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.

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 Effect of Siguan Acupuncture on Gastrointestinal Motility: A Randomized, Sham-Controlled, Crossover Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
Kyung-Min Shin ◽  
Ji-Eun Park ◽  
Sanghun Lee ◽  
Sun-Mi Choi ◽  
Yo-Chan Ahn ◽  
...  
Keyword(s):  
Gastrointestinal Motility ◽  
Acupuncture Treatment ◽  
Gastrointestinal Symptoms ◽  
Sham Acupuncture ◽  
The Body ◽  
Acupuncture Group ◽  
The Real ◽  
Real Acupuncture ◽  
Significant Difference ◽  
Sham Acupuncture Group

Siguan acupoints have been used to treat gastrointestinal symptoms in acupuncture practices for a long time. This study aimed to investigate the effects of Siguan acupuncture on gastrointestinal motility under accelerated conditions using a randomized, sham-acupuncture-controlled, crossover study. Twenty-one healthy male subjects were hospitalized and randomized into either a real acupuncture group (at Siguan acupoints) or a sham acupuncture group. Subjects were administered with mosapride citrate (15 mg a day) for 2 days starting 24 hours before the first acupuncture treatment. Immediately after the administration of radio markers, acupuncture treatment was conducted 4 times at 12-hour intervals. Gastrointestinal motility was assessed using radiograph distribution of the radio-markers located in the small intestine, ascending colon, transverse colon, descending colon, rectum, and outside the body immediately after the first acupuncture treatment and at 6, 12, 24, and 48 hours. After a 2-week washout period, the real acupuncture group in the first session was treated with sham acupuncture in the second session, and vice versa. Gastrointestinal motility was generally reduced in the real acupuncture group compared with the sham acupuncture group throughout the 4 different time points. A significant difference was observed at 24 hours following the first acupuncture treatment (P<0.05).

Developing and Validating a Sham Acupuncture Needle

2009 ◽  
Vol 27 (3) ◽  
pp. 118-122 ◽  
Author(s):  
Elizabeth A Tough ◽  
Adrian R White ◽  
Suzanne H Richards ◽  
Brian Lord ◽  
John L Campbell
Keyword(s):  
Randomised Controlled Trial ◽  
Trigger Point ◽  
Controlled Trial ◽  
Sham Acupuncture ◽  
Previous Experience ◽  
Credibility Scale ◽  
Significant Difference ◽  
Sham Intervention ◽  
Sham Acupuncture Group ◽  
Randomised Controlled

Objectives To develop a sham needle device and test its credibility as a control for acupuncture when used in a randomised controlled trial of myofascial trigger point needling in patients with whiplash associated pain. Methods Sham needles were developed by blunting true acupuncture needles. Whiplash injured patients (<16 weeks duration) were randomly allocated to receive either true acupuncture or the “placebo” sham needle control. The true and sham needling interventions were delivered using the same standardised procedure. Patients were informed that they would receive either real or placebo needles, and asked (i) to state which treatment they believed they had received (treatment belief); (ii) to complete the four item Borkovec and Nau self-assessment credibility scale. Results were compared between groups and the analysis explored whether a patient's previous experience of acupuncture was related to their treatment belief. Other outcomes of the study will be reported elsewhere. Results 20 patients received the true acupuncture and 21 received the sham. There was no significant difference between the treatment beliefs of the two groups (χ 2 = 1.51; p>0.2) nor in the mean item scores on the Borkovec and Nau credibility scale (t test, p values ranged from 0.38 to 0.87). Of the patients in the sham acupuncture group who had previous experience of acupuncture, none recorded receiving the sham intervention. Conclusion Within the context of this pilot study, the sham acupuncture intervention was found to be a credible control for acupuncture. This supports its use in a planned, definitive, randomised controlled trial on a similar whiplash injured population.

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 Effect of “Deqi” during the Study of Needling “Wang’s Jiaji” Acupoints Treating Spasticity after Stroke

2014 ◽  
Vol 2014 ◽  
pp. 1-8 ◽  
Author(s):  
Huanqin Li ◽  
Huilin Liu ◽  
Cunzhi Liu ◽  
Guangxia Shi ◽  
Wei Zhou ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Statistical Difference ◽  
Early Stage ◽  
Controlled Trial ◽  
Muscle Tension ◽  
Sham Acupuncture ◽  
Acupuncture Group ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial ◽  
Sham Acupuncture Group

Background.Acupuncture has been shown to reduce spasticity and prevent the onset of spasticity after stroke. The purpose of this study is to assess the effect of “Deqi” during needling “Wang’s Jiaji” acupoints treating spasticity in the early stage of stroke.Methods. This study is a multicenter, prospective, randomized, controlled trial. 238 patients with stroke (<21 days) participated and were randomly allocated to the verum-acupuncture (n=121) group or sham-acupuncture group (n=117). The verum-acupuncture group received verum acupuncture required to produce the sense of “Deqi” while the sham-acupuncture group received sham acupuncture without “Deqi.” Patients in both groups followed the same 30 min acupuncture regimen 5 times per week for a period of 4 weeks. Scales of MAS, FMA, ADL, MBI, NIHSS, SS-QOL, and MRS were measured at baseline and at 2, 4, and 12 weeks after intervention.Results.Significant differences were observed between two groups. The MRS rating composition has the statistical difference after 4 weeks (P=0.017). The score of MAS, FMA, Barthel, and SSQOL in verum-acupuncture group has increased significantly compared with the sham-acupuncture group after 12 weeks. There was 14% reduction of higher muscle tension in the verum-acupuncture group.Conclusion.Acupuncture “Wang’s Jiaji” points with sensation of “Deqi” in the early stage may reduce the occurrence and decrease the severity of spasticity after stroke.

Effect of Acupuncture on Perception Threshold: A Randomised Controlled Trial

2012 ◽  
Vol 30 (1) ◽  
pp. 32-36
Author(s):  
Shuang Wu ◽  
Hidenori Yamaguchi ◽  
Koh Shibutani
Keyword(s):  
Controlled Trial ◽  
Mental Foramen ◽  
Sham Acupuncture ◽  
Acupuncture Group ◽  
Control Group ◽  
Perception Threshold ◽  
Left Hand ◽  
Before And After ◽  
Sham Acupuncture Group ◽  
Randomised Controlled

Objective To determine the current perception thresholds (CPTs) for arm and mental foramen areas to enable a quantitative evaluation of the effectiveness of acupuncture treatment. Methods Ninety-eight volunteers enrolled as participants and were randomly assigned to one of three groups: an acupuncture group (34 subjects); a sham acupuncture group (32 subjects) and a waiting group (32 subjects). CPTs for the arm and mental foramen areas were determined before and after acupuncture at LI4 Hegu of the left hand. A Neurometer CPT was used to evaluate the perception threshold at the homolateral mental foramen and arm. For further exploration, thresholds of homolateral and contralateral mental foramina were determined before and after acupuncture in a subgroup of 13 participants in the acupuncture group. Results Acupuncture at LI4 increased the perception thresholds of the left mental foramen in the acupuncture group significantly (p<0.01). The increases were significantly greater than in the control group for all frequencies, and significantly greater than sham acupuncture for 250 Hz and 5 Hz. In the subgroup, only the CPTs at 5 Hz increased significantly for the contralateral mental foramen. Conclusions Acupuncture at LI4 increases the perception threshold in the mandibular area, but not in the arm. This finding is probably related to the analgesic effect of acupuncture.

scholarly journals Acupuncture for Psychosomatic Symptoms of Hwa-byung, an Anger Syndrome: A Feasibility Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Yujin Choi ◽  
In-Hye Park ◽  
Jung-Eun Kim ◽  
Ojin Kwon ◽  
Ae-Ran Kim ◽  
...  
Keyword(s):  
Effect Size ◽  
Controlled Trial ◽  
A Priori ◽  
Pilot Trial ◽  
Sham Acupuncture ◽  
Acupuncture Group ◽  
Psychosomatic Symptoms ◽  
Randomized Controlled ◽  
Trial Testing ◽  
Sham Acupuncture Group

Objectives: Emerging studies found the potential effects of acupuncture for treating chronic pain and mental disorders, namely, depressive and anxiety disorders. Acupuncture is widely used for treating culture-related anger syndrome, Hwa-byung. This pilot trial aimed to investigate the feasibility of a clinical trial testing acupuncture for the psychosomatic symptoms of Hwa-byung.Methods: A total of 26 patients with Hwa-byung planned to be randomly assigned to the acupuncture or sham acupuncture groups. About 10 treatment sessions were applied over 4 weeks. The 100-mm visual analog scale was used to measure the six major Hwa-byung symptoms: stuffiness in the chest, heat sensations, pushing-up in the chest, feeling a mass in the throat, feelings of unfairness, and hard feelings. The criteria for assessing the success of this pilot trial were defined as improvement in three or more of the six Hwa-byung symptoms after treatment, with an effect size &gt;0.2.Results: A total of 15 patients were finally included and randomly assigned to the acupuncture group (n = 7) or the sham acupuncture group (n = 8). After 10 treatment sessions, the Cohen's d effect sizes for acupuncture compared to sham acupuncture were &gt;0.2 for each one of the six major Hwa-byung symptoms, which met our a priori criteria for success. Also, the effect size for the somatic symptoms of “stuffiness in the chest” was 0.81 (95% CI −0.40, 2.20), referring to a large effect size.Conclusions: Our results suggest that acupuncture treatment would be regarded as an acceptable intervention for a full-scale study of psychosomatic symptoms in patients with Hwa-byung.Trial Registration:cris.nih.go.kr, identifier: KCT0001732.

scholarly journals Effect of acupuncture at Zusanli (ST36) point on antral contraction function under ultrasound guidance: study protocol of a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Yingqi Chen ◽  
Yu Bian ◽  
Shanshan Li ◽  
Yuanyuan Zhao ◽  
Jiaying Li ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Sham Acupuncture ◽  
Acupuncture Group ◽  
Superficial Fascia ◽  
Manual Acupuncture ◽  
Randomized Controlled ◽  
Objective Evidence ◽  
Contraction Function ◽  
Sham Acupuncture Group

Abstract Background Although the relationship between deqi sensations and curative effect has always been controversial, deqi sensations has been regarded as the key indicator of clinical efficacy of acupuncture therapy. There is little evidence for standardization or visualization of the mechanism of acupuncture’s therapeutic effect. This trial aims to evaluate the effect of needling at Zusanli (ST36) on antral contraction function as visualized by ultrasound. Methods This is a two-arm, single-blind, randomized, controlled trial. A total of 116 acupuncture-naïve healthy subjects will be randomly allocated to the acupuncture group or sham acupuncture group in a 1:1 ratio. Participants in the acupuncture group will receive manual acupuncture at Zusanli (ST36) with the needling depth at crural interosseous membrane. Those in the sham acupuncture group will be given penetrating needling depth at the superficial fascia layer. The primary outcome will be the changes in antral contraction frequency (ACF) before and after acupuncture. The secondary outcomes will be the changes in the thermal infrared spectrum of gastric area skin, the antral contraction amplitude (ACA), the antral movement index (AMI), and the scores on the Chinese version of Massachusetts General Hospital Acupuncture Sensation Scale (C-MASS). The adverse events will be evaluated and recorded in detail. Discussion This study may provide visual and objective evidence regarding the safety and efficacy of manual acupuncture at Zusanli (ST36). In addition, the results of this study will help to identify the role of Zusanli (ST36)in the inducing deqi. Trial registration Chinese Clinical Trial Registry ChiCTR2000040686. Registered on 8 December 2020

scholarly journals Comparison of Salbutamol and Salbutamol with ipratropium bromide in children with exacerbation of Asthma in terms of peak expiratory flow rate (PEFR).

2021 ◽  
Vol 28 (11) ◽  
pp. 1611-1615
Author(s):  
Sadaf Minhas ◽  
Saqib Aslam ◽  
Muhammad Azhar Farooq ◽  
Ayesha Anwar ◽  
Farhan Zahoor ◽  
...  
Keyword(s):  
Peak Expiratory Flow ◽  
Ipratropium Bromide ◽  
Controlled Trial ◽  
P Value ◽  
Significant Difference ◽  
Group A ◽  
Expiratory Flow ◽  
The Difference ◽  
Group B ◽  
Trial Setting

Objective: To compare the Salbutamol alone and Ipratropium Bromide supplemented Salbutamol in children with exacerbation of asthma in terms of PEFR. Study Design: Randomized Controlled Trial. Setting: Pediatrics Emergency, KRL Hospital Islamabad. Period: 1st August 2016 to 31 January 2017. Material & Methods: Group A patients were given only Salbutamol (0.15mg/kg per dose with minimum 2.5 mg, maximum 5 mg/dose). Group B was given Ipratropium Bromide supplemented Salbutamol (250 mcg/dose for <20 kg while 500 mcg/dose for >20kg of Ipratropium Bromide with same dose of Salbutamol as prescribed for Group A). Baseline spirometry was performed on each patient and after measurement of baseline peak expiratory flow. The outcome was measured by Peak flow meter and reassessed at 60 minutes. Results: Comparison of salbutamol alone and ipratropium bromide supplemented salbutamol in children with exacerbation of asthma in terms of PEFR shows that 40.5 + 4.28 in Group-A and 59.5 +4.75 in Group-B, P-value was calculated as 0.0001, showing a significant difference between the two groups while the difference in increase was recorded as 19%. Conclusion: We concluded that salbutamol alone is significantly less effective when compared with Ipratropium Bromide supplemented Salbutamol in children with exacerbation of asthma in terms of PEFR.

scholarly journals Comparative study of magnesium, sodium valproate, and concurrent magnesium-sodium valproate therapy in the prevention of migraine headaches: a randomized controlled double-blind trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Samira Khani ◽  
Seyed Amir Hejazi ◽  
Mehdi Yaghoubi ◽  
Ehsan Sharifipour
Keyword(s):  
Sodium Valproate ◽  
Migraine Prophylaxis ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
The Third ◽  
Migraine Headaches ◽  
Parallel Group ◽  
Significant Difference ◽  
Group A ◽  
Group B

Abstract Objective This study aimed to assess the efficacy of concurrent magnesium-sodium valproate therapy and compare it with either magnesium or sodium valproate alone in migraine prophylaxis. Materials and methods This randomized single-center double-blind parallel-group controlled clinical trial study was conducted on migraine patients within the age range of 18–65 years. The subjects with at least four monthly attacks were randomly assigned to group A (n = 82) sodium valproate, group B (n = 70) magnesium with sodium valproate, and group C (n = 70) magnesium. The patients passed a one-month baseline without prophylactic therapy and then received a 3-month treatment. The characteristics of migraine, including frequency, severity, duration of the attacks, and the number of painkillers taken per month, were monthly recorded in each visit. The Migraine Disability Assessment (MIDAS) and Headache Impact Test-6 (HIT-6) scores were recorded at the baseline and after 3 months of treatment in each group. Within- and between-group analyses were performed in this study. Results The obtained results revealed a significant reduction in all migraine characteristics in all groups compared to those reported for the baseline (P <  0.001). Intragroup data analysis indicated that there was no statistically significant difference in headache frequency between groups A and B in the third month (P = 0.525); nevertheless, three other parameters showed a significant reduction in group B, compared to those reported for group A in the third month (P <  0.05). On the other hand, group C could not effectively reduce measured parameters in the patients, compared to groups A and B after 3 months (P <  0.001). Furthermore, the MIDAS and HIT-6 scores significantly diminished in groups A, B, and C compared to those reported at the baseline (P <  0.001), and these changes were more significant in groups A and B than in group C (P <  0.001). Conclusion The obtained results of this study revealed that magnesium could enhance the antimigraine properties of sodium valproate in combination therapy and reduce the required valproate dose for migraine prophylaxis.

Sign in / Sign up

Export Citation Format

Share Document