A Double-Blind Comparison of Prazepam with Diazepam, Chlorazepate Dipotassium and Placebo in Anxious Out-Patients

1979 ◽  
Vol 7 (2) ◽  
pp. 147-151 ◽  
Author(s):  
Louis F Fabre ◽  
David M McLendon ◽  
Arthur Mallette
Keyword(s):  
Data Analysis ◽  
Side Effects ◽  
Rating Scale ◽  
Double Blind ◽  
Drug Study ◽  
Patient Reported ◽  
Symptom Check List ◽  
Blind Comparison ◽  
Lost To Follow Up ◽  
Age Range

This study compared prazepam with diazepam, chlorazepate dipotassium, and placebo in the treatment of anxious out-patients. Patients were screened for participation in the study to be sure they met the criteria for inclusion. Patients were excluded if they had complicating physical or mental problems. All patients signed an informed consent. Seventy-three patients entered the study, thirteen did not complete at least two weeks of treatment and were not used in the data analysis. Of these thirteen, ten did not return and were lost to follow-up, two entered the hospital for reasons unrelated to the drug study, and one patient on diazepam was terminated because of increased anxiety. Sixty patients were used in the data analysis, thirty-six males and twenty-four females with an age range of 21–61 years. Side-effects were minimal. Drowsiness was reported by two people in the placebo group, one taking chlorazepate dipotassium, three on prazepam and one on diazepam. One diazepam patient reported nausea and vomiting. Scores on the Zung Self-Rating Scale for Anxiety showed all three drug groups to be superior to placebo. The Hopkins Symptom Check-list found prazepam and diazepam to be superior to placebo and chlorazepate. No differences among the groups were found in the Hamilton Anxiety Scale. Prazepam may offer advantages over the other available benzodiazepines since it may be more readily absorbed than chlorazepate and has less side-effects than diazepam.

A Double Blind Comparison of Alprazolam and Amitriptyline Hydrochloride in the Treatment of Nonpsychotic Depression

1988 ◽  
Vol 33 (3) ◽  
pp. 218-222 ◽  
Author(s):  
A.N. Singh ◽  
N.P.V. Nair ◽  
B. Suranyi-Cadotte ◽  
G. Schwartz ◽  
E. Lizondo
Keyword(s):  
Side Effects ◽  
Rating Scale ◽  
Symptom Scale ◽  
Double Blind ◽  
Psychiatric Rating ◽  
Hamilton Anxiety Rating Scale ◽  
Amitriptyline Hydrochloride ◽  
Psychiatric Rating Scale ◽  
Blind Comparison ◽  
Nonpsychotic Depression

In a six week, double-blind, parallel study of alprazolam and amitriptyline hydrochloride in 130 outpatients suffering from moderate to severe nonpsychotic depression, alprazolam was as effective as amitriptyline hydrochloride in relieving depressive symptoms and significantly more effective in relieving symptoms of anxiety and somatization. Alprazolam showed an earlier onset of activity in most measurements of efficacy and produced fewer side effects than amitriptyline hydrochloride. Anticholinergic side effects were reported more frequently by patients taking amitriptyline hydrochloride, while drowsiness was reported more frequently by patients taking alprazolam. At the end of the study, the average daily doses were 2.4 mg alprazolam and 135 mg amitriptyline hydrochloride. The Hamilton Psychiatric Rating Scale for Depression, Hamilton Anxiety Rating Scale, Physician's Global Impressions, Patients’ Global Impressions, Hopkins Self-Rating Symptom Scale, and Symptom and Side Effects Checklist were evaluated at the end of weeks 1, 2, 3 and 6 to determine and compare the efficacy and safety of the two study drugs.

EEG Synchronized TMS for Individualized Therapy in Major Depressive Disorder

2011 ◽  
Vol 26 (S2) ◽  
pp. 1144-1144
Author(s):  
Y. Jin ◽  
J. Phillips ◽  
Yueqin Huang ◽  
Steven Heurta
Keyword(s):  
Major Depressive Disorder ◽  
Side Effects ◽  
Depressive Disorder ◽  
Active Treatment ◽  
Rating Scale ◽  
Repetitive Transcranial Magnetic Stimulation ◽  
Stimulus Frequency ◽  
List Type ◽  
Major Depressive ◽  
Double Blind

IntroductionEfficacy of conventional repetitive transcranial magnetic stimulation (rTMS) in major depressive disorder (MDD) is limited. The authors report here on an alternative treatment using low energy synchronized TMS (sTMS) at the intrinsic frequency of subjects’ alpha electroencephalogram (EEG).ObjectivesEstablish efficacy and safety profile of sTMS in MDD.Aim(1)Examine the clinical effectiveness of sTMS.(2)Identify adverse effects associated with sTMS.MethodsFifty-two MDD subjects with 17-item Hamilton Depression Rating Scale (HAMD17) scores >17 were enrolled into a randomized, sham controlled, double-blind trial. Current medication remained unchanged during the trial. Depressive symptoms were evaluated by HAMD17 administered weekly.EEGs were recorded at baseline to determine the stimulus frequency and at week 4 to evaluate the physiological effect. sTMS was delivered through three 6000-G cylindrical neodymium magnets synchronously rotating at a rate equal to the subject's intrinsic alpha frequency.ResultsForty-five subjects completed at least 1 week of treatment and were evaluable. Those who received active treatment had superior clinical response to sham (t = 2.54, P = 0.01), where 55.2% in the active treatment group were clinical responders versus 12.5% in sham (X2 = 7.82, P = 0.005). No significant side effects were reported. The clinical improvement was correlated with the degree of EEG improvement (r = .46, P = 0.009).ConclusionsA therapeutic effect in MDD subjects can be achieved through administration of sTMS at the subject's alpha EEG frequency. Because of minimal side effects, this appears to be a safe and effective treatment option.

A Comparative Trial of Opipramol and Chlordiazepoxide in the Treatment of Anxiety

1973 ◽  
Vol 1 (3) ◽  
pp. 145-150 ◽  
Author(s):  
K Jepson ◽  
G Beaumont
Keyword(s):  
Clinical Trial ◽  
General Practice ◽  
Side Effects ◽  
Rating Scale ◽  
Comparative Trial ◽  
Anxiety Score ◽  
Double Blind ◽  
Somatic Anxiety ◽  
Daily Dose ◽  
The Difference

A daily dose of 200 mg of opipramol (Insidon, Geigy) and 30 mg of chlordiazepoxide (Librium, Roche) were compared in a clinical trial in general practice. The trial was double blind and a stratified randomisation technique was employed. Twenty four patients received opipramol and twenty six chlordiazepoxide for four weeks. A total anxiety score and separate ‘psychic’ anxiety and ‘somatic’ anxiety scores were recorded, using a rating scale initially and after two and four weeks treatment. No overall difference in efficacy was found between the two drugs—opipramol producing a 76% improvement and chlordiazepoxide 64% by the end of the study. There was no difference in the relief of psychic anxiety. Although opipramol appeared to give more relief of somatic anxiety, the difference was not statistically significant. Again although opipramol relieved more individual symptoms than chlordiazepoxide, none of the differences were significant. 70% of patients on opipramol and 74% of those on chlordiazepoxide were classified ‘better’ globally by both doctor and patient by the end of the trial. The total number of side effects recorded was similar on both drugs although drowsiness occurred twice as frequently on chlordiazepoxide as it did on opipramol.

A 6-months, randomised, placebo-controlled evaluation of efficacy and tolerability of a low-dose 7-day buprenorphine transdermal patch in osteoarthritis patients naïve to potent opioids

2010 ◽  
Vol 1 (3) ◽  
pp. 122-141 ◽  
Author(s):  
Harald Breivik ◽  
Tone Marte Ljosaa ◽  
Kristian Stengaard-Pedersen ◽  
Jan Persson ◽  
Hannu Aro ◽  
...  
Keyword(s):  
Side Effects ◽  
Pain Relief ◽  
Low Dose ◽  
Rating Scale ◽  
Secondary Outcome ◽  
Double Blind Study ◽  
Double Blind ◽  
Skin Reactions ◽  
Local Skin

AbstractObjectivePatients with osteoarthritis (OA) pain often have insufficient pain relief from non-opioid analgesics. The aim of this trial was to study efficacy and tolerability of a low dose 7-day buprenorphine transdermal delivery system, added to a NSAID or coxib regimen, in opioid-naïve patients with moderate to severe OA pain.MethodsA 6 months randomised, double-blind, parallel-group study at 19 centres in Denmark, Finland, Norway, and Sweden, in which OA patients (>40 years) with at least moderate radiographic OA changes and at least moderate pain in a hip and/or knee while on a NSAID or a coxib were randomised to a 7-day buprenorphine patch (n = 100) or an identical placebo patch (n = 99). The initial patch delivered buprenorphine 5 μg/h. This was titrated to 10 or 20 μg/h, as needed. Rescue analgesic was paracetamol 0.5–4 g daily. Statistical analysis of outcome data was mainly with a general linear model, with treatment as factor, the primary joint of osteoarthritis, baseline scores, and season as covariates.ResultsMost patients had OA-radiographic grade II (moderate) or grade III (severe), only 8 in each group had very severe OA (grade IV). The median buprenorphine dose was 10 μg/h. 31 buprenorphine-treated patients and 2 placebo-treated patients withdrew because of side effects. Lack of effect caused 12 placebo-treated and 7 buprenorphine-treated patients to withdraw. The differences in effects between treatments: Daytime pain on movement, recorded every evening on a 0–10 numeric rating scale decreased significantly more (P = 0.029) in the buprenorphine group. Patients’ Global Impression of Change at the end of the double blind period was significantly improved in the buprenorphine group (P = 0.017). The chosen primary effect outcome measure, the Western Ontario and McMaster Universities (WOMAC) OA Index for Pain (P = 0.061), and secondary outcome measures, the WOMAC OA score for functional abilities (P = 0.055), and the WOMAC total score (P = 0.059) indicated more effects from buprenorphine than placebo, but these differences were not statistically significant. In a post-hoc, subgroup analysis with the 16 patients with radiographic grad IV (very severe) excluded, WOMAC OA Index for Pain was significantly (P = 0.039) reduced by buprenorphine, compared with placebo. WOMAC OA score for stiffness and the amount of rescue medication taken did not differ. Sleep disturbance, quality of sleep, and quality of life improved in both groups. Side effects: Typical opioid side effects caused withdrawal at a median of 11 days before completing the 168 days double blind trial in 1/3 of the buprenorphine group. Mostly mild local skin reactions occurred equally often (1/3) in both groups.ConclusionsAlthough the 24 hours WOMAC OsteoArthritis Index of pain was not statistically significantly superior to placebo, day-time movement-related pain and patients’ global impression of improvement at the end of the 6-months double blind treatment period were significantly better in patients treated with buprenorphine compared with placebo. Opioid side effects caused 1/3 of the buprenorphine-patients to withdraw before the end of the 6-months double blind study period.ImplicationsA low dose 7-days buprenorphine patch at 5–20 μg/h is a possible means of pain relief in about 2/3 of elderly osteoarthritis patients, in whom pain is opioid-sensitive, surgery is not possible, NSAIDs and coxibs are not recommended, and paracetamol in tolerable doses is not effective enough. Vigilant focus on and management of opioid side effects are essential.

A Double-Blind Comparison of Pentazocine-Paracetamol and Dextropropoxyphene-Paracetamol Compound Tablets

1972 ◽  
Vol 1 (1) ◽  
pp. 26-29 ◽  
Author(s):  
S G Flavell Matts
Keyword(s):  
Side Effects ◽  
Severe Pain ◽  
Significant Preference ◽  
Double Blind ◽  
Blind Comparison ◽  
A Minor

In a double-blind cross-over comparison of two mild analgesic compound tablets patients in moderate or severe pain showed a significant preference for the pentazocine-paracetamol compound tablet. Side effects were of a minor nature only and no patient dropped out of the trial because of them. It is concluded that significantly more patients (p <0.01) prefer the pentazocine-paracetamol compound to the dextropropoxyphene-paracetamol compound.

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 Epidural Pethidine or Fentanyl during Caesarean Section: A Double-Blind Comparison

1989 ◽  
Vol 17 (2) ◽  
pp. 157-165 ◽  
Author(s):  
M. J. Paech
Keyword(s):  
Side Effects ◽  
Caesarean Section ◽  
Epidural Fentanyl ◽  
Double Blind Study ◽  
Double Blind ◽  
Significant Difference ◽  
Single Bolus Dose ◽  
Clinical Advantage ◽  
Blind Comparison

The onset, quality and duration of analgesia and side-effects of a single bolus dose of either epidural pethidine 50 mg or fentanyl 100 mcg, administered immediately post-delivery, were compared in a randomised, double-blind study of fifty-five women undergoing epidural caesarean section. The onset of effect was more rapid with fentanyl, a significantly larger number of women achieving complete pain relief fifteen minutes post-administration (P<0.05). The quality of analgesia was good in both groups and the quality and duration of effective analgesia not significantly different. The incidence and severity of side-effects were low, with no significant difference between groups. One patient in the pethidine group experienced early onset respiratory depression; however, she did not require active treatment. Epidural fentanyl 100 mcg appears to offer a small clinical advantage over pethidine 50 mg for intraoperative use during caesarean section.

A Comparison of Two Butyrophenones with Trifluoperazine

1966 ◽  
Vol 11 (1) ◽  
pp. 26-30 ◽  
Author(s):  
G. Marjerrison ◽  
W. Hrychuk ◽  
E.I. Varsanyi
Keyword(s):  
Side Effects ◽  
Rating Scale ◽  
Drug Action ◽  
Small Study ◽  
Clinical Effects ◽  
Double Blind ◽  
Morbidity Score ◽  
Closed Ward

A small study was carried out to compare the clinical effects of the two butyrophenone compounds, triperidol and haloanisone to those of trifluoperazine, in a population of chronically hospitalized long-term schizophrenics in a closed ward setting. Twenty-seven patients were randomly assigned to one of the three compounds, and treated for a twelve-week period under double-blind conditions. Observations with a modified PRP rating scale, based on ward nurses' monthly ratings, revealed an over-all improvement after one month of treatment, but differences between the three drugs were not apparent and the over-all decrease of this PRP morbidity score was not sustained in subsequent ratings. Psychiatrist's ratings on the IMPS revealed several symptom-factor differences with treatment. Between-drug differences on these factors were apparent. They are discussed in terms of the possible differences in type of drug action which they may reflect. The incidence of parkinsonistic side effects with each drug is presented. In no case did the side effects prevent continued treatment with the compound.

Atomoxetine versus Methylphenidate in Paediatric Outpatients with Attention Deficit Hyperactivity Disorder: A Randomized, Double-Blind Comparison Trial

2007 ◽  
Vol 41 (3) ◽  
pp. 222-230 ◽  
Author(s):  
Yufeng Wang ◽  
Yi Zheng ◽  
Yasong Du ◽  
Dong H. Song ◽  
Yee-Jin Shin ◽  
...  
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Attention Deficit ◽  
Rating Scale ◽  
Response Rates ◽  
Double Blind Study ◽  
Adhd Symptoms ◽  
Double Blind ◽  
Hyperactivity Disorder ◽  
End Point ◽  
Blind Comparison

Objective: To (i) test whether atomoxetine is non-inferior to methylphenidate in treating symptoms of attention deficit hyperactivity disorder (ADHD) in paediatric patients; and (ii) determine the tolerability of the two drugs. Method: This double-blind study was conducted in 6- to 16-year-old outpatients with ADHD (DSM-IV) in China, Korea and Mexico (January–October 2004). Patients were randomly assigned to once-daily atomoxetine (0.8–1.8 mg kg−1 day−1; n = 164) or twice-daily methylphenidate (0.2–0.6 mg kg−1 day−1; n = 166) for ∼8 weeks. Primary efficacy assessment was the comparison of response rates (≥40% reduction from baseline to end point in total score) on the Attention Deficit Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and -Scored. Tolerability measures included, but were not limited to, the assessment of treatment-emergent adverse events (TEAEs) and weight. Results: Atomoxetine was non-inferior to methylphenidate in improving ADHD symptoms based on response rates (atomoxetine, 77.4%; methylphenidate, 81.5%; one-sided 95% lower confidence limit = −11.7%, p = 0.404). Treatment-emergent adverse effects experienced significantly more frequently in the atomoxetine group, compared with the methylphenidate group, included anorexia (37.2% vs. 25.3%; p = 0.024), nausea (20.1% vs. 10.2%; p = 0.014), somnolence (26.2% vs. 3.6%; p <0.001), dizziness (15.2% vs. 7.2%; p = 0.024) and vomiting (11.6% vs. 3.6%; p = 0.007), most of which were of mild or moderate severity. Atomoxetine-treated patients experienced a small but significantly greater mean weight loss from baseline to end point than methylphenidate-treated patients (−1.2 kg vs. −0.4 kg; p <0.001). Conclusions: This study suggests that atomoxetine is non-inferior to methylphenidate in the improvement of ADHD symptoms in paediatric outpatients. Although both of the drugs were well tolerated, atomoxetine was associated with a higher incidence of TEAEs than methylphenidate.

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