Pharmacopuncture in Korea: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Table 1

Characteristics of the included studies.

Author, year	Design	Types of disease	Sample size (M/F)	Pharmacopuncture group; (No. of participants analyzed/randomized)	Control group; (No. of participants analyzed/; randomized)	Outcome measures	Main results	AE
(IV) Endocrine, nutritional, and metabolic diseases (n = 3)
Lim, 2013 [9]	Parallel; 2 arms	Abdominal obesity	28 (0/28)	(A) Wild ginseng complex pharmacopuncture (14/15)	(B) NSP (14/15)	(1) Anthropometry; ① BMI, ② weight, ③ WC; ④ HC, and ⑤ WHR; (2) Blood test; ① TC, ② TG,; ③ HDL cholesterol,; ④ LDL cholesterol,; ⑤ CRP, and; ⑥ AST, ALT, γ-GT, BUN, and creatinine; (3) Body composition (BFM, BFP, FFM, and BMR); (4) Abdominal fat (TFA, SFA, VFA, and VSR)	(1); ①, ②, and ③ Positive; ④, ⑤ NS; (2); ①, ②, ③, ⑤, and ⑥ NS; ④ Positive; (3) NS; (4) NS	n.r.
Kim, 2011; (2) [10]	Parallel; 2 arms	Abdominal obesity	31 (0/31)	(A) Capsicum frutescens L. pharmacopuncture + diet therapy + exercise (13/20)	(B) NSP + diet therapy + exercise (18/20, in case of outcome measures 1, 2, and 4; 16/20, in case of outcome measure 3)	(1) Anthropometry; ① BMI, ② WC; ③ weight, and ④ WHR; (2) Abdominal fat (TFA, VFA); (3) Energy expenditure; (4) Questionnaires	(1); ①, ② Positive; ③, ④ Positive; (2) Positive; (3) NA; (4) NS	Moderate AEs related with anesthesia cream or pharmacopuncture (4 in group (A), 2 in group (B))
Kim  et al., 2009 [11]	Parallel; 2 arms	Obesity	52 (8/44)	(A) EAP + diet therapy + EA + HM + exercise (24/35)	(B) NSP + diet therapy + EA + HM + exercise (28/35)	(1) Weight; (2) BMI; (3) Waist	(1) Positive; (2) Positive; (3) Positive	n.r.
(VI) Diseases of the nervous systems (n = 6)
Park  et al.,; 2011 (1) [12]	Parallel; 2 arms	Chronic headache	35 (5/30)	(A) CS pharmacopuncture (17/20)	(B) NSP (18/20)	(1) HIT; (2) No. of headache-free days; (3) SF-36	(1) Positive; (2) Positive; (3) Positive	Injection-site pain (2 in group (A), 3 in group (B)), ecchymosis (2 in group (A))
Shin  et al., 2009 [13]	Parallel; 2 arms	Postauricular pain accompanied with Bell’s palsy	30 (15/15)	(A) Soyeom pharmacopuncture + A + HM + PT (SSP, massage, exercise, HP, and ICT) (15/15)	(B) A + HM + PT (SSP, massage, exercise, HP, and ICT) (15/15)	(1) VAS; (2) Duration of pain (d); (3) Yanagihara score	(1) Positive; (2) Positive; (3) NS	n.r.
Choi  et al., 2009 [14]	Parallel; 2 arms	Postauricular pain accompanied with Bell’s palsy	30 (14/16)	(A) Soyeom pharmacopuncture + A + HM + PT (SSP, massage, exercise, ICT, and negative) (15/15)	(B) A + HM + PT (SSP, massage, exercise, ICT, and negative) (15/15)	(1) VAS; (2) Yanagihara score	(1) Positive; (2) NS	n.r.
Kim  et al., 2006 [15]	Parallel; 2 arms	Functional headache	26 (11/15)	(A) HHT pharmacopuncture (13/13)	(B) NSP (13/13)	(1) VAS; (2) BPI	(1) Positive; (2) Positive	n.r.
Lim  et al., 2005 [16]	Parallel; 2 arms	Carpal tunnel syndrome	40 (7/33)	(A) Scolopendrid pharmacopuncture + A + EA + HM + PT (PB, ultrasound, HP, microwave, ICT, and SSP) (20/20)	(B) A + EA + HM + PT (PB, ultrasound, HP, microwave, ICT, and SSP) (20/20)	(1) VAS; (2) PRGA based on symptoms and VAS (excellent/good/; fair/poor)	(1) n.r.; (2) NS	n.r.
Lee  et al., 2005 [17]	Parallel; 2 arms	Bell’s palsy	44 (21/23)	(A) HPP + A + HM + WM + PT (EST, IR, HP, massage, and exercise) (23/23)	(B) NSP + A + HM + WM + PT (EST, IR, HP, massage, and exercise) (21/21)	Yanagihara score	Positive	n.r.
(IX) Diseases of the circulatory system (n = 1)
Noh  et al., 2009 [18]	Parallel; 2 arms	Leg spasticity of stroke patients	20 (8/12)	(A) HPP + A (11/11, in case of outcome measures 1, 3, and 4; 10/11, in case of outcome measure 2)	(B) Distilled water pharmacopuncture + A (9/9)	(1) MAS; (2) H/M ratio; (3) BBS; (4) TUG	(1) NS; (2) NS; (3) NS; (4) Positive	n.r.
(XI) Diseases of the digestive system (n = 2)
Lee, 2013 [19]	Parallel; 2 arms	Dyspepsia	60 (16/44)	(A) HPP + HM (30/30)	(B) A + HM (30/30)	NDI-K	NS	n.r.
Park  et al., 2008 [20]	Parallel; 2 arms	Chronic constipation	21 (5/16)	(A) CS pharmacopuncture (11/12)	(B) NSP (10/12)	(1) Defecation frequency, consistency, and ease of evacuation; (2) VAS; (3) QOL; (4) HRV	(1) Significant difference in (A); N in (B); (2) Significant difference in (A); N in (B); (3) N; (4) Significant improvement of LF/HF ratio in (A) after 2-week follow-up	Mild AEs such as ecchymosis, pain during injection, and redness in group (A); Moderate pain during injection in group (B)
(XIII) Diseases of the musculoskeletal system and connective tissue (n = 15)
Seo, 2013 [21]	Parallel; 2 arms	Shoulder pain caused by stroke	24 (10/14)	(A) Ouhyul pharmacopuncture + other treatments (13/16)	(B) NSP + other treatments (11/13)	(1) NRS; (2) PROM; (3) FMMA	(1) NA; (2) NS; (3) NS	General pain (1 in group (A)), transient local site pain (1 in group (B)), and fatigue (1 in group (B))
Lee  et al.,; 2012 (1) [22]	Parallel; 3 arms	Cervicalgia caused by TA	87 (42/45)	(A) HHT pharmacopuncture + tuina + A + HM + IR (34/34)	(B) Tuina + A + HM + IR (29/29); (C) HHT pharmacopuncture + A + HM + IR (24/24)	(1) VAS; (2) NDI	(1) Positive; (2) Positive	n.r.
Lee  et al.,; 2012 (2) [23]	Parallel; 2 arms	Cervicalgia caused by TA	82 (40/42)	(A) HHT pharmacopuncture + A + HM (37/37)	(B) Tuina + A + HM (45/45)	(1) VAS; (2) NDI	(1) NS; (2) NS	n.r.
Woo  et al., 2011 [24]	Parallel; 2 arms	Cervicalgia caused by TA	60 (28/32)	(A) Ouhyul pharmacopuncture +; A + IR (30/30)	(B) Tuina + A + IR (30/30)	(1) VAS; (2) NDI	(1) NS; (2) NS	n.r.
Kim  et al.,; 2011 (1) [25]	Parallel; 2 arms	LBP caused by TA	81 (44/37)	(A) HHT pharmacopuncture + A + HM (35/49)	(B) Tuina + A + HM (46/49)	(1) ODI; (2) VAS	(1) NS; (2) NA	n.r.
Jeong  et al., 2011 [26]	Parallel; 2 arms	Acute LBP	30 (21/9)	(A) BUM pharmacopuncture + A (15/21)	(B) A (15/21)	(1) VAS; (2) ODI	(1) Positive; (2) NS	n.r.
Jun  et al.,; 2011 [27]	Parallel; 2 arms	HNP of the L-spine	20 (9/11)	(A) ShinBaro pharmacopuncture + A + CCP + HM + tuina + PT (ICT, TENS, microwave, and HP) (10/10)	(B) A + CCP + HM + tuina + PT (ICT, TENS, microwave, and HP) (10/10)	(1) NRS; (2) ODI	(1) ① LBP decrement: positive; ② Sciatica decrement: N; (2) NS	None
Im  et al., 2011 [28]	Parallel; 2 arms	Acute cervicalgia by TA	20 (7/13)	(A) Soyeom pharmacopuncture + A + HM + cupping + PT (ICT, ultrasound, and HP) (10/13)	(B) A + HM + cupping + PT (ICT, ultrasound, and HP) (10/13)	(1) VAS; (2) NDI; (3) DITI	(1) Positive; (2) NS; (3) NS	n.r.
Park  et al.,; 2011 (2) [29]	Parallel; 2 arms	Cervicalgia	20 (0/20)	(A) Carthami-Flos pharmacopuncture + A + HM + PT (HP, TENS, and ICT) (10/10)	(B) A + HM + PT (HP, TENS, and ICT) (10/10)	(1) VAS; (2) NDI; (3) MENQOL	(1) Positive; (2) Positive; (3) Positive	n.r.
Kim  et al., 2010 (1) [30]	Parallel; 2 arms	OA (knee)	53 (9/44)	(A) Root bark of UDP pharmacopuncture (29/30)	(B) NSP (24/30)	(1) VAS; (2) WOMAC (pain/total score); (3) KHAQ; (4) SF-36	(1) NA; (2) NS; (3) NS; (4) NS	Nausea, itching (1 in group (A)), and dizziness (1 in group (B))
Song  et al., 2009 [31]	Parallel; 2 arms	HNP of the L-spine	30 (15/15)	(A) Soyeom pharmacopuncture + A + HM + PT (TENS, HP, and ICT) + wet cupping (15/15)	(B) A + HM + PT (TENS, HP, and ICT) + wet cupping (15/15)	(1) VAS; (2) SLRT	(1) Positive; (2) NS	n.r.
Kang  et al., 2008 [32]	Parallel; 3 arms	Acute ankle sprain	52 (17/35)	(A) HHT pharmacopuncture (17/20)	(B) A (17/20); (C) BVP (18/20)	(1) NRS; (2) AHS	(1) Negative; (2) Negative	n.r.
Lee  et al., 2007 [33]	Parallel; 3 arms	HNP of the L-spine	60 (28/32)	(A) Ouhyul pharmacopuncture + A + HM + PT (HP, ICT, TENS, and negative) (20/20, in case of outcome measure 1, 2; 6/20, in case of outcome measure 3)	(B) A + HM + PT (HP, ICT, TENS, and negative) (20/20, in case of outcome measures 1, 2; 8/20, in case of outcome measure 3); (C) BVP + A + HM + PT (HP, ICT, TENS, and negative) (20/20, in case of outcome measures 1, 2; 9/20, in case of outcome measure 3)	(1) VAS; (2) PRGA based on symptoms and physical examination (excellent/good/; fair/poor); (3) SLRT	(1) Positive; (2) NA; (3) NS	n.r.
Park  et al., 2006 [34]	Parallel; 2 arms	OA (knee)	60 (35/25)	(A) HPP + PT (HP, ultrasound massage, ICT, FES, and exercise) (30/30)	(B) A + PT (HP, ultrasound massage, ICT, FES, and exercise) (30/30)	(1) Lysholm score; (2) Nine-point scale	(1) NS; (2) NS	n.r.
Bae  and Park, 2004 [35]	Parallel; 2 arms	Shoulder pain caused by stroke	41 (19/22)	(A) Ouhyul pharmacopuncture + A + HM + PT (21/21)	(B) NSP + A + HM + PT (20/22)	(1) MBI; (2) Weakness grade; (3) NIHSS; (4) AI; (5) VAS	(1) NS; (2) Significant difference in (B); (3) NS; (4) NS; (5) NS	n.r.
(XIV) Diseases of the genitourinary system (n = 1)
Kim  et al., 2008 [36]	Parallel; 2 arms	Dysmenorrhea	49 (0/49)	(A) HPP (25/25)	(B) NSP (24/24)	(1) MMP; (2) MSSL	(1) NS; (2) NS	n.r.
(XV) Pregnancy, childbirth, and the puerperium (n = 1)
Kim  et al., 2010 (2) [37]	Parallel; 2 arms	Postpartum women’s heat feeling, sweat, and thirst	25 (0/25)	(A) HPP + A + HM (13/16)	(B) NSP + A + HM (12/16)	(1) VAS; ① Heating feeling; ② Thirst; ③ Sweet in movement; ④ Sweet during sleeping; (2) CBC; (3) 7-zone-diagnostic system; (4) HRV	(1); ① NS; ② NA; ③ NS; ④ NS; (2) NS; (3) NS; (4) Positive	None

Disease classification according to the ICD-10 code. Data are expressed as mean ± SD unless stated otherwise.
; ; .
A: acupuncture; AE: adverse event; AHS: ankle-hindfoot scale; AI: activity index; BBS: Berg balance scale; BFM: body fat mass; BFP: body fat percentage; BMI: body mass index; BMR: basal metabolic rate; BPI: brief pain inventory (general activity, mood, enjoyment of life, relations with other people, and sleep); BUM: Calculus Bovis.Fel Ursi.Moschus; BVP: bee-venom pharmacopuncture; CBC: complete blood cell count; CCP: Coptis chinensis pharmacopuncture; CS: Carthami-Semen; d: days; DITI: digital infrared thermographic imaging; EA: electroacupuncture; EAP: Ephedra sinica Stapf-Aconitum carmichaeli Debx. pharmacopuncture; EST: electrical stimulation therapy; F: female; FES: functional electrical stimulation; FFM: fat-free mass; FMMA: Fugl-Meyer motor assessment; HC: hip circumference; HHT: Hwangryunhaedok-tang; HIT: headache impact test; HM: herb medicine; H/M ratio: H-reflex/M-response ration; HNP of L-spine: herniation of nucleus pulposus of lumbar spine; HP: hot pack; HPP: Hominis Placenta Pharmacopuncture; HRV: heart rate variability; ICT: interferential current therapy; IR: infraradiation; KHAQ: Korean Health Assessment Questionnaire; LBP: low back pain; M: male; MAS: modified Ashworth scale; MBI: modified Barthel index; MENQOL: menopause-specific quality of life questionnaire; MMP: measure of menstrual pain; MPQ-SF: McGill Pain Questionnaire-Short Form; MSSL: menstrual symptom severity list; N: no significant difference before and after treatment; NA: not assessable; NDI: neck disability index; NDI-K: Nepean Dyspepsia Index-Korean; negative: (B) significantly better than (A); NIHSS: National Institutes of Health Stroke Scale; No.: number; n.r.: not reported; NRS: numerical rating scale; NS: neutral (no significant difference between groups); NSP: normal saline pharmacopuncture; OA: osteoarthritis; ODI: Oswestry disability index; PB: paraffin bath; positive: (A) significantly better than (B); PRGA: patient-reported global assessment; PROM: painless passive range of motion; PT: physical therapy; QOL: quality of life; SFA: subcutaneous fat area; SF-36: short form 36 health survey; SLRT: straight leg raising test; SSP: silver spike point; TA: traffic accident; TC: total cholesterol; TENS: transcutaneous electrical nerve stimulation; TFA: total fat area; TG: triglyceride; TUG: time up and go; UDP: Ulmus davidiana Planch.; VAS: visual analog scale; VFA: visceral fat area; VSR: visceral VFA/SFA ratio; WC: waist circumference; WHR: waist-hip ratio; wks: weeks; WM: western medicine; WOMAC: Western Ontario and McMaster Universities.