scholarly journals A Randomized, Placebo-controlled, Double-blind Study on the Effects of SZL on Patients With Mild to Moderate Depressive Disorder With Comparison to Fluoxetine

2020 ◽  
Author(s):  
yuan hu ◽  
yichen wang ◽  
chao chen ◽  
wenshan yang ◽  
weiyu zhu ◽  
...  
Keyword(s):  
Depressive Disorder ◽  
Depression Scale ◽  
Double Blind Study ◽  
Double Blind ◽  
Moderate Depression ◽  
Parallel Group ◽  
Clinical Presentations ◽  
Significant Difference ◽  
To Receive ◽  
Target Effects

Abstract Objective: Kaixinsan (KXS) decoction, as an ancient’s herbal formula, has been demonstrated to be active in various animal models resembling human depression with multi-target effects. This very first study evaluated the efficacy and tolerability of Shen Zhi Ling (SZL) tables (KXS preparation), compared with fluoxetine (FLX, positive comparator), in patients with mild to moderate depressive disorder.Methods: In this randomized double-blind parallel-group study, 156 patients with mild to moderate depression without taken any antidepressants in the past 6 months or 4 straight weeks were randomized to receive either 3.2g/d SZL plus 20mg/d FLX placebo (SZL group) or 20mg/d FLX plus 3.2g/d SZL placebo (FLX group), for 8 weeks. Their clinical presentations and some metabolic indexes were assessed during the 8 weeks visiting period.Results: Patients in SZL group showed a statistically significant improvement after 8 weeks of treatment in HAMD-17 score (18.79±2.09 to 4.43±4.71, p<0.001) and self-rating depression scale (SDS) score (58.49±8.89 to 39.84±12.09, p<0.001), but not in N-back total respond time (1145.55±608.26 to 1128.47±387.49, p>0.05). In addition, no significant difference at 8 weeks of treatment was found between SZL and FLX groups in SDS score (39.84±12.09 vs. 36.63±12.44) and N-back respond time (1128.47±387.49 vs. 1089.43±352.08) as well as reduction of HAMD-17 score (14.79±4.88 vs. 15.24±4.29) (p>0.05 for all). However, the serum APOB, APOC3 and ALB levels and HDL-C/LDL-C ratio decreased significantly in patients after SZL treatment, while only APOB/APOA1 ratio decreased significantly in FLX group. Other metabolic indexes did not alter significantly after treated with SZL or FLX.Conclusion: The efficacy and safety profile of SZL are comparable to that of fluoxetine in patients with mild to moderate depression. The beneficial effect of SZL is probably associated with improvement of lipid metabolic balance.

Duloxetine augmentation in resistant obsessive compulsive disorder: Surveying a new medication for challenges in treatment of OCD

2017 ◽  
Vol 41 (S1) ◽  
pp. S415-S415
Author(s):  
A. Mowla
Keyword(s):  
Obsessive Compulsive Disorder ◽  
Primary Outcome Measure ◽  
Controlled Clinical Trial ◽  
Double Blind Study ◽  
Obsessive Compulsive ◽  
Double Blind ◽  
Compulsive Disorder ◽  
Significant Difference ◽  
Competing Interest ◽  
To Receive

IntroductionUp to 50% of patients with OCD have failed to respond in SSRI trials, so looking for pharmacological alternatives in treatment of obsessive compulsive disorder (OCD) seems necessary.ObjectivesSurveying duloxetine augmentation in treatment of resistant OCD.AimsStudy the effects of serotonin-norepinephrine enhancers for treatment of OCD.MethodsThis augmentation trial was designed as an 8-week randomized controlled, double blind study. Forty-six patients suffering from OCD who had failed to respond to at least 12 weeks of treatment with a selective serotonin reuptake inhibitor (fluoxetine, citalopram or fluvoxamine) were randomly allocated to receive duloxetine or sertraline plus their current anti OCD treatment. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) was the primary outcome measure.ResultsForty-six patients (24 of 30 in duloxetine group and 22 of 27 in sertraline group) completed the trial. Both groups showed improvement over the 8-week study period (mean Y-BOCS total score at week 8 as compared with baseline: P < 0.001 and P < 0.001) without significant difference (P = 0.861). Those receiving duloxetine plus their initial medications experienced a mean decrease of 33.0% in Y-BOCS score and the patients with sertraline added to their initial medication experienced a mean decrease of 34.5% in Y-BOCS.ConclusionsOur double blind controlled clinical trial showed duloxetine to be as effective as sertraline in reducing obsessive and compulsive symptoms in resistant OCD patients. However, it needs to be noted that our study is preliminary and larger double blind placebo controlled studies are necessary to confirm the results.Disclosure of interestThe authors have not supplied their declaration of competing interest.

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

1997 ◽  
Vol 25 (4) ◽  
pp. 175-181 ◽  
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.

scholarly journals Sexual Function during Bupropion or Paroxetine Treatment of Major Depressive Disorder

2006 ◽  
Vol 51 (4) ◽  
pp. 234-242 ◽  
Author(s):  
Sidney H Kennedy ◽  
Kari A Fulton ◽  
R Michael Bagby ◽  
Andrea L Greene ◽  
Nicole L Cohen ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Sexual Function ◽  
Rating Scale ◽  
Primary Objective ◽  
Major Depressive ◽  
Double Blind ◽  
Significant Difference ◽  
To Receive ◽  
Over Time

Objective: The primary objective was to evaluate sexual function (SF) separately in men and women with major depressive disorder (MDD) before and during treatment with bupropion sustained release (SR) or paroxetine. The secondary objectives involved a comparative evaluation of the Sex Effects Scale (Sex FX) and the Investigator-Rated Sexual Desire and Functioning Scale (IRSD-F), as well as a comparison of antidepressant outcomes and an examination of the relation between level of depression and SF over time. Method: There were 141 patients (68 women and 73 men) who met DSM-IV criteria for a current major depressive episode. They were randomly assigned to receive bupropion SR (150 to 300 mg daily) or paroxetine (20 to 40 mg daily) under double-blind trial conditions. Patients were assessed at baseline and at 2, 4, 6, and 8 weeks with the 17-item Hamilton Depression Rating Scale (HDRS17), Sex FX, and IRSD-F. Results: Prior to treatment, women reported significantly lower SF on both the Sex FX and IRSD-F scales, compared with men. During treatment, there were no significant drug differences on measures of SF over time for women; however, men who were treated with paroxetine reported a worsening of SF, whereas bupropion SR did not significantly alter SF. Both bupropion SR and paroxetine produced clinically and statistically significant reductions in HDRS17 scores as well as comparable rates of response and remission. There was a statistically significant correlation between the 2 measures of SF at all visits. There was also a significant inverse relation between depression and SF in women, but not in men, irrespective of drug. Conclusion: According to the Sex FX scale, a significant difference in antidepressant-related sexual dysfunction was detected in men, but not women, during treatment with bupropion SR or paroxetine.

scholarly journals Comparison of Ondansetron with Gabapentin for prevention of intrathecal morphine induced pruritus

2019 ◽  
Vol 2 (3) ◽  
pp. 142-148
Author(s):  
Rohini Sigdel ◽  
Anil Shrestha ◽  
Roshana Amatya
Keyword(s):  
Single Dose ◽  
Intrathecal Morphine ◽  
Double Blind Study ◽  
Physical Status ◽  
Hyperbaric Bupivacaine ◽  
Double Blind ◽  
Subarachnoid Block ◽  
Significant Difference ◽  
Group 2 ◽  
To Receive

Background: Ondansetron has been used successfully for prophylaxis and treatment of intrathecal morphine induced pruritus. Gabapentin has anxiolytic, antiemetic, antipruritic effects and has also been shown to potentiate the analgesic effect of intrathecally or epidurally administered opioids. Materials and method: We compared the effectiveness of oral gabapentin with intravenous ondansetron to prevent incidence of intrathecal morphine induced pruritus. In a prospective, double-blind study, sixty patients aged 18-65 years with ASA physical status I and II undergoing surgery under subarachnoid block were randomized to receive placebo tablets (ondansetron group) or gabapentin 1200 mg (gabapentin group) 2 hours before surgery. Patients receiving placebo tablets received 8 mg of intravenous ondansetron and those receiving gabapentin received 4 ml of intravenous normal saline just prior to subarachnoid block with 3 ml of 0.5% hyperbaric bupivacaine plus 0.2 mg morphine. The incidence, onset, severity, location of pruritus and incidence of side effects were studied for next 24 hours. Results: The overall incidence of pruritus was 48.3%. The incidence, severity, location of pruritus was comparable between the two groups. There was significant difference between the onset of pruritus between groups (p=0.009). The incidence and grade of nausea vomiting, requirement of intraoperative sedation was comparable between groups. The incidence of urinary retention was significantly high in gabapentin group (p=0.020). Respiratory depression was observed in one patient. Conclusion: A single dose of 1200 mg oral gabapentin 2 hours before, is as effective as prophylactic intravenous ondansetron 8 mg for prevention of intrathecal morphine induced pruritus.

Pyridoxine is not effective for the prevention of hand foot syndrome (HFS) associated with capecitabine therapy: Results of a randomized double-blind placebo-controlled study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9007-9007 ◽  
Author(s):  
S. Lee ◽  
S. Lee ◽  
Y. Chun ◽  
M. Kim ◽  
H. Chang ◽  
...  
Keyword(s):  
Placebo Group ◽  
Chemotherapy Regimen ◽  
Controlled Study ◽  
Double Blind Study ◽  
Double Blind ◽  
Significant Difference ◽  
Hand Foot Syndrome ◽  
Version 2.0 ◽  
The Mean ◽  
To Receive

9007 Introduction: Although pyridoxine has been used empirically for the prevention of HFS associated with capecitabine, its efficacy has not been proven yet. We performed a prospective randomized double-blind study to determine whether pyridoxine can prevent the development of HFS when given concurrently with capecitabine. Method: Chemotherapy-naive patients (pts) with gastrointestinal tract cancers who were going to have capecitabine-containing chemotherapy were randomized to receive either oral pyridoxine (200 mg/day) or placebo daily during chemotherapy after stratified by chemotherapy regimen: 1) capecitabine alone, 2) capecitabine and cisplatin, or 3) docetaxel, capecitabine, and cisplatin. The patients were observed until grade 2 or 3 HFS (by NCI CTC version 2.0) developed or capecitabine containing chemotherapy ended. When grade 2 or 3 HFS developed in pts in placebo group, the pts were randomized again to receive either pyridoxine or placebo for next cycle of chemotherapy in order to determine whether pyridoxine could improve the HFS. Result: From Jun 2004 to Oct 2005, total 389 pts were entered onto the study. But, 29 pts (15 in placebo group and 14 in pyridoxine group) were excluded from the study because of ineligibility or pts’ refusal. Pts’ characteristics were well balanced between the 2 groups. Grade 2 or 3 HFS developed in 55 of 180 (30.6%) pts in placebo group and in 57 of 180 (31.7%) pts in pyridoxine group. (p=0.788) The median cycles of chemotherapy to grade 2 or 3 HFS was 3 in both groups. The mean cumulative dose of capecitabine until occurrence of grade 2 or 3 HFS was not different statistically between the two groups. (221,157.5 mg/m2 vs. 259,808.5 mg/m2, p=0.788). Total 44 of 55 pts in placebo group who had grade 2 or 3 HFS were randomized to receive either placebo or pyridoxine at next cycle. There was no significant difference between the two groups in the proportion of pts with improvement of HFS (43% vs 48%, p=0.94). Conclusion: These results indicated that pyridoxine is not effective for the prevention of HFS associated with capecitabine therapy. No significant financial relationships to disclose.

A Comparison of Median Effective Doses of Intrathecal Levobupivacaine and Ropivacaine for Labor Analgesia

2005 ◽  
Vol 102 (3) ◽  
pp. 651-656 ◽  
Author(s):  
Alex T. Sia ◽  
Raymond W. Goy ◽  
Yvonne Lim ◽  
Cecilia E. Ocampo
Keyword(s):  
Confidence Interval ◽  
Probit Analysis ◽  
Labor Analgesia ◽  
Double Blind Study ◽  
Double Blind ◽  
Significant Difference ◽  
Effective Doses ◽  
To Receive ◽  
Higher Doses ◽  
Effective Analgesia

Background The study was designed to determine and compare the median effective doses (MEDs) of intrathecal ropivacaine with levobupivacaine for labor analgesia. Methods In this double-blind study, 100 parturients in early labor were randomized to receive either intrathecal ropivacaine or levobupivacaine. For each drug, the patients were assigned to receive one of the five doses studied, namely 1, 1.5, 2, 2.5, or 3 mg. Effective analgesia was defined as a pain score (0-100 visual analog scale) of less than 10 within 15 min of injection, lasting for 45 min or more after the induction of analgesia. MEDs were derived from probit analysis. The duration of analgesia rendered by the two drugs at 2.5 and 3 mg was also compared. Results The MED for levobupivacaine was 1.07 mg (95% confidence interval, 0.88-1.25 mg), and the MED for ropivacaine was 1.40 mg (95% confidence interval, 1.20-1.61 mg). Levobupivacaine was found to be 1.31 (95% confidence interval, 1.04-2.01) times more potent than ropivacaine. At doses of 2.5 mg or greater, there was no significant difference in duration of analgesia between levobupivacaine (median, 63.5 min; range, 46-123 min) and ropivacaine (median, 59.0 min; range, 47-93 min; P = 0.18). We detected no difference in the incidence of hypotension, nausea and vomiting, motor block, or abnormal fetal heart tracing between the two drugs. Conclusions The MED of intrathecal ropivacaine for labor analgesia was significantly greater than levobupivacaine experimentally, but this significance was reduced when the comparison was based on molar potency. There was no difference in the duration of analgesia or adverse effects between the two drugs at higher doses (2.5 mg or greater).

scholarly journals The Influence of Adrenaline on Postoperative Analgesia after Subarachnoid Morphine

1993 ◽  
Vol 21 (1) ◽  
pp. 79-84 ◽  
Author(s):  
M. J. Paech
Keyword(s):  
Side Effects ◽  
Postoperative Analgesia ◽  
Saline Group ◽  
Control Group ◽  
Double Blind Study ◽  
Gynaecological Surgery ◽  
Normal Saline Group ◽  
Double Blind ◽  
Significant Difference ◽  
To Receive

A randomised, double-blind study was conducted to investigate the postoperative effects of subarachnoid morphine, with or without adrenaline, after major gynaecological surgery. Seventy-five women having spinal anaesthesia combined with either sedation or general anaesthesia were randomised to receive subarachnoid morphine 0.25 mg with (group MA) or without (group M) adrenaline 200 ūg; or normal saline (group C). Groups M (n=22) and MA (n=25) differed significantly from control (n=23) with respect to the quality and duration of postoperative analgesia (P<0.0002) and to a higher incidence of pruritus (P<0.02). Groups were similar with respect to the incidence of other postoperative side-effects and respiratory data, although the latter showed a trend to less hypoxaemia in the control group. There was no significant difference in any outcome between groups MA and M. It was concluded that, under the study conditions in a post-gynaecological surgery population, the addition of adrenaline to subarachnoid morphine was of no benefit.

scholarly journals Intramuscular Ketorolac for Postoperative Analgesia following Laparoscopic Sterilisation

1994 ◽  
Vol 22 (1) ◽  
pp. 22-24 ◽  
Author(s):  
M. H. Shapiro ◽  
B. L. Duffy
Keyword(s):  
Side Effects ◽  
Intramuscular Injection ◽  
Double Blind Study ◽  
Day Case ◽  
Double Blind ◽  
Apparent Lack ◽  
Pain Scores ◽  
Significant Difference ◽  
To Receive ◽  
Intramuscular Ketorolac

The analgesic effect of intramuscular ketorolac was assessed by double blind study in forty women presenting for day-case laparoscopic sterilisation. The patients were randomly allocated to receive either ketorolac 30 mg or saline by intramuscular injection immediately following induction of general anaesthesia. There was no statistically significant difference between the groups in pain scores, opioid requirements or incidence of nausea and vomiting in the postoperative period. In view of the potential side-effects of ketorolac, and the apparent lack of efficacy when used prophylactically, the routine use of the drug in this group of patients cannot be recommended.

A Double-Blind Comparison of Meptazinol and Placebo in Patients with Acute and Chronic Pain Presenting to the General Practitioner

1982 ◽  
Vol 10 (6) ◽  
pp. 408-413 ◽  
Author(s):  
C E Parker ◽  
A F Langrick
Keyword(s):  
Chronic Pain ◽  
Analgesic Efficacy ◽  
Double Blind Study ◽  
Double Blind ◽  
Clinical Evaluations ◽  
Significant Difference ◽  
Chronic Pain Patients ◽  
Blind Comparison ◽  
To Receive ◽  
Pain Patients

In a double-blind study the analgesic efficacy and acceptability of meptazinol 200 mg was compared with placebo in patients suffering from acute or chronic pain. Patients were randomly allocated to receive either 200 mg of meptazinol or one tablet of placebo 4 to 6 hourly over a 14-day period. Clinical evaluations were made by the physician at baseline and again at the end of the study. The patients made daily recordings of pain using a visual analogue scale. The results showed that meptazinol was a more effective and acceptable analgesic than placebo. There was no significant difference in the incidence of adverse effects reported by patients in either treatment group.

Propofol Anaesthesia in Electroconvulsive Therapy

1994 ◽  
Vol 165 (4) ◽  
pp. 506-509 ◽  
Author(s):  
Christopher F. Fear ◽  
Carl S. Littlejohns ◽  
Eryl Rouse ◽  
Paul McQuail
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Electroconvulsive Therapy ◽  
Rating Scale ◽  
Induction Agent ◽  
Double Blind Study ◽  
Major Depressive ◽  
Seizure Duration ◽  
Double Blind ◽  
Induction Agents

BackgroundThe induction agent propofol is known to reduce electroconvulsive therapy (ECT) seizure duration. It is assumed that outcome from depression is adversely affected by this agent. This study compares propofol and methohexitone as induction agents for ECT.MethodIn a prospective, randomised, double-blind study 20 subjects with major depressive disorder (DSM-III-R criteria) received propofol or methohexitone anaesthesia. The Hamilton Depression Rating Scale and Beck Depression Inventory were used to assess depression before therapy, at every third treatment, and at the end of therapy. Seizure duration was measured using the cuff technique.ResultsMean seizure durations (P < 0.01) and mean total seizure duration (P < 0.01) were shorter in the propofol group. There was no difference in outcome.ConclusionsUse of propofol may not adversely affect outcome from depression and it is not necessarily contraindicated as an induction agent for ECT. Our results should be interpreted cautiously, and larger studies are needed.

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