted by K Kay Okawa, MD, and triazolam 0.5 mg was compared to secobarbital 100 mg in trials conducted by K Kay Okawa, MD and George S Allen, MD. The results of the latter two studies were combined and the data analyzed jointly. Triazolam 0.5 mg was found to be preferred and to be significantly better than both placebo and secobarbital 100 mg in the treatment of insomnia. Analysis of sleep questionnaire data showed triazolam to be superior to either placebo or secobarbital on the following parameters: how much the medication helped the patient sleep; onset of sleep; duration of sleep; and number of nocturnal awakenings. No differences were observed between treatments in any trial with regard to the patient's feeling of alertness the next morning. The side-effects reported for all treatments did not significantly interfere with the patients' ability to function.

Preference Studies of Triazolam with Standard Hypnotics in Out-Patients with Insomnia

1976 ◽  
Vol 4 (4) ◽  
pp. 247-254 ◽  
Author(s):  
Louis F Fabre ◽  
David M McLendon ◽  
Robert T Harris
Keyword(s):  
Side Effects ◽  
Sleep Duration ◽  
Chloral Hydrate ◽  
Sleep Onset ◽  
The Other ◽  
Questionnaire Data ◽  
Double Blind ◽  
Sleep Questionnaire ◽  
Efficacy Parameters ◽  
Better Than

One hundred and four patients suffering from insomnia took part in four different two-night double-blind crossover trials of triazolam. In three separate studies, triazolam 0·5 mg was compared to placebo, flurazepam 30 mg and chloral hydrate 500 mg. Triazolam 0·5 mg was found to be preferred and to be superior to placebo, flurazepam and chloral hydrate in the treatment of insomnia. Analysis of sleep questionnaire data showed triazolam to be superior to the other treatments on the following: How much did the medication help you sleep, onset of sleep, duration of sleep and number of awakenings. Additionally, triazolam was superior to chloral hydrate on the feeling in the morning parameter. In another comparison of triazolam 0·25 mg to flurazepam 15 mg, triazolam was not significantly better than flurazepam on any of the efficacy parameters except that the patients felt more alert the morning following triazolam than following flurazepam. On all efficacy endpoints, trends for all parameters favoured triazolam 0·25 mg over flurazepam 15 mg. Untoward side-effects in these four studies were minimal.

Hypnotic Efficacy of Triazolam and Methyprylon in Insomniac In-Patients

1976 ◽  
Vol 4 (1) ◽  
pp. 55-58 ◽  
Author(s):  
P Lomen ◽  
O I Linet
Keyword(s):  
Side Effects ◽  
Sleep Onset ◽  
Double Blind ◽  
Hypnotic Effect ◽  
Sleep Parameters ◽  
Hypnotic Efficacy ◽  
Rapid Sleep

The hypnotic effect of a new triazolobenzodiazepine, triazolam ( Halcion®) 0.5 mg and methyprylon 300 mg was compared in twenty oncologic inpatient volunteers with insomnia using the preference technique. On the first night of the two-night trial, triazolam or methyprylon was given on a double-blind basis and on the second night the patients received the alternate medication. Following each trial night the patients were interviewed in regard to their sleep. Of the seventeen patients who completed the study, eleven patients preferred triazolam, three preferred methyprylon and three had no preference ( p = 0.057). Analysis of the various sleep parameters showed that triazolam helped the patients sleep more than methyprylon ( p = 0.013), induced more rapid sleep onset ( p = 0.003), gave a longer duration of sleep ( p = 0.013). The treatment was considered a success if the patient went to sleep in thirty minutes or less and slept for at least six hours. Triazolam was more successful than methyprylon in this respect ( p = 0.012). There were no side-effects reported on either of the drugs.

Comparative Efficacy of Triazolam, Flurazepam and Placebo in Out-Patients Insomniacs

1978 ◽  
Vol 6 (4) ◽  
pp. 337-342 ◽  
Author(s):  
Angela J Bowen
Keyword(s):  
Crossover Trial ◽  
Sleep Onset ◽  
Quality Of Sleep ◽  
Comparative Efficacy ◽  
Short Term ◽  
Night Time ◽  
Double Blind ◽  
Hypnotic Efficacy ◽  
Better Than

The short-term hypnotic efficacy of triazolam was compared to that of flurazepam and placebo in 120 out-patient insomniacs. Each patient was studied with a two-night, double-blind crossover trial. Triazolam (0.5 mg) was compared to placebo and flurazepam (30 mg). Triazolam (0.25 mg) was compared to flurazepam (15 mg and 30 mg). Triazolam (0.5 mg) was preferred to both placebo and flurazepam (30 mg). Triazolam (0.5 mg) was superior to placebo in improving quality of sleep, shortening sleep onset, increasing sleep duration, and reducing the number of night-time awakenings. Triazolam (0.5 mg) was superior to flurazepam (30 mg) in speeding sleep onset and increasing the quality of sleep. Triazolam (0.25 mg) was preferred to flurazepam (15 mg) and was significantly better than flurazepam on all sleep questions. Triazolam (0.25 mg) was preferred by more patients than flurazepam (30 mg) and was judged equally efficacious on indivdual sleep questions. Reports of side-effects were minimal for both drugs.

Efficacy of Nimodipine in the Prophylaxis of Migraine

Cephalalgia ◽  
1985 ◽  
Vol 5 (1) ◽  
pp. 39-43 ◽  
Author(s):  
H Havanka-Kanniainen ◽  
E Hokkanen ◽  
VV Myllylä
Keyword(s):  
Side Effects ◽  
Drug Treatment ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Final Value ◽  
Prophylactic Drug ◽  
Better Than

The efficacy of nimodipine in the prophylaxis of migraine was assessed in a double-blind, placebo-controlled, cross-over study carried out on 33 patients, 20 of whom suffered from classic and 13 from common migraine. Four patients dropped out, but not as a result of the side effects of the drug. The duration of drug treatment was 8 weeks. The dosage used was 30 mg four times daily. Nimodipine proved to be better than placebo, the number of migraine attacks and severity of headache showing a significant reduction. The drug was well tolerated and no marked side effects were noted. The results suggest that nimodipine is a useful new prophylactic drug for migraine, but further studies are needed before its final value can be evaluated.

A Controlled Trial of Baclofen in Children with Cerebral Palsy

1973 ◽  
Vol 1 (2) ◽  
pp. 398-404 ◽  
Author(s):  
P J Milla ◽  
A D M Jackson
Keyword(s):  
Cerebral Palsy ◽  
Side Effects ◽  
Dose Reduction ◽  
Crossover Trial ◽  
Controlled Trial ◽  
Drug Effects ◽  
Double Blind ◽  
Muscle Spasticity ◽  
Children With Cerebral Palsy ◽  
Better Than

A double-blind crossover trial against placebo was conducted to assess the effects of the GABA derivative, baclofen, on the disabilities due to muscle spasticity in twenty children suffering from cerebral palsy. Baclofen performed very significantly better than placebo in reducing spasticity and significantly better than placebo in allowing both active and passive limb movements to be carried out. Notable improvement was also seen in scissoring. Side-effects were minimal and responded promptly to dose reduction. The evaluation of drug effects on muscle spasticity and the pharmacodynamics of baclofen are discussed. Recommendations are made regarding dosage of baclofen in childhood.

Double-Blind Comparison of Maternal Analgesia and Neonatal Neurobehaviour following Intravenous Butorphanol and Meperidine

1979 ◽  
Vol 7 (3) ◽  
pp. 224-230 ◽  
Author(s):  
Robert Hodgkinson ◽  
Robert W Huff ◽  
Robert H Hayashi ◽  
Farkhanda J Husain
Keyword(s):  
Side Effects ◽  
Severe Pain ◽  
Randomized Study ◽  
Analgesic Efficacy ◽  
Foetal Heart Rate ◽  
Efficacy And Safety ◽  
Cervical Dilation ◽  
Double Blind ◽  
Significant Difference ◽  
Blind Comparison

Butorphanol (1 mg and 2 mg) and meperidine (40 mg and 80 mg), given intravenously, were evaluated for analgesic efficacy and safety in a double-blind randomized study employing 200 consenting pre-partum patients in moderate to severe pain during the late first stage of labour. Both drugs provided adequate relief of pain to the mothers. There was no significant difference in the rate of cervical dilation, the foetal heart rate, the Apgar score, pain relief or neonatal neurobehavioural scores between those receiving butorphanol and those receiving meperidine. Twenty-two mothers who received butorphanol and eleven who received meperidine nursed their infants with no adverse effects observed. Side-effects were generally infrequent in this study; however, more side-effects were reported by the patients and observed by the investigator in the meperidine-treated cases (13%) than in the cases treated with butorphanol (2%).

scholarly journals EFFICACY AND SAFETY OF STANDARDIZED CINNAMON BARK EXTRACT FOR THE PREVENTION OF CHEMOTHERAPY-INDUCED WEIGHT LOSS AND ALOPECIA IN PATIENTS WITH BREAST CANCER: A RANDOMIZED, DOUBLE-BLIND, AND PLACEBO-CONTROLLED STUDY

2019 ◽  
pp. 163-168
Author(s):  
AJAY MEHTA ◽  
SUCHITRA MEHTA ◽  
PRASAD THAKURDESAI
Keyword(s):  
Breast Cancer ◽  
Weight Loss ◽  
Side Effects ◽  
Cancer Patients ◽  
Outcome Measures ◽  
Bark Extract ◽  
Efficacy And Safety ◽  
Breast Cancer Patients ◽  
Double Blind ◽  
Cinnamon Bark

Objective: The objective of the study was to evaluate the effects of IND02 (standardized Cinnamon bark extract) supplementation for the prevention of side effects of cancer chemotherapy in female patients with breast cancer. Methods: The study was conducted using double-blind, placebo-controlled design in 34 female breast cancer patients during the first 4 consecutive 21-day cycles of the standard chemotherapy regimen. The active treatment (IND02 capsules, 400 mg, one capsule, and thrice a day) or matching placebo was orally administrated in randomized (1:1 ratio) patients. The efficacy outcome measures were reduction in chemotherapy-induced weight loss, alopecia (hair fall), and other side effects. The safety outcome measures were hematology, ECG, vital signs, adverse event monitoring, and laboratory safety measurements. Results: The patients on the treatment with IND02 had shown significant protection from chemotherapy-induced severe weight loss (cachexia) and alopecia (reduced hair density and % hairs in the anagen phase, and increased % hairs in telogen phase) which was seen in the placebo group. IND02 treatment was found safe and well-tolerated during the study. Conclusion: Concomitant use of IND02 in breast cancer patients during breast cancer chemotherapy showed a clinical promise regarding efficacy and safety in preventing chemotherapy-induced weight loss and alopecia.

Tolfenamic Acid, Metoclopramide, Caffeine and Their Combinations in The Treatment of Migraine Attacks

Cephalalgia ◽  
1984 ◽  
Vol 4 (4) ◽  
pp. 253-263 ◽  
Author(s):  
Riitta A Tokola ◽  
Pentti Kangasniemi ◽  
Pertti J Neuvonen ◽  
Olavi Tokola
Keyword(s):  
Side Effects ◽  
Clinical Studies ◽  
Tolfenamic Acid ◽  
Acute Migraine ◽  
Double Blind ◽  
Better Than

Tolfenamic acid is a fenamate which inhibits prostaglandin (PG) biosynthesis and may act as a PG antagonist as well. Caffeine and metoclopramide are used in combination with analgesics and ergotamine in the treatment of migraine attacks, but controlled clinical studies on fixed combinations with analgesics are rare. The effects of orally given tolfenamic acid (200 mg), caffeine (100 mg), metoclopramide (10 mg), tolfenamic acid + caffeine (200 mg + 100 mg), tolfenamic acid + metoclopramide (200 mg + 10 mg) and placebo were studied in 49 migraine patients (3 men, 46 women) in a double-blind randomized cross-over study comprising 482 migraine attacks. The patients were allowed to take either one or two capsules of each preparation for an attack. Additional drugs were allowed after 3 h. Parameters characterizing the effects and side-effects of the drugs were registered. Tolfenamic acid and its combinations were found to be effective in the treatment of acute migraine, but caffeine and metoclopramide alone did not differ from placebo. Combination with metoclopramide was better than tolfenamic acid alone as judged by the smaller dose needed and the intensity of attack. Between tolfenamic acid alone and its caffeine combination there were no statistically significant differences.

Efficacy of Nimodipine in Comparison with Pizotifen in the Prophylaxis of Migraine

Cephalalgia ◽  
1987 ◽  
Vol 7 (1) ◽  
pp. 7-13 ◽  
Author(s):  
H Havanka-Kanniainen ◽  
E Hokkanen ◽  
V V Myllylä
Keyword(s):  
Side Effects ◽  
Therapeutic Efficacy ◽  
Effective Drug ◽  
Double Blind ◽  
Placebo Period ◽  
Drug Treatments ◽  
Better Than

The efficacy of nimodipine in comparison with that of pizotifen was assessed in the prophylaxis of migraine in a double-blind cross-over study, in which a double-dummy technique was also utilized. The study was carried out on 43 migraine patients, of whom 15 had classic and 28 had common migraine. A 4-week run-in placebo period preceded the drug treatments, the drug treatments lasted 12 weeks, and there was a washout placebo period of 4 weeks between nimodipine and pizotifen treatments. The dosages used were 40 mg three times daily for nimodipine and 0.5 mg three times daily for pizotifen. Both nimodipine and pizotifen proved to be better than placebo, the number of migraine attacks showing a significant reduction. There was no difference between nimodipine. and pizotifen in antimigrainous efficacy, but there were fewer side effects during the nimodipine period. The results suggest that nimodipine is an effective drug for the prophylaxis of migraine, with few side effects and therapeutic efficacy equal to that of pizotifen.

Long-term efficacy and safety of zolpidem extended-release 12.5 mg, in old patients with chronic primary insomnia: a randomized, double-blind, placebo-controlled, parallel-group, multicenter study

2011 ◽  
Vol 26 (S2) ◽  
pp. 1567-1567
Author(s):  
J. Zarra ◽  
L. Schmidt
Keyword(s):  
Extended Release ◽  
Sleep Onset ◽  
Primary Insomnia ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Old Patients ◽  
Double Blind Placebo ◽  
Term Efficacy ◽  
Parallel Group

ObjectiveTo evaluate long-term efficacy and safety of zolpidem extended-release, in old patients for chronic primary insomnia.DesignMulticenter, randomized, double-blind, placebo-controlled, parallel-group.MethodPopulation: Outpatient with aged more of 65 years. Diagnosis: DSM-IV criteria for chronic primary insomnia; Treatment: Single-dose zolpidem extended-release 12.5 mg (n = 128) or placebo (n = 127), self-administered every night.ResultsPatient's Global Impression (PGI) and Clinical Global Impression-Improvement (CGI-I) were assessed every 4 weeks up to six month. Patient Morning Questionnaire (PMQ), recorded daily, assessed subjective sleep measures-sleep onset latency (SOL), total sleep time (TST), number of awakenings (NAW), wake time after sleep onset (WASO), and quality of sleep (QOS)-and next-day functioning. Zolpidem extended-release also was statistically significantly superior to placebo at every time point for PGI (Items 1–4) and CGI-I (P < 0.0001, rank score), TST, WASO, QOS (P < 0.0001), and SOL (P < or = 0.0014); NAW (Months 2–6; P < 0.0001). Sustained improvement (P < 0.0001, all time points) was observed in morning sleepiness and ability to concentrate (P = 0.0014, month 6) with zolpidem extended-release compared with placebo. Most frequent adverse events for zolpidem extended-release were headache, anxiety and somnolence to the morning. No rebound effect was observed during the first 3 nights of discontinuation.ConclusionsThese findings establish the efficacy of dosing of zolpidem extended-release 12.5 mg for up to 6 months. Treatment provided sustained and significant improvements in sleep onset and maintenance and also improved next-day concentration and morning sleepiness.

Sign in / Sign up

Export Citation Format

Share Document