Assessing the Reporting Quality of Randomized Controlled Trials on Acupuncture for Acute Ischemic Stroke Using the CONSORT Statement and STRICTA_Chinese Journal of Evidence-Based Medicine

Authors：

ZHANG Xiaoli ,  LI Jing , ZHANG Mingming , YUAN Wenming

Department of Evidence-Based Medicine and Clinical Epidemiology, West China Hospital, Sichuan University. Chengdu 610041, China;

Corresponding author：

LI Jing, Email: lijing68@hotmail.com

Keywords：

Acute ischemic stroke; Acupuncture; Reporting quality; CONSORT; STRICTA

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Objective 　To evaluate the reporting quality of randomized controlled trials (RCTs) on acupuncture for acute ischemic stroke.
Methods　 Six databases including The Cochrane Central Register of Controlled Trials (CENTRAL, Issue 4, 2005), MEDLINE (1966 to December 2005), EMbase (1984 to December 2005), China National Knowledge Infrastructure (CNKI, 1994 to December 2005), China Biomedicine Database disc (CBMdisc, 1980 to December 2005), VIP (a full text issues database of China, 1989 to December 2005) were searched systematically. Handsearch for further references was conducted. Language was limited to Chinese and English. We identified 74 RCTs that used acupuncture as an intervention and assessed the quality of these reports against the Consolidated Standards for Reporting of Trials (CONSORT) statement and Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA).
Results 　In regard to the items in the CONSORT statement, 54 (73%) RCTs described baseline demographic and clinical characteristics in each group. Twenty-six (35%) mentioned the method of generating the random sequence, with 4 (5%) using a computer allocation. Only 6 (8%) RCTs had adequate allocation concealment, with 5 RCTs using sealed opaque envelopes and 1 RCT using centralized computer allocation. Only 8 (11%) RCTs used blinding, including 5 described as double-blind. Four (5%) RCTs reported the sample size calculation and 5 (7%) RCTs reported that an intention-to-treat (ITT) analysis. In regard to the items in STRICTA , only 4 (5%) RCTs reported the numbers of needles inserted. In 35 (47%) RCTs the needle type was reported, but only 26 (35%) mentioned the depths of insertion. Only 1 (1%) RCT mentioned the length of clinical experience and 6 (8%) RCTs reported the background of the acupuncture practitioners, but none stated the duration of their training.
Conclusion 　The reporting quality of RCTs of acupuncture for acute ischemic stroke was low. The CONSORT statement and STRICTA should be used to standardize the reporting of RCTs of acupuncture.

Citation： ZHANG Xiaoli,LI Jing,ZHANG Mingming,YUAN Wenming. Assessing the Reporting Quality of Randomized Controlled Trials on Acupuncture for Acute Ischemic Stroke Using the CONSORT Statement and STRICTA. Chinese Journal of Evidence-Based Medicine, 2006, 06(8): 586-590. doi: Copy

1.	陈松清, 王一萍, 李怡新. 颈部针刺治疗急性期脑梗塞95例. 中国康复理论与实践, 1997; 3(4): 161-162.
2.	司全明, 吴根诚, 曹小定. 电针治疗急性脑梗塞患者临床疗效观察. 中国针灸, 1999;(3):137-139.
3.	段国俊, 唐强, 张春英, 等. 不同部位脑梗塞针刺效应比较. 中国针灸, 1997; (10): 591-593.
4.	姜松鹤, 孟庆刚, 唐强, 等. 头穴透刺配合尿激酶治疗急性脑梗塞的临床研究. 中医药学报, 1998; (3): 51-52.
5.	张小澍，袁玉民. 急性脑梗塞患者VIP,SS,PP改变及电针对其的影响. 针刺研究, 1996; (4): 10-16.
6.	Park J, Hophood V, White AR, et al. Effectiveness of acupuncture for stroke: A systematic review. Journal of Neurology, 2001; 248(7):558-63.
7.	Johansson K, Lindgren I, Widner H, et al. Can sensory stimulation improve the functional outcome in stroke patients? Neurology, 1993; 43: 2189-2192.
8.	Chen SQ, Wang YP, Li YX. Effects of acupuncture on neck in the treatment of 95 cases of acute cerebral infarction. Chinese Journal of Rehabilitation Therapy and Practic, 1997; 3(4):161-162.
9.	Si QM, Wu GC, Cao XL. Effects of electroacupuncture on acute cerebral infarction. Chinese Acupuncture and Moxibustion, 1999;(3):137-139.
10.	Duan GJ, Tang Q, Zhang CY, et al. Comparison of effects of acupuncture on cerebral infarction in different parts. Chinese Acupuncture and Moxibustion, 1997;(10):591-593.
11.	Jiang SH, Meng QG, Tang Q, et al. Effect of scalp acupuncture combinated with urokinase on acute cerebral infarction. Acta Chinese Medicine and Pharmacology, 1998; (3): 51-52.
12.	Gunilla GH, Lisbet C, Ulrika K, et al. Effects of Acupuncture Treatment on Daily Life Activities and Quality of Life. Stroke, 1998; 29: 2100-2108.
13.	Johansson BB, Haker E, Arbin MV, et al. Acupuncture and transcutaneous nerve stimulation in stroke rehabilitation-A randomized, controlled trial. Stroke, 2001; 32: 707-713.
14.	Zhang XS, Yuan YM. The changes of vasoactive intestinal peptide somatostatin and pancreatic polypeptide in blood and CSF of acute cerebral infarction patients and the effect of acupuncture. Acupuncture Research, 1996; (4):10-16.
15.	Altman DG, Schulz K, Moher D, et al. The Revised CONSORT Statement for Reporting Randomized Trials Explanation and Elaboration. Ann Intern Med, 2001; 134(8): 663-694.
16.	MacPherson H, White A, Cummings M, et al. STRICTA (Standards for Reporting Interventions in Controlled Trials of Acupuncture). Acupuncture in Medicine, 2002; 20(1): 22-25.
17.	Schulz KF, Chalmers I, Hayes RJ, et al. Empirical evidence of bias - dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA, 1995; 272: 408-412.

1. 陈松清, 王一萍, 李怡新. 颈部针刺治疗急性期脑梗塞95例. 中国康复理论与实践, 1997; 3(4): 161-162.
2. 司全明, 吴根诚, 曹小定. 电针治疗急性脑梗塞患者临床疗效观察. 中国针灸, 1999;(3):137-139.
3. 段国俊, 唐强, 张春英, 等. 不同部位脑梗塞针刺效应比较. 中国针灸, 1997; (10): 591-593.
4. 姜松鹤, 孟庆刚, 唐强, 等. 头穴透刺配合尿激酶治疗急性脑梗塞的临床研究. 中医药学报, 1998; (3): 51-52.
5. 张小澍，袁玉民. 急性脑梗塞患者VIP,SS,PP改变及电针对其的影响. 针刺研究, 1996; (4): 10-16.
6. Park J, Hophood V, White AR, et al. Effectiveness of acupuncture for stroke: A systematic review. Journal of Neurology, 2001; 248(7):558-63.
7. Johansson K, Lindgren I, Widner H, et al. Can sensory stimulation improve the functional outcome in stroke patients? Neurology, 1993; 43: 2189-2192.
8. Chen SQ, Wang YP, Li YX. Effects of acupuncture on neck in the treatment of 95 cases of acute cerebral infarction. Chinese Journal of Rehabilitation Therapy and Practic, 1997; 3(4):161-162.
9. Si QM, Wu GC, Cao XL. Effects of electroacupuncture on acute cerebral infarction. Chinese Acupuncture and Moxibustion, 1999;(3):137-139.
10. Duan GJ, Tang Q, Zhang CY, et al. Comparison of effects of acupuncture on cerebral infarction in different parts. Chinese Acupuncture and Moxibustion, 1997;(10):591-593.
11. Jiang SH, Meng QG, Tang Q, et al. Effect of scalp acupuncture combinated with urokinase on acute cerebral infarction. Acta Chinese Medicine and Pharmacology, 1998; (3): 51-52.
12. Gunilla GH, Lisbet C, Ulrika K, et al. Effects of Acupuncture Treatment on Daily Life Activities and Quality of Life. Stroke, 1998; 29: 2100-2108.
13. Johansson BB, Haker E, Arbin MV, et al. Acupuncture and transcutaneous nerve stimulation in stroke rehabilitation-A randomized, controlled trial. Stroke, 2001; 32: 707-713.
14. Zhang XS, Yuan YM. The changes of vasoactive intestinal peptide somatostatin and pancreatic polypeptide in blood and CSF of acute cerebral infarction patients and the effect of acupuncture. Acupuncture Research, 1996; (4):10-16.
15. Altman DG, Schulz K, Moher D, et al. The Revised CONSORT Statement for Reporting Randomized Trials Explanation and Elaboration. Ann Intern Med, 2001; 134(8): 663-694.
16. MacPherson H, White A, Cummings M, et al. STRICTA (Standards for Reporting Interventions in Controlled Trials of Acupuncture). Acupuncture in Medicine, 2002; 20(1): 22-25.
17. Schulz KF, Chalmers I, Hayes RJ, et al. Empirical evidence of bias - dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA, 1995; 272: 408-412.

Chinese Journal of Evidence-Based Medicine

Assessing the Reporting Quality of Randomized Controlled Trials on Acupuncture for Acute Ischemic Stroke Using the CONSORT Statement and STRICTA

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