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.

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.

A Double-Blind Comparative Clinical Trial of Floctafenine and Four Other Analgesics Conducted in General Practice

1976 ◽  
Vol 4 (3) ◽  
pp. 179-182 ◽  
Author(s):  
D M Lomas ◽  
J Gay ◽  
R N Midha ◽  
D L Postlethwaite
Keyword(s):  
Clinical Trial ◽  
General Practice ◽  
Side Effects ◽  
Analgesic Effect ◽  
Rank Order ◽  
Controlled Trial ◽  
The Other ◽  
Double Blind ◽  
Comparative Clinical Trial

Three hundred and twelve patients suffering from painful conditions were admitted to a multicentre, double-blind controlled trial, conducted in general practice in which five analgesics—floctafenine (Idarac), paracetamol, aspirin, dihydrocodeine and pentazocine—were compared. Overall ratings of analgesic effect placed floctafenine first in rank order. Floctafenine was statistically significantly superior in effect to pentazocine but not to the other three agents as far as doctor ratings were concerned; and superior to both pentazocine and dihydrocodeine in the opinion of patients. Fewer patients experienced side-effects on floctafenine than on the other four analgesics and this difference between floctafenine and pentazocine, and floctafenine and dihydrocodeine was statistically significant.

Double-Blind Placebo Controlled Oral Analgesic Comparison of Butorphanol and Pentazocine in Patients with Moderate to Severe Post-Operative Pain

1973 ◽  
Vol 1 (2) ◽  
pp. 422-428
Author(s):  
Robert E S Young
Keyword(s):  
The Other ◽  
Dose Effect ◽  
Surgical Patients ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Oral Analgesic ◽  
Post Operative Pain ◽  
Maximum Pain ◽  
Better Than ◽  
Observation Period

A double-blind, randomized trial was conducted in 120 post-surgical patients to evaluate the oral analgesic activity of butorphanol tartrate (4 mg and 8 mg) and pentazocine HCl (50 mg) as compared to placebo. Both doses of butorphanol as well as pentazocine proved to be significantly (p <0.05) more effective than placebo. Butorphanol 4 mg and pentazocine 50 mg were never significantly different from each other, while butorphanol 8 mg was significantly better than both butorphanol 4 mg as well as pentazocine 50 mg in several instances, demonstrating a significant dose effect relationship for butorphanol. All of the active treatments provided maximum pain relief within 1 to 2 hours and were effective over 4 hours. In contrast to the other treatments, none of the 8 mg butorphanol patients required remedication during the 4-hour observation period. Generally, the incidence of side-effects appeared low.

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.

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.

Comparative Efficacy of Lormetazepam (Noctamid®) and Diazepam (Valium®) in 100 Out-Patients with Insomnia

1981 ◽  
Vol 9 (3) ◽  
pp. 199-202 ◽  
Author(s):  
M Sastre y Hernández ◽  
H-D Hentschel ◽  
K Fichte
Keyword(s):  
Side Effects ◽  
Sleep Disorders ◽  
Blind Study ◽  
Double Blind Study ◽  
Comparative Efficacy ◽  
Double Blind ◽  
Better Than

Lormetazepam (Noctamid®) at a dosage of 1 mg was compared with diazepam (Valium®) at a dosage of 5 mg in a 7-day double-blind study. The study involved fifty patients in the lormetazepam group and fifty patients in the diazepam group. All the patients were suffering from sleep disorders as a concomitant symptom of general diseases. Lormetazepam was significantly better than diazepam in the: Reduction of the time taken to fall asleep (p < 0.05) Prolongation of the duration of uninterrupted sleep (p < 0.05) Reduction of the frequency of awakening (p < 0.05) Lormetazepam displayed no hang-over effects or other side-effects and, in this respect too, was significantly superior to diazepam (p < 0.05).

scholarly journals F reticulocyte response in sickle cell anemia treated with recombinant human erythropoietin: a double-blind study

Blood ◽  
1993 ◽  
Vol 81 (1) ◽  
pp. 9-14 ◽  
Author(s):  
RL Nagel ◽  
E Vichinsky ◽  
M Shah ◽  
R Johnson ◽  
E Spadacino ◽  
...  
Keyword(s):  
Steady State ◽  
Side Effects ◽  
Sickle Cell ◽  
Sickle Cell Anemia ◽  
Recombinant Human Erythropoietin ◽  
The Other ◽  
Double Blind Study ◽  
Double Blind ◽  
Human Erythropoietin ◽  
Iron Deficient

Abstract Studies on baboons and preliminary observations in three patients with sickle cell anemia (SS) suggested that high doses of pulse administered recombinant human erythropoietin (rHuEPO) stimulate F-reticulocyte production. We now report on the administration of rHuEPO in a double- blind format to ascertain frequency of response and potential precipitation of side effects. Ten patients were enrolled, but one was discontinued due to the indication of a blood transfusion. Of the other nine, five received rHuEPO in escalating doses (from 400 to 1,500 U per kg twice daily [BID] per week), alternating with a placebo, in blinded fashion. The second group, consisting of four patients, followed an identical protocol (except starting dose was 1,000 U/Kg, BID per week) and were iron supplemented during treatment. The criterion of response was a transient doubling (as a minimum) of the steady-state F- reticulocyte level. We found that none of the five patients in the first group responded to rHuEPO, and two of them became iron deficient, as judged by a significant decrease in ferritin. Of the second group, four patients responded with F-reticulocyte increases. In three patients, open label administration of rHuEPO confirmed the effect. We observed seven painful episodes during this study, two during the EPO administration and five during the placebo arm. Three patients were phlebotomized because the hemoglobin level increased 1.5 g/dL more than steady-state levels. Of the six patients followed-up by percent dense cell determinations, one exhibited increased levels during periods of the treatment, whereas the other five showed no change. No anti-rHuEPO antibodies were detected. We conclude that rHuEPO can stimulate F- reticulocyte response in some patients with sickle cell anemia, without apparent negative clinical side effects. The state of iron stores may be critical. Whether higher doses of rHuEPO and/or a different regimen might induce sustained F cells and fetal hemoglobin increases remains to be determined.

The Initiation of Long-Term Pharmacotherapy in Schizophrenia: Dosage and Side Effect Comparisons Between Oral and Depot Fluphenazine*

1976 ◽  
Vol 09 (04) ◽  
pp. 159-169 ◽  
Author(s):  
Nina R. Schooler ◽  
J. Levine ◽  
Keyword(s):  
Side Effects ◽  
Side Effect ◽  
Dosage Forms ◽  
The Other ◽  
Oral Drug ◽  
Double Blind ◽  
Moderate Severity ◽  
Treatment Groups ◽  
The Relationship

SummaryThis report focuses on two comparisons between oral and depot fluphenazine specifically FPZ decanoate: 1) can equivalent dosages for the two drugs be established and do these equivalencies change over six months of treatment; 2) what are the side effects seen with the two drugs during the early weeks of administration.Patients in the study receive either oral or depot FPZ as the active treatment but in order to preserve double blind conditions, they are also given the other treatment in placebo form. No dosage equivalence is established by the protocol, however, if dosage is adjusted, both forms must be changed and in the same direction. During the first weeks of treatment there is a linear relationship between the two dosage forms but a range of relatively low dosages of the oral compound (5-20 mg) is associated with a single dose (25 mg/q 3 weeks) of FPZ decanoate. At higher dosages of the oral drug the relationship is linear. Side effects of some kind are noted in over 60 percent of patients in both treatment groups after four weeks of treatment, while symptoms of at least moderate severity occur in almost 40 percent. Only symptoms involving the extrapyramidal system and sleep disturbance are observed in more than 20 percent of the patients. Benztropine was prescribed only if needed and was administered to 65 percent of patients. In general, those receiving benztropine had more side effects than those who did not. These differences reached significance for extrapyramidal symptoms and depression.Based on these data, we conclude that at the dosages used in this study there are no side effect differences between these two forms of fluphenazine in the early weeks of administration. Dosage equivalence between the two drugs can be set within the range of 5- 60 mg/day oral and 12.5-100 mg/three weeks depot.

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