Dextromethorphan and Codeine: Objective Assessment of Antitussive Activity in Patients with Chronic Cough

1983 ◽  
Vol 11 (2) ◽  
pp. 92-100 ◽  
Author(s):  
Heinrich Matthys ◽  
Bärbel Bleicher ◽  
Ulrich Bleicher
Keyword(s):  
Side Effects ◽  
Chronic Cough ◽  
Crossover Trial ◽  
Objective Assessment ◽  
Subjective Assessment ◽  
Double Blind ◽  
Cough Frequency ◽  
Increasing Trend ◽  
Antitussive Activity ◽  
Cough Suppressant

Dextromethorphan, the most widely used cough suppressant in the U.S.A., was compared with codeine, the traditional European antitussive, in a double-blind, crossover trial using both an objective and subjective assessment of efficacy in sixteen patients with chronic, stable cough. Both preparations, at a dose of 20 mg, were similarly effective in reducing cough frequency. Dextromethorphan lowered cough intensity to a greater degree than codeine (p < 0·0008) and was considered the better antitussive by the majority of patients (p < 0·001). In view of its lack of side-effects, its safety even in overdose and its non-narcotic status, the increasing trend in Europe to use dextromethorphan as a substitute for codeine in the treatment of cough is to be welcomed.

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.

Baclofen: A Team Approach to Drug Evaluation of Spasticity in Childhood

1980 ◽  
Vol 25 (4) ◽  
pp. S26-S28 ◽  
Author(s):  
Ian McKinlay ◽  
Elizabeth Hyde ◽  
Neil Gordon
Keyword(s):  
Side Effects ◽  
Crossover Trial ◽  
Drug Evaluation ◽  
Day School ◽  
Team Approach ◽  
Double Blind ◽  
Handicapped Children ◽  
Functional Activities ◽  
Everyday Activities ◽  
Physically Handicapped

A double blind crossover trial of baclofen against placebo was carried out in 20 children with spasticity in a day school for physically handicapped children. No significant benefit from baclofen in functional activities was observed and an unacceptable incidence of side-effects was recorded. However, interesting differences between the observations during formal testing and during everyday activities were noted and these may have implications for future trials. A longer study using a lower dose (e.g. 1 mg/kg) might achieve different results.

scholarly journals Functional Changes of the Genitourinary and Gastrointestinal Systems before and after the Treatment of Endometrial Cancer—A Systematic Review

2021 ◽  
Vol 10 (23) ◽  
pp. 5579
Author(s):  
Marcin Oplawski ◽  
Agata Średnicka ◽  
Aleksandra Dutka ◽  
Sabina Tim ◽  
Agnieszka Mazur-Bialy
Keyword(s):  
Endometrial Cancer ◽  
Urinary Incontinence ◽  
Side Effects ◽  
Pelvic Floor ◽  
Prospective Studies ◽  
Current Knowledge ◽  
Pelvic Floor Dysfunction ◽  
Objective Assessment ◽  
Subjective Assessment ◽  
Functional Changes

The incidence of endometrial cancer (EC), which coexists with such civilization diseases as diabetes, obesity or hypertension, is constantly increasing. Treatment includes surgery as well as brachytherapy, teletherapy, rarely chemotherapy or hormone therapy. Due to the good results of the treatment, the occurrence of side effects of therapy becomes a problem for the patients. One of the large groups of side effects includes the pelvic organ prolapse, urinary and fecal incontinence. The aim of this study was to present current knowledge on the occurrence of pelvic floor dysfunction in women treated for EC. A literature review was conducted in the PubMED and WoS databases, including articles on pelvic floor dysfunction in women with EC. PRISMA principles were followed in the research methodology. A total of 1361 publications were retrieved. Based on the inclusion and exclusion criteria, 24 papers were eligible for the review. Mostly retrospective studies based on different questionnaires were evaluated. No prospective studies were found in which, in addition to subjective assessment, clinical examination and objective assessment of urinary incontinence were used. Studies show a significant increase in the incidence of pelvic floor disorders, including urinary incontinence, after various forms of EC treatment. We believe that assessment of complications after endometrial cancer treatment is clinically relevant. The review emphasizes the importance of programming prospective studies to prevent and address these disorders at each stage of oncologic treatment.

scholarly journals Gefapixant in two randomised dose-escalation studies in chronic cough

2020 ◽  
Vol 55 (3) ◽  
pp. 1901615 ◽  
Author(s):  
Jaclyn A. Smith ◽  
Michael M. Kitt ◽  
Peter Butera ◽  
Steven A. Smith ◽  
Yuping Li ◽  
...  
Keyword(s):  
Dose Escalation ◽  
Chronic Cough ◽  
Taste Disturbance ◽  
Double Blind ◽  
Cough Frequency ◽  
High Daily Dose ◽  
Patient Reported ◽  
Daily Dose ◽  
To Receive ◽  
Dose Patient

Background and objectivesGefapixant has previously demonstrated efficacy in the treatment of refractory chronic cough at a high daily dose. The current investigations explore efficacy and tolerability of gefapixant, a P2X3 receptor antagonist, for the treatment of chronic cough using a dose-escalation approach.Materials and methodsTwo randomised, double-blind, placebo-controlled, crossover, dose-escalation studies recruited participants with refractory chronic cough. Patients were assigned to receive ascending doses of gefapixant (study 1: 50–200 mg, study 2: 7.5–50 mg) or placebo for 16 days, then crossed-over after washout. The primary end-point was awake cough frequency assessed using a 24-h ambulatory cough monitor at baseline and on day 4 of each dose. Patient-reported outcomes included a cough severity visual analogue scale and the cough severity diary.ResultsIn clinical studies, gefapixant doses ≥30 mg produced maximal improvements in cough frequency compared with placebo (p<0.05); reported cough severity measures improved at similar doses. Taste disturbance exhibited a different relationship with dose, apparently maximal at doses ≥150 mg.ConclusionsP2X3 antagonism with gefapixant demonstrates anti-tussive efficacy and improved tolerability at lower doses than previously investigated. Studies of longer duration are warranted.

scholarly journals TriMaster: randomised double-blind crossover study of a DPP4 inhibitor, SGLT2 inhibitor and thiazolidinedione as second-line or third-line therapy in patients with type 2 diabetes who have suboptimal glycaemic control on metformin treatment with or without a sulfonylurea—a MASTERMIND study protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e042784
Author(s):  
Catherine Angwin ◽  
Caroline Jenkinson ◽  
Angus Jones ◽  
Christopher Jennison ◽  
William Henley ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Side Effects ◽  
Crossover Trial ◽  
Treatment Options ◽  
Sglt2 Inhibitor ◽  
Oral Glucose ◽  
Double Blind ◽  
Glucose Lowering ◽  
South Central

IntroductionPharmaceutical treatment options for patients with type 2 diabetes mellitus (T2DM) have increased to include multiple classes of oral glucose-lowering agents but without accompanying guidance on which of these may most benefit individual patients. Clinicians lack information for treatment intensification after first-line metformin therapy. Stratifying patients by simple clinical characteristics may improve care by targeting treatment options to those in whom they are most effective. This academically designed and run three-way crossover trial aims to test a stratification approach using three standard oral glucose-lowering agents.Methods and analysisTriMaster is a randomised, double-blind, crossover trial taking place at up to 25 clinical sites across England, Scotland and Wales. 520 patients with T2DM treated with either metformin alone, or metformin and a sulfonylurea who have glycated haemoglobin (HbA1c) >58 mmol/mol will be randomised to receive 16 weeks each of a dipeptidyl peptidase‐4 inhibitor, sodium-glucose co-transporter-2 inhibitor and thiazolidinedione in random order. Participants will be assessed at the end of each treatment period, providing clinical and biochemical data, and their experience of side effects. Participant preference will be assessed on completion of all three treatments. The primary endpoint is HbA1c after 4 months of therapy (allowing a range of 12–18 weeks for analysis). Secondary endpoints include participant-reported preference between the three treatments, tolerability and prevalence of side effects.Ethical approvalThis study was approved by National Health Service Health Research Authority Research Ethics Committee South Central—Oxford A, study 16/SC/0147. Written informed consent will be obtained from all participants. Results will be submitted to a peer-reviewed journal and presented at relevant scientific meetings. A lay summary of results will be made available to all participants.Trial registration numbers12039221; 2015-002790-38 and NCT02653209.

Comparison of Fenoterol and Orciprenaline with regard to Broncho-Dilating Action and β2 – Selectivity

1980 ◽  
Vol 8 (3) ◽  
pp. 205-216 ◽  
Author(s):  
Takao Sasaki ◽  
Tamotsu Takishima ◽  
Ryoichi Sugiura
Keyword(s):  
Side Effects ◽  
Oral Administration ◽  
Crossover Trial ◽  
Respiratory Impedance ◽  
Subjective Symptoms ◽  
Measuring Time ◽  
Double Blind ◽  
Significant Difference ◽  
Cent Increase ◽  
Finger Tremor

A double-blind crossover trial was performed comparing orciprenaline (10 mg) and fenoterol (5 mg) by oral administration in forty-four patients with bronchial asthma. Measurement of VC, FEV1, respiratory impedance (ZR), blood pressure and pulse rate, and observation of subjective symptoms, rales and side-effects, were made over the 4 hours following oral administration of the drugs. FEV1 increased through the 4 hours reaching a peak at 3 hours with both drugs. The per cent increase of FEV1 was statistically significant at each measuring time for both drugs (p < 001), and was significantly larger in fenoterol than in orciprenaline at 2 and 3 hours (p < 0.05). ZR with fenoterol decreased from 2 hours to 4 hours with a significant difference from ZR with orciprenaline (p < 0.05). Side-effects such as palpitation, finger tremor or headache were seen in 36.4% cases with fenoterol and 30.5% with orciprenaline, but the degree of the side-effects was minimal. Finger tremor was observed in one case with orciprenaline and ten cases with fenoterol. Palpitation was observed in five cases with each of the drugs. Because finger tremor seems to be due to β2-stimulation and palpitation seems to be due to β1-stimulation, fenoterol was supposed to be more β2-selective than orciprenaline. In conclusion fenoterol had a high β2 selectivity and a powerful and long-lasting broncho-dilating effect compared with orciprenaline.

Ketamine-midazolam versus meperidine-midazolam for painful procedures in pediatric oncology patients.

1997 ◽  
Vol 15 (1) ◽  
pp. 94-102 ◽  
Author(s):  
C M Marx ◽  
J Stein ◽  
M K Tyler ◽  
M L Nieder ◽  
S B Shurin ◽  
...  
Keyword(s):  
Side Effects ◽  
Crossover Trial ◽  
Bone Marrow Aspiration ◽  
University Teaching ◽  
Inpatient Service ◽  
Double Blind ◽  
Pediatric Hematology ◽  
Behavioral Abnormalities ◽  
Parents And Children ◽  
End Tidal

PURPOSE To compare the efficacy, characteristics of onset/recovery, and safety of ketamine/atropine/midazolam with meperidine/midazolam used as premedication for painful procedures in children with cancer. METHODS A randomized, double-blind crossover trial for two successive painful procedures (bone marrow aspiration or biopsy, lumbar puncture, or combined procedures) was performed at a referral-based pediatric hematology-oncology clinic and associated inpatient service of a university teaching hospital. Twenty-two children, aged 24 to 178 months, were enrolled and 18 (81.8%) completed the double-blind, crossover trial. Each child received intravenous premedication with either meperidine 2 mg/kg and midazolam 0.1 mg/kg (MM) or atropine 0.01 mg/kg, midazolam 0.05 mg/kg, and ketamine 1.5 mg/kg (KM) on one occasion followed by the alternative regimen on a second occasion. The initial premedication regimen was chosen by random assignment. RESULTS Efficacy was assessed by a trained observer using the Observational Scale of Behavioral Distress-Revised (OSBD-R). Operator, nurse, parent, and patient opinions of efficacy were recorded on a visual analog scale (VAS). Side effects were monitored by pulse oximetry, nasal end-tidal capnography, and serial blood pressure measurements. Use of KM resulted in significantly less procedural distress than MM (1.37 +/- 2.20 v 7.04 +/- 8.06 OSBD-R units; P < .05). Both operators and nurses rated KM more effective than MM. KM use was associated with earlier readiness for the procedure (19.2 v 24.0 minutes) and more rapid recovery (39.3 v 74.6 minutes for removal of monitoring devices and 58.5 v 87.1 minutes for discharge). Procedures undertaken after ketamine sedation were associated with fewer side effects than observed with MM sedation (hypoxia, 17.7% v 82.4%; hypotension, 16.6% v 55.6%; reduced respiratory rate, 0% v 38.9%). The incidence of emergence reactions or behavioral abnormalities within 24 hours postprocedure was similar in both treatment groups. At 7 days postprocedure, no child had persistent behavioral abnormalities and all children had amnesia for the procedure. Parents and children expressed a preference for KM over MM in 12 of 18 cases (P < .05). CONCLUSION A premedication regimen of KM produced superior sedation with a faster onset and recovery and fewer side effects than a MM combination.

Flunarizine in Prophylaxis of Childhood Migraine: A Double-Blind, Placebo-Controlled, Crossover Study

Cephalalgia ◽  
1988 ◽  
Vol 8 (1) ◽  
pp. 1-6 ◽  
Author(s):  
Fulvio Sorge ◽  
Roberto De Simone ◽  
Enrico Marano ◽  
Maria Nolano ◽  
Giuseppe Orefice ◽  
...  
Keyword(s):  
Side Effects ◽  
Crossover Trial ◽  
Average Duration ◽  
Base Line ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Childhood Migraine ◽  
Group A ◽  
Group B ◽  
Line Observation

An 8-month, double-blind, placebo-controlled, crossover trial of flunarizine in the prophylaxis of migraine has been performed in 70 children. After 4 weeks of medication-free base-line observation, 35 children (group A) received flunarizine (5 mg/day) and 35 (group B) received placebo over a 12-week period. After a 4-week washout they crossed treatments for another 12 weeks. Sixty-three patients completed the trial. In both groups flunarizine significantly reduced the frequency and average duration of headache attacks. In group A efficacy was maintained after placebo crossover for the last 4 months of the study. Five subjects in group B stopped placebo because of ineffectiveness; two children in group A discontinued flunarizine treatment, one because of excessive daytime sedation and the other because therapy was ineffective. The main side effects were daytime sedation and weight gain. It is concluded that flunarizine is an effective drug for the treatment of childhood migraine. In a study of this length no serious side effects were discovered.

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