Validation of a Simplified Sham Acupuncture Technique for Its Use in Clinical Research: A Randomised, Single Blind, Crossover Study

2010 ◽  
Vol 28 (1) ◽  
pp. 33-36 ◽  
Author(s):  
Marcelo Kreiner ◽  
Ana Zaffaroni ◽  
Ramón Alvarez ◽  
Glenn Clark

Objectives The validity of a new sham acupuncture technique was tested on acupuncture naïve healthy subjects. Methods The procedure was tested in accupoints LI4 and ST6 in a randomised, single blind and crossover study. The participants were blind to which technique they received. 32 healthy volunteers (15 men, 17 women, aged between 20 and 62 years, mean age 34 years) were recruited at the Universidad de la República, Uruguay. Interventions Participants were randomly assigned to one of two groups: (1) real acupuncture or (2) sham acupuncture. After 30 min, the patients were ‘needled’ again in a crossover design. Main outcome measures A yes/no questionnaire was used to assess the credibility and characteristics of the procedure. Results For the credibility question (do you think you received real acupuncture?) no statistically significant group differences were evident before or after the crossover. Subjects who answered yes to this question ranged from 14/16 (87.5%) before crossover to 10/16 (62.5%) after crossover for the sham and 12/16 (75%) before crossover to 15/16 (93.8%) after crossover for the real acupuncture. The question that showed a significant difference (only after crossover) was the question, “did you feel the needle penetrating the skin?”; after crossover 12/16 (75%) subjects in the real acupuncture group said yes and 2/16 (12%) subjects in the sham group said yes to this question (p<0.01). Conclusions These data suggests that this method is credible and constitutes a simple and inexpensive technique for use as a control in clinical research in acupuncture naïve subjects.

2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
Kyung-Min Shin ◽  
Ji-Eun Park ◽  
Sanghun Lee ◽  
Sun-Mi Choi ◽  
Yo-Chan Ahn ◽  
...  

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).


2012 ◽  
Vol 56 (4) ◽  
pp. 250-258 ◽  
Author(s):  
Andressa Bornschein ◽  
Gilberto Paz-Filho ◽  
Hans Graf ◽  
Gisah A. de Carvalho

OBJECTIVE: Compliance to levothyroxine treatment in hypothyroidism is compromised by daily schedule, and a weekly dose may be an alternative. SUBJECTS AND METHODS: This was a randomized, crossover study. Fourteen females were assigned to daily or weekly doses of LT4. After six weeks, they switched regimens. Thyroid parameters were measured at baseline, and after 42 and 84 days. Echocardiogram and hyperthyroidism symptoms were evaluated before and four hours after LT4 intake. RESULTS: In the weekly dose treatment, fT4 levels were higher after taking LT4, and lower seven days after the last dose; by the 6th week there was a small decrease in T3 levels. TSH remained unchanged and there were no hyperthyroidism symptoms or echocardiographic manifestations. CONCLUSION: Weekly dose leads to transient increases in fT4, without hyperthyroidism or cardiac symptoms. That approach seems to be a safe alternative for the treatment of hypothyroidism.


2020 ◽  
Vol 28 (6) ◽  
pp. 844-853
Author(s):  
Nicholas L. Lerma ◽  
Chi C. Cho ◽  
Ann M. Swartz ◽  
Hotaka Maeda ◽  
Young Cho ◽  
...  

The purpose of this study was to explore the feasibility and acceptability of a seated pedaling device to reduce sedentary behavior (SB) in the homes of older adults. Methods: Each participant (N = 20) was outfitted with an activity monitor and seated pedaling device in the home for 7 days and randomly assigned to one of four light-intensity pedaling groups (15, 30, 45, and 60 min/day). Results: There was 100% adherence in all groups and significant group differences in the minutes pedaled per day (p < .001), with no significant difference in the total pedaling days completed (p = .241). The 15-, 30-, 45-, and 60-min groups experienced a 4.0%, 5.4%, 10.6%, and 11.3% reduction in SB on the days pedaled, respectively. Conclusion: Clinically relevant reductions in SB time were achievable in this 1-week trial. Long-term adherence and the impact of replacing SB with seated light activities on geriatric-relevant health outcomes should be investigated.


2015 ◽  
Vol 2015 ◽  
pp. 1-7 ◽  
Author(s):  
Miho Takayama ◽  
Hiroyoshi Yajima ◽  
Akiko Kawase ◽  
Ikuo Homma ◽  
Masahiko Izumizaki ◽  
...  

It remains an open question whether placebo/sham acupuncture, in which the needle tip presses the skin, can be used as a placebo device for research on pain. We compare the analgesic effect of the skin-touch placebo needle with that of the no-touch placebo needle, in which the needle tip does not touch the skin, in a double-blind crossover manner including no-treatment control in 23 healthy volunteers. The subjects received painful electrical stimulation in the forearm before and during needle retention to the LI 4 acupoint and after the removal of the needle and rated pain intensity using a visual analogue scale. We found no significant difference in analgesic effects among the skin-touch placebo needle, no-touch placebo needle, and no-treatment control at every point before, during, and after the treatments (p>0.05). The results indicate that the skin-touch placebo needle can be used as a placebo device in clinical studies on pain.


1982 ◽  
Vol 10 (4) ◽  
pp. 214-218 ◽  
Author(s):  
L A Verbruggen ◽  
E Cytryn ◽  
H Pintens

Twenty-one patients entered a double-blind crossover study to compare nabumetone with naproxen. After a I-week run-in period using a coated acetylsalicylic acid preparation, ten patients received nabumetone (1 g at night) over a period of 2 weeks, followed by 2 weeks on naproxen (250 mg b.i.d), while eleven patients received the same treatments in the reverse order. Morning stiffness, overall pain and night pain showed no significant difference after either treatment. A wide range of objective measurements were made relating to the hips, knees, and cervical and lumbar spine. No statistically significant differences were observed in the relatively small number of patients involved. Both treatments, however, appeared to produce a similar improvement in the patients. The physician's assessment showed that improvement occurred in a majority of the patients over the total trial period. Both drugs were considered to be equally effective and were both well tolerated. There was no special patient preference for either the first or second treatment. A total of eight patients reported side-effects, three during naproxen alone, three during both treatments, and two during the run-in period. In terms of tolerance, fifteen patients had no drug preference, six preferred nabumetone, none preferred naproxen. No evidence was found of changes in renal, hepatic or haematopoietic function with the two drugs tested.


Nutrition ◽  
2013 ◽  
Vol 29 (9) ◽  
pp. 1122-1126 ◽  
Author(s):  
Kalliopi Karatzi ◽  
Victoria G. Rontoyanni ◽  
Athanase D. Protogerou ◽  
Aggeliki Georgoulia ◽  
Konstantinos Xenos ◽  
...  

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