The selection of dermatomes for sham (placebo) acupuncture points is relevant for the outcome of acupuncture studies: a systematic review of sham (placebo)-controlled randomized acupuncture trials

2020 ◽  
Vol 38 (4) ◽  
pp. 211-226 ◽  
Author(s):  
Thomas Ots ◽  
Asal Kandirian ◽  
Istvan Szilagyi ◽  
Susan M DiGiacomo ◽  
Andreas Sandner-Kiesling
Keyword(s):  
Clinical Outcomes ◽  
Sham Acupuncture ◽  
The Body ◽  
Acupuncture Points ◽  
Inclusion Criteria ◽  
Active Constituents ◽  
Randomized Controlled ◽  
Placebo Acupuncture ◽  
Reflex System ◽  
Selection Of

Background: Many randomized controlled trials (RCTs) of acupuncture reveal no significant differences between acupuncture and so-called placebo acupuncture. There is a strong tendency to replace the term “placebo” by the term “sham,” because any needling stimulates a certain physiological response. However, neither concept accounts for the great diversity of results in RCTs comparing verum acupuncture and sham (placebo) acupuncture. Some trials have shown little or no difference, while other studies have found statistically significant differences. Objective: Verum acupuncture and sham (placebo) acupuncture may achieve similar results to the extent that they share active constituents. We identified these common active constituents as dermatomes: the segmental structure of the human body. In our study, we tested the hypothesis that the more verum and sham (placebo) acupuncture share the same dermatomes, the closer the clinical outcomes will be, and vice versa. Methods: All major databases were searched for RCTs that tested acupuncture versus sham (placebo) acupuncture. The dermatome charts of Hansen and Schliack were used to verify verum and sham (placebo) needling locations. Reported clinical outcomes were assessed in relation to the percentage of overlap between the dermatomes stimulated by acupuncture and sham (placebo) acupuncture. Results: Our literature search yielded a total of 1738 references. Thirty-four studies met the inclusion criteria. The effects of sham (placebo) acupuncture varied according to the dermatomes stimulated: high overlap with those stimulated by verum acupuncture resulted in almost identical efficacy, while low overlap resulted in significant differences in efficacy. Clinical outcomes were similar when verum acupuncture and sham (placebo) acupuncture shared the same dermatomes (p < 0.01). Discussion: The findings of this review confirm our hypothesis. Acupuncture studies that employed verum and sham locations on overlapping dermatomes helped to create a mediocre to negative picture of acupuncture’s efficacy. The segmental structure of the body with its interconnected reflex system offers an additional neurophysiological explanation for the effectiveness of acupuncture applied to structures segmentally innervated by the spinal and visceral nervous system. Further comparative acupuncture studies should be based on knowledge of segmental anatomy. In testing verum acupuncture versus sham acupuncture, the chosen sham acupuncture needling locations should be situated on non-overlapping dermatomes.

scholarly journals Manual acupuncture versus sham acupuncture and usual care for the prevention of primary dysmenorrhea (PD): study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Lingling Yu ◽  
Shiqin Liu ◽  
Cuihong Zheng ◽  
Wenhua Liu ◽  
Hua Wang ◽  
...  
Keyword(s):  
Usual Care ◽  
Short Form ◽  
Sham Acupuncture ◽  
Acupuncture Points ◽  
Primary Dysmenorrhea ◽  
Efficacy And Safety ◽  
Manual Acupuncture ◽  
Menstrual Cycles ◽  
Randomized Controlled ◽  
High Quality Evidence

Abstract Background Primary dysmenorrhea (PD) is a leading cause of dysmenorrhea among adolescent girls. Manual acupuncture may be considered as an effective treatment for PD, but high-quality evidence remains limited. This trial aims to evaluate the efficacy and safety of acupuncture for the prevention of PD as compared with sham acupuncture and usual care. Methods/design This is a three-arm, randomized, controlled clinical trial in which the patients, assessors, and statisticians will be blinded. A total of 300 acupuncture-naive patients who were diagnosed as PD will be randomly allocated to the verum acupuncture, sham acupuncture, or usual care groups in a 2:2:1 ratio. Patients in the verum acupuncture group will receive manual acupuncture at specific acupuncture points with penetrating needling, while those in the sham acupuncture group will receive non-penetrating needling at non-acupuncture points. They will be given five sessions over a menstrual cycle for 3 menstrual cycles. Patients in the usual care group will receive health education and informed to receive manual acupuncture for free after waiting for 7 menstrual cycles. The primary outcome will be the change from baseline in the Cox Menstrual Symptom Scale Score (CMSS). The secondary outcomes will be the changes in Massachusetts General Hospital Acupuncture Sensation Scale (MASS), visual analog scale (VAS), Short-Form McGill Pain Questionnaire 2 (SF-MPQ-2), Pittsburgh Sleep Quality Index (PSQI), Beck Anxiety Inventory (BAI), Beck Depression Inventory II (BDI- II), Acupuncture Expectancy Scale (AES), 60-item NEO Personality Inventory-Short Form (NEO-FFI), and acute medication intake. The adverse events will be recorded at every visit. The analyses will be performed base on a full analysis set (FAS) and a per-protocol set (PPS). Discussion This study may provide high-quality evidence regarding the efficacy and safety of manual acupuncture for PD. In addition, the results of this study will help to identify the efficacy of acupuncture due to the specific effects of acupuncture or placebo effects of acupuncture ritual. Trial registration Clinical Trials.gov NCT02783534. Registered on 26 May 2016

scholarly journals P1466SYSTEMATIC LITERATURE REVIEW OF CLINICAL EVIDENCE FOR THE BODY COMPOSITION MONITOR IN DIALYSIS AND CKD

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Agnieszka Raddatz ◽  
Ulrich Moissl ◽  
Alistair Ray ◽  
Christian Eichinger ◽  
Peter Wabel
Keyword(s):  
Blood Pressure ◽  
Body Composition ◽  
Clinical Outcomes ◽  
Observational Studies ◽  
Fluid Overload ◽  
Fluid Management ◽  
The Body ◽  
Randomized Controlled ◽  
Body Composition Monitor ◽  
Significant Difference

Abstract Background and Aims The Body Composition Monitor (BCM) is a bioimpedance spectroscopy device to monitor the hydration status of dialysis and CKD patients. NICE (UK) reported only limited evidence on the clinical effectiveness in its Diagnostic Guidance 29. The aim of this work was to provide a structured review of the available evidence up to September 2018 grouped by the most important clinical outcomes (fluid overload, blood pressure, mortality and cardiovascular events). Method MEDLINE, Embase and Cochrane databases were interrogated from 2006 to September 2018. Search and review of identified studies was conducted in compliance with the guidelines for Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Results Of 4497 articles identified, 843 were included for full-text review; 424 were full publications and were selected for further analysis. Eight randomized controlled trial (RCT) studies and 150 observational studies met the predefined inclusion criteria; of these, observational studies that recruited at least 100 patients and additionally reported important clinical outcomes such as mortality, cardiovascular (CV) events or hospitalization were selected. Two further RCTs were identified by supplementary searches, giving a total of 10 RCTs (total 2.156 patients) and 41 observational studies (total 168.453 patients) included in this review. The data was grouped by reported outcomes and for each outcome it was analyzed if an effect of BCM-monitored fluid management, or an association between BCM assessment and the respective outcome could be shown. A meta-analysis of the results was not conducted. Reduction of fluid overload RCTs have shown that BCM-monitored fluid management and subsequent alteration of dialysis parameters can lead to effective reduction of fluid overload. Lowering of blood pressure RCTs have indicated that BCM-monitored fluid management can effectively lower blood pressure. Impact on mortality / association with mortality Multiple observational studies have shown a strong association between BCM measurements and mortality. One RCT demonstrated that mortality outcomes can be significantly improved in HD patients with BCM-guided fluid management, while two RCTs reported no significant difference in mortality outcomes. Impact on Cardio Vascular (CV) related events Multiple observational studies have indicated that BCM measurements can predict CV events. One RCT indicated that CV events can be reduced by BCM-monitored fluid management, and two further RCTs indicated that using BCM guidance was at least as good as conventional fluid management. Conclusion There is a strong body of evidence for various important outcomes covering a large patient basis - additional evidence is needed in well designed randomized controlled trials e.g. to demonstrate the effect of reducing BCM determined dehydration.

scholarly journals Specification of Interventions and Selection of Control in Acupuncture Randomized Controlled Trials: A Cross-Sectional Study

2021 ◽  
Author(s):  
Jiali Liu ◽  
Ling Li ◽  
Xiaochao Luo ◽  
Xuan Qin ◽  
Ling Zhao ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Treatment Effect ◽  
Cross Sectional Study ◽  
Sham Acupuncture ◽  
Waiting List ◽  
Controlled Trials ◽  
Sectional Study ◽  
Cross Sectional ◽  
Randomized Controlled ◽  
Selection Of

Abstract Background: Specification of interventions and selection of control are two methodological determinants for a successful acupuncture trial. However, it is not fully understood about the current practice of these two determinants. We thus conduced a cross-sectional study to examine specification of interventions and selection of control among current acupuncture randomized controlled trials (RCTs). Methods: We searched PubMed for acupuncture RCTs published in the core clinical journals and complementary and alternative medicine (CAM) journals from January 2010 to December 2019 (10 years), and included RCTs that assessed treatment effects of acupuncture versus any type of control. Teams of methods-trained investigators who had experiences in acupuncture trials independently screened reports for eligibility and collected data, using a prespecified standardized questionnaire. We used network meta-analyses to investigate whether treatment effect was differential in patients with chronic pain when using sham acupuncture as a control versus using waiting-list or no treatment.Results: Of 319 eligible RCTs, most well specified style of acupuncture (86.8%), acupoint prescription (96.2%), type of needle stimulation (90.3%) and needle retention time (85.6%). However, other acupuncture details were less specified, including achievement of response sought (65.5%) and needle manipulation (50.5%), specification of number of needle insertions (21.9%), angle and direction of insertion (31.3%), patients posture (32.3%) and co-interventions (22.9%). Sham acupuncture (41.4%) was the most frequently used control, followed by waiting-list or no treatment (32.9%). There was no differential treatment effect when using sham acupuncture versus waiting-list/no treatment as a control (SMD = -0.15, 95% CI -0.91 to 0.62).Conclusions: Over a decade of research practice, important gaps remained in the specification of acupuncture interventions, including specification of response sought, needle manipulation, and co-interventions. While sham acupuncture was largely used, waiting-list or no treatment may also be used as an appropriate control.

scholarly journals A Literature Review of de qi in clinical studies

2013 ◽  
Vol 31 (2) ◽  
pp. 132-142 ◽  
Author(s):  
Ji-Eun Park ◽  
Yeon-Hee Ryu ◽  
Yan Liu ◽  
Hee-Jung Jung ◽  
Ae-Ran Kim ◽  
...  
Keyword(s):  
English Language ◽  
Treatment Effects ◽  
Acupuncture Treatment ◽  
Sham Acupuncture ◽  
Acupuncture Points ◽  
Placebo Acupuncture ◽  
Real Acupuncture ◽  
Measurement Tools ◽  
The Relationship ◽  
De Qi

Objectives De qi is a sensation experienced by a patient or an acupuncturist during acupuncture treatment. Although de qi is considered to be important in acupuncture treatment, there are not many studies about de qi and its character. The purpose of this study is to review de qi questionnaires and evaluate the relationship between de qi and acupuncture points, stimulation and treatment effects. Methods A search was conducted using three English-language databases (PubMed, Cochrane and ScienceDirect) and seven Korean databases with the keywords ‘ de qi’ and ‘needle sensation’. The included studies were then categorised as following: (1) de qi measurement tools, (2) the relationship between de qi and acupuncture points, (3) the relationship between de qi and stimulation, (4) the relationship between de qi and treatment effects and (5) attitudes and opinions toward de qi. Results Several questionnaires have been developed to evaluate de qi, and the most frequent sensation in those questionnaires was ‘heavy’ and ‘numb’. Although a few studies showed specificity to acupuncture points, information is still lacking to be able to draw a clear conclusion about the relationship between de qi and acupuncture points. Also, greater de qi was elicited in real acupuncture than placebo acupuncture in many studies. The relationship between de qi and treatment effects was controversial. Conclusions It seems that real acupuncture induced greater de qi than sham acupuncture, and the relationship between de qi, acupuncture points and treatment effects was controversial. However, the current literature evaluating de qi is not sufficient to derive clear conclusions. Further studies with more objective indices and rigorous methodologies are needed.

scholarly journals Manual Acupuncture As Prophylaxis For Migraine Without Aura: Study Protocol For A Multi-Center, Randomized, Single Blinded Trial

2021 ◽  
Author(s):  
Jiao Chen ◽  
Siyuan Zhou ◽  
Mingsheng Sun ◽  
Yanan Wang ◽  
Xiaoqin Chen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Migraine Without Aura ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Placebo Control ◽  
Acupuncture Points ◽  
Manual Acupuncture ◽  
Randomized Controlled ◽  
Placebo Acupuncture

Abstract Background: Migraine is a highly prevalent neurological disorder. It is the third most prevalent disorder and the seventh highest cause of disability worldwide. Acupuncture may be a viable prophylactic treatment option for frequent or uncontrolled migraine. Clinical studies comparing acupuncture and placebo acupuncture have not reached a consistent conclusion in confirming whether acupuncture is effective in migraine prophylaxis. The effect of acupuncture mainly depends on acupoints and needles operation. We found that the design of the placebo acupuncture in previous studies included shallow needling at sham acupoints, non-penetrating needling at sham acupoints, and needling at inactive acupuncture points to achieve the inert effect of control group, but the non-penetrating needling at true acupoints was ignored. This randomized controlled trial aims to use true acupoints for non-penetrating acupuncture as control to evaluate the efficacy of manual acupuncture for the prophylaxis of migraine without aura (MWoA).Methods/design: This is a single-blinded, randomized, controlled, prospective, multi-center trial with two parallel treatment groups. A total of 198 eligible patients with MWoA will be randomly divided into two groups (1:1 allocation ratio). The intervention group will receive manual acupuncture and the control group will receive placebo acupuncture (non-penetrating). Patients will receive three acupuncture treatment sessions per week for 4 consecutive weeks. All patients will then receive a 12-week follow-up.Discussion: In this study, we are evaluating the efficacy and safety of manual acupuncture in the prophylaxis of MWoA. The placebo control is using non-penetrating needling verum acupoints. It is essential to determine an appropriate control method to ensure the methodological quality of a randomized controlled trial.Trial registration: The trial has been registered in the Chinese Clinical Trial Registry (Approval No. ChiCTR2000032308) in April 2020.

PENGEMBANGAN BAHAN AJAR IPA SMP PADA TEMA ENERGI DALAM TUBUH MENGGUNAKAN METODE 4STMD

EDUSAINS ◽  
2019 ◽  
Vol 8 (2) ◽  
pp. 166-175
Author(s):  
Gia Juniar Nur Wahidah ◽  
Sjaeful Anwar
Keyword(s):  
Concept Maps ◽  
The Body ◽  
Instructional Materials ◽  
Teaching Material ◽  
Test Results ◽  
Teaching Materials ◽  
Eligibility Criteria ◽  
Material Development ◽  
Selection Step ◽  
Selection Of

Abstract This research aims to produce science teaching materials in junior level with Energy in The Body as the theme using Four Steps Teaching Material Development  (4STMD). The material is presented in an integrated way so that students can  think holistically and contextually. The method used in this study is Research and Development. In this R&D methods is used 4STMD. There are four steps done on the development of teaching materials, the selection step, structuring step, characterization, and didactic reduction. Selection step includes the selection of indicators in accordance with the demands of the curriculum which is then developed with the selection of concepts and values that are integrated with the concept of science. Structuring step includes make macro structures, concept maps, and multiple representations. Characterization's step includes preparation instruments, then  trial to students to identify difficult concepts. The last, didactic reduction was done by neglect and the annotations in the form of sketches.The test results readability aspect instructional materials lead to the conclusion that by determining the main idea, the legibility of teaching materials reached 67%, with moderate readability criteria. Test results of feasibility aspects based on the results of questionnaires to the 11 teachers lead to the conclusion that the overall, level of eligibility teaching materials reached 91% with the eligibility criteria well. Keywords: teaching materials; energy; 4STMD Abstrak Penelitian ini bertujuan untuk menghasilkan bahan ajar IPA SMP pada tema Energi dalam Tubuh menggunakan metode Four Steps Teaching Material Development (4STMD). Materi disajikan secara terpadu sehingga memacu siswa untuk berpikir secara holistik dan kontekstual. Metode penelitian yang digunakan pada penelitian ini adalah metode penelitian dan pengembangan. Dalam penelitian dan pengembangan yang ini, digunakan metode Four Steps Teaching Material Development (4STMD). Terdapat empat tahap yang dilakukan pada pengembangan bahan ajar, yakni tahap seleksi, strukturisasi, karakterisasi, dan reduksi didaktik. Tahap seleksi meliputi pemilihan indikator yang sesuai dengan tuntutan kurikulum yang kemudian dikembangkan dengan pemilihan konsep dan nilai yang diintegrasikan dengan konsep IPA. Tahap strukturisasi meliputi pembuatan struktur makro, peta konsep, dan multipel representasi dari materi. Tahap karakterisasi meliputi penyusunan instrumen karakterisasi, kemudian uji coba kepada siswa untuk mengidentifikasi konsep sulit. Tahap terakhir, yaitu reduksi didaktik konsep terhadap konsep sulit. Reduksi didaktik yang dilakukan berupa pengabaian dan penggunaan penjelasan berupa sketsa. Hasil uji aspek keterbacaan bahan ajar menghasilkan kesimpulan bahwa berdasarkan penentuan ide pokok, keterbacaan bahan ajar mencapai 67%, dengan kriteria keterbacaan tinggi. Hasil uji aspek kelayakan berdasarkan hasil angket terhadap 11 orang guru menghasilkan kesimpulan bahwa secara keseluruhan tingkat kelayakan bahan ajar mencapai 91% dengan kriteria kelayakan baik sekali. Kata Kunci: bahan ajar; energi; 4STMD  Permalink/DOI: http://dx.doi.org/10.15408/es.v8i2.2039  

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