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Addiction
Protocol
Acupuncture for substance use disorders: a protocol of systematic review and meta-analysis of randomised controlled trials
  1. Chao-ren Tan1,
  2. Meng Qiao2,
  3. JIN CHANG1,
  4. Shu-Min Chen1,
  5. Yingying Wang1
  1. 1 Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, People's Republic of China
  2. 2 Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, People's Republic of China
  1. Correspondence to Dr Yingying Wang; yyw261206{at}126.com

Abstract

Introduction Substance use disorders (SUDs) are common and highly disabling, causing serious long-term harm to people’s health. Despite the existence of evidence-based interventions for treating SUDs, many individuals remain symptomatic regardless of treatment, and relapse is common. Acupuncture has been examined for the treatment of SUDs, but available evidence is mixed. This comprehensive systematic review and meta-analysis aims to provide updated evidence which will include both English and Chinese studies to investigate the effectiveness and safety of different types of acupuncture for the treatment of alcohol, tobacco and illicit drug use disorders.

Methods and analysis This protocol is guided by the Preferred Reporting Items for Systematic Reviews and Meta Analysis Protocols. A thorough search for relevant studies in multiple electronic databases (PubMed, Embase, PsycINFO, Cochrane Library, China National Knowledge Infrastructure, VIP, Wan-fang and China Biomedical Database) and clinical trial registries will be conducted. Population-Intervention-Comparator-Outcomes-Study design criteria will be adopted for study inclusion. Only randomised controlled trials analysing the efficacy and safety of acupuncture for SUDs will be included. Two reviewers will independently conduct the study selection, data extraction and quality assessment, and disagreements will be solved by a third senior reviewer or by contacting study authors. Frequency and quantity of substance use, abstinence rate, withdrawal symptoms, treatment drop-out and relapse rates are primary outcomes. Functional status, health-related quality of life and adverse events are secondary outcomes. The risk of bias and quality of evidence will be assessed by the revised Cochrane risk-of-bias tool for randomised trials and guidelines of the Grading of Recommendations Assessment, Development and Evaluation working group, respectively. When sufficient data is available, subgroup analyses will be performed to further compare the differences in the primary and secondary outcomes based on the type of substance use, acupuncture, co-intervention status, comparison group, measurement tools, length of follow-up, risk of bias of included studies and countries of studies conducted.

Ethics and dissemination No private information is used in the entire process of the systematic review. Therefore, ethical approval is not required. Findings of the proposed systematic review will be published in a peer-reviewed journal and/or disseminated through conference presentations.

Protocol registration number The protocol has been archived in the Prospero repository (PROSPERO 2024 CRD42024566389).

  • Acupuncture
  • Substance misuse
  • Meta-Analysis
  • Randomized Controlled Trial
  • Systematic Review
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2024-095435

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    STRENGTHS AND LIMITATIONS OF THIS STUDY

    • This study will search both English and Chinese databases and include only randomised controlled trials to provide updated evidence on the effectiveness and safety of acupuncture on substance use disorders (SUDs).

    • Subgroup analyses based on the countries of studies conducted will be conducted to investigate potential publication bias.

    • Apart from outcomes relating to effectiveness and safety, other outcomes including withdrawal symptoms and health-related quality of life will also be included to comprehensively assess the effect of acupuncture for SUDs.

    • Given the variability in the type of substance use, acupuncture, co-intervention status, comparison group, measurement tools, length of follow-up and risk of bias of included studies, subgroup analyses based on these factors will be conducted to determine the heterogeneity.

    • The number of studies included may be limited in subgroups.

    Introduction

    Substance use disorders (SUDs), such as those involving illegal drugs, nicotine or alcohol, are prevalent and significantly disabling, causing substantial long-term harm to individuals’ health. According to the WHO report1 and data from the United Nations Office on Drugs and Crime,2 in 2021, an estimated 1.25 billion people smoked tobacco, 400 million people suffered from alcohol use disorders and 39.5 million people had drug use disorders. Moreover, tobacco use results in over 8 million deaths annually, 2.6 million deaths are attributed to alcohol consumption and psychoactive drug use accounts for nearly 0.6 million deaths each year, as reported in 2019.3 Additionally, individuals with SUDs often face a range of coexisting physical and mental health issues, including infectious diseases, cardiovascular ailments, neurological impairments, diabetes, cancer, major depressive disorder, bipolar I disorder, antisocial personality disorder and borderline personality disorder.4 It is estimated that approximately 5.7% of the global burden of disease, measured in disability-adjusted life years, is due to smoking, 2.5% due to alcohol and 1% due to illicit drugs.5 Given their high prevalence and adverse effects on health, tackling SUDs has become a priority.

    Acupuncture, a traditional therapeutic intervention deeply rooted in East Asian countries, is gaining traction in various regions and nations, including Europe and the Americas. As described by traditional Chinese medicine, acupuncture involves inserting and manipulating solid needles into specific meridian points to regulate and balance the body’s energy flow, known as ‘Qi’. This energy circulates through meridians, connecting organs and systems throughout the body, thereby exerting a positive therapeutic effect on various bodily organs, systems and functions.6 Ample evidence supports the efficacy of acupuncture for treating a wide array of conditions, such as acute and chronic pain,7 8 poststroke cognitive impairment, insomnia,9 constipation, knee osteoarthritis, depression and more.10

    The first documented instance of using acupuncture to address SUDs dates back to 1972. A doctor in Hong Kong suggested that acupuncture could alleviate opioid withdrawal symptoms.11 Since then, there has been a growing public interest in exploring the effectiveness and underlying mechanisms of acupuncture for treating SUDs. Several randomised controlled trials (RCTs) have shown that acupuncture outperforms sham acupuncture in reducing the dosage of substances and mitigating cravings in patients with SUDs, including those related to alcohol,12 opioids,13 heroin14 15 and cocaine.16 In one multicentre RCT, it was reported that after an 8-week treatment period, the carbon monoxide-confirmed 24-hour abstinence rate and the duration until relapse in the acupuncture group were comparable to those in the nicotine replacement therapy group.17 Furthermore, individuals with SUDs often face a heightened risk of relapse due to physical or psychological withdrawal symptoms, particularly anxiety and cravings. However, acupuncture has also been found effective in alleviating these withdrawal symptoms, thereby preventing relapse.18–21 Additionally, numerous meta-analyses have demonstrated the efficacy of acupuncture for SUDs.21–25 Nevertheless, despite the promising findings regarding acupuncture’s potential benefits for SUDs, some RCTs and meta-analyses have produced conflicting results that do not support the use of acupuncture for such disorders.26–29 Factors such as the country of study conducted, substance use, acupuncture methods, outcomes assessed and publication dates of included studies might contribute to these contradictory conclusions. Therefore, we conducted a comprehensive systematic review and meta-analysis, including both English and Chinese studies, to provide updated evidence on the effectiveness and safety of various types of acupuncture in treating SUDs.

    Methods

    Study registration

    The protocol has been archived in the Prospero repository (PROSPERO 2024 CRD42024566389) on 17 July 2024 and will strictly adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol (PRISMA-P) guidelines.30 The detailed PRISMA-P checklist can be found in the online supplemental file 1.

    Supplemental material

    Patient and public involvement

    No patients or public are involved in the design, conduct, reporting or dissemination of this research.

    Eligibility criteria

    The Population-Intervention-Comparator-Outcome-Study design criteria will determine primary study inclusion.

    Population

    To be considered in this review, studies must recruit adult participants who are 18 years of age or older with SUDs, including nicotine, alcohol and illicit drug use disorders (ie, heroin, amphetamine, cocaine, opioid, cannabis and/or stimulants). Participants will be included, regardless of gender, occupation, education level or condition severity.

    Intervention

    As described in detail previously,21 studies must include at least one intervention arm that administered solid needles into known acupuncture points, either as an adjunctive or monotherapy, with or without electrostimulation. Studies involving full-body acupuncture, auricular acupuncture or other specific body sites will be included. Those investigating acupuncture via laser, heat or light will be omitted unless needles were also used. Studies on dry needling or trigger-point therapy not associated with traditional acupuncture will be excluded.

    Comparison

    As described in detail previously,21 studies that included sham acupuncture, ‘treatment as usual’ or ‘standard care’, passive comparators (eg, wait-list control, no-treatment) or other active treatments as comparators will be included.

    Outcomes

    Studies that reported one or more of the following outcomes will be included. Studies may involve any duration of treatment and follow-up period, and there will be no restrictions based on the treatment setting.

    Primary outcomes

    Frequency and quantity of substance use, abstinence rates, withdrawal symptoms, treatment drop-out and relapse rates.

    Secondary outcomes

    Functional status, health-related quality of life and adverse events.

    Study design

    Only parallel group, individual-RCTs or cluster-RCTs will be included. No restrictions will be placed on sample size or country of origin.

    Information sources and search strategy

    A comprehensive search of multiple electronic databases will be conducted, including PubMed, Embase, PsycINFO, Cochrane Library, Chinese National Knowledge Infrastructure, VIP Database, Wanfang Database and Chinese Biomedical Database for English and Chinese language RCTs. In addition, the clinical trials registers including the Cochrane Central Register of Controlled Trials, ClinicalTrials.gov and the WHO International Clinical Trials Registry platform and theses will also be searched. Furthermore, reference lists of all included studies and previous systematic reviews related to this topic will be inspected to identify additional relevant studies in March 2025. The detailed search strategies are presented in online supplemental file 2. In case of missing information, we will contact the first and/or corresponding author of the included studies published in the last 30 years.

    Supplemental material

    Study selection and data collection

    Study selection

    All identified records will be extracted to EndNote (Analytics, Philadelphia, Pennsylvania, USA) reference management software for automatic duplication and title/abstract screening. Two reviewers will independently screen identified titles/abstracts for inclusion, and disagreements will be resolved by discussion with a third senior reviewer or by acquiring full articles for further inspection. Full texts of relevant titles and abstracts will be obtained and imported to Zotero V.5.0 (Corporation for Digital Scholarship, Vienna, Virginia, USA) for further review. Then, two independent reviewers will evaluate them against the eligibility criteria. Study selection will be reported in flow diagrams according to the PRISMA statement.30 31 A table will present studies excluded at the full-text screening stage, along with the reasons for their exclusion. Any discrepancies will be discussed with a third senior reviewer or by contacting the study authors. Figure 1 outlines the planned study selection process.

    Figure 1
    Figure 1

    Planned study selection process. CBM, Chinese Biomedical Database; CNKI, Chinese National Knowledge Infrastructure; RCT randomised controlled trial; VIP, China Science and Technology Journal Database.

    Data extraction

    Two reviewers will independently extract data on specifically developed forms from the included studies for the following items:

    1. Participants: gender, age and baseline substance use.

    2. Interventions: type of needle acupuncture (whole body, microsystem acupuncture, acupoints), dosage (intensity, frequency, duration) and co-intervention(s).

    3. Comparators: type of comparator.

    4. Outcomes: frequency and quantity of substance use, abstinence rates, withdrawal symptoms, treatment drop-out, relapse rates, functional status, health-related quality of life and adverse events, at each time point of measurement.

    5. Setting: geographic region, number of sites and language.

    6. Study design: arms, purpose, inclusion and exclusion criteria characteristics, sample size, items relevant to risk of bias and quality ratings.

    7. Others: first author of the study and year of publication.

    Discrepancies will be resolved by discussion with a third senior reviewer or by contacting study authors.

    Translations of non-English papers

    For the non-English literature published with English translations, the origin translations will be adopted. For those without English translations, two reviewers will independently conduct the translation, and disagreements will be resolved by discussion with a third senior reviewer.

    Risk of bias assessment

    Two independent reviewers will assess the methodological quality of outcomes using the revised Cochrane risk-of-bias tool for randomised trials,32 which considers the five domains of randomisation process: (1) the randomisation process; (2) deviations of intended interventions; (3) missing outcome data; (4) measurement of the outcome; (5) selection of the reported result. A response of either ‘low risk’, ‘some concerns’ or ‘high risk’ will be assigned for each domain, and outcomes will be rated as low risk (low risk of bias for all five domains), some concerns (some concerns of bias for at least one domain but without high risk) or high risk (high risk of bias for at least one domain). Discrepancies will be resolved by discussion with a third senior reviewer.

    Certainty assessment

    As described previously,33 the overall certainty of evidence across RCTs will be appraised using Grading of Recommendations Assessment, Development and Evaluation criteria, which categorise findings into four tiers (high, moderate, low and very low) by assessing limitation of design, inconsistency, indirectness, imprecision and publication bias.

    Data synthesis

    Statistical analyses will be conducted in Review Manager V.5.3 (RevMan V.5.3; Cochrane Collaboration, Oxford, UK) and Stata V.12 software (Stata Corporation, College Station, Texas, USA). Due to anticipated heterogeneity across studies, meta-analyses of all outcomes will be performed using the random-effect model with 95% CIs. Objective measures (eg, urine toxicology) will be prioritised to synthesise where feasible (≥3 studies). The effect sizes of measures will be evaluated with standardised mean differences34 for continuous outcome measures, with a value <0.2 considered very small, 0.2–0.5 as small, 0.5–0.8 as moderate and >0.8 as large and ORs35 for dichotomous outcomes. If data cannot be pooled between intervention studies (eg, an insufficient number of RCTs investigating the respective outcome), findings will be reported in narrative syntheses for each outcome variable. The heterogeneity of the included studies will be evaluated by the Cochran Q test and the I2 statistics, and I2 >25%, 50% and 75% indicates low, moderate and high heterogeneity, respectively. The level of significance for all tests was set to p value =0.05.

    Dealing with missing data

    Efforts will be made to contact the primary or corresponding author of the original article to address missing or incomplete data within the study. If missing data are unavailable, analyses of continuous outcomes will prioritise change scores rather than endpoint values, using statistical approaches addressing incomplete outcome data (eg, mixed models of repeated measurement, multiple imputations) instead of last-observation carried forward or observed-case analyses. Unavailable SD will be calculated through test statistics35 or validated imputation from other included studies.36

    For dichotomous outcomes, when studies report only observed cases, missing participants will be conservatively classified as treatment non-responders without adverse events to avoid overestimation of rare side effects, ensuring methodologically rigorous efficacy evaluations.

    Subgroup analysis

    When heterogeneity is detected and sufficient data is available, subgroup analyses will be performed to further compare the differences in the primary and secondary outcomes based on the type of substance use (alcohol, opioids, stimulants, nicotine, cannabis and polysubstance), type of acupuncture (auricular, body acupuncture, and auricular+body acupuncture), co-intervention status (adjunctive vs monotherapy), comparison group (treatment as-usual, sham-acupuncture, passive (eg, wait-list control, no-treatment) and active treatments), measurement tools (biological markers vs self-reports), length of follow-up (postintervention, short-term (4 weeks) and long-term (over 4 weeks), risk of bias of included studies (high-risk bias, some concern) and low-risk bias) and countries of studies conducted (China vs others).

    Assessment of publication bias

    Publication bias will be evaluated by visual inspection of the funnel plot for asymmetry and using Egger’s regression intercept test. Asymmetry of the two sides of the funnel plot suggests a high possibility of publication bias, and Egger’s test will be used to confirm. A p value＜0.05 indicates the presence of publication bias, whereas a p value ≥0.05 suggests the absence of such bias.

    Sensitivity analysis

    Sensitivity analyses, including influence analysis and meta-analysis, with or without trials with a high-risk bias, will be conducted to assess the robustness of the primary outcomes. Influence analysis qualitatively evaluated the influence of each study on the net results by sequentially excluding one study at a time, and a meta-analysis will be implemented to quantitatively analyse the robustness by excluding trials with a high overall risk of bias.

    Study period

    This systematic review will be conducted from 15 December 2024 to 30 May 2025.

    Discussion

    SUDs are chronic, relapsing psychiatric conditions characterised by compulsive drug-seeking and drug-taking behaviour, which remains one of the most critical public health problems in the world. A growing body of research suggests that acupuncture may be beneficial for SUDs, as it has been shown to increase abstinence rates, reduce cravings, improve withdrawal symptoms and enhance quality of life.15 17 18 21 22 25 This effect is believed to result from the bidirectional role of acupuncture in regulating neurotransmitters involved in drug craving modulation via somatosensory afferent mechanisms and normalising hyporeactivity or hyperactivity of the mesolimbic dopamine system in substance addiction.37 Despite abundant evidence supporting the efficacy and safety of acupuncture for SUDs, it is not included as a recommendation in most clinical practice guidelines.1 38–40 And this is partly attributed to the inconsistent results reported in some RCTs and meta-analyses that did not support the use of acupuncture for SUDs,18 26 28 29 as well as low-quality studies included in these analyses.40 Therefore, we propose to conduct this systematic review and meta-analysis, comprehensively searching both English and Chinese databases, to provide updated evidence on the effectiveness of acupuncture as a treatment for SUDs, which may guide evidence-based clinical practice and improve patient outcomes.

    Ethics and dissemination

    There are no ethical considerations and no need for ethical approval as patients or private data will not be collected. The results will be published in a peer-reviewed journal.

    Ethics statements

    Patient consent for publication

    Acknowledgments

    The authors would like to thank those who provided comments on the revision of this review.

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    Footnotes

    • C-rT and MQ are joint first authors.

    • C-rT and MQ contributed equally.

    • Contributors Conceptualisation: CT and YW. Data curation: CT, MQ and JC. Formal analysis: CT, MQ, JC and SC. Investigation: CT, MQ and JC. Methodology: CT, MQ and SC. Project administration: CT and MQ. Resources: CT and MQ. Software: CT and MQ. Supervision: YW. Validation: CT and YW. Visualisation: CT and YW. Writing: CT and MQ. Writing-review and editing: CT, MQ and YW. Guarantor is YW. All authors read and approved the final manuscript.

    • Funding Yingying Wang is funded by Capital’s Funds for Health Improvement and Research (Grant No. 2024-2-4372) and the National Administration of Traditional Chinese Medicine Youth Qihuang Project Special Fund (Grant No. 11055).

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were not involved in the design, conduct, reporting or dissemination plans of this research.

    • Provenance and peer review Not commissioned; externally peer reviewed.

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