Medical Policy

Policy Num:      11.003.130
Policy Name:    Acupuncture for Pain Management, Nausea and Vomiting, and Opioid Dependence
Policy ID:          [11.003.130]  [Ac / B / M+ / P-]  [7.01.157]

Last Review:       December 16, 2024
Next Review:       December 20, 2025
 

Related Policies:

08.001.007 - Dry Needling of Trigger Points for Myofascial Pain
02.01.103 - Trigger Point and Tender Point Injections
13.009.004 - Temporomandibular Joint Disorder

  Acupuncture for Pain Management, Nausea and Vomiting, and Opioid Dependence

Summary

Description

Acupuncture describes a group of procedures intended to stimulate anatomical points with the goal of precipitating physiologic changes. Acupuncture has been proposed to treat the pain of various etiologies as well as other non-pain disorders including the alleviation of opioid dependence withdrawal symptoms. This review addresses acupuncture for pain management, nausea and vomiting, and opioid dependence.

Summary of Evidence

Pain-Related Conditions

For individuals who have episodic migraines who receive acupuncture, the evidence includes randomized controlled trials (RCTs), a nonrandomized comparative study, and systematic reviews. Relevant outcomes include symptoms, functional outcomes, medication use, and treatment-related morbidity. Pooled analyses of 15 sham-controlled trials on episodic migraine in a Cochrane review found significantly better outcomes with acupuncture, which were considered to be clinically significant. Pooled analyses of trials on acupuncture versus prophylactic medication found a significant benefit of acupuncture at the end of treatment but not at the end of the follow-up period. The evidence is sufficient to determine that the technology results in an improvement in the net health outcomes.

For individuals who have tension-type headaches who receive acupuncture, the evidence includes RCTs and systematic reviews. Relevant outcomes include symptoms, functional outcomes, medication use, and treatment-related morbidity. Pooled analyses in a Cochrane review on acupuncture for tension-type headaches consistently found statistically significant benefits of acupuncture compared with sham up to 5 to 6 months. The clinical significance of the findings was not assessed. The evidence is sufficient to determine that the technology results in an improvement in the net health outcomes.

For individuals who have low back pain who receive acupuncture, the evidence includes RCTs and systematic reviews. Relevant outcomes include symptoms, functional outcomes, medication use, and treatment-related morbidity. An updated Cochrane review found that acupuncture may not play a clinically meaningful role as compared to sham treatment in pain relief immediately after treatment and quality of life in the short-term. Additionally, acupuncture did not improve back function in the immediate term as compared to sham. Acupuncture was found to be more effective than no treatment in improving pain and function in the immediate term. Pooled analyses of sham-controlled randomized trials on chronic low back pain in 2 different meta-analyses found improvements in pain up to 3 months. No significant global improvement was observed at up to 3 months in the acupuncture group. Longer-term sham-controlled data for this outcome are not available. Pooled analyses from other meta-analyses found no clinically meaningful improvement regarding pain or function among the acupuncture recipients compared with the group receiving other treatments ). The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have other pain-related conditions (eg, shoulder pain, lateral elbow pain, carpal tunnel syndrome, cancer pain in adults, chronic pain in adults with spinal cord injury, pain in endometriosis, pain in rheumatoid arthritis) who receive acupuncture, the evidence includes RCTs and systematic reviews of these trials. Relevant outcomes include symptoms, functional outcomes, medication use, and treatment-related morbidity. The RCTs were generally of low quality and/or lacked significantly better outcomes with acupuncture than with control conditions. One meta-analysis of 7 RCTs in cancer pain found better pain reduction with true acupuncture versus sham acupuncture, but heterogeneity was high and the difference between groups was of questionable clinical significance. Another meta-analysis of 22 RCTs in patients with chronic spinal pain found acupuncture therapy to significantly improve pain as compared to sham acupuncture, usual care, or no treatment; however, included studies were of small sample size, had significant heterogeneity, and had blinding concerns. A systematic review of 9 RCTs in patients with chemotherapy-induced peripheral neuropathy also found high heterogeneity and a need for higher quality RCTs. The evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.

Nausea and Vomiting

For individuals who have nausea or vomiting or are at high-risk of nausea or vomiting who receive acupuncture, the evidence includes RCTs and meta-analyses. Relevant outcomes include symptoms, functional outcomes, medication use, and treatment-related morbidity. Two Cochrane reviews and 1 meta-analysis addressed acupuncture for treating nausea and vomiting in pregnancy. The few RCTs identified did not find significant differences in outcomes between acupuncture and sham acupuncture. A 2023 RCT found greater efficacy of acupuncture, doxylamine-pyridoxine, and the combination compared with placebo in women with moderate or severe nausea and vomiting during early pregnancy, but the clinical importance of this effect is questionable. A 2024 meta-analysis found that acupuncture plus Western medicine may be a more beneficial treatment than Western medicine alone for nausea and vomiting associated with pregnancy. A third Cochrane review addressed chemotherapy-induced nausea and vomiting. Findings were not robust. A pooled analysis of 4 trials (1 on manual acupuncture, 3 on electroacupuncture) found that the acupuncture intervention was associated with a significantly lower incidence of acute vomiting during the next 24 hours. However, no individual trial had a significant finding for this outcome, and a pooled analysis of the 3 trials on electroacupuncture did not find a significant benefit from electroacupuncture on acute vomiting. Moreover, data from these trials were not available on 3 of the 4 outcomes of interest. An additional RCT comparing true acupuncture to sham acupuncture for chemotherapy-induced nausea and vomiting did not find a difference between treatment groups in terms of the complete response rate of nausea or vomiting. A 2023 meta-analysis found no difference in acute nausea or vomiting between acupuncture and sham when both interventions were added to usual care in patients with chemotherapy-induced nausea and vomiting. A fourth Cochrane review addressed 10 interventions involving stimulation of the wrist acupuncture point PC6 for postoperative nausea and vomiting (PONV). Conclusions about acupuncture could not be drawn from this review because only a small number of studies assessed acupuncture and review findings were not stratified by intervention. An additional systematic review of 10 trials that evaluated acupuncture therapy for PONV after gynecologic surgery showed that acupuncture therapy significantly reduced the incidence of PONV with a similar incidence of adverse events as compared to the use of a placebo or sham acupuncture; however, the authors concluded that a large, multicenter study is still required to compare the effects of acupuncture on preventing PONV with other noninvasive acupoint stimulation techniques. The evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.

Opioid Dependence

For individuals who have opioid dependence who receive acupuncture, the evidence includes RCTs and systematic reviews. Relevant outcomes include symptoms, functional outcomes, medication use, and treatment-related morbidity. A Cochrane review identified a single RCT, which did not find a significant benefit from acupuncture in reducing opioid consumption in patients with chronic non-cancer-related pain. A narrative systematic review concluded that there is insufficient evidence from high-quality RCTs to draw conclusions about the efficacy of acupuncture in the treatment of opioid addiction. A more recent network meta-analysis found that acupuncture may be effective in treating patients receiving methadone therapy for opioid dependence, but methadone therapy was not well described and all included trials were conducted in China. The evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.

Additional Information

Not applicable.

Objective

The objective of this evidence review is to determine whether the use of acupuncture improves the net health outcome for individuals with pain-related conditions, nausea and vomiting, and opiate dependence.

Policy Statements

Acupuncture may be considered medically necessary for treatment of episodic migraines and/or tension-type headaches.

Acupuncture is considered investigational for the treatment of other pain-related conditions including but not limited to:

• Low back pain

• Shoulder pain

• Lateral elbow pain

• Carpal tunnel syndrome

• Cancer pain in adults

• Chronic pain in patients with spinal cord injury

• Pain in endometriosis

• Pain in rheumatoid arthritis.

Acupuncture is considered investigational for the prevention or treatment of nausea and/or vomiting.

Acupuncture is considered investigational for opioid reduction or cessation in opiate users.

Policy Guidelines

Acupuncture is reported based on 15-minute increments of face-to-face contact with the patient, not the duration of acupuncture needle(s) placement.

Coding

See the Codes table for details.

Benefit Application

BlueCard/National Account Issues

State or federal mandates (eg, Federal Employee Program) may dictate that certain U.S. Food and Drug Administration approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only by their medical necessity.

Acupuncture is considered within the scope of practice of a licensed physician. However, some physicians may seek additional training in acupuncture. Nonphysicians who have completed appropriate training may also be licensed to perform acupuncture. State regulations may affect the range of providers offering acupuncture.

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered.  Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

Background

Acupuncture

Acupuncture is a traditional form of Chinese medical treatment that has been practiced for over 2000 years. It involves piercing the skin with needles at specific body sites. The placement of needles into the skin is dictated by the location of meridians. These meridians, or channels, are thought to mark patterns of energy, called Qi (chi), that flow through the human body. According to traditional Chinese philosophy, illness occurs when the energy flow is blocked or unbalanced, and acupuncture is a way to influence chi and restore balance. Another tenet of this philosophy is that all disorders are associated with specific points on the body, on or below the skin surface.

Several physiologic explanations of acupuncture’s mechanism of action have been proposed, including an analgesic effect from the release of endorphins or hormones (eg, cortisol, oxytocin), a biomechanical effect, and/or an electromagnetic effect.

There are 361 classical acupuncture points located along 14 meridians,^1, and different points are stimulated depending on the condition treated. In addition to traditional Chinese acupuncture, there are a number of modern styles of acupuncture, including Korean and Japanese acupuncture. Modern acupuncture techniques can involve stimulation of additional non-meridian acupuncture points. Acupuncture is sometimes used along with manual pressure, heat (moxibustion), or electrical stimulation (electroacupuncture). Acupuncture treatment can vary by style and by the practitioner and is personalized to the patient. Thus, patients with the same condition may receive stimulation of different acupuncture points.

The scientific study of acupuncture is challenging due to the multifactorial nature of the intervention, variability in practice, and individualization of treatment. There has been much discussion in the literature on the ideal control condition for studying acupuncture. Ideally, the control condition should be able to help distinguish between specific effects of the treatment and nonspecific placebo effects related to factors such as patient expectations and beliefs and the patient-provider therapeutic relationships. A complicating factor in the selection of a control treatment is that it is not clear whether all 4 components (ie, the acupuncture needles, the target location defined by traditional Chinese medicine, the depth of insertion, and the stimulation of the inserted needle) are necessary for efficacy. Sham acupuncture interventions vary; they can involve superficial insertion of needles or insertion of needles at the “wrong” points. A consensus recommendation on clinical trials of acupuncture, published by White et al (2002), recommends distinguishing between a penetrating and nonpenetrating sham control.^2,

Acupuncture has been used to treat a large variety of conditions. This review addresses acupuncture for treating chronic pain, to ameliorate nausea and vomiting symptoms, and to alleviate withdrawal symptoms of opioid users.

Acupuncture for the treatment of temporomandibular joint disorder is addressed in evidence review 13.009.004.

Regulatory Status

The U.S. Food and Drug Administration has cleared acupuncture needles for marketing but does not regulate the practice of acupuncture.^3,

Rationale

This evidence review was created in November 2016 and has been updated regularly with searches of the PubMed database. The most recent literature update was performed through October 8, 2024.

Evidence reviews assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent 1 or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. Randomized controlled trials are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

In addition, pain and other outcomes (eg, drug cravings, nausea) are subjective outcomes and, thus, may be particularly susceptible to placebo effects. Because of these factors, sham-controlled trials are essential to demonstrate the clinical effectiveness of acupuncture compared with alternatives (eg, continued medical management).

Promotion of greater diversity and inclusion in clinical research of historically marginalized groups (e.g., People of Color [African-American, Asian, Black, Latino and Native American]; LGBTQIA (Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, Asexual); Women; and People with Disabilities [Physical and Invisible]) allows policy populations to be more reflective of and findings more applicable to our diverse members. While we also strive to use inclusive language related to these groups in our policies, use of gender-specific nouns (e.g., women, men, sisters, etc.) will continue when reflective of language used in publications describing study populations.

Population Reference No. 1

Pain-Related Conditions: Episodic Migraine

Clinical Context and Therapy Purpose

The purpose of acupuncture is to provide a treatment option that is an alternative to or an improvement on existing therapies in individuals with episodic migraines.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals with episodic migraines.

Interventions

The therapy being considered is acupuncture.

Comparators

The following therapies are currently being used to treat episodic migraines: medication therapy and other conservative therapies.

Outcomes

The general outcomes of interest are symptoms (eg, migraine frequency, pain reduction), functional outcomes, medication use, and treatment-related morbidity.

Follow-up over months is of interest to relevant outcomes for episodic migraines.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Systematic Reviews

A Cochrane review by Linde et al (2016) included RCTs at least 8 weeks in duration that compared acupuncture with sham acupuncture, prophylactic medication treatment, and/or no acupuncture in patients with episodic migraines.^4, Trials focusing on chronic migraine were excluded. The primary efficacy outcome was headache frequency, and the secondary outcome was the proportion of responders (at least a 50% reduction in migraine frequency). Twenty-one RCTs met reviewers’ selection criteria; all were parallel-group trials. Fifteen trials included a sham acupuncture control group, 5 had a prophylactic medication group, and 5 had a no acupuncture group (several trials had >2 arms). Acupuncture interventions were heterogeneous (eg, number of sessions, length of sessions, standardized vs. individualized placement of needles). Risk of bias was assessed in 13 sham-controlled trials; all attempted blinding and the overall risk of bias was considered to be low. None of the 3 trials comparing acupuncture with prophylactic medication were blinded, and dropout rates were high in 2. Overall, these trials were considered at considerable risk of bias. Key outcomes for the acupuncture versus sham acupuncture and acupuncture versus prophylactic medication analyses are shown in Table 1.

Table 1. Key Outcomes for Episodic Migraine

In a pooled analysis comparing acupuncture with sham acupuncture, acupuncture had statistically significant effects on the reduction of headache frequency and on response rates at both follow-ups. Reviewers considered the differences between groups to be small but clinically relevant. Fewer trials compared acupuncture with prophylactic medication. There was a significantly greater effect of acupuncture on reduction in headache frequency and response rates at the end of treatment but not at the end of follow-up.

Giovanardi et al (2020) completed a more recent systematic review and meta-analysis that evaluated the efficacy and safety of acupuncture versus pharmacological prophylaxis of migraine.^5, The review included 9 RCTs, the majority of which were discussed in the Cochrane review by Linde et al (2016). Results were similar with the authors concluding that acupuncture is mildly more effective and much safer than medication for the prophylaxis of migraine.

Randomized Controlled Trials

Zhao et al (2017) conducted an RCT in 3 clinical centers in China to investigate the long-term effects of acupuncture for migraine prophylaxis compared with sham acupuncture and being placed in a waiting-list control group.^6, Adults (18 to 65 years) with migraines without aura (N=245) were recruited from hospital outpatient departments and randomized to acupuncture, sham acupuncture, and waiting-list groups. Participants in the acupuncture and sham acupuncture groups were blinded and received treatment 5 days a week for 4 weeks for a total of 20 sessions. Participants in the waiting-list group did not receive acupuncture but were informed that 20 sessions of acupuncture would be provided free of charge at the end of the trial. The change in the frequency of migraine attacks from baseline to week 16, as recorded in patient diaries, was the primary outcome. Secondary outcome measures included the number of migraine days, average headache severity, and medication intake every 4 weeks within 24 weeks. The mean change in frequency of migraine attacks differed significantly among the 3 groups at 16 weeks after randomization (p<.001); the mean (standard deviation) frequency of attacks decreased in the acupuncture group by 3.2 (2.1), in the sham acupuncture group by 2.1 (2.5), and in the waiting-list group by 1.4 (2.5); a greater reduction was observed in the acupuncture group than in the sham acupuncture group (difference, 1.1 attacks; 95% confidence interval [CI], 0.4 to 1.9; p=.002) and in the acupuncture versus waiting-list group (difference, 1.8 attacks; 95% CI, 1.1 to 2.5; p<.001). Sham acupuncture did not differ statistically from the waiting-list group (difference, 0.7 attacks; 95% CI, -0.1 to 1.4; p=.07).

Nonrandomized Comparative Studies

Tastan et al (2018) published a comparative study of 3 treatments for migraines.^7, Ninety patients were included in the study and assigned to the acupuncture group (n=30), hypnotherapy group (n=30), or pharmacotherapy group (n =30; acetaminophen 650 mg or 1300 mg was used). Visual analog scale (VAS) and Migraine Disability Assessment scores decreased significantly for all 3 groups after 3 months (p<.001). For acupuncture and hypnotherapy, the percentage reduction in the VAS score was significantly higher than pharmacotherapy at 3 months (p<.001). Also, the percentage reduction for the Migraine Disability Assessment score was significantly higher for acupuncture and hypnotherapy than pharmacotherapy (p=.007 and p=.002, respectively). The study was limited by its short follow-up time, lack of blinding, and lack of assessment of patients’ demographic characteristics.

Section Summary: Episodic Migraine

Pooled analyses of 15 sham-controlled trials on episodic migraine in a Cochrane review found significantly better outcomes with acupuncture. The magnitude of the difference between acupuncture and sham acupuncture was small but considered clinically relevant. Similar findings were observed in a more recent RCT and a comparative study. A limitation of the sham-controlled literature is the variability in intervention protocols, which makes it difficult to draw conclusions about any specific approach to acupuncture. Pooled analyses of trials on acupuncture versus prophylactic medication found a significant benefit of acupuncture at the end of treatment but not at the end of the follow-up period.

For individuals who have episodic migraines who receive acupuncture, the evidence includes randomized controlled trials (RCTs), a nonrandomized comparative study, and systematic reviews. Relevant outcomes include symptoms, functional outcomes, medication use, and treatment-related morbidity. Pooled analyses of 15 sham-controlled trials on episodic migraine in a Cochrane review found significantly better outcomes with acupuncture, which were considered to be clinically significant. Pooled analyses of trials on acupuncture versus prophylactic medication found a significant benefit of acupuncture at the end of treatment but not at the end of the follow-up period. The evidence is sufficient to determine that the technology results in an improvement in the net health outcomes.

Population Reference No. 2

Pain-Related Conditions: Tension-Type Headache

Clinical Context and Therapy Purpose

The purpose of acupuncture is to provide a treatment option that is an alternative to or an improvement on existing therapies in individuals with tension-type headaches.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals with tension-type headaches.

Interventions

The therapy being considered is acupuncture.

Comparators

The following therapies are currently being used to treat tension-type headaches: medication therapy and other conservative therapies.

Outcomes

The general outcomes of interest are symptoms (eg, headache frequency, pain reduction), functional outcomes, medication use, and treatment-related morbidity.

Follow-up over months is of interest to relevant outcomes.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Systematic Reviews

Another Cochrane review by Linde et al (2016) included RCTs at least 8 weeks in duration that compared acupuncture with sham acupuncture, standard care, or another comparator intervention in adults with episodic or chronic tension-type headache.^8, Interventions had to include at least 6 acupuncture sessions given at least once a week. The primary outcome measure was treatment response (at least a 50% reduction in headache frequency) 3 to 4 months after randomization. Outcomes at 8 weeks or less, 5 to 6 months, and more than 6 months after randomization were reviewed. Secondary outcomes included the number of headache days, headache intensity, frequency of analgesic use, and headache scores.

Twelve RCTs met reviewers’ inclusion criteria; all were parallel-group trials. Seven RCTs included a sham control group, and all were blinded. Control groups in other trials were physical therapy (3 studies), relaxation or massage (2 studies), and delayed acupuncture treatment (similar to a no-treatment group). One study had more than 2 arms. The trials that did not use a sham control were considered at major risk of bias. Key outcomes are shown in Table 2.

Table 2. Key Outcomes for Tension-Type Headache

In a pooled analysis comparing acupuncture with sham acupuncture, acupuncture had statistically significant effects on treatment response (the primary outcome) and the number of headache days at all time points for which data were available. There were insufficient data for pooling on other secondary outcome measures. Cochrane reviewers did not comment on whether the differences between groups in pooled analyses were clinically significant.

Kolokotsios et al (2021) conducted a systematic review and meta-analysis of 15 trials (N=1267) that evaluated the effectiveness of acupuncture on headache intensity and frequency in patients with tension-type headache.^9, Of the included studies, only 4 met the inclusion criteria for the meta-analysis (n=557). The average number of acupuncture sessions per patient in these studies was 9 and the average duration of treatment was 5.5 weeks. Results revealed that headache frequency after the last treatment was not significantly lower in the acupuncture group versus the placebo/sham group (mean difference, -1.53; 95% CI, -4.73 to 1.67); however, there was a trend toward improvement in the frequency of headaches in the long term (p=.06). Additionally, the VAS score was slightly reduced in the acupuncture group as compared with control after the last treatment (mean difference, -0.29; 95% CI, -1.21 to 0.62; p=.53). Long term, acupuncture was associated with a significant reduction in VAS (mean difference, -0.41; 95% CI, -0.72 to -0.10; p=.009).

Section Summary: Tension-Type Headache

Pooled analyses in a Cochrane review on acupuncture for tension-type headache consistently found statistically significant benefits of acupuncture compared with sham acupuncture. These findings were specific to 5 to 6 months of follow-up; there were insufficient data to conduct analyses of longer-term follow-up (ie, >6 months). Reviewers did not comment on the clinical significance of the findings.

For individuals who have tension-type headaches who receive acupuncture, the evidence includes RCTs and systematic reviews. Relevant outcomes include symptoms, functional outcomes, medication use, and treatment-related morbidity. Pooled analyses in a Cochrane review on acupuncture for tension-type headaches consistently found statistically significant benefits of acupuncture compared with sham up to 5 to 6 months. The clinical significance of the findings was not assessed. The evidence is sufficient to determine that the technology results in an improvement in the net health outcomes.

Population Reference No. 3

Pain-Related Conditions: Low Back Pain

Clinical Context and Therapy Purpose

The purpose of acupuncture is to provide a treatment option that is an alternative to or an improvement on existing therapies in individuals with low back pain.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals with low back pain.

Interventions

The therapy being considered is acupuncture.

Comparators

The following therapies are currently being used to treat low back pain: medication therapy, physical therapy, and other conservative therapies.

Outcomes

The general outcomes of interest are symptoms (eg, pain reduction), functional outcomes, medication use, and treatment-related morbidity.

Follow-up over months is of interest to relevant outcomes.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Systematic Reviews

Lam et al (2013) conducted a systematic review and meta-analysis of RCTs to evaluate the effectiveness of acupuncture for nonspecific chronic low back pain.^10, Among the 32 studies included in the systematic review, 25 studies presented relevant data for meta-analysis. Reviewers adopted a minimally important change of 15 mm in VAS score, 2 points for numeric pain scale score for pain, 5 points for Roland-Morris Disability Questionnaire score, and 10 points for Oswestry Disability Index score for pooled results that use the same outcome scales (ie, mean difference) to determine if an intervention had a clinically significant effect on pain. Acupuncture had a clinically meaningful reduction in levels of self-reported pain compared with sham and improved function when compared with no treatment in the immediate postintervention period. Levels of function also improved clinically when acupuncture plus usual care was compared with usual care alone. When acupuncture was compared with medications (nonsteroidal anti-inflammatory drugs, muscle relaxants, analgesics) and usual care, there were statistically significant differences between the control and the intervention groups, but these differences were too small to be of any clinical significance (Table 3).

A systematic review performed by Chou et al (2017) included the Lam et al (2013) meta-analysis described above and found 4 additional RCTs pertaining to acupuncture for chronic low back pain.^11, However, no updated meta-analysis was performed. Only 1 of the additional trials was considered "good quality." This trial found improved pain scores after 6 weeks with acupuncture versus sham acupuncture, but no significant differences in Oswestry Disability Index score.

Furlan et al (2005) published a Cochrane review of acupuncture and dry needling for low back pain.^12, Reviewers included RCTs in adults with nonspecific low back pain and myofascial pain syndrome in the low back. The RCTs had to report at least 1 of 4 outcome measures: pain intensity measured by a VAS, global improvement measure, back-specific functional status scale (eg, Roland-Morris Disability Questionnaire, Oswestry Disability Index), or return to work. Only 1 sham-controlled study on acupuncture for acute back pain was found, and it did not find between-group differences in pain or function after 1 treatment session. Six RCTs compared acupuncture with sham acupuncture. Chronic pain outcomes are reported in Table 3.

Pain was significantly lower with acupuncture than with sham immediately after treatment and after short-term follow-up (up to 3 months), but there was no significant difference between groups at intermediate follow-up (3 months to 1 year). Similarly, global improvement scores were significantly better in the acupuncture group than in the sham group immediately after treatment, but there was no significant between-group difference at the short-term follow-up. In pooled analyses of studies comparing acupuncture with other interventions (eg, massage, spinal manipulation, medication), there were significant differences immediately after treatment and at intermediate follow-up, favoring the other intervention groups; reviewers did not find a significant between-group difference at short-term follow-up.

An updated Cochrane review by Mu et al (2020) included 33 RCTs (N=8270) that assessed the effects of acupuncture compared to sham intervention, no treatment, or usual care for chronic nonspecific low back pain in adults with pain lasting more than 3 months without a specific etiology.^13, The primary outcomes were pain, back-specific functional status, and quality of life. Overall, the majority of studies had a high risk of performance bias due to lack of blinding and a few studies had a high risk of detection, attrition, reporting, or selection bias. Outcomes are reported in Table 3. Overall, the authors concluded that acupuncture may not play a more clinically meaningful role than sham in relieving pain immediately after treatment or in improving quality of life in the short term, and acupuncture did not improve back function compared to sham in the immediate term. However, acupuncture was more effective than no treatment in improving pain and function in the immediate term.

A systematic review and meta-analysis by Lin et al (2024) evaluated acupuncture versus oral medications for acute and subacute low back pain.^14, Fourteen studies were included (N= 1263); the results showed that acupuncture therapy was marginally more effective than oral medication in reducing pain (p< 0.00001; I² = 92%; mean difference [MD] −1.17, 95% CI [−1.61 to −0.72]; moderate effect, extremely low-quality evidence). Tests like the Roland-Morris Disability Questionnaire (RMDQ), the Lumbar Range of Motion (LROM), and the Schober test were used to evaluate functional status. For RMDQ, acupuncture therapy demonstrated a statistically significant advantage over oral medication (p< 0.00001; I² = 90%, standardized mean difference [SMD] − 1.42, 95% CI [− 2.22 to − 0.62]; large effect, very low-quality evidence).There were no statistically significant differences between acupuncture therapy and oral medication for the other functional status tests.

Table 3. Key Outcomes for Chronic Low Back Pain

Section Summary: Low Back Pain

An updated Cochrane review found that acupuncture may not play a clinically meaningful role as compared to sham treatment in pain relief immediately after treatment and quality of life in the short-term. Additionally, acupuncture did not improve back function in the immediate term as compared to sham. Acupuncture was found to be more effective than no treatment in improving pain and function in the immediate term. Pooled analyses of sham-controlled randomized trials on chronic low back pain in 2 different meta-analyses found improvement in pain up to 3 months. No significant global improvement was observed at up to 3 months. Sham-controlled data beyond a 3-month follow-up were not available for this outcome. In pooled analyses of acupuncture versus other treatments, 2 meta-analyses found statistically significant but not clinically meaningful improvement in terms of pain reduction and functional improvements for acupuncture compared with other medications.

For individuals who have low back pain who receive acupuncture, the evidence includes RCTs and systematic reviews. Relevant outcomes include symptoms, functional outcomes, medication use, and treatment-related morbidity. An updated Cochrane review found that acupuncture may not play a clinically meaningful role as compared to sham treatment in pain relief immediately after treatment and quality of life in the short-term. Additionally, acupuncture did not improve back function in the immediate term as compared to sham. Acupuncture was found to be more effective than no treatment in improving pain and function in the immediate term. Pooled analyses of sham-controlled randomized trials on chronic low back pain in 2 different meta-analyses found improvements in pain up to 3 months. No significant global improvement was observed at up to 3 months in the acupuncture group. Longer-term sham-controlled data for this outcome are not available. Pooled analyses from other meta-analyses found no clinically meaningful improvement regarding pain or function among the acupuncture recipients compared with the group receiving other treatments ). The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Population Reference No 4

Pain-Related Conditions: Other Pain-Related Conditions

Clinical Context and Therapy Purpose

The purpose of acupuncture is to provide a treatment option that is an alternative to or an improvement on existing therapies in individuals with other pain-related conditions (eg, shoulder pain, lateral elbow pain, carpal tunnel syndrome, cancer pain in adults, chronic pain in adults with spinal cord injury, pain in endometriosis, pain in rheumatoid arthritis).

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals with other pain-related conditions (eg, shoulder pain, lateral elbow pain, carpal tunnel syndrome, cancer pain in adults, chronic pain in adults with spinal cord injury, pain in endometriosis, pain in rheumatoid arthritis).

Interventions

The therapy being considered is acupuncture.

Comparators

The following therapies are currently being used to treat other pain-related conditions: medication therapy, physical therapy, and other conservative therapies.

Outcomes

The general outcomes of interest are symptoms, functional outcomes, medication use, and treatment-related morbidity.

Follow-up times vary by disease processes, but would typically range across months for relevant outcomes.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Systematic Reviews

Various Cochrane reviews have found insufficient evidence to demonstrate that acupuncture is effective for treating shoulder pain,^15, lateral elbow pain,^16, carpal tunnel syndrome,^17,18, hip osteoarthritis,^19, cancer pain in adults,^20, chronic pain in patients with spinal cord injury,^21, pain in endometriosis,^22, and pain in rheumatoid arthritis.^23, These reviews identified few RCTs, low-quality RCTs, and/or lack of significantly better outcomes with acupuncture than with control conditions.

He et al (2020) published an additional systematic review and meta-analysis on acupuncture for cancer pain.^24, Seven sham-controlled trials were identified, and a meta-analysis of data from these trials found that true acupuncture reduced pain more than sham acupuncture (mean difference, −1.38 points; 95% CI, −2.13 to −0.64). However, heterogeneity was high (I²=81%), and the clinical significance of the difference between groups is uncertain. No analyses were performed to compared true acupuncture to other active interventions.

Huang et al (2021) conducted a systematic review and meta-analysis that analyzed the efficacy and safety of acupuncture for the treatment of chronic spinal pain.^25, The review included 22 RCTs with 2588 patients who had chronic neck pain, chronic low back pain, or sciatica for more than 3 months. Any type of acupuncture therapy was included in the systematic review/meta-analysis such as traditional acupuncture, electro-acupuncture, fire needling, auricular acupuncture, abdominal acupuncture, warm acupuncture, and bee venom acupuncture. Control interventions included usual care, no treatment, sham acupuncture, placebo, or pharmacologic therapies. The primary outcome was pain intensity. Overall, standard acupuncture was utilized in 16 studies, the duration of interventions ranged from 1 treatment to 8 weeks of treatment, and follow-up ranged from 2 weeks to 1 year after the final treatment. A pooled analysis revealed acupuncture to significantly improve chronic spinal pain as compared to sham acupuncture (weighted mean difference [WMD], -12.05; 95% CI, -15.86 to -8.24), usual care (WMD, -9.57; 95% CI, -13.48 to -9.44), and no treatment (WMD, -17.1; 95% CI, -24.83 to -9.37). Acupuncture was also associated with improvement in physical functioning at short-, intermediate-, and long-term follow-up. Of note, the meta-analysis had significant heterogeneity, which may have been due to the differing forms of acupuncture utilized and quality of included studies. Additionally, the majority of included trials had only short- and intermediate-term follow-up data and a relatively small sample size. Blinding of treatment was also difficult due to the nature of acupuncture therapy.

Pei et al (2023) published a systematic review and meta-analysis of 9 RCTs (N=582) evaluating acupuncture or electroacupuncture in patients with chemotherapy-induced peripheral neuropathy (CIPN).^26, Comparators included pharmacotherapy, sham, or no treatment. Pain outcomes were a secondary outcome. Heterogeneity was high, thus, the majority of outcomes were summarized with qualitative analysis. However, meta-analysis of 4 studies (n=260) was performed comparing vitamin B to acupuncture for sensory neuropathy finding improved outcomes with acupuncture versus vitamin B (risk ratio, 1.60; 95% CI, 1.31 to 1.95; I²=0%). Current RCTs are of low methodologic quality and higher quality trials are necessary to draw conclusions regarding the efficacy of acupuncture for CIPN.

Section Summary: Other Pain-Related Conditions

There are numerous systematic reviews and meta-analyses evaluating acupuncture for various pain conditions. Generally, these analyses have found insufficient evidence to demonstrate that acupuncture is effective. One meta-analysis of 7 RCTs in cancer pain found better pain reduction with true acupuncture versus sham acupuncture, but heterogeneity was high and the difference between groups was of questionable clinical significance. Another meta-analysis of 22 RCTs in patients with chronic spinal pain found acupuncture therapy to significantly improve pain as compared to sham acupuncture, usual care, or no treatment; however, included studies were of small sample size, had significant heterogeneity, and had blinding concerns. For patients with CIPN, a systematic review found high heterogeneity among RCTs and concluded a need for higher quality trials.

For individuals who have other pain-related conditions (eg, shoulder pain, lateral elbow pain, carpal tunnel syndrome, cancer pain in adults, chronic pain in adults with spinal cord injury, pain in endometriosis, pain in rheumatoid arthritis) who receive acupuncture, the evidence includes RCTs and systematic reviews of these trials. Relevant outcomes include symptoms, functional outcomes, medication use, and treatment-related morbidity. The RCTs were generally of low quality and/or lacked significantly better outcomes with acupuncture than with control conditions. One meta-analysis of 7 RCTs in cancer pain found better pain reduction with true acupuncture versus sham acupuncture, but heterogeneity was high and the difference between groups was of questionable clinical significance. Another meta-analysis of 22 RCTs in patients with chronic spinal pain found acupuncture therapy to significantly improve pain as compared to sham acupuncture, usual care, or no treatment; however, included studies were of small sample size, had significant heterogeneity, and had blinding concerns. A systematic review of 9 RCTs in patients with chemotherapy-induced peripheral neuropathy also found high heterogeneity and a need for higher quality RCTs. The evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.

Population Reference No. 5

Nausea and Vomiting

Clinical Context and Therapy Purpose

The purpose of acupuncture is to provide a treatment option that is an alternative to or an improvement on existing therapies in individuals with nausea or vomiting or at high-risk of nausea or vomiting.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals with nausea or vomiting or at high-risk of nausea or vomiting.

Interventions

The therapy being considered is acupuncture.

Comparators

The following therapies are currently being used to treat nausea or vomiting: medication therapy and other conservative therapies.

Outcomes

The general outcomes of interest are symptoms (eg, reductions in the incidence of nausea and vomiting), functional outcomes, medication use, and treatment-related morbidity.

Follow-up times vary by disease processes, but would typically range across months for relevant outcomes.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Hyperemesis Gravidarum

Systematic Reviews

Boelig et al (2016) published a Cochrane review of various interventions for treating hyperemesis gravidarum (severe nausea and vomiting during pregnancy [morning sickness]).^27, Reviewers did not identify any studies comparing acupuncture with a placebo intervention. One RCT comparing acupuncture with medication (metoclopramide) did not find a significant difference between groups in the rates of symptom reduction (relative risk [RR], 1.40; 95% CI, 0.79 to 2.49) or cessation of symptoms (RR, 1.51; 95% CI, 0.92 to 2.48).

A Cochrane review by Matthews et al (2015), assessing interventions for nausea and vomiting in early pregnancy, identified 2 RCTs by the same research group on traditional acupuncture, but only 1 trial presented data in a form suitable for extraction.^28, The RCT did not find significant differences in outcomes in patients treated with acupuncture versus sham. For example, for mean nausea score on day 7, the difference was -0.70 (95% CI, -1.36 to -0.04); and for mean vomiting score on day 7, the difference was -0.10 (95% CI, -0.58 to 0.38).

Jin et al (2024) evaluated acupuncture therapy for nausea and vomiting during pregnancy in a systematic review and meta-analysis. ^29,There were 24 RCTs (N=2390 women) included in the analysis. Acupuncture was performed alone or in combination with the control group (e.g, sham acupuncture, placebo, no treatment, or Western medicine). Pregnancy-Unique Quantification of Emesis (PUQE) scores and ineffective rates were significantly lower with acupuncture plus WM than with WM alone (PUQE: MD, 1.95; 95% CI, 3.08 to 0.81; p =.0008, I² =90%; 6 studies) (ineffective rates: RR, 0.27; 95% CI, 0.19 to 0.39; p<.00001; I² = 7%; 16 studies). Along with a shorter period of stay, acupuncture plus Western medicine also led to a higher improvement in ketonuria and lower ratings on the Chinese Medicine Syndrome Scale and nausea and vomiting of pregnancy (NVP) QOL scale. When it came to lowering ineffective rates, acupuncture outperformed Western medicine (RR, 0.50; 95% CI 0.30 to 0.81; p =.006; I² = 0%; 5 studies). Improvements in PUQE scores and ketonuria negative rates were similar across acupuncture and Western Medicine.

Randomized Controlled Trials

Wu et al (2023) reported a 2x2 factorial, double-blind, RCT conducted at 13 centers in China.^30, The trial enrolled 352 women in early pregnancy with moderate to severe nausea and vomiting. Patients were randomized to receive active or sham acupuncture and doxylamine-pyridoxine or placebo for 14 days. All active treatments had greater improvement on the Pregnancy-Unique Quantification of Emesis (PUQE) score at day 15 than control with mean differences of -0.7 (95% CI, -1.3 to -0.1) for acupuncture, -1.0 (95% CI, -1.6 to -0.4) for doxylamine-pyridoxine, and -1.6 (95% CI, -2.2 to -0.9) for the combination. Although both acupuncture and doxylamine-pyridoxine were significantly more effective than placebo, the clinical importance of this effect is questionable.

Chemotherapy-Induced Nausea and Vomiting

Systematic Reviews

A Cochrane review by Ezzo et al (2006) addressed various types of acupuncture point stimulation (ie, needles, magnetic, acupressure, electrical stimulation) for reducing nausea and vomiting associated with chemotherapy.^31, Primary outcomes were acute vomiting, acute nausea, delayed vomiting, and delayed nausea. Reviewers included RCTs with any comparison group, and sensitivity analyses were conducted on sham-controlled versus non-sham-controlled trials. In addition, subgroup analyses were conducted on each method of acupuncture point stimulation. Fourteen RCTs met eligibility criteria, and 11 were included in the analysis. Of them, a single RCT used manual acupuncture (ie, insertion, manual rotation of needles) and 3 used electroacupuncture. The remaining trials used other techniques, largely self-administered acupressure using fingers or a wristband. Pooled analysis of the 4 trials using either manual acupuncture or electroacupuncture found a statistically significant reduction in the incidence of acute vomiting during the next 24 hours in the acupuncture group versus the control group (RR, 0.74; 95% CI, 0.58 to 0.94; p=.01). However, none of the individual trials showed a significant benefit of acupuncture or electroacupuncture on acute vomiting; and pooled analysis of the 3 trials on electroacupuncture was not statistically significant (RR, 0.86; 95% CI, 0.68 to 1.09). Data were not available for the other 3 primary outcomes.

A more recent systematic review by Yan et al (2023) identified 38 RCTs (N=2503) evaluating acupuncture for prevention of chemotherapy-induced nausea and vomiting.^32, All trials compared acupuncture with sham acupuncture or usual care. In comparison to usual care, acupuncture plus usual care did not significantly reduce acute nausea but did reduce acute vomiting (risk ratio, 2.20; 95% CI, 0.66 to 7.33 and risk ratio, 1.13; 95% CI, 1.02 to 1.25, respectively). There were no significant differences between acupuncture and sham in terms of acute nausea (risk ratio, 0.87; 95% CI, 0.26 to 2.90) or vomiting (risk ratio, 1.05; 95% CI, 0.72 to 1.53) when both interventions were added to usual care. Overall the evidence was of low certainty and higher quality RCTs with large sample sizes are needed.

Randomized Controlled Trials

Li et al (2020) reported an additional single-blind RCT in 134 patients undergoing chemotherapy.^33, Patients were randomized to receive true acupuncture (n=68) or sham acupuncture (n=66) in addition to antiemetics. Interventions were administered twice on day 1 of chemotherapy, then daily for the next 4 days. The rates of complete response of nausea or vomiting did not differ significantly between groups at any time point during the 21-day follow-up period, except at day 21, where the true acupuncture group exhibited a higher complete response rate for nausea (83.9% vs. 67.2%, p=.033).

Postoperative Nausea and Vomiting

Systematic Reviews

A Cochrane review by Lee et al (2015) evaluated 10 interventions for stimulating the wrist acupuncture point PC6 for the prevention of postoperative nausea and vomiting (PONV).^34, Reviewers identified 59 trials; a plurality of them addressed acupressure, which can be self-administered. Because there were no analyses specific to acupuncture, its effect on PONV could not be determined.

Zheng et al (2021) performed a systematic review and meta-analysis involving 10 trials (9 RCTs and 1 prospective cohort) that evaluated the effectiveness of acupuncture therapy on PONV after gynecologic surgery.^35, A total of 1075 women who had undergone gynecologic surgery with general anesthesia were included. Included studies evaluated the use of acupuncture and its derived techniques (eg, transcutaneous acupoint electrical stimulation, acupressure, and acupoint application) versus placebo or sham acupuncture. Primary outcomes of the analysis included the incidence of postoperative nausea and the incidence of postoperative vomiting. Results revealed that acupuncture therapy was associated with a significant reduction in the risk of developing postoperative nausea and postoperative vomiting by 48% (RR, 0.52; 95% CI, 0.44 to 0.61; p<.00001) and 42% (RR, 0.58; 95% CI, 0.49 to 0.68; p<.00001), respectively. There were no significant differences between groups with regard to the incidence of adverse effects (eg, bleeding and needle pain; p=.54). Acupuncture therapy was also significantly associated with a reduced rate of rescue antiemetic usage (p<.00001) and an increased degree of satisfaction with postoperative recovery (p<.0001). The authors concluded that acupuncture therapy is effective and safe for PONV prophylaxis in patients undergoing gynecologic surgery; however, a large, multicenter study is still required to compare the effects of acupuncture on preventing PONV with other noninvasive acupoint stimulation techniques.

Section Summary: Nausea and Vomiting

Two Cochrane reviews and 1 meta-analysis addressed acupuncture for treating nausea and vomiting in pregnancy. A 2016 review identified 1 RCT on hyperemesis gravidarum, and that trial did not find a significant difference in outcomes for patients receiving acupuncture versus metoclopramide. A 2015 review identified 2 RCTs by the same research group. One of the RCTs had data suitable for extraction, and it did not find a significant difference in outcomes between acupuncture and a sham intervention. A 2023 RCT found greater improvement on the PUQE score at day 15 than control with mean differences of -0.7 (95% CI, -1.3 to -0.1) for acupuncture, -1.0 (95% CI, -1.6 to -0.4) for doxylamine-pyridoxine, and -1.6 (95% CI, -2.2 to -0.9) for the combination, but the clinical importance of this effect is questionable. A 2024 meta-analysis found that acupuncture plus Western medicine may be a more beneficial treatment than Western medicine alone for nausea and vomiting associated with pregnancy.

A 2006 Cochrane review addressed acupuncture for treating chemotherapy-induced nausea and vomiting. It was withdrawn by Cochrane because a planned 2014 update was not completed. The review identified a trial on manual acupuncture and 3 on electroacupuncture. Pooled analysis of these 4 trials found a significantly lower incidence of acute vomiting during the next 24 hours with acupuncture or electroacupuncture versus a control condition. However, these findings were not robust; no individual trial had a significant finding for this outcome and pooled analysis of the 3 trials on electroacupuncture did not find a significant benefit from electroacupuncture on acute vomiting. A 2023 meta-analysis found no difference in acute nausea or vomiting between acupuncture and sham when both interventions were added to usual care. Moreover, the number of trials was small and data were not available on 3 of the 4 outcomes. An additional trial comparing true acupuncture to sham acupuncture for chemotherapy-induced nausea and vomiting did not find a difference between treatment groups in terms of the complete response rate of nausea or vomiting.

A 2015 Cochrane review assessed 10 interventions for stimulation of the wrist acupuncture point PC6 to prevent or delay PONV. Conclusions could not be drawn on acupuncture for PONV because only a few studies evaluated acupuncture and findings were not stratified by intervention. An additional systematic review of 10 trials that evaluated acupuncture therapy for PONV after gynecologic surgery showed that acupuncture therapy significantly reduced the incidence of PONV with a similar incidence of adverse events as compared to the use of a placebo or sham acupuncture.

For individuals who have nausea or vomiting or are at high-risk of nausea or vomiting who receive acupuncture, the evidence includes RCTs and meta-analyses. Relevant outcomes include symptoms, functional outcomes, medication use, and treatment-related morbidity. Two Cochrane reviews and 1 meta-analysis addressed acupuncture for treating nausea and vomiting in pregnancy. The few RCTs identified did not find significant differences in outcomes between acupuncture and sham acupuncture. A 2023 RCT found greater efficacy of acupuncture, doxylamine-pyridoxine, and the combination compared with placebo in women with moderate or severe nausea and vomiting during early pregnancy, but the clinical importance of this effect is questionable. A 2024 meta-analysis found that acupuncture plus Western medicine may be a more beneficial treatment than Western medicine alone for nausea and vomiting associated with pregnancy. A third Cochrane review addressed chemotherapy-induced nausea and vomiting. Findings were not robust. A pooled analysis of 4 trials (1 on manual acupuncture, 3 on electroacupuncture) found that the acupuncture intervention was associated with a significantly lower incidence of acute vomiting during the next 24 hours. However, no individual trial had a significant finding for this outcome, and a pooled analysis of the 3 trials on electroacupuncture did not find a significant benefit from electroacupuncture on acute vomiting. Moreover, data from these trials were not available on 3 of the 4 outcomes of interest. An additional RCT comparing true acupuncture to sham acupuncture for chemotherapy-induced nausea and vomiting did not find a difference between treatment groups in terms of the complete response rate of nausea or vomiting. A 2023 meta-analysis found no difference in acute nausea or vomiting between acupuncture and sham when both interventions were added to usual care in patients with chemotherapy-induced nausea and vomiting. A fourth Cochrane review addressed 10 interventions involving stimulation of the wrist acupuncture point PC6 for postoperative nausea and vomiting (PONV). Conclusions about acupuncture could not be drawn from this review because only a small number of studies assessed acupuncture and review findings were not stratified by intervention. An additional systematic review of 10 trials that evaluated acupuncture therapy for PONV after gynecologic surgery showed that acupuncture therapy significantly reduced the incidence of PONV with a similar incidence of adverse events as compared to the use of a placebo or sham acupuncture; however, the authors concluded that a large, multicenter study is still required to compare the effects of acupuncture on preventing PONV with other noninvasive acupoint stimulation techniques. The evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.

Population Reference No. 6

Opioid Dependence

Clinical Context and Therapy Purpose

The purpose of acupuncture is to provide a treatment option that is an alternative to or an improvement on existing therapies in individuals with opioid dependence.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals with opioid dependence.

Interventions

The therapy being considered is acupuncture.

Comparators

The following therapies are currently being used to treat opioid dependence: tapering, medication therapy, counseling, and other replacement therapies.

Outcomes

The general outcomes of interest are symptoms, functional outcomes, medication use, and treatment-related morbidity.

Follow-up over weeks to months is of interest to relevant outcomes.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Non-Cancer Pain

Systematic Reviews

Eccleston et al (2017) published a Cochrane review of interventions for reducing prescribed opioid use in patients with chronic non-cancer pain who had a treatment goal of reduction or cessation of opioid use.^36, Selection criteria included RCTs comparing interventions with sham, active control, or usual care. One RCT on acupuncture was identified. It compared 6 weeks of electroacupuncture (n=17) with sham electroacupuncture (n=18). At the end of treatment, 64% of the electroacupuncture group and 46% of the sham group had reduced opioid consumption; the difference between groups was not statistically significant. At the 20-week follow-up, patients in the electroacupuncture group, but not the sham group, had significantly increased opioid use from their posttreatment level.

Opioid Addiction

Systematic Reviews

Other than the Eccleston et al (2017) review, ^36, no Cochrane reviews were identified on acupuncture in opioid users. A systematic review by Lin et al (2012) addressed acupuncture for treating opioid addiction.^37, Reviewers searched for RCTs of individuals who met criteria for opioid or heroin addiction; trials could be blinded or unblinded. Ten trials met these inclusion criteria. None mentioned blinding. Four studies used acupuncture with manual stimulation, 4 used auricular acupuncture, 1 used electroacupuncture, and another used a Chinese acupoint stimulating device (Han’s acupoint nerve stimulator). Reviewers rated 8 trials as low quality and 2 as higher quality. The 2 studies rated higher quality both examined auricular acupuncture, and both reported that this treatment did not have a significant effect on outcomes when used as an adjunct to standard methadone treatment services. Reviewers did not pool study findings. They concluded that there was insufficient evidence to draw conclusions on the efficacy of acupuncture for treating opioid addiction.

A network meta-analysis by Wen et al (2021) investigated the impact of acupuncture in individuals with opioid dependence receiving methadone maintenance treatment.^38, A total of 20 RCTs (N=1997) evaluating patients with opioid dependence, as diagnosed by the Chinese Classification of Mental Disorders second or third editions or Diagnostic and Statistical Manual of Mental Disorders third or fourth editions, compared methadone maintenance treatment, traditional Chinese medicine (Chinese formulated herbal products), or 4 types of acupuncture (manual acupuncture, electroacupuncture, auricular acupuncture, and transcutaneous electrical acupoint stimulation [TEAS]). Heroin was the most commonly abused opioid across all trials. Treatment duration ranged from 7 to 90 days. A total of 14 studies that covered 8 head-to-head comparisons reported the recovery rate, which was assessed by the proportion of participants who were completely detoxified, nearly detoxified, or partially detoxified from therapy, indicated by varying levels of withdrawal. In the pair-wise meta-analysis, no statistically significant differences were observed in terms of recovery rate between methadone maintenance therapy and the various types of acupuncture. Withdrawal symptom scores measured by the Modified Himmelsbach Opiate Withdrawal Scale (MHOWS) were measured by 9 studies that included 8 direct comparisons of 5 interventions. A significant decrease in MHOWS score was observed with manual acupuncture compared to methadone maintenance therapy (-8.59; 95% CI, -15.96 to -1.23; p<.01). A network meta-analysis was also conducted to rank interventions for opioid dependence. In the comparisons for recovery rate, manual acupuncture was the most efficacious intervention for opioid dependence and methadone maintenance therapy was the least efficacious among all interventions; a statistically significant difference was only observed in manual acupuncture versus maintenance methadone therapy (risk ratio, 0.72; 95% CI, 0.50 to 0.95). In terms of withdrawal scores, manual acupuncture demonstrated a significant decrease in MHOWS scores compared to methadone therapy (-5.74; 95% CI, -11.60 to -0.10). While authors concluded that acupuncture may be effective for treating patients receiving methadone maintenance therapy, there were many limitations. All selected trials were conducted in China, and no trials were at low risk of bias. Additionally, methadone maintenance therapy, including doses and frequency, were not well described.

Section Summary: Opioid Dependence

A Cochrane review identified an RCT that did not find a significant benefit from acupuncture in reducing opioid consumption in patients with chronic non-cancer-related pain. A narrative systematic review concluded that there was insufficient evidence from high-quality RCTs to draw conclusions on the efficacy of acupuncture in the treatment of opioid addiction. A more recent network meta-analysis found that acupuncture may be effective in treating patients receiving methadone therapy for opioid dependence, but methadone therapy was not well described, and all included trials were conducted in China.

For individuals who have opioid dependence who receive acupuncture, the evidence includes RCTs and systematic reviews. Relevant outcomes include symptoms, functional outcomes, medication use, and treatment-related morbidity. A Cochrane review identified a single RCT, which did not find a significant benefit from acupuncture in reducing opioid consumption in patients with chronic non-cancer-related pain. A narrative systematic review concluded that there is insufficient evidence from high-quality RCTs to draw conclusions about the efficacy of acupuncture in the treatment of opioid addiction. A more recent network meta-analysis found that acupuncture may be effective in treating patients receiving methadone therapy for opioid dependence, but methadone therapy was not well described and all included trials were conducted in China. The evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.

Supplemental Information

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Practice Guidelines and Position Statements

Guidelines or position statements will be considered for inclusion in ‘Supplemental Information’ if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

American College of Rheumatology

The guidelines from the American College of Rheumatology (2019) on the treatment of osteoarthritis conditionally recommend acupuncture for patients with hip, knee, and/or hand osteoarthritis.^39, Guideline authors note that the evidence for efficacy of acupuncture in osteoarthritis remains a subject of controversy. The greatest number of positive trials with the largest effect sizes have been in patients with knee osteoarthritis. The authors conclude: "While the 'true' magnitude of effect is difficult to discern, the risk of harm is minor, resulting in the Voting Panel providing a conditional recommendation."

American College of Physicians

A guideline from the American College of Physicians (2017) strongly recommends nonpharmacologic therapy for the initial treatment of chronic low back pain: this may include "exercise, multidisciplinary rehabilitation, acupuncture, mindfulness-based stress reduction (moderate-quality evidence), tai chi, yoga, motor control exercise, progressive relaxation, electromyography biofeedback, low-level laser therapy, operant therapy, cognitive behavioral therapy, or spinal manipulation (low-quality evidence)."^40,

Department of Veterans Affairs/Department of Defense

The Department of Veterans Affairs/Department of Defense (2023) guideline on the primary care management of headache found insufficient evidence to recommend for or against acupuncture for the treatment of headache.^41, According to guideline authors, "the quality of the evidence in the use of acupuncture was very low. The body of evidence had limitations, including a small sample size and confounders in the analysis, and the effect size was very small for the most robust outcome".

The Department of Veterans Affairs/Department of Defense (2020) guideline on the non-surgical management of hip and knee osteoarthritis found insufficient evidence to recommend for or against the use of acupuncture in this setting.^42,

The Department of Veterans Affairs/Department of Defense (2022) guideline on the treatment of low back pain suggests offering acupuncture to patients with chronic low back pain.^43, The authors state: "Acupuncture appears to have a small benefit for the reduction of pain for those with chronic LBP [low back pain] in the intermediate-term (3 to 12 months). The evidence from two SRs [systematic reviews] and one small RCT [randomized controlled trial] favored acupuncture over sham for the critical outcome of pain intensity." For acute low back pain, there was insufficient evidence to recommend for or against the use of acupuncture.

National Institute for Health and Care Excellence

The NICE (2012) guidance, updated in 2021, on the diagnosis and management of headaches in those over 12 years of age recommended a course of up to 10 sessions of acupuncture over 5 to 8 weeks for prophylactic treatment of chronic tension-type headaches.^44,

For migraines, the guidance recommended a course of up to 10 sessions of acupuncture over 5 to 8 weeks for prophylactic treatment if both topiramate and propranolol were unsuitable or ineffective.^44,

The NICE (2016) guidance, updated in 2020, on the assessment and management of low back pain and sciatica in those over 16 years of age recommended not offering acupuncture for low back pain with or without sciatica.^45,

North American Spine Society

The North American Spine Society (2020) guideline on low back pain states that "in patients with low back pain, there is conflicting evidence that acupuncture provides improvements in pain and function as compared to sham acupuncture."^46, However, the guideline recommends acupuncture in addition to usual care in patients with chronic low back pain, stating that "addition of acupuncture to usual care is recommended for short-term improvement of pain and function compared to usual care alone."

Society for Integrative Oncology and American Society of Clinical Oncology

The Society for Integrative Oncology and the American Society of Clinical Oncology (ASCO) released joint guidance in 2022 on integrative approaches to managing pain in adults with cancer.^47, The recommendations provided related to acupuncture are below:

• "Acupuncture should be offered to patients experiencing aromatase inhibitor-related joint pain in breast cancer (Evidence based, benefits outweigh harms; Evidence quality: Intermediate; Strength of recommendation: Moderate).

• Acupuncture may be offered to patients experiencing general pain or musculoskeletal pain from cancer (Evidence based, benefits outweigh harms; Evidence quality: Intermediate; Strength of recommendation: Moderate).

• Acupuncture may be offered to patients experiencing chemotherapy-induced peripheral neuropathy from cancer treatment (Evidence based-informal consensus, benefits outweigh harms; Evidence quality: Low; Strength of recommendation: Weak).

• Acupuncture or acupressure may be offered to patients undergoing cancer surgery or other cancer-related procedures such as bone marrow biopsy (Evidence based-informal consensus, benefits outweigh harms; Evidence quality: Low; Strength of recommendation: Weak)."

U.S. Preventive Services Task Force Recommendations

No U.S. Preventive Services Task Force recommendations on acupuncture have been identified.

Medicare National Coverage

A national coverage determination, updated in January 2020, states the following on acupuncture^48,:

"Effective for claims with dates of service on and after January 21, 2020, acupuncture is only covered for chronic low back pain under section 1862(a)(1)(A) of the Social Security Act (the Act). See National Coverage Determination section 30.3.3 for specific coverage criteria. Medicare reimbursement for acupuncture, as an anesthetic, or as an analgesic or for other therapeutic purposes, may not be made unless the specific indication is excepted. All indications for acupuncture outside of National Coverage Determination section 30.3.3 remain non-covered."

National Coverage Determination section 30.3.3 states the following with respect to coverage of acupuncture for chronic low back pain^49,:

"Effective for services performed on or after January, 21, 2020, CMS will cover acupuncture for Medicare patients with chronic lower back pain. Up to 12 visits in 90 days are covered for Medicare beneficiaries under the following circumstance:

• For the purpose of this decision, chronic low back pain is defined as:

  • Lasting 12 weeks or longer;

  • nonspecific, in that it has no identifiable systemic cause (i.e., not associated with metastatic, inflammatory, infectious, etc. disease);

  • not associated with surgery; and,

  • not associated with pregnancy.

• An additional 8 sessions will be covered for those patients demonstrating an improvement.

• No more than 20 acupuncture treatments may be administered annually

• Treatment must be discontinued if the patient is not improving or is regressing.

All types of acupuncture including dry needling for any condition other than chronic low back pain are non-covered by Medicare."

Centers for Medicare & Medicaid Services issued a 2003 national coverage analysis of acupuncture for fibromyalgia^50, and a 2003 decision analysis on acupuncture for osteoarthritis,^51, both indicating noncoverage of the service. National coverage determinations for acupuncture for fibromyalgia and osteoarthritis were updated in January 2020 but continue to indicate noncoverage of the service for these disease states.^52,

Ongoing and Unpublished Clinical Trials

Some currently ongoing and unpublished trials that might influence this review are listed in Table 4.

Table 4. Summary of Key Trials

References

1. World Health Organization (WHO). A Proposed Standard International Acupuncture Nomenclature: Report of a WHO Scientific Group. 1991; https://apps.who.int/iris/bitstream/handle/10665/40001/9241544171_eng.pdf. Accessed October 1, 2024.
2. White P, Lewith G, Berman B, et al. Reviews of acupuncture for chronic neck pain: pitfalls in conducting systematic reviews. Rheumatology (Oxford). Nov 2002; 41(11): 1224-31. PMID 12421994
3. Food and Drug Administration. Complementary and Alternative Medicine Products and their Regulation by the Food and Drug Administration. Updated May 6, 2020. https://www.fda.gov/RegulatoryInformation/Guidances/ucm144657.htm. Accessed October 1, 2024.
4. Linde K, Allais G, Brinkhaus B, et al. Acupuncture for the prevention of episodic migraine. Cochrane Database Syst Rev. Jun 28 2016; 2016(6): CD001218. PMID 27351677
5. Giovanardi CM, Cinquini M, Aguggia M, et al. Acupuncture vs. Pharmacological Prophylaxis of Migraine: A Systematic Review of Randomized Controlled Trials. Front Neurol. 2020; 11: 576272. PMID 33391147
6. Zhao L, Chen J, Li Y, et al. The Long-term Effect of Acupuncture for Migraine Prophylaxis: A Randomized Clinical Trial. JAMA Intern Med. Apr 01 2017; 177(4): 508-515. PMID 28241154
7. Tastan K, Ozer Disci O, Set T. A Comparison of the Efficacy of Acupuncture and Hypnotherapy in Patients With Migraine. Int J Clin Exp Hypn. 2018; 66(4): 371-385. PMID 30152732
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50. Center for Medicare and Medicaid Services (CMS). National Coverage Determination (NCD) for Acupuncture for Fibromyalgia (30.3.1). June 24, 2020; https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=283&ncdver=2&bc=AAAAIAAAAAAA&. Accessed October 5, 2024.
51. Center for Medicare and Medicaid Services (CMS). National Coverage Determination (NCD) for Acupuncture for Osteoarthritis (30.3.2). June 24, 2020; https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=284&ncdver=2&bc=AAAAIAAAAAAA&. Accessed October 7, 2024.
52. Center for Medicare and Medicaid Services (CMS). Decision Memo for ACUPUNCTURE for Fibromyalgia (CAG- 00174N). 2003; https://www.cms.gov/medicare-coverage-database/details/technology-assessments-details.aspx?TAId=18&SearchType=Advanced&CoverageSelection=Both&NCSelection=NCA%7CCAL%7CNCD%7CMEDCAC%7CTA%7CMCD&ArticleType=SAD%7CEd&PolicyType=Both&s=All&CntrctrType=10&KeyWord=power&KeyWordLookUp=Title&KeyWordSearchType=Exact&kq=true&bc=IAAAACAAAAAA&. Accessed October 1, 2024.

Codes

Policy History