Pharmacopuncture (herbal acupuncture) is a new form of acupuncture treatment combining acupuncture and the injection of herbal medicine to the acupuncture points (acupoints). In Korea, pharmacopuncture was first officially introduced to the traditional Korean medicine (TKM) community in 1967 by Sang-Cheon Nam. While the conventional acupuncture treatment incorporates the physical stimulation of associated meridians and acupoints, pharmacopuncture adds chemical ingredients from therapeutic herbs with pharmacological effects [
The effects of pharmacopuncture can be immediately observed after treatment because herbal extracts are directly absorbed without the need to pass through the gastrointestinal tract. Additionally, both patients with difficulty swallowing and those who refuse to take herbal medicine may profit by receiving pharmacopuncture treatment [
Since the 1970s, studies on pharmacopuncture conducted mostly in animals have reported that
This systematic review aims to summarise existing results of randomized controlled trials (RCTs) conducted in Korea to establish the clinical evidence of the safety and efficacy of pharmacopuncture for various conditions.
We searched PubMed, Ovid Medline, and Korean databases, including the Oriental Medicine Advanced Searching Integrated System (OASIS), the Korean Studies Information Service System, RISS4U, Korea Institute of Science and Technology Information, KOREAMED, DBPIA, Korea National Assembly Library, the Journal of Korean Pharmacopuncture Institute, and the Journal of Korean Acupuncture and Moxibustion Medicine Society from inception to December 2014. Reference lists of reviews and relevant articles were examined for additional studies.
The search terms used for PubMed were as follows: (pharmacopuncture
All RCTs evaluating pharmacopuncture treatment on various conditions were considered. Studies enrolling participants who reported any disorder or disease were eligible for inclusion. Hence, we classified each disorder or disease according to the International Statistical Classification of Diseases and Related Health Problems, 10th revision (ICD-10) [
Studies which assessed the combined effects of pharmacopuncture plus other interventions (e.g., pharmacopuncture plus acupuncture) were also considered when the identical intervention was administered to both the pharmacopuncture group and the control group.
For control groups, we considered placebo or sham, other interventions, and no interventions. Placebo or sham interventions were injections of normal saline or distilled water into the pharmacopuncture points or nonacupuncture points. Other interventions included acupuncture, herbal/western medicine, cupping, tuina, diet therapy, and physical therapy, including hot pack, transcutaneous electrical nerve stimulation (TENS), interferential current therapy (ICT), ultrasound, massage, and exercise.
There was no restriction on the type of outcome measures, but they had to be relevant to the conditions. All the trials were conducted in Korea.
Nonrandomized trials, animal or cell studies, literature research, and quasi-RCTs (methods of allocating participants to a treatment group which are not truly random, e.g., hospital record number or alternation, and date of birth) were excluded. Trials including healthy participants were excluded.
We did not include trials testing bee-venom pharmacopuncture or injection of conventional medicine because they did not investigate the chemical effects of herbal medicine. Trials comparing different types of pharmacopuncture were excluded because the efficacy of control intervention could not be determined.
We reviewed all searched articles to evaluate their eligibility for inclusion. In case of uncertainties, authors were contacted for further information.
After the selection of studies, we extracted the following data from the selected articles: author, year of publication, study design, participants (age, gender), diseases or disorders, pharmacopuncture intervention, control intervention, outcome measures, main results, and adverse events (Table
Characteristics of the included studies.
Author, year | Design | Types of disease | Sample size (M/F) | Pharmacopuncture group |
Control group |
Outcome measures | Main results | AE |
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Lim, 2013 [ |
Parallel |
Abdominal obesity | 28 (0/28) | (A) Wild ginseng complex pharmacopuncture (14/15) | (B) NSP (14/15) | (1) Anthropometry |
(1) |
n.r. |
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Kim, 2011 |
Parallel |
Abdominal obesity | 31 (0/31) | (A) |
(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) |
Moderate AEs related with anesthesia cream or pharmacopuncture (4 in group (A), 2 in group (B)) |
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Kim et al., 2009 [ |
Parallel |
Obesity | 52 (8/44) | (A) EAP + diet therapy + EA + HM + exercise (24/35) | (B) NSP + diet therapy + EA + HM + exercise (28/35) | (1) Weight |
(1) Positive |
n.r. |
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Park et al., |
Parallel |
Chronic headache | 35 (5/30) | (A) CS pharmacopuncture (17/20) | (B) NSP (18/20) | (1) HIT |
(1) Positive |
Injection-site pain (2 in group (A), 3 in group (B)), ecchymosis (2 in group (A)) |
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Shin et al., 2009 [ |
Parallel |
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 |
(1) Positive |
n.r. |
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Choi et al., 2009 [ |
Parallel |
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 |
(1) Positive |
n.r. |
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Kim et al., 2006 [ |
Parallel |
Functional headache | 26 (11/15) | (A) HHT pharmacopuncture (13/13) | (B) NSP (13/13) | (1) VAS |
(1) Positive |
n.r. |
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Lim et al., 2005 [ |
Parallel |
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 |
(1) n.r. |
n.r. |
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Lee et al., 2005 [ |
Parallel |
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. |
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Noh et al., 2009 [ |
Parallel |
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 |
(1) NS |
n.r. |
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Lee, 2013 [ |
Parallel |
Dyspepsia | 60 (16/44) | (A) HPP + HM (30/30) | (B) A + HM (30/30) | NDI-K | NS | n.r. |
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Park et al., 2008 [ |
Parallel |
Chronic constipation | 21 (5/16) | (A) CS pharmacopuncture (11/12) | (B) NSP (10/12) | (1) Defecation frequency, consistency, and ease of evacuation |
(1) Significant difference in (A) |
Mild AEs such as ecchymosis, pain during injection, and redness in group (A) |
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Seo, 2013 [ |
Parallel |
Shoulder pain caused by stroke | 24 (10/14) | (A) Ouhyul pharmacopuncture + other treatments (13/16) | (B) NSP + other treatments (11/13) | (1) NRS |
(1) NA |
General pain (1 in group (A)), transient local site pain (1 in group (B)), and fatigue (1 in group (B)) |
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Lee et al., |
Parallel |
Cervicalgia caused by TA | 87 (42/45) | (A) HHT pharmacopuncture + tuina + A + HM + IR (34/34) | (B) Tuina + A + HM + IR (29/29) |
(1) VAS |
(1) Positive |
n.r. |
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Lee et al., |
Parallel |
Cervicalgia caused by TA | 82 (40/42) | (A) HHT pharmacopuncture + A + HM (37/37) | (B) Tuina + A + HM (45/45) | (1) VAS |
(1) NS |
n.r. |
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Woo et al., 2011 [ |
Parallel |
Cervicalgia caused by TA | 60 (28/32) | (A) Ouhyul pharmacopuncture + |
(B) Tuina + A + IR (30/30) | (1) VAS |
(1) NS |
n.r. |
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Kim et al., |
Parallel |
LBP caused by TA | 81 (44/37) | (A) HHT pharmacopuncture + A + HM (35/49) | (B) Tuina + A + HM (46/49) | (1) ODI |
(1) NS |
n.r. |
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Jeong et al., 2011 [ |
Parallel |
Acute LBP | 30 (21/9) | (A) BUM pharmacopuncture + A (15/21) | (B) A (15/21) | (1) VAS |
(1) Positive |
n.r. |
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Jun et al., |
Parallel |
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 |
(1) ① LBP decrement: positive |
None |
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Im et al., 2011 [ |
Parallel |
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 |
(1) Positive |
n.r. |
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Park et al., |
Parallel |
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 |
(1) Positive |
n.r. |
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Kim et al., 2010 (1) [ |
Parallel |
OA (knee) | 53 (9/44) | (A) Root bark of UDP pharmacopuncture (29/30) | (B) NSP (24/30) | (1) VAS |
(1) NA |
Nausea, itching (1 in group (A)), and dizziness (1 in group (B)) |
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Song et al., 2009 [ |
Parallel |
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 |
(1) Positive |
n.r. |
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Kang et al., 2008 [ |
Parallel |
Acute ankle sprain | 52 (17/35) | (A) HHT pharmacopuncture (17/20) | (B) A (17/20) |
(1) NRS |
(1) Negative |
n.r. |
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Lee et al., 2007 [ |
Parallel |
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) |
(1) VAS |
(1) Positive |
n.r. |
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Park et al., 2006 [ |
Parallel |
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 |
(1) NS |
n.r. |
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Bae and Park, 2004 [ |
Parallel |
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 |
(1) NS |
n.r. |
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Kim et al., 2008 [ |
Parallel |
Dysmenorrhea | 49 (0/49) | (A) HPP (25/25) | (B) NSP (24/24) | (1) MMP |
(1) NS |
n.r. |
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Kim et al., 2010 (2) [ |
Parallel |
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) |
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:
Characteristics of pharmacopuncture interventions in the included studies.
Author, |
Types and |
Regimen | Pharmacopuncture points |
Extraction method |
Types of |
Amount of injection | Depth of injection | Angle of injection | Cointerventions |
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Park et al., 2011 (1) [ |
CS, fixed | 8 sessions |
Bilateral GB20, GB21, and EX-HN5 | Alcohol immersion (N) | 27 G | 0.1 mL each | n.r. | n.r. | None |
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Jeong et al., 2011 [ |
BUM, partially individualized | 3 sessions |
Bilateral BL23, BL25, and BL26 + tender points | n.r. | n.r. | 0.05 mL × 10 (total 0.5 mL) | n.r. | n.r. | A |
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Park et al., 2011 |
Carthami-Flos, fixed | 15 sessions |
Bilateral GB20, GB21 | Pressing (Y) | 1.0 mL syringe, 26 G | 0.05 mL × 4 (total 0.2 mL) | 10–30 mm | n.r. | A + HM + PT (HP, TENS, and ICT) |
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Park et al., 2008 [ |
CS, fixed | 8 sessions |
ST25, ST27, BL52, and CV6 | Alcohol immersion (N) | 1.0 mL syringe, 27 G | 0.1 mL × 7 |
0.5–1 inch | n.r. | None |
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Seo, |
Ouhyul, fixed | 6 sessions |
Unilateral LI15, TE14, GB21, SI11, and SI12 | Distillation (Y) | 30 G | 0.1 mL × 5 |
n.r. | n.r. | Other treatments (the type is not mentioned) |
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Lee et al., 2012 |
HHT, partially individualized | 8 sessions |
GV16, GB20, GB21, and so forth | n.r. | 29 G | Total 1 mL | n.r. | n.r. | A + HM + IR |
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Lee et al., 2012 |
HHT, partially individualized | 8 sessions |
GV16, GB20, GB21, and so forth | n.r. | 29 G | Total 1 mL | n.r. | n.r. | A + HM |
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Woo et al., 2011 [ |
Ouhyul, individualized | 4 sessions |
Ashi points (neck) | n.r. | 1.0 mL syringe | Total 1 mL | n.r. | n.r. | A + IR |
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Kim et al., 2011 (1) [ |
HHT, fixed | 8 sessions |
Bilateral BL23, BL25, GV3, GB30, and so forth | n.r. | 29 G | Total 1 mL | n.r. | n.r. | A + HM |
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Jun et al., 2011 [ |
ShinBaro, individualized | 14 sessions |
EX-B2 in the most severe level of disc herniation | Distillation (Y) | 1.0 mL syringe, 26 G | 1 mL × 2 |
Intramuscular (3 cm) | Perpendicular | A + CCP + HM + tuina + PT (ICT, TENS, microwave, and HP) |
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Im et al., 2011 [ |
Soyeom, partially individualized | 5 sessions |
Ashi points (neck) + tender points + bilateral GB20, GB21, and GV14 | n.r. | 1.0 mL syringe, 30 G | 0.05–0.1 mL each |
n.r. | n.r. | A + HM + cupping + PT (ICT, ultrasound, and HP) |
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Song et al., 2009 [ |
Soyeom, individualized | 3 sessions |
EX-B2 in the level of disc herniation | n.r. | 1.0 mL syringe, 29 G | 1 mL × 2 |
n.r. | n.r. | A + HM + PT (TENS, HP, and ICT) + wet cupping |
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Shin et al., 2009 [ |
Soyeom, fixed | 3 sessions |
TE17 on the affected side | Distillation (Y) | 1.0 mL syringe, 26 G | Total 0.6–0.8 mL | n.r. | n.r. | A + HM + PT (SSP, massage, exercise, HP, and ICT) |
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Choi et al., 2009 [ |
Soyeom, fixed | n.r. | TE17 on the affected side | n.r. | n.r. | Total 0.4 mL | n.r. | n.r. | A + HM + PT (SSP, massage, exercise, ICT, and negative) |
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Kang et al., 2008 [ |
HHT, fixed | 3 sessions |
GB39, GB40, GB41, BL60, BL62, and ST36 | n.r. | 29 G | 0.1 mL × 6 |
n.r. | n.r. | None |
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Lee et al., 2007 [ |
Ouhyul, individualized | for 9 d | Ashi points (lumbar) | n.r. | n.r. | 0.6 mL each | n.r. | n.r. | A + HM + PT (HP, ICT, TENS, and negative) |
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Kim et al., 2006 [ |
HHT, fixed | 4 sessions |
Bilateral GB20, GB21, and LI4 | Distillation (Y) | 1.0 mL syringe, 30 G | 0.1 mL × 6 |
n.r. | n.r. | None |
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Bae and Park, |
Ouhyul, fixed | 3 sessions |
SI10, LI15, TE14, and GB21 + Gyun-joong (Master Dong’s acupuncture point) | n.r. | 1.0 mL syringe | 0.05–0.1 mL × 5 |
n.r. | n.r. | A + HM + PT |
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Lee, |
HPP, partially individualized | 6 sessions |
ST19, ST25, ST27, BL18, BL20, BL21, BL23, and so forth | n.r. | 1.0 mL syringe, 0.3 × 8 mm | 0.05 mL each |
n.r. | n.r. | HM |
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Kim, 2011 |
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16 sessions |
Abdomen | n.r. | Mesogun | 0.05 mL × 60 (total 3 mL) | n.r. | n.r. | Diet therapy + exercise |
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Kim et al., 2010 |
Root bark of UDP, partially individualized | 12 sessions |
ST35, EX-LE5, EX-LE2, and Ashi points on the affected side | Distillation |
1.0 mL syringe, 29 G | n.r. | 5–15 mm | n.r. | None |
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Kim et al., 2010 |
HPP, fixed | 5 sessions |
CV4, bilateral BL23 | n.r. | 1.0 mL syringe, 26 G | 0.4 mL (CV4), 0.3 mL (BL23) |
n.r. | n.r. | A + HM |
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Noh et al., 2009 [ |
HPP, fixed | 15 sessions |
ST36, GB34, BL55, BL56, and BL57 | n.r. | 1.0 mL syringe, 30 G | 0.4 mL × 5 |
10 mm | Perpendicular | A |
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Kim et al., 2008 [ |
HPP, fixed | 5 sessions |
CV4, bilateral ST36, SP9, and SP6 | n.r. | 1.0 mL syringe, |
1 mL (CV4), 1 mL (bilateral ST36, SP9, and SP6) |
Equal to needle length | n.r. | None |
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Park et al., 2006 [ |
HPP, partially individualized | 6–9 sessions (2-3 times per wk for 3 wks) | BL23, ST35, EX-LE4, GB34, SP10, and ST34 + Ashi points | n.r. | U-100 insulin syringe | 0.1 mL each | n.r. | n.r. | PT (HP, ultrasound massage, ICT, FES, and exercise) |
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Lim et al., 2005 [ |
Scolopendrid, fixed | 8–12 sessions (2-3 times per wk for 4 wks) | Between flexor carpi radialis tendon and median nerve | Alcohol immersion (Y) | 1.0 mL syringe | 1 mL each | Subcutaneous (flexor retinaculum) | 45 degrees | A + EA + HM + PT (PB, ultrasound, HP, microwave, ICT, and SSP) |
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Lee et al., 2005 [ |
HPP, fixed | 3 times per wk (during hospitalization); |
GB14, SI18, ST4, ST6, TE17, and TE23 on the affected side | n.r. | 1.0 mL syringe, 29 G | 0.05 mL × 6 |
n.r. | n.r. | A + HM + WM + PT (EST, IR, HP, massage, and exercise) |
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Lim, |
Wild ginseng + BUM, fixed | 10 sessions |
Left and right sides of four points inferior to and four points superior to the navel points on the stomach and the spleen and gallbladder meridians (total 24 points) | Distillation (wild ginseng, Y) |
n.r. | 0.2 mL each |
n.r. | n.r. | None |
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Kim et al., 2009 [ |
EAP, fixed | 10 sessions |
ST25, CV4, CV6, and GB26 | Distillation (Y) | n.r. | 0.5 mL × 4 |
n.r. | n.r. | Diet therapy + EA + HM + exercise |
Pharmacopuncture classification according to the treatment rationale.
A: acupuncture; BUM:
We evaluated the ROB for the included studies according to the Cochrane Collaboration’s ROB assessment tool [
We rated ROB for each item using “Yes (Y, low ROB),” “Unclear (U, uncertain or unknown ROB),” or “No (N, high ROB).” For patient blinding in studies with a placebo control, we assessed the study as having a low ROB when it clearly stated that patients were blinded. For the outcome assessor blinding, we judged that if it was clearly reported that the outcome assessor was blinded or the outcome measure was evaluated by blinded participants only, it was rated as having a low ROB. If the outcome measure was assessed by unblinded participants only, we rated it as having a high ROB. If the outcome measures were mixed with subjective and objective assessments and we could not obviously judge whether the outcome assessor was blinded or not, it was rated as having an unclear ROB. As for the incomplete outcome data reporting it was rated as having a low ROB if the number and reason for attrition were clearly reported in each group and were similar between groups and the percentage of withdrawals and drop-outs did not exceed 20% for short-term and 30% for long-term follow-up [
Meta-analysis was performed using the Review Manager software (version 5.2 for Windows; the Nordic Cochrane Centre, Copenhagen, Denmark). We used the mean difference (MD) and 95% confidence intervals (CI) to estimate the effect of an intervention for continuous outcomes using a random-effects model.
If it was impossible to perform statistical pooling, studies were assigned to 1 of 4 categories to classify the result for interpretation. The comparison between two groups was based on the results of original study: (1) positive when the pharmacopuncture group was significantly better than the control group, P; (2) negative when the control group was significantly better than the pharmacopuncture group, N; (3) neutral when there was no significant difference between the groups, NS; and (4) not assessable when the results were complicated or the presented data were insufficient, NA.
To address the heterogeneity among the included studies, the
Our search terms yielded 5,124 records: 49 from Ovid Medline or PubMed and 5,075 from domestic databases or relevant journals. After duplicated studies were removed, 3,030 records were screened. Based on the title and abstract, 2,929 records were excluded; 687 articles were inappropriate for the topic of this review; 2,105 were not clinical studies or were nonrandomized trials; and 137 trials did not satisfy the pharmacopuncture or control group criteria. Out of the remaining 101 studies, a total of 29 RCTs (Korean:
Flow diagram of literature search.
Overall included RCTs (29): data of 1,321 participants were included in the review. The number of participants in each group ranged from 10 to 37 in the pharmacopuncture group and from 9 to 46 in the control group. The median sample sizes per arm were 17 in the pharmacopuncture group and 18 in the control group.
The types of diseases/disorders were very heterogeneous. Thus, we classified them using ICD-10 codes. The most common disorders were diseases of the musculoskeletal system and connective tissue (XIII,
Details of pharmacopuncture interventions based on the revised STRICTA and modified to suitable patterns for pharmacopuncture are summarised in Table
When pharmacopuncture was classified by treatment rationale, meridian field pharmacopuncture was practiced in four trials [
The types of pharmacopuncture were highly variable. Out of the 29 included studies, 12 tested monoherbal medicine pharmacopuncture: six studies [
Participants received fixed (i.e., all participants received the same treatment), partially individualized (using a fixed set of points to be given with a set of points to be used flexibly), or individualized pharmacopuncture treatment (each participant received a tailored treatment). Out of the 29 studies, 18 used fixed [
The number of pharmacopuncture sessions ranged from 3 to 16 over 6 days to 8 weeks.
Regarding pharmacopuncture points used in the studies, 19 studies [
As for the extraction methods of pharmacopuncture, 6 studies [
In total, 24 studies mentioned the type of injector: 16 studies [
Each amount of injection ranged from 0.05 mL to 1 mL, and the total amount of injection ranged from 0.2 mL to 5 mL. Only one study [
Seven studies [
The angle of injection was reported in only three studies: two studies [
In this review, control procedures were classified into four types. First, pharmacopuncture was compared with normal saline [
Outcome measures reported in the included studies were very diverse because of the various types of focused diseases. Intensity of discomfort (e.g., measured with the visual analogue scale, the numeric rating scale) was investigated in 20 trials [
The majority of the included trials were assessed as having a high ROB. Details of the ROB assessments are presented in Table
Risk of bias (ROB) assessment
Author, |
Random sequence generation | Allocation concealment | Blinding |
Incomplete outcome |
Selective reporting | ||
---|---|---|---|---|---|---|---|
Patient blinding | Practitioner blinding | Outcome assessor blinding | |||||
Seo, 2013 [ |
Y | Y | U | N | Y | Y | Y |
Lee, 2013 [ |
U | U | N | N | U | Y | Y |
Lim, 2013 [ |
Y | U | U | U | U | Y | Y |
Lee et al., 2012 (1) [ |
Y | U | N | N | U | Y | Y |
Lee et al., 2012 (2) [ |
U | U | N | N | N | Y | Y |
Park et al., 2011 (1) [ |
Y | Y | Y | Y | Y | Y | Y |
Woo et al., 2011 [ |
Y | U | N | N | N | Y | Y |
Kim et al., 2011 (1) [ |
U | U | N | N | N | N | Y |
Jeong et al., 2011 [ |
U | U | N | N | N | N | Y |
Jun et al., 2011 [ |
Y | Y | N | N | N | Y | Y |
Im et al., 2011 [ |
U | U | N | N | U | N | Y |
Park et al., 2011 (2) [ |
Y | U | N | N | N | Y | Y |
Kim, 2011 (2) [ |
U | U | Y | U | U | N | Y |
Kim et al., 2010 (1) [ |
U | Y | Y | Y | Y | Y | Y |
Kim et al., 2010 (2) [ |
U | U | Y | U | U | N | Y |
Noh et al., 2009 [ |
Y | U | Y | Y | U | Y | Y |
Kim et al., 2009 [ |
Y | N | Y | N | U | N | Y |
Song et al., 2009 [ |
U | U | N | N | U | Y | Y |
Shin et al., 2009 [ |
Y | U | N | N | U | Y | Y |
Choi et al., 2009 [ |
U | U | N | N | U | Y | Y |
Kang et al., 2008 [ |
U | U | N | N | U | Y | Y |
Park et al., 2008 [ |
Y | U | Y | N | Y | Y | Y |
Kim et al., 2008 [ |
Y | U | Y | U | Y | Y | Y |
Lee et al., 2007 [ |
U | U | N | N | U | Y | Y |
Kim et al., 2006 [ |
U | U | Y | U | Y | Y | Y |
Park et al., 2006 [ |
U | U | N | N | U | Y | Y |
Lim et al., 2005 [ |
U | U | N | N | U | Y | N |
Lee et al., 2005 [ |
U | U | Y | U | U | U | Y |
Bae and Park, 2004 [ |
U | U | Y | Y | U | Y | Y |
Twelve out of the 25 studies reported adequate methods of sequence generation, such as using a random number table, computer random number generator, randomization code, or coin toss [
The participant, practitioner, and outcome assessor each were blinded in only two trials [
In terms of addressing incomplete outcome data, 13 studies [
As for the selective outcome reporting, we could not locate and compare the protocols of any of the included studies. Therefore, we judged the ROB based on the described methods in each study. One study [
The key outcomes from the included studies are provided in Table
Low back pain (
A total of 10 studies were available for statistical pooling (Figures
Effect of pharmacopuncture in obesity. BMI: body mass index; CI: confidence intervals; SD: standard deviation.
Pharmacopuncture versus normal saline: weight decrement (kg)
Pharmacopuncture versus normal saline: waist circumference decrement (cm)
Pharmacopuncture versus normal saline: BMI decrement (kg/m2)
Effects of pharmacopuncture on musculoskeletal conditions. CI: confidence intervals; SD: standard deviation; VAS: visual analog scale.
Pharmacopuncture + other interventions versus other interventions: VAS improvement
Pharmacopuncture versus tuina: VAS score
Among the three studies on obesity, two studies [
In five studies on musculoskeletal diseases [
As statistical pooling was impossible in the other seven trials, detailed results were described as follows. Two trials on HNP of the L-spine [
The results of pharmacopuncture were composited for each disease. For headache, both Carthami-Semen and Hwangryunhaedok-tang pharmacopuncture improved symptoms compared with normal saline injection [
The effect of
One study of
One study on
Only five studies reported AEs. In the study by Seo [
We performed sensitivity analyses by excluding studies with predefined less desirable characteristics, and the results from the musculoskeletal studies were robust.
When the analyses were limited to two studies with a low ROB for random sequence generation and/or allocation concealment [
There was no study with ≥40 participants per arm.
Our review on pharmacopuncture aimed to establish the evidence of pharmacopuncture treatment of any disease. The analyses of two trials on obesity [
Most of the included studies had methodological weaknesses. Thirteen out of 25 studies [
There were some limitations in this review. Our review only included trials conducted in Korea and published in Korean or English. Therefore, we could not necessarily remove a potential language bias. Egger et al. [
The included trials were mostly of poor quality; thus, the reported data are likely to be overestimated. In addition, most of the included studies were small. Median sample sizes per arm were 17 in the pharmacopuncture group and 18 in the control group. The effect size of small studies may have been inflated due to poor methodological design and conduct [
The efficacy of the treatment used for the control group, such as acupuncture, herbal medicine, and tuina manual therapy, was not yet established; therefore, we could not attribute “positive” results solely to the effectiveness of pharmacopuncture. Additionally, clinically meaningful information on follow-up results was sparse in the majority of the included trials. Therefore, the available evidence prevented us from further examining how long its benefit was maintained.
As we included all conditions/diseases, the focus of our review may seem blurred. However, this review provides an overview of the entire primary pharmacopuncture researches conducted in Korea. The results help to set priorities and directions for future research on pharmacopuncture.
Although this review represented the applicability of pharmacopuncture, the standardisation of pharmacopuncture intervention was not performed. Thus, in the future, it is absolutely necessary to standardise it to apply pharmacopuncture in routine clinical practice. The degree of pharmacopuncture stimulation could be influenced by the following factors: (1) pharmacopuncture types; (2) concentration and extraction methods of pharmacopuncture; (3) amount, depth, and angle of injection; (4) syringe types, including thickness and length; (5) pharmacopuncture points; and (6) number of sessions based on the STRICTA guidelines [
However, the standardisation of these factors has yet to be completed, and there is no firmly established research method for pharmacopuncture studies; therefore, pharmacopuncture interventions of the included trials were very heterogeneous. In addition, future studies should include not only a test of the efficacy and safety of pharmacopuncture but also an examination of the validity of the intervention based on the standardised guidelines.
The results of this review demonstrate the effectiveness of pharmacopuncture for the treatment of obesity and musculoskeletal diseases compared with normal saline injections and other interventions, respectively; however, given the methodological flaws and small sample sizes, the available evidence is insufficient to recommend pharmacopuncture as an evidence-based treatment option. In the future, the standardisation of pharmacopuncture intervention and the adequate reporting of pharmacopuncture intervention in accordance with STRICTA guidelines are needed.
The authors declare that they have no conflict of interests.
Jong-In Kim and Jimin Park designed this review. Jimin Park and Myeong Soo Lee searched the databases, screened studies for inclusion, extracted data, and evaluated the quality of the included studies. They were checked by Jong-In Kim, Byung-Cheul Shin, and Hyangsook Lee. Boryang Kim, Hyangsook Lee, and Jimin Park conducted the analyses and discussed their findings with Jong-In Kim, Myeong Soo Lee, and Byung-Cheul Shin. All authors read and approved the final paper.
This study is supported by Korean Institute of Oriental Medicine (K15080).