A randomized, double-blind study of alpidem vs placebo in the prevention and treatment of benzodiazepine withdrawal syndrome

SummaryThe aim of the trial was to assess alpidem efficacy in preventing and treating the benzodiazepine (BZ) withdrawal syndrome (WS). A multicentre, double-blind, randomized versus placebo, parallel group study of six-week duration was carried out in outpatients suffering from generalized anxiety or adjustment disorder with an anxious mood and taking non-hypnotic BZ as continuous course of therapy of at least one-year duration. At the entry, the patients abruptly discontinued BZs and were treated with 50 mg/bid/tid of alpidem or placebo. Withdrawal syndrome diagnosis was (regarding treatment allocation) formulated by an independent psychiatrist, according to DSM-III-R and an appropriate scale, the SESSB. One hundred seventy-three patients were randomized and 148 completed the study. Withdrawal syndrome occurred in 27 patients of the alpidem group (31.0%) and in 38 patients of the placebo group (44.2%). A severe WS was diagnosed in 11.1% of the patients in the alpidem group and in 31.6% of the placebo group. If not having been withdrawn from the market, alpidem could have been useful for the prevention of BZ withdrawal syndrome.

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Amphetamine Withdrawal: II. A Placebo-Controlled, Randomised, Double-Blind Study of Amineptine Treatment

Australian & New Zealand Journal of Psychiatry ◽

10.1046/j.1440-1614.1999.00518.x ◽

1999 ◽

Vol 33 (1) ◽

pp. 94-98 ◽

Cited By ~ 24

Author(s):

Manit Srisurapanont ◽

Ngamwong Jarusuraisin ◽

Jaroon Jittiwutikan

Keyword(s):

Placebo Group ◽

Therapeutic Effects ◽

Double Blind Study ◽

Double Blind ◽

Intention To Treat ◽

Parallel Group ◽

Amphetamine Withdrawal ◽

The Mean ◽

Group 2 ◽

Treat Analysis

Objective: The aim of this study was to examine the benefits of amineptine, a dopamine agonist antidepressant, in treating amphetamine withdrawal. Method: Inpatients with amphetamine withdrawal were recruited to participate in this placebo-controlled, randomised, double-blind, parallel group, 2-week comparison of amineptine and placebo treatments. The treatment effects were evaluated by means of the self-administered Amphetamine Withdrawal Questionnaire (AWQ) and the interviewer-administered Clinical Global Impression (CGI) scale. An intention-to-treat analysis was applied to evaluate the therapeutic effects at the end of week 1 and week 2. Results: Twenty-two patients took part in each treatment group. The week-1 and week-2 intention-to-treat analyses showed that the mean AWQ reversed vegetative scores (combined scores of decreased energy, increased appetite and craving for sleep items) of the amineptine group were significantly lower than those of the placebo group. The general condition of the amineptine group assessed by CGI also significantly improved at the end of week 2. Although the discontinuation rate due to dissatisfaction with treatment of amineptine group (1/21) was much lower than that of placebo group (6/22), those rates were not significantly different (p = 0.09). Conclusions: Amineptine is specifically effective for treating a major component of amphetamine withdrawal: a reversed vegetative syndrome. Although more than 2 weeks of amineptine treatment may contribute further benefits, both risks and benefits should be taken into account in doing so.

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The Effect of Warfarin Sodium on the Duration of Platelet Aggregation

Thrombosis and Haemostasis ◽

10.1055/s-0038-1655087 ◽

1967 ◽

Vol 18 (03/04) ◽

pp. 766-778 ◽

Cited By ~ 2

Author(s):

H. J Knieriem ◽

A. B Chandler

Keyword(s):

Platelet Count ◽

Placebo Group ◽

Platelet Aggregation ◽

Prothrombin Time ◽

Platelet Rich Plasma ◽

Healthy Adults ◽

Double Blind Study ◽

Double Blind ◽

Warfarin Sodium

SummaryThe effect of the administration of warfarin sodium (Coumadin®) on the duration of platelet aggregation in vitro was studied. Coumadin was given for 4 consecutive days to 10 healthy adults who were followed over a period of 9 days. The duration of adenosine diphosphate-induced platelet aggregation in platelet-rich plasma, the prothrombin time, and the platelet count of platelet-rich plasma were measured. Four other healthy adults received placebos and participated in a double-blind study with those receiving Coumadin.Although administration of Coumadin caused a prolongation of the prothrombin time to 2 or 21/2 times the normal value, a decrease in the duration of platelet aggregation was not observed. In most individuals who received Coumadin an increase in the duration of platelet aggregation occurred. The effect of Coumadin on platelet aggregation was not consistently related to the prothrombin time or to the platelet count. In the placebo group there was a distinct relation between the duration of platelet aggregation and the platelet count in platelet-rich plasma.The mean increase in the duration of platelet aggregation when compared to the control value before medication with Coumadin was 37.7%. In the placebo group there was a mean increase of 8.4%. The difference between the two groups is significant (p <0.001). Increased duration of platelet aggregation also occurred in two individuals who received Coumadin over a period of 10 and 16 days respectively.

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A One Year Double Blind Study Of The Effect Of Halofenate And Clofibrate In Patients With Hyperlipoproteinemia

Acta Clinica Belgica ◽

10.1080/17843286.1975.11717029 ◽

1975 ◽

Vol 30 (5) ◽

pp. 398-408 ◽

Cited By ~ 4

Author(s):

R. Rottiers ◽

J. van Egmond

Keyword(s):

Blind Study ◽

Double Blind Study ◽

Double Blind ◽

One Year

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The long-term effects of homeopathic treatment of chronic headaches: one year follow-up and single case time series analysis

British Homeopathic Journal ◽

10.1054/homp.1999.0473 ◽

2001 ◽

Vol 90 (02) ◽

pp. 63-72 ◽

Cited By ~ 17

Author(s):

H Walach ◽

T Lowes ◽

D Mussbach ◽

U Schamell ◽

W Springer ◽

...

Keyword(s):

Time Series ◽

Single Case ◽

Double Blind Study ◽

Long Term Effects ◽

Double Blind ◽

Homeopathic Treatment ◽

Chronic Headaches ◽

One Year

AbstractLittle is known about long-term effects of homeopathic treatment. Following a double-blind, placebo controlled trial of classical homeopathy in chronic headaches, we conducted a 1-year observational study of 18 patients following the double-blind phase, and a complete follow-up study of all trial participants. Eighteen patients received free treatment for daily diary data (frequency, intensity, duration of headaches) over the course of 1 y. All patients enrolled in the double-blind study were sent a 6-week headache diary, a follow-up questionnaire, a personality inventory and a complaint list. Eighty-seven, of the original 98 patients enrolled returned questionnaires, 81 returned diaries. There was no additional change from the end of the trial to the one-year follow-up. The improvement seen at the end of the 12-week trial was stable after 1 y. No differential effects according to treatment after the trial could be seen. Patients with no treatment following the trial had the most improvement after 1 y. Five of 18 patients can be counted responders according to ARIMA analysis of single-case time-series. Patients with double diagnoses and longer treatment duration tended to have clearer improvements than the rest of the patients. Approximately 30% of patients in homeopathic treatment will benefit after 1 y of treatment. There is no indication of a specific, or of a delayed effect of homeopathy.

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Long-term efficacy and safety of agomelatine in non-depressed out-patients with generalized anxiety disorder. A 26-week randomised double-blind placebo-controlled parallel group study following an open-label period of 16 weeks with agomelatine (25 mg/day with the possibility for blinded dose-adjustment to 50 mg/day)

http://isrctn.org/> ◽

10.1186/isrctn38094599 ◽

2012 ◽

Author(s):

Istvan Bitter

Keyword(s):

Anxiety Disorder ◽

Generalized Anxiety Disorder ◽

Dose Adjustment ◽

Generalized Anxiety ◽

Efficacy And Safety ◽

Open Label ◽

Double Blind ◽

Double Blind Placebo ◽

Parallel Group

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Efficacy of Calcipotriol 0.005% Ointment for Uremic Xerosis with Pruritus in Chronic Kidney Diseases Undergoing Hemodialysis Patients: Randomized Double Blind Clinical Trial

BioScientia Medicina ◽

10.32539/bsm.v5i6.319 ◽

2021 ◽

Vol 5 (6) ◽

pp. 531-539

Author(s):

Widyastuti ◽

Yulia Farida Yahya ◽

Suroso Adi Nugroho ◽

Soenarto Kartowigno ◽

M. Izazi Hari Purwoko ◽

...

Keyword(s):

Adverse Effect ◽

Placebo Group ◽

Visual Analog Scale ◽

Kidney Diseases ◽

Double Blind Study ◽

Surface Lipid ◽

Dry Skin ◽

Analog Scale ◽

Double Blind ◽

Skin Score

Introduction: Uremic xerosis with pruritus (UXP) is a chronic cutaneous complication among patients undergoing maintenance renal dialysis. Uremic xerosis level is directly related with pruritus severity or vice versa. Uremic xerosis with pruritus may lead to discomfort and negative psychological effect. The ethiopathogenesis still unknown, Most of treatments are empirical, and there is no effective and safe therapy. Emollient has not been effective enough to improve quality of life. There is some report about efficacy of topical vitamin D in xerosis and chronic pruritus. Objective: We evaluate the efficacy of calcipotriol 0.005% ointment for uremic xerosis and uremic pruritus in chronic kidney disease patients undergoing hemodialysis. Material & methode: Sixty two patients with UXP were enrolled, randomized double blind study. Patients were divided to two group, calcipotriol 0.005% ointment group or placebo. In baseline, patients were instructed to apply twice daily for four weeks. We assesesment the efficacy and safety of calcipotriol 0.005% ointment and placebo after 2nd and 4th weeks treatment using overall dry skin score (ODSS), visual analog scale (VAS), corneometer and sebumeter. We also assessed adverse effect and tolerance this drugs using visual assessment scale. Results: Overall dry skin score (ODSS) and visual analog scale (VAS) significantly decreased in calcipotriol 0.005% ointment group than in placebo group (p <0.05). Skin hydration level based on Corneometer score and skin surface lipid based on Sebumeter score was significantly increased in calcipotriol 0.005% ointment group than in placebo group (p <0.05). Cure rate and clinical improvement for calcipotriol 0.005% ointment group was significantly higher than placebo group. There was no adverse effect between two groups after treatment. Conclusion: calcipotriol 0.005% ointment is effective than placebo and can be used as alternative or adjuctive treatment and safe and tolerance for UXP.

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Double-blind study of cyamemazine and diazepam in the alcohol withdrawal syndrome

Human Psychopharmacology Clinical and Experimental ◽

10.1002/hup.718 ◽

2005 ◽

Vol 20 (7) ◽

pp. 511-519 ◽

Cited By ~ 10

Author(s):

Jean-Daniel Favre ◽

Hervé Allain ◽

Henri-Jean Aubin ◽

Elisabeth Frija-Orvoen ◽

Claudine Gillet ◽

...

Keyword(s):

Alcohol Withdrawal ◽

Withdrawal Syndrome ◽

Alcohol Withdrawal Syndrome ◽

Blind Study ◽

Double Blind Study ◽

Double Blind

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A Parallel-Group Comparison of Astemizole and Loratadine for the Treatment of Perennial Allergic Rhinitis

Journal of International Medical Research ◽

10.1177/030006059702500401 ◽

1997 ◽

Vol 25 (4) ◽

pp. 175-181 ◽

Cited By ~ 66

Author(s):

H Al-Muhaimeed

Keyword(s):

Allergic Rhinitis ◽

Statistical Significance ◽

Double Blind Study ◽

Perennial Allergic Rhinitis ◽

Double Blind ◽

Once Daily ◽

Runny Nose ◽

Parallel Group ◽

The Mean ◽

To Receive

The efficacy and safety of the two antihistamines, astemizole and loratadine, were compared in a double-blind study of 84 patients with perennial allergic rhinitis. Patients were randomized to receive orally either astemizole 10 mg once daily ( n = 40) or loratadine 10 mg once daily ( n = 44) for 1 week. No other antirhinitis medication was allowed during the study. By day 7 the mean daily symptom scores, recorded on diary cards, were lower in patients receiving astemizole than in those receiving loratadine for runny nose, itchy nose and sneezing, although not for blocked nose, and treatment differences only reached statistical significance for runny nose. After 7 days, 53.75% of patients on astemizole and 38.6% on loratadine were free of symptoms, and 87% of patients on astemizole described the treatment as good or excellent compared with 62% on loratadine. The present results suggest that astemizole may be more effective than loratadine in controlling symptoms of perennial allergic rhinitis.

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Extraoral Photobiomodulation for Prevention of Oral and Oropharyngeal Mucositis in Head and Neck Cancer Patients: Interim Analysis of A Randomized, Double-Blind, Clinical Trial

10.21203/rs.3.rs-693435/v1 ◽

2021 ◽

Author(s):

Elisa Kauark-Fontes ◽

Cesar Augusto Migliorati ◽

Joel B Epstein ◽

Nathaniel Simon Treister ◽

Carolina Guimarães Bonfim Alves ◽

...

Keyword(s):

Placebo Group ◽

Double Blind ◽

Oncological Outcomes ◽

Double Blind Clinical Trial ◽

First Occurrence ◽

Anti Inflammatory ◽

One Year ◽

Oropharyngeal Mucositis

Abstract PurposeTo assess the safety and efficacy of prophylactic extraoral photobiomodulation (PBM) for the prevention of oral and oropharyngeal mucositis (OM) on clinical outcomes and survival in patients with oral cavity and oropharyngeal squamous cell carcinoma (OOPSCC).MethodsOOPSCC patients who received radiotherapy (RT) were prospectively randomized to two groups: prophylactic extraoral PBM and placebo. OM grade (NCI), pain (VAS), analgesia, and anti-inflammatory prescriptions were assessed weekly. Quality of life questionnaires (QoL) were performed at the first and last day of RT. Following RT, participants were evaluated quarterly for oncological outcomes follow-up.Results55 patients met the inclusion criteria. The first occurrence of OM was observed at week 1, for the placebo group (p = 0.014). Later OM onset and severity was observed for the PBM group, with first occurrence at week 2 (p = 0.009). No difference in severe OM incidence was observed (p > 0.05). Lower mean pain score was noted at week 7 for the PBM group (2.1) compared to placebo group (4.5) (p = 0.009). Less analgesics (week 3; p = 0.009/week 7; p = 0.02) and anti-inflammatory prescription (week 5; p = 0.0346) were observed for the PBM group. Better QoL scores were observed for the PBM group at last day of RT (p = 0.0034). No difference in overall survival among groups, was observed in one year of follow-up (p = 0.889).ConclusionProphylactic extraoral PBM can delay OM onset, reduce pain, as well as reduced analgesic and anti-inflammatory prescription requirements. Extraoral PBM was associated with better QoL. There was no evidence of PBM impact on oncological outcomes. TRN:RBR-4w4swx (date of registration: 01/20/2020)

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