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
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.
. [J]. Frontiers of Medicine, 2021, 15(5): 767-775.
Xuqiang Wei, Baoyan Liu. Acupuncture is ineffective for chronic low back pain? A critical analysis and rethinking. Front. Med., 2021, 15(5): 767-775.
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
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
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
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