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ÇØ À̺´Ã¶´Ô µî Àü¹®°¡ ºÐµéÀÌ Ãß°¡ ¼³¸í, ¿À·ù µî ÁöÀûÇØ Áֽñ⠹ٶø´Ï
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1. ħ¼ú È¿°ú ½ÃÇè°ú ³í¹®   

³úÁ¹Áß¿¡ ħ¼úÀÌ È¿°ú°¡ Àִ°¡? ¿ì¼± ±× ȯÀÚ°¡ ³úÁ¹ÁßÀ̶ó´Â Á¤È®ÇÑ Áø
´ÜÀÌ ÀÖ¾î¾ß ÇÕ´Ï´Ù. ±×¸®°í ³úÁ¹Áß È¯Àڴ ħ¼ú¸¸ °®°í Ä¡·áÇÏ´Â °æ¿ì´Â
°ÅÀÇ ¾ø°í ¿Ü°úÀû óġ ¶Ç´Â (¼­¾ç) ¾à¹° ¿ä¹ý µî Á¤Åë ¹æ¹ýÀ» ½ÃÇàÇϱâ
¶§¹®¿¡ ÀÌ Á¤Åë¹æ¹ý¸¸À» ½ÃÇàÇÑ °æ¿ì¿Í Á¤Åë Ç÷¯½º ħ¼úÀ» ½ÃÇàÇÑ °æ¿ì¸¦
ºñ±³ÇÏ¿© ħ¼úÀÌ È¯ÀÚÀÇ Ä¡·áȸº¹¿¡ ±â¿©Çß´ÂÁö¸¦ ÆÇ´ÜÇÕ´Ï´Ù. À̶§ Ä¡·á
ȸº¹ È¿°ú´Â ¹Ì¸® ¼³Á¤ÇØ ³õÀº ÁöÇ¥¿¡ µû¶ó Á¡¼ö·Î ³ªÅ¸³À´Ï´Ù.

ÀÓ»ó½ÃÇè¿¡¼­´Â ÀÌÁ߸ͽÃÇèÀÌ °¡Àå ¹Ù¶÷Á÷ÇÕ´Ï´Ù. ±×·¯³ª ħ¼úÀÇ ÀÌÁ߸ͽÃ
ÇèÀº ºÒ°¡´ÉÇÕ´Ï´Ù. ¼³È¤ °¡Â¥(sham) ħ¼úÀÌ ÀÖ´Ù°í Çصµ Àǻ絵 ¸ð¸¦ °¡
Â¥ ħ¼úÀÌ °¡´ÉÇÒÁö »ý°¢ÇØ º¾´Ï´Ù. ±×·¡¼­ ÃæºÐÇÑ ¼öÀÇ È¯ÀÚ¸¦ ¹«ÀÛÀ§Àû
À¸·Î ħ¼ú±º°ú ºñħ¼ú±ºÀ¸·Î ³ª´©¾î ħ¼ú±º¿¡¸¸ ħ¼úÀ» ½ÃÇàÇÏ°í ¾î¶² ȯ
ÀÚ°¡ ¾î´À ±º¿¡ ¼ÓÇÏ´ÂÁö ¸ð¸£´Â Æò°¡ÀÚ·Î ÇÏ¿©±Ý Ä¡·áȸº¹ È¿°ú¸¦ Æò°¡ÇÏ
°Ô ÇÕ´Ï´Ù. ÀÌ·± ½ÃÇè¹æ¹ýÀ» ¹«ÀÛÀ§ ÅëÁ¦ ½ÃÇè(randomized controlled trial)
À̶ó°í ÇÕ´Ï´Ù.

ÀÌ ½ÃÇè¿¡¼­ ³ª¿Â °á°ú´Â ³í¹®À¸·Î Åõ°íÇÕ´Ï´Ù. À̶§ ħ¼úÀÇ È¿°ú°¡ ³ªÅ¸
³µ°Ç ³ªÅ¸³ªÁö ¾Ê¾Ò´ø ¸ðµÎ°¡ Áß¿äÇÑ °á°úÀÔ´Ï´Ù. ÀÌ ³í¹®À» Á¢¼öÇÑ Çмú
ÀâÁöÀÇ ÆíÁýÀÚ´Â À̸¦ ÀÌ ºÐ¾ß Àü¹®°¡¿¡°Ô º¸³» ½É»çÇÏ°Ô ÇÕ´Ï´Ù. ÇÑ ¸¶µð
·Î Á¦´ë·Î µÈ ¿¬±¸ÀÎÁö Æò°¡ÇÕ´Ï´Ù. ¾Õ¼­ ¸»ÇÑ Áø´ÜÀÌ Á¦´ë·Î µÈ ȯÀÚÀÎÁö,
ÁøÁ¤À¸·Î ¹«ÀÛÀ§ ÅëÁ¦½ÃÇèÀÎÁö, Ä¡·áȸº¹ Æò°¡±âÁØÀÇ ¼³Á¤°ú Æò°¡°¡ Á¦´ë
·Î µÇ¾ú´ÂÁö, Åë°è󸮰¡ Á¦´ë·Î µÇ¾ú´ÂÁö µîµîÀ» »ìÆ캼 °ÍÀÔ´Ï´Ù. ÀÌ·¸°Ô
Çؼ­ ±× ÀâÁöÀÇ ±âÁØ¿¡ ¸Â´Â °ÍÀÌ °ñ¶óÁ® ÀâÁö¿¡ ½Ç¸³´Ï´Ù.

2. ħ¼ú È¿°ú ´ÙÅùÀÇ ÆÇÁ¤ 

ÇмúÀâÁö¿¡ ½Ç¸° ³í¹®À̶ó°í ÀüºÎ °°Áö ¾Ê½À´Ï´Ù. ÀϹÝÀûÀ¸·Î ±¹Á¦Àû Çмú
ÀâÁöÀÇ ³í¹®Àº ÀÏÁ¤ÇÑ ¼öÁØÀ» °®Ãá °ÍÀ¸·Î ÀÎÁ¤¹Þ½À´Ï´Ù. ±×·±µ¥ ÀÌ·± ÇÐ
¼úÀâÁöÀÇ ³í¹®µµ ħ¼úÀÇ È¿°ú¿¡ ´ëÇØ ÀÏÄ¡µÈ °á°ú°¡ ¾ø½À´Ï´Ù. ±àÁ¤, ºÎÁ¤
¸ðµÎ°¡ ÀÖ½À´Ï´Ù. ÀüüÀûÀ¸·Î ħ¼úÀÌ È¿°ú°¡ ÀÖ´ÂÁö, ¾ø´ÂÁö ¸»Çϱ⠾î·Æ½À
´Ï´Ù. È¿°ú°¡ ÀÖ´Ù°í ´ÜÁ¤ÇÏÁö ¸»¶ó, È¿°ú°¡ ¾ø´Ù°í ´ÜÁ¤ÇÏÁö ¸»¶ó, Àڽſ¡
¸Â´Â ³í¹®À» ´ë¸ç °è¼Ó ´ÙÅú´Ï´Ù. À̶§ °úÇÐÀÇ ¼¼°è¿¡¼­ ÀÎÁ¤ÇÏ´Â ÆÇÁ¤¹ý
ÀÌ ¾øÁö ¾Ê½À´Ï´Ù. 

°£´ÜÈ÷ ¸»Çϸé, °¡Àå ÀßµÈ, Áï ÃæºÐÇÑ È¯ÀÚ¸¦ ´ë»óÀ¸·Î ¿À·ù¸¦ Á¦°ÅÇÒ ÃÖ¼±
ÀÇ µðÀÚÀÎÀ¸·Î ½ÃÇèµÈ ¿¬±¸ °á°ú¸¦ ±Ù°Å·Î ¸»ÇÒ ¼ö ÀÖ½À´Ï´Ù. ¾Õ¼­ À̺´Ã¶
´ÔÀº ÀÌ·± »ç·Ê¸¦ µé¾ú½À´Ï´Ù. ±×¸®°í ¸¹Àº ÀÓ»ó ½ÃÇè °á°ú¿¡¼­ ½ÃÇè ±âÁØ
ÀÇ ¾ö°Ý¼º Á¤µµ¿Í È¿°ú Á¤µµÀÇ »ó°ü¼ºÀ» ºÐ¼®ÇÏ´Â ¸ÞŸ ºÐ¼®¹ýÀÌ ÀÖ½À´Ï
´Ù. ½ÃÇè ÅëÁ¦°¡ ¾ö°ÝÇÒ¼ö·Ï È¿°ú°¡ Àû¾îÁ³´Ù¸é ±× È¿°ú ÁÖÀåÀº ½ÃÇèµðÀÚ
ÀλóÀÇ ¹®Á¦¿¡¼­ ºñ·ÔµÈ °ÍÀÌ¸ç ¿ÏÀüÈ÷ ÅëÁ¦µÈ ½ÃÇè¿¡¼­´Â È¿°ú°¡ ¾øÀ¸¸®
¶ó°í º¸´Â °ÍÀÔ´Ï´Ù. ħ¼úÀ» ¸ÞŸ ºÐ¼®ÇÏ¿© È¿°ú°¡ ¾ø´Ù°í ÇÑ ³í¹®µéµµ ÀÖ
½À´Ï´Ù.

3. ¿Á½ºÆÛµåÆÀ ¿¬±¸

±×¸®°í À̹ø¿¡ ¼Ò°³ÇÒ ¿Á½ºÆÛµåÆÀÀÇ ¿¬±¸¿Í °°Àº ¹æ¹ýµµ ÀÖ½À´Ï´Ù. À̵éÀº
³úÁ¹Áß È¸º¹¿¡ ħ¼úÀÇ È¿°ú À¯¹«¸¦ °¡¸®Áö ¾Ê°í ÀÏÁ¤ ¼öÁØÀ» °¡Áø ³í¹®À»
ÅÃÇÏ¿© ½ÃÇè µðÀÚÀÎ µî ¿À·ù °¡´É¼ºÀ» °ËÅäÇÏ¿© ±× °á°ú°¡ ¿ø³í¹®À» ÁöÁö
ÇÏ´ÂÁö¸¦  Æò°¡ÇÏ¿´½À´Ï´Ù.

À̵éÀº ¹«ÀÛÀ§ ÅëÁ¦ ½ÃÇèµÈ ³í¹® 7°³¸¦ ¼±ÅÃÇÏ¿© ºÐ¼®Çß½À´Ï´Ù. ±¹Á¦Àû Àâ
Áö¿¡ °ÔÀçµÈ ³í¹®µéµµ º¸ÀÔ´Ï´Ù. 7°³ ³í¹® Áß¿¡¼­ º»·¡ 1°³´Â È¿°ú°¡ ¾ø´Ù
°í ÇÑ °ÍÀε¥, ±×´ë·ÎÀ̸ç È¿°ú°¡ ÀÖ´Ù°í ÇÑ 6°³ Áß¿¡¼­ 2°³ ¸¸ÀÌ ¿À·ù°¡
¾ø´Â °ÍÀ¸·Î Æò°¡µÇ¾ú´Ù°í ÇÕ´Ï´Ù. ´Ù½Ã ¸»Çؼ­ 7°³ÀÇ ºñ±³Àû Á¦´ë·Î ½ÃÇà
µÇ¾ú´Ù°í º» ÀÓ»ó½ÃÇè¿¡¼­ 5°³´Â È¿°ú°¡ ¾ø°Å³ª È¿°ú°¡ ÀÖ´Ù°í ¸»ÇÒ ¼ö ¾ø
À¸¸ç 2°³¸¸ÀÌ ¿øÀúÀÚÀÇ È¿°ú°¡ ÀÖ´Ù´Â °á·ÐÀ» ¹øº¹ÇÒ ¿À·ù¸¦ ã¾Æ³»Áö ¸ø
Çß´Ù´Â ¸»ÀÔ´Ï´Ù. 

¿Á½ºÆÛµåÆÀÀº "ħ¼úÀÌ ³úÁ¹Áß¿¡ µµ¿òÀÌ µÈ´Ù´Â ¾î¶² ±Ù°Å°¡ Àִ°¡?"¶ó°í
Áú¹®ÇÏ¸ç ´äÀº °£´ÜÇÏ´Ù°í Çß½À´Ï´Ù. 6°³ÀÇ ³í¹®ÀÌ Ä§¼úÀÌ È¿°ú°¡ ÀÖ´Ù°í
ÇßÀ¸³ª ÀÌ·¸°Ô Æò°¡ÇØ º¸¸é ¾î¶² ¹æ½ÄÀ¸·Îµç ³úÁ¹Áß¿¡ ħ¼úÀÌ À¯¿ëÇÏ´Ù´Â
³³µæÇÒ ¸¸ÇÑ ±Ù°Å°¡ ¾ø´Ù°í Çß½À´Ï´Ù. µû¶ó¼­ ħ¼ú ½Ã¼úÀº ȯÀÚÀÇ Ä¡·á¸¦
À§ÇØ ÁýÁßÇØ¾ß ÇÒ º´¿øÀÚ¿øÀ» ºÒÇÊ¿äÇÏ°Ô ³¶ºñÇϰųª ºÐ»ê½Ãų »ÓÀ̶ó°í
Çß½À´Ï´Ù.

¾Æ·¡ 7°³ÀÇ ³í¹®(¿Á½ºÆÛµåÆÀ ³í¹® ÀÎ¿ë ¹øÈ£¸¦ ±×´ë·Î ³ªÅ¸³Â½À´Ï´Ù)°ú Æò
°¡ °á°ú¸¦ ³ªÅ¸³»¸ç Á¦ÀÏ ¹Ø¿¡´Â ¿Á½ºÆÛµåÆÀ ³í¹® ÃÊ·ÏÀ» ÷ºÎÇÏ¿´½À´Ï´Ù.
¾Æ·¡ÀÇ positive, negative´Â È¿°ú À¯¹«¸¦ ÀÌÇØÇϱ⠽±°Ô Ç¥ÇöÇÑ °ÍÀÔ´Ï´Ù.
negative¿¡ ¼³¸íÀÌ ºÙÀº °ÍÀº º»·¡ positive¶ó°í ³ª¿Â °ÍÀ̳ª Æò°¡°á°ú
positive ÆÇÁ¤¿¡ ¿À·ù°¡ ÀÖ¾î È¿°ú°¡ ¾ø°Å³ª ÀÖ´Ù°í ÇÒ ¼ö ¾ø´Ù°í º» °ÍÀÔ
´Ï´Ù. 

17. Li D, Wenduo L, Lihua W, Yulin Z, Huaizhong L. Clinical
observation on acupuncture therapy for cerebral hemorrhage. J Trad
Chin Med 1989, 9:9-13.

**positive

18. Hu H, Chung C, Liu TJ, Chen RC, Chen C, Chou P, Huang W, Lin
JCT, Tsuei JJ. A randomized controlled trial on the treatment for acute
partial ischaemic stroke with acupuncture. Neuroepidemiol 1993,
12:106-13.

**negative : positive result depended only on sub group analysis and on
only some outcomes.

19. Johansson K, Lindgren I, Widner H, Wiklund I, Johansson BB. Can
sensory stimulation improve the functional outcome in stroke patients?
Neurology 1993, 43:2189-92.

**positive

20. Kjendahl A, Sallstrom S, ¨ªstern PE, Stanghelle JK, Borchgrevik
CF. A one year follow-up study on the effects of acupuncture in the
treatment of stroke patients in the subacute stage: a randomized,
controlled study. Clin Rehabil 1997, 11:192-200.

**negative : statistical significance only obtained on small differences
between start and finish points.

21. Gosman-Hedstrom G, Claesson L, Klingenstierna U, Carlsson J,
Olausson B, Frizell M, Fagerberg B, Blomstrand C. Effects of
acupuncture treatment on daily life activities and quality of life: A
controlled, prospective, and randomized study of acute stroke patients.
Stroke 1998, 29:2100-8.

**negative :

22. Si Q, Wu G, Cao X. Effects of elecroacupuncture on acute cerebral
infarction. Acupunct & Electro-therapeut Res Int J 1998, 23:117-124.

**negative :  there was no difference between patients at beginning and
end of study.

23. Wong AMK, Su T, Tang F, Cheng P, Liaw M. Clinical trial of
electrical acupuncture on hemiplegic stroke patients. Am J Phys Med
Rehabil 1999, 78:117-122.

**negative : statistical analysis and reported results are not
believable. For instance Table 4 in the paper has exactly the same mean
symptom improvement score and variability for seven different items.

.......................................................
©Bandolier: 08-Jan-2001

Assessing the evidence of effectiveness of acupuncture for stroke
rehabilitation: stepped assessment of likelihood of bias
 
Lesley A Smith, Owen A Moore, Henry J McQuay, Andrew Moore
Pain Research Unit and Nuffield Department of Anaesthetics
University of Oxford
Oxford Radcliffe Hospital
The Churchill
Headington
Oxford OX3 7LJ, UK

Correspondence to RA Moore, Pain Research Unit
Tel: +44 1865 226132
Fax: +44 1865 226978
email: andrew.moore@pru.ox.ac.uk

-----------------------------------
Abstract

Objective: To investigate the effects of known potential sources of bias
on whether acupuncture is beneficial in treating stroke.

Data sources: Cochrane Library, MEDLINE, EMBASE, PubMed and
reference lists of previous reviews were used to seek randomised
controlled trials. There were seven randomised trials that met the
inclusion criteria.

Methods: Pooling of outcomes was known to be unlikely. Trials were
judged by the authors and by us as being positive (acupuncture was
helpful) or negative (no benefit could be shown). The effect of trial
quality, validity and origin were examined to investigate whether these
affected the overall outcome. The overall outcome - is there evidence of
a benefit and is the size of that benefit worthwhile? - was examined
from the perspective of the highest quality trials.

Results: Our conclusion was that two studies had a positive result and
five a negative. The three observer blind trials we judged to be
negative. The single trial with a quality score of three was negative.
The two trials with a validity score of nine or more we judged to be
negative. Two of the three European studies we judged to be negative.
Sensitivity analyses based on blinding, reporting quality, validity score
and country of origin all showed a higher proportion of positive results
for poor quality trials than for those of higher quality.

Conclusion: Sensitivity analysis for known sources of bias is important
where "vote-counting" replaces data pooling. There were no high
quality trials of acupuncture for stroke that showed that it was
beneficial.
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