The American Journal of Chinese Medicine, Vol. 37, No.

1, 3543 2009 World Scientic Publishing Company Institute for Advanced Research in Asian Science and Medicine

Evidence Based Acupuncture Practice Recommendations for Peripheral Facial Paralysis

Hui Zheng, Ying Li and Min Chen Department of Acupuncture and Moxibusion Chengdu University of Traditional Chinese Medicine Chengdu 610075, China

Abstract: The objective is to analyze the treatment used in relatively high quality randomized controlled trials to identify any similarities of therapeutic approaches and subsequently present recommendations for a standard acupuncture procedure for the treatment of peripheral facial paralysis (PFP). We searched Chinese and English language literatures through MEDLINE (January 1966 to October 2007), EMbase (January 1980 to October 2007), Chinese Biomedical Database (January 1978 to October 2007) and China National Knowledge Infrastructure (January 1979 to October 2007) for randomized controlled trials. With independent assessment by 2 observers, 33 of 386 originally identied articles were nally included. The extracted information from these articles was focused on the selection of meridians and acupoints, types of stimulation and duration of treatment. On the whole, when treating PFP, the best acupoints options are Dicang (ST4), Xiaguan (ST7), Jiache (ST6), Chengjiang (CV24), Yingxiang (LI20), Quanliao (SI18), Yifeng (TE17), Yangbai (GB14), Sibai (ST2), Fengchi (GB20), Shuigou (GV26), Yuyao (EX-HN4) and Hegu (LI4). Manual stimulation or electroacupuncture combined with moxibustion is recommended. Moreover, the suggested duration of acupuncture treatment refers to once a day, 10 times for each course, 2 to 5 days as courses interval, and 20 to 40 treatments in total. Keywords: Evidence Based; Acupuncture; Recommendations; Peripheral Facial Paralysis.

Introduction Peripheral facial paralysis (PFP) is a common disease with an annual incidence of 1530 per 100,000 of population. PFP may result in complete or partial paralysis of the facial muscles and may be associated with tasting, salivation, tearing disorders, etc. Most patients recover completely, but about 1530% are reported to be left with different degrees of
Correspondence to: Dr. Hui Zheng, Department of Acupuncture and Moxibusion, Chengdu University of Traditional Chinese Medicine, Chengdu 610072, China. Tel: (+86) 135-1813-7928, E-mail: zhhui126@yahoo.com.cn

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sequelae (Ljstad et al., 2005). There are many possible causes of PFP, the most common cause of PFP is Bells palsy. Other causes of acquired PFP are less common, including the Ramsay Hunt syndrome, Lyme disease, etc. (Donald, 2004). According to traditional Chinese medicine (TCM) theories, PFP is caused by the attack of pathogenic wind and cold on Yangming and Shaoyang meridians, which leads to malnutrition of the muscle and the meridians. Consequently, the malnutrition of the facial muscles results in facial paralysis, which is diagnosed as a wry face in TCM (Tang et al., 1999). Acupuncture is reported to be efcacious and widely used for the treatment of PFP in China. A Cochrane review on acupuncture for Bells palsy, concluded that acupuncture is benecial and has no harmful side-effects in treating Bells palsy (He et al., 2007). Since acupuncture is benecial and has few side-effects, it is necessary for us to nd out a reliable and efcacious clinical practice protocol to treat PFP with acupuncture. Before making an acupuncture practice protocol for PFP, we should nd out acceptable answers for 3 questions below: First, which meridians and acupoints are best to choose? Second, which acupuncture therapy is the best choice? Third, how many acupuncture treatments should a patient receive to achieve satised effect? It is reliable to answer these questions through a systematic review of relatively high quality clinical trials of using acupuncture to treat PFP. In this study, we collected those literatures related to the randomized controlled trials (RCTs) and the treatment of PFP with acupuncture. The information from these literatures was extracted and further analyzed to answer the above questions, to nd out reliable guidance for clinical practice of treating PFP with acupuncture.

Methods Search Strategy Computerized literature searches were conducted in the following databases: OVID MEDLINE (January 1966 to October 2007), OVID EMbase (January 1980 to October 2007), Chinese Biomedical Database (January 1978 to October 2007) and China National Knowledge Infrastructure (January 1979 to October 2007). Search restrictions included only human subjects in both English and Chinese languages. The search strategy was formulated according to Cochrane Handbook for Systematic Reviews of Interventions (Higgins and Green, 2006): (1) exp bell palsy/; (2) exp facial paralysis/; (3) exp facial nerve/; (4) exp facial nerve disease/; (5) bell palsy/; (6) facial paralysis/; (7) facial nerve/; (8) facial nerve disease/; (9) facial nerve paralysis/; (10) bell$ pals $.ti, ab, tw.; (11) facial paralysis. ti, ab, tw.; (12) facial paresis .ti, ab, tw.; (13) facial nerve disease. ti, ab, tw.; (14) 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 10 or 11 or 12 or 13; (15) exp acupuncture/; (16) exp acupuncture therapy/; (17) exp acupuncture analgesia/; (18) exp acupoint/; (19) exp ear acupuncture/; (20) acupuncture.mp. [mp = ti, ot, ab, nm, hw]; (21) acupuncture therapy.mp. [mp = ti, ot, ab, nm, hw]; (22) acupuncture analgesia.mp. [mp = ti, ot, ab, nm, hw]; (23) acupoint$.mp. [mp = ti, ot, ab, nm, hw]; (24) elec$ acupuncture.mp. [mp = ti, ot, ab, nm, hw]; (25) ear$ acupuncture.mp. [mp = ti, ot, ab, nm, hw]; (26) acupuncture.ti, ab, tw.; (27) acupuncture therap$.ti, ab, tw.; (28) acupuncture analgesia.ti, ab, tw.; (29) acupoint$.

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ti, ab, tw.; (30) elec$ acupuncture.ti, ab, tw.; (31) ear$ acupuncture.ti, ab, tw.; (32) exp moxibustion/; (33) moxibustion.mp. [mp = ti, ot, ab, nm, hw]; (34) moxibustion.ti, ab, tw.; (35) 15 or 16 or 17 or 18 or 19 or 20 or 21 or 22 or 23 or 24 or 25 or 26 or 27 or 28 or 29 or 30 or 31 or 32 or 33 or 34; (36) 14 and 35. Selection Criteria Inclusion criteria: (1) To ensure reasonable methodological soundness of the involved studies, only RCTs were included. (2) The study included participants with facial paralysis due to lesions of the ipsilateral facial nerve or lesions of the ipsilateral facial nucleus. (3) RCTs where therapies were used according to theory of acupuncture and moxibustion were included. Exclusion criteria: (1) Animal studies were excluded. (2) Duplications of published papers were excluded. (3) Before exclusion of relatively low quality RCTs, Jadad scale was used to assess the methodological quality of the papers. The 5-point Jadad quality assessment score is suited to assess internal validity of a trial and this simple method has already been validated. Points were awarded as follows: the study was described as randomized, 1 point; the randomization scheme was described and appropriate, 1 point, on the contrary, inappropriate randomization method, reduce 1 point; the study was described as double blind, 1 point; the method of double blinding was appropriate, 1 point; there was a description of withdrawals and dropouts, 1 point (Jadad et al., 1996). To ensure that the recommendations are based on high quality RCTs, only the trials rated more than 2 points were eventually adopted and further analyzed in consideration of the nal scores of all trials and regarding the difculty in performing blinding in acupuncture trials. All the papers were assessed by 2 independent reviewers (H. Zheng and M. Chen), and disagreements were resolved by referring back to the original trial report and through discussion among all authors. Data Extraction The RCTs that satised the selection criteria were examined for the following information: meridians and acupoints used, types of stimulation, number of treatments, frequency of treatment, duration of the individual treatment, the total duration of the treatment. If data from the trial reports were insufcient or missing, we tried our best to contact the authors for additional information. Finally, all the above information was entered into Microsoft access 2003 for exact data extraction. Results Three hundred and eighty six RCTs were found, 33 of them scored higher than 2 points with Jadad scale. All of the trials were performed in China. More details are available in Table 1 (Chen, 2005; Chen et al., 2004; Feng, 2002; Huang, 2007; Huang and An, 2005; Huang and Li, 2003; Jia et al., 1999; Jiang et al., 2004; Lao and Li, 2005; Li, 1997; Li et al., 2004; Li, 2005; Liao, 2006; Lin, 2004; Liu and Zhou, 2004; Liu et al., 2007; Ma, 2001;

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Table 1. Jadad Score of RCTs Jadad Score Number of RCTs 0 144 1 209 2 31 3 1 4 0 5 1

Ma et al., 2003; Pan and Li, 2004; Tang, 2004; Tian et al., 2006; Wang and Wan, 2005; Wang and She, 2006; Wang, 2004; Wang et al., 2004; Wang, 2007; Xu, 2002; Yang and Li, 2005; Yu, 2004; Zhang et al., 2004; Zhao et al., 2006; Zhao and Tian, 2005; Zhu, 2005). Meridians chosen to treat PFP were mainly Large Intestine Meridian, Stomach Meridian, Triple Energizer Meridian, Gallbladder Meridian, etc. According to the frequency of acupoints use, most of them were Yang meridians. As for acupoints chosen for treatment, the most frequently used acupoints were Hegu (LI4), Dicang (ST4), Xiaguan (ST7), Jiache (ST6) and Chengjiang (CV24), which were reported to be efcacious by at least 20 RCTs. Moreover, Yingxiang (LI20), Quanliao (SI18), Yifeng (TE17) and Yangbai (GB14) were reported to be efcacious by at least 15 RCTs. At last, Sibai (ST2), Fengchi (GB20), Shuigou (GV26) and Yuyao (EX-HN4) were reported to be efcacious by at least 10 RCTs. More details are available in Table 2. We summarized types of stimulation used in every RCT, and tried to nd out the methods most commonly used. According to the literatures, types of stimulation can be divided into monotherapy and combined therapy. The most frequently used monotherapy was electroacupuncture, which was reported to be efcacious by 5 RCTs. And intermittent wave was better than continuous wave, especially in treating persistent facial paralysis. Other types of monotherapies were acupuncture point injection and point application therapies which were supported by only 1 RCT each. Combined therapy is much more frequently used than monotherapy in treating PFP; it was supported by 26 RCTs. The therapies mentioned in the 26 RCTs could be classied into 3 types, according to therapies that most frequently
Table 2. Selection of Meridians and Acupoints Meridians/Extraordinary Points Large Intestine Meridian Stomach Meridian Acupoints (Frequency) Hegu (LI4)(20), Yingxiang (LI20)(15), Quchi(LI11)(1) Heliao (LI19)(3) Dicang (ST4)(22), Xiaguan (ST7)(22), Jiache (ST6)(21), Sibai (ST2)(10), Zusanli (ST36)(4), Touwei (ST8)(3), Juliao (ST3)(2), Fenglong(ST40)(1) Quanliao (SI18)(19), Tinggong(SI19)(2) Cuanzhu (BL2)(8), Jingming (BL1)(3) Yifeng (TE17)(15), Waiguan (TE5)(3), Sizhukong (TE23)(3) Yangbai (GB14)(17), Fengchi (GB20)(11), Hanyan (GB4)(6), Tinghui (GB2)(2), Wangu (GB12)(2), Xuanli (GB6)(1), Toulinqi (GB11)(1), Zulinqi (GB41)(1), Xiaxi (GB43)(1) Shuigou (GV26)(10), Dazhui (GV14)(1), Shenting(GV24)(1) Chengjiang (CV24)(20), Lianquan (CV23)(2), Zhongwan(CV12)(1) Taichong (LR3)(3), Lieque (LU7)(2), Xuehai (SP10)(1) Yuyao (EX-HN4)(10), Taiyang(EX-HN5)(9)

Small Intestine Meridian Bladder Merdian Triple Energizer Meridian Gallbladder Meridian

Governor Vessel Conception Vessel Other Meridians Extraordinary Points

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appeared in the literatures. The 3 types were electro-acupuncture combined with other therapies, manual stimulation combined with other therapies and 3-edged needle combined with point application. Three-edged needle combined with point application were listed alone, since 3-edged needle is a special instrument, in principal, which is different from liform needle. Manual stimulation combined with other therapies were the most frequently used combined therapy, with 17 RCTs supported, and manual stimulation combined with moxibustion were at the top of them. Moreover, a high quality RCT (with Jadad score of 5) suggested that manual stimulation combined with moxa stick moxibustion is much better than using prednisone combined with vitamin B as a controlled treatment. Furthermore, we found that electro- acupuncture combined with moxibustion was still at the top of the electro-acupuncture combined with other therapies category. Therefore, manual stimulation or electro-acupuncture should be combined with moxibustion, as the literatures suggested. More details are available in Table 3. At last, the course of treatment was taken into consideration, which could help acupuncturists decide how many treatments a patient should take and how many treatment will be enough to achieve satised effect. We found out that the most frequently mentioned course of treatment was once a day, 10 treatments a course, with a 2 to 5 days rest between each course. Most of the patients were cured after 20 to 40 treatments, as reported. More details are available in Table 4. Discussion The purpose of this article is to analyze the treatment protocol of relatively high quality RCTs and if possible recommend a standard acupuncture treatment for PFP. Based on the analysis of extracted data from literatures, we recommended some acupuncture treatment
Table 3. Types of Stimulation Needling and Moxibustion Method Monotherapy Electro-Acupuncture Acupuncture Point Injection Point Application Combined Therapy Electro-Acupuncture + Other Therapies Electro-Acupuncture + Moxibustion Electro-Acupuncture + Acupuncture Point Injection Manual Simulation + Other Therapies Manual Stimulation + Moxibustion Manual Stimulation + Point Application Manual Stimulation + Tdp Manual Stimulation + Traditional Chinese Tuina Manual Stimulation + Microwave Acumoxa Manual Stimulation + Laser Acupuncture Manual Stimulation + Traditional Chinese Medicine Three-Edged Needle + Point Application Frequency 7 5 1 1 26 8 5 3 17 5 3 3 3 1 1 1 1

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Table 4. Duration of Treatment Course of Treatment (Frequency) 10 Treatments a Course (23) 7 Treatments a Course (2) 6 Treatments a Course (3) 5 Treatments a Course (2) Others (3) Interval (Frequency) 25 days (23) 26 days (2) 24 days (3) 24 days (2) not clear Treatments (Frequency) 2040 (22) not clear 1035 (3) 1030 (2) 24 (1)

protocols for PFP, referred to the selection of meridians and acupoints, types of stimulation and duration of treatment. First, best acupoints belong to Yang meridians, such as Dicang (ST4), Xiaguan (ST7), Jiache (ST6), Chengjiang (CV24), Yingxiang (LI20), Quanliao (SI18), Yifeng (TE17), Yangbai (GB14), Sibai (ST2), Fengchi (GB20), Shuigou (GV26), Yuyao (EX-HN4) and Hegu (LI4). Second, a combined therapy has priority to a monotherapy; however, if a monotherapy has to be taken into consideration because of a facility limitation (e.g. lack of moxa, etc.), electro-acupuncture will be the best choice. With regard to combined therapies, manual stimulation or electro-acupuncture combined with moxibustion is the best type of stimulation. Third, acupuncture treatment is suggested to be given once a day, 10 times each course, 2 to 5 days as courses interval, and 20 to 40 treatments in total. During the assessment of RCTs, we found only 1 RCT with Jadad score higher than 3 points (Li et al., 2004). The quality of most other clinical trials needed improvement. These trials mainly claimed to be RCT, however, lacked sufcient supportive information, such as method used for randomization allocation, information about allocation concealment, blinding, withdrawal, dropout, etc. The principles of assigning score to the trials with poor quality are listed as follows. First, some trials only mentioned that we used method of randomization allocation, without further description of the randomization method applied in the trial. The supplied information is not enough to judge if the randomization was appropriate, anyhow, they still scored 1 point according to Jadad scale. Second, in spite of the mention of randomized allocation, some trials had scored 0 point due to incorrect randomization allocation methods (e.g. patients were allocated alternately, or according to date of birth, hospital number, etc.). Third, those trials without blinding treatment scored 0 point. Finally, 0 point was assigned to the trials that lacked details of withdrawal and dropout. These trials mainly concentrated on the treatment phase and rarely paid attention to the follow-up phase. The quality of clinical trials of acupuncture needs to be improved. First, it is critical to use a correct method to generate allocation sequence, like using random number table or specic computer software. In addition, the information about allocation concealment ought to be clearly presented. For instance, use of opaque and sealed envelopes, central randomization will be considered adequate for allocation concealment. Second, in spite of its difculty in practice, blinding is necessary for high quality acupuncture trials and is important to improve the efcacy of acupuncture. Blinding patients and outcome assessors from group assignment are recognized as adequate in acupuncture trials. In blinding patients, non-acupoint or sham acupuncture is preferable and is mostly accepted. In blinding outcome assessors, central

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randomization is a perfect approach. When unable to perform central randomization, it is necessary to make sure that care providers would not get involved in outcome assessment, and vice versa. Third, more attention has to be paid to follow-up phase. As a RCT of treating migraine with acupuncture reported that true acupuncture was able to provide longlasting effects, while sham acupuncture only can provide a transient benet. According to this research, true acupuncture did not show better effect than sham acupuncture until 3 months after treatment (Facco et al., 2008). Briey, in advance of any trial, it is of utmost importance, to have a good experiment design considering the randomization method and adequate blinding, etc. Apart from a good design, trials should be reported in a suitable format, such as the widely accepted CONSORT statement. Some principles of reporting have to be followed, for example, when randomization is mentioned, sequence generation and allocation concealment should be reported. It is suggested that RCTs should be reported following the detailed checklist of CONSORT concerning each part of the Title, Abstract, Introduction, Methods, Results and Discussion, as empirical evidence indicates that not reporting the information is associated with biased estimates of treatment effect (Moher et al., 2001). In addition, regarding the specialty of TCM trials, CONSORT for TCM is developed in order to attach a balance between modern research methodology and features of TCM (Wu et al., 2007). In conclusion, we presented several recommendations for treating PFP with acupuncture on the basis of relatively high quality RCTs. However, according to the results in this study, there is an urgent need to improve the quality of RCTs. Acknowledgments This research was nancially supported in part by the grants from National Key Technology R & D Program of China (2006BAI12B03) to Professor Y. Li. References
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