A Controlled Study of Trancopal in the Treatment of Sleep Disturbances Due to Anxiety

1978 ◽  
Vol 6 (2) ◽  
pp. 115-120 ◽  
Author(s):  
J M T Warnock
Keyword(s):  
Placebo Group ◽  
Side Effects ◽  
Sleep Disturbances ◽  
Controlled Study ◽  
Night Time ◽  
Double Blind ◽  
Matching Placebo ◽  
Daily Record ◽  
Single Night

Sixty-eight patients presenting with sleep disturbances due to mild neurotic anxiety were treated for two weeks with a single night-time dose of 400 mg Trancopal or matching placebo under double-blind conditions. Patients kept a daily record of the quality of their sleep and the observer carried out a weekly rating of anxiety using a modified Hamilton scale. By Day 7 patients receiving Trancopal had a significantly better rating for sleep and mean Hamilton scores for day-time anxiety than the placebo group. Side-effects were minimal. It was concluded that for patients with sleep disturbances due to neurotic anxiety Trancopal is a well tolerated and effective alternative to the hypnotics.

A Controlled Study of Trancopal in Sleep Disturbances Due to Rheumatic Disease

1978 ◽  
Vol 6 (2) ◽  
pp. 111-114 ◽  
Author(s):  
L Cohen
Keyword(s):  
Sleep Disturbances ◽  
The Elderly ◽  
Controlled Study ◽  
Double Blind Study ◽  
Quality Of Sleep ◽  
Double Blind ◽  
Acceptable Alternative ◽  
Daily Record ◽  
Rheumatic Patients

A placebo controlled, double-blind study was carried out in six centres in general practice to assess the effectiveness of Trancopal in treating sleep disturbances due to rheumatic disorders. Eighty-five patients received a usual dose of two tablets of Trancopal or matching placebo at night for two weeks. Patients were assessed weekly and kept a daily record of the quality of sleep. All ratings showed that patients slept significantly better on Trancopal than on placebo. Day-time rheumatic stiffness however was not significantly reduced. Six patients receiving Trancopal reported side-effects chiefly drowsiness (five patients) which was controlled by dose reduction. It was concluded that for rheumatic patients Trancopal offers an acceptable alternative to current hypnotics over which it may prove to have some advantages, particularly for the elderly.

Ondansetron Is Effective to Treat Spinal or Epidural Morphine-induced Pruritus 

1999 ◽  
Vol 90 (2) ◽  
pp. 432-436 ◽  
Author(s):  
Alain Borgeat ◽  
Hans-Ruedi Stirnemann
Keyword(s):  
Placebo Group ◽  
Side Effects ◽  
Visual Analog Scale ◽  
Case Reports ◽  
Controlled Study ◽  
Epidural Administration ◽  
Analog Scale ◽  
Double Blind ◽  
Hemoglobin Oxygen Saturation ◽  
Group A

Background Spinally and epidurally administered morphine is frequently associated with pruritus. Isolated case reports indicate that ondansetron may be effective in this context. This study aims to investigate the effectiveness of ondansetron to treat this side effect. Methods In a prospective, randomized, double-blind, placebo-controlled study, 100 patients with pruritus (> 4 on a visual analog scale, on which 0 represents no pruritus and 10 represents worst pruritus imaginable) after spinal or epidural administration of morphine, received either 8 mg ondansetron intravenously (ondansetron group) in 100 ml NaCl 0.9% or vehicle (placebo group). A decrease of more than 4 points on the visual analog scale 60 min after treatment was considered a success. Changes in levels of pain and sedation, hemodynamic values, and other side effects were checked regularly. The presence or absence of pruritus was assessed for the last time 24 h later. Results The two groups were similar for demographic characteristics, the route of administration of morphine, and severity of pruritus at the beginning of the study. The ondansetron group showed a success rate of 70% versus 30% for the placebo group (P > 0.05). Among the successfully treated patients, three (9%) in the ondansetron group and six (40%) in the placebo group reported the recurrence of pruritus (P < 0.05). Among the successfully treated patients, none complained of residual pruritus 24 h later. No changes in pain or sedation levels were noted. Hemodynamic values remained stable, hemoglobin oxygen saturation did not decrease, and no other side effects were observed. Conclusion The administration of 8 mg ondansetron intravenously is an effective treatment for spinally or epidurally administered morphine-induced pruritus. In this clinical condition the treatment is safe and well tolerated.

scholarly journals Effects of Piracetam as an Adjuvant Therapy on Attention-Deficit/Hyperactivity Disorder: A Randomized, Double-Blind, Placebo-Controlled Trial

2021 ◽  
Vol 15 (2) ◽  
Author(s):  
Kaveh Alavi ◽  
Elham Shirazi ◽  
Maryam Akbari ◽  
Zahra Shahrivar ◽  
Fatemeh-Sadat Noori ◽  
...  
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Placebo Group ◽  
Side Effects ◽  
Adjuvant Therapy ◽  
Attention Deficit ◽  
Controlled Study ◽  
Double Blind ◽  
Children With Adhd ◽  
Double Blind Placebo ◽  
Hyperactivity Disorder

Background: Stimulants are highly effective in controlling symptoms of Attention-deficit/hyperactivity disorder (ADHD), but 30% of individuals with ADHD do not respond to them or cannot tolerate their side effects; thus, alternative treatment approaches need to be considered. Objectives: To evaluate the effect and safety of piracetam as an adjuvant therapy plus methylphenidate (MPH) in children with ADHD. Methods: Thirty-six children with ADHD (6-16 years old), admitted to three academic outpatient child psychiatric clinics in the second half of 2015, were randomly assigned to the “methylphenidate plus piracetam group” and the “methylphenidate plus placebo” group, in a double-blind, placebo-controlled study, for 6 weeks. The “Conner’s Parents’ Rating Scale-Revised (CPRS-R), Children Symptom Inventory-4 (CSI-4), Clinical Global Impression-Improvement scale (CGI-I), and Children’ Global Assessment Scale (CGAS) were completed at baseline and at the ends of the third and the sixth week, and the New York State Psychiatric Institute side effect forms were completed weekly, as outcome measures. Results: The level of improvement in CPRS-R, CSI-4, and CGI-I scales were significantly higher in the “methylphenidate plus piracetam” group compared with the “methylphenidate plus placebo” group. Side effects were not remarkable in any group. Conclusions: Piracetam as a short-term adjuvant treatment to methylphenidate can have considerable therapeutic effect and safety profile in children with ADHD and deserves further exploration to assess its potentialities in ADHD treatment.

scholarly journals Double-Blind Cross-Over Placebo Controlled Study of Flunarizine in Patients With Therapy Resistant Epilepsy

1989 ◽  
Vol 16 (2) ◽  
pp. 187-190 ◽  
Author(s):  
E. Starreveld ◽  
F. de Beukelaar ◽  
A.F. Wilson ◽  
D.R. McLean ◽  
Helen P. Findlay
Keyword(s):  
Placebo Group ◽  
Depressive Symptoms ◽  
Side Effects ◽  
Seizure Frequency ◽  
Controlled Study ◽  
Double Blind ◽  
Adverse Side Effects ◽  
Generalized Seizures ◽  
Daily Dose ◽  
The Mean

ABSTRACT:Twenty-five patients with long-standing therapy resistant epilepsy were studied in an eight-month double- blind cross-over add-on trial with a daily dose of 15 mg flunarizine. In five patients the seizure frequency decreased 50% or more. The mean seizure frequency reduction in the patients on flunarizine was 35%. Particularly the control of secondary generalized seizures improved. Flunarizine did not significantly alter the plasma levels of the regular anticonvulsant drugs. Minimal adverse side effects were reported equally in the flunarizine and the placebo group. In three patients depressive symptoms improved and two patients became free of postictal headaches. Flunarizine appears to be a safe adjuvant anticonvulsant.

scholarly journals Efficacy of probiotics in irritable bowel syndrome: A randomized, double blind placebo-controlled study

2016 ◽  
Vol 6 (1) ◽  
pp. 21 ◽  
Author(s):  
Md. Zahidur Rahman ◽  
Mohammad Shoaib Chowdhury ◽  
Mohammad Asadur Rahman ◽  
Shohely Parveen ◽  
Rajib Barua ◽  
...  
Keyword(s):  
Irritable Bowel Syndrome ◽  
Placebo Group ◽  
Intestinal Microbiota ◽  
Therapeutic Potential ◽  
Intestinal Barrier ◽  
Controlled Study ◽  
Double Blind ◽  
Before And After ◽  
Irritable Bowel

<p><strong>Background:</strong> Gut flora have important trophic effects on intestinal epithelia and on immune structure and fonction.They also protect colonized host against invasion by alien microbes.Recent research suggests that an imbalance of the intestinal microbiota and a dysfunctional intestinal barrier might trigger irritable bowel syndrome (lBS). As probiotics have been reported to restore the intestinal microbiota and the gut barrier, the therapeutic potential of probiotics within IBS became of strong interest. <strong></strong></p><p><strong>Objectives: </strong>To assess the efficacy of probiotics in lBS. <strong></strong></p><p><strong>Methods: </strong>Patients of 15 to 60 years old and both sexes were included f om the out patient department (OPD) of gastroenterology, Bangabandhu Sheikh Mujib Medi­cal University (BSMMU). A validated lBS-QOL instmment consisted of 34 questions used to assess improvement of quality of Iife before and after treatment. A total of 65 diarrhoea predominant LBS patients were randomised to receive either probiotics(n-33) or placebo(n-32) twice daily frir 6 weeks.</p><p><strong>Results:</strong> At the end of 6 weeks therapy, improvement in various symptoms(abclominal pain, stool frequency, consistency and 11atulence) in probiotics group was statistically significant. Mean QOL score before treatment was 103 in probiotics group and I 06 in placebo group. After 6 weeks of treatment mean QOL score was 82 in probiotics group and I 02.58 in placebo group. No side effects of the therapeutic agents were observed in any patient during the trial. <strong></strong></p><p><strong>Conclusions:</strong> Probiotics effectively alleviates global IBS and improves TBS symptoms simultaneously with an improvement of quality of life.</p>

Report on a Double-Blind Comparison of Two Different Regimens of Dothiepin (Prothiaden)

1983 ◽  
Vol 11 (1) ◽  
pp. 15-20 ◽  
Author(s):  
J Boening
Keyword(s):  
Side Effects ◽  
Therapeutic Effect ◽  
Rating Scale ◽  
Endogenous Depression ◽  
Clinical Impression ◽  
Night Time ◽  
Double Blind ◽  
Significant Difference ◽  
Single Night ◽  
Node Group

Thirty patients diagnosed as suffering from endogenous depression were entered into a 3-week double-blind trial comparing three times a day dosage of dothiepin with a single night-time dosage in a dosage range of 75 mg to 225 mg per day. The trial was conducted on in-patients and assessments were made pretrial and after 1 and 3 weeks. The patients were assessed by clinician-rated scales for psychomotor and psychic symptoms and by Zung's self-rating scale. Fifteen patients received dothiepin three times a day (day-time group) and fifteen received it as a single night-time dose (node group). There were two withdrawals in the day-time group and three in the node group. All withdrawals were due to lack of therapeutic effect. Over the 3-week trial 67% of the day-time group and 47% of the node group showed a clinical improvement. It was found that there was no statistically significant difference between the two methods of treatment. In the day-time group seven patients and in the night-time group nine patients suffered from side-effects. No particular pattern of side-effects emerged. There were no drug-related changes in the laboratory results. It was concluded that the therapeutic effect of both dosage regimes should be regarded as equivalent. Advantages, due to the specific action of dothiepin, compared with classical antidepressants for reference, could, however, not be presumed by the clinical impression.

scholarly journals Randomised, Double-Blind, Placebo-Controlled Study of Iguratimod in the Treatment of Active Spondyloarthritis

2021 ◽  
Vol 8 ◽  
Author(s):  
Yan Li ◽  
Kunpeng Li ◽  
Zheng Zhao ◽  
Yanyan Wang ◽  
Jingyu Jin ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Placebo Group ◽  
Physical Function ◽  
Combined Treatment ◽  
Final Analysis ◽  
Spinal Mobility ◽  
Controlled Study ◽  
Double Blind ◽  
Significant Difference

Background and Purpose: The effect of Iguratimod in the treatment of rheumatoid arthritis was confirmed in past studies. In terms of the mechanism of the effect and clinical application experience, Iguratimod has a potential value in the treatment of spondyloarthritis (SpA). This study evaluated the efficacy and safety of Iguratimod on active SpA.Methods: Subjects with active SpA were enrolled and randomly divided into two groups at a ratio of 1:2 (placebo vs. Iguratimod). On the basis of non-steroidal anti-inflammatory drugs, combined treatment with Iguratimod or placebo, followed by follow-up every 4 weeks for 24 weeks. The primary efficacy endpoint was to evaluate the alleviation rate of ASAS20; the important improvement of ASDAS and the efficacy of spinal mobility, physical function and quality of life at the 24th week.Results: A total of 48 cases in the Iguratimod group and 25 cases in the placebo group were included in the final analysis. On the 24th week, the percentage of responders to ASAS20 (80 vs. 44%) and ASAS40 (56 vs. 20%) treated with Iguratimod were significantly higher than that in the placebo group (P &lt; 0.05). Twelve cases had gastrointestinal discomfort, of which eight were in the Iguratimod group (16.7%, one case withdrew from the study due to diarrhoea) and four were in the placebo group (16.0%). No significant difference was found between the two groups (P &lt; 0.05). Three cases of elevated transaminase were observed in the Iguratimod group and none in the placebo group, with no significant difference (P &lt; 0.05).Conclusion: Iguratimod could significantly reduce the symptoms and signs of patients with active SpA. It could improve the physical function and quality of life of these patients and the overall safety and tolerance are good.

Quality of life assessment in patients with moderate to severe allergic rhinitis treated with montelukast and/or intranasal steroids: a randomised, double-blind, placebo-controlled study

2014 ◽  
Vol 128 (3) ◽  
pp. 242-248 ◽  
Author(s):  
B-S Goh ◽  
M I M Ismail ◽  
S Husain
Keyword(s):  
Quality Of Life ◽  
Allergic Rhinitis ◽  
Placebo Group ◽  
Fluticasone Propionate ◽  
Nasal Spray ◽  
Life Assessment ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo

AbstractObjective:This study investigated improvements in quality of life associated with eight weeks of montelukast and/or intranasal steroid treatment for moderate to severe allergic rhinitis.Methods:A single-centre, prospective, randomised, double-blind, placebo-controlled study was carried out. Assessments were made using the Rhinoconjunctivitis Quality of Life Questionnaire and symptom scales.Results:A total of 128 patients (aged 13–51 years) were randomly assigned to one of two groups. In the montelukast group, patients were treated with montelukast tablets and fluticasone propionate nasal spray (n = 64). In the placebo group, treatment comprised a placebo and fluticasone propionate. The results showed significant improvements in symptom scores and quality of life scores for both groups after one month and two months of treatment, compared with baseline values; these improvements were significantly greater for the montelukast group compared with the placebo group. The mean number of loratadine tablets taken by each patient during the study period was only 0.73 for the montelukast group compared with 9 for the placebo group.Conclusion:The combination of montelukast tablets and fluticasone propionate nasal spray improved symptom control and overall quality of life for moderate to severe allergic rhinitis patients.

Early switching from morphine to methadone plus acetaminophen in the analgesia of oncologic patientes: A randomized, double-blind, placebo-controlled study

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e20579-e20579
Author(s):  
D. I. Cubero ◽  
W. J. David Filho ◽  
A. del Giglio
Keyword(s):  
Side Effects ◽  
Sudden Change ◽  
Pain Scale ◽  
Controlled Study ◽  
Life Questionnaire ◽  
Double Blind ◽  
Methadone Dose ◽  
Oncologic Patients ◽  
To Receive

e20579 Background: The objective of this study is to evaluate the efficacy of methadone as substitute for morphine and to investigate if the addition of acetaminophen could reduce the time to attain an equianalgesic methadone dose and to improve the level of analgesia of oncologic patients. Methods: Fifty patients in regular use of morphine with a stable dose for at least 1 week were submitted to the sudden change of this opioid for methadone and randomized in a double blind way to receive acetaminophen (750 mg PO every 6 hours) or placebo for a 7-day period. Data regarding level of pain and side effects were collected and a quality of life questionnaire (QLQ-C30) was applied. Results: Substitution of morphine for methadone resulted in improvement of the toxicity profile with reduction in obstipation (p < 0.001) and xerostomia (p = 0.03). There was improvement in the Numeric Pain Scale (p = 0.03) as well as a significant improvement in the functional level and symptomatology according to the QLQ-C30 questionnaire. Addition of acetaminophen did not reflect improvement in analgesia and also reduction in time of stabilization of methadone doses. At the end of the study most patients (70.8%, p 0.001) preferred to continue with methadone instead of returning to morphine. Conclusions: Early switching from morphine to methadone showed to be safe and efficient in the reduction of side effects improvement of analgesia allowing a comfortable dosage at a lower cost. In this scenario the association with acetaminophen did not reflect improvement of analgesia or reduction in time for equianalgesia. No significant financial relationships to disclose.

A randomized, double-blind, placebo-controlled study of the safety and efficacy of olanzapine for the prevention of chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e21699-e21699
Author(s):  
So Yeon Jeon ◽  
Hye Sook Han ◽  
Woo Kyun Bae ◽  
Moo-Rim Park ◽  
Sang-Cheol Lee ◽  
...  
Keyword(s):  
Placebo Group ◽  
Complete Response ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Controlled Study ◽  
Moderately Emetogenic Chemotherapy ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Phase 0

e21699 Background: Olanzapine was found to be effective for preventing acute and delayed emesis in patients receiving highly emetogenic chemotherapy by randomized phase 3 study. However, there is limited data for the efficacy of olanzapine combined with palonosetron and dexamethasone in patients receiving moderately emetogenic chemotherapy (MEC). Methods: We conducted randomized, double-blind, placebo-controlled study to determine whether olanzapine could reduce the frequency of CINV and improve quality of life (QOL) in patients receiving palonosetron and dexamethasone for the prophylaxis of MEC induced nausea and vomiting. Two groups received either 10 mg of olanzapine orally or matching placebo daily on days 1 through 4. The primary end point was the complete response (no emesis and no use of rescue medication) for the acute phase (0-24 hours after chemotherapy). Secondary end points included the complete responses for the delayed (24-120 hours) and overall phase (0-120 hours), proportion of significant emesis (VAS ≥ 25 mm) for overall phase, use of rescue medications, and effect on QOL by Functional Living Index-Emesis (FLIE) questionnaire. Results: Fifty-six patients were randomized and fifty-four patients were evaluable (29 assigned to olanzapine, and 25 to placebo). The complete response rate was not significant between olanzapine and placebo group in the acute (96.5% vs. 88.0%, P = 0.326), delayed (69.0% vs. 48.0%, P = 0.118), and overall phase (69.0% vs. 48.0%, P = 0.118). However, the percentage of patients with significant emesis (17.2% vs. 44.0%, P = 0.032) and the use of rescue medications (0.03±0.19 vs. 1.88±2.88, P = 0.002) were significantly lower with olanzapine than with placebo in the overall phase. Furthermore, olanzapine group experienced a better QOL than the placebo group, as reported on the FLIE questionnaire (P = 0.015). Conclusions: Olanzapine in addition to palonosetron and dexamethasone significantly improved the management of emesis and QOL among previously untreated patients receiving MEC, although the efficacy was limited to reduce the frequency of CINV. Clinical trial information: NCT02400866.

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