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.

BACKGROUND

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 thepractitioner 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 four 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, eg, 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 a separate policy on 'Temporomandibular Joint Dysfunction' (Policy #079 in the Medicine Section).

Regulatory Status

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

Related Policies

• Dry Needling of Myofascial Trigger Points (Policy #152 in the Treatment Section)
• Trigger Point Injections (Policy #107 in the Treatment Section)
• Temporomandibular Joint Dysfunction (Policy #079 in the Medicine Section)

(NOTE: There are member contract benefits that refer to the Horizon BCBSNJ medical policy specifically for coverage of acupuncture for treatment of nausea/vomiting associated with surgery, chemotherapy, and pregnancy. In such cases, acupuncture would be covered for this specific indication.)

· Low back pain
· Shoulder pain
· Lateral elbow pain
· Carpal tunnel syndrome
· Cancer pain in adults
· Chronic pain in members with spinal cord injury
· Pain in endometriosis
· Pain in rheumatoid arthritis.

(NOTE: There are member contract benefits that refer to the Horizon BCBSNJ medical policy specifically for coverage of acupuncture for treatment of nausea/vomiting associated with surgery, chemotherapy, and pregnancy. In such cases, acupuncture would be covered for this specific indication.)

· 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.

FIDE-SNP Coverage:

For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.

[RATIONALE: This policy was created in 1999 and has been updated regularly with searches of the MEDLINE database. The most recent literature update was performed through September 9, 2019.

Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life, and ability to function¾including benefits and harms. Every clinical condition has specific outcomes that are important to patients and 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 technology, two domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent one 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. RCTs 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).

Pain-Related Conditions: Episodic Migraine

Clinical Context and Test Purpose

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

The question addressed in this policy is: Does the use of acupuncture improve the net health outcome for individuals with episodic migraines?

The following PICOs were used to select literature to inform this review.

Patients

The relevant population of interest are individuals with episodic migraines.

Interventions

The therapy being considered is acupuncture.

Patients with episodic migraines are actively managed by neurologists and primary care providers in an outpatient setting.

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.

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.

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, five had a prophylactic medication group, and five 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 three trials comparing acupuncture with prophylactic medication were blinded, and dropout rates were high in two; overall, these trials were considered at considerable risk of bias. Key outcomes for the acupuncture vs sham acupuncture and acupuncture vs prophylactic medication analyses are shown in Table 1.

Table 1. Key Outcomes for Episodic Migraine

Outcomes	Follow-Up	No. Trials	Results
			Treatment Effect	95% CI	p
Acupuncture vs sham
Reduction in headache frequency	End of treatment	12	SMD = -0.18	-0.28 to -0.08	<0.001
	End of follow-up	10	SMD = -0.19	-0.30 to -0.09	<0.001
Responsea	End of treatment	14	RR=1.24	1.11 to 1.36	<0.001
	End of follow-up	11	RR=1.25	1.13 to 1.39	0.004
Acupuncture vs prophylactic medication
Reduction in headache frequency	End of treatment	3	SMD = -0.25	-0.39 to -0.10	0.001
	End of follow-up	3	SMD = -0.13	-0.28 to 0.01	0.08
Response	End of treatment	3	RR=1.24	1.08 to 1.44	0.003
	End of follow-up	3	RR=1.11	0.97 to 1.26	0.12

CI: confidence interval; RR: relative risk ratio; SMD: standardized mean difference.

^aAt least a 50% reduction in headache frequency.

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.

Randomized Controlled Trials

Zhao et al (2017) conducted an RCT in3 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.^5, Adults (18-65 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 inpatient 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<0.001); 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 than in the sham acupuncture group (difference, 1.1 attacks; 95% confidence interval [CI], 0.4 to 1.9; p=0.002) and in the acupuncture vs waiting-list group (difference, 1.8 attacks; 95% CI, 1.1 to 2.5; p<0.001). Sham acupuncture did not differ statistically from the waiting-list group (difference, 0.7 attacks; 95%I, -0.1 to 1.4; p=0.07).

Nonrandomized Comparative Studies

Tastan et al (2018) published a comparative study of 3 treatments for migraines.^6, 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 650mg or 1300mg was used). Visual analog scale (VAS) and Migraine Disability Assessment scores decreased significantly for all three groups after three months (p<0.001). For acupuncture and hypnotherapy, the percentage reduction in the VAS score was significantly higher than pharmacotherapy at three months (p<0.001). Also, the percentage reduction for the Migraine Disability Assessment score was significantly higher for acupuncture and hypnotherapy than pharmacotherapy (p=0.007 and p=0.002, 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 vs mediation found a significant benefit of acupuncture at the end of treatment but not at the end of the follow-up period.

Pain-Related Conditions: Tension-Type Headache

Clinical Context and Test Purpose

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

The question addressed in this policy is: Does the use of acupuncture improve the net health outcome for individuals with tension-type headaches?

The following PICOs were used to select literature to inform this review.

Patients

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

Interventions

The therapy being considered is acupuncture.

Patients with tension-type headaches are actively managed by neurologists and primary care providers in an outpatient clinical setting.

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 principles outlined for indication 1.

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.^7, Interventions had to include at least six 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 eight weeks or less, five to six months, and more than six 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 (three studies), relaxation or massage (two studies), and delayed acupuncture treatment (similar to a no-treatment group). One study had more than two 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

Outcomes	Follow-Up	No. Trials	Results
			Treatment Effect	95% CI	p
Acupuncture vs sham
Responsea	Up to 2 mo after randomization	4	RR=1.26	1.10 to 1.45	<0.001
	3-4 mo after randomization	4	RR=1.27	1.00 to 1.48	0.003
	5-6 mo after randomization	4	RR=1.17	1.02 to 1.35	0.02
No. headache days	Up to 2 mo after randomization	4	MD = -1.49	-2.58 to -0.39	0.008
	3-4 mo after randomization	4	MD = -1.62	-2.69 to -0.54	0.003
	5-6 mo after randomization	4	MD = -1.51	-2.59 to -0.43	0.006

CI: confidence interval; MD: mean difference; RR: relative risk ratio.

^a At least a 50% reduction in headache frequency.

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.

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 five to six 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.

Pain-Related Conditions: Low Back Pain

Clinical Context and Test Purpose

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

The question addressed in this policy is: Does the use of acupuncture improve the net health outcome for individuals with low back pain?

The following PICOs were used to select literature to inform this review.

Patients

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

Interventions

The therapy being considered is acupuncture.

Patients with low back pain are actively managed by physical therapists and primary care providers in an outpatient setting.

Comparators

The following therapies are currently being used to treat with 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 principles outlined for indication 1.

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.^8, 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 (see Table 3).

Furlan et al (2005) published a Cochrane review of acupuncture and dry needling for low back pain.^9, 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 one of four 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 one sham-controlled study on acupuncture for acute back pain was found, and it did not find between-group differences in pain or function after one treatment session. Six RCTs compared acupuncture with sham acupuncture.^9, Chronic pain outcomes are reported in Table 3.

Table 3. Key Outcomes for Chronic Low Back Pain

Outcomes	Follow-Up	No. Trials	Results
			Treatment Effect	95% CI	p
Lam et al (2013)8,
Acupuncture vs no treatment
Pain	Immediately postintervention	5	SMD = -0.72	-0.94 to -0.49	<0.001
Levels of function	Immediately postintervention	5	SMD = -0.94	-1.41 to -0.47	<0.001
Acupuncture vs medication
Pain	Immediately postintervention	3	MD = -10.56	-20.34 to -0.78	0.03
Levels of function	Immediately postintervention	3	SMD = -0.36	-0.67 to -0.04	0.03
Acupuncture vs sham acupuncture
Pain	Immediately postintervention	4	MD = -16.76	-33.33 to -0.19	0.05
	6-12 wk	3	MD = -9.55	-16.52 to -2.58	0.007
Acupuncture in addition to usual care vs usual care
Pain	Immediately postintervention	4	MD = -13.99	-20.48 to -7.50	<0.001
	10-36 wk	4	MD = -12.91	-21.97 to -3.85	0.005
Levels of function	Immediately postintervention	3	SMD = -0.87	-1.61 to -0.14	0.02
	10-36 wk	2	SMD = -0.51	-0.91 to -0.12	0.01
Furlan et al (2005)9,
Acupuncture vs sham
Pain	Immediately after treatment	5	MD = -10.21	-14.99 to -5.44	<0.001
	Up to 3 mo	2	MD = -17.79	-25.5 to -10.07	<0.001
	3 mo to 1 y	2	MD = -5.74	-14.72 to 3.25	0.21
Global improvement	Immediately after treatment	3	RR=1.23	1.04 to 1.46	0.019
	Up to 3 mo	3	RR=1.44	0.92 to 2.24	0.11
Acupuncture vs other intervention
Pain	Immediately after treatment	5	SMD=0.48	0.21 to 0.75	<0.001
	Up to 3 mo	2	SMD = -0.19	-2.74 to 2.36	0.88
	3 mo to 1 y	2	SMD=2.48	1.02 to 3.94	<0.001

CI: confidence interval; MD: mean difference; RR: relative risk; SMD: standardized mean difference.

The pain was significantly lower with acupuncture than with sham immediately after treatment and after short-term follow-up (up to three months), but there was no significant difference between groups at intermediate follow-up (three months to one year). Similarly, 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.

Section Summary: Low Back Pain

A Cochrane review found insufficient evidence from a sham-controlled trial to assess acupuncture and acute back pain. The trial had limitations (eg, only one session of acupuncture) and did not find significantly better outcomes with acupuncture vs sham acupuncture. Pooled analyses of sham-controlled randomized trials on chronic low back pain in two different meta-analyses found improvement in pain up to three months. No significant global improvement was observed at up to three months. Sham-controlled data beyond a three-month follow-up were not available. In pooled analyses of acupuncture vs other treatments, one of the meta-analyses found statistically significant but not clinically meaningful improvement in terms of pain reductions and functional improvements for acupuncture compared with other medications both during the immediate postintervention period and 10 to 36 weeks postintervention.

Pain-Related Conditions: Other Pain-Related Conditions

Clinical Context and Test Purpose

The purpose of acupuncture is to provide a treatment option that is an alternative to or an improvement on existing therapies in patients 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 question addressed in this policy is: Does the use of acupuncture improve the net health outcome for individuals with other pain-related conditions?

The following PICOs were used to select literature to inform this review.

Patients

The relevant populations of interest are 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.

Patients with other pain-related conditions are actively managed by physical therapists and primary care providers in an outpatient setting.

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 principles outlined for indication 1.

Systematic Reviews

Various Cochrane reviews have found insufficient evidence to demonstrate that acupuncture is effective for treating shoulder pain,^10, lateral elbow pain,^11, carpal tunnel syndrome,^12, cancer pain in adults,^13, chronic pain in patients with spinal cord injury,^14, pain in endometriosis,^15, and pain in rheumatoid arthritis.^16,These reviews identified few RCTs, low-quality RCTs, and/or lack of significantly better outcomes with acupuncture than with control conditions.

Section Summary: Other Pain-Related Conditions

Current evidence is insufficient to draw conclusions on the efficacy of acupuncture for other pain-related conditions.

Nausea and Vomiting

Clinical Context and Test Purpose

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

The question addressed in this policy is: Does the use of acupuncture improve the net health outcome for individuals with nausea and vomiting?

The following PICOs were used to select literature to inform this review.

Patients

The relevant populations of interest are individuals with nausea or vomiting or at high-risk of nausea or vomiting.

Interventions

The therapy being considered is acupuncture.

Patients with nausea or vomiting or at high-risk of nausea or vomiting are actively managed by primary care providers in an outpatient clinical setting.

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 principles outlined for indication 1.

Hyperemesis Gravidarum

Boelig et al (2016) published a Cochrane review of various interventions for treating hyperemesis gravidarum (severe nausea and vomiting during pregnancy [morning sickness]).^17, 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.^18, The RCT did not find significant differences in outcomes in patients treated with acupuncture vs 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).

Chemotherapy-Induced Nausea and Vomiting

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.^19, 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 vs 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 three 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 vs the control group (RR=0.74; 95% CI, 0.58 to 0.94; p=0.01). 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 three primary outcomes.

An updated review by Ezzo et al (2014) was meant to be published; however, the authors were unable to complete the update within the recommended time period, and the review was withdrawn.^20,

Postoperative Nausea and Vomiting

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).^21, 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.

Section Summary: Nausea and Vomiting

Two Cochrane reviews 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 vs 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 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 three 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 vs a control condition. However, these findings were not robust¾no individual trial had a significant finding for this outcome and pooled analysis of the three trials on electroacupuncture did not find a significant benefit from electroacupuncture on acute vomiting. Moreover, the number of trials was small and data were not available on three of the four outcomes.

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.

Opioid Dependence

Clinical Context and Test Purpose

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

The question addressed in this policy is: Does the use of acupuncture improve the net health outcome for individuals with opioid dependence?

The following PICOs were used to select literature to inform this review.

Patients

The relevant population of interest are individuals with opioid dependence.

Interventions

The therapy being considered is acupuncture.

Patients with opioid dependence are actively managed by multiple specialists in the in- and outpatient settings.

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 principles outlined for indication 1.

Non-Cancer Pain

Windmill et al (2013) 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.^22, 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.

Opiate Addiction

Other than the Windmill et al (2013) review,^22, no Cochrane reviews were identified on acupuncture in opioid users. A systematic review by Lin et al (2012) addressed acupuncture for treating opiate addiction.^23, Reviewers searched for RCTs of individuals who met criteria for opiate 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, four used auricular acupuncture, one used electroacupuncture, and another used a Chinese acupoint stimulating device (Han’s acupoint nerve stimulator). Reviewers rated eight trials as low quality and two as higher quality. The two 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 opiate addiction.

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 opiate addiction.

Summary of Evidence

Pain-Related Conditions

For individuals who have episodic migraines who receive acupuncture, the evidence includes RCTs and systematic reviews. The 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 vs 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 a meaningful improvement in the net health outcome.

For individuals who have tension-type headaches who receive acupuncture, the evidence includes RCTs and systematic reviews. The 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 five to six months. The clinical significance of the findings was not assessed. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have low back pain who receive acupuncture, the evidence includes RCTs and systematic reviews. The relevant outcomes include symptoms, functional outcomes, medication use, and treatment-related morbidity. A Cochrane review identified a single sham-controlled trial on acute low back pain and outcomes were not significantly better with acupuncture. Findings for chronic back pain in the Cochrane review were mixed. Pooled analyses of sham-controlled randomized trials on chronic low back pain in two different meta-analyses found improvements in pain up to three months. No significant global improvement was observed at up to three months in the acupuncture group. Longer-term sham-controlled data are not available. Pooled analyses found no clinically meaningful improvement regarding pain or function among the acupuncture recipients compared with the group receiving other treatments (eg, pain immediately postintervention or during 10 to 36 weeks postintervention). The evidence is insufficient to determine the effects of the technology on health outcomes.

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 a few RCTs and systematic reviews of these trials. The relevant outcomes include symptoms, functional outcomes, medication use, and treatment-related morbidity. The RCTs were of low quality and/or lacked significantly better outcomes with acupuncture than with control conditions. The evidence is insufficient to determine the effects of the technology on 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. The relevant outcomes include symptoms, functional outcomes, medication use, and treatment-related morbidity. Two Cochrane reviews 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 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 three trials on electroacupuncture did not find a significant benefit from electroacupuncture on acute vomiting. Moreover, data from these trials were not available on three of the four outcomes of interest. A fourth Cochrane review addressed ten interventions involving stimulation of the wrist acupuncture point PC6. Conclusions about acupuncture could not be drawn from this review because only a small number of studies of assessed acupuncture and review findings were not stratified by intervention. The evidence is insufficient to determine the effects of the technology on health outcomes.

Opioid Dependence

For individuals who have opioid dependence who receive acupuncture, the evidence includes RCTs and systematic reviews. The 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 opiate addiction. The evidence is insufficient to determine the effects of the technology on health outcomes.

SUPPLEMENTAL INFORMATION

Practice Guidelines and Position Statements

American College of Rheumatology

The guidelines from the American College of Rheumatology (2012) on the treatment of osteoarthritis with acupuncture recommended the following:

“Treatment with traditional Chinese acupuncture or instruction in the use of transcutaneous electrical stimulation are conditionally recommended only when the patient with knee osteoarthritis has chronic moderate to severe pain and is a candidate for total knee arthroplasty but either is unwilling to undergo the procedure, has comorbid medical conditions, or is taking concomitant medications that lead to a relative or absolute contraindication to surgery or a decision by the surgeon not to recommend the procedure….”^24,

National Institute for Health and Care Excellence

TheNational Institute for Health and Care Excellence (2012)guidance, updated in 2015, on the diagnosis and management 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.^25,

For migraines, the guidance recommended a course of up to ten sessions of acupuncture over five to eight weeks for prophylactic treatment if both topiramate and propranolol were unsuitable or ineffective.^25,

TheInstitute (2016)guidance 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.^26,

U.S. Preventive Services Task Force Recommendations

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

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

NCT No.	Trial Name	Planned Enrollment	Completion Date
Ongoing
NCT02834702	Sinew Acupuncture for Neck Pain: Randomized Controlled Trial	130	Jun 2020
Unpublished
NCT02770963	Efficacy of Acupuncture for Discogenic Sciatica: a Randomized Controlled Trial	60	Jun 2018 (unknown)

NCT: national clinical trial.

^a Denotes industry-sponsored or cosponsored trial.]
________________________________________________________________________________________

Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

___________________________________________________________________________________________________________________________

Index:
Acupuncture
Pain Management, Acupuncture for
Nausea and Vomiting, Acupuncture for
Opioid Dependence, Acupuncture for
Electroacupuncture

References:
1. World Health Organization (WHO). A Proposed Standard International Acupuncture Nomenclature: Report of a WHO Scientific Group. 1991; http://apps.who.int/medicinedocs/en/d/Jh2947e/4.3.html. Accessed September 9, 2019.

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):1224-1231. PMID 12421994.

3. Food and Drug Administration. Complementary and Alternative Medicine Products and their Regulation by the Food and Drug Administration. https://www.fda.gov/RegulatoryInformation/Guidances/ucm144657.htm. Accessed September 9, 2019.

4. Linde K, Allais G, Brinkhaus B, et al. Acupuncture for the prevention of episodic migraine. Cochrane Database Syst Rev. Jun 28 2016(6):CD001218. PMID 27351677.

5. 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.

6. 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 Aug 29;66(4). PMID 30152732.

7. Linde K, Allais G, Brinkhaus B, et al. Acupuncture for the prevention of tension-type headache. Cochrane Database Syst Rev. Apr 19 2016;4:CD007587. PMID 27092807.

8. Lam M, Galvin R, Curry P. Effectiveness of acupuncture for nonspecific chronic low back pain: a systematic review and meta-analysis. Spine (Phila Pa 1976). Nov 15 2013;38(24):2124-2138. PMID 24026151.

9. Furlan AD, van Tulder MW, Cherkin DC, et al. Acupuncture and dry-needling for low back pain. Cochrane Database Syst Rev. Jan 25 2005(1):CD001351. PMID 15674876.

10. Green S, Buchbinder R, Hetrick S. Acupuncture for shoulder pain. Cochrane Database Syst Rev. Apr 18 2005(2):CD005319. PMID 15846753.

11. Green S, Buchbinder R, Barnsley L, et al. Acupuncture for lateral elbow pain. Cochrane Database Syst Rev. 2002(1):CD003527. PMID 11869671.

12. O'Connor D, Marshall S, Massy-Westropp N. Non-surgical treatment (other than steroid injection) for carpal tunnel syndrome. Cochrane Database Syst Rev. 2003(1):CD003219. PMID 12535461.

13. Paley CA, Johnson MI, Tashani OA, et al. Acupuncture for cancer pain in adults. Cochrane Database Syst Rev. Oct 15 2015(10):CD007753. PMID 26468973.

14. Boldt I, Eriks-Hoogland I, Brinkhof MW, et al. Non-pharmacological interventions for chronic pain in people with spinal cord injury. Cochrane Database Syst Rev. Nov 28 2014(11):CD009177. PMID 25432061.

15. Zhu X, Hamilton KD, McNicol ED. Acupuncture for pain in endometriosis. Cochrane Database Syst Rev. Sep 07 2011(9):CD007864. PMID 21901713.

16. Casimiro L, Barnsley L, Brosseau L, et al. Acupuncture and electroacupuncture for the treatment of rheumatoid arthritis. Cochrane Database Syst Rev. Oct 19 2005(4):CD003788. PMID 16235342.

17. Boelig RC, Barton SJ, Saccone G, et al. Interventions for treating hyperemesis gravidarum. Cochrane Database Syst Rev. May 11 2016(5):CD010607. PMID 27168518.

18. Matthews A, Haas DM, O'Mathuna DP, et al. Interventions for nausea and vomiting in early pregnancy. Cochrane Database Syst Rev. Sep 08 2015(9):CD007575. PMID 26348534.

19. Ezzo J, Streitberger K, Schneider A. Cochrane systematic reviews examine P6 acupuncture-point stimulation for nausea and vomiting. J Altern Complement Med. Jun 2006;12(5):489-495. PMID 16813514.

20. Ezzo J, Richardson MA, Vickers A, et al. WITHDRAWN: Acupuncture-point stimulation for chemotherapy- induced nausea or vomiting. Cochrane Database Syst Rev. Nov 21 2014(11):CD002285. PMID 25412832.

21. Lee A, Chan SK, Fan LT. Stimulation of the wrist acupuncture point PC6 for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev. Nov 02 2015(11):CD003281. PMID 26522652.

22. Windmill J, Fisher E, Eccleston C, et al. Interventions for the reduction of prescribed opioid use in chronic non- cancer pain. Cochrane Database Syst Rev. Sep 01 2013(9):CD010323. PMID 23996347.

23. Lin JG, Chan YY, Chen YH. Acupuncture for the treatment of opiate addiction. Evid Based Complement Alternat Med. 2012;2012:739045. PMID 22474521.

24. American College of Rheumatology. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. 2012; https://www.guideline.gov/summaries/summary/36893/american-college-of-rheumatology-2012- recommendations-for-the-use-of-nonpharmacologic-and-pharmacologic-therapies-in-osteoarthritis-of-the-hand- hip-and-knee?q=acupuncture. Accessed September 9, 2019.

25. National Institute for Health and Care Excellence (NICE). Headaches in over 12s: diagnosis and management [CG150]. 2012; https://www.nice.org.uk/guidance/cg150/resources/headaches-in-over-12s-diagnosis-and- management-pdf-35109624582853. Accessed September 9, 2019.

26. National Institure for Health and Care Excellence (NICE). Low back pain and sciatica in over 16s: assessment and management [NG59]. 2016; https://www.nice.org.uk/guidance/ng59/resources/low-back-pain-and-sciatica-in- over-16s-assessment-and-management-pdf-1837521693637. Accessed September 9, 2019.

27. Center for Medicare and Medicaid Services (CMS). National Coverage Determination (NCD) for ACUPUNCTURE (30.3). n.d.; https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=11&ncdver=1&bc=AAAAgAAAAAAA&. Accessed September 9, 2019.

28. 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 September 9, 2019.

29. Center for Medicare and Medicaid Services (CMS). Decision Memo for Acupuncture for Osteoarthritis (CAG- 00175N). 2003; https://www.cms.gov/medicare-coverage-database/details/technology-assessments-details.aspx?TAId=19&NCAId=84&type=Open&bc=ACAAAAAAQAAA&. Accessed September 9, 2019.

Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

97810
97811
97813
97814