A Double-Blind Placebo-Controlled Study of Buspirone in Diazepam Withdrawal in Chronic Benzodiazepine Users

1990 ◽  
Vol 157 (2) ◽  
pp. 232-238 ◽  
Author(s):  
C. H. Ashton ◽  
M. D. Rawlins ◽  
S. P. Tyrer
Keyword(s):  
Controlled Trial ◽  
Dropout Rate ◽  
Withdrawal Symptoms ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Diazepam Withdrawal ◽  
Benzodiazepine Withdrawal

A double-blind placebo-controlled trial of 23 chronic benzodiazepine users showed that overall, buspirone did not appear to be helpful in alleviating benzodiazepine withdrawal symptoms. Buspirone (5 mg t.d.s.) or placebo was administered for four weeks before, during and after diazepam withdrawal. Patients taking buspirone had a markedly higher dropout rate (seven out of 11) than those taking placebo (one out of 12). Mean daily diazepam dosage at entry was significantly higher in the buspirone group, but overall initial diazepam dosage was not related to outcome. Higher subjectively rated anxiety at the start of withdrawal was significantly related to higher dropout rate, irrespective of treatment, and was greater (although not significantly so) in the buspirone group.

scholarly journals Faecal microbiota transplantation alters gut microbiota in patients with irritable bowel syndrome: results from a randomised, double-blind placebo-controlled study

Gut ◽  
2018 ◽  
Vol 67 (12) ◽  
pp. 2107-2115 ◽  
Author(s):  
Sofie Ingdam Halkjær ◽  
Alice Højer Christensen ◽  
Bobby Zhao Sheng Lo ◽  
Patrick Denis Browne ◽  
Stig Günther ◽  
...  
Keyword(s):  
Gut Microbiota ◽  
Controlled Trial ◽  
Symptom Relief ◽  
Controlled Study ◽  
Faecal Microbiota ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Faecal Microbiota Transplantation ◽  
Faecal Samples ◽  
Significant Difference

ObjectiveIBS is associated with an intestinal dysbiosis and faecal microbiota transplantation (FMT) has been hypothesised to have a positive effect in patients with IBS. We performed a randomised, double-blind placebo-controlled trial to investigate if FMT resulted in an altered gut microbiota and improvement in clinical outcome in patients with IBS.DesignWe performed this study in 52 adult patients with moderate-to-severe IBS. At the screening visit, clinical history and symptoms were assessed and faecal samples were collected. Patients were randomised to FMT or placebo capsules for 12 days and followed for 6 months. Study visits were performed at baseline, 1, 3 and 6 months, where patients were asked to register their symptoms using the IBS-severity scoring system (IBS-SSS) and IBS-specific quality of life (IBS-QoL). Prior to each visit, faecal samples were collected.ResultsA significant difference in improvement in IBS-SSS score was observed 3 months after treatment (p=0.012) favouring placebo. This was similar for IBS-QoL data after 3 months (p=0.003) favouring placebo. Patients receiving FMT capsules had an increase in faecal microbial biodiversity while placebos did not.ConclusionIn this randomised double-blinded placebo-controlled study, we found that FMT changed gut microbiota in patients with IBS. But patients in the placebo group experienced greater symptom relief compared with the FMT group after 3 months. Altering the gut microbiota is not enough to obtain clinical improvement in IBS. However, different study designs and larger studies are required to examine the role of FMT in IBS.Trial registration numberNCT02788071.

scholarly journals Oral Intake of Hydrangea serrata (Thunb.) Ser. Leaves Extract Improves Wrinkles, Hydration, Elasticity, Texture, and Roughness in Human Skin: A Randomized, Double-Blind, Placebo-Controlled Study

Nutrients ◽  
2020 ◽  
Vol 12 (6) ◽  
pp. 1588
Author(s):  
Da-Bin Myung ◽  
Jeong-Hun Lee ◽  
Hee-Soo Han ◽  
Kwang-Young Lee ◽  
Hye Shin Ahn ◽  
...  
Keyword(s):  
Human Skin ◽  
Elastic Recovery ◽  
Controlled Trial ◽  
Water Extract ◽  
Hot Water ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Skin Wrinkles

Previously, we reported that the hot water extract of Hydrangea serrata leaves (WHS) and its active component, hydrangenol, possess in vitro and in vivo effects on skin wrinkles and moisturization. We conducted a randomized, double-blind, placebo-controlled trial to clinically evaluate the effect of WHS on human skin. Participants (n = 151) were randomly assigned to receive either WHS 300 mg, WHS 600 mg, or placebo, once daily for 12 weeks. Skin wrinkle, hydration, elasticity, texture, and roughness parameters were assessed at baseline and after 4, 8, and 12 weeks. Compared to the placebo, skin wrinkles were significantly reduced in both WHS groups after 8 and 12 weeks. In both WHS groups, five parameters (R1–R5) of skin wrinkles significantly improved and skin hydration was significantly enhanced when compared to the placebo group after 12 weeks. Compared with the placebo, three parameters of skin elasticity, including overall elasticity (R2), net elasticity (R5), and ratio of elastic recovery to total deformation (R7), improved after 12 weeks of oral WHS (600 mg) administration. Changes in skin texture and roughness were significantly reduced in both WHS groups. No WHS-related adverse reactions were reported. Hence, WHS could be used as a health supplement for skin anti-aging.

Studies of Carbamazepine Extended-Release Capsules in Bipolar Disorder

CNS Spectrums ◽  
2005 ◽  
Vol 10 (6) ◽  
pp. 3-5
Author(s):  
Richard H. Weisler
Keyword(s):  
Extended Release ◽  
Rating Scale ◽  
Controlled Trial ◽  
Controlled Study ◽  
Mixed States ◽  
Open Label ◽  
Young Mania ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Bipolar Patients

This discussion reviews data from two 3-week, double-blind, placebo-controlled pivotal trials of carbamazepine extended release capsules (CBZ ERC; SPD417.301 and SPD417.304); pooled results from these trials; data from a 3-week, double-blind, placebo-controlled trial in lithium non-responders or non-tolerators (SPD417.302); and additional supportive data from a 6-month, open-label, extension trial (SPD417.303). In addition, information on a retrospective chart review of 600 adolescent and adult bipolar patients on CBZ ERC is presented.In the first large double-blind, placebo-controlled study assessing CBZ ERC in acute mania, manic and mixed bipolar patients from multiple centers were hospitalized and all medications were discontinued. After reaching a stable baseline 2–5 days later, the patients were randomized to CBZ ERC (n=101; 59% with mixed states) or placebo (n=103; 47% with mixed states) for 3 weeks. An aggressive initial titration schedule was implemented, beginning with 200 mg BID and increased by 200 mg/day until good clinical response was achieved or the patient could not tolerate the dosage. Many patients were taking 1,200–1,600 mg/day by the end of week 1. Efficacy was assessed using the Young Mania Rating Scale (YMRS). The Clinical Global Impressions (CGI) scale and the Hamilton Rating Scale for Depression (HAM-D) were also followed.

scholarly journals Effect of Melatonin on Cognitive Function and Sleep in relation to Breast Cancer Surgery: A Randomized, Double-Blind, Placebo-Controlled Trial

2014 ◽  
Vol 2014 ◽  
pp. 1-9 ◽  
Author(s):  
Melissa Voigt Hansen ◽  
Michael Tvilling Madsen ◽  
Lærke Toftegård Andersen ◽  
Ida Hageman ◽  
Lars Simon Rasmussen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Placebo Group ◽  
Cognitive Function ◽  
Cognitive Dysfunction ◽  
Controlled Trial ◽  
Dropout Rate ◽  
Sleep Efficiency ◽  
Mean Difference ◽  
Double Blind ◽  
Double Blind Placebo

Background.Sleep disturbances and cognitive dysfunction are common in patients with breast cancer. Disturbed sleep leads to poor cognitive performance and exogenous melatonin may improve sleep and attenuate cognitive dysfunction. We hypothesized that melatonin would improve sleep and cognitive function after surgery.Methods.This study reports secondary endpoints from a randomized, double-blind, placebo-controlled trial. Women, 30–75 years, were randomized to 6mg oral melatonin/placebo for 3 months. We assessed postoperative cognitive dysfunction (POCD) with a neuropsychological test battery, sleep with a diary, and sleep quality with VAS.Results. 54 patients were randomized to melatonin (n=28) or placebo (n=26); 11 withdrew (10 placebo, 1 melatonin,P=0.002). The incidence of POCD was 0% (0/20) [95% CI 0.0%; 16.8%] in the placebo group and 0% (0/26) [95% CI 0.0%; 13.2%] in the melatonin group 2 weeks postoperatively (P=1.00) and 6.3% (1/16) [95% CI 0.0%; 30.2%] in the placebo group and 0% (0/26) [95% CI 0.0%; 13.2%] in the melatonin group 12 weeks postoperatively (P=0.38). Sleep efficiency was significantly greater in the melatonin group; mean difference was 4.28% [95% CI 0.57; 7.82] (P=0.02). The total sleep period was significantly longer in the melatonin group; mean difference was 37.0 min [95% CI 3.6; 69.7] (P=0.03).Conclusion.Melatonin increased sleep efficiency and total sleep time but did not affect cognitive function. The dropout rate was significantly lower in the melatonin group. This trial is registered with Clinicaltrials.govNCT01355523.

Studies of Carbamazepine Extended-Release Capsules in Bipolar Disorder

CNS Spectrums ◽  
2005 ◽  
Vol 10 (S1) ◽  
pp. 3-5
Author(s):  
Richard H. Weisler
Keyword(s):  
Extended Release ◽  
Rating Scale ◽  
Controlled Trial ◽  
Controlled Study ◽  
Mixed States ◽  
Open Label ◽  
Young Mania ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Bipolar Patients

This discussion reviews data from two 3-week, double-blind, placebo-controlled pivotal trials of carbamazepine extended release capsules (CBZ ERC; SPD417.301 and SPD417.304); pooled results from these trials; data from a 3-week, double-blind, placebo-controlled trial in lithium non-responders or non-tolerators (SPD417.302); and additional supportive data from a 6-month, open-label, extension trial (SPD417.303). In addition, information on a retrospective chart review of 600 adolescent and adult bipolar patients on CBZ ERC is presented.In the first large double-blind, placebo-controlled study assessing CBZ ERC in acute mania, manic and mixed bipolar patients from multiple centers were hospitalized and all medications were discontinued. After reaching a stable baseline 2–5 days later, the patients were randomized to CBZ ERC (n=101; 59% with mixed states) or placebo (n=103; 47% with mixed states) for 3 weeks. An aggressive initial titration schedule was implemented, beginning with 200 mg BID and increased by 200 mg/day until good clinical response was achieved or the patient could not tolerate the dosage. Many patients were taking 1,200–1,600 mg/day by the end of week 1. Efficacy was assessed using the Young Mania Rating Scale (YMRS). The Clinical Global Impressions (CGI) scale and the Hamilton Rating Scale for Depression (HAM-D) were also followed.

A Controlled Trial of Dothiepin and Placebo in Treating Benzodiazepine Withdrawal Symptoms

1996 ◽  
Vol 168 (4) ◽  
pp. 457-461 ◽  
Author(s):  
Peter Tyrer ◽  
Brian Ferguson ◽  
Cosmo Hallström ◽  
Marian Michie ◽  
Stephen Tyrer ◽  
...  
Keyword(s):  
Tricyclic Antidepressants ◽  
Drug Withdrawal ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Withdrawal Symptoms ◽  
Antidepressant Effect ◽  
Double Blind ◽  
Benzodiazepine Dependence ◽  
Benzodiazepine Withdrawal ◽  
To Receive

BackgroundThe possibility that treatment with tricyclic antidepressants, in the form of dothiepin, might attenuate benzodiazepine withdrawal symptoms was investigated in a double-blind trial.MethodEighty-seven non-depressed psychiatric out-patients with putative normal dose benzodiazepine dependence had their benzodiazepines reduced in stepwise amounts of 20% of the original dose for eight weeks. The patients were randomised to receive dothiepin (with dosage increasing to 150 mg/day) or placebo as an aid to withdrawal before benzodiazepine reduction and these drugs were taken for four further weeks before being stopped.ResultsFewer patients entered and completed the study than expected and a Type II error was possible in the results. Although there was some evidence of withdrawal symptoms being less marked in those patients allocated to dothiepin this was independent of any antidepressant effect as depression scores were lower in the placebo group in the early phase of withdrawal (P<0.01). Of those completing the study, greater satisfaction (P=0.03) was recorded by those who had received dothiepin; no other differences reached statistical significance.ConclusionsDothiepin (and by implication other tricyclic antidepressants) might have some value in reducing benzodiazepine withdrawal symptoms but does not aid drug withdrawal.

Acute Blocking of Naloxone-Precipitated Opiate Withdrawal Symptoms by Methohexitone

1990 ◽  
Vol 157 (5) ◽  
pp. 748-752 ◽  
Author(s):  
N. Loimer ◽  
R. Schmid ◽  
K. Lenz ◽  
O. Presslich ◽  
J. Grünberger
Keyword(s):  
Bolus Injection ◽  
Controlled Trial ◽  
Drop Out ◽  
Withdrawal Symptoms ◽  
Opiate Withdrawal ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Withdrawal Therapy ◽  
Drop Out Rates ◽  
Withdrawal Signs

In a double-blind placebo-controlled trial of 18 patients, methohexitone blocked objective signs of opiate withdrawal caused by a bolus injection of naloxone. Furthermore, in continuing the naloxone therapy for 48 hours, no withdrawal signs appeared. Levels of withdrawal distress returned to normal levels within six days. This approach can be regarded as an effective and well tolerated withdrawal therapy with low drop-out rates.

scholarly journals Efficacy and Safety of Yokukansan in Treatment-Resistant Schizophrenia: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial

2015 ◽  
Vol 2015 ◽  
pp. 1-11 ◽  
Author(s):  
Tsuyoshi Miyaoka ◽  
Motohide Furuya ◽  
Jun Horiguchi ◽  
Rei Wake ◽  
Sadayuki Hashioka ◽  
...  
Keyword(s):  
Placebo Group ◽  
Controlled Trial ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Treatment Resistant ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Intention To Treat ◽  
The Difference ◽  
The Individual

Objectives. We aimed at evaluating both the efficacy and safety of TJ-54 (Yokukansan) in patients with treatment-resistant schizophrenia. This randomized, multicenter, double-blind, placebo-controlled study was conducted.Methods. One hundred and twenty antipsychotic-treated inpatients were included. Patients were randomized to adjuvant treatment with TJ-54 or placebo. During a 4-week follow-up, psychopathology was assessed using the Positive and Negative Syndrome Scale (PANSS).Results. TJ-54 showed a tendency of being superior to placebo in reduction total, positive, and general PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant in both per-protocol set (PPS) and intention-to-treat (ITT). However, in PPS analysis, compared to the placebo group, the TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores for lack of spontaneity and flow of conversation (TJ-54:−0.23±0.08; placebo:−0.03±0.08,P<0.018), tension (TJ-54:−0.42±0.09; placebo:−0.18±0.09,P<0.045), and poor impulse control (TJ-54:−0.39±0.10; placebo:−0.07±0.10,P<0.037).Conclusions. The results of the present study indicate that TJ-54 showed a tendency of being superior to placebo in reduction PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant. However, compared to the placebo group, TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores.

scholarly journals Effects of Bushen-Jiangya granules on blood pressure and pharmacogenomic evaluation in low-to-medium risk hypertension: study protocol for a randomized double-blind controlled trial

2021 ◽  
Author(s):  
xiaochen Yang ◽  
Xingjiang Xiong ◽  
Yun Zhang ◽  
Yongmei Liu ◽  
Hongzheng Li ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Inflammatory Responses ◽  
Controlled Trial ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Medium Risk ◽  
Tcm Syndrome ◽  
And Control

Abstract IntroductionHypertension is one of the most important risk factors for cardiovascular disease, and its treatment and control rates are still low worldwide. The most effective strategy is that patients with hypertension should be diagnosed and treated early. Preliminary studies showed that the Bushen Jiangya granule (BSJY) may suppress ventricular hypertrophy and inflammatory responses, lower blood pressure and protect the target organs of hypertension. We designed a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of BSJY in patients with low-to-medium risk hypertension.Methods and analysisThis trial is a one-center, randomized, double-blind, placebo-controlled study. A total of 260 participants will be randomized in a 1:1 ratio to an experiment group (BSJY plus amlodipine) and a control group (placebo plus amlodipine). The trial cycle will last 8 weeks. The primary outcome is blood pressure, which is reduced to a threshold set out in Guiding Principles for Clinical Research of New Chinese Medicines. The secondary outcomes include the change in 24-h average systolic and diastolic blood pressure, heart rate variability, pharmacogenomic Evaluation, improvement in TCM Syndrome, serum pro-inflammatory/anti-inflammatory cytokines, etc. between the two groups. Safety in medication will also be evaluated. All the data will be recorded in electronic case report forms and analyzed by SPSS V.22.0.Ethics and dissemination This study has been approved by Research Ethics Committee of Guang’anmen Hospital,China Academy of Chinese Medical Sciences in Beijing, China (No. 2019-186-KY-01). The participants are volunteers, understand the process of this trial and sign an informed consent. The results of this study will be disseminated to the public through peer-reviewed journals and academic conferences. DiscussionWe hypothesize that patients with low-to-medium risk hypertension will benefit from BSJY. If successful, this study will provide evidence-based recommendations for clinicians.

Nasal Immunotherapy is Effective in the Treatment of Rhinitis Due to Mite Allergy. A Double Blind Placebo-Controlled Study with Rhinological Evaluations

2002 ◽  
Vol 15 (2) ◽  
pp. 141-147 ◽  
Author(s):  
D. Passàli ◽  
L. Bellussi ◽  
G.C. Passàli ◽  
F. M. Passàli
Keyword(s):  
Allergic Rhinitis ◽  
Mucociliary Clearance ◽  
Controlled Trial ◽  
Controlled Study ◽  
Perennial Allergic Rhinitis ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Nasal Provocation ◽  
Mite Allergy ◽  
Perennial Rhinitis

The aim of this paper is to evaluate the efficacy of intranasal hyposensitizing therapy in perennial rhinitis. 36 patients suffering from perennial allergic rhinitis (Dermatophagoides-sensitive) underwent a double blind placebo-controlled trial for a period of 8 months. The efficacy of nasal immunotherapy was evaluated by collecting symptoms score and evaluating objective rhinological parameters (nasal resistance, cross areas and volumes, mucociliary clearance times, specific nasal provocation threshold). A significant improvement (p0,01) of symptom score of active against placebo group was observed after treatment. Also objective nasal parameters (total nasal resistances, mucociliary clearance, C-notch area, and provocative threshold) significantly (p0,01) improved after treatment. Adverse local reactions were rare and did not interfere with the protocol. The results underline the efficacy and quickness of local nasal immunotherapy in the treatment of perennial allergic rhinitis documented by the improvement of subjective and objective parameters.

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