Hindawi Publishing Corporation

BioMed Research International

Volume 2016, Article ID 5191729, 7 pages
http://dx.doi.org/10.1155/2016/5191729

Review Article
The Effectiveness and Safety of Acupuncture for Patients with
Chronic Urticaria: A Systematic Review

Qin Yao,1,2 Shanshan Li,1 Xiaoxu Liu,1,2 Zongshi Qin,1,2 and Zhishun Liu1
1
Department of Acupuncture, Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China
2
School of Graduates, Beijing University of Chinese Medicine, Beijing 100029, China

Correspondence should be addressed to Zhishun Liu; liuzhishun@aliyun.com

Received 20 February 2016; Revised 15 April 2016; Accepted 3 May 2016

Academic Editor: Enrico Heffler

Copyright © 2016 Qin Yao et al. This is an open access article distributed under the Creative Commons Attribution License, which
permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Background. Acupuncture might have effectiveness in relieving the symptoms of chronic urticaria. There are currently no systematic
reviews of acupuncture for chronic urticaria published in English. Objective. We conducted a systematic review to assess the
effectiveness and safety of acupuncture for chronic urticaria. Methods. A systematic review and meta-analysis of randomized,
controlled trials were performed. The primary outcome was global symptom improvement. Results. We included 6 studies with
406 participants. Three trials showed significant difference between acupuncture and drugs in global symptom improvement
(relative risk 1.37; 95% CI 1.11–1.70; 𝑃 = 0.003). As an adjuvant to medication, acupuncture was also beneficial for global symptom
improvement (relative risk 1.77; 95% CI 1.41–2.22; 𝑃 < 0.01). There were no severe adverse events related to acupuncture. Limitations.
Some methodological limitations were observed. The overall risk of bias in the 6 included trials was high and all included RCTs were
conducted in China and published in Chinese. Besides, the lack of proper control groups and the use of different rating methods
and cut-offs in the included trials also made the evidence of this review limited. Conclusions. Acupuncture might be effective and
safe for chronic urticaria in relieving symptoms, based on a low level of evidence. To draw a reliable conclusion, more high quality
trials are needed in the future. This trial is registered with PROSPERO CRD42015015702.

1. Introduction Besides, studies signified acupuncture may be effective in

relieving the symptoms of chronic urticaria [10–12]. More-
Chronic urticaria is a common disease with recurrent pruritic over, there are currently no systematic reviews of acupuncture
wheals and/or angioedema continuing for more than 6 weeks for chronic urticaria published in English. The aim of this
[1–4]. The prevalence is 0.5–1%, and nearly 20% of people review is to evaluate systematically the effectiveness and
suffer from acute urticaria at least once during their lifetimes safety of acupuncture therapy for patients with chronic
[5]. The peak age of incidence is between 20 and 40 years urticaria. We expect that this review will provide more
[5]. The incidence ratio is nearly 2 : 1 between women and convincing evidence to help clinicians make decisions when
men [5]. Chronic urticaria has a negative impact on the treating chronic urticaria.
patient’s quality of life as well as on the cost of social health
care [2, 6, 7]. For the treatment, the first-line treatment
of chronic urticaria is second-generation H1 -antihistamines
2. Methods and Analysis
(sgAH) [1], which have minimal adverse events [8, 9]. If The review protocol was registered on PROSPERO and was
symptom persists, higher dosages (up to 4x) of sgAH will be also published on BMJ Open [13]. The primary outcome
given, followed by omalizumab (anti-IgE), cyclosporine A, or was changed from improvement in pruritus and wheals in
montelukast (leukotriene antagonist) [1]. protocol to global symptom improvement in this review
Acupuncture has a long history and been widely used because the main outcome of the included RCTs was global
in clinical practice for treating chronic urticaria in China. symptom improvement.
2 BioMed Research International

2.1. Inclusion Criteria. We included randomized, controlled RevMan software, version 5.2, was applied for the data
trials that evaluated acupuncture for patients with chronic analysis and quantitative data synthesis. For dichotomous
urticaria [1–4, 14, 15]. The intervention comparisons consisted data, we used risk ratios (RRs) with 95% confidence intervals
of acupuncture compared with no treatment/placebo/sham (CIs) for analysis. No continuous data were assessed in this
acupuncture [16]/other active therapies or acupuncture in review. A fixed effect model was used for data synthesis
addition to another active therapy compared with the same because all the 𝐼2 test results were less than 50% in this
active therapy. Trials of acupuncture only compared with meta-analysis. We decided not to detect reporting biases and
another form of acupuncture or a different type of traditional small-study effects with funnel plots because of an insufficient
Chinese medicine (TCM) (e.g., Chinese herbal medicine) number of studies. Subgroup analysis was not conducted
were excluded. The primary outcomes were global symptom for the same reason. Sensitivity analysis was not conducted
improvement, measured by urticaria activity score (UAS) because no significant heterogeneity was detected.
[2, 17] or other validated scales. The secondary outcomes We used the Grading of Recommendations Assessment,
included quality of life [18, 19] and the recurrence rate during Development, and Evaluation (GRADE) to judge the overall
the follow-up period. Adverse events were also assessed. quality of the evidence for the primary outcomes. The
Studies were only included when global symptom improve- following domains were assessed: risk of bias, consistency,
ment was reported. directness, precision, publication bias, and additional points.
The assessments were classified into four levels: high, moder-
ate, low, or very low [21, 22].
2.2. Literature Search. We electronically searched the fol-
lowing databases from their inception to January 2016: the
Cochrane Central Register of Controlled Trials, PubMed, 3. Results
EMBASE, the Web of Science, Traditional Chinese Medicine
databases, China National Knowledge Infrastructure, the 3.1. Study Selection and Study Characteristics. We identified
Chinese Biomedical Literature Database, the Chinese Sci- 700 references through electronic searches. In total, 6 RCTs
entific Journal Database, and the Wan-Fang Database. We with 406 enrolled participants were included (Figure 1) [23–
produced a search strategy based on the guidance of the 28]. The characteristics of the included trials are summarized
Cochrane handbook guidelines [20]. The search strategy for in Table 1. All included trials were conducted in China and
PubMed is exhibited in Appendix. We also searched related were published in Chinese between 2005 and 2011 [23–25].
conference proceedings, trial registers, and the reference lists All included patients met the criteria for chronic urticaria. All
of the identified publications for additional trials. included studies reported consistent baseline characteristics
of sex and age.
2.3. Data Collection and Analysis. We conducted the fol- In total, all the treatments adopted in the included
lowing processes in data collection and analysis: selection trials were based on traditional Chinese medicine theory.
of studies, data extraction and management, assessment Electroacupuncture was applied in 2 RCTs, while manual
of risk of bias, dealing with missing data, assessment of acupuncture was used in the other 4 RCTs. Xuehai (SP
heterogeneity, assessment of reporting biases, data synthesis, 10), Zusanli (ST 36), and Quchi (LI 11) were applied the
sensitivity analysis, subgroup analysis, and grading the qual- most frequently in the included studies (4/6, 66.7%). Other
ity of evidence. acupoints used were Sanyinjiao (SP 6), Hegu (LI 4), Pishu (BL
20), Ganshu (BL 18), and Shendao (GV 11). The duration of
Two of the review authors (Qin Yao and Zongshi Qin)
the interventions was 2 weeks (2 trials) or 4 weeks (4 trials).
independently screened the titles, abstracts, and keywords
The frequency of interventions ranged from once per day
of the retrieved studies and further assessed the full texts. to twice per week. Only one trial mentioned a follow-up of
Excluded studies were recorded with explanations. Two 10 weeks. Three of the 6 RCTs compared acupuncture with
authors independently extracted the data and completed the pharmacological medications, and 3 of the 6 RCTs compared
predefined data extraction form. General information, par- acupuncture plus medication versus medication. All drugs
ticipants, methods, interventions, outcomes, results, adverse included belonged to the H1 -antihistamine class.
events, conflicts of interest, ethical approval, and other All 6 trials reported global symptom improvement. For
information were extracted. Disagreements were resolved by global symptom improvement, an effect index was employed
discussion between the two authors and arbitrated by a third for layering the strata in all the included trials, following
author (Zhishun Liu) when necessary. Authors of the studies a symptom score rating method: effect index = (baseline
were contacted for clarification and missing data. symptom score − symptom score after treatment)/baseline
The risk of bias was assessed with Cochrane Collabo- symptom score ∗ 100%. More than 60% was defined as
ration’s tool by two independent authors (Shanshan Li and remarkable improvement and the cure stratum in 5 of the
Xiaoxu Liu), including the following domains: sequence included trials, and the remaining 1 trial used 80% as the
generation, allocation sequence concealment, blinding of cut-off point. We combined all the remarkable improvement
participants and personnel and outcome assessors, incom- and cure outcomes (more than 60%) into a single positive
plete outcome data, selective outcome reporting, and other category and the remaining data into a negative category.
sources of bias. The assessments were classified into three Then, the new data were extracted as a dichotomous out-
levels: low risk, high risk, and unclear risk. come for global symptom improvement. One trial reported
BioMed Research International 3

Table 1: Chronic urticaria. The characteristics of included trials.

Course,
Reference Comparisons Methods Outcomes
wk
Random number table
Chen 2009 [23] Electroacupuncture, 30; Global symptom
Adequate allocation concealment 4
unpublished thesis loratadine, 30 improvement
Blinding of outcome assessors: unclear
Process of randomization: unclear
Tang 2006 [24] Acupuncture, 30; Global symptom
Allocation concealment: unclear 2
unpublished thesis loratadine, 30 improvement
Blinding of outcome assessors: unclear
Process of randomization: unclear Global symptom
Acupuncture, 30;
Gao et al. 2009 [25] Allocation concealment: unclear 2 improvement recurrence
cetirizine, 30
Blinding of outcome assessors: unclear rate
Electroacupuncture plus Simple random method
Global symptom
Xie et al. 2009 [26] mizolastine, 30; Allocation concealment: unclear 4
improvement
mizolastine, 30 Blinding of outcome assessors: unclear
Random number table
Xu and Zhang 2011 Acupuncture plus Global symptom
Allocation concealment: unclear 4
[27] cetirizine, 35; cetirizine, 35 improvement
Blinding of outcome assessors: unclear
Acupuncture plus Process of randomization: unclear
Global symptom
Song et al. 2005 [28] cetirizine, 47; cetirizine, Allocation concealment: unclear 4
improvement
49 Blinding of outcome assessors: unclear

700 records identified

3.2. Risk of Bias in Included RCTs. The risk of bias assess-
through database ment is depicted in Figure 2. All included RCTs mentioned
searching and additional randomization. One RCT was randomized using random
sources
number tables, and it kept the allocation schedule safely
64 duplicated records removed concealed using opaque envelopes [23]. Another RCT was
636 records randomized using random number tables without mention-
screened (abstract and ing whether the schedule is concealed or not [27]. The
title)
details of the randomization and allocation concealment were
598 records removed unclear in the remaining 4 RCTs, even after contacting the
authors for advanced information. Moreover, none of the
included RCTs blinded the acupuncturists, the participants,
29 records assessed for and the statisticians. Additionally, none of the included RCTs
eligibility
reported drop-outs, based on contacting of the authors or
1 record awaiting classification
due to lack of full text screening of the full texts.

3.3. Effect on Global Symptom Improvement. In this meta-

28 full-text articles Full-text articles excluded for the analysis, 6 RCTs were divided into 2 parts to conduct the
assessed for eligibility following reasons (n = 22): meta-analysis, depending on the different types of compar-
(i) Duplications (n = 1) ison groups.
(ii) Not true rcts (n = 4)
(iii) Interventions did not meet the 3.3.1. Acupuncture versus Medication. Three trials [23–25]
including criteria (n = 8) (180 participants) compared the effects of acupuncture versus
6 studies included in medication (loratadine or cetirizine). There was a statistically
quantitative synthesis (iv) Participants did not meet the
(meta-analysis) including criteria (n = 2) significant difference between acupuncture and drugs in
(v) Without comparison (n = 2) global symptom improvement. The RR for global symptom
(vi) Outcomes assessment did not improvement was 1.37 (95% CI 1.11–1.70; 𝑃 = 0.003; 𝐼2 = 23%,
meet the including criteria (n = 5) Figure 3). GRADE analysis indicated that the overall quality
of the evidence for this outcome was low due to a high risk of
Figure 1: Study flow diagram. bias and the imprecision and sparseness of the data.

3.3.2. Acupuncture Plus Medication versus Medication. Three

studies [26–28] (226 participants) compared acupuncture
the recurrence rate. Quality of life was not reported in any of plus medication versus the same medication with regard to
the included trials. Safety was evaluated in all clinical trials. global symptom improvement. The RR for global symptom
4 BioMed Research International

Random sequence generation (selection bias)

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)

0 25 50 75 100
(%)

Low risk of bias

Unclear risk of bias
High risk of bias

Figure 2: Chronic urticaria. risk of bias graph.

Acupuncture Drugs Risk ratio Risk ratio

Study or subgroup Weight
Events Total Events Total M-H, fixed, 95% CI M-H, fixed, 95% CI
Gao et al. 2009 [25] 22 30 20 30 39.2% 1.10 [0.79, 1.53]
Tang 2006 [24] 21 30 14 30 27.5% 1.50 [0.96, 2.35]
Chen 2009 [23] 27 30 17 30 33.3% 1.59 [1.14, 2.22]

Total (95% CI) 90 90 100.0% 1.37 [1.11, 1.70]

Total events 70 51
2 2
Heterogeneity: 𝜒 = 2.58, df = 2 (P = 0.27); I = 23% 0.01 0.1 1 10 100
Test for overall effect: Z = 2.94 (P = 0.003) Favours [control] Favours [experimental]

Figure 3: Forest plot of comparison: acupuncture versus medication; outcome: global symptom improvement.

improvement was 1.77 (95% CI 1.41–2.22; 𝑃 < 0.01; 𝐼2 = reported 1 case of local skin hemorrhage and 1 case of feeling
0%, Figure 4). There was a statistically significant differ- faint during acupuncture [29]. One trial reported 1 case of
ence between acupuncture plus medication and medication feeling faint during acupuncture [30]. Another trial reported
regarding global symptom improvement. GRADE analysis 1 case of gastrointestinal discomfort, but the intervention in
indicated that the overall quality of the evidence for this out- this trial was acupuncture versus Chinese herbal decoction
come was low due to a high risk of bias and the imprecision [31]. One trial reported 1 case of menstrual disorders, but
and sparseness of the data. the symptoms disappeared after the intervention stopped,
and the intervention in this trial was acupuncture versus
3.4. The Recurrence Rate. The recurrence rate was evaluated cetirizine [32]. Moreover, a nervous feeling experienced by
by global symptom improvement. Only Gao’s study [25] some patients when receiving acupuncture was reported [33].
reported the recurrence rate. In Gao’s report, acupuncture None of the remaining clinical trials reported any adverse
showed a lower recurrence rate than cetirizine over 10 weeks reactions related to acupuncture.
of follow-up (𝑃 = 0.06).
4. Discussion
3.5. Quality of Life. None of the trials reported on quality of
life. The aim of this meta-analysis was to evaluate the effectiveness
and safety of acupuncture therapy for chronic urticaria.
3.6. Adverse Events. We included all clinical trials of In total, 6 RCTs with 406 participants were included
acupuncture for treating chronic urticaria in a safety evalu- in this meta-analysis. The primary outcome was global
ation. There were only 15 articles out of the 212 of the clinical symptom improvement. When comparing acupuncture with
articles with 792 participants that mentioned safety evalua- medications (loratadine, cetirizine), the combined results of
tions related to acupuncture or acupuncture with other thera- 3 RCTs indicated that acupuncture might be more effective
pies to treat chronic urticaria. None of these studies reported than drugs. As an adjunct to medication, the combined
any severe adverse events related to acupuncture. One trial results of 3 RCTs suggested that acupuncture plus drugs
BioMed Research International 5

Acupuncture plus drugs Drugs Risk ratio Risk ratio

Study or subgroup Weight
Events Total Events Total M-H, fixed, 95% CI M-H, fixed, 95% CI
Song et al. 2005 [28] 35 47 21 49 41.5% 1.74 [1.21, 2.50]
Xie et al. 2009 [26] 28 30 18 30 36.3% 1.56 [1.14, 2.12]
Xu and Zhang 2011 [27] 24 35 11 35 22.2% 2.18 [1.27, 3.74]

Total (95% CI) 112 114 100.0% 1.77 [1.41, 2.22]

Total events 87 50
Heterogeneity: 𝜒2 = 1.27, df = 2 (P = 0.53); I 2 = 0% 0.01 0.1 1 10 100
Test for overall effect: Z = 4.96 (P < 0.00001) Favours [control] Favours [experimental]

Figure 4: Forest plot of comparison: acupuncture plus medication versus medication; outcome: global symptom improvement.

was superior to drugs in improving global symptoms. The and measured as continuous data, rather than strata, in future
results indicated that acupuncture might have beneficial studies.
effects for the treatment of chronic urticaria as an adjunct Only 1 of the included RCTs was designed to assess
to medication. However, the overall quality of the evidence the patients’ recurrence rate during the follow-up period.
assessed by the GRADE approach for this meta-analysis This RCT showed that acupuncture had a lower recurrence
was low. There was a high overall risk of bias in the 6 rate by 10-week follow-up, compared to cetirizine [25]. The
included trials, which has also been found to be a common results suggested that acupuncture might have better long-
phenomenon in previous Chinese studies [34, 35]. term effects than pharmacological therapy. Because clinically
First, the poor methodology of the included RCTs was a urticaria often occurs repeatedly, a longer follow-up is needed
source of bias. The processes of randomization and allocation in future studies for an assured conclusion.
concealment were not clearly described in most of the We conducted a descriptive analysis due to the variety of
included studies. No information was mentioned regarding adverse reactions and the different types of clinical studies.
the blinding of statisticians. None of these trials were reg- So far, most of the studies have focused mainly on the
istered in a clinical trials registry. Moreover, 2 RCTs were effectiveness of acupuncture. We assessed 212 clinical articles
unpublished theses for Master’s degrees [23, 24], and all related to acupuncture or acupuncture with other therapies
included RCTs were conducted in China and published in to treat urticaria, of which only 4 trials with 5 cases reported
Chinese, so the results should be explained cautiously. tolerable and mild adverse reactions. None of the other trials
The lack of proper control groups was another significant mentioned any adverse reactions related to acupuncture.
source of bias. Without comparisons of acupuncture to no Therefore, we conclude that acupuncture is considered safe
treatment/placebo/sham acupuncture in this meta-analysis, for treating patients with chronic urticaria.
we could not conclude that acupuncture had specific biolog-
ical effects. All the included RCTs compared acupuncture to 5. Conclusion
drugs or acupuncture plus drugs to drugs, and they did not
conduct expectation evaluations. Thus, pretreatment prefer- In conclusion, there is low quality evidence for the effective-
ences and greater expectations for acupuncture might have ness of acupuncture for chronic urticaria in relieving symp-
existed among the participants, and better responses might toms based on the results of this meta-analysis. Acupuncture
have been merged into the acupuncture group. Moreover, is safe for treating patients with chronic urticaria, according
some articles implied that acupuncture might only have to the current evidence. For future research, the quality
powerful placebo effects [36–38]. of research must be improved, including the processes of
Regarding outcomes, although all the included RCTs randomization, blinding of outcome assessors, and longer
reported global symptom improvement, different rating follow-up. A consistent measurement for primary outcomes
methods and cut-off points were applied. Because these rating is necessary. The urticaria activity score (UAS) is recom-
methods and cut-off points were mostly self-defined, it is mended. Well-designed trials with larger sample sizes are
difficult to assess the effects of acupuncture by dichotomous necessary for reliable evidence regarding the effectiveness of
outcomes. We chose only one cut-off point to combine all acupuncture to treat chronic urticaria.
the positive outcomes into a single positive category and the
remaining outcomes into a negative category, which might Appendix
have resulted in differences between our results and those
of the original studies. In addition, we hold the opinion A Search Strategy Used in PubMed
that the effects of acupuncture might be better measured
by a score rating method as continuous data than by being (1) To Identify Relevant Outcomes (Chronic Urticaria).
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6 BioMed Research International

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Abstract] OR Body acupuncture [Title/Abstract] OR Scalp “Annual direct and indirect health care costs of chronic idio-
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