Authors’ Response to Dr. Zhang on the Methodological and Sham Acupuncture Issues

Abstract Background Acupuncture is widely used for pain diseases while evidence of its efficacy for sciatica is insufficient. We aim to explore the feasibility and efficacy of acupuncture with different acupoint selecting strategies for sciatica induced by lumbar disc herniation. Methods This is a multicenter, three-arm, patient-assessor-blinded randomized controlled pilot trial. Ninety patients will be assigned randomly into 3 groups including disease-affected meridians (DAM) group, non-affected meridians (NAM) group, and sham acupuncture (SA) group in a 1:1:1 ratio. The trial involves a 4-week treatment along with follow-up for 22 weeks. The primary outcome is the change of leg pain intensity measured by the visual analogue scale (VAS) from baseline to week 4 after randomization. Secondary outcomes include functional status, back pain intensity, and quality of life. Adverse events will also be recorded. Discussion The results will inspire the optimal acupuncture strategy for sciatica and help establish a better design as well as power calculation for a full-scale study. Trial registration ChiCTR2000030680 (Chinese Clinical Trial Registry, http://www.chictr.org.cn, registered on 9 March 2020).

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The cerebral mechanism of acupuncture for chronic insomnia with gastrointestinal disorder: protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-021-05332-3 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Wei Peng ◽

Xiaojuan Hong ◽

Yaru Huangfu ◽

Zhao Sun ◽

Wei Shen ◽

...

Keyword(s):

Rating Scale ◽

Acupuncture Treatment ◽

Sham Acupuncture ◽

Acupuncture Group ◽

Chronic Insomnia ◽

Self Rating ◽

Real Acupuncture ◽

Gi Symptoms ◽

Mri Scans ◽

Multimodal Mri

Abstract Background Many patients with chronic insomnia disorder (CID) have gastrointestinal (GI) symptoms. First-line insomnia medications do not treat GI problems. Acupuncture has a comprehensive regulative action on both CID and GI disorder and is receiving increasing attention. Recent studies indicate that both CID and GI diseases may cause abnormal brain activity. However, the neurological mechanism underlying the effect of acupuncture on such diseases is still unclear. The aim of this study is to explore the pathological mechanisms of CID with GI discomfort, as well as the main response characteristics of acupuncture treatment from multiple perspectives using multimodal magnetic resonance imaging (MRI). Methods A total of 60 participants with CID and GI disorders will be randomly divided into two groups (real acupuncture group and sham acupuncture group; ratio of 1:1). Patients will receive 20 sessions (five sessions per week) of real acupuncture treatment or sham acupuncture treatment. The primary outcome is the aggregate score on the Pittsburgh Sleep Quality Index. Secondary outcomes are scores on the Gastrointestinal Symptom Rating Scale, Self-Rating Anxiety Scale, and Self-Rating Depression Scale. Multimodal MRI scans and clinical assessments will be performed both at baseline and post-treatment. Another 30 age-, sex-, and education-matched healthy subjects will be recruited as controls and will receive MRI scans and clinical evaluations. Discussion This study aims to provide scientific evidence for the mechanism of acupuncture in treating CID with GI disorder using multimodal MRI imaging data on brain structure, function, and metabolism. Trial registration Chinese Clinical Trial Registry, ChiCTR1800017092 (URL: http://www.chictr.org.cn/showproj.aspx?proj=27173). Registered on July 11, 2018.

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Complementary and alternative interventions for stroke recovery – a narrative overview of the published evidence

Journal of Complementary and Integrative Medicine ◽

10.1515/jcim-2020-0062 ◽

2021 ◽

Vol 0 (0) ◽

Author(s):

Narayanaswamy Venketasubramanian

Keyword(s):

Motor Function ◽

Meta Analysis ◽

Cochrane Review ◽

Sham Acupuncture ◽

Stroke Recovery ◽

Cochrane Library ◽

Walking Ability ◽

Alternative Interventions ◽

Published Evidence ◽

Complementary And Alternative

Abstract Objectives Stroke survivors dissatisfied with their progress often seek complementary and alternative interventions (CAI). This paper reviews the evidence for CAIs in stroke recovery. Methods A literature search was performed for publications until December 2019 of CAI for stroke in Pubmed, Cochrane Library, EMBASE, CINAHL, AMED. Evidence was assessed according to Oxford Centre for Evidence-based Medicine criteria. Results In a meta-analysis, acupuncture reduced death or dependency compared to control at the end of follow-up and over the long term (≥3 months), OR 0.61(95%CI 0.46–0.79) and OR 0.67(95%CI 0.53–0.85) respectively, but was neutral against sham acupuncture. A Cochrane review of acupuncture vs. sham acupuncture in subacute or chronic stroke vs. showed no differences in motor function and quality of life. Three trials found favourable effects of moxibustion on motor function (SMD=0.72, 95%CI 0.37–1.08, p<0.0001). Two trials showed cupping compared to acupuncture reduced hemiplegic shoulder pain and upper-limb ‘myodynamia’. A meta-analysis of traditional Chinese medicines for ischaemic stroke showed marked improvement in neurological deficit on stroke scales. There was no evidence for Ayurveda, homoeopathy or reiki. Tui-na reduced the Modified Ashworth Scale in some muscle groups. Marma massage improved Motricity Index and trunk control. Thai massage and herbal treatments improved the Barthel Index. On meta-analysis, Yoga improved memory and anxiety, while tai-chi improved activities of daily living, balance and walking ability. Studies were generally of poor quality. Conclusions The evidence for benefit of CAIs for stroke recovery is weak. More research is needed to justify these treatments for stroke, by well-conducted, adequately-sized, double-blinded, randomized controlled trials.

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Active Albuterol or Placebo, Sham Acupuncture, or No Intervention in Asthma

New England Journal of Medicine ◽

10.1056/nejmoa1103319 ◽

2011 ◽

Vol 365 (2) ◽

pp. 119-126 ◽

Cited By ~ 190

Author(s):

Michael E. Wechsler ◽

John M. Kelley ◽

Ingrid O.E. Boyd ◽

Stefanie Dutile ◽

Gautham Marigowda ◽

...

Keyword(s):

Sham Acupuncture

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A Blinded Randomised Trial of Acupuncture (Manual and Electroacupuncture) Compared with a Non-Penetrating Sham for the Symptoms of Osteoarthritis of the Knee

Acupuncture in Medicine ◽

10.1136/aim.26.2.69 ◽

2008 ◽

Vol 26 (2) ◽

pp. 69-78 ◽

Cited By ~ 51

Author(s):

Ronald W Jubb ◽

Emad S Tukmachi ◽

Peter W Jones ◽

Emma Dempsey ◽

Lynn Waterhouse ◽

...

Keyword(s):

Randomised Trial ◽

Symptomatic Improvement ◽

Sham Acupuncture ◽

Mean Difference ◽

Acupuncture Group ◽

Control Group ◽

Acupuncture Points ◽

Osteoarthritis Of The Knee ◽

Womac Pain ◽

Treatment Comparison

Objectives To compare the effect of acupuncture (manual and electroacupuncture) with that of a non-penetrating sham (‘placebo’ needle) in patients with osteoarthritic knee pain and disability who are blind to the treatment allocation. Methods Acupuncture naive patients with symptomatic and radiological evidence of osteoarthritis of the knee were randomly allocated to a course of either acupuncture or non-penetrating sham acupuncture using a sheathed ‘placebo’ needle system. Acupuncture points for pain and stiffness were selected according to acupuncture theory for treating Bi syndrome. Both manual and electrical stimulation were used. Response was assessed using the WOMAC index for osteoarthritis of the knee, self reported pain scale, the EuroQol score and plasma β-endorphin. The effectiveness of blinding was assessed. Results There were 34 patients in each group. The primary end point was the change in WOMAC pain score after the course of treatment. Comparison between the two treatment groups found a significantly greater improvement with acupuncture (mean difference 60, 95% CI 5 to 116, P=0.035) than with sham. Within the acupuncture group there was a significant improvement in pain (baseline 294, mean change 95, 95% CI 60 to 130, P<0.001) which was not seen by those who had sham acupuncture (baseline 261, mean change 35, 95% CI-10 to 80, P=0.12). Similar effects within group, but not between groups, were seen with the secondary end points of WOMAC stiffness, WOMAC function, and self reported pain. One month after treatment the between group pain difference had been lost (mean difference 46; 95% CI −9 to 100, P=0.10) although the acupuncture group was still benefiting compared to baseline (mean difference 59; 95% CI 16 to 102, P=0.009). The EuroQol score, a generic measure of health related quality of life, was not altered by the treatments. A minority of patients correctly guessed their treatment group (41% in the acupuncture group and 44% in the control group). Plasma β-endorphin levels were not affected by either treatment. Conclusions Acupuncture gives symptomatic improvement for patients with osteoarthritis of the knee, and is significantly superior to non-penetrating sham acupuncture. The study did not confirm earlier reports of release of plasma β-endorphin during acupuncture.

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Divergent neural processes specific to the acute and sustained phases of verum and SHAM acupuncture

Journal of Magnetic Resonance Imaging ◽

10.1002/jmri.22393 ◽

2010 ◽

Vol 33 (1) ◽

pp. 33-40 ◽

Cited By ~ 23

Author(s):

Jixin Liu ◽

Wei Qin ◽

Qian Guo ◽

Jinbo Sun ◽

Kai Yuan ◽

...

Keyword(s):

Sham Acupuncture ◽

Neural Processes

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Immediate Effect of Acupuncture on the Sleep Pattern of Patients with Obstructive Sleep Apnoea

Acupuncture in Medicine ◽

10.1136/aim.2009.001867 ◽

2010 ◽

Vol 28 (3) ◽

pp. 115-119 ◽

Cited By ~ 14

Author(s):

Anaflávia O Freire ◽

Gisele C M Sugai ◽

Sônia Maria Togeiro ◽

Luiz Eugênio Mello ◽

Sérgio Tufik

Keyword(s):

Obstructive Sleep Apnoea ◽

Placebo Treatment ◽

Acute Effect ◽

Sham Acupuncture ◽

Sleep Apnoea ◽

Sleep Pattern ◽

Control Group ◽

Respiratory Events ◽

Obstructive Sleep ◽

Before And After

Background Most patients with obstructive sleep apnoea (OSA) do not tolerate treatment with nasal continuous positive airway pressure, the ‘gold standard’ treatment for this condition. It was shown in a pilot study that acupuncture was more effective than placebo treatment (sham acupuncture) in producing significant changes in the respiratory events assessed by polysomnography (PSG). Objectives To investigate the immediate effect of manual acupuncture (MA) and electroacupuncture (EA) on the sleep pattern of patients presenting with moderate OSA. Methods 40 patients with an Apnoea–Hypopnoea Index (AHI) of 15–30/h were randomly allocated to MA treatment (n=10), EA 10 Hz treatment (n=10), EA 2 Hz treatment (n=10) and a no-treatment control group (n=10). The patients received MA or EA (2 or 10 Hz) just before the PSG study at 20:00. Results The AHI (p=0.005; p=0.005), the Apnoea Index (p=0.038; p=0.009) and the respiratory events (p=0.039; p=0.014) decreased significantly in the MA and EA 10 Hz groups, respectively (AHI (21.9, 11.2), Apnoea Index (5.15, 0.7), respiratory events (120.5, 61.0) in the MA group before and after. AHI (20.6, 9.9), Apnoea Index (8.2, 0.3), respiratory events (117.0, 56.0) in the EA 10 Hz group before and after). The micro-arousals decreased only in the MA group (146.0 vs 88.5, p=0.0002). There were no significant changes in the EA 2 Hz group or in the control group. Conclusion A single session of either MA or EA 10 Hz had an acute effect in reducing the AHI as well as the number of nocturnal respiratory events of patients presenting with moderate OSA.

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