Randomized Clinical Controlled Trials with Herbal Acupuncture (Pharmacopuncture) in Korea - A Systematic Review

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서 론

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(Randomized Controlled Clinical Trial, RCT) Randomized Clinical Controlled Trials with Herbal Acupuncture

(Pharmacopuncture) in Korea - A Systematic Review

Bong-Ky Park, Jung-Hyo Cho, Chang-Gue Son

Department of Liver-Immunity in Oriental Medicine College, Daejeon University

Objective: By assessing the quality of methodology and synthesis of results of RCTs (Randomized Controlled Clinical Trials) with herbal acupuncture (pharmacopuncture), we hope to help with administrating herbal acupuncture therapy in clinic and conducting RCT with herbal acupuncture.

Methods: Reports of RCT conducted in Korea published in medical journals until February 2009 were collected. We surveyed elementary information of RCTs, evaluated randomization, double-blinding, allocation concealment and put together the results of RCTs by seven clinical topics.

Results: 38 RCTs with herbal acupuncture were selected, then adequate methods for randomization and allocation concealment were found in 39% and 5% of studies. Complete double-blinding and a clear accounting of all participants were conducted in 42% and 50% of reports. The synthesis of RCTs revealed that herbal acupuncture was useful and effective on degenerative gonarthritis, omarthralgia on cerebrovascular accident, acute ankle sprain, back sprain, neck sprain, headache, rheumatoid arthritis and tennis elbow, generally.

Conclusions: Although further improvement in quality of methodology of RCTs with herbal acupuncture is required, clinical usefulness of herbal acupuncture was shown especially on disorders of musculoskeletal system via RCTs.

Key Words : herbal acupuncture, pharmacopuncture, RCT, randomized clinical controlled trial, systematic review 박봉기, 조정효, 손창규

대전대학교 한의과대학 간장면역학교실 Original Article

Received：29 June 2009 Revised：30 July 2009 Accepted：30 July 2009

Correspondence to：손창규(Chang-Gue Son)

(301-724) 대전시 중구 대흥동 22-5번지 대전대학교 부속한방병원 간장면역학교실

Tel：+82-42-229-6807, Fax：+82-42-254-3403, E-mail：[email protected]

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결 과

1. 약침 관련 RCT 기본 정보

136 RCT

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of RCT Clinical trial RCT

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Fig. 2.

Screening titles/abstracts

Included titles/abstracts

N=136

Screening full-text articles N = 39

Studied available for data

N = 38

Excluded article N = 1 No randomized Excluded articles

N = 97 No randomized

Fig. 1.

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Gonarthrit is 7 (18%)

Omarhragia on CVA 4 (10%) Ankle sprain

4 (11%) Back

pain 4 (11%) Neck pain 3 (8%) Heart rate

variability 5 (13%) Safety &

side effect 4 (11%)

60~69 3 (8%)

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19 . (Table 1)

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randomized 38 (100%) 0 (0%)

Randomization scheme described and appropriate 16 (42%) 22 (58%)

Allocation concealment method 2 (5%) 36(95%)

Double-blind 16 (42%) 22 (58%)

Double blinding appropriate 15 (39%) 1 (3%)

A description of dropouts and withdrawals 19 (50%) 19 (50%)

Table 1.

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Questions Author (Reference)

Jadad score

Pharmacopuncture (Control)

Subjects Duration

(Times)

Conclusion

Degenerative gonarthritis

Yang KR (13) 3 Bee Venom (Acupuncture)

33 4 wks (8) More effective in Bee Venom than warm acupuncture

Kim SC (14) 3 SBV

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(Bee Venom)

30 2 wks (6)

More effective in SBV than Bee Venom on pain and side effect

Na WM (15) 1 SBV

(Bee Venom)

36 2 wks (6)

More effective in Bee Venom than SBV SBV let down side effect

An BJ (17) 3 Bee Venom

(Acupuncture)

30 1 wk (2~3) More effective in Bee Venom than acupuncture Lee SN (18) 1 Bee Venom

(SBV)

50 1 wk (2~3) More effective in Bee Venom than SBV

Omarthralgia on CVA

Ko CN (19) 5 Bee Venom

(Normal saline)

43 2 wks (6) More effective in Bee Venom than normal saline Eom JY (20) 1 Bee Venom

(Acupuncture)

30 4 wks (12) More effective in Bee Venom than acupuncture on pain

Ankle sprain

Song HS (25) 5 Bee Venom (Acupuncture)

24 1 wk (7) More effective in Bee Venom than acupuncture

Lee H (26) 1 Bee Venom

(Acupuncture)

32 no data (4)

More effective in Bee Venom than acupuncture (partly significant)

Back pain

Kim JH (27) 2 SBV

(Bee Venom)

39 2 wks (4) More effective in Bee Venom than SBV

Lee TH (29) 3 SBV

(Bee Venom)

24 no data (4) No significant effect Kim KT (30) 2 Bee Venom

(Acupuncture)

24 10 days (5) More effective in Bee Venom than acupuncture

Neck Pain

Song BY (32) 2 SBV

(Normal saline)

25 no data (5)

More effective in SBV than normal saline after 5th treatment

Kim KT (33) 4 Bee Venom (Normal saline)

21 no data More effective in Bee Venom than normal saline

Headache Kim HK (36) 1 HHD

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(Normal saline)

26 1 wk (4) More effective in Hwangryunhaedok than normal saline Tennis elbow An GH (38) 1 Bee Venom

(Acupuncture)

24 no data More effective in Bee Venom than acupuncture Rheumatoid Lee SH (39) 3 Bee Venom

(Acupuncture)

69 8 wks (16)

More effective in Bee Venom than acupuncture after 2 month

SBV

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: Sweet Bee Venom, CVA : Cerebro-Vascular Accident, HHD

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: Hwangryunhaedok-tang

Table 2.

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감사의 글

(B080043).

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