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.

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.

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 Sham-Controlled Trial of Acupuncture as An Adjunct in Migraine Prophylaxis

2014 ◽  
Vol 32 (1) ◽  
pp. 12-16 ◽  
Author(s):  
Mohsen Foroughipour ◽  
Amir Reza Golchian ◽  
Mohsen Kalhor ◽  
Saeed Akhlaghi ◽  
Mohammad Taghi Farzadfard ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Sham Acupuncture ◽  
Migraine Prophylaxis ◽  
Acupuncture Group ◽  
Migraine Headaches ◽  
Prophylactic Drugs ◽  
Significant Difference ◽  
Group A ◽  
The Difference ◽  
Sham Acupuncture Group

Background Migraine is one of the most common types of headache, with significant socioeconomic effects. Prophylactic drugs are used to prevent migraine headaches but are unpromising. Objective To assess the effects of adding acupuncture to conventional migraine prophylaxis. Methods One hundred patients with migraine (41 male, 59 female), in whom prophylactic drugs had not produced a fall of at least 50% in the number of attacks, entered the study. The patients were randomised into two groups, sham and true acupuncture. The patients in both groups continued their prophylactic treatment and received 12 sessions of either true or sham acupuncture. Each session was 30 min and was repeated three times a week. The number of headaches in the two groups was compared at baseline, and at the end of four successive months. Results There was no significant difference in the frequency of attacks between the two groups before intervention. After 1 month, the frequency of attacks each month decreased from 5.1 (0.8) to 3.4 (1.2) in the true acupuncture group, and from 5.0 (0.8) to 4.4 (1.1) in the sham acupuncture group (a significant difference, p<0.001). The frequency continued to decrease in month 2 but increased in months 3 and 4; however, it was still significantly lower than baseline, and the difference remained significant after month 4. Conclusions Acupuncture is applicable as an adjunct to prophylactic drugs in migraineurs in whom the number of attacks does not fall with prophylactic medication.

Intradermal Acupuncture on Shen-Men and Nei-Kuan Acupoints Improves Insomnia in Stroke Patients by Reducing the Sympathetic Nervous Activity: A Randomized Clinical Trial

2009 ◽  
Vol 37 (06) ◽  
pp. 1013-1021 ◽  
Author(s):  
Seung Yeop Lee ◽  
Yong Hyeon Baek ◽  
Seong Uk Park ◽  
Sang Kwan Moon ◽  
Jung Mi Park ◽  
...  
Keyword(s):  
Heart Rate ◽  
Heart Rate Variability ◽  
Controlled Trial ◽  
Nervous Activity ◽  
Sham Acupuncture ◽  
Acupuncture Group ◽  
Sympathetic Nervous Activity ◽  
Stroke Patients ◽  
Double Blind ◽  
Intradermal Acupuncture

This study is a double-blind randomized controlled trial on the effect of intradermal acupuncture on insomnia after stroke. Hospitalized stroke patients with insomnia were enrolled in the study and were randomly assigned to either a real intradermal acupuncture group (RA group) or a sham acupuncture group (SA group). The RA group received intradermal acupuncture on Shen-Men (He-7) and Nei-Kuan (EH-6) for three days, and the SA group received sham acupuncture on the same points. The effect of acupuncture on insomnia was measured using Insomnia Severity Index (ISI) and Athens Insomnia Scale (AIS) at baseline and three days after treatment. To assess the effect of acupuncture on the autonomic nervous function, the subjects' blood pressure and heart rate variability were monitored. Fifty-two subjects (27 in the RA group and 25 in the SA group) were included in the final analysis. The insomnia-related scales ISI and AIS showed greater improvement of insomnia in the RA group than in the SA group. Moreover, there is a greater reduction of the number of non-dippers and a greater decrease of the LF/HF ratio (heart rate variability) in the RA group than in the SA group. These results indicate that sympathetic hyperactivities were stabilized in the RA group. It can thus be concluded that intradermal acupuncture on Shen-Men and Nei-Kuan is a useful therapeutic method for post stroke-onset insomnia as it reduces sympathetic hyperactivities.

Acupuncture for Diagnostic Fiberoptic Bronchoscopy: A Prospective, Randomized, Placebo-Controlled Study

2006 ◽  
Vol 34 (03) ◽  
pp. 409-415 ◽  
Author(s):  
Luca Cabrini ◽  
Luigi Gioia ◽  
Marco Gemma ◽  
Giulio Melloni ◽  
Angelo Carretta ◽  
...  
Keyword(s):  
Fiberoptic Bronchoscopy ◽  
Sham Acupuncture ◽  
Controlled Study ◽  
Double Blind Study ◽  
Patient Anxiety ◽  
Double Blind ◽  
Before And After ◽  
Routine Basis ◽  
Group A ◽  
Group B

Patients usually fear fiberoptic bronchoscopy (FBS) and they report a low level of satisfaction after this examination. We evaluated the efficacy of acupuncture in decreasing patient anxiety before diagnostic FBS and in improving tolerance to the examination. In a prospective double-blind study, we enrolled 48 patients scheduled to undergo diagnostic FBS. Patients were randomly assigned to one of three groups. Group A (16 patients): standard FBS, with airway topic anesthesia; Group B (16 patients): standard FBS, with airway topic anesthesia and acupuncture treatment; Group C (16 patients): standard FBS, with airway topic anesthesia and sham acupuncture. EKG, non-invasive arterial pressure, and pulse oximetry were monitored on a routine basis. We evaluated patient anxiety before and after acupuncture and, at the end of FBS, the discomfort suffered during the examination by a 100-mm Visual Analog Scale (VAS). Patient satisfaction in Group A was 50% worse than in Group B ( p = 0.04). We observed a strong, even if not statistically significant, tendency toward a lower pre-FBS anxiety in Group B. Patients in group C had values very close to those recorded in group A. We observed no adverse event and no differences in cardio-respiratory parameters in these three groups; in particular, we did not observe a respiratory depression in Group B. Acupuncture seems an effective resource for a Thoracic Endoscopic Room to improve patient tolerance to FBS.

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.

scholarly journals Acupuncture at the P6 Acupoint to Prevent Postoperative Pain after Craniotomy: A Randomized, Placebo-Controlled Study

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Jian-Qin Lv ◽  
Peng-Cheng Li ◽  
Li Zhou ◽  
Wen-Fu Tang ◽  
Ning Li
Keyword(s):  
Postoperative Pain ◽  
Controlled Trial ◽  
Sham Acupuncture ◽  
Acupuncture Group ◽  
Controlled Study ◽  
Pain Scores ◽  
Significant Difference ◽  
Lower Pain ◽  
Sham Acupuncture Group ◽  
De Qi

Objective. Acute pain management after craniotomy can be challenging. Previous studies have shown inadequate pain control following the procedure. Oral medication can sometimes be delayed by postoperative nausea, and use of anesthetics may impair the assessment of brain function. We conducted this prospective study to evaluate the effect of acupuncture at the P6 acupoint on postoperative pain, nausea, and vomiting in patients undergoing craniotomy. Methods. The authors conducted a randomized, placebo-controlled trial among 120 patients scheduled for craniotomy under general anesthesia. 120 patients were randomly assigned into an acupuncture group or a sham acupuncture group. All patients received standardized anesthesia and analgesia treatment. Acupuncture was executed in the recovery room after surgery. For the acupuncture group, the P6 points on each wrist were punctured perpendicularly to a depth of 20 mm. Needles were retained for 30 min and stimulated every 10 min to maintain the De-Qi sensation. For the sham acupuncture group, sham points on each wrist were punctured perpendicularly to a depth of 5 mm. Needles were retained for 30 min with no stimulation during the duration. The postoperative pain scores, PONV, and dose of tramadol were assessed 24 h, 48 h, and 72 h after surgery. Results. A total of 117 patients completed the study. There was no statistically significant difference in baseline data between the two groups ( P > 0.05 ). The VAS pain score of the acupuncture group was lower than that of the sham acupuncture group, and this difference was statistically significant ( P = 0.002 ). There was no difference in pain scores between the two groups during 0–24 h and 48–72 h ( P > 0.05 ). The incidence of vomiting in the acupuncture group was lower than that in the sham acupuncture group during the 0–24 h period (13.8% vs. 28.8%, P = 0.048 ). There was no difference in vomiting, however, during the 24–72 h period ( P > 0.05 ). No significant differences were found in the degree of nausea and the dose of tramadol between the two groups at either time point in the acupuncture group and sham acupuncture group. Conclusion. The use of acupuncture at the P6 acupoint in neurosurgery patients did result in significantly lower pain scores and reduction in the incidence of vomiting after craniotomy. There were no significant side effects. Acupuncture at the P6 acupoint was well tolerated and safe in this patient population.

scholarly journals Fourteen-days Evolution of COVID-19 Symptoms During the Third Wave in Non-vaccinated Subjects and Effects of Hesperidin Therapy: A randomized, double-blinded, placebo-controlled study.

2021 ◽  
Author(s):  
Jocelyn Dupuis ◽  
Pierre Laurin ◽  
Jean-Claude Tardif ◽  
Leslie Hausermann ◽  
Camille Rosa ◽  
...  
Keyword(s):  
Placebo Group ◽  
Missing Values ◽  
Controlled Trial ◽  
Controlled Study ◽  
Shortness Of Breath ◽  
Bias Analysis ◽  
Double Blind ◽  
Runny Nose ◽  
Group A ◽  
Double Blinded

COVID-19 symptoms can cause substantial disability, yet no therapy can currently reduce their frequency or duration. We conducted a double-blind placebo-controlled trial of hesperidin 1000 mg once-daily for 14 days in 216 symptomatic non-vaccinated COVID-19 subjects. Thirteen symptoms were recorded after 3, 7, 10 and 14 days. The primary endpoint was the proportion of subjects with any of four cardinal (group A) symptoms: fever, cough, shortness of breath or anosmia. At baseline, symptoms in decreasing frequency were: cough (53.2%), weakness (44.9%), headache (42.6%), pain (35.2%), sore throat (28.7%), runny nose (26.9%), chills (22.7%), shortness of breath (22.2%), anosmia (18.5%), fever (16.2%), diarrhea (6.9%), nausea/vomiting (6.5%) and irritability/confusion (3.2%). Group A symptoms in the placebo vs hesperidin group was 88.8% vs 88.5% (day 1) and reduced to 58.5 vs 49.4 % at day 14 (OR 0.69, 95% CI 0.38–1.27, p = 0.23). At day 14, 15 subjects in the placebo group and 28 in the hesperidin group failed to report their symptoms. In an attrition bias analysis imputing ″no symptoms″ to missing values, the hesperidin group shows reduction of 14.5 % of group A symptoms from 50.9% to 36.4% (OR: 0.55, 0.32–0.96, p = 0.03). Anosmia, the most frequent persisting symptom (29.3%), was lowered by 7.3% at 25.3 % in the hesperidin group vs 32.6% in the placebo group (p = 0.29). Mean number of symptoms in placebo and hesperidin was 5.10 ± 2.26 vs 5.48 ± 2.35 (day 1) and 1.40 ± 1.65 vs 1.38 ± 1.76 (day 14) (p = 0.92). In conclusion, most non-vaccinated COVID-19 infected subjects remain symptomatic after 14 days with anosmia being the most frequently persisting symptom. Hesperidin 1g daily may help reduce group A symptoms. Earlier treatment of longer duration and/or higher dosage should be tested.

Pregabalin As A Premedicant To Attenuate Pressor Response In Patients Undergoing Laparoscopic Cholecystectomy: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study

2020 ◽  
Vol 11 (3) ◽  
pp. 3418-3423
Author(s):  
Sweety Agrawal ◽  
Shubdha Bhagat ◽  
Pratibha Deshmukh ◽  
Amol Singham
Keyword(s):  
Laparoscopic Cholecystectomy ◽  
Pressor Response ◽  
Controlled Study ◽  
Double Blind ◽  
Co2 Insufflation ◽  
Ramsay Sedation Scale ◽  
Minute Interval ◽  
Group A ◽  
Group B ◽  
Induction Of Anaesthesia

The present study was done to evaluate the ability of oral pregabalin to attenuate the pressor response to airway instrumentation in patients undergoing laparoscopic cholecystectomy under general anesthesia. Sixty-four adult patients aged between 25-55 year of either gender belonging to ASA-1 or ASA2 physical status weighing 50-70 kg were enrolled in this study. Thirty-two patients each were randomized to group A, or group B. Patients in group A received tablet Pregabalin (150mg) and those in group B received placebo orally one hour before induction of anaesthesia. Heart rate, blood pressure, and sedation were assessed preoperatively before giving the tablets and after 30 minutes, and just before induction of anaesthesia. Intraoperative, pulse rate, mean arterial pressure, ECG in the lead II, SPO2 and ETCO2 were monitored. All the above parameters were noted during laryngoscopy and intubation, 3 minutes after CO2 insufflation, and then at every 10-minute interval till the end of surgery. These parameters were also recorded after extubating the patient. The Ramsay sedation scale was used to assess the sedation at the baseline, one hour after drug intake , one hour after extubation and 4 hour after surgery. Any adverse effects in the postoperative period were recorded. The result of our study shows that pre-emptive administration of oral pregabalin 150 mg significantly reduced the pressor response at the time of laryngoscopy and intubation, after CO2 insufflation and just after extubation. We conclude that oral pregabalin premedication is effective in successful attenuation of hemodynamic pressor response to laryngoscopy, intubation and pneumoperitoneum in patients undergoing laparoscopic cholecystectomy

scholarly journals Treatment of bipolar depression with supraphysiologic doses of levothyroxine: a randomized, placebo-controlled study of comorbid anxiety symptoms

2019 ◽  
Vol 7 (1) ◽  
Author(s):  
Maximilian Pilhatsch ◽  
Thomas J Stamm ◽  
Petra Stahl ◽  
Ute Lewitzka ◽  
Anne Berghöfer ◽  
...  
Keyword(s):  
Bipolar Disorder ◽  
Rating Scale ◽  
Bipolar Depression ◽  
Phenotypic Expression ◽  
Anxiety Symptoms ◽  
Controlled Study ◽  
Double Blind ◽  
Comorbid Anxiety ◽  
Depressed Patients ◽  
Depressive Episodes

Abstract Background Symptoms of anxiety co-occur in a variety of disorders including in depressive episodes of bipolar disorder and in patients with thyrotoxicosis. Treatment of refractory bipolar disorder with supraphysiologic doses of levothyroxine (L-T4) has been shown to improve the phenotypic expression of the disorder and is associated with an increase of circulating thyroid hormones. However, it might be associated with somatic and mental adverse effects. Here we report the investigation of the influence of treatment with supraphysiologic doses of L-T4 on symptoms of anxiety in patients with refractory bipolar depression. Methods Post-hoc analysis from a 6-week, multi-center, randomized, double-blind, placebo-controlled study of the effects of supraphysiologic L-T4 treatment on anxiety symptoms in bipolar depression. Anxiety symptoms were measured weekly with the Hamilton anxiety/somatization factor (HASF) score of the Hamilton Depression Rating Scale (HAMD) and the State- and Trait Anxiety Inventory (STAI). Results Treatment of both groups was associated with a significant reduction in anxiety symptoms (p < 0.001) with no statistical difference between groups (LT-4: from 5.9 (SD = 2.0) at baseline to 3.7 (SD = 2.4) at study end; placebo: from 6.1 (SD = 2.4) at baseline to 4.4 (SD = 2.8) at study end; p = 0.717). Severity of anxiety at baseline did not show a statistically significant correlation to the antidepressive effect of treatment with supraphysiologic doses of L-T4 (p = 0.811). Gender did not show an influence on the reduction of anxiety symptoms (females: from 5.6 (SD = 1.7) at baseline to 3.5 (SD = 2.4) at study end; males: from 6.1 (SD = 2.3) at baseline to 4.0 (SD = 2.4) at study end; p = 0.877). Conclusions This study failed to detect a difference in change of anxiety between bipolar depressed patients treated with supraphysiologic doses of L-T4 or placebo. Comorbid anxiety symptoms should not be considered a limitation for the administration of supraphysiologic doses of L-T4 refractory bipolar depressed patients. Trial registration ClinicalTrials, ClinicalTrials.gov identifier: NCT01528839. Registered 2 June 2012—Retrospectively registered, https://clinicaltrials.gov/ct2/show/study/NCT01528839

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