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Autonomic Neuroscience: Basic and Clinical
j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / a u t n e u
Acupuncture and heart rate variability: A systematic review
Sanghoon Lee a, Myeong Soo Lee b,d,⁎, Jun-Yong Choi c, Seung-Won Lee a, Sang-Yong Jeong b, Edzard Ernst d
Department of Acupuncture and Moxibustion, College of Oriental Medicine, Kyung Hee University, Seoul, South Korea Division of Standard Research, Korea Institute of Oriental Medicine, Daejeon, South Korea c Department of Internal Medicine, School of Korean Medicine, Pusan National University, Yangsan, South Korea d Complementary Medicine, Peninsula Medical School, Universities of Exeter & Plymouth, Exeter UK
a r t i c l e
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a b s t r a c t
Acupuncture has been reported to affect the autonomic system. Currently, there are no systematic reviews examining the effect of acupuncture on HRV available in the literature. Therefore, the aim of this systematic review was to summarize and critically assess the effects of acupuncture on heart rate variability. We searched the literature using 14 databases for articles published from the earliest available publications until October 2009 without language restrictions. We included randomized clinical trials (RCTs) comparing acupuncture and sham acupuncture. The risk of bias in each study was assessed using the Cochrane criteria. Twelve RCTs met all of the inclusion criteria. One RCT evaluated the effects of acupuncture in patients with minor depression or anxiety disorders and another RCT examined the effect of acupuncture on migraine patients. Another four RCTs tested the effects of acupuncture in healthy subjects who were exposed to several conditions, including mental stress, fatigue from driving, and caffeine intake. The remaining six RCTs assessed the effects of acupuncture on healthy subjects in a normal state without any stressors. Five RCTs found signiﬁcant differences in HRV between patients treated with acupuncture versus those treated with sham acupuncture (controls). However, the majority of the other RCTs showed inconsistent results or did not identify signiﬁcant differences in HRV spectral parameters among individuals treated with acupuncture as compared to those treated with sham acupuncture. In conclusion, sham-controlled RCTs showed variable results and no clear evidence that acupuncture has any speciﬁc effects on HRV. Therefore, more rigorous research appears to be warranted. © 2010 Elsevier B.V. All rights reserved.
Article history: Received 17 July 2009 Received in revised form 13 January 2010 Accepted 17 February 2010 Keywords: Acupuncture Heart rate variability Placebo Systematic review
Contents Introduction . . . . . . . . . . . . . . . . . . . Methods . . . . . . . . . . . . . . . . . . . . 2.1. Data sources . . . . . . . . . . . . . . . 2.2. Study selection . . . . . . . . . . . . . . 2.3. Data extraction and assessment of the risk of 2.4. Data synthesis . . . . . . . . . . . . . . 3. Results . . . . . . . . . . . . . . . . . . . . . 3.1. Study description . . . . . . . . . . . . . 3.2. Risk of bias . . . . . . . . . . . . . . . . 3.3. Outcomes . . . . . . . . . . . . . . . . 3.3.1. Dysfunctional states . . . . . . . 3.3.2. Healthy subjects in stressed states . 3.3.3. Healthy subjects in normal states . 4. Discussion . . . . . . . . . . . . . . . . . . . Acknowledgements . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . 1. 2. . . . . . . . . . . . . bias . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 6 6 6 6 8 8 8 9 9 9 9 11 11 12 12
⁎ Corresponding author. Division of Standard Research, Korea Institute of Oriental Medicine, Daejeon, 305-811, South Korea. Tel.: + 82 42 868 9266; fax: 82 42 863 9464. E-mail addresses: firstname.lastname@example.org, email@example.com (M.S. Lee). 1566-0702/$ – see front matter © 2010 Elsevier B.V. All rights reserved. doi:10.1016/j.autneu.2010.02.003
MSL) (Table 2).kisti. Data from the articles were validated and extracted according to pre-deﬁned criteria by two independent reviewers (SHL. acupuncure AND (heart rate variability OR HRV) 2.org http://china. Acupuncture is hypothesized to modulate the autonomic nervous system and thereby revitalize the balance of metabolism in the body (Lin and Chen. 2. Many acupuncture studies have evaluated its effect on HRV.jstage. such as laser acupuncture or moxibustion. It can be deﬁned as the insertion of needles into the skin and underlying tissues at particular sites of the body (known as acupuncture points) to treat patients' symptoms or diseases or as part of preventative medicine practices (Ernst. 2008). Lee et al.go. and is also becoming increasingly popular in Western countries.2. the physiological mechanisms underlying acupuncture therapy have not been clearly deﬁned. Study selection All of the RCTs in which human subjects were treated with needle acupuncture with or without electric stimulation were considered for inclusion in the review. There were no disagreements between the three reviewers regarding the assessment of risk of bias. However. SWL) if needed. acupuncure AND (heart rate variability OR HRV) 2. Data sources The following electronic databases were searched from for all studies that had been published as of October 2009: Medline. Data extraction and assessment of the risk of bias Hard copies of all articles were obtained and read in full by two independent reviewers (SHL. the references of all of the articles we identiﬁed were manually searched for other relevant articles. The trials had to use spectral analysis of HRV as the outcome measurement to be included.co.koreanstudies.re. Considering that it is virtually impossible to blind therapists to the use of acupuncture. To be included. The analysis of HRV provides quantitative information regarding autonomic control mechanisms in the body.6 S.go. who sought the opinion of other reviewers (JYC.jp/browse/ -char/en acupuncture AND (heart rate variability OR HRV) a Only English search terms were used for J-STAGE because its search platform is only available in English. blinding and allocation concealment (Higgins and Altman.jsp http://www. 1985. Database Korean Studies Information Service System (KISS) DBPIA Publisher Korean Studies Information Co. 2. Trials testing forms of acupuncture other than needle acupuncture. trials had to compare needle acupuncture with any type of sham acupuncture. The Cochrane Library 2009 (Issue 4). We also manually searched our departmental ﬁles and the relevant journals FACT (Focus on Alternative and Complementary Therapies) and Forschende Komplementärmedizin und Klassische Naturheilkunde (Research in Complementary and Classical Natural Medicine) for appropriate articles that had been published as of October 2009. including pain. Power spectral analysis of heart rate variability (HRV) has recently been used as a sensitive index of autonomic nervous system activity (Pomeranz et al. Introduction Acupuncture is one of the most popular forms of complementary medicine available and it is used by many populations for a variety of conditions (Barnes et al. MSL) and if needed. Its practitioners claim that it is effective at treating a wide range of conditions.kr/main.koreamed.riss4u. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Several methods have been proposed to study beat-to-beat ﬂuctuations in heart rate in both the time and frequency domains. Dissertations and abstracts were included as long as they contained sufﬁcient detail.kr Science Society Maul Korea Institute of Science and Technology Information (KISTI) Korea Education & Research Information Service Korean Association of Medical Journal Editors National Assembly Library of the Republic of Korea Research Information Center for Health China National Knowledge Infrastructure (CNKI) http://society. there is no systematic review of these data available in the literature. Hence. CINAHL.com/kns50/ single_index. Nurimedia www. The search terms used were “acupuncture AND (heart rate variability OR HRV)” and the Korean and/or Chinese language terms for “acupuncture AND heart rate variability”. however. withdrawals.net/index. the objective of this systematic review was to summarize and critically assess the evidence from randomized clinical trials (RCTs) regarding the effects of acupuncture on HRV. for therapeutic or preventive purposes. 2006 Wang.1. MSL). 2003). Trials were included if they employed acupuncture as the sole treatment being evaluated. we assessed patient and assessor blinding separately.nanet. PsycINFO. 2008).dbpia. musculoskeletal disorders. . 2008).org/ www.3. Risk of bias was assessed using the Cochrane criteria to evaluate the following aspects of the trials: randomization. In addition.aspx 1. Currently.html Research Information Service System (RISS) KoreaMed Korean National Assembly Library Database of RICH China Academic Journals Full-text Database http://www. EMBASE. 2006).eastview. and nine Asian Medical Databases (listed in Table 1). Acupuncture was deﬁned as the insertion of needles into the skin and underlying tissues. and several neurologic disorders (Ernst. were excluded. 1996).net/ Search terms used 1.richis. / Autonomic Neuroscience: Basic and Clinical 155 (2010) 5–13 1. by seeking the opinion of a third reviewer (EE)... URL http://search. Table 1 Information about the Asian databases used to search for articles for this review. Methods 2. No language restrictions were imposed. Discrepancies were resolved through discussions between two reviewers (SHL.jst.kr www. blinding. 2. It is particularly widely used in East Asian countries. J-STAGEa Japan Science and Technology Information Aggregator (electronic) http://www. at previously described acupuncture points.
B→: NS 3) A→. at 5 min after 3rd treatment. B→: NS U. and after AT n.: not reported.N Park et al.Y. n = 10) (C) AT without driving (A) AT (15 min. (2005) Taiwan Parallel 111 healthy subjects 1). during treatment. Seating Rest.r.Y.U S.r. 3rd treatment (before. during.Y. (2003) German Design Sample size conditions Intervention (Regimen) Heart rate variability Main results Inter-group differences Respiratory regulation Measuring position Measuring time n. NS: before 10th treatment 2) A→.N Chang et al. NS: not signiﬁcant. B↑: NS No regulation Supine Baseline.N.N. superﬁcial stimulation. B→: NS 1) A→. 15 min.Y. B↑: NS 2) A↑.05 2) A↑. n = 10) (B) Sham AT (minimal penetration on non-acupuncture points.U. B→: P b 0. C in a randomized order with 3 days between sessions. B→: NS 3) A↑.r.r.U Rheu et al. n = 12) (B) Sham AT (minimal penetration on non-acupuncture point.Table 2 Summary of randomized clinical trials examining acupuncture and heart rate variability.r. B→: NS. after AT n. n = 38) (C) No treatment (n = 34) (A) AT (15 min.N. and after AT n.N U.r. n = 15) B) Sham EA (minimal penetration on non-acupuncture point. total 10 sessions. N: not reported or inappropriate. n = 20) 1) LF/HF 2) log LF 3) log HF Backer et al.05 3) A→. 15 min. n = 39) (B) Sham AT (penetration on non-acupuncture points. n = 20) (B) Sham AT (10 min. Post-Stress.Y. n = 9) (B) Sham AT (24 min. End of task (simulated driving).U 1) LF 2) HF 1) A↑.r.05 2) A ↓.r. n = 18) (A) AT (15 min. n = 38) 1) LF/HF 2) LF 3) HF 1) A↑.05 U.r.N Jeong et al. (2002) Taiwan Cross-over 9 healthy subjects A) EA (2 Hz.B→: NS 2) A→.Y. LF: low frequency power. B→: P b 0. First authors (year) Origin Agelink et al.r. B→: NS.05) U. Before and during AT U.U.05 U. NS at 15 min after 3rd treatment. penetration on non-acupuncture points. allocation concealment performed). Y. (2005) China Parallel 29 healthy subjects with fatigue (after 3 h driving workout) Parallel 40 healthy subjects with mental stress Kang and Kim (2009) Korea (A) AT (30 min. n= 17) (B) Sham AT (minimal penetration on non-acupuncture point. before 10th treatment Yes Seating 1st and 12th session (before. 2) A→. n = 12) (A) AT (20 min. n = 9) (A) AT (20 min. B→: P b 0.U. n = 15) C) EA plus atropine injection Sessions A.. Post-Acupuncture n. Before and 60 min after caffeine was ingested.B→: NS 1) A↓. n = 18) (B) Sham AT (minimal penetration on non-acupuncture point. n = 13) (B) Sham AT (minimal penetration on non-acupuncture point. B→: NS U. n.N. except 2nd min during treatment (P b 0. 5 min and 15 min after treatment). except 1st min during treatment (P b 0.r.U.Y. B↓: NS. (2008) Korea Parallel 24 healthy men with mental stress Y.r. no electric stimulation.N. n. B→: NS 2)–3) A→.r. Before and after AT n.r.N. Y: appropriate. n = 19) (B) Sham AT (minimal penetration on non-acupuncture point.05) 2) A↑.U Y.N.U AA: auricular acupuncture.U 1) LFn 2) HFn 1) A↓.B→: NS Y. ↓: signiﬁcantly decreased compared with baseline: → : no change. non-penetration on non-acupuncture point. n = 12) (A) AT (24 min. after treatment n.Y.B→: NS 2) A→.U. n. n = 14) 1) HF 2) LF 1) A↓. 20 min. B→: P b 0. during 1st and 12th session 2) A↓. once daily in weekdays for 2 weeks. n = 10) (A) AT (10 min. Y.r. B→: NS 2) A↓. Seating Before. patient-blinded. B→: P b 0. n.Y.U Huang et al. B↑: NS 3) A↑. B→: P b 0. Supine Pre-stress. assessor blinded.Y. B↑: NS 1) A↑. and after AT Risk of bias Parallel 38 patients with minor depression or anxiety disorders (A) AT (15 min.U 1) LF/HF 2) LFn 3) HFn 1) LF/HF 2) LFn 3) HFn 1) LF/HF 2) LF 3) HF 1) LF 2) HF 1)–2) A↓.Y.N. both acutely and after 10 sessions 1) A↓. B.05. aRisk of bias (sequence generation. (2008) German Parallel 22 healthy men Cross-over 20 healthy acupuncture-naïve subjects 1) A↓.008. n = 12) (B) Sham AT (minimal penetration on non-acupuncture point. 12 sessions. U:unclear.Y. Seating 5 min before mental stress. 30 min.Y. 15 min. during. Supine 10 min before treatment. after treatment n.Y. (2008) German Parallel 30 migraine patients Li et al. n = 12) (B) Sham AT (minimal penetration on acupuncture points. n = 13) (A) AT (15 min. during and after) n. before and after treatment n. (2005) Taiwan Cross-over 15 healthy subjects Haker et al. B→: P b 0. AT: acupuncture: n. / Autonomic Neuroscience: Basic and Clinical 155 (2010) 5–13 1) A→.N.N.Y. B→: NS. supine Baseline. Baseline. Lee et al. B→: P b 0. ↑: signiﬁcantly increased compared with baseline.05 3) A↑.N. 7 . n = 12) (C) AA (25 min. HFn: normalized high frequency power. n.r. incomplete data.r. (2008) Korea Parallel 26 healthy subjects after caffeine consumption Y. both acutely and after 10 sessions 3) A→. (2000) Denmark Cross-over 12 healthy subjects Wang et al. (A) AT (25 min. during 1st and 12th session Y. B→: NS.U. during.. (2006) Korea Streitberger et al.N. n. LFn: normalized low frequency power.N. HF: high frequency power.
Manual acupuncture was used in 11 trials (Agelink et al. Key data regarding the 12 RCTs that were found to meet our inclusion criteria are summarized in Table 2. one trial was from China (Li et al. four studies were conducted in Korea (Kang and Kim..... Backer et al.5 (Follmann et al.. Streitberger et al. 2000. Data synthesis The mean change in outcome measures compared with baseline was used to assess differences between the intervention groups and the control groups. Haker et al. 2002). Wang et al. 2006. 2005. and one trial was from Denmark (Haker et al. Copenhagen: The Nordic Cochrane Centre). 2003.. Kang and Kim. whereby effect estimates of the common outcome measure were plotted against sample size.. 2000). 2009). Ten RCTs included healthy subjects who were either at their normal baseline state or under conditions of stress (Kang and Kim.. 2008. Huang et al. Park et al. 2008. Summary estimates of the treatment effect were calculated using the more conservative approach of a random effects model.. Fig. 2005).. and standardized mean differences (SMDs) were used when studies measured the outcome on different scales. .0 for Windows. 2009). while the other studies included patients with minor depression and anxiety disorders (Agelink et al. 2009. Rheu et al. 2005. Results 3.. 2003. For studies with insufﬁcient information.. Weighted mean differences (WMDs) were used when studies measured the outcome on the same scale.8 S. 2008).. Post hoc sensitivity analyses were performed to test the robustness of the overall effect. 2005. UOS: uncontrolled observational study. / Autonomic Neuroscience: Basic and Clinical 155 (2010) 5–13 2. RCT: randomized clinical trial. The Chi-squared test. 25 of which were RCTs. 2005. 1. 2008. 2003) or migraine headaches (Backer et al.1. We attempted to assess publication bias using a funnel plot.. 2008.. tau2 and the Higgins I2 test were used to assess heterogeneity. 2008).4. The variance of the change was inferred using a correlation factor of 0. 3. Jeong et al. Huang et al.. Differences compared with sham control were considered relevant in the context of this study. Study description The searches identiﬁed 135 potentially relevant articles. three studies were from Taiwan (Chang et al. we contacted the primary authors to acquire and verify data where possible.. Backer et al. Three RCTs originated from Germany (Agelink et al... 1992). WMDs or SMDs and 95% conﬁdence intervals (CIs) were calculated using the Cochrane Collaboration's software (Review Manager Version 5. Li et al. 1. CCT: non-randomized clinical trial. The reasons that articles were excluded during the selection process are described in Fig. Flowchart of trial selection process. A total of 123 studies were excluded. Lee et al. A total of 354 participants were included in these trials.
Chang et al. 2009.... 2005.. Backer et al.. Kang and Kim. relative to sham acupuncture. 2008. and electroacupuncture (EA) was employed in 1 trial (Chang et al. and HF power among patients who were treated with acupuncture as compared to the sham controls at 15 min after 3rd acupuncture treatment and before 10th treatment.3.1. 2008). 2008. Li et al. (B) low frequency power (LF). 2005. / Autonomic Neuroscience: Basic and Clinical 155 (2010) 5–13 9 Streitberger et al.. One RCT (Park et al. Jeong et al. 2008). 2005. 2005. Jeong et al.. 2003). Li et al. 2008... 2008. 2008. 2005... Backer et al. Park et al... there were no signiﬁcant differences identiﬁed with regard to the LF/HF ratio.. including fatigue after driving (Li et al..2.. Jeong et al. 2008) controlled for respiratory frequency. and caffeine consumption (Jeong et al. 2000.. Healthy subjects in stressed states Four RCTs tested the effect of acupuncture on HRV among healthy patients under several conditions of stress... 2000).. Park et al. Additionally.. 2005) found that individuals treated with acupuncture exhibited a signiﬁcant increase in HF power and a decrease in the LF power and the HF/LF ratio as compared to the individuals in the sham control group after all participants had fatigue induced with a 3 h driving simulation. Haker et al. Rheu et al.. Rheu et al.3. 2002) employed penetration at non-acupuncture points. Details regarding patients who dropped out or withdrew from the study were described in four trials (Backer et al. 2008. Park et al.. Kang and Kim.3. Eight of the included trials adopted a parallel group study design (Agelink et al. Risk of bias Five RCTs described the methods of randomization that were used (Agelink et al. Lee et al. Park et al.. 2008. 2003. 2002). The other trials (Chang et al.. 2008. LF power. Kang and Kim.. and one RCT (Streitberger et al. One RCT used minimal acupuncture on acupuncture points (Haker et al. Backer et al. Rheu et al. 2. 2005. Li et al. 2003. Huang et al. 2008.. In migraine patients. 2009. Two RCTs assessed the effects of acupuncture after a period of mental stress in healthy subjects (Kang and Kim. Eight RCTs employed minimal acupuncture at non-acupuncture points as the control intervention (Agelink et al. Dysfunctional states Two RCTs tested the effects of acupuncture (total 10 sessions or 12 sessions) on HRV as compared to minimal penetrating acupuncture on non-acupuncture points in patients with minor depression or anxiety disorders (Agelink et al. Wang et al. 2005). Jeong et al.S. . 2006).. 2009). Backer et al. 2008). 2009. 2005..... 2008) employed both subject and assessor blinding. 2003) or patients who suffered from migraine headaches (Backer et al. Streitberger et al. 2002). None of the 12 trials reported details regarding allocation concealment. 2008. 2005). 2008....... The acupuncture group exhibited a decrease in the LF/HF ratio at 5 min after the third treatment relative to the sham control... 2008) employed non-penetrating acupuncture at non-acupuncture points. 2008). Wang et al. 2009. 2006) and four used a cross-over design (Chang et al. Kang and Kim. However. Backer et al.2. 2008) 3. 2008). 2008. but no changes in HF power (Backer et al. 2003. mental stress (Kang and Kim.. 2006. Park et al.. Fig.. All of the included trials used subject blinding and three trials (Agelink et al. 2005). two RCTs (Huang et al. but acupuncture did not inﬂuence overall LF and HF power in these patients with minor depression or anxiety disorders (Agelink et al. Outcomes 3. it is notable that the patients who were clinical responders in both the treatment and sham groups exhibited a decrease in LF power during treatment sessions. Huang et al. 2008. 3. Wang et al. Park et al. 2005.... Jeong et al.. 2009. Statistical or clinical heterogeneity among the studies prohibited us from pooling data for analysis. 3.. but not LF power. 2008.. 2009. 2003. 2003. acupuncture signiﬁcantly decreased HF power. Jeong et al... 2005. 2008. (C) LF/HF ratio as compared to sham acupuncture after induction of mental stress in healthy subjects. 2008).. 2008. Kang and Kim.... Only one study (Backer et al. Four RCTs utilized a supine position for measurement of HRV (Haker et al. Streitberger et al. 2000. Forest plot of the effects of acupuncture on (A) high frequency power (HF). 2008) did not report details regarding the position from which HRV was measured... One RCT (Li et al. Huang et al. 2002) and four measured HRV from a seated position (Agelink et al. Wang et al.
18. . χ2 = 0.43 to 0.10 S. (B) low frequency power (LF). 2A).29.78. heterogeneity: τ2 = 0. P = 0.21. χ2 = 4. while the other RCT (Kang and Kim. heterogeneity: τ2 = 0.00. P b 0. 95% CIs − 1. 2C).60 to 0. (E) low frequency power (LF). Fig. LF/HF: n = 61. The other RCT. 95% CIs − 1.07.52. SMDs − 0.47.36. WMDs − 0. I2 = 76%. P = 0. SMDs 0. P = 0. 2009) failed to do so. P = 0. (F) LF/HF ratio during acupuncture as compared to sham acupuncture. I2 = 94%.56.04. (D) high frequency power (HF).39. Lee et al. heterogeneity: τ2 = 0. 95% conﬁdence intervals (CIs) − 0.79. our meta-analysis also failed to show signiﬁcant differences between two groups despite the present of a high degree of heterogeneity (LF: n = 61.73. χ2 = 17. Fig.0001. 2B. which compared the effects of acupuncture versus sham acupuncture on HRV Fig. Regarding LF power and the LF/HF ratio. Fig. P = 0. 3.53. Forest plot of the effects of acupuncture on (A) high frequency power (HF). (C) LF/HF ratio in normal healthy subjects after acupuncture. I2 = 0%. / Autonomic Neuroscience: Basic and Clinical 155 (2010) 5–13 showed signiﬁcant differences in the LF/HF ratio and the LF power between the acupuncture group and the control group.93 to 0. The meta-analysis of these two trials did not indicate that acupuncture had favorable effects on HF power (n = 61.53.58.
Five RCTs that assessed the effects of acupuncture on HRV showed signiﬁcant differences between the acupuncture group and the sham control group (Agelink et al. GV20 PC6. 2008.. heterogeneity: τ2 = 0.75. Park et al. 2006. Yes Yes Yes Yes Yes Yes Yes Rationale for acupuncture point selection Previous study TCM theory Previous studies TCM theory Previous studies Previous studies n. 2003. 95% CIs −0. 2005) measured it in the seated position.03. χ2 = 7. 2006. Lee et al. χ2 = 4..r. Huang et al. Kang et al.. A third RCT (Li et al. Backer et al.62. 95% CIs −0. Streitberger et al... n. (2005) Rheu et al... Another potential confound is the position in which the HRV parameters were measured.87. P = 0. Haker et al. P = 0..r. 2005. and bilateral HT7... First author (year) Agelink et al. Park et al.56.r. 2002). Streitberger et al..00. n. 2008. 2008. Rheu et al. n..26. Huang et al. or LF patterns in HRV as compared to sham acupuncture (Agelink et al.. All of the included RCTs employed a single-blinded (patientblinded) methodology.07. Huang et al. 2008. a parameter that can affect cardiac autonomic activities. n. χ2 = 0.57.... 2005.83. which tested the effects of acupuncture after a 3 h stress exposure showed that acupuncture had signiﬁcant effects on HRV. 2005.89.r. Wang et al. Five of the twelve RCTs that were included in this review assessed various patient populations in various states (i.26 to 0. (2005) Haker et al. n. SP4 PC6 ST36 (bilateral) (A) LI4 (right) (B) LI4 (left) (C) LU1 in the Left ear Sishencong points PC6 (Bilateral) PC6. 2008. Kang and Kim.. Considered Considered Considered Considered Considered Considered Considered Manipulation n. χ2 = 4. Overall. 10 years n. (2008) n. 2005. TE5. 4. Sishencong points. 2005. Our meta-analysis also did not show signiﬁcant differences between sham acupuncture and acupuncture with regard to HRV among healthy patients under stress and in their normal states.r.. (2008) Jeong et al..r.28. χ2 = 2. The same applied for LF/HF ratio with high heterogeniety (n = 52. Rheu et al.95. Four RCTs (Haker et al.03. Rheu et al.. 2008)... 2008.... Details regarding patient drop-out and withdrawal were described in four of the included RCTs (Backer et al. 2002) measured HRV in the supine position and four trials (Agelink et al.. (2006) Streitberger et al. (2008) Li et al.r. Patient positioning during measurement can inﬂuence autonomic activities.. TE23. SP4 LI4 De-qi n.. Three RCTs were double-blinded (i.47 to 1. LF: n = 129. Trials with inadequate blinding and/or inadequate allocation concealment may be subject to selection bias and would therefore be likely to generate exaggerated treatment effects.53. heterogeneity: τ2 = 0. The rationale for acupuncture point selection was stated in 10 RCTs (Agelink et al. P = 0..24 to 0.48. Backer et al. 2002).. The concealment of treatment allocation was not reported in any of the included trials. Huang et al. P = 0.r. Considered Considered n. 2000. 2005. Kang and Kim. TCM: traditional Chinese Medicine. Park et al. Another RCT (Wang et al. both the patient and the assessor were blinded) (Agelink et al.25. 2005.48. I2 = 78%). Jeong et al. P = 0. χ2 = 0. 2009. heterogeneity: τ2 = 0. Discussion Few sham-controlled RCTs have tested the effects of acupuncture on HRV. 95% CIs − 1. Only one trial (Backer et al..48 to 0. 2008). Jeong et al. No Yes Yes Yes Previous Previous Previous Previous studies studies studies studies n. our meta-analysis revealed no signiﬁcant differences in either parameter (HF: n = 129. Kang and Kim. SMDs 0. 2005. The fourth RCT reported signiﬁcant differences between acupuncture and sham acupuncture with regard to HRV in healthy patients who were experiencing mental stress (Park et al. 2008. Haker et al.. WMDs −0. 2006. Meta-analysis did not show signiﬁcant differences in HF power (n = 52. heterogeneity: τ2 = 2. Backer et al. 2008) measured patients' respiratory frequency. 2005..r..r. 3C).44.05. 2005. 2005) and the sham control groups. 2003) or migraine headaches (Backer et al.e. 3 years n. and their results were therefore prone to type II errors. n. 2002) did not provide clear information regarding assessor blinding. Five studies failed to show statistical differences in HRV between the acupuncture (Haker et al. GB41 (bilateral for all of the above points).. P = 0. Park et al. and it is therefore important to consider patient positioning when assessing the function of the autonomic nervous system. 95% CIs − 0.. SMDs −0. Huang et al. heterogeneity: τ2 = 0.61. 1 year n.. Rheu Table 3 Summary of acupuncture treatments administered in the included studies. Two RCTs showed that acupuncture had a changes in pattern of HF or LF in HRV in patients with mild depression or anxiety disorders (Agelink et al.. 2003. LR3.. Wang et al. P = 0. Additionally. Jeong et al. 2006. Rheu et al. 2002). HF.. PC6. I2 = 0%) and LF power (n = 52. 2008. BL62 GB20. LF/HF: n = 129.. 2008. 2000. 2008).r Wang et al.73 to 0. 2003. SMDs 0.00.r.: not reported. Backer et al.87. 2005).r. 2008. 2006).r.. while the other nine trials (Chang et al.72 to 0.. Ex-HN5. I2 = 87%). Li et al..3. Li et al.01.46. 2009). I2 = 20%. 2000. 3B. Two RCTs reported the values of HRV recorded during acupuncture (Chang et al. heterogeneity: τ2 = 0.r. I2 = 53%.0006. 2003. reported no signiﬁcant differences between the two groups (Jeong et al. 95% CI −0.15. P = 0.. (2008) Chang et al.46. P = 1.e. stressed state versus normal state) suggested that acupuncture had changes in the pattern of LF/ HF. 2003. 2006). 95% CIs −3.. P = 0.. 2008.r.56. 2000. 2009. Streitberger et al.. Li et al. I2 = 0%.. Healthy subjects in normal states The other six RCTs examined the impact that manual acupuncture or electroacupuncture (EA) (as compared to sham acupuncture) had on HRV in healthy subjects (Chang et al. Li et al..82. 2008) or EA groups (Chang et al. (2003) Backer et al.11.3. Acupuncture points GV20. 2008). Wang et al.12. Park et al. Wang et al. Three of the included RCTs could be combined into a meta-analysis (Chang et al.. 3A. LI4 (bilateral) HT7 PC6.S. P = 0. (2005) Kang et al. Li et al.. 2005. 2005. 2008. 2002) assessed effects of acupuncture on Sishencong points (EX-HN1) in healthy subjects and reported that acupuncture had point-speciﬁc effects on HRV... Fig.. / Autonomic Neuroscience: Basic and Clinical 155 (2010) 5–13 11 after caffeine consumption. our ﬁndings provide no convincing evidence that acupuncture has signiﬁcant effects on HRV. most of the RCTs had small sample sizes. Backer et al. . 2008. These latter studies were therefore subject to performance and detection bias. and the LF/HF ratio.0. 2005. P = 0.... Fig. Fig. 2008. 2008. The majority of the existing studies fail to suggest that acupuncture is an effective modality for modulating HRV.51. 3.. Huang et al.... When we compared the effects of acupuncture versus sham acupuncture on HF and LF power. (2000) Experience of acupuncturist n. Rheu et al. (2009) Park et al. WMDs 0.. Rheu et al. Wang et al.51. (2002) Huang et al. SMDs 0. 2005. 2009.06.
D. Clin. M. W..M. Kuo. 157–164. Physiol 248..M. C. E.. 1997... / Autonomic Neuroscience: Basic and Clinical 155 (2010) 5–13 et al.. J. 2006.F. Pach. E. N. Chen. Therefore. non-penetrating sham acupuncture was reported to have signiﬁcant effects on placebo tablets at treating subjective pain complaints (Kaptchuk et al. Gordon. 2008. Chang. Y. The fact that.. Kerr.. Moreover.. In the present data set... R. 2009. Atropine-induced HRV alteration is not amended by electroacupuncture on Zusanli. 187–241. Wang et al. 125–137.R. 1997 Pittler et al.. Jeong. 2008. Backer. Sham device v inert pill: randomised controlled trial of two placebo treatments.. Michalsen. Ernst. Rheu et al... 778–786. In a previous study.G. C. Huang et al.MD.G. Epidemiol 53. Jeong et al.. Acupuncture analgesia: a review of its mechanisms of actions. et al. 307–314. Lin.. R. P. J. The other RCT. Lemmer... Shannon.T. M.A. Wang et al.T. K. overall. Seo.. and we cannot therefore completely elucidate the non-speciﬁc effects of acupuncture. E. Chen. 2005.. acupuncture could be effective.. Chang et al.H. 2003. a range of methods have been used in these types of studies. This suggests that the effects of needle acupuncture with or without electric stimulation may be nonspeciﬁc in nature. M.. L. Short time effect of caffeine on heart rate variability and the effect of acupuncture at Neiguan (PC6): a randomized double blind pilot study.B. H151–153. B. Eur. Streitberger et al. 2005.. N.. Li et al. Kutz. E.C.. Increase in the vagal modulation by acupuncture at neiguan point in the healthy subjects. and an ideal placebo cannot be designed before the exact mechanism by which acupuncture works is elucidated. R. Kang and Kim. Hyattsville. 2005). these results provide no convincing evidence for the effectiveness of acupuncture in modulating HRV in dysfunctional or stressful states or in normal states in healthy subjects. A... 2006).. 2006.J. Complementary and alternative medicine use among adults and children: United States. 107–115. Streitberger et al.. Mak... Barger. Bjerring. Melchart. E.U. Ernst. Eleven RCTs reported the manipulation methods used by the acupuncture practitioners (Backer et al. I. Effects of acupuncture on heart rate variability in normal subjects under fatigue and non-fatigue state.. R. and no-treatment groups. C.. Zhou and Chen.H. D. K.H. Park et al. D. regardless of the site at which it is administered. Park. 633–640. E. Suh. Egekvist. Legedza. In total. there is no good evidence regarding the effect of acupuncture on HRV could have several possible interpretations.W. Beeinﬂusst Akupunktur die autonom kardiale Regulation bei Patienten mit leichten depressiven Episoden oder Angststörungen? Fortschr. J.. Chang... Variance imputation for overviews of clinical trials with continuous response. 2002). Lehmann. G.H. D. Nam. 2002) (Table 3). J. J. Bloom. it is not evident whether the presence or absence of de-qi had an important inﬂuence on HRV. W. One problem with acupuncture clinical trials is ﬁnding a suitable placebo control. BMJ 332. C.. Clin. . A. 635–645. Cutler. B. In conclusion. which could explain why no beneﬁcial effects could be demonstrated in normal healthy subjects. Haker. Niggemeyer. Nahin. Jung. 2008. This needle sensation (de-qi) was assessed in nine RCTs (Backer et al. T..S.J. J. 2000. Rothstein et al.S.. Knoblauch.. References Agelink. England. reported signiﬁcant effects of acupuncture on LF and LF/HF power as compared to no treatment among patients with hypertension (Zhou and Chen. Penetrating acupuncture.. H.. Clin.. Chin.. showed no signiﬁcant differences in HRV between the real acupuncture. 769–773. J. C. Schnyer.. Oriental Neuropsychiatry 20. regardless of the acupuncture technique employed. Acupuncture in migraine: investigation of autonomic effects.H.. Kim.. 2005.. none of the studies identiﬁed strong evidence of the effects of real acupuncture as compared with sham acupuncture. Jeong et al.. R. J. C. Li et al. Z. Effect of sensory stimulation (acupuncture) on sympathetic and parasympathetic activities in healthy subjects. J. Orient. Ting. Effects of acupuncture on autonomic nervous system in normal subjects under mental stress. I.). Abbot.H.L. Korean J.S. A fourth interpretation is that acupuncture may only be effective in pathologic conditions..L. 2008). Auton.. P. Assessing risk of bias in included studies.. Altman. J.. Epidemiol 45. Moon. these facts limit the conclusiveness of this systematic review considerably. B. Intern. Chen. Caudill. Appl. Streitberger et al. Green. through extensive search. K.. the use of multiple reviewers. Stason. Schneider.. acupuncture could be an ineffective modality for modulating cardiac autonomic activity.. G.H. Needle stimulation causing a typical needle sensation has been claimed to be an important factor in obtaining the optimal effects of acupuncture. there is no universally accepted placebo.. 2005. Med 29. A. no 12. 2008. 2000... Am. First. C.C.E. it would be interesting to further analyze the two RCTs that employed a no-treatment control group (Huang et al. Haker et al. Acupuncture—a critical analysis. Alternatively. Acknowledgements S. Davis. Chang et al. and quality of the RCTs that are available are too low to draw ﬁrm conclusions. Lin. (Eds. S.. Ko. M... C....M. Nam... the number. E.. J. 2008. We tried to reduce bias in this systematic review. Klieser.. Bertling. these results may also be explained by any of the four hypotheses discussed above. Tan..N.M. Bae.. 2007. Higgins. H. but they must overcome the many limitations present in the current literature. W.. D. J. I. West Sussex.T. 2008).. which was excluded from this review because of the absence of sham control group.B. Lee. Chow. J. Am.. Cochrane Handbook for Systematic Reviews of Interventions. J. Huang. Macaulay. Nerv.. the association between sympathetic activity and LF power as well as the LF/HF ratio remains unclear.G. L..S. D.. Barnes. Wiley-Blackwell. Syst 79....P. all of which comprised healthy subjects. Chin. Dobos.. 2005. Psychiatr 71.. 2008. but may have been administered sub-optimally (e. H. G.. 2008 One RCT (Huang et al. Korean Oriental Med 29. 2000. Further limitations include the paucity and the often suboptimal methodological quality of the primary data. Chin. 2005. Only three RCTs reported the experience level of the acupuncture practitioners (Jeong et al. P... 480. some of which may not be adequate. 2008. C. J. Rheu et al... Lee et al. Park et al. R. which was included in this review.. however.12 S. could potentially induce physiological modulations that might inﬂuence various symptoms. Follmann.D. 2006.H. Kang and Kim. Cho.. 2008. 2008.. J. and inclusion of non-English studies. S. 2009. Further rigorous RCTs seem warranted to further examine this topic. Lee was supported by the Program of Kyung Hee University for the Young Researcher in Medical Science (KHU-20071513). Pomeranz. 2008. 391–397.. It is conceivable that several negative RCTs remain unpublished.. 1992. 2005. E. Elliott. including pain and autonomic nervous system-related symptoms. Park. Thus. J. While HF power is associated with parasympathetic activity (assuming regulated breathing patterns). However. 2005). J.. 2008.. 2008. They generally range from non-/minimal/normal needle penetration at non-acupuncture points to minimal needle penetration at acupuncture points.N.J. 2009. H. S...H. Alternative therapy bias. A. Med 259.. Location bias in controlled clinical trials of complementary/alternative therapies.H. Linde.S. 2008. Haker et al.. Kaptchuk. 2006. 2008. P. Med 33. Kang.. M. 2005. size. selective publishing and reporting are other major causes of bias that must be considered (Ernst and Pittler. 1985.. In the present systematic review. S. However. 2000. D.K. J. Kirsch. we cannot be absolutely certain that we succeeded. sham acupuncture. Pain 24. 106–115. D.. Sanner. Kilborn. Lo. Kang and Kim. 2005. 52–59. pp. The authors quoted previous studies or expert consensus to justify their point selection.. Yang.H. Grossman. M. 485–489. Wang.. A third interpretation is that sham acupuncture may also be effective and may be the reason that no inter-group differences could be demonstrated. The ﬁnding that penetrating sham acupuncture performed at non-acupuncture points had similar outcomes to acupuncture might be due to a physiological effect of needle penetration or the therapeutic relationship between the practitioner and the patient. Much of the clinical literature on acupuncture shows that sham acupuncture has superior clinical effects than non-treatment does. 2000..S.S. The other three trials did not report these details. Med 36.. 141–149.S. In: Higgins. W..P. Kim.F. D.L. L. National Center for Health Statistics. H.T.. Huang et al. Neurol. Ernst.. J. Am. Li.S.. Although we made a strong effort to retrieve all RCTs on the subject. Several sham acupuncture methods have been proposed for use in acupuncture trials. 2006). Physiol 94.. Nature 385. However.Y. J. Int.. Am..... Our review has a number of important limitations.g. 2009. 165–176. J. Med 33. thereby distorting the overall picture.. 2005. Eich.C... inappropriate acupuncture points could have been used) in these studies. Adam. R..S. Pittler. The effect of mental stress stimulation and acupuncture at Shinmun (HT7) on heart rater variability. Stone. Pittler. Huang. Harkness. Kim. Cohen.A.J. National health statistics reports. 2008. Goldman. Assessment of autonomic function in humans by heart rate spectral analysis. Y.
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