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Acupunture For Esential HT
Acupunture For Esential HT
Review
a r t i c l e
i n f o
Article history:
Received 24 July 2013
Accepted 2 September 2013
Available online 6 September 2013
Keywords:
Acupuncture
Blood pressure
Hypertension
Systematic review
a b s t r a c t
Background: To systematically assess the current clinical evidence of acupuncture for hypertension.
Search strategy: The PubMed, EMBASE, Chinese Biomedical Literature Database (CBM), Chinese National Knowledge Infrastructure (CNKI), Chinese Scientic Journal Database (VIP), and Wan-fang Data in the Cochrane Library
were searched until January, 2013. All the randomized controlled trials (RCTs) based on acupuncture compared
with western medicine, sham acupuncture or lifestyle intervention in patients with hypertension were included.
RCTs were included as well as combined acupuncture with western medicine compared with western medicine.
In addition, RCTs based on acupuncture compared with sham acupuncture combined with western medicine
in patients with essential hypertension were included. No language restriction was used. Review Manager 5.1
software was used for data analysis. Study selection, data extraction, quality assessment, and data analyses
were conducted according to the Cochrane standards.
Results: 35 randomized trials (involving 2539 patients) were included. The methodological quality of the included
trials was evaluated as generally low. Two trials reported the effect of acupuncture compared with sham acupuncture in combinations of western medicine. Acupuncture signicantly reduced SBP (7.47 mm Hg, 95% CI 10.43
to 4.5, P b 0.00001) and DBP (4.22 mm Hg, 95% CI 6.26 to 2.18, P b 0.0001) and no heterogeneity between
studies was detected. However, other studies had substantial heterogeneity due to the quality of them was poor, and
their sample sizes were not satisfactory as an equivalence study. Five trials described the adverse effects.
Conclusions: While there are some evidences that suggest potential effectiveness of acupuncture for hypertension,
the results were limited by the methodological aws of the studies. Therefore, further thorough investigation,
large-scale, proper study designed, randomized trials of acupuncture for hypertension will be required to justify
the effects reported here.
2013 The Authors. Published by Elsevier Ireland Ltd. Open access under CC BY-NC-ND license.
1. Introduction
Hypertension is a well-recognized risk factor for cardiovascular disease and stroke, which are the most frequent cause of deaths all over
the world [1,2]. It has been estimated that 29% of the world's adult
population, or 1.56 billion people, will have hypertension by the
year of 2025 [3]. Essential hypertension (EH), a complex disease,
which accounts for 95% of hypertensive cases, is an increasingly serious
worldwide public-health challenge and is generally considered as a paradigmatic multi-factorial disease that is determined by a combination of
genetic factors, environmental stimuli and their interaction [4,5]. The
prevention and management of hypertension are major public health
0167-5273 2013 The Authors. Published by Elsevier Ireland Ltd. Open access under CC BY-NC-ND license.
http://dx.doi.org/10.1016/j.ijcard.2013.09.001
318
Chinese health-care system for at least 2500 years and is widely practiced in the United States [18]. Acupuncture is based on the TCM concept
that there are channels (or meridians) of energy ow (qi) within
the body that help maintain the health of the individual and that disease and pain result from imbalances of qi [19]. Acupuncture as a
nonpharmacological intervention has been used to treat a wide variety
of condition to regulate cardiovascular diseases, and acupuncture therapy is used on patients with mild or borderline hypertension who want
to avoid treatment cost, adverse effects, and complications [20]. Possible mechanisms by which acupuncture reduces blood pressure in
hypertensive patients include decreases in plasma renin, aldosterone
and angiotensin II activity [21,22], increased excretion of sodium and
changes in plasma norepinephrine, serotonin and endorphin levels
[23,24]. Meanwhile, there have been a large number of clinical trials
of acupuncture on hypertension and RCTs [25,26]. In addition, several
reviews claimed that acupuncture has therapeutic effects on blood
pressure in patients with hypertension [27,28]. These reviews are, however, non-systematic and are therefore open to bias. The aim of this
systematic review is to assess randomized clinical trials (RCTs) rigorously testing the effectiveness of acupuncture in human patients with
hypertension.
allocation concealment (selection bias), blinding of participants and personnel (performance bias), blinding of outcome assessment (detection bias), incomplete outcome data
(attrition bias), selective reporting (reporting bias), and other biases. The quality of all the
included trials was categorized to low/unclear/high risk of bias (Yes for a low of bias,
No for a high risk of bias, Unclear otherwise). Then trials were categorized into three
levels: low risk of bias (all the items were in low risk of bias), high risk of bias (at least
one item was in high risk of bias), unclear risk of bias (at least one item was in unclear).
The supporting PRISMA checklist is available as supporting information; see Checklist S1.
2.1. Database and search strategies
Literature searches were conducted in the Cochrane Central Register of Controlled
Trials (CENTRAL) in the Cochrane Library (January, 2013), the PubMed, EMBASE, Chinese
Biomedical Literature Database (CBM), Chinese National Knowledge Infrastructure (CNKI),
Chinese Scientic Journal Database (VIP), Wan-fang Data. Databases in Chinese were
searched to retrieve the maximum possible number of trials of acupuncture for essential
hypertension because acupuncture is mainly used and researched in China. All of those
searches ended on January, 2013. Ongoing registered clinical trials were searched in
the website of international clinical trial registry by U.S. National Institutes of Health
(http://clinicaltrials.gov/). The following search terms were used individually or
combined: hypertension, blood pressure, essential hypertension, acupuncture,
electroacupuncture (EA), clinical trial, and randomized controlled trial. The bibliographies of included studies were searched for additional references.
2.2. Inclusion criteria
All the parallel randomized controlled trials (RCTs) of all the prescriptions based on
acupuncture compared with western medicine, sham acupuncture or lifestyle intervention in patients with hypertension were included. RCTs were included as well, combined
acupuncture with western medicine compared with western medicine. In addition,
RCTs based on acupuncture compared with sham acupuncture combined with western
medicine in patients with essential hypertension were included. Studies were excluded
if they were nonrandomized studies and/or involving other forms of acupuncture such
as transcutaneous electrical nerve stimulation, laser acupuncture. There were no restrictions on population characteristics, language and publication type. The main outcome
measure was blood pressure. Duplicated publications reporting the same groups of participants were excluded.
2.3. Data extraction and quality assessment
Two reviewers (W. Liu, X. J. Xiong) extracted data and evaluated data's quality and
content independently. We conducted data extraction using a standardized procedure.
Initially, abstracts were screened to exclude obviously ineligible reports, and then all
remaining articles were reviewed. We classied trials and abstracts according to patient
characteristics, study design, and therapy duration. Reviewing study design included the
following criteria: methods of sequence generation, allocation concealment, complete
description of those who were blinded, and use of intention-to-treat analysis and whether
the trial was stopped prior to the planned duration, all methodological features in addition
capable of impacting effect sizes. The outcome measures included BP and adverse events.
The data was entered into an electronic database by the two reviewers separately,
avoiding duplicate entries; in the case where the two entries did not match, an inspection
will be conducted, and a third person may be involved for verication. In order to obtain
full information regarding conference abstracts, we had contacted the study authors by
email and/or telephone communication. Disagreement was resolved by discussion and
reached consensus through a third party (J. Wang).
The methodological quality of trials was assessed independently using criteria from
the Cochrane Handbook for Systematic Review of Interventions, Version 5.1.0 (W. Liu,
X. J. Xiong) [29]. The items included random sequence generation (selection bias),
3. Results
3.1. Description of included trials
319
out or withdraw [59]. However, the trial did not intend to analyze the
cause, and no trials used intention-to-treat analysis. None of the trials
had a pre-trial estimation of sample size. Five trails reported information
on follow-up [32,53,59,61,62]. Selective reporting was generally unclear
in the RCTs due to the inaccessibility of the trail protocol.
35 RCTs were included in the group of studies of patients with essential hypertension ([3064]). The effect estimates of acupuncture were
shown in the Figs. 23.
3.3.1. Acupuncture versus western medicine
A total of 19 trials [30,31,33,34,37,41,42,4452,54,55,59] reported
the effect of acupuncture compared with western medicine on hypertension. A change in blood pressure was reported in 11 trials [37,41,
42,44,45,47,48,50,52,54,59] of the included RCTs.
Only 4 independent trials did show better effect: Yang [37] demonstrated that electro-acupuncture on Qu Chi (LI11) and Tai Chong (LR3)
320
Table 1
Characteristics and methodological quality of included studies.
Study ID
Sample (M/F)
Age (yrs)
Diagnosis standard
Intervention
Control
Course (day)
Outcome
measure
T:47.35 11.59
C:48.35 10.64
T:61.4 9.2
C:61.7 9.6
T:61.2
C:63.2
18 to 70
(T/C not reported)
Acupuncture
Acupuncture
Hypertension diagnostic
criteria (unclear)
Hypertension diagnostic
criteria (unclear)
Acupuncture plus
western medicine
Acupuncture
30 (7 days/week;
20 min per day)
10 (30 min per day,
5 days/course)
90 (15 days/course)
BP
Captopril tablets
(25 mg tid)
Nimodipine (40 mg tid)
BP
T:63.2
C:61.5
T:53.62 9. 83
C:52.16 10.04
Acupuncture plus
western medicine
Acupuncture plus
western medicine
Captopril tablets
(12.5 mg bid or tid)
Benzene sulfonic acid
amlodipine piece
(2.5 mg qd)
Captopril tablets
(12.5 mg tid)
90 (once a day,
15 days/course)
28 (20 min per day,
28 days/course)
BP
Benazepril hydrochloride
tablets (10 mg qd)
Left-hand amlodipine
(5 mg qd)
Captopril tablets
(12.5 mg tid)
Captopril tablets
(12.5 mg tid) and
Aspirin enteric-coated
tablets (75 mg qd)
Nicardipine piece
(20 mg tid)
BP
BP
59
34/25
92
T:32/14; C:30/16
106
T:30/23; C:28/25
90
T:31/28; C:17/14
Ma et al. [42]
80
T:25/15; C:22/18
T:66.39 5.4
C:64.58 7.1
Hu et al. [43]
60
T:20/10; C:22/8
T:77.8 4.2
C:77.1 3.4
70
T:19/16; C:19/16
60
T:16/14; C:17/13
60
T:18/12; C:20/10
60
T:20/10; C:21/9
80
T:22/18; C:23/17
84
T:27/15; C:24/18
T:63.57 8.08
C:65.20 8.86
T:32 to 64
C:32 to 65
T:54.75 7.12
C:51.72 10.38
T:54.75 7.1
C:67.8 12.0
T:43.84 8.3
C:44.20 8.4
30 to 65
(T/C not reported)
60
T:14/16; C:13/17
60
T:22/8; C:20/10
100
T:28/22; C:26/24
50
T:15/10; C:16/9
T:56.51 6.28
C:58.12 6.15
T:56.5
C:55.5
T:42 to 64
C:41 to 64
T:57.32 8.2
C:58.21 7.3
52
T:19/7; C:18/8
60
T1:7/13;
T2;6/14 C:11/9
75
T:28/17; C:19/11
T:57.8 10.9
C:58.4 11.6
T1:55.9 8.1
T2:55.6 6.0
C:55.00 6.4
T:63.60 8.20
C:65.20 8.00
Guo [48]
Cheng [49]
Dan [54]
Wu et al. [55]
BP
21 (once a day,
7 days/course)
Wang and
Cheng [38]
Jia et al. [39]
30 (once a day,
10 days/course)
Hydrochlorothiazide
(12.525 mg bid)
Electroacupuncture
China Guidelines on
Prevention and Management
of High Blood Pressure
2006 (CGPMHBP2006)
25 to 60
1999 WHOISH GMH
Electroacupuncture
(T/C not reported)
plus western medicine
T:46.4 5.7
Chinese Guidelines for
Acupuncture plus
C:44.7 6.8
the Management of
western medicine
Hypertension2005
(CGMH2005)
T:46.4 5.2
1998 WHOISH GMH
Acupuncture plus
C:45.2 6.3
western medicine
T:56.5 7.9
1999 WHOISH GMH
Acupuncture
C:55.6 8.6
Captopril tablets
Acupuncture
98
T:17/13; C:20/10
BP
35 to 75
1999 WHOISH GMH
(T/C not reported)
Yang [37]
Western medicine
BP
T:40.4 5.2
C:41.7 4.2
Electroacupuncture
BP
Acupuncture plus
western medicine
Amlodipine (5 mg qd)
Acupuncture
Acupuncture
Hypertension diagnostic
criteria (unclear)
1999 WHOISH GMH
Acupuncture
Enalapril maleate
(10 mg qd)
Metoprolol (100 mg qd)
Acupuncture
Acupuncture
Acupuncture
Enalapril maleate
(10 mg qd)
Levamlodipine besylate
tablets (2.5 mg qd)
Acupuncture
Acupuncture
Acupuncture
Captopril tablets
(25 mg tid)
Compound reserpine
tablets (1 tablet tid)
Metoprolol sustained
release tablet (12.5 mg bid)
Extended release
Nifedipine tablets
(20 mg bid)
Acupuncture
Captopril tablets
(25 mg tid)
Acupuncture plus
western medicine
BP; adverse
effect
BP
321
Table 1 (continued)
Study ID
Sample (M/F)
Age (yrs)
Diagnosis standard
Intervention
Control
Course (day)
41
T:4/11; C:5/10
T:49 to 56
C:51 to 57
Hypertension diagnostic
criteria (unclear)
Acupuncture
60
T:24/6; C:22/8
T:56.7 10.3
C:57.5 9.9
Sham acupuncture
plus antihypertensive
medication
Captopril (12.525 mg tid)
Electroacupuncture
Nicardipine tablets
(20 mg tid)
Acupuncture
Sham acupuncture
56 (20 min/time,
twice a week)
BP; adverse
effect
Acupuncture
Sham acupuncture
84 (20 min/day)
Acupuncture
Sham acupuncture
70 (twice-weekly
30 min)
BP; adverse
effect
BP; adverse
events
Acupuncture
Sham acupuncture
plus antihypertensive
medication
Acupuncture
Lifestyle intervention
T:40.3 11.4
C:46.1 14.2
Acupuncture plus
western medicine
Outcome
measure
Table 2
Quality assessment of included randomized controlled trials.
Included trials
Random sequence
generation
Allocation
concealment
Blinding of participants
and personnel
Blinding of outcome
assessment
Incomplete
outcome data
Selective
reporting
Other sources
of bias
Risk of
bias
Feng [30]
Li [31]
Luo [32]
Liu [33]
Yang [34]
Liu [35]
Zhang [36]
Yang [37]
Wang [38]
Jia et al. [39]
Liu et al. [40]
Liao et al. [41]
Ma et al. [42]
Hu et al. [43]
Chen et al. [44]
Guo et al. [45]
Huang et al. [46]
Wang et al. [47]
Guo [48]
Cheng [49]
Huang et al. [50]
Zhang et al. [51]
Ye et al. [52]
Shen et al. [53]
Dan [54]
Wu et al. [55]
Zhang et al. [56]
Yin et al. [57]
Jiang et al. [58]
Wan et al. [59]
Kim et al. [60]
Kraft K. et al. [61]
Macklin [62]
Flachskampf [63]
Zhao and Fan. [64]
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
opaque envelopes
Unclear
Unclear
opaque envelopes
Unclear
opaque envelopes
opaque envelopes
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
No
No
No
No
Yes
No
No
Yes
No
Yes
No
No
No
Yes
No
Yes
No
No
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
Unclear
High
High
High
Unclear
High
Unclear
Unclear
High
High
High
High
High
High
High
High
High
High
High
High
Unclear
High
High
High
High
High
High
Unclear
High
Unclear
Unclear
High
Unclear
Unclear
High
322
323
324
SE(MD)
0.5
1.5
MD
2
-100
-50
50
100
SE(MD)
0.2
0.4
0.6
0.8
1
-100
MD
-50
50
100
subgroups were analyzed based on methodological variables of acupuncture arms and control arms. The BP-lowering effect of acupuncture plus
western medicine was signicantly higher than that of western medicine
(SBP: 10.20, 14.00 to 6.40, P b 0.0001; DBP: 4.34, 6.79 to
1.90, P = 0.0005). The BP also decreased signicantly from baseline
with acupuncture than sham acupuncture plus western medicine (SBP:
7.47, 10.43 to 4.5, P b 0.00001; DBP: 4.22, 6.26 to 2.18,
P b 0.0001). Acupuncture achieved signicant effect modication on
BP change magnitude compared with lifestyle (SBP: 13.50, 15.06
to 11.94, P b 0.00001; DBP: 5.25, 6.01 to 4.49, P b 0.00001),
whereas, compared with western medicine, acupuncture showed no signicant effect modication (SBP: 0.77, 3.89 to 2.35, P = 0.63;
DBP: 0.10, 1.60 to 1.79, P = 0.91). Compared with sham acupuncture,
acupuncture statistically showed no signicant effect modication with
statistically signicant heterogeneity (SBP: 0.26, 2.40 to 2.91, P =
0.25; DBP: 1.04, 2.56 to 0.47, P = 0.18). However, according to
potential publication bias and low-quality trials, available data are
not adequate to draw a denite conclusion of acupuncture for essential hypertension. And the positive ndings should be interpreted
conservatively.
Before recommending the conclusion of this review to clinical
practice, we have to consider the following weaknesses in this
review. Firstly, in accordance with previous studies [73], the quality
of the included RCTs was generally low. The 35 trials included in this
paper had risk of bias in terms of design, reporting, methodology.
Only 8 RCTs stated randomization procedure, for the rest 27 trials,
they just mentioned that the patients were randomized into two
groups with no further information. Allocation concealment was only
mentioned in 4 RCTs [57,60,62,63]. A number of trials [32,33,3537,
48,49,54] only have one author, which is impossible for an RCT to be
done properly in terms of randomization procedure and the allocation
concealment. Therefore, we could suspect the truth of some of these
claimed RCTs. In addition, all the trials did not describe the blinding
in details. It directly led to performance bias and detection bias due to
patients and researchers being aware of the therapeutic interventions for the subjective outcome measures. If poorly designed, all
the trials would show larger differences compared with well designed
trials [74,75].
Secondly, heterogeneity is worthy of being paid attention to. Many
factors affect the effects of heterogeneity, such as acupuncture modalities, acupoint selection, frequency and duration of the treatment
sessions. One of the major limitations was the application of various
kinds of acupuncture point treatments used in different trials. More
than 30 different acupoints were investigated in the 35 trials. The
acupoints differed in meridians, syndromes, and the clinical efcacy. It
is difcult to assess the effect of a particular acupuncture point by
means of the evidence synthesis of studies. As a result, it is impossible
to conduct meaningful meta-analysis for a specic acupoints, or difcult
to undertake subgroup analyses to explore specic factors that may
have an impact on the effects of the treatment regimen. In addition,
two acupuncture modalities were reported, i.e. manual acupuncture
and electroacupuncture. Most of them used manual acupuncture and
electroacupuncture was selected in 4 RCTs [37,38,42,59]. In addition,
the differences of frequency and duration of the treatment sessions
(10 to 30 min per session acupuncture treatments, ranged from 10 to
90 days) affected the effects of acupuncture, thus made contributions
to the great heterogeneity. Not only that, all trials specied 10 diagnostic criteria of hypertension without 7, selective reporting bias might
exist in this conclusion, and reduce the homogeneity of the research
objects. All the 24 RCTs prohibited us to perform meaningful sensitivity
analysis.
Thirdly, only 6 trials of 24 trials did mention adverse effect. Even for
the trials that reported adverse events, their report was very brief, providing limited information. Therefore, a conclusion about the safety of
acupuncture cannot be made clearly. Five trails reported information
on follow-up, but not mentioned the details. In order to properly assess
325
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