scholarly journals A Double-Blind Randomized Study of Cisapride in the Treatment of Nonulcer Dyspepsia

1997 ◽  
Vol 11 (2) ◽  
pp. 127-134 ◽  
Author(s):  
MC Champion ◽  
KL MacCannell ◽  
ABR Thomson ◽  
R Tanton ◽  
S Eberhard ◽  
...  
Keyword(s):  
Multicentre Study ◽  
Epigastric Pain ◽  
Lower Abdominal Pain ◽  
Symptom Cluster ◽  
Nonulcer Dyspepsia ◽  
Double Blind ◽  
Early Satiety ◽  
Treatment Groups ◽  
Significant Difference ◽  
Single Blind

Cisapride is a substituted benzamide with gastrointestinal prokinetic effects presumed to be due to the enhancement of the physiological release of acetylcholine at the myenteric plexus. In a multicentre study, 189 patients with nonulcer dyspepsia (NUD) received single-blind placebo treatment for two weeks. A total of 123 patients with no or minimal response to placebo and epigastric pain of at least moderate severity and frequency were randomly assigned to one of three parallel double-blind treatments for six weeks: cisapride 10 mg tid, cisapride 20 mg tid or placebo. The severity and frequency of individual symptoms (epigastric pain, heartburn, nausea, vomiting, anorexia, postprandial discomfort, regurgitation, lower abdominal pain, bloating and constipation) were assessed on a four- and five-point categorical scale, respectively, by the investigator at three on-treatment visits and by patients in a daily diary. Analysis of investigator and patient assessments for differences in symptom severityxfrequency composite scores among the three treatment groups showed no statistically significant differences for individual symptoms or symptom clusters. As assessed by the investigator, and compared with baseline, cisapride 20 mg tid significantly (P<0.05) improved epigastric pain, bloating and early satiety as well as improved the total symptom cluster. Investigator evaluation of the five most severe and frequent symptoms for each patient showed statistically significant improvement in each treatment group. For patient diary assessments, statistically significant within-treatment improvement of the total symptom cluster, the five most severe symptoms cluster, bloating and early satiety was observed for both cisapride 20 mg and placebo, whereas epigastric pain significantly (P<0.05) improved in all three treatment groups. Investigator evaluation of global response (good + excellent) rate at the end of the six-week treatment period was 38% for cisapride 20 mg, 47% for cisapride 10 mg and 33% for placebo. No statistically significant difference in this parameter among treatments was noted. Cisapride was well tolerated at both doses with a side effect profile comparable with that of placebo. It is concluded that, in this double-blind multicentre study with a single-blind two-week placebo run-in phase, cisapride 10 mg tid and 20 mg tid were not effective compared with placebo in improving symptoms in NUD patients. This study re-emphasizes the good prognosis of patients with NUD, with 14% of patients improving in the two-week placebo run-in phase and a further 33% improving in the next six weeks while on placebo. Within-treatment analysis of investigator assessments showed improvement for cisapride 20 mg tid suggesting a trend for efficacy at this dose.

Relief of pain and trismus in patients treated with naproxen or acetylsalicylic acid after tonsillectomy

1988 ◽  
Vol 102 (1) ◽  
pp. 39-42 ◽  
Author(s):  
S. Kristensen ◽  
K. Tveteraas ◽  
P. Hein ◽  
H. B. Poulsen ◽  
K. E. Outzen
Keyword(s):  
Clinical Trial ◽  
Acetylsalicylic Acid ◽  
Pain Intensity ◽  
Sleep Disturbances ◽  
Significant Positive Correlation ◽  
Controlled Trial ◽  
Double Blind ◽  
Treatment Groups ◽  
Significant Difference ◽  
Therapeutic Gain

AbstractThe pain-relieving efficacy of naproxen and acetylsalicylic acid (ASA) in tonsillectomized patients was compared in a double blind parallel clinical trial comprising 83 patients, among whom 42 were treated with naproxen and 41 with ASA. The patients were treated post-operatively for two days with either naproxen suppositories 500 mg. twice, or ASA effervescent tablets 1000 mg. three times, daily.The therapeutic gain was evaluated by recording the intensity of pain, reduced ability to open the mouth (trismus), consumption of supplementary analgesic (parcetamol), and pain-related sleep disturbances.The statistical analysis of the results revealed no differences in pain intensity, consumption of additional analgesics or pain-related sleep disturbances in the two treatment groups. A considerable degree of trismus was demonstrated in most of the tonsillectomized patients. This reduced ability to open the mouth was gradually overcome in the naproxen group while it remained unchanged in the ASA group, however, no statistical significant difference could be demonstrated. Additionally, no significant positive correlation between pain intensity and trismus was proven. The pain-relieving effect, however, was unsatisfactory in both the naproxen and the ASA group, and clinical controlled trial studies of alternative analgetics in tonsillectomized patients are still to be encouraged.

Effect of Evening Bromazepam Administration on Blood Pressure and Heart Rate in Mild Hypertensive Patients

Pharmacology ◽  
2019 ◽  
Vol 104 (1-2) ◽  
pp. 1-6
Author(s):  
Alfredo Costa ◽  
Daniele Bosone ◽  
Matteo Cotta Ramusino ◽  
Giulia Perini ◽  
Natascia Ghiotto ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
Ambulatory Monitoring ◽  
Night Time ◽  
Double Blind ◽  
Hypertensive Patients ◽  
Treatment Groups ◽  
Significant Difference ◽  
Nocturnal Increase ◽  
Mild Hypertensive

Aim: To assess the effects of chronic evening oral administration of bromazepam alone or in combination with propranolol on ambulatory blood pressure (BP) and heart rate (HR) in mild hypertensive subjects. Methods: Thirty-seven mild hypertensive patients after a 2-week placebo period were randomized to bromazepam 3 mg, propranolol 40 mg, bromazepam 3 mg plus propranolol 40 mg or placebo for 2 weeks according to a double-blind, double dummy, cross-over design. After each treatment period, 24-h BP and HR ambulatory monitoring was performed by using a non-invasive device. Results: Ambulatory monitoring showed that during night-time SBP and DBP values were unaffected by bromazepam as compared to placebo, whereas SBP was significantly reduced by propranolol both when taken alone and in combination with bromazepam. HR nocturnal values were significantly reduced by propranolol, whereas they were significantly increased by bromazepan both when taken alone (+11.5%, p < 0.05 vs. placebo) and in combination with propranolol (+12.8%, p < 0.05 vs. propranolol). No significant difference in day-time values of SBP, DBP and HR was observed among the 4 treatment groups. Conclusions: In mild hypertensive patients, evening consumption of bromazepam for a 2-week period did not affect BP, while it increased nocturnal HR. Such an increase was observed both when bromazepam was taken alone and in combination with propranolol, which suggests that it depends on a bromazepam mediated decrease in vagal tone. Whatever the mechanism, the HR nocturnal increase might be of clinical relevance, due to the role of high HR as cardiovascular risk factor, particularly in already at risk hypertensive subjects.

The Efficacy and Safety of Tanacetum Parthenium (Feverfew) in Migraine Prophylaxis—a Double-Blind, Multicentre, Randomized Placebo-Controlled Dose-Response Study

Cephalalgia ◽  
2002 ◽  
Vol 22 (7) ◽  
pp. 523-532 ◽  
Author(s):  
V Pfaffenrath ◽  
HC Diener ◽  
M Fischer ◽  
M Friede ◽  
HH Henneicke-von Zepelin
Keyword(s):  
Dose Response ◽  
Baseline Period ◽  
Dependent Manner ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Treatment Groups ◽  
Tanacetum Parthenium ◽  
Number Of Patients ◽  
Significant Difference ◽  
Efficacy Parameter

Tanacetum parthenium (feverfew), is a well-known herb for the prophylactic treatment of migraine. The primary objective was to show a dose-response of a new stable extract (MIG-99) reproducibly manufactured with supercritical CO2 from feverfew ( T. parthenium). Furthermore, the study should provide data on the safety and tolerability of MIG-99. In a randomized, double-blind, multicentre, controlled trial with an adaptive design, the clinical efficacy and safety of three dosages of MIG-99 (2.08 mg; 6.25 mg; 18.75 mg t.i.d.) were compared with placebo. The patients ( n = 147) suffered from migraine with and without aura according to International Headache Society (IHS) criteria and were treated with one of the study medications for 12 weeks after a 4-week baseline period. The primary efficacy parameter was the number of migraine attacks during the last 28 days of the treatment period compared with baseline. Secondary endpoints were total and average duration and intensity of migraine attacks, mean duration of the single attack, number of days with accompanying migraine symptoms, number of days with inability to work due to migraine as well as type and amount of additionally taken medications for the treatment of migraine attacks. The design of the study included a pre-planned adaptive interim analysis for patients with at least four migraine attacks within the baseline period. With respect to the primary and secondary efficacy parameter, a statistically significant difference was not found between the overall and the confirmatory intention-to-treat (ITT) sample in the exploratorily analysed four treatment groups. The frequency of migraine attacks for the predefined confirmatory subgroup of patients ( n = 49) with at least four migraine attacks during the baseline period decreased in a dose-dependent manner ( P = 0.001). The highest absolute change of migraine attacks was observed under treatment with 6.25 mg t.i.d. (mean ± SD = x1.8 ± 1.5 per 28 days) compared with placebo (-0.3 ± 1.9; P = 0.02). Overall, 52 of 147 (35%) patients reported at least one adverse event (AE). The incidence of AEs in the active treatment groups was similar to that in the placebo group, and no dose-related effect was observed in any safety parameter. MIG-99 failed to show a significant migraine prophylactic effect in general. Accordingly, in the ITT analysis a dose-response relationship could not be observed. MIG-99 was shown to be effective only in a small predefined subgroup of patients with at least four attacks during the 28-day baseline period where the most favourable benefit-risk ratio was observed with a dosage of three capsules of 6.25 mg MIG-99 extract per day. Because of the low number of patients, these findings need to be verified in a larger sample. The incidence of AEs was similar for all treatment groups.

Disophrol® Syrup versus Rinomar® Syrup in the Treatment of Allergic Rhinitis in Children

1982 ◽  
Vol 10 (6) ◽  
pp. 426-430 ◽  
Author(s):  
Friedrich Horak
Keyword(s):  
Allergic Rhinitis ◽  
Seasonal Allergic Rhinitis ◽  
Adverse Reactions ◽  
Nasal Secretion ◽  
Response To Therapy ◽  
Efficacy And Safety ◽  
Patient Response ◽  
Treatment Groups ◽  
Significant Difference ◽  
Single Blind

In this single-blind study, the efficacy and safety of Disophrol® Syrup was compared to Rinomar® Syrup in seventy-eight paediatric patients with seasonal allergic rhinitis. Patients took 5–10 ml of the randomly assigned medication three to four times daily for a 2-week period. Severity of nasal obstruction, nasal secretion and mucosal swelling was graded and patient response to each week of therapy evaluated. An overall favourable response to Disophrol® Syrup was observed in thirty-one out of thirty-five (89%) patients and in thirty out of thirty-five (86%) patients in the Rinomar® group. No statistically significant difference in patient response to therapy between treatment groups was noted and no mentionable adverse reactions were reported.

A Comparison of Biperiden Hydrochloride (Akineton) and Benzhexol (Artane) in the Treatment of Drug-Induced Parkinsonism

1980 ◽  
Vol 8 (5) ◽  
pp. 343-346 ◽  
Author(s):  
R V Magnus
Keyword(s):  
Clinical Efficacy ◽  
Blind Study ◽  
Drug Induced ◽  
Treatment Groups ◽  
Significant Difference ◽  
Highly Effective ◽  
Single Blind

A single-blind study compared the clinical efficacy of biperiden hydrochloride (Akineton®, Abbott) and benzhexol (Artane®, Lederle) in the treatment of neuroleptic-induced Parkinsonism. Both drugs were highly effective and all patients responded favourably to medication. No significant difference was observed between the two treatment groups when individual symptoms were examined.

Double-blind placebo-controlled trial of etanercept in the prevention of work disability in ankylosing spondylitis: Table 1

2010 ◽  
Vol 69 (11) ◽  
pp. 1926-1928 ◽  
Author(s):  
Nick Barkham ◽  
Laura C Coates ◽  
Helen Keen ◽  
Elizabeth Hensor ◽  
Alexander Fraser ◽  
...  
Keyword(s):  
Placebo Group ◽  
Ankylosing Spondylitis ◽  
Clinical Outcomes ◽  
Job Loss ◽  
Controlled Trial ◽  
Controlled Study ◽  
Double Blind ◽  
Treatment Groups ◽  
Gait Parameters ◽  
Significant Difference

ObjectivesEtanercept has been shown to be rapidly effective in suppressing disease activity in ankylosing spondylitis (AS). The aim of this study was to determine whether etanercept improves work instability as measured by the Ankylosing Spondylitis Work Instability Scale (AS-WIS).MethodForty patients with active AS who were in work but were work unstable were recruited. Patients were randomised to receive 25 mg etanercept or placebo twice weekly for 12 weeks. The primary outcome was change in AS-WIS at week 12. The AS-WIS is a patient-derived outcome measure which allows stratification of the risk of job loss. Secondary outcomes included clinical outcomes and gait parameters.ResultsThe mean improvement in AS-WIS score at week 12 was 2.75 in the etanercept group and 0.68 in the placebo group (p=0.125). The risk of job loss decreased for 11 (55%) of the etanercept group compared with 7 (35%) in the placebo group. Conversely, the risk of job loss increased in 3 (15%) of the placebo group compared with 1 (5%) in the etanercept group. There was no statistically significant difference between treatment groups in change in WIS categories (Mann–Whitney U test=0.153, p=0.160). Significant improvement with etanercept was seen at week 12 in clinical outcomes and gait parameters. Etanercept was well tolerated, with no dropouts due to adverse events.ConclusionThis small study confirms the efficacy of etanercept on clinical outcome measures in patients with AS and suggests an effect on work instability which needs to be replicated in a larger controlled study.

scholarly journals Recurrence of Acute Duodenal Ulcer

1994 ◽  
Vol 8 (1) ◽  
pp. 21-26
Author(s):  
RJ Bailey ◽  
IG Morrison-Cleator ◽  
A Farley ◽  
A Archambault ◽  
M Oravec ◽  
...  
Keyword(s):  
Ulcer Healing ◽  
Healing Rate ◽  
Multicentre Trial ◽  
Epigastric Pain ◽  
Symptomatic Relief ◽  
Ulcer Recurrence ◽  
Double Blind ◽  
Duodenal Ulcers ◽  
Treatment Groups ◽  
Ulcer Healing Rate

Nizatidine, 300 mg once nightly, was compared with cimetidine, 800 mg once nightly, for treatment of 212 adult out-patients with acute duodenal ulcers in an eight-week randomized, double-blind, multicentre trial. Patients were endoscoped at weeks 2, 4 and 8, regardless of ulcer healing status. No significant differences in ulcer healing rates between treatment groups were seen at weeks 2 and 4, but at week 8, nizatidine had a significantly higher ulcer healing rate (P=0.036) than cimetidine (86% versus 74%, respectively). Patients with healed ulcers at either week 2 or week 4 had a final endoscopy performed at week 8. The rate of ulcer recurrence was significantly greater (P=0.021) in the cimetidine group at week 8 compared with the nizatidine group: 21% versus 7.3%, respectively. Increasing tolerance to H2receptor antagonist therapy with prolonged use may explain the higher recurrence rate of cimetidine. Both drugs provided equally rapid and effective symptomatic relief from epigastric pain after two weeks of therapy. Both were equally safe and free from treatment-related adverse effects.

scholarly journals Sarilumab for the treatment of ankylosing spondylitis: results of a Phase II, randomised, double-blind, placebo-controlled study (ALIGN)

2014 ◽  
Vol 74 (6) ◽  
pp. 1051-1057 ◽  
Author(s):  
Joachim Sieper ◽  
Jürgen Braun ◽  
Jonathan Kay ◽  
Salvatore Badalamenti ◽  
Allen R Radin ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Fungal Infections ◽  
Human Monoclonal Antibody ◽  
High Sensitivity ◽  
Controlled Study ◽  
Double Blind ◽  
Treatment Groups ◽  
Significant Difference ◽  
Interleukin 6 Receptor ◽  
Hs Crp

ObjectivesThe ALIGN study (NCT01061723) evaluated the efficacy and safety of sarilumab, the first fully human monoclonal antibody against interleukin-6 receptor-α (IL-6Rα), in patients with ankylosing spondylitis (AS).MethodsPatients with active AS despite conventional treatment were randomised to placebo, or one of five subcutaneous dose regimens of sarilumab (100, 150 or 200 mg every other week, or 100 or 150 mg every week), for 12 weeks. The primary efficacy end point was the percentage of patients achieving the Axial SpondyloArthritis international Society (ASAS) 20 response criteria at week 12. Secondary endpoints included ASAS40 response, ASAS partial remission, AS Disease Activity Score, high-sensitivity C-reactive protein (hs-CRP) value, and safety.ResultsBaseline demographic and disease characteristics of the 301 patients enrolled were similar across treatment groups. At week 12, there was no statistically significant difference in ASAS20 response rate between placebo (ASAS20 = 24.0%) and any sarilumab dose group. A significantly greater reduction in hs-CRP value was achieved with the higher sarilumab doses versus placebo. No other statistically significant differences were evident for secondary efficacy endpoints.The most common treatment-emergent adverse events reported for sarilumab included infections (non-serious), neutropenia, and increase in alanine aminotransferase. No cases of tuberculosis, opportunistic, or fungal infections, or bowel perforations were reported. Seven patients experienced a treatment-emergent serious adverse event (all in sarilumab treatment groups). No deaths occurred.ConclusionsThe ALIGN study shows that IL-6Rα blockade with sarilumab was not an effective treatment for AS. Sarilumab was generally well tolerated with a manageable safety profile.

Naproxen Sodium in the Treatment of Migraine

Cephalalgia ◽  
1985 ◽  
Vol 5 (1) ◽  
pp. 5-10 ◽  
Author(s):  
ES Johnson ◽  
DM Ratcliffe ◽  
M Wilkinson
Keyword(s):  
Placebo Group ◽  
Rescue Medication ◽  
Naproxen Sodium ◽  
Double Blind ◽  
Treatment Groups ◽  
Parallel Group ◽  
Significant Difference ◽  
Previous Visit ◽  
Premonitory Symptoms ◽  
Visual Disturbances

Seventy patients with classical or common migraine were treated during their attacks with either naproxen sodium or placebo in a randomised, double-blind parallel group study. The initial dose of naproxen sodium was 825 mg followed one hour later by a further 550 mg, if symptoms were the same or had improved. If the migraine symptoms had worsened, patients were offered an escape analgesic combination of 1000 mg paracetamol and 10 mg metoclopramide. Patients were assessed at monthly intervals for changes in the severity and duration of headache, premonitory symptoms (mainly visual disturbances) and photophobia, nausea and vomiting associated with migraine attacks that had occurred since the previous visit. Patients were studied for a maximum of ten attacks and significant improvement was observed in the severity and duration of headache when the patients were on naproxen sodium. Also the premonitory symptoms and photophobia improved significantly on naproxen sodium and significantly less rescue analgesics were required. Patients suffering from common migraine had less severe headaches and photophobia when taking naproxen sodium than when taking placebo and the headaches were shorter in duration and patients took less rescue analgesic. No significant difference was observed between the treatment groups in patients with classical migraine. Ten patients in the placebo group and six in the naproxen sodium group reported side-effects but these were possibly related to the use of rescue medication. Naproxen sodium proved safe and effective in common migraine attacks, but in this study efficacy was not established for classical migraine.

Combined Intranasal Ipratropium Bromide and Oxymetazoline in Experimental Rhinovirus Infection

1998 ◽  
Vol 12 (2) ◽  
pp. 125-130 ◽  
Author(s):  
Anne Pitkäranta ◽  
Margaret T. Wecker ◽  
David C. Korts ◽  
Frederick G. Hayden
Keyword(s):  
Middle Ear ◽  
Ipratropium Bromide ◽  
Neutralizing Antibody ◽  
Nasal Discharge ◽  
Double Blind ◽  
Mucus Production ◽  
Treatment Groups ◽  
Rhinovirus Infection ◽  
Middle Ear Pressure ◽  
Significant Difference

The topical anticholinergic ipratropium bromide and topical decongestant oxymetazoline were tested to determine whether oxymetazoline alone and the combination were well tolerated and reduced rhinorrhea and middle ear pressure abnormalities during experimental rhinovirus infection. The study was double-blind, placebo-controlled, and double dummy in design. Healthy volunteers (n = 109) with low serum neutralizing antibody titer (≤1:2) were. Treatments inoculated with rhinovirus (type 39 or Hank's strain) and randomized to treatment with ipra-tropium bromide 0.06% two sprays per nostril (84 μg per treatment) and oxymetazoline 0.05% two sprays per nostril, oxymetazoline alone, or placebo. Treatments were self administered twice daily for 5 days beginning 1 day after rhinovirus inoculation. The overall infection rate was 83% and of those infected, 88% felt that they had a cold. During the 3-hour period after dosing, the increase in nasal discharge was significantly lower in the combined ipratropium and oxymetazoline (0.13 ± 0.17 gm/3 hr, mean ± SE) than after oxymetazoline alone (0.60 ± 0.18 gm/3 hr) or vehicle (0.73 ± 0.18 gm/3 hr). Over the 5-day observation period, total daily nasal discharge also tended to be lower in the ipratropium plus oxymetazoline group (3.67 ± 0.70 gm/24 hr, mean ± SE) compared to oxymetazoline (5.61 ± 0.73; 35% reduction) or the vehicle (5.04 ± 0.73; 27% reduction) recipients, but the differences were not statistically significant. Subjective assessments of rhinorrhea indicated that the severity of rhinorrhea was significantly better among patients receiving oxymetazoline alone or with ipratropium compared to the vehicle. No significant difference in the cumulative frequencies of middle ear pressure abnormalities (27–31%) were found among the treatment groups. Oxymetazoline does not consistently stimulate or decrease nasal mucus production, and ipratropium added to oxymetazoline is well tolerated and reduces rhinorrhea during experimental rhinovirus infection.

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