scholarly journals Clinical Evaluation of Acupuncture as Treatment for Complications of Cerebrovascular Accidents: A Randomized, Sham-Controlled, Subject- and Assessor-Blind Trial

2017 ◽  
Vol 2017 ◽  
pp. 1-10 ◽  
Author(s):  
Hsien-Yin Liao ◽  
Wen-Chao Ho ◽  
Chun-Chung Chen ◽  
Jaung-Geng Lin ◽  
Chia-chi Chang ◽  
...  
Keyword(s):  
Rating Scale ◽  
Primary Outcome Measure ◽  
Sham Acupuncture ◽  
Acupuncture Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Double Blind Study ◽  
Double Blind ◽  
Psychological Improvement ◽  
To Receive

Background and Purpose. The effect of acupuncture as treatment for poststroke complications is questionable. We performed a randomized, sham-controlled double-blind study to investigate it.Methods. Patients with first-time acute stroke were randomized to receive 24 sessions of either real or sham acupuncture during an eight-week period. The primary outcome measure was change in National Institute of Health Stroke Scale (NIHSS) score. Secondary outcome measures included changes in Barthel Index (BI), Instrumental Activities of Daily Living (IADL), Hamilton Depression Rating Scale (HAM-D), and Visual Analogue Scale (VAS) for pain scores.Results. Of the 52 patients who were randomized to receive acupuncture (n=28) or placebo (n=24), 10 patients in the acupuncture group and 9 patients in the placebo group failed to complete the treatment. In total, 18 patients in the acupuncture group and 15 patients in the control group completed the treatment course. Reduction in pain was significantly greater in the acupuncture group than in the control group (pvalue = 0.04). There were no significant differences in the other measures between the two groups.Conclusions. Acupuncture provided more effective poststroke pain relief than sham acupuncture treatment. However, acupuncture had no better effect on neurological, functional, and psychological improvement.

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 6-months, randomised, placebo-controlled evaluation of efficacy and tolerability of a low-dose 7-day buprenorphine transdermal patch in osteoarthritis patients naïve to potent opioids

2010 ◽  
Vol 1 (3) ◽  
pp. 122-141 ◽  
Author(s):  
Harald Breivik ◽  
Tone Marte Ljosaa ◽  
Kristian Stengaard-Pedersen ◽  
Jan Persson ◽  
Hannu Aro ◽  
...  
Keyword(s):  
Side Effects ◽  
Pain Relief ◽  
Low Dose ◽  
Rating Scale ◽  
Secondary Outcome ◽  
Double Blind Study ◽  
Double Blind ◽  
Skin Reactions ◽  
Local Skin

AbstractObjectivePatients with osteoarthritis (OA) pain often have insufficient pain relief from non-opioid analgesics. The aim of this trial was to study efficacy and tolerability of a low dose 7-day buprenorphine transdermal delivery system, added to a NSAID or coxib regimen, in opioid-naïve patients with moderate to severe OA pain.MethodsA 6 months randomised, double-blind, parallel-group study at 19 centres in Denmark, Finland, Norway, and Sweden, in which OA patients (>40 years) with at least moderate radiographic OA changes and at least moderate pain in a hip and/or knee while on a NSAID or a coxib were randomised to a 7-day buprenorphine patch (n = 100) or an identical placebo patch (n = 99). The initial patch delivered buprenorphine 5 μg/h. This was titrated to 10 or 20 μg/h, as needed. Rescue analgesic was paracetamol 0.5–4 g daily. Statistical analysis of outcome data was mainly with a general linear model, with treatment as factor, the primary joint of osteoarthritis, baseline scores, and season as covariates.ResultsMost patients had OA-radiographic grade II (moderate) or grade III (severe), only 8 in each group had very severe OA (grade IV). The median buprenorphine dose was 10 μg/h. 31 buprenorphine-treated patients and 2 placebo-treated patients withdrew because of side effects. Lack of effect caused 12 placebo-treated and 7 buprenorphine-treated patients to withdraw. The differences in effects between treatments: Daytime pain on movement, recorded every evening on a 0–10 numeric rating scale decreased significantly more (P = 0.029) in the buprenorphine group. Patients’ Global Impression of Change at the end of the double blind period was significantly improved in the buprenorphine group (P = 0.017). The chosen primary effect outcome measure, the Western Ontario and McMaster Universities (WOMAC) OA Index for Pain (P = 0.061), and secondary outcome measures, the WOMAC OA score for functional abilities (P = 0.055), and the WOMAC total score (P = 0.059) indicated more effects from buprenorphine than placebo, but these differences were not statistically significant. In a post-hoc, subgroup analysis with the 16 patients with radiographic grad IV (very severe) excluded, WOMAC OA Index for Pain was significantly (P = 0.039) reduced by buprenorphine, compared with placebo. WOMAC OA score for stiffness and the amount of rescue medication taken did not differ. Sleep disturbance, quality of sleep, and quality of life improved in both groups. Side effects: Typical opioid side effects caused withdrawal at a median of 11 days before completing the 168 days double blind trial in 1/3 of the buprenorphine group. Mostly mild local skin reactions occurred equally often (1/3) in both groups.ConclusionsAlthough the 24 hours WOMAC OsteoArthritis Index of pain was not statistically significantly superior to placebo, day-time movement-related pain and patients’ global impression of improvement at the end of the 6-months double blind treatment period were significantly better in patients treated with buprenorphine compared with placebo. Opioid side effects caused 1/3 of the buprenorphine-patients to withdraw before the end of the 6-months double blind study period.ImplicationsA low dose 7-days buprenorphine patch at 5–20 μg/h is a possible means of pain relief in about 2/3 of elderly osteoarthritis patients, in whom pain is opioid-sensitive, surgery is not possible, NSAIDs and coxibs are not recommended, and paracetamol in tolerable doses is not effective enough. Vigilant focus on and management of opioid side effects are essential.

scholarly journals Efficacy of ethyl-eicosapentaenoic acid in bipolar depression: Randomised double-blind placebo-controlled study

2006 ◽  
Vol 188 (1) ◽  
pp. 46-50 ◽  
Author(s):  
Sophia Frangou ◽  
Michael Lewis ◽  
Paul McCrone
Keyword(s):  
Eicosapentaenoic Acid ◽  
Rating Scale ◽  
Bipolar Depression ◽  
Unipolar Depression ◽  
Adjunctive Treatment ◽  
Secondary Outcome ◽  
Controlled Study ◽  
Double Blind Study ◽  
Young Mania ◽  
Double Blind

BackgroundEpidemiological and clinical studies suggest that increased intake of eicosapentaenoic acid (EPA) alleviates unipolar depression.AimsTo examine the efficacy of EPA in treating depression in bipolar disorder.MethodIn a 12-week, double-blind study individuals with bipolar depression were randomly assigned to adjunctive treatment with placebo (n=26) or with 1g/day (n=24) or 2 g/day (n=25) of ethyl-EPA. Primary efficacy was assessed by the Hamilton Rating Scale for Depression (HRSD), with changes in the Young Mania Rating Scale and Clinical Global Impression Scale (CGI) as secondary outcome measures.ResultsThere was no apparent benefit of 2g over 1g ethyl-EPA daily. Significant improvement was noted with ethyl-EPA treatment compared with placebo in the HRSD (P=0.04) and the CGI (P=0.004) scores. Both doses were well tolerated.ConclusionsAdjunctive ethyl-EPA is an effective and well-tolerated intervention in bipolar depression.

scholarly journals Effects of Intraoperative Nefopam on Catheter-Related Bladder Discomfort in Patients Undergoing Robotic Nephrectomy: A Randomized Double-Blind Study

2019 ◽  
Vol 8 (4) ◽  
pp. 519
Author(s):  
Chi-Bum In ◽  
Young-Tae Jeon ◽  
Ah-Young Oh ◽  
Se-Jong Jin ◽  
Byeong-Seon Park ◽  
...  
Keyword(s):  
Postoperative Period ◽  
Rating Scale ◽  
Numeric Rating Scale ◽  
Control Group ◽  
Double Blind Study ◽  
Analgesic Agent ◽  
Double Blind ◽  
Robotic Nephrectomy ◽  
Male Patients ◽  
Numeric Rating

Catheter-related bladder discomfort (CRBD) is one of the most difficult symptoms during the postoperative period. Nefopam is a non-narcotic analgesic agent, which also has anticholinergic action. This study was performed to evaluate the effects of nefopam on CRBD in male patients undergoing robotic nephrectomy. A total of 109 male patients were randomly divided into two groups: the control group (n = 55) received 20 mL of normal saline, and the nefopam group (n = 54) received 20 mg of nefopam 1 h before the end of the operation. At postoperative times of 20 min, 1 h, 2 h, and 6 h, the severity of CRBD was measured using an 11-point numeric rating scale, respectively. The severity of CRBD in the nefopam group was significantly lower than that in the control group at 20 min (4.8 ± 1.3 vs. 2.3 ± 1.0, respectively, p = 0.012) and at 1, 2, and 6 h (3.5 ± 1.2, 2.7 ± 0.9, and 2.5 ± 1.0 vs. 4.1 ± 0.8, 1.6 ± 0.8, and 1.3 ± 0.6, respectively, p < 0001). Intraoperative nefopam administration reduced the severity of CRBD in patients undergoing robotic nephrectomy.

Traditional Acupuncture for Reflex Sympathetic Dystrophy: A Randomised, Sham-Controlled, Double-Blind Trial

1995 ◽  
Vol 13 (2) ◽  
pp. 78-80 ◽  
Author(s):  
E Ernst ◽  
KL Resch ◽  
V Fialka ◽  
D Ritter-Dittrich ◽  
Y Alcamioglu ◽  
...  
Keyword(s):  
Reflex Sympathetic Dystrophy ◽  
Rating Scale ◽  
Controlled Trial ◽  
Sham Acupuncture ◽  
Acupuncture Group ◽  
Outcome Variable ◽  
Controlled Study ◽  
Double Blind ◽  
Subjective Success ◽  
Group A

Acupuncture has been suggested as helpful in reflex sympathetic dystrophy (RSD), but no controlled study has yet been published. The hypothesis of this randomised, double-blind, sham-controlled trial, therefore, was that traditional Chinese acupuncture improves subjective as well as objective signs in this condition. Patients were included when suffering from clinically and scintigraphically confirmed acute RSD of the upper or lower limb, with a history between one and four months. They were randomly assigned to either traditional acupuncture (group A) or sham acupuncture (group S). Treatments were applied five times a week for three weeks, each session lasting for 30 minutes. Both groups received identical standard treatments in addition. The primary outcome variable had been pre-defined to be pain, as measured by visual analogue scale assessed before each treatment. Subjective success was also recorded by the patients on a rating scale. Due to force of circumstances, only 14 patients were entered into the study, therefore no test statistics could be performed and the data was evaluated descriptively. At baseline, pain was almost identical in both groups. During the course of the study, patients in group A demonstrated a more pronounced reduction of pain: 28.6% ± 1.9 vs 17.9% ± 2.4 (Mean ± SEM). Similarly, subjective success was rated to favour traditional acupuncture. It is concluded that acupuncture may be useful in the management of pain in patients with acute RSD, but that the present results are not conclusive. Larger, rigorous studies are required to answer the question.

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 Comparison between intrathecal nalbuphine and butorphanol as adjuvants to isobaric ropivacaine in elective lower limb orthopedic surgeries: A prospective, randomized, double blind study

2020 ◽  
Author(s):  
Akash Nirmal ◽  
Yashpal Singh ◽  
Sharad Kumar Mathur ◽  
Satish Patel
Keyword(s):  
Postoperative Analgesia ◽  
Lower Limb ◽  
Primary Outcome Measure ◽  
Blind Study ◽  
Double Blind Study ◽  
Motor Blockade ◽  
Chi Square ◽  
Double Blind ◽  
Lower Limb Surgery ◽  
To Receive

Background: Intrathecal ropivacaine is now routinely used for lower limb surgery. Adjuvants e.g. fentanyl, dexmedetomidine or morphine etc. are commonly used to prolong the intraoperative anesthesia or postoperative analgesia. The available literature lacks information on use of butorphanol and nalbuphine as adjuvants with 0.75% isobaric ropivacaine. We aimed to compare nalbuphine and butorphanol as adjuvant with isobaric ropivacaine in lower limb orthopedic surgeries. Methodology: After institutional ethical committee approval and informed written consent, a total of 108 patients of ages between 18 to 65 y, of either sex, American Society of Anesthesiologists (ASA) grade ӏ & ӏӏ, scheduled for elective lower limb orthopedic surgeries, were enrolled and  randomly allocated into two groups: Group RN; to receive isobaric ropivacaine (0.75%, 7.5 mg/ml) 2.5 ml plus nalbuphine 500 µg (0.5 ml), and Group RB; to receive isobaric ropivacaine 2.5 ml plus butorphanol 100 µg (0.5 ml) intrathecally. Primary outcome measure was the duration of sensory‑motor blockade from the time of intrathecal drug administration. Statistical analysis was performed by using t-test and chi-square test as applicable. A p < 0.05 was considered as significant. Results: Duration of sensory (p < 0.001) and motor blockade (p = 0.02) was significantly prolonged in nalbuphine group than butorphanol group. Onset of blockade was earlier in nalbuphine group. Duration of motor block and sensory analgesia was prolonged in group RN (p < 0.001). Perioperative hemodynamic parameters and the observed side effects including bradycardia, hypotension, nausea and vomiting, sedation and shivering were comparable between the two groups (p = 0.77). Conclusion: Intrathecal nalbuphine produces prolonged motor blockade as well as postoperative analgesia than intrathecal butorphanol when used as adjuvants to isobaric 0.75% ropivacaine. Citation: Nirmal A, Singh Y, Mathur SK, Patel S. Comparison between intrathecal nalbuphine and butorphanol as adjuvants to isobaric ropivacaine in elective lower limb orthopedic surgeries: A prospective, randomized, double blind study. Anaesth pain & intensive care 2019;23(4)__ Received: 22 August 2019; Reviewed: 8, 9 October 2019; 6, 7 November 2019; Revised: 18 November 2019; Reviewed: 19 November 2019; Accepted: 20 November 2019

scholarly journals Paranasal sinus air suction for immediate pain relief of acute migraine – a randomized, double blind pilot study

BMC Neurology ◽  
2019 ◽  
Vol 19 (1) ◽  
Author(s):  
S. M. R. Bandara ◽  
S. Samita ◽  
A. M. Kiridana ◽  
D. M. P. U. K. Ralapanawa ◽  
H. M. M. T. B. Herath
Keyword(s):  
Pain Relief ◽  
Paranasal Sinus ◽  
Rating Scale ◽  
International Headache Society ◽  
Treated Group ◽  
Control Group ◽  
Double Blind Study ◽  
Airflow Rate ◽  
Acute Migraine ◽  
Double Blind

Abstract Background Migraine is a primary headache disorder, which cause significant disability in adolescence. This double blind, randomized clinical trial assessed the immediate effects of suction of paranasal sinus air during an acute migraine episode. Methods A randomized, double blind study was conducted with 56 selected Sri Lankan school children of 16–19 years of age. Participants who met International Headache Society criteria for migraine (with or without aura) were included in the study. Subjects were randomly allocated into 2 groups where one group was subjected to three intermittent 10 sec paranasal air suctions with a ten sec suction free interval between two suctions for each nostril and the other group was subjected to placebo air suction (no paranasal air suction) in similar arrangement. Severity of headache and sub–orbital tenderness before and after suction were recorded using standard pain rating scale. Results After dropouts, treated and placebo groups consisted of 27 and 23 subjects respectively. The mean headache pain score drop in the treated group was significantly higher compared to that of the control group. Moreover, there was a difference in the treatment response between the types of headache (with or without aura). With respect to tenderness there was a statistically significant drop in the treated group compared to the control. In general, airflow rates in left and right nostrils were different in these subjects. However such difference was not seen in the tenderness on two sides. Nevertheless it was revealed that airflow rate has a slight negative correlation with the tenderness irrespective of the side. Conclusion Sixty–second paranasal air suction can provide an immediate pain relief for acute migraine in adolescents. We did not assess pain outcomes beyond 60 s, but the initial responses suggests the need to further study the efficacy of paranasal suction in migraine. A further study is suggested to evaluate the acute effects, efficacy and side effects of paranasal air suction using follow up over a prolong period. Trial registration Sri Lanka Clinical Trials Registry SLCTR/2017/018, 29 Jun 2017. Retrospectively registered.

Effectiveness of Extended-release Formulation of Quetiapine as Monotherapy for the Treatment of Acute Bipolar Mania (Trial D144CC00004)

2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1 ◽  
Author(s):  
C. Datto ◽  
A. Nordenhem ◽  
M. Minkwitz ◽  
B. Dettore ◽  
L. Acevedo ◽  
...  
Keyword(s):  
Extended Release ◽  
Rating Scale ◽  
Analysis Of Covariance ◽  
Secondary Outcome ◽  
Double Blind Study ◽  
Double Blind ◽  
Once Daily ◽  
Bipolar I Disorder ◽  
Manic Symptoms ◽  
Quetiapine Xr

Objectives:To evaluate the effectiveness of extended release quetiapine fumarate (quetiapine XR) as once-daily monotherapy for manic symptoms in bipolar I disorder.Methods:In this 3-week, randomized, parallel-group, double-blind study, adults with bipolar I disorder (most recent episode manic or mixed; with or without rapid cycling) were randomized to once-daily treatment with either quetiapine XR (n=149; Day 1, 300 mg; Day 2, 600 mg; Day 3 through Week 3, 400-800 mg flexibly dosed) or placebo (n=159). Primary outcome measure was change from baseline to Week 3 in Young Mania Rating Scale (YMRS) total score. Secondary outcome measures included YMRS response and remission and change in Clinical Global Impression-Bipolar (CGI-BP)-Severity of Illness and -Change scales. Change from baseline was compared between groups with analysis of covariance, using the last observation carried forward approach for missing data.Results:Once-daily quetiapine XR was associated with significant, sustained improvement in manic symptoms compared with placebo, beginning on Day 4 (P< 0.001) and continuing through Week 3 (mean change: -14.34 versus -10.52; P< 0.001). At Week 3, quetiapine XR-treated patients showed significantly greater response (P< 0.01) and remission (P< 0.01) rates and improvement in CGI-BP-associated scores than placebo-treated patients. Adverse events were mild to moderate in intensity, the most common being sedation, dry mouth, and somnolence for quetiapine XR.Conclusions:Once-daily quetiapine XR monotherapy (400-800 mg) was efficacious (from Day 4 through Week 3) and generally well tolerated in the treatment of manic episodes associated with bipolar I disorder.Supported by funding from AstraZeneca Pharmaceuticals LP.

scholarly journals Low Dose Niacin Versus Placebo Treatment for Parkinson's Disease: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Chandramohan Wakade ◽  
Raymond Chong ◽  
Marissa Seamon ◽  
Sharad Purohit ◽  
Bababihari Giri ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Low Dose ◽  
Rating Scale ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Double Blind Study ◽  
Double Blind ◽  
One Year ◽  
Time Point

Abstract Background Parkinson's Disease (PD) patients have lower niacin levels compared to their spouses. The main objective was to study low-dose daily niacin supplementation on motor symptoms in Parkinson's disease subjects. Methods Forty-Seven PD patients were randomly assigned to receive low-dose niacin or placebo in a randomized, double-blind study for the first six months. After the double-blind phase, all participants received open-label niacin for the next six months. All patients were evaluated at baseline, six months, and one year of treatment. The main outcome measure was the Unified Parkinson's Disease Rating Scale III (UPDRS III) scores. Secondary outcome measures were depression, sleep quality, mental flexibility and cognition, and physical fatigue. Results Niacin treatment was tolerated well by 45 subjects. The baseline mean UPDRS III score was 21.3 ± 15.8 for the niacin group and 22.4 ± 11.8 for placebo. The change with six months of placebo was 1.5 [95% CI, -0.73 to 3.73], and niacin was − 1.06 [95% CI, -3.68 to 1.57]. From six to twelve months, the average UPDRS III score decreased for the placebo group by 2.66 [95% CI, -0.95 to 6.24] and the niacin group by 4.63 [95% CI, 1.42 to 7.83]. Eight subjects withdrew from the study before the 6-month time point and eight more before the one-year time point due to voluntary discontinuation, flushing, or inability to continue (SARS-CoV-2 shut-down). Conclusion Low-dose niacin supplementation may be helpful as an adjunct therapy in improving motor function in PD. Trial registration: Clinicaltrials.gov, NCT03462680. Registered 12 March 2018- Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03462680?term=gpr109A&draw=2&rank=1

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