Olanzapine versus placebo for out-patients with anorexia nervosa

BackgroundAnorexia nervosa (AN) is a serious psychiatric illness associated with significant morbidity and mortality. There is little empirical support for specific treatments and new approaches are sorely needed. This two-site study aimed to determine whether olanzapine is superior to placebo in increasing body mass index (BMI) and improving psychological symptoms in out-patients with AN.MethodA total of 23 individuals with AN were randomly assigned in double-blind fashion to receive olanzapine or placebo for 8 weeks together with medication management sessions that emphasized compliance. Weight, other physical assessments and measures of psychopathology were collected.ResultsEnd-of-treatment BMI, with initial BMI as a covariate, was significantly greater in the group receiving olanzapine [F(1, 20)=6.64, p=0.018]. Psychological symptoms improved in both groups, but there were no statistically significant group differences. Of the 23 participants, 17 (74%) completed the 8-week trial. Participants tolerated the medication well with sedation being the only frequent side effect and no adverse metabolic effects were noted.ConclusionsThis small study suggests that olanzapine is generally well tolerated by, and may provide more benefit than placebo for out-patients with AN. Further study is indicated to determine whether olanzapine may affect psychological symptoms in addition to BMI.

Download Full-text

The efficacy, safety, and tolerability of levofloxacin quadruple therapy for helicobacter pylori eradication: a randomized, double-blind clinical trial

10.21203/rs.3.rs-53307/v1 ◽

2020 ◽

Author(s):

Fariborz Mansour-Ghanaei ◽

Behnam Masihypour ◽

Mohammad Fathalipour ◽

Soheil Hassanipour ◽

Homayoon Sokhanvar ◽

...

Keyword(s):

Clinical Trial ◽

Helicobacter Pylori ◽

Alternative Therapy ◽

Double Blind ◽

Intention To Treat ◽

Bismuth Subcitrate ◽

Double Blind Clinical Trial ◽

End Of Treatment ◽

H Pylori ◽

To Receive

Abstract BackgroundThe incidence of microbial resistance is increasing, and new rescue regimens are needed in order to treat Helicobacter pylori (H. pylori) infection. To evaluate the efficacy, safety, and tolerability of levofloxacin based quadruple therapies in the eradication of H. pylori.MethodsIn a randomized, double-blind clinical trial, 220 patients with dyspepsia and H. pylori infection were randomly assigned to receive either bismuth subcitrate 240 mg, pantoprazole 20 mg, amoxicillin 1000 mg twice a day, and levofloxacin 500 mg daily for seven days (BPAL-7), or ten days (BPAL-10). The eradication of H. pylori was evaluated two months after the end of treatment, and adverse drug reactions (ADRs) were assessed during the intervention.ResultsAccording to intention-to-treat and per-protocol, the eradication rate was significantly lower in the BPAL-7 regimen 49.1% (95% CI: 39.3–57.8) and 47.6% (95% CI: 39.7–58.4), respectively compared to the BPAL- 10 regimen 62.7% (95% CI: 53.6–72.8) and 62.4% (95% CI: 55.1–72.8), respectively. The incidence of ADRs was not statistically significant between BPAL-7 (33.6%) and BPAL-10 (36.7%) groups.ConclusionAlthough the ADRs were negligible in both groups, these regimens could not be an ideal alternative therapy for H. pylori because of low eradication rates compared to standard regimens.Trial registration: The study reviewed and approved by the Iranian Registry of Clinical Trials (IRCT201406141155N19). This trial was retrospectively registered on July 10, 2015.

Download Full-text

The Efficacy, Safety, And Tolerability of Levofloxacin Quadruple Therapy For Helicobacter Pylori Eradication: A Randomized, Double-Blind Clinical Trial

10.21203/rs.3.rs-53307/v2 ◽

2021 ◽

Author(s):

Fariborz Mansour-Ghanaei ◽

Behnam Masihypour ◽

Mohammad Fathalipour ◽

Soheil Hassanipour ◽

Homayoon Sokhanvar ◽

...

Keyword(s):

Clinical Trial ◽

Helicobacter Pylori ◽

Alternative Therapy ◽

Double Blind ◽

Intention To Treat ◽

Bismuth Subcitrate ◽

Double Blind Clinical Trial ◽

End Of Treatment ◽

H Pylori ◽

To Receive

Abstract The incidence of microbial resistance is increasing, and new rescue regimens are needed in order to treat Helicobacter pylori (H. pylori) infection. To evaluate the efficacy, safety, and tolerability of levofloxacin based quadruple therapies in the eradication of H. pylori. In a randomized, double-blind clinical trial, 220 patients with dyspepsia and H. pylori infection were randomly assigned to receive either bismuth subcitrate 240 mg, pantoprazole 20 mg, amoxicillin 1000 mg twice a day, and levofloxacin 500 mg daily for seven days (BPAL-7), or ten days (BPAL-10). The eradication of H. pylori was evaluated two months after the end of treatment, and adverse drug reactions (ADRs) were assessed during the intervention. According to intention-to-treat and per-protocol, the eradication rate was significantly lower in the BPAL-7 regimen 49.1 % (95 % CI: 39.3-57.8) and 47.6 % (95 % CI: 39.7-58.4), respectively compared to the BPAL- 10 regimen 62.7 % (95 % CI: 53.6-72.8) and 62.4 % (95 % CI: 55.1-72.8), respectively. The incidence of ADRs was not statistically significant between BPAL-7 (33.6 %) and BPAL-10 (36.7 %) groups. Although the ADRs were negligible in both groups, these regimens could not be an ideal alternative therapy for H. pylori because of low eradication rates compared to standard regimens.Trial registration: The study reviewed and approved by the Iranian Registry of Clinical Trials (IRCT201406141155N19).

Download Full-text

The Effect of DHA Supplementation on Cognition in Patients with Bipolar Disorder: An Exploratory Randomized Control Trial

Nutrients ◽

10.3390/nu12030708 ◽

2020 ◽

Vol 12 (3) ◽

pp. 708

Author(s):

Valentina Ciappolino ◽

Giuseppe DelVecchio ◽

Cecilia Prunas ◽

Angela Andreella ◽

Livio Finos ◽

...

Keyword(s):

Bipolar Disorder ◽

Corn Oil ◽

Controlled Trial ◽

Group Differences ◽

Double Blind ◽

Significant Group ◽

Brief Assessment ◽

Wide Range ◽

Randomized Control ◽

The Impact

Bipolar disorder (BD) is a severe mental disorder with a wide range of cognitive deficits, both in the euthymic and acute phase of the disease. Interestingly, in recent years, there has been a growing interest in investigating the impact of ω-3 polyunsaturated fatty acids on cognition in BD. In this context, the aim of this study is to evaluate the effect of docosahexaenoic acid (C22:6 ω-3, DHA) supplementation on cognitive performances in euthymic BD patients. This is an exploratory, single-centre, double-blind randomized controlled trial evaluating 12 weeks DHA supplementation (1250 mg daily) vs. a placebo (corn oil) in 31 euthymic BD patients compared to 15 healthy controls (HCs) on cognitive functions, assessed by the Brief Assessment of Cognition in Affective Disorder (BAC-A). Plasma levels of DHA were measured. After 12 weeks of treatment, no significant group differences were observed in all neuropsychological tests between the four groups, except for the emotion inhibition test, where HCs with DHA had higher scores compared to either BD with DHA (z = 3.9, p = 0.003) or BD with placebo (t = 3.7, p = 0.005). Although our results showed that DHA could be effective for ameliorating cognition in healthy subjects, future studies are still needed to clarify the impact of DHA on cognition in BD.

Download Full-text

A randomised clinical trial to evaluate the acceptability and efficacy of an early phase, online, guided augmentation of outpatient care for adults with anorexia nervosa

Psychological Medicine ◽

10.1017/s0033291719002824 ◽

2019 ◽

Vol 50 (15) ◽

pp. 2610-2621 ◽

Cited By ~ 7

Author(s):

Valentina Cardi ◽

Gaia Albano ◽

Suman Ambwani ◽

Li Cao ◽

Ross D. Crosby ◽

...

Keyword(s):

Anorexia Nervosa ◽

Eating Disorder ◽

Social Adjustment ◽

Outpatient Service ◽

Group Differences ◽

Control Group ◽

Outpatient Services ◽

Motivation To Change ◽

Significant Group ◽

Treatment As Usual

AbstractBackgroundOutpatient interventions for adult anorexia nervosa typically have a modest impact on weight and eating disorder symptomatology. This study examined whether adding a brief online intervention focused on enhancing motivation to change and the development of a recovery identity (RecoveryMANTRA) would improve outcomes in adults with anorexia nervosa.MethodsParticipants with anorexia nervosa (n = 187) were recruited from 22 eating disorder outpatient services throughout the UK. They were randomised to receiving RecoveryMANTRA in addition to treatment as usual (TAU) (n = 99; experimental group) or TAU only (n = 88; control group). Outcomes were measured at end-of-intervention (6 weeks), 6 and 12 months.ResultsAdherence rates to RecoveryMANTRA were 83% for the online guidance sessions and 77% for the use of self-help materials (workbook and/or short video clips). Group differences in body mass index at 6 weeks (primary outcome) were not significant. Group differences in eating disorder symptoms, psychological wellbeing and work and social adjustment (at 6 weeks and at follow-up) were not significant, except for a trend-level greater reduction in anxiety at 6 weeks in the RecoveryMANTRA group (p = 0.06). However, the RecoveryMANTRA group had significantly higher levels of confidence in own ability to change (p = 0.02) and alliance with the therapist at the outpatient service (p = 0.005) compared to the control group at 6 weeks.ConclusionsAugmenting outpatient treatment for adult anorexia nervosa with a focus on recovery and motivation produced short-term reductions in anxiety and increased confidence to change and therapeutic alliance.

Download Full-text

Preoperative Anxiolysis and Postoperative Recovery in Women Undergoing Abdominal Hysterectomy

Anesthesiology ◽

10.1097/00000542-200103000-00009 ◽

2001 ◽

Vol 94 (3) ◽

pp. 415-422 ◽

Cited By ~ 31

Author(s):

Zeev N. Kain ◽

Ferne B. Sevarino ◽

Christine Rinder ◽

Sharon Pincus ◽

Gerianne M. Alexander ◽

...

Keyword(s):

Treatment Group ◽

Postoperative Pain ◽

Abdominal Hysterectomy ◽

Group Differences ◽

Mcgill Pain Questionnaire ◽

Patient Controlled Analgesia ◽

Significant Group ◽

Time Points ◽

Clinical Recovery ◽

To Receive

Background Every year, millions of patients receive sedatives for reduction of anxiety before surgery, but there is little objective data on the effect of this treatment on postoperative outcomes. To address this issue, the effects of benzodiazepine administration were evaluated in women undergoing abdominal surgery. Methods Patients were randomized to receive 1 mg of oral lorazepam the night before surgery and 5 mg of intramuscular midazolam on the morning of surgery (n = 34), or to receive a placebo the night before surgery and on the morning of surgery (n = 36). Postoperative pain (Visual Analogue Scale for pain, McGill Pain Questionnaire) and analgesic consumption (patient-controlled analgesia), and clinical recovery parameters such as time to discharge from hospital were evaluated after surgery. Results Patient-controlled analgesia use showed a marginal main effect of treatment group (F(1,51) = 2.8; P = 0.047). Post boc analysis demonstrated that patient-controlled analgesia consumption was significantly lower in the treatment group only during the first 4 h of patient-controlled analgesia use after surgery (P = 0.027). There were no significant group differences at any later postoperative time points (P = not significant). There were no group differences in the cumulative Percocet (Pfizer, New York, NY) consumption in the postoperative period (P = not significant). Further, self-reported postoperative pain did not differ significantly between groups at any of the time points (P = not significant). There were also no group differences with regard to any postoperative clinical recovery parameters. Conclusions Benzodiazepines administered before surgery have minimal beneficial effects on the postoperative clinical course of women undergoing abdominal hysterectomy.

Download Full-text

An Examination Of A Brief Intervention Targeting Causal Attributions For Daytime Fatigue

10.32920/ryerson.14655606 ◽

2021 ◽

Author(s):

Andrea L. Harris

Keyword(s):

Brief Intervention ◽

Causal Attributions ◽

Cognitive Change ◽

Mood States ◽

Group Differences ◽

Information Control ◽

Post Intervention ◽

Significant Group ◽

To Receive

Research has shown that poor sleepers focus primarily on their sleep as a cause of daytime fatigue rather than the multitude of other possible causes of fatigue. This can create sleep-related anxiety and further perpetuate the insomnia. In order to lessen the increased focus on sleep, the present study investigated whether people could learn to consider other attributions for fatigue via an information-based intervention, and whether this cognitive change would have implications for relevant mood states. Participants were randomized to receive either “causes of fatigue” information (FI), or generic sleep-information (control), and were tested pre- and post-intervention. FI participants were significantly more likely to consider non-sleep-related attributions for fatigue at post-intervention, relative to control participants. There were no significant group differences on relevant mood states. These results demonstrate that attributions or fatigue are amenable to change via an information-based intervention; thus, this research explores one avenue toward refining insomnia treatments.

Download Full-text

Vitamin and Mineral Supplementation in Down's Syndrome

PEDIATRICS ◽

10.1542/peds.72.5.707 ◽

1983 ◽

Vol 72 (5) ◽

pp. 707-713

Author(s):

Forrest C. Bennett ◽

Stephen McClelland ◽

Elinor A. Kriegsmann ◽

Lori Brazee Andrus ◽

Clifford J. Sells

Keyword(s):

School Achievement ◽

Down's Syndrome ◽

Down’S Syndrome ◽

Group Differences ◽

Double Blind ◽

Significant Group ◽

School Aged Children ◽

Public Media ◽

Mentally Retarded Children ◽

Vitamin And Mineral Supplementation

The claim that large, nonspecific doses of vitamins and minerals improve the performance of mentally retarded children has recently reappeared in both the scientific literature and the public media. This hypothesis was examined in a double-blind, case-control study involving 20 home-reared children with Down's syndrome between 5 and 13 years of age. Children were randomly assigned by matched pairs to either a vitamin/mineral group or placebo group for an 8-month study period. No significant group differences or suggestive trends were found in any tested area of development or behavior, including intelligence (IQ), school achievement, speech and language, and neuromotor function. No group differences in appearance, growth, or health were seen. No support was found for the orthomolecular hypothesis in school-aged children with Down's syndrome.

Download Full-text

MDMA-assisted psychotherapy for treatment of anxiety and other psychological distress related to life-threatening illnesses: a randomized pilot study

Scientific Reports ◽

10.1038/s41598-020-75706-1 ◽

2020 ◽

Vol 10 (1) ◽

Author(s):

Philip E. Wolfson ◽

Julane Andries ◽

Allison A. Feduccia ◽

Lisa Jerome ◽

Julie B. Wang ◽

...

Keyword(s):

Modern Medicine ◽

Experimental Session ◽

Double Blind Study ◽

Open Label ◽

Double Blind ◽

Significant Group ◽

Novel Approach ◽

Life Threatening ◽

Anxiety Depression ◽

To Receive

AbstractThe success of modern medicine creates a growing population of those suffering from life-threatening illnesses (LTI) who often experience anxiety, depression, and existential distress. We present a novel approach; investigating MDMA-assisted psychotherapy for the treatment of anxiety in people with an LTI. Participants with anxiety from an LTI were randomized in a double-blind study to receive MDMA (125 mg, n = 13) or placebo (n = 5) in combination with two 8-h psychotherapy sessions. The primary outcome was change in State-Trait Anxiety Inventory (STAI) Trait scores from baseline to one month post the second experimental session. After unblinding, participants in the MDMA group had one open-label MDMA session and placebo participants crossed over to receive three open-label MDMA sessions. Additional follow-up assessments occurred six and twelve months after a participant’s last experimental session. At the primary endpoint, the MDMA group had a greater mean (SD) reduction in STAI-Trait scores, − 23.5 (13.2), indicating less anxiety, compared to placebo group, − 8.8 (14.7); results did not reach a significant group difference (p = .056). Hedges’ g between-group effect size was 1.03 (95% CI: − 5.25, 7.31). Overall, MDMA was well-tolerated in this sample. These preliminary findings can inform development of larger clinical trials to further examine MDMA-assisted psychotherapy as a novel approach to treat individuals with LTI-related anxiety.Trial Registration: clinicaltrials.gov Identifier: NCT02427568, first registered April 28, 2015.

Download Full-text

A Double-Blind, Randomized, Placebo-Controlled Crossover Clinical Study of the Effects of Alpha-s1 Casein Hydrolysate on Sleep Disturbance

Nutrients ◽

10.3390/nu11071466 ◽

2019 ◽

Vol 11 (7) ◽

pp. 1466

Author(s):

Hyeon Jin Kim ◽

Jiyeon Kim ◽

Seungyeon Lee ◽

Bosil Kim ◽

Eunjin Kwon ◽

...

Keyword(s):

Sleep Quality ◽

Sleep Disturbance ◽

Sleep Onset ◽

Casein Hydrolysate ◽

Group Differences ◽

Poor Sleep ◽

Moderate Degree ◽

Double Blind ◽

Significant Group ◽

Similar Tendency

This study evaluated the effects of alpha-s1 casein hydrolysate (ACH; Lactium®) on the subjective and objective sleep profiles of a community-based sample of Koreans with poor sleep quality. We performed a double-blind, randomized crossover trial with 48 participants (49.0 ± 1.7 years old, 65% female) who exhibited a mild to moderate degree of sleep disturbance. Either ACH or placebo was administered for the initial four weeks, and the counterpart was administered in precisely the same manner after a four-week washout period. Sleep disturbance scales, daytime functioning, and psychiatric aspects showed a similar tendency to improve during both ACH and placebo phases without significant group differences. Overall perceived sleep profiles in sleep diaries were significantly improved during the ACH phase, represented by increased total sleep time and sleep efficiency (SE), as well as decreased sleep latency and wake after sleep onset (WASO). Interestingly, actigraphy demonstrated significantly increased SE after continuous use of ACH for four weeks, clearly more improved when compared to two weeks of use. The polysomnography measures showed a similar tendency without statistically significant group differences. Our findings suggest that refined ACH was well tolerated and could improve sleep quality, with possible cumulative beneficial effects with long-term administration.

Download Full-text

Chinese Medicine Shensongyangxin Is Effective for Patients with Bradycardia: Results of a Randomized, Double-Blind, Placebo-Controlled Multicenter Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2014/605714 ◽

2014 ◽

Vol 2014 ◽

pp. 1-6 ◽

Cited By ~ 10

Author(s):

Yunfang Liu ◽

Ning Li ◽

Zhenhua Jia ◽

Feng Lu ◽

Jielin Pu

Keyword(s):

Heart Rate ◽

Multicenter Trial ◽

Controlled Study ◽

Control Group ◽

Placebo Control ◽

Trial Group ◽

Average Heart Rate ◽

Double Blind ◽

End Of Treatment ◽

To Receive

To evaluate the efficacy and safety of Shensong Yangxin (SSYX) in patients with bradycardia arrhythmias, a randomized, double-blind, and placebo-controlled study was conducted. Patients with bradycardia were randomly assigned to receive either SSYX (trial group,n=115) or placebo (control group,n=104) for 4 weeks. ECG, 24-hour continuous ECG recording, echocardiography, and hepatic and renal function were evaluated at baseline and after treatment. Results showed that the average heart rate, the fastest heart rate, and the lowest heart rate in the trial group were all significantly higher than those in the control group at the end of treatment (P<0.05or 0.01, resp.). Compared with pretreatment, the average heart rate, the fastest heart rate, and the lowest heart rate in the trial group all increased significantly after treatment (P<0.05or 0.01, resp.). Both the efficacy and the symptom scores in the trial group were significantly better than those in the control group after treatment (both havingP<0.01). No severe adverse effects were reported. In conclusion, SSYX treatment significantly increased the heart rate in patients with bradycardia without severe side effects. The exact mechanisms remain to be further explored.

Download Full-text