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Original Research |

Acupuncture for Chronic Severe Functional Constipation: A Randomized, Controlled TrialAcupuncture for Chronic Constipation ONLINE FIRST

Zhishun Liu, MD, PhD; Shiyan Yan, PhD; Jiani Wu, MD; Liyun He, MD, PhD; Ning Li, MD; Guirong Dong, MD; Jianqiao Fang, MD, PhD; Wenbin Fu, MD; Lixin Fu, MD, PhD; Jianhua Sun, MD, PhD; Linpeng Wang, MD; Shun Wang, MD; Jun Yang, MD; Hongxing Zhang, MD; Jianbin Zhang, MD, PhD; Jiping Zhao, MD; Wei Zhou, MD; Zhongyu Zhou, MD; Yanke Ai, PhD; Kehua Zhou, MD, DPT; Jia Liu, MD, PhD; Huanfang Xu, MD, PhD; Yuying Cai, MD, PhD; and Baoyan Liu, MD
[+] Article, Author, and Disclosure Information

This article was published at www.annals.org on 13 September 2016.


From Guang'anmen Hospital, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing Traditional Chinese Medicine Hospital of Capital Medical University, Dongzhimen Hospital of Beijing University of Chinese Medicine, Huguosi Hospital of Chinese Medicine of Beijing University of Chinese Medicine, Beijing; West China Hospital of Sichuan University, Chengdu, Sichuan; Yueyang Hospital of Integrated Traditional Chinese and Western Medicine of Shanghai University of Traditional Chinese Medicine, Shanghai; The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang; Guangdong Province Hospital of Traditional Chinese Medicine, Guangzhou, Guangdong; The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin; Jiangsu Province Hospital of Traditional Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing, Jiangsu; Heilongjiang Province Academy of Chinese Medical Science, Ha'erbin, Heilongjiang; The First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, Anhui; Wuhan Integrated Traditional Chinese Medicine and Western Medical Hospital, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, Hubei, China; and Daemen College, Physical Therapy Wound Care Clinic, Amherst, New York.

Note: Of the 15 sites involved in this work, 13 were hospitals of traditional Chinese medicine: Guang'anmen Hospital, Beijing Traditional Chinese Medicine Hospital, Huguosi Hospital of Chinese Medicine, and Dongzhimen Hospital in Beijing; The Third Affiliated Hospital of Zhejiang Chinese Medical University in Hangzhou; The First Affiliated Hospital of Anhui University of Chinese Medicine in Hefei; Jiangsu Province Hospital of Traditional Chinese Medicine, and Nanjing University of Chinese Medicine in Nanjing; Guangdong Province Hospital of Traditional Chinese Medicine in Guangzhou; Wuhan Integrated Traditional Chinese Medicine and Western Medical Hospital in Wuhan; Heilongjiang Province Hospital of Chinese Medical Science in Ha'erbin; The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine in Tianjin; and Yueyang Hospital of Integrated Traditional Chinese and Western Medicine in Shanghai, China. The other 2 sites were Western medicine hospitals: the Chinese People's Liberation Army General Hospital (301 Hospital) in Beijing and West China Hospital in Chengdu, China.

Acknowledgment: The authors thank all of the members of the data and safety monitoring board: Lixing Lao, PhD, MB; Claudia M. Witt, MD, MBA; Justin C.Y. Wu, MD; Hugh Macpherson, PhD; Zhaoxiang Bian, MD, PhD; Chen Yao, PhD; and Zhiwei Xia, MD (Supplement Table 1). They also thank Dr. Zhiwei Xia from Peking University Third Hospital for consultation and training in differential diagnosis of constipation; Prof. Xiaohua Zhou from the Department of Biostatistics, University of Washington, for design and statistical guidance; and Prof. Jiqian Fang from the School of Public Health, Sun Yat-sen University, for his guidance in the revision of our manuscript.

Grant Support: By the Ministry of Science and Technology of the People's Republic of China through the Twelfth Five-Year National Science and Technology Pillar Program (grant 2012BAI24B01).

Disclosures: Authors have disclosed no conflicts of interest. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-3118.

Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer and Johnson & Johnson.

Reproducible Research Statement:Study protocol: See the Supplement. Statistical code: Available from Dr. Yan (e-mail, yanshiyan0927@sina.com). Data set: Available for purchase from Dr. Yan (e-mail, yanshiyan0927@sina.com).

Requests for Single Reprints: Baoyan Liu, MD, China Academy of Chinese Medical Sciences, 16 Nanxiaojie Dongzhimennei, Dongcheng, Beijing, China 100700; e-mail, 13601180524@139.com.

Current Author Addresses: Drs. Z. Liu, Wu, Xu, and Cai: Guang'anmen Hospital, China Academy of Chinese Medical Sciences, No. 5 Beixian'ge Street, Xicheng, Beijing, China 100053.

Drs. Yan, He, Ai, and J. Liu: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, 16 Nanxiaojie Dongzhimennei, Dongcheng, Beijing, China 100700.

Dr. Li: West China Hospital of Sichuan University, Chengdu, Sichuan, 37 Guoxuexiang, Wuhou, Chengdu, Sichuan, China 610041.

Dr. Dong: Yueyang Hospital of Integrated Traditional Chinese and Western Medicine of Shanghai University of Traditional Chinese Medicine, 110 Ganhe Road, Hongkou, Shanghai, China 200437.

Dr. Fang: The Third Affiliated Hospital of Zhejiang Chinese Medical University, 219 Moganshan Road, Gongshu, Hangzhou, Zhejiang, China 310005.

Dr. W. Fu: Guangdong Province Hospital of Traditional Chinese Medicine, 111 Dade Road, Yuexiu, Guangzhou, Guangdong, China 510120.

Dr. L. Fu: The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, 314, Anshan West Road, Nankai, Tianjin, China 300000.

Dr. Sun: Jiangsu Province Hospital of Traditional Chinese Medicine, 155 Hanzhong Road, Qinhuai, Nanjing, Jiangsu, China 210029.

Dr. L. Wang: Beijing Traditional Chinese Medicine Hospital of Capital Medical University, 23 Meishuguan Houjie, Dongcheng, Beijing, China 100010.

Dr. S. Wang: Heilongjiang Province Academy of Chinese Medical Science, 33 Xidazhi Street, Nangang, Ha'erbin, Heilongjiang, China 150080.

Dr. Yang: The First Affiliated Hospital of Anhui University of Chinese Medicine, 117 Meishan Road, Hefei, Anhui, China 230031.

Dr. H. Zhang: Wuhan Integrated Traditional Chinese Medicine and Western Medical Hospital, 215 Zhongshan Avenue, Qiaokou, Wuhan, Hubei, China 430022.

Dr. J. Zhang: Nanjing University of Chinese Medicine, 282 Hanzhong Road, Gulou, Nanjing, Jiangsu, China 210029.

Dr. J. Zhao: Dongzhimen Hospital of Beijing University of Chinese Medicine, 5 Haiyuncang, Dongcheng, Beijing, China 100700.

Dr. W. Zhao: Huguosi Hospital of Chinese Medicine of Beijing University of Chinese Medicine, 83 Mianhua Hutong, Xicheng, Beijing, China 100035.

Dr. Z. Zhou: Hubei Provincial Hospital of Traditional Chinese Medicine, 4 Huayuanshan Street, Wuhan, Hubei, China 430061.

Dr. K. Zhou: Daemen College, Physical Therapy Wound Care Clinic, 4380 Main Street, Amherst, NY 14226.

Dr. B. Liu: China Academy of Chinese Medical Sciences, 16 Nanxiaojie Dongzhimennei, Dongcheng, Beijing, China 100700.

Author Contributions: Conception and design: Z. Liu, L. He, B. Liu.

Analysis and interpretation of the data: S. Yan, K. Zhou, H. Xu.

Drafting of the article: Z. Liu, S. Yan, J. Wu, K. Zhou.

Critical revision of the article for important intellectual content: Z. Liu, J. Wu, L. He, K. Zhou, B. Liu.

Final approval of the article: Z. Liu, S. Yan, J. Wu, L. He, N. Li, G. Dong, J. Fang, L. Fu, J. Sun, L. Weng, S. Wang, J. Yang, H. Zhang, J. Zhang, J. Zhao, W. Zhou, Z. Zhou, Y. Ai, K. Zhou, J. Liu, Y. Cai, B. Liu.

Provision of study materials or patients: N. Li, G. Dong, J. Fang, L. Fu, J. Sun, L. Wang, S. Wang, J. Yang, H. Zhang, J. Zhang, J. Zhao, W. Zhou, Z. Zhou, Y. Cai.

Statistical expertise: S. Yan.

Obtaining of funding: Z. Liu, B. Liu.

Administrative, technical, or logistic support: L. He, N. Li, W. Fu, B. Liu.

Collection and assembly of data: Y. Ai, J. Liu, H. Xu.


Ann Intern Med. Published online 13 September 2016 doi:10.7326/M15-3118
© 2016 American College of Physicians
Text Size: A A A

Background: Acupuncture has been used for chronic constipation, but evidence for its effectiveness remains scarce.

Objective: To determine the efficacy of electroacupuncture (EA) for chronic severe functional constipation (CSFC).

Design: Randomized, parallel, sham-controlled trial. (ClinicalTrials.gov: NCT01726504)

Setting: 15 hospitals in China.

Participants: Patients with CSFC and no serious underlying pathologic cause for constipation.

Intervention: 28 sessions of EA at traditional acupoints or sham EA (SA) at nonacupoints over 8 weeks.

Measurements: The primary outcome was the change from baseline in mean weekly complete spontaneous bowel movements (CSBMs) during weeks 1 to 8. Participants were followed until week 20.

Results: 1075 patients (536 and 539 in the EA and SA groups, respectively) were enrolled. The increase from baseline in mean weekly CSBMs during weeks 1 to 8 was 1.76 (95% CI, 1.61 to 1.89) in the EA group and 0.87 (CI, 0.73 to 0.97) in the SA group (between-group difference, 0.90 [CI, 0.74 to 1.10]; P < 0.001). The change from baseline in mean weekly CSBMs during weeks 9 to 20 was 1.96 (CI, 1.78 to 2.11) in the EA group and 0.89 (CI, 0.69 to 0.95) in the SA group (between-group difference, 1.09 [CI, 0.94 to 1.31]; P < 0.001). The proportion of patients having 3 or more mean weekly CSBMs in the EA group was 31.3% and 37.7% over the treatment and follow-up periods, respectively, compared with 12.1% and 14.1% in the SA group (P < 0.001). Acupuncture-related adverse events during treatment were infrequent in both groups, and all were mild or transient.

Limitations: Longer-term follow-up was not assessed. Acupuncturists could not be blinded.

Conclusion: Eight weeks of EA increases CSBMs and is safe for the treatment of CSFC. Additional study is warranted to evaluate a longer-term treatment and follow-up.

Primary Funding Source: Ministry of Science and Technology of the People's Republic of China through the Twelfth Five-Year National Science and Technology Pillar Program.

Figures

Grahic Jump Location
Figure 1.

Trial flow diagram.

CSBM = complete spontaneous bowel movement; EA = electroacupuncture; SA = sham electroacupuncture.

* The intention-to-treat analyses consisted of all randomly assigned patients, including 3 who received no treatment. All participants had baseline data.

Grahic Jump Location
Grahic Jump Location
Figure 2.

Weekly CSBMs during the study.

Data are observed values of weekly CSBMs; error bars represent 95% CIs. The EA group had more than 2 CSBMs per week from weeks 4 to 20, and the SA group had 1.52 or fewer CSBMs per week throughout weeks 1 to 20. The differences between the EA and SA groups in repeatedly measured CSBMs per week were tested through the general linear model; the differences of the change from baseline in mean weekly CSBMs between groups were significant for the treatment and follow-up periods (P < 0.001). CSBM = complete spontaneous bowel movement; EA = electroacupuncture; SA = sham electroacupuncture.

* At 4 weeks, 1 patient in EA group missed the 2-week defecation diaries but completed all other defecation diaries.

† At 6 weeks, 1 patient in SA group missed the 2-week defecation diaries but completed all other defecation diaries.

Grahic Jump Location

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References

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Can the Role of Ethical Compliance be explored in Clinical Research of Unification in China? Still a Long Way to Go
Posted on September 20, 2016
Ling-Feng Zeng, MD, PhD1, 2; Wei-Xiong Liang, MD3; Wen-Hu Bao, MD, PhD4; Qi Wang, MD1, 3; and Jun Liu, MD2
Institute of Clinical Pharmacology, Guangzhou University of Chinese Medicine
Conflict of Interest: None Declared
Comment to the article by Dr. Liu et al. “Acupuncture for Chronic Severe Functional Constipation: A Randomized, Controlled Trial.”

Recently, a series of articles from China have been withdrawn for scientific misconduct, and some debates involving research integrity have been raised (1). With several updated versions, the Declaration of Helsinki (DoH) emphasized on research ethics, still has been served as the guidance for current research in clinical trial practice. Recent research guidelines adopted by researchers, authors and journal editors within China and globally, almost all underlined the fundamentality of strictly following the ethical principles coincided with the DoH. These domains include informed consent from subjects, approval of regional ethical committees (RECs), weighting of risk-benefit for vulnerable groups, study registration of protocols, and disclosure of potential conflicts of interest. Additionally, REC approval should be in place before recruiting the first participant, and further rechecked before final research data published in academic journals (2).

The paper by Dr. Liu et al. (3) has followed above standards of practice, thus attempted to conduct ethical trial involving acupuncture for chronic severe functional constipation (CSFC). The authors should be congratulated for their important research. They reported the study was performed in accordance with the guidelines of DoH and was approved by RECs from 15 responsible sites. Nevertheless, the informative version of DoH was not described in this article. We found the study protocol (4) published in 2013, reported in Page-3 of ‘Ethical considerations’ with the terms ‘The trial follows the principles of the Declaration of Helsinki (Version Edinburgh 2000).’ However, the DoHs have been updated by World Medical Association (WMA) General Assembly (e.g. Version Washington DC 2002, Version Tokyo 2004, Version Seoul 2008, and Version Fortaleza 2013). All previous versions of DoH have been replaced, and should not be applied or cited except for historical purposes(5). Another important issue would be ‘additional protection’ for vulnerable groups, especially for obtaining assent for elderly subjects with CSFC who lack capacity for consent, but the paper by Liu et al. (3-4) did not cover this.

In conclusion, this issue does not hope for a simple solution; however, if the efforts are attempted to take focusing on governmental regulations, education in ethics consideration for research staffs, and strict enhancement by journal editors not to publish articles with defects, the ethical compliance in clinical trial could be made better. Dr. Liu have made a good point on this issue, providing references for improving trial standards of practice in China. Great congratulation should be expressed for their earnest research.


References

1. Editorial. China's medical research integrity questioned. Lancet. 2015; 385: 1365. [PMID: 25890401] doi: 10.1016/S0140-6736(15)60700-0
2. Drazen JM, Van Der Weyden MB, Sahni P, Rosenberg J, Marusic A, Laine C, et al. Uniform format for disclosure of competing interests in ICMJE journals. Ann Intern Med. 2010; 152: 125-126. [PMID: 20083831] doi: 10.7326/0003-4819-152-2-200901190-00160
3. Liu Z, Yan S, Wu J, He L, Li N, Dong G, et al. Acupuncture for Chronic Severe Functional Constipation: A Randomized, Controlled Trial. Ann Intern Med. 2016 Sep 13. [PMID: 27618593] doi: 10.7326/M15-3118. [Epub ahead of print]
4. Liu Z, Liu J, Zhao Y, Cai Y, He L, Xu H, et al. The efficacy and safety study of electro-acupuncture for severe chronic functional constipation: study protocol for a multicenter, randomized, controlled trial. Trials. 2013; 14: 176. [PMID: 23768191] doi: 10.1186/1745-6215-14-176
5. World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013; 310: 2191-2194. [PMID: 24141714] doi: 10.1001/jama.2013.281053

Conflict of interest
The authors have no potential conflict of interests.

Corresponding author: Jun Liu, MD, Ethics Committee, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China; e-mail, liujun01y@163.com; Qi Wang, MD, Institute of Clinical Pharmacology, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China; e-mail, wqdme01@163.com.

Note: These authors (LF. Zeng and WX. Liang) contributed equally to this work. This work was partially supported by the National Natural Science Foundation of China (No. 81473698), and the Cultivation Project for Excellent Doctoral Dissertation of Guangdong Province (No. A1-AFD015141Z10504).


Current Author Addresses:
Ling-Feng Zeng, MD, PhD
Institute of Clinical Pharmacology, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China; Ethics Committee, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Wei-Xiong Liang, MD
Drug Clinical Trial Institute, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Wen-Hu Bao, MD, PhD
Ethics Review Committee, World Federation of Chinese Medicine Societies, Beijing 100101, China.
Qi Wang, MD
Institute of Clinical Pharmacology, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China; Drug Clinical Trial Institute, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Jun Liu, MD
Ethics Committee, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Acupuncture for chronic functional constipation: a potential therapy
Posted on September 23, 2016
Li-Wen Zhang, Guang-Xia Shi, Cun-Zhi Liu
Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
Conflict of Interest: None Declared
Acupuncture for chronic functional constipation: a potential therapy

Correspondence to: Dr. Cun-Zhi Liu, Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University.
Postal address: No.23 Meishuguanhou Street, Dongcheng District, Beijing 100010, China.
E-mail: lcz623780@126.com

In the article “Acupuncture for Chronic Severe Functional Constipation: A Randomized, Controlled Trial”[1], the authors concluded that eight weeks of electroacupuncture (EA) increases complete spontaneous bowel movements (CSBMs) and is safe for the treatment of chronic severe functional constipation (CSFC). This multicenter trial was conducted at 15 sites in China with a large sizes (1075 participants). The blinding assessment results and low dropout rate suggest that blinding was successful with shallow needling at nonacupoints as a control. We do not object to this conclusion, but have some suggestions and concerns about the design of this clinical trial.
Firstly, we believe that this study design could potentially exaggerate the placebo effect of acupuncture. They conducted the multicenter trial at 15 sites——13 traditional Chinese medicine (TCM) hospitals and 2 Western medicine hospitals. Though this is a broad recruitment strategy, the eligible participants may more tend to be willing to accept TCM treatment. The treatment expectancy and credibility did not be assessed during the period of treatment, thus, the related effect on patients is largely unknown. The participants recruited by TCM hospitals may have a stronger expectancy and credibility for acupuncture treatment, so the results of this trial may overstate the effect of acupuncture for CSFC.
Secondly, in this study the EA stimulation lasted for 30 minutes with a current intensity of 0.1 to 1 mA depending on the participant's comfort level. The current intensity is an important factor for EA and was not reported of each person. If the individual data has been recorded, the optimum parameter for CSFC treatment could be analyzed and a basis may be provided for future related guidelines and treatment protocol. Furthermore, individualized treatment according to different types of TCM syndrome differentiation should be taken. The diagnostic and treatment procedures of TCM should be tailored to each individual’s specific symptoms[2].
Thirdly, the acupuncturists asked participates to guess EA or SA they received after treatments in weeks 4 and 8 to test the success of blinding. The answer of blinding assessment should involve a “not sure”, for participates who do not know which group they were allocated to. It is helpful to blinding that participates don't have to choose which group they were in. Most chronic constipation is associated with greater impairment in quality of life and depression[3], therefore, the depressive and anxiety symptoms for CSFC participates should be assessed.
References
[1] Liu Z, Yan S, Wu J, et al. Acupuncture for Chronic Severe Functional Constipation: A Randomized, Controlled Trial. Ann Intern Med. 2016.
[2] Conboy L, Gerke T, Hsu KY, St JM, Goldstein M, Schnyer R. The Effectiveness of Individualized Acupuncture Protocols in the Treatment of Gulf War Illness: A Pragmatic Randomized Clinical Trial. PLoS One. 2016. 11(3): e0149161.
[3] Koloski NA, Jones M, Wai R, Gill RS, Byles J, Talley NJ. Impact of persistent constipation on health-related quality of life and mortality in older community-dwelling women. Am J Gastroenterol. 2013. 108(7): 1152-8.
Risk Reduction of Minimization involving Placebo-Controlled Clinical Trials of Acupuncture
Posted on September 24, 2016
Ning-Sheng Wang, MD; Ling-Feng Zeng, MD, PhD; Li-Ting Zhu, MD, PhD; Xing Zeng, MD, PhD; and Chuan-Jian Lu, MD, PhD (NS. Wang and LF. Zeng contributed equally to this work.)
Ethics Committee, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Conflict of Interest: None Declared
Comment to the article by Dr. Liu et al. “Acupuncture for Chronic Severe Functional Constipation: A Randomized, Controlled Trial.”

As the ‘gold standard’ of methodology in clinical research, randomized controlled trials have been increasingly viewed as one of the most remarkable social constructions (1). It aimed to demonstrate that certain health benefits could be produced by a new intervention, and this process justified with its risk. Finally, all these positive responses of biomedical development should be further verified before applied in clinical practice. The voluntary patients contributed to major sources of subjects that participating in the trials (2); however, most of them included in the group that using placebo-oriented therapies. Due to a large proportion of trials involving new drugs or devices might not show effective results in a short time, many subjects could not benefit from pilot projects (3). Thus, it is a compelling moral responsibility to guarantee subjects’ basic health away from harm.

In this paper by Dr. Liu et al. (4), the control conditions of sham electroacupuncture at nonacupoints involved the denial or delay of routine medical care. Nowadays, very few patients with chronic severe functional constipation do not obtain at least partial benefits from routine therapies; to some extents, the application of no-therapy control or placebo-oriented treatment might be viewed as a harmful or unethical choice. Consequently, it should be well considered whether the harms or risks for subjects outweigh the benefits of particular study objectives, especially while refusing to receive a timely therapy of proven therapeutic effects. The ethics concerns of taking a placebo might be minimal when the disorders to be managed in the study were observed in chronic and stable conditions (5), especially the delay or denies of a proven therapeutic therapy just resulted in a relatively low risk for the subjects. In this case, one of the better solutions is to offer the subjects with therapy at the completion of the study, and guarantee the subjects to receive positive treatment as acupuncture was indicated to be helpful. Also, this approach should be described in the predesigned trial protocol.

Conversely, if the subjects’ conditions developed rapidly or even found serious consequences while withdrawn a proven therapeutic therapy, the only ethical choice might be to guarantee the adoption of proven therapeutic invention in each group of the study. In this context, the acupuncture may be considered as an adjuvant treatment with routine therapies. In all, the protection of subjects’ rights, health and safety should be the primary concern in human clinical trials.


References

1. Laine C, De Angelis C, Delamothe T, Drazen JM, Frizelle FA, Haug C, et al. Clinical trial registration: looking back and moving ahead. Ann Intern Med. 2007; 147: 275-277. [PMID: 17548404]
2. Snyder L; American College of Physicians Ethics, Professionalism, and Human Rights Committee. American College of Physicians Ethics Manual: sixth edition. Ann Intern Med. 2012; 156: 73-104. [PMID: 22213573] doi: 10.7326/0003-4819-156-1-201201031-00001
3. Zhang J, Huang H, Shen X. Cultivating and investing in clinical research in China. Lancet. 2015; 386: 1506-1508. [PMID: 26466054] doi: 10.1016/S0140-6736(15)00341-4
4. Liu Z, Yan S, Wu J, He L, Li N, Dong G, et al. Acupuncture for Chronic Severe Functional Constipation: A Randomized, Controlled Trial. Ann Intern Med. 2016 Sep 13. [PMID: 27618593] doi: 10.7326/M15-3118. [Epub ahead of print]
5. World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013; 310: 2191-2194. [PMID: 24141714] doi: 10.1001/jama.2013.281053


Conflict of interest
The authors have no potential conflict of interests.

Corresponding author: Chuan-Jian Lu, MD, PhD, Drug Clinical Trial Institute, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China; e-mail: chuanjianlugcp@163.com; Xing Zeng, MD, PhD, Ethics Committee, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China; e-mail: xingzengethics@163.com.

Note: These authors (NS. Wang and LF. Zeng) contributed equally to this work. This work was partially supported by the National Science and Technology Major Project (No. 2012ZX09303009-003), Project of Guangdong Provincial Department of Finance (No.[2014]157), and the Cultivation Project for Excellent Doctoral Dissertation of Guangdong Province (No. A1-AFD015141Z10504).


Current Author Addresses:

Ning-Sheng Wang, MD
Institute of Clinical Pharmacology, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China.

Ling-Feng Zeng, MD, PhD
Institute of Clinical Pharmacology, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China; Ethics Committee, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.

Li-Ting Zhu, MD, PhD
Institutes of Science and Development, Chinese Academy of Sciences, Beijing 100190, China.

Xing Zeng, MD, PhD
Ethics Committee, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.

Chuan-Jian Lu, MD, PhD
Drug Clinical Trial Institute, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
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