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Frontiers of Medicine

ISSN 2095-0217

ISSN 2095-0225(Online)

CN 11-5983/R

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Front. Med.    2021, Vol. 15 Issue (5) : 767-775    https://doi.org/10.1007/s11684-020-0785-6
LETTER TO FRONTIERS OF MEDICINE
Acupuncture is ineffective for chronic low back pain? A critical analysis and rethinking
Xuqiang Wei1, Baoyan Liu1,2()
1. College of Acupuncture and Orthopedic, Hubei University of Chinese Medicine, Wuhan 430065, China
2. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China
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Abstract

Acupuncture is a promising treatment for relieving pain and improving lower back function in clinical practice. However, evidence from randomized clinical trials (RCTs) remains controversial. Most RCTs conclude that acupuncture procedures for chronic low back pain (CLBP) had no significant difference in efficacy and belonged to placebo. We carefully reviewed and analyzed the methodology and implementation of sham acupuncture in RCTs. Controversial evidence of acupuncture for CLBP is only a microcosm of the evaluation methodological limitation of acupuncture. Inappropriate selection of sham acupuncture controls, rigorous RCT research models, and incorrect interpretation of results may contribute to negative evidence. Evaluating and disregarding the holistic efficacy of acupuncture with an explanatory RCT model based on evaluation drugs may be unwise. Moreover, sham acupuncture is often proven to be non-inert, unreasonable, and with low fidelity. Pitfalls of the explanatory RCT model and sham acupuncture design should be avoided. Establishing a new evaluation system that is in line with the clinical characteristics of acupuncture and obtaining high-quality evidence are difficult but promising tasks.
Keywords chronic low back pain      sham acupuncture      acupuncture      methodology      therapeutic evaluation     
Corresponding Author(s): Baoyan Liu   
Just Accepted Date: 03 February 2021   Online First Date: 16 April 2021    Issue Date: 01 November 2021
 Cite this article:   
Xuqiang Wei,Baoyan Liu. Acupuncture is ineffective for chronic low back pain? A critical analysis and rethinking[J]. Front. Med., 2021, 15(5): 767-775.
 URL:  
https://academic.hep.com.cn/fmd/EN/10.1007/s11684-020-0785-6
https://academic.hep.com.cn/fmd/EN/Y2021/V15/I5/767
Domains Experimental group Control group Underlying hypothesis of acupuncture effect
Location Acupoint Non-acupoint Acupoint specific
Meridian Non-meridian Meridian specific
Stimulation De Qi sensation Non-De Qi sensation Perception specific
Manual operation Physical stimulation (electricity, magnet, laser, or visually virtual) Stimulation specific (different parameter specific)
Deep insert Shallow insertion Needing depth specific
Needling Standard procedure Non-standard procedure Procedure specific
Penetration Penetration skin Non-penetration skin Penetration specific
Tab.1  Common sham acupuncture design in RCTs
Domains Acupuncture characteristics RCT model Flaws or traps in acupuncture RCTs
Intervention principle Individual and integration concept Homogenization and standardization Regression from optimal to average
Intervention attributes Integration of specific and non-specific factors The intervention itself is the only specific factor The non-specific factors of acupuncture were dissected
Population Wide crowd Fixed population Draws conclusions from limited population
Blind method Operated by an acupuncturist without blinding Strictly double blind or triple blind The blind method has poor implement ability and low reliability
Control Sham acupuncture or minimal acupuncture Blank control or inert treatment Control styles are “non-inert”
Acupuncture regimen Flexible Stationary Ignores the correspondence between treatment and disease change
Treatment Dynamic adjustment Stable Loss of acupuncture characteristics and flexibility
Effect composition Multiple (acupoint, stimulus, operation, environment, and psychology and expectation) Monotonous (needling or electric stimulus) Acupuncture properties are split
Diagnosis and treatment sequence Traditional Chinese medicine diagnosis: synchronous or dynamic changes Biomedical diagnosis: diagnosis is fixed and made prior to treatment Violates the concept of acupuncture treatment
Evaluation indicators Subjective and objective indicators Objective biological indicators Ignores the patient’s subjective perception of treatment
Settings Real-world Ideal-world Poor extrapolation
Tab.2  Traps or flaws of acupuncture RCT models in different domains
Elements Efficacy Effectiveness Implementation
Hypothesis Acupuncture is invalid Acupuncture is not as effective Reproducibility and extensibility of the acupuncture program are poor
Object Strictly limited participants Limited participants Participants, implementation environment, and strategies
Intervention program Single fixed acupuncture program Single or multiple dynamic acupuncture programs Acupuncture education and training (skills, knowledge, and others); single or multiple dynamic acupuncture programs
Control selection Placebo or blank control Positive control or standard treatment or waitlist Health strategy or policy
Outcomes Disease-related indicators Health-related indicators a Implementation-related indicators and Health-related indicators
Research purpose Verification of the acupuncture effect Comparison of the acupuncture effectiveness or program optimization Reproducibility and extension of effective acupuncture programs
Validity Internal≥external External≥internal Focus on applicability and fidelity
Model examples Explanatory RCTs b CERs, Pragmatic RCTs, and others Implementation research design, hybrid design, and others.
Tab.3  Comparison of different clinical research methods in acupuncture
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