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meta-analysis

ACUPUNCTURE FOR ESSENTIAL HYPERTENSION


Leo-Wi Kim, , ; Jiang Zhu, , MD PhD MD MS

Objective • To assess the efficacy of acupuncture for treatment of significant heterogeneity. In high-quality trials, blood pressure
essential hypertension and the efficacy of acupuncture using pre- was significantly lower in treatments of acupuncture plus anti-
scription adhering to the principles of “syndrome differentiation.” hypertensive drug arms than in sham-acupuncture plus hyper-
Data Sources • Medline, Embase, Cochrane Central Register, and tensive drug arms (two comparisons: SBP: -5.72 mmHg, -8.77 to
China National Knowledge Infrastructure (September 2008). -2.68; DBP: -2.80, -5.07 to -0.54), with no significant heterogene-
Study Selection • Randomized, controlled trials comparing ity. As for trials using prescription adhering to the principles of
acupuncture with sham acupuncture, antihypertensive drugs, syndrome differentiation, we found a significant blood pressure
Chinese herbal medicine, or exercise in essential hypertension. reduction with acupuncture arms in comparison with control
Data Extraction • Two reviewers independently assessed trials arms (11 comparisons: SBP: -6.46 mmHg, -8.04 to -4.87; DBP:
for inclusion, extracted data, assessed methodological quality, -3.07, -4.17 to -1.96) with no significant heterogeneity. In con-
and extracted outcome data on blood pressure. trast, in trials not using prescription adhering to the principles
Data Synthesis • Treatment effects were summarized as mean of syndrome differentiation, we found no significant reduction
differences with 95% confidence intervals. Twenty trials were in blood pressure with acupuncture arms in comparison with
included: three trials were relatively rigorous while others were control arms (eight comparisons: SBP: -1.55 mmHg, -5.39 to
methodologically suboptimal. Acupuncture arms achieved sig- 2.29; DBP: -2.12, -4.97 to 0.73) with significant heterogeneity.
nificant effect modification on blood pressure compared with Conclusions • Because of the paucity of rigorous trials and the
control arms (19 comparisons: systolic blood pressure [SBP]: mixed results, these findings result in limited conclusions.
mean difference -4.23 mmHg, 95% confidence intervals -6.47 to More rigorously designed and powered studies are needed.
-1.99; diastolic blood pressure [DBP]: -2.53, -3.99 to -1.08), with (Altern Ther Health Med. 2009;16(2):e-pub ahead of print.)

Leo-Wi Kim, MD, PhD, is a lecturer in the department of Evidence from randomized controlled trials (RCTs) shows that
Oriental Medicine Resources, College of Science and effective medication reduces the risk of cardiovascular morbidity
Engineering, Far East University, Korea. Jiang Zhu, MD, MS, and mortality.3,4 There is concern that the benefits demonstrated in
is a professor in the Departments of Acupuncture and RCTs of antihypertensive medication are not implemented in
Moxibustion, College of Acupuncture and Moxibustion, everyday clinical practice5 and that the goals of lowered BP are
Beijing University of Traditional Chinese Medicine, China. achieved in only 25% to 40% of the patients who take antihyperten-
sive medication.1,5,6 The recent studies have emphasized the bene-
Corresponding author: Leo-Wi Kim, MD, PhD fits of early and good BP control, confirming the requirement for
E-mail: leowikim@naver.com two or three antihypertensive agents to achieve satisfactory con-
trol.7,8 In order to reduce the likelihood of drug toxicity and pill
Editor’s note: Due to space limitations, four tables and figures burden and to aid adherence, a combination of established agents
(Tables 2 and 4; Figures 4 and 5) were omitted from the print ensuring efficacy and using a low dose is required.9 It is empha-
version of the article. The full version of the article appears here. sized that the majority of the hypertensive population will require
individualized therapy to achieve the recommended goals and that
oday, hypertension represents a growing worldwide individualized therapy has potential for reducing the burden of

T public health concern. Recent data suggest that 26.4%


of the world’s adult population suffers from hyperten-
sion.1 The presence of high blood pressure (BP) dou-
bles the risk of ischemic heart disease and increases
the incidence of stroke four-fold.2 Thus hypertension is an impor-
tant public-health challenge both because of its high frequency and
because of the concomitant risk of cardiovascular diseases.
cardiovascular disease, particularly of stroke.10
In traditional Chinese medicine (TCM), acupuncture plays a
central role in a comprehensive system of medicine aimed at
maintaining health and correcting disease processes. One of the
important concepts of TCM is “syndrome differentiation.” It
means to analyze, induce, synthesize, judge, and summarize the
clinical data of symptoms and signs collected with the diagnostic

B ALTERNATIVE THERAPIES, mar/apr 2010, VOL. 16, NO. 2 Acupuncture for Essential Hypertension
methods of TCM into specific syndromes. The therapeutic meth- the Cochrane Back Review Group, 14,15 with disagreements
ods are then decided according to the result of syndrome differ- resolved by consensus. We awarded a maximum of 11 points in
entiation.11 The therapies related to treating hypertension in 11 categories: Was the method of randomization adequate? Was
TCM include Chinese herbs, acupuncture, acupressure, moxibus- the treatment allocation concealed? Were the groups similar at
tion, and qigong. Acupuncture as a nonpharmacological inter- baseline? Was the patient blinded to intervention? (We could not
vention has been used to treat a wide variety of conditions to be certain that invasive sham needles were sufficiently credible as
regulate cardiovascular diseases in the East for centuries. sham control to the treatment being evaluated; therefore, we
Recently, acupuncture has become one of the most popular com- assigned 0.5 point to invasive sham and 1 point to noninvasive
plementary therapies in the West.12 Acupuncture therapy is used sham.) Was the care provider blinded to intervention? Was the
on patients with mild or borderline hypertension who want to outcome assessor blinded to intervention? Were co-interventions
avoid drug therapy or as an alternative therapeutic option to avoided or similar? Was the compliance acceptable in all groups?
reduce dosages of antihypertensive agents. Was the dropout rate described and acceptable? Was the timing
The aim of this review is to evaluate the efficacy of acupunc- of outcome assessment identical and adequate in assessment of
ture in treatment of essential hypertension and the effect of acu- the efficacy acupuncture for treating hypertension in all groups
puncture using prescription adhering to the principles of (0.5 point to the identical timing, 0.5 point to the adequate tim-
syndrome differentiation and to identify whether acupuncture ing)? Did the analysis include an intention-to-treat analysis? We
therapy appeared sufficiently promising as to justify further considered a score of 6 or more points to indicate high quality.
large-scale RCTs.
Data Synthesis and Analysis
METHODS We categorized the included trials into predefined subgroups.
Eligibility Criteria The subgroup analyses were performed separately, depending on
We included all RCTs of acupuncture that were a sole treat- the quality of trials. Some trials used pre-selected, unified acu-
ment or an adjuvant treatment for medication in adult patients points for all the participants, whereas others grouped all the par-
with essential hypertension. We included trials with needle inser- ticipants into several categories by syndrome differentiation and
tion into traditional meridian points. Trials that used auriculo- used different pre-selected acupoints according to category. As
therapy, laser acupuncture, or electroacupressure (without prescription adhering to the principles of syndrome differentiation
needle insertion) were excluded. We excluded trials that evaluat- is the most important basic principle of TCM theory, we per-
ed the efficacy of acupuncture only after one treatment as well as formed two subgroup analyses for evaluating the effect of prescrip-
trials of secondary hypertension. tion adhering to the principles of syndrome differentiation.
We calculated the mean differences (MD) with 95% confi-
Study Identification and Selection dence intervals (CI) by using the values of the outcome at the end
We searched electronic databases Medline, Embase, Cochrane of treatment. If any further follow-ups were measured, we per-
Central Register, and China National Knowledge Infrastructure formed a separate analysis of each measurement point. The het-
(CNKI) from January 1, 1980, to January 10, 2008, and updated it erogeneity between trials was tested with χ2 statistic (Cochran’s
to September 31, 2008. We combined acupuncture-related terms Q test),16 computing the square distance of each study from the
(acupuncture, acupoint, needling, or moxibustion) with hypertension- combined effect. We also calculated the quantity I2,17 which
related terms (blood pressure, hypertension, or hypertensive). We also describes the percentage variation across studies that is due to
manually searched the reference lists from primary articles. We heterogeneity rather than chance. The random-effect model was
imposed no restrictions on the type or language of publication. We used if the heterogeneity statistic among studies was statistically
considered older RCTs that were included in previous reviews of significant18; otherwise, the fixed-effect model was used.19 By
acupuncture for lowering blood pressure.13 using a funnel plot, we assessed potential publication bias.20 All
statistical analyses were performed using Review Manager
Data Extraction Version 5.0.16 (The Nordic Cochrane Centre, The Cochrane
Two reviewers independently screened all citations and Collaboration, 2008, Copenhagen, Denmark).
abstracted data. We extracted data pertaining to quality of the
methods, participants, interventions, and outcomes. All the tri- RESULTS
als reported composite outcomes, so they were not appropriate Search Results
for meta-analysis. Instead, we extracted BP data that were objec- This review identified a total of 687 titles and four manual
tively defined and were common among trials. All other out- searches that met the search criteria. The full articles of the
comes were excluded from this review. retrieved 188 trials were read to assess their appropriateness for
meta-analysis. Data from 20 articles21-40 of 47 potentially appro-
Quality Assessment priate RCTs met the inclusion criteria. Four trials24, 32, 35, 40 were
Two reviewers independently assessed the methodological identified through Medline, Embase, or Cochrane Central
quality of included trials by using an 11-item scale developed by Register, four trials 23, 26, 31, 38 were identified through both Medline

Acupuncture for Essential Hypertension ALTERNATIVE THERAPIES, mar/apr 2010, VOL. 16, NO. 2 C
and CNKI database, and 12 trials 21, 22, 25, 27-30, 33, 34, 36, 37, 39 were from the
CNKI database. We excluded 27 trials: 15 for not presenting sep-
arate results for BP, one for insufficient outcome data, eight for Potentially relevant studies identified and screened
for retrieval (N=687):
one-time treatment, two for duplicate reports, and one trial for
Medline (n=129)
not having kept the antihypertensive drug’s dose uniform during Embase (n=103)
the duration of the acupuncture treatment. Figure 1 presents a Cochrane Central (n=36)
flow chart of retrieved trials and trials excluded with specified CNKI (n=415)
reasons. All trials had been conducted in four different countries Manual search (n=4)
and published in English journals (three trials32,35,40), a German
journal (one trial24), or Chinese journals (16 trials).
Excluded (n=499):
Trial Characteristics Nonrandomized trials, or review (n=399)
A total of 1528 patients from 20 trials were included in this Not an in vivo human trial (n=100)
review. Table 1 details additional characteristic of the interven-
tions in the included RCTs. Acupuncture was the sole treatment
in 11 trials, whereas in nine trials, acupuncture was used as a
Studies retrieved for more detailed evaluation (n=188)
cooperative treatment for medication. As for control, sham acu-
puncture was adopted for control in four trials24,32,35,40, whereas 14
trials21-23,25,26,28,30,31,33,34,36-39 used antihypertensive drugs only as a con-
trol, one trial27 used Chinese herbal medicine plus an antihyper- Excluded (n=141):
tensive drug, and one trial29 used exercise only. Search overlap (n=58)
Nonrandomized trials (n=29)
In all the trials, the selection of acupoints was designed for
Not essential hypertensive patients (n=28)
the purpose of reducing the BP of hypertensive patients. Eight Protocol manuscript (n=2)
trials used unified acupoints for all those participants, whereas Not inserted into tender points (n=18)
11 trials grouped all those participants into three to five catego- Preferred inter-acupoints (n=1)
ries by syndrome differentiation and used different pre-selected Preferred inter-manipulations (n=5)
acupoints according to those categories. One article32 provided
two separate active formulas: one was “TCM individualized”
(using prescription adhering to the principles of syndrome dif- Potentially appropriate RCTs to be included (n=47)
ferentiation), and the other was “TCM standardized” (not using
prescription adhering to the principles of syndrome differentia-
tion but using unified acupoints).
Excluded (n=27):
Trial Quality Not presenting separate results for BP (n=15)
Insufficient outcome data (n=1)
Table 2 summarizes the qualities of the 20 included RCTs.
One-time treatment (n=8)
The methodological qualities of 17 trials, which were published
Duplicate reports (n=2)
in Chinese or German journals, were suboptimal. Only three tri- Not having kept the antihypertensive drug’s
als32,35,40 published in English journals were relatively rigorous. dose uniform during the duration of the
In terms of randomization, only one trial32 used an allocation acupuncture treatment (n=1)
procedure that would be considered as concealed. Two trials32,40
were double-blinded, and two trials24,35 were single-blinded.
Four trials24,32,35,40 used sham needles as control, and two trials32,35
were analyzed on intention-to-treat basis. Lost follow-up was RCTs included in the reviews (n=20 trials, 1528 patients)
Quality of trials categorized as follows:
described in four trials24,32,35,40 and further follow-up occurred in
High-quality (n=3 trials, 358 patients)
two of these trials.32,35 Low-quality (n=17 trials, 1170 patients)
Acupuncture interventions in trials categorized as follows:
Quantitative Data Syntheses Acupuncture only (n=11 trials)
Blood Pressure Acupuncture plus medication (n=9 trials)
Acupuncture arms achieved significant effect modification Measurement points as follows:
on BP compared with control arms (systolic blood pressure After ≤5 d of treatment (n=19 trials)
[SBP]: MD -4.23 mmHg, 95% CI random -6.47 to -1.99; diastolic After 3 wks of treatment (n=1 trial)
blood pressure [DBP]: -2.53, -3.99 to -1.08). We found significant
heterogeneity for this outcome (SBP: χ2=69.11, I²=74%; DBP: FIGURE 1 Flow of Studies Through Selection Process
χ²=59.80, I²=70%). The funnel plot showed asymmetry consis-

D ALTERNATIVE THERAPIES, mar/apr 2010, VOL. 16, NO. 2 Acupuncture for Essential Hypertension
TABLE 1 Characteristic of Interventions and Outcomes in Included Trials*
Study ID Location Acupuncture rationale Needling Details
(Year)
Style of Rationale for Prescription Unified acupoints Additional acupoints by syndrome types Depths of
acupunc- treatment adhering to the (auricular acupoints) insertion
ture principles of (cun)
TCM syndrome
differentiation

He XW, China Chinese TCM pattern Used BL23, LI11, ST40 4 types: hyperactivity of liver yang: BL18, LR03; yin asthenia NR
199421 diagnoses and yang hyperactivity: SP06, ST36; asthenia of yin and
yang: SP06, GV04; asthenia of yang: GV04
Yin ZF, 199422 China Chinese TCM pattern Used GB20, LI11, SP06, ST36 3 types: hyperactivity of liver yang: LR03; asthenia of kidney NR
diagnoses and liver yin: KI03; retention of phlegmatic dampness: ST40
Dan Y, 199823 China Chinese TCM pattern Used BL17, GB20, LI04, LI11, LR03 3 types: yin asthenia and yang hyperactivity: KI07, PC06; NR
diagnoses retention of phlegmatic dampness: SP04, ST40; asthenia of
yin and yang: SP06, ST36
Kraff K, Germany Chinese TCM pattern Used BL18, BL23, GB20, GV20, — 0.5 cm
199924 diagnoses HT07, KI03, LR02, LR03, SP06
Chen YF, China Chinese TCM pattern Not LI11, ST40 — NR
200025 diagnoses
Jiang XL, China Chinese NR Not LI11, LR03, ST40 —
200326
Song YM, China Chinese TCM pattern Used BL18, BL23, GB20, LI11, LR03, LR02 was added to headaches or dizziness, HT07 to insom- NR
200327 diagnoses ST36 nia, PC06 to palpitation.

Wu QM, China Chinese NR Not GV20, LI04, LR03 — 0.5~1


200328

Zhao DJ, China Chinese NR Not CV04, LR03, SP06, ST36, ST40 — NR
200329,
Hu LH, China Chinese TCM pattern Used GB20, GV20, HT07, LI11, SP06 3 types: hyperactivity of liver yang: LR03; asthenia of kidney NR
200430 diagnoses (Heart, Liver, Kidney, Shenmen, and liver yin: KI03; retention of phlegmatic dampness: ST40
Jiangyagou)
Zhang YL, China Chinese TCM pattern Used GB20, LI11, SP06, ST36 3 types: hyperactivity of liver yang: LR03; asthenia of kidney 1~1.5
200531 diagnoses and liver yin: KI03; retention of phlegmatic dampness: ST40
Macklin EA, United Chinese TCM pattern Formula 1 used GB20, GV20, LI04, LI11, LR03 5 types: hyperactivity of liver yang: GB21, GB34, GB43, 0.3~1.5
200632 States diagnoses (Heart, Liver, Shenmen, LR02, ST36, ST44, Taiyang; asthenia of kidney yin and
Jiangyagou, Sympathetic nerve) hyperactivity of liver yin: BL18, BL23, HT07, KI03, SP06, yin-
tang; retention of phlegmatic dampness: BL20, BL64, CV12,
PC06, SP06, ST08, ST36, ST40; asthenia of yin and yang:
BL23, CV04, CV06, GV04, KI03, SP06, ST36; asthenia of qi
and blood and hyperactivity of liver yang: BL18, BL20, BL23,
CV04, CV06, HT07, KI03, SP06, ST36
Formula 2 not GB20, LI11, LR03, SP06, ST36 —
used (Heart, Jiangyagou)
Wang C, China Chinese NR Not GV20, LI11, LR03, ST36 — NR
200633
Wang LY, China Chinese NR Not GB20 — 0.8~1
200634
Flachskampf Germany Chinese TCM pattern Used BL18, BL23, BL64, CV04, CV06, 4 types: hyperactivity of liver yang, retention of phlegmatic
FA, 200735 diagnoses CV12, GV20, GB20, LI04, LI11, dampness, asthenia of yin and yang, yin asthenia and yang
LR02, LR03, PC06, SP06, ST36, hyperactivity.
ST40, Taiyang
Guo YH, China Chinese NR Not GV20, KI03, LI11, LR03, SP06, — NR
200736 ST36, ST40
Hu LH, China Chinese TCM pattern Used GB20, GV20, LI11, SP06 3 types: hyperactivity of liver yang: LR03; asthenia of kidney NR
200737 diagnoses (Wrist-ankle acupuncture) and liver yin: KI03; retention of phlegmatic dampness: ST40
Huang F, China Chinese TCM pattern Used GB20, LI11, LR03, PC06, ST36, Only enrolled patients with syndrome of phlegmatic reten- 30mm or
200738 diagnoses ST40 tion and blood stasis in Luo. 20mm
Wang X, China Chinese TCM pattern Not LR03 — 0.5~0.8
200739 diagnoses
Yin C, 200740 Korea Saam acu- Saam acu- Used — 3 types: BL25, LI11, ST36 for reinforcement of large intestine NR
puncture of puncture the- meridian energy, BL13, LU09, SP03 for lung, CV04, KI02,
Korean ory of Korean KI07 for kidney, GV14, GB20, LI01 for bladder. HT07, PC06
acupuncture were added when a psychological factor was considered.

TCM indicates traditional Chinese medicine; BP, blood pressure; ABPM, ambulatory blood pressure monitoring; Chinese-herb, Chinese herbal medicine; ET, end of treatment; NR: Not reported.
†A: reducing manipulation by twirling, rotating, lifting and thrusting the needle; B: reducing manipulation by twirling and rotating the needle; C: reinforcing or reducing manipulation by twirling and rotating

Acupuncture for Essential Hypertension ALTERNATIVE THERAPIES, mar/apr 2010, VOL. 16, NO. 2 E
TABLE 1 Characteristic of Interventions and Outcomes in Included Trials, continued*
24. Kraft K, Coulon S. Effect of a standardized acupuncture treatment on complains, blood
pressure and serum Needling
lipidsDetails
of hypertensive, postmenopausal women. Co-interventions
A randomized, Duration, Control Practitioner Outcomes Measurement
controlled clinical study [article in German]. Forsch Komplementarmed. 1999;6(2):74-79. Days Interventions Background Points
Deqi Needle Needle type Needle Additional
25. Chen YF, Qian H, Li L, et al. Effects of acupuncture on contents of plasma endothelin Other (Sessions, n)
angiotensin in the patient stimulation;
feelingandretention of hypertension. medication
Zhongguo Zhen interventions
Jiu.
time
2000;20(11):691-694. manipulations*
(min)
26. Jiang X. Effects of magnetic needle acupuncture on blood pressure and plasma ET-1
level in the patient of hypertension. J Tradit Chin Med. 2003;23(4):290-291.
27. Song YM, Song D, Du LL. Clinical observation on acupuncture combined with medi-
NR cine in 64 cases NR
15~20 of hypertension. Shanxi JManual;
Tradit Chin
F Med. 2003;24(11):1005-1006.
No No 30 (daily) Antihypertensive NR BP, BP change ET
28. Wu QM, Feng GX. The correlation between hypotensive effect and plasma Ang after drugs magnitude
warm acu-moxi on Kaisiguan(Extra) and Baihui(DV20) points. New J Tradit Chin Med.
2003;35(12):45-47.
NR29. Zhao30 DJ, Fan QL. NREffects of acupunctureManual; F resistance
on insulin No in the patient of No hyper- 42 (21) Antihypertensive NR BP After 1 d of
tension. Zhongguo Zhen Jiu. 2003;23(3):165-167. drugs treatment
30. Hu20~30
After LH, Yan W,NR Chen WG, Zhou GM, Jiang Manual;L, Yang
F YY. Clinical
No observation on Noelec- 21 (daily) Nifedipine NR ABPM ET
Deqi troacupuncture combined with Cizhu sticked to the auricular points and medicine for
treatment of hypertension. Chin J Physical Med Rehabil. 2004;26(4):248-249.
31. Zhang YL, Li CP, Peng M, Yang HS. Effects of acupuncture combined with medicine on
After neuropeptide
30 YNRin the patient of hypertension
Manual[article in Chinese].
No Zhongguo Zhen
No Jiu. 84 (24) Invasive sham NR ABPM ET
Deqi 2005;25(3):155-157. acupuncture
32. Macklin EA, Wayne PM, Kalish LA, et al. Stop Hypertension with the Acupuncture
After Research
15~30 Program NR (SHARP): results Manual; A or E Nocontrolled clinicalNo
of a randomized, trial. 14 (daily) Nifedipine NR BP ET
Deqi Hypertension. 2006;48(5):838-845.
33. Wang C, Cheng ZQ. Clinical effective valuation and its mechanical analysis of acupunc-
After ture30 on obese NR hypertensive patients. Manual; NR Captopril
Liaoning J Tradit Chin Med.
No 20 (daily) Captopril NR BP After 1 d of
Deqi 2006;33(10):1327-1328. treatment
NR34. WangNR LY, ChenNR Manual; Feffect and
BG. Clinical study on therapeutic Nifedipine,
adjustment to plasmaNo ET 30 (daily) Nifedipine, NR BP ET
and serum TNF-α in the patient of essential hypertension with acupuncture
captopril, aspirinat Fengchi captopril, aspirin
point. J Hubei College of Tradit Chin Med. 2006;8(1):8-10. enteric-coated, enteric-coated,
35. Flachskampf FA, Gallasch J, Gefeller O, et al. Randomized trial Chinese
of acupuncture
herb to lower blood Chinese herb
pressure. Circulation. 2007;115(24):3121-3129.
After
36. Guo YH. Clinical observation on effect of acupuncture on insulin resistance in Moxibustion
20 No 38, 1.5 cun, Manual; A No hyper- 30 (daily) Captopril NR BP After 5d of
Deqi tension. Acta Chin Huatuopian needles,
Med Pharmacol. 2007;35(6):51-53. treatment
Chana
37. Hu LH, Yan W, Zhou GM, Chen SQ, Wu YP. Clinical observation on wrist-ankle acu-
After puncture
20 combined
NR with medicine for Manual; treatmentE of hypertension.
No Chin J Cardiovasc
Behavior 40 (30) Behavior therapy NR BP ET
Deqi Rehabil Med. 2007;16(2):184-185. therapy
38. Huang F, Yao GX, Huang XL, Liu YN. Clinical observation on acupuncture for treat-
After ment30 of hypertension
0.3x40 mm of phlegm-stasisElectrical
blocking collateralAmlodipine Aricular
type [article in Chinese]. 24 (daily) Amlodipine NR ABPM ET
Deqi Zhongguo Zhen Jiu. 2007;27(6):403-406. (2-3Hz); E acupuncture
39. Wang X, Wu HL, Li SQ. An assessment of antihypertensive effect of acupuncture at
Taichong(LR 3) with ambulatory blood pressure monitoring. J New Chin Med.
After 2007;39(11):21-22.
30 No 28, 2 cun, Hua- Manual; C Nifedipine No 20 (daily) Nifedipine NR BP ET
Deqi
40. Yin C, Seo B, Park tuopian
HJ, etneedles, China a promising adjunctive therapy for essential
al. Acupuncture,
After hypertension:
30 a0.16~0.3x13~5
double-blind, randomized,
mm Manual; controlled
NR trial.NoNeurol Res. 2007;29Auricular
Suppl acu- 42-56 (≤12) Invasive sham Described BP change mag- After 3 wk of
Deqi 1:S98-S103. stainless steel, Seirin puncture acupuncture, 0.2x15, nitude treatment (after
41. Kaptchuk TJ, Stason WB, Davis
Kasei needles, RB, et al. Sham device v inert pill: randomised con-
Japan; 25, 30 mm needles, 10 wk of random
trolled trial of two placebo treatments. BMJ. 2006;18(7538):391-397.
Carbo needles, China 16 mm depth assignment),
42. Park J, White AR, Ernst E. New sham method in auricular acupuncture. Arch Intern
Med. 2001;161(6):894; author reply 895.
after 4, 6, 9, 12
43. Streitberger K, Kleinhenz J. Introducing a placebo needle into acupuncture research. Lancet. mo of random
1998;352(9125):364-365. assignment
44. White P, Lewith G, Hopwood V, Prescott P. The placebo needle, is it a valid and con-
vincing placebo for use in acupuncture trials? A randomised, single-blind, cross-over
pilot trial. Pain. 2003;106(3):401-409.
45. Park J. Sham needle control needs careful approach. Pain. 2004;109(1-2):195-196.
After 30
46. Streitberger K,0.35x50
Vickers mm A. Placebo in Electrical;
acupuncture NRtrials.
Benazepril Exercise, dietet-
Pain. 2004;109(1-2):195; 56 (32) Benazepril, exercise, NR BP ET
Deqi author reply 197-199. ic treatment dietetic treatment
47. Kaptchuk
After 30 TJ, Kelley
0.25x40JM, mm
Conboy LA, et Manual;
al. Components
A ofNo
placebo effect: randomised
No 28 (daily) Metoprolol NR BP, BP change After 5 d of
Deqi controlled trial stainlessin steel
patients with irritable bowel syndrome. BMJ. magnitude treatment
2008;336(7651):999-1003.
NR 30 EB, Webb
48. Dennehy 0.25x25~50
A, Suppes mm, Manual;
T. Assessment NR in the
of beliefs Used or not of acupunc-
effectiveness No 42 (22) Invasive sham Described ABPM, BP ET, after 3, 6 mo
ture for treatmentShenzhou needles,
of psychiatric symptoms. J Altern Compl Med. 2002;8(4):421-425. acupuncture change of treatment
49. Pittler MH, Abbot chinaNC, Harkness EF, Ernst E. Location bias in controlled clinical trials magnitude
of complementary/alternative therapies. J Clin Epidemiol. 2000;53(5):485-489.
50. Pham B, Klassen TP, Lawson ML, Moher D. Language of publication restrictions in sys-
After 30 NR Manual; E No No 30 (daily) Enalapril maleate NR BP After 5d of
tematic reviews gave different results depending on whether the intervention was con-
Deqi ventional or complementary. J Clin Epidemiol. 2005;58(8):769-776. treatment
NR 30
51. MacPherson H,0.3x40
White mm A, Cummings M,Manual;
Jobst K,ERose K, Amlodipine
Niemtzow R; STandards Wrist-ankle
for 20 (daily) Amlodipine NR ABPM, BP change ET
Reporting Interventions in Controlled Trails of Acupuncture. Standards for reporting acupuncture magnitude
interventions in controlled trials of acupuncture: The STRICTA recommendations.
After STandards
30 0.3x40 mm
for Reporting Interventions Manual; A Trails
in Controlled Captopril No
of Acupuncture. Acupunct 28 (daily) Captopril NR BP ET
Deqi Med. 2002;20(1):22-25.
After 20 No. 28, Huatuopian Manual; B No No 7 (daily) Captopril NR ABPM ET
Deqi needles, China
After No reten- NR Manual; G Used Auricular acu- 56 (17) Noninvasive sham NR BP, BP change ET, after 4 wk of
Deqi tion puncture, exer- acupuncture magnitude intervention
cise (Park’s sham needle),
antihypertensive
drugs, exercise

the needle; D: twirling, rotating, lifting and thrusting the needle; E: uniform reinforcing-reducing manipulation; F: reinforcing or reducing manipulation; G: twirling the needle.

F ALTERNATIVE THERAPIES, mar/apr 2010, VOL. 16, NO. 2 Acupuncture for Essential Hypertension
TABLE 2 Quality Assessment in Included Trials mmHg, 95% CI fixed -9.16 to -7.60; DBP: -4.54, -5.08 to -4.00)
with no significant heterogeneity (SBP: χ²=1.21, I²=17%; DBP:
Study ID, Year Quality Assessment Items*
(Composite score)
χ²=0.69, I²=0%) (Table 3, Figure 3).
At the treatment’s completion of one trial,32 there was no BP
He XW, 199421 NR,NR,1,NR,NR,NR,1,NR,NR,1,NR (3) measurement; however, the first measurement occurred 3 weeks
Yin ZF, 1994 22
NR,NR,NR,NR,NR,NR,1,NR,NR,1,NR (2) after the treatment’s completion. Acupuncture achieved no sig-
23
nificant effect modification on BP change magnitude compared
Dan Y, 1998 NR,NR,1,NR,NR,NR,1,NR,NR,1,NR (3)
with sham acupuncture (SBP: MD 0.20 mmHg, 95% CI -0.74 to
24
Kraff K, 1999 NR,NR,NR,0.5,NR,NR,1,1,1,1,0 (4.5) 1.14; DBP: 0.00, -1.96 to 1.96) (Table 3).
Chen YF, 2000 25
NR,NR,NR,NR,NR,NR,1,NR,NR,1,NR (2) Another trial35 measured BP at 3 months and 6 months after
26
the treatment’s completion. Acupuncture plus antihypertensive
Jiang XL, 2003 NR,NR,NR,NR,NR,NR,1,NR,NR,1,NR (2)
drugs achieved no significant effect on BP compared with sham
27
Song YM, 2003 NR,NR,NR,NR,0,NR,1,NR,NR,1,NR (2) acupuncture plus hypertensive drug.
28
Wu QM, 2003 1,NR,1,NR,NR,NR,1,NR,NR,1,NR (4)
29
Low-quality Trials
Zhao DJ, 2003 1,NR,1,NR,NR,NR,1,NR,NR,1,NR (4)
Five subgroups were analyzed based on methodological
Hu LH, 200430 NR,NR,1,NR,NR,NR,1,NR,NR,1,NR (3) variables of acupuncture arms and control arms. The BP
Zhang YL, 200531 NR,NR,1,NR,NR,NR,1,NR,NR,1,NR (3) decreased significantly from baseline with acupuncture plus
antihypertensive drugs than with antihypertensive drugs. The
Macklin EA, 200632 1,1,1,0.5,0,1,1,1,1,0.5,1 (9)
BP-lowering effect of acupuncture plus Chinese herbal medi-
33
Wang C, 2006 NR,NR,1,NR,NR,NR,1,NR,NR,1,NR (3) cine and antihypertensive drug was also significantly higher
Wang LY, 200634 1,NR,1,NR,NR,NR,1,NR,NR,1,NR (4) than that of Chinese herbal medicine plus antihypertensive
drug, whereas, compared with antihypertensive drugs, acu-
Flachskampf FA, 200735 1,NR,1,0.5,0,0,1,1,1,1,1 (7.5)
puncture statistically showed no significant effect modifica-
36
Guo YH, 2007 1,NR,1,NR,NR,NR,1,NR,NR,1,NR (4) tion with statistically significant heterogeneity. Compared
Hu LH, 200737 NR,NR,1,NR,NR,NR,1,NR,NR,1,NR (3) with sham acupuncture, acupuncture showed no significant
effect modification. Compared with the exercise arm, acupunc-
Huang F, 200738 1,NR,1,NR,NR,NR,1,NR,NR,1,NR (4)
ture plus exercise arm also showed no significant effect (Table
Wang X, 200739 NR,NR,1,NR,NR,NR,1,NR,NR,1,NR (3) 3, Figure 2).
Yin C, 200740 1,NR,1,1,NR,1,1,1,1,1,NR (8) In the analysis of BP change magnitude, the efficacy of acu-
puncture was not significant when compared with antihypertensive
*NR indicates not reported. Eleven categories: randomization, allocation con-
drugs. Also, compared with antihypertensive drugs, the efficacy of
cealment, similarity at baseline, blinding for participants, blinding for care
provider, blinding for outcome assessors, similarity of co-interventions, com- acupuncture plus antihypertensive drug was not significant.
pliance in all groups, dropout, timing of outcome assessment, intention-to-
treat analysis. Effect of Acupuncture Using Prescription Adhering to the
Principles of Syndrome Differentiation in TCM Diagnosis
tent with publication bias (Table 3, Figure 2). As for trials using prescription adhering to the principles of
Acupuncture arms achieved significant effect modification syndrome differentiation, we found a significant reduction in BP
on BP change magnitude compared with control arms (SBP: MD with acupuncture arms in comparison with control arms (SBP:
-5.98 mmHg, 95% CI random -9.48 to -2.47; DBP: -3.95, -5.19 to MD -6.46 mmHg, fixed -8.04 to -4.87; DBP: -3.07, -4.17 to -1.96,
-2.72) with a significant heterogeneity (SBP: χ²=67.39, I²=94%; with no significant heterogeneity [SBP: χ²=11.37, I²=12%; DBP:
DBP: χ²=9.65, I²=59%). There was an indication of publication χ²=15.72, I²=36%]). There was no indication of publication bias
bias (Table 3, Figure 3). on inspection of funnel plots for asymmetry (Table 4, Figure 4).
In contrast, in trials not using prescription adhering to the
High-quality Trials principles of syndrome differentiation, we found no significant
BP was significantly lower with acupuncture plus antihyper- reduction in BP with acupuncture arms in comparison with con-
tensive drugs than with sham acupuncture plus hypertensive trol arms (SBP: MD -1.55 mmHg, random -5.39 to 2.29; DBP:
drugs (SBP: MD -5.72 mmHg, 95% CI fixed -8.77 to -2.68; DBP: -2.12, -4.97 to 0.73), with significant heterogeneity (SBP:
-2.80, -5.07 to -0.54). We found no significant heterogeneity for χ²=39.24, I²=82%; DBP: χ²=43.64, I²=84%). There was an indica-
this outcome (SBP: χ²=0.38, I²=0%; DBP: χ²=0.66, I²=0%) (Table tion of publication bias (Table 4, Figure 5).
3, Figure 2).
Acupuncture plus antihypertensive drugs achieved signifi- Adverse Effects of Acupuncture
cant effect modification on BP change magnitude compared with In only three trials35,39,40 were adverse effects discussed. In
sham acupuncture plus hypertensive drugs (SBP: MD -8.38 those trials, no serious adverse effects associated with acupunc-

Acupuncture for Essential Hypertension ALTERNATIVE THERAPIES, mar/apr 2010, VOL. 16, NO. 2 G
TABLE 3 Efficacy of Acupuncture on Blood Pressure
Systolic Blood Pressure (mmHg) Diastolic Blood Pressure (mmHg)
Comparisons Participants Mean difference† P Heterogeneity Mean difference† P Heterogeneity
Sub-groups (n) (n) (95% CI, Fixed) value‡ P value‡ (95% CI, Fixed) value‡ P value‡

Blood pressure21,22,23,24,25,26,27,28,29,30,31,33,34,35,36,37,38,39,40 19 1336 -4.23[-6.47,-1.99]§ <.001 <.001 -2.53[-3.99,-1.08]§ <.001 <.001


35,40
High-quality trials ACHD vs SAHD 2 170 -5.72[-8.77,-2.68] <.001 .54 -2.80[-5.07,-0.54] .02 .42
Low-quality trials AC vs SA24 1 10 -5.00[-12.80,2.80] .21 — -0.50[-4.59,3.59] .81 —
AC vs HD21,22,23,25,28,34,36,39 8 596 0.35[-2.75,3.45]§ .83 .003 -0.05[-2.03,1.94]§ .96 .02
ACHD vs HD26,30,31,33,37,38 6 404 -7.48[-9.44,-5.52] <.001 .70 -4.39[-6.57,-2.20]§ <.001 .02
ACCHHD vs CHHD27 1 96 -10.50[-14.75,-6.25] <.001 — -8.30[-11.82,-4.78] <.001 —
AC plus exercise vs 1 60 -11.00[-28.00,6.00] .20 — -7.50[-15.03,0.03] .05 —
Exercise29
High-quality trials:
3 months after treatment ACHD vs SAHD35 1 140 -2.00[-5.98,1.98] .32 — 0.00[-3.01,3.01] 1.00 —
6 months after treatment ACHD vs SAHD35 1 140 2.00[-2.31,6.31] .36 — 0.00[-2.82,2.82] 1.00 —

Blood pressure change magnitude21,34,35,37,40 5 338 -5.98[-9.48,-2.47]§ <.001 <.001 -3.95[-5.19,-2.72]§ <.001 .05
35,40
High-quality trials ACHD vs SAHD 2 170 -8.38[-9.16,-7.60] <.001 .27 -4.54[-5.08,-4.00] <.001 .41
Low-quality trials AC vs HD21,34 2 108 -4.41[-10.39,1.56]§ .15 <.00001 -2.27[-6.94,2.41]§ .34 .009
ACHD vs HD37 1 60 -2.30[-6.14,1.54] .24 — -2.70[-6.13,0.73] .12 —
High-quality trials:
3 weeks after treatment AC vs SA32 2 188 0.20[-0.74,1.14] .68 1.00 -0.00[-1.96,1.96]§ 1.00 <0.001
*AC indicates acupuncture; SA, sham acupuncture; HD, antihypertensive drug; ACHD, acupuncture plus antihypertensive drug; SAHD, sham acupuncture plus anti-
hypertensive drug; CHHD, Chinese herbal medicine plus antihypertensive drug; ACCHHD, acupuncture plus Chinese herbal medicine and antihypertensive drug.
†Values<0 favor acupuncture; values>0 favor control.
‡ANOVA P value for difference across groups.
§Random-effect model.

ture were reported. The minor adverse effects observed were ples of syndrome differentiation lowered BP in essential hyper-
temporary: spot bleeding, feeling of pain in the skin-puncture tension, whereas the acupuncture therapy not using prescription
site, and some patients, temporary giddiness. adhering to the principles of syndrome differentiation did not.
These findings have limitations, however.
DISCUSSION
Main Findings Strengths and Weaknesses of Included Trials
Blood Pressure–lowering Effect The majority of trials evaluated failed to specify many fac-
Although limited rigorous trials preclude definitive conclu- tors: whether allocation was concealed, randomization was ade-
sions, this meta-analysis found that acupuncture therapy is asso- quate, outcome assessors were blinded, lost follow-up was
ciated with BP-lowering benefits in essential hypertension. One described completely, or whether data were analyzed on an
trial35 had a significant BP-lowering effect at the endpoint; how- intention-to-treat basis.
ever, the effect had disappeared at 3 months after the treatment’s Only four trials24,32,35,40 described the methods of blinding and
completion. In another active trial,32 the BP measured 3 weeks randomization used. One trial had different clinicians perform
after the treatment’s completion was indistinguishable from that diagnosis, acupuncture treatment, and outcomes assessment.32
associated with sham treatment. The benefit potentially could Another trial separated patients based on a language barrier
not be explained by durability effect as hypertension is typically between clinicians and patients.35 Although these two trials
a chronic and discrete condition. In addition, the treatment sought isolating methods that may have overcome any potential
application of one term was too short, and sessions were too bias attributable to clinician expectations, doing so is problemat-
infrequent for conclusion. ic. There is only a slim chance that the care provider may be
blinded to treatment assignments in acupuncture clinical trials
Effect of Prescription Adhering to the Principles of Syndrome because the acupuncturist can generally distinguish whether he or
Differentiation in TCM Diagnosis she is using sham needles and nonacupoints. Acupuncture is
The process of diagnosis in TCM is based on an understand- known to be associated with behaviors embedded in medical ritu-
ing of the imbalance between the forces of yin and yang and syn- als.41 In addition, we think that a clinician should be motivated
drome differentiation.11 This meta-analysis found that the primarily to perform a successful procedure for all patients rather
acupuncture therapy using prescription adhering to the princi- than to show that acupuncture is an effective adjuvant procedure

H ALTERNATIVE THERAPIES, mar/apr 2010, VOL. 16, NO. 2 Acupuncture for Essential Hypertension
FIGURE 2 Efficacy of Acupuncture on Blood Pressure
Systolic Blood Pressure (SBP)
Systolic Blood Pressure (SBP) Acupuncture Control Mean Difference Mean Difference
Study or Subgroup Mean SD Total Mean SD Total Weight IV, Random, 95% Cl IV, Random, 95% Cl
1.1.1 ACHD vs SAHD (high-quality trials)
Flachskampf FA, 2007 125.0 12.0 72 130.0 11.0 68 6.70% -5.00 [-8.81, -1.19]
Yin C, 2007 122.1 6.6 15 129.1 7.5 15 5.80% -7.00 [-12.06, -1.94]
Subtotal (95% CI) 87 83 12.50% -5.72 [-8.77, -2.68]
Heterogeneity: Tau²=0.00; chi²=0.38, df=1 (P=.54); I²=0%
Test for overall effect: Z=3.69 (P=.0002)
1.1.2 AC vs SA
Kraft K, 1999 142.0 7.0 5 147 5.5 5 4.10% -5.00 [-12.80, 2.80]
Subtotal (95% CI) 5 5 4.10% -5.00 [-12.80, 2.80]
Heterogeneity: Not applicable
Test for overall effect: Z=1.26 (P=.21)
1.1.3 AC vs HD
Chen YF, 2000 135.6 12.4 35 129 11 35 5.50% 6.60 [1.11, 12.09]
Dan Y, 1998 128.1 12.8 26 128 12 26 4.70% 0.10 [-6.64, 6.84]
Guo YH, 2007 138.7 9.0 40 133.4 9.6 40 6.50% 5.30 [1.22, 9.38]
He XW, 1994 144.2 31.1 18 143.7 15.4 30 1.70% 0.50 [-14.89, 15.89]
Wang LY, 2006 162.2 3.5 30 164.4 3.6 30 7.80% -2.20 [-4.00, -0.40]
Wang X, 2007 116.3 11.9 65 119 13.6 63 6.20% -2.70 [-7.13, 1.73]
Wu QM, 2003 145.7 16.5 40 144 17 40 4.40% 1.70 [-5.64, 9.04]
Yin ZF, 1994 136.5 11.9 48 142 13 30 5.40% -5.50 [-11.24, 0.24]
Subtotal (95% CI) 302 294 42.20% 0.35 [-2.75, 3.45]
Heterogeneity: Tau²=11.60; chi²=21.72, df=7 (P=.003); I²=68%
Test for overall effect: Z=0.22 (P=.83)
1.1.4 ACHD vs HD
Hu LH, 2004 129.0 8.0 45 135.0 9.0 45 6.90% -6.00 [-9.52, -2.48]
Hu LH, 2007 131.8 9.6 30 137.3 9.8 30 5.90% -5.50 [-10.41, -0.59]
Huang F, 2007 128.9 13.1 30 140.0 18.0 30 4.00% -11.10 [-19.07, -3.13]
Jiang XL, 2003 137.6 16.1 30 145.1 9.2 30 4.80% -7.50 [-14.14, -0.86]
Wang C, 2006 126.1 7.7 30 134.7 6.5 29 6.80% -8.60 [-12.23, -4.97]
Zhang YL, 2005 127.8 13.3 45 137.7 14.1 30 5.00% -9.90 [-16.27, -3.53]
Subtotal (95% CI) 210 194 33.40% -7.48 [-9.44, -5.52]
Heterogeneity: Tau²=0.00; chi²=3.02, df=5 (P=.70); I²=0%
Test for overall effect: Z=7.49 (P<.00001)
1.1.5 ACCHHD vs CHHD
Song YM, 2003 126.8 9.0 64 137.3 10.5 32 6.40% -10.50 [-14.75, -6.25]
Subtotal (95% CI) 64 32 6.40% -10.50 [-14.75, -6.25]
Heterogeneity: Not applicable
Test for overall effect: Z=4.84 (P<.00001)
1.1.6 AC plus exercise vs Exercise
Zhao DJ, 2003 129.0 36.0 30 140.0 31.0 30 1.40% -11.00 [-28.00, 6.00]
Subtotal (95% CI) 30 30 1.40% -11.00 [-28.00, 6.00]
Heterogeneity: Not applicable
Test for overall effect: Z=1.27 (P=.20)
Total (95% CI) 698 638 100% -4.23 [-6.47, -1.99]
Heterogeneity: Tau²=15.84; chi²=69.11, df=18 (P<.00001); I²=74% -20 -10 0 10 20
Favors Favors
Test for overall effect: Z=3.70 (P=.0002) acupuncture control

Acupuncture for Essential Hypertension ALTERNATIVE THERAPIES, mar/apr 2010, VOL. 16, NO. 2 I
FIGURE 3 Efficacy of Acupuncture on Blood Pressure Change Magnitude
3.1 Systolic Blood Pressure (SBP)
Systolic Blood Pressure (SBP) Acupuncture Control Mean Difference Mean Difference
Study or Subgroup Mean SD Total Mean SD Total Weight IV, Random, 95% Cl IV, Random, 95% Cl

2.1.1 ACHD vs SAHD (High quality trials)


Flachskampf FA, 2007 -6.5 2.3 72 1.8 2.5 68 22.50% -8.30 [-9.10, -7.50]
Yin C, 2007 -14.8 5.5 15 -4.0 6.7 15 16.80% -10.80 [-15.19, -6.41]
Subtotal (95% CI) 87 83 39.30% -8.58 [-10.13, -7.03]
Heterogeneity: Tau2=0.54; chi2=1.21, df=1 (P=.27); I2=17%
Test for overall effect: Z=10.86 (P<.00001)
2.1.2 AC vs HD
He XW, 1994 -27.2 3.8 18 -19.7 3.0 30 21.10% -7.50 [-9.56, -5.44]
Wang LY, 2006 -13.7 2.4 30 -12.3 3.7 30 21.80% -1.40 [-2.98, 0.18]
Subtotal (95% CI) 48 60 42.80% -4.41 [-10.39, 1.56]
Heterogeneity: Tau2=17.73; Chi2=21.26, df=1 (P<.00001); I2=95%
Test for overall effect: Z=1.45 (P=.15)
2.1.3 ACHD vs HD
Hu LH, 2007 -15.6 8.6 30 -13.3 6.4 30 17.90% -2.30 [-6.14, 1.54]
Subtotal (95% CI) 30 30 17.90% -2.30 [-6.14, 1.54]
Heterogeneity: Not applicable
Test for overall effect: Z=1.18 (P=.24)
Total (95% CI) 165 173 100% -5.98 [-9.48, -2.47]
Heterogeneity: Tau2=14.07; chi2=67.39, df=4 (P<.00001); I2=94%
-20 -10 0 10 20
Test for overall effect: Z=3.34 (P=.0008) Favors Favors
acupuncture control
3.2 Diastolic Blood Pressure (DBP)
Diastolic Blood Pressure (DBP) Acupuncture Control Mean Difference Mean Difference
Study or Subgroup Mean SD Total Mean SD Total Weight IV,Random, 95% Cl IV, Random, 95% Cl

2.2.1 ACHD vs SAHD (High quality trials)


Yin C, 2007 -6.9 3.7 15 -1.1 4.7 15 11.90% -5.80 [-8.83, -2.77]
Flachskampf FA, 2007 -3.8 1.6 72 0.7 1.7 68 38.70% -4.50 [-5.05, -3.95]
Subtotal (95% CI) 87 83 50.60% -4.54 [-5.08, -4.00]
Heterogeneity: Tau2=0.00; chi2=0.69, df=1 (P=.41); I2=0%
Test for overall effect: Z=16.52 (P<.00001)
2.2.2 AC vs HD
He XW, 1994 -16.4 2.3 18 -12.0 1.8 30 29.40% -4.40 [-5.64, -3.16]
Wang LY, 2006 -6.8 7.2 30 -7.2 6.1 30 10.10% 0.40 [-2.98, 3.78]
Subtotal (95% CI) 48 60 39.50% -2.27 [-6.94, 2.41]
Heterogeneity: Tau2=9.83; chi2=6.84, df=1 (P=.009); I2=85%
Test for overall effect: Z=0.95 (P=.34)
2.2.3 ACHD vs HD
Hu LH, 2007 -9.5 8.3 30 -6.8 4.8 30 9.90% -2.70 [-6.13, 0.73]
Subtotal (95% CI) 30 30 9.90% -2.70 [-6.13, 0.73]
Heterogeneity: Not applicable
Test for overall effect: Z=1.54 (P=.12)
Total (95% CI) 165 173 100.00% -3.95 [-5.19, -2.72]
Heterogeneity: Tau2=0.95; chi2=9.65, df=4 (P=.05); I2=59% 10 20
-20 -10 0
Test for overall effect: Z=6.27 (P<.00001) Favors Favors
acupuncture control

J ALTERNATIVE THERAPIES, mar/apr 2010, VOL. 16, NO. 2 Acupuncture for Essential Hypertension
TABLE 4 Effect of Acupuncture Using Prescription Adhering to the Principles of “Syndrome Differentiation” in TCM Diagnosis
Systolic Blood Pressure (mmHg) Diastolic Blood Pressure (mmHg)

Comparisons Participants Mean difference* Heterogeneity Mean difference* Heterogeneity


Subgroups (n) (n) (95% CI, Fixed) P value† P value† (95% CI, Fixed) P value† P value†
Prescription adhering to the principles of syndrome differentiation
Blood
pressure21,22,23,24,27,30,31,35,37,38,40 11 739 -6.46 [-8.04,-4.87] <.001 .33 -3.07 [-4.17,-1.96] <.001 .11
Blood pressure change
magnitude21,35,37,40 4 278 -7.37 [-9.60,-5.14]‡ <.001 .01 -4.48 [-4.97,-3.99] <.001 .62
Prescription not adhering to the principles of syndrome differentiation
Blood pressure25,26,28,29,33,34,36,39 8 597 -1.55 [-5.39,2.29]‡ .43 <.001 -2.12 [-4.97,0.73]‡ .15 <.001
Blood pressure change
magnitude34 1 60 -1.40 [-2.98,0.18] .08 — 0.40 [-2.98,3.78] .82 —
*Values<0 favor acupuncture; values>0 favor control.
†ANOVA P value for difference across groups.
‡Random-effect model.

in the field. Therefore, it seems better in reality that the diagnos- Twenty-four-hour ambulatory blood pressure monitoring
ing procedure for selection of the acupuncture formula is left up (APBM) devices were used for measurement in six out of the 20
to the clinician who will conduct the acupuncture. trials. In the measurement of BP, the improvements for future
Three trials24,32,35 used an invasive sham acupuncture tech- study include using ABPM devices to obtain more accurate
nique that involved the insertion of a similar number of needles at recordings of dynamic changes within a 24-hour period.
a similar depth but at nonacupoints. On the other hand, one trial40
used noninvasive sham acupuncture with a needle device that Limitations
works like a retractable magic sword: the needle appears to be pen- This systematic review is to assess the BP-lowering effect of
etrating the skin, and the patient sees and feels a sensation of nee- acupuncture in treatment of essential hypertension with a com-
dle penetration, but the needle is actually retracted up the needle prehensive search and is the first to assess the difference between
shaft.42,43 In the majority of acupuncture clinical research, sham the effects of prescription adhering to the principles of syndrome
acupuncture differs only minimally from active acupuncture and differentiation usage and nonusage.
may expose subjects to a degree of risk similar to that of the active The main limitation of this review was the paucity of high-
procedure.44 The invention and application of sham-acupuncture quality RCTs. Three rigorous trials were published in English
devices have greatly enhanced the quality of acupuncture clinical journals, whereas most of the trials using inadequate methodolo-
research. Although many debates still exist on whether such nee- gy were published in Chinese journals. In the complementary
dles are the best control for an RCT of acupuncture,45,46 noninvasive and alternative medicine field, 1 study49 found that trials pub-
sham acupuncture seems to be more distinguishable from genuine lished in low–impact factor or non–impact factor journals were
acupuncture than invasive sham acupuncture.42,43,47 more likely to report positive results than those published in
The frequency of sessions in acupuncture therapy varies high-impact mainstream medical journals and that the quality of
according to cultural and geographical differences in addition to the trials was also associated with the journal of publication.
issues of time and cost. Almost all trials published in China had Poor-quality trials generally had less precise estimates of effect
treatments delivered daily, whereas trials in other locations deliv- and tended to overestimate the effect. High-quality trials have
ered treatment with lesser frequency. been defined as research that is carried out in a way that allows
One trial48 assessing the efficacy of acupuncture for both readers to trust the results50 with subgroup analyses being per-
physical and psychiatric symptoms and conditions demonstrated formed separately.
that beliefs or expectations could exert a powerful influence on Another limitation is “included heterogeneity.” Substantial
treatment effects. One40 of the included trials assessed this using heterogeneity is indicated by the fact that the control interven-
a subjective measurement with a value on the anticipation/satis- tions differed across trials. This heterogeneity is probably caused
faction scale. This increased only in real acupuncture therapy, by differential formula of sham needles or differential selection
corresponding to the period when the BP-lowering effect of acu- of antihypertensive medications across trials. The selected acu-
puncture was prominent. This study shows that even if psycho- points were not similar across trials, and the number of used
social benefits have existed in the treatment, it is still based on acupoints differed greatly across trials. Also, the duration of
the efficacy of acupuncture. treatment and frequency of sessions differed across trials.

Acupuncture for Essential Hypertension ALTERNATIVE THERAPIES, mar/apr 2010, VOL. 16, NO. 2 K
FIGURE 4 Effect of Acupuncture Using Prescription Adhering to the Principles of “Syndrome Differentiation” in TCM Diagnosis
FIGURE 4-1 Systolic Blood Pressure (SBP)
Systolic blood pressure (SBP) Acupuncture Control Mean Difference Mean Difference
Study or Subgroup Mean SD Total Mean SD Total Weight IV, Random, 95% Cl IV, Random, 95% Cl
3.1.1 Blood pressure
He XW, 1994 144.2 31.1 18 143.7 15.4 30 0.20% 0.50 [-14.89, 15.89]
Yin ZF, 1994 136.5 11.9 48 142 13 30 1.30% -5.50 [-11.24, 0.24]
Dan Y, 1998 128.1 12.8 26 128 12 26 0.90% 0.10 [-6.64, 6.84]
Kraft K, 1999 142 7 5 147 5.5 5 0.70% -5.00 [-12.80, 2.80]
Song YM, 2003 126.8 9 64 137.3 10.5 32 2.40% -10.50 [-14.75, -6.25]
Hu LH, 2004 129 8 45 135 9 45 3.50% -6.00 [-9.52, -2.48]
Zhang YL, 2005 127.8 13.3 45 137.7 14.1 30 1.10% -9.90 [-16.27, -3.53]
Hu LH, 2007 131.8 9.6 30 137.3 9.8 30 1.80% -5.50 [-10.41, -0.59]
Yin C, 2007 122.1 6.6 15 129.1 7.5 15 1.70% -7.00 [-12.06, -1.94]
Flachskampf FA, 2007 125 12 72 130 11 68 3.00% -5.00 [-8.81, -1.19]
Huang F, 2007 128.9 13.1 30 140 18 30 0.70% -11.10 [-19.07, -3.13]
Subtotal (95% CI) 398 341 17.10% -6.46 [-8.04, -4.87]
Heterogeneity: chi2=11.37, df=10 (P=.33); I2=12%
Test for overall effect: Z=7.99 (P<.00001)
3.1.2 Blood pressure change magnitude
He XW, 1994 -27.2 3.8 18 -19.7 3 30 10.10% -7.50 [-9.56, -5.44]
Hu LH, 2007 -15.6 8.6 30 -13.3 6.4 30 2.90% -2.30 [-6.14, 1.54]
Yin C, 2007 -14.8 5.5 15 -4 6.7 15 2.20% -10.80 [-15.19, -6.41]
Flachskampf FA, 2007 -6.5 2.3 72 1.8 2.5 68 67.60% -8.30 [-9.10, -7.50]
Subtotal (95% CI) 135 143 82.90% -8.06 [-8.78, -7.34]
Heterogeneity: hi2=10.79, df=3 (P=.01); I2=72%
Test for overall effect: Z=21.94 (P<.00001)
Total (95% CI) 533 484 100.00% -7.78 [-8.44, -7.13]
Heterogeneity: chi2=25.43, df=14 (P=.03); I2=45% -20 -10 0 10 20
Test for overall effect: Z=23.28 (P<.00001) Favors Favors
acupuncture control
FIGURE 4-2 Diastolic Blood Pressure (DBP)
Diastolic blood pressure (DBP) Acupuncture Control Mean Difference Mean Difference
Study or Subgroup Mean SD Total Mean SD Total Weight IV, Random, 95% Cl IV, Random, 95% Cl
3.2.1 Blood pressure
He XW, 1994 87 12 18 87.2 8.3 30 0.50% -0.20 [-6.49, 6.09]
Yin ZF, 1994 90 10 48 91.6 11.4 30 0.80% -1.60 [-6.56, 3.36]
Dan Y, 1998 84 8.2 26 84.1 8.6 26 1.00% -0.10 [-4.67, 4.47]
Kraft K, 1999 91.5 2.9 5 92 3.65 5 1.20% -0.50 [-4.59, 3.59]
Song YM, 2003 75 8.3 64 83.3 8.3 32 1.60% -8.30 [-11.82, -4.78]
Hu LH, 2004 80 6 45 83 7 45 2.80% -3.00 [-5.69, -0.31]
Zhang YL, 2005 75 7.4 45 77.8 8.4 30 1.50% -2.80 [-6.50, 0.90]
Hu LH, 2007 72 6.9 30 77.2 6.2 30 1.80% -5.20 [-8.52, -1.88]
Yin C, 2007 76.8 5.2 15 80.7 4.5 15 1.70% -3.90 [-7.38, -0.42]
Huang F, 2007 81 7.2 30 82.5 7.8 30 1.40% -1.50 [-5.30, 2.30]
Flachskampf FA, 2007 78 9 72 80 9 68 2.20% -2.00 [-4.98, 0.98]
Subtotal (95% CI) 398 341 16.40% -3.07 [-4.17, -1.96]
Heterogeneity: chi2=15.72, df=10 (P=.11); I2=36%
Test for overall effect: Z=5.44 (P<.00001)
3.2.2 Blood pressure change magnitude
He XW, 1994 -16.4 2.3 18 -12 1.8 30 13.00% -4.40 [-5.64, -3.16]
Flachskampf FA, 2007 -3.8 1.6 72 0.7 1.7 68 66.70% -4.50 [-5.05, -3.95]
Yin C, 2007 -6.9 3.7 15 -1.1 4.7 15 2.20% -5.80 [-8.83, -2.77]
Hu LH, 2007 -9.5 8.3 30 -6.8 4.8 30 1.70% -2.70 [-6.13, 0.73]
Subtotal (95% CI) 135 143 83.60% -4.48 [-4.97, -3.99]
Heterogeneity: chi2=1.79, df=3 (P=.62); I2=0%
Test for overall effect: Z=17.95 (P<.00001)
Total (95% CI) 533 484 100.00% -4.25 [-4.70, -3.80]
Heterogeneity: chi2=22.79, df=14 (P=.06); I2=39%
Test for overall effect: Z=18.62 (P<.00001) -20 -10 0 10 20
Favors Favors
acupuncture control

L ALTERNATIVE THERAPIES, mar/apr 2010, VOL. 16, NO. 2 Acupuncture for Essential Hypertension
FIGURE 5 Effect of Acupuncture Using Prescription Not Adhering to the Principles of “Syndrome Differentiation” in TCM Diagnosis
FIGURE 5-1 Systolic Blood Pressure (SBP)
Systolic blood pressure (SBP) Acupuncture Control Mean Difference Mean Difference
Study or Subgroup Mean SD Total Mean SD Total Weight IV, Random, 95% Cl IV, Random, 95% Cl
4.1.1 Blood pressure
Chen YF, 2000 135.6 12.4 35 129 11 35 10.40% 6.60 [1.11, 12.09]
Wu QM, 2003 145.7 16.5 40 144 17 40 7.90% 1.70 [-5.64, 9.04]
Jiang XL, 2003 137.6 16.1 30 145.1 9.2 30 8.80% -7.50 [-14.14, -0.86]
Zhao DJ, 2003 129 36 30 140 31 30 2.30% -11.00 [-28.00, 6.00]
Wang C, 2006 126.1 7.7 30 134.7 6.5 29 13.40% -8.60 [-12.23, -4.97]
Wang LY, 2006 162.2 3.5 30 164.4 3.6 30 16.20% -2.20 [-4.00, -0.40]
Wang X, 2007 116.3 11.9 65 119 13.6 63 12.10% -2.70 [-7.13, 1.73]
Guo YH, 2007 138.7 9 40 133.4 9.6 40 12.60% 5.30 [1.22, 9.38]
Subtotal (95% CI) 300 297 83.60% -1.55 [-5.39, 2.29]
Heterogeneity: Tau2=21.90; chi2=39.24, df=7 (P<.00001); I2=82%
Test for overall effect: Z=0.79 (P=.43)
4.1.2 Blood pressure change magnitude
Wang LY, 2006 -13.7 2.4 30 -12.3 3.7 30 16.40% -1.40 [-2.98, 0.18]
Subtotal (95% CI) 30 30 16.40% -1.40 [-2.98, 0.18]
Heterogeneity: Not applicable
Test for overall effect: Z=1.74 (P=.08)
Total (95% CI) 330 327 100.00% -1.49 [-4.28, 1.31]
Heterogeneity: Tau2=11.74; chi2=39.50, df=8 (P<.00001); I2=80% -20 -10 0 10 20
Favors Favors
Test for overall effect: Z=1.04 (P=.30) acupuncture control
FIGURE 5-2. Diastolic Blood Pressure (DBP)
Diastolic blood pressure (DBP) Acupuncture Control Mean Difference Mean Difference
Study or Subgroup Mean SD Total Mean SD Total Weight IV, Random, 95% Cl IV, Random, 95% Cl
4.2.1 Blood pressure
Chen YF, 2000 78 8.5 35 75.3 8.5 35 10.70% 2.70 [-1.28, 6.68]
Wu QM, 2003 84 10 40 85.4 9.9 40 10.20% -1.40 [-5.76, 2.96]
Zhao DJ, 2003 81 12 30 88.5 17.3 30 6.50% -7.50 [-15.03, 0.03]
Jiang XL, 2003 76 5.7 30 85.1 5.9 30 12.10% -9.10 [-12.04, -6.16]
Wang C, 2006 83 6.1 30 87.1 5.4 29 12.10% -4.10 [-7.04, -1.16]
Wang LY, 2006 92 3.3 30 95 2.9 30 13.70% -3.00 [-4.57, -1.43]
Guo YH, 2007 85.3 7.8 40 84 6.6 40 11.80% 1.30 [-1.87, 4.47]
Wang X, 2007 76 11 65 73.1 9.7 63 11.30% 2.90 [-0.69, 6.49]
Subtotal (95% CI) 300 297 88.40% -2.12 [-4.97, 0.73]
Heterogeneity: Tau2=13.22; cChi2=43.64, df=7 (P<.00001); I2=84%
Test for overall effect: Z=1.46 (P=.15)
4.2.2 Blood pressure change magnitude
Wang, LY 2006 -6.8 7.2 30 -7.2 6.1 30 11.60% 0.40 [-2.98, 3.78]
Subtotal (95% CI) 30 30 11.60% 0.40 [-2.98, 3.78]
Heterogeneity: Not applicable
Test for overall effect: Z=0.23 (P=.82)
Total (95% CI) 330 327 100.00% -1.82 [-4.42, 0.77]
Heterogeneity: Tau =12.16; chi =46.35, df=8 (P<.00001); I2=83%
2 2
-20 -10 0 10 20
Test for overall effect: Z=1.38 (P=.17) Favors Favors
acupuncture control

Acupuncture for Essential Hypertension ALTERNATIVE THERAPIES, mar/apr 2010, VOL. 16, NO. 2 M
Although we conducted extensive searches to identify relevant
studies, the funnel plots showed asymmetry consistent with pub-
lic bias. We cannot rule out the possibility that small, negative
studies were not identified or were unpublished.

CONCLUSIONS
Although current estimates of the efficacy of acupuncture on
essential hypertension are significant, as there is a relative paucity
of rigorous trials and even those have mixed results, these find-
ings have limitations. Further, more rigorously designed studies
are necessary, and more serious consideration should be given
regarding the specific character of acupuncture therapy.51

Acknowledgment
This meta-analysis was supported by National Basic Research Program of China (973 Program,
grant number 2005CB523308).

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