Table 2.
Adverse events associated with auricular therapy reported in clinical trials.
| Study | Reason for AT and practitioner | Intervention (details of AT) and control | Selected acupoints | AEs (number of Cases) of AT and outcome | Quality of AEs Reporting△ |
|---|---|---|---|---|---|
| Studies on auricular acupuncture | |||||
| Prisco et al., 2013 [26] RCT (N = 35) Department of Veterans Affairs Medical Center, Washington DC, USA |
R: PTSD-related insomnia P: physician |
Intervention (true AT): (i) Method: auricular acupuncture with spring handle needles (0.16 × 15 mm) (ii) Duration: two treatments weekly (45 minutes per treatment) for 8 weeks Control 1 (sham AT): auricular acupuncture at nonacupuncture points Control 2: waiting-list control |
True AT: shenmen, liver, kidney, sympathetic, hippocampus Sham AT: nonacupuncture points located on the helix of the ear |
Uncomfortable at the needling site (n = 1) Outcome: withdrawal |
(1) Not reported (2) Not reported (3) Not reported (4) Not reported (5) Not reported (6) Adequate (7) Not reported |
|
| |||||
| Lua and Talib, 2013 [27] RCT (N = 97) Three Methadone Maintenance Treatment (MMT) Centers, Terengganu, Malaysia |
R: drug dependence P: acupuncturist |
Intervention (MMT + AT): (i) Method: auricular acupuncture (needles: 0.25 × 12.55 mm) (ii) Duration: three treatments weekly (30 minutes per treatment) for 8 weeks Control: MMT only |
Shenmen, sympathetic, kidney, liver, lung | Light headache (n = 17) Slight bleeding (n = 14) Tingling sensations (n = 19) Pain (n = 17) and nausea (n = 19) Drowsiness (n = 11) and dizziness (n = 19) Dry mouth (n = 15) and slight fever (n = 19) Outcome: not reported |
(1) Adequate (2) Adequate (3) Not reported (4) Adequate (5) Adequate (6) Inadequate (7) Adequate |
|
| |||||
| Hunter et al., 2012 [28] RCT (N = 52) Primary Care & A University Population, Northern Ireland, UK |
R: chronic low back pain P: physiotherapist |
Intervention (exercise + AT): (i) Method: auricular acupuncture with Seirin Pyonex ear needles (1.80 × 0.26 mm) (ii) Duration: one treatment (48 hours) weekly for 6 weeks Control: exercise only |
Shenmen, lumbar spine, cushion | Pain and redness (not reported) Minor bleeding (not reported) Swelling around the needling site (n = 1)# Outcome: (i) NR (for pain, redness, and bleeding) (ii) Recovery (for swelling) |
(1) Adequate (2) Not reported (3) Not reported (4) Not reported (5) Not reported (6) Inadequate (7) Partially adequate |
|
| |||||
| Michalek-Sauberer et al., 2012 [29] RCT (N = 182) Outpatient Clinic, Medical University of Vienna, Vienna, Austria |
R: state anxiety before dental treatment P: investigator with a diploma of acupuncture |
Intervention (true AT): (i) Method: auricular acupuncture (needles: 0.2 × 15 mm) (ii) Duration: twenty minutes until the start of dental treatment Control 1 (sham AT): auricular acupuncture at nonspecific points Control 2: no intervention |
True AT: relaxation, tranquilizer, master cerebral Sham AT: tonsil, finger, shoulder |
Warmth or a strange feeling at the treated ear or dizziness (n = 26) Outcome: not reported |
(1) Not reported (2) Not reported (3) Not reported (4) Not reported (5) Not reported (6) Not reported (7) Not reported |
|
| |||||
| Lien et al., 2012 [30] RCT (N = 90) Taipei City Hospital, Taiwan |
R: obesity P: acupuncturist |
Intervention (true AT): (i) Method: auricular acupuncture (needles: 2 mm tip and 10 mm annular-shaped body) (ii) Duration: three treatments weekly for 4 weeks Control 1: auricular stimulation using magnetic pellets Control 2 (sham AT): needles with the tips removed |
Shenmen, stomach, hunger, endocrine | Dizziness (n = 1) Outcome: withdrawal |
(1) Adequate (2) Partially adequate (3) Not reported (4) Not reported (5) Not reported (6) Adequate (7) Not reported |
|
| |||||
| Hsu et al., 2009 [31] RCT (N = 60) Taipei Hospital, Taiwan |
R: obesity P: acupuncturist |
Intervention (true AT): (i) Method: auricular acupuncture (needles: 2 mm tip and 10 mm annular-shaped body) (ii) Duration: two treatments weekly (3 days per treatment) for 6 weeks Control (sham AT): needles with the tips removed |
Shenmen, stomach, hunger, endocrine | Minor inflammation at the needling site (n = 1) Mild tenderness at the needling site (n = 9) Outcome: not reported |
(1) Adequate (2) Not reported (3) Not reported (4) Not reported (5) Not reported (6) Adequate (7) Not reported |
|
| |||||
| Wang et al., 2009 [32] RCT (N = 159) Yale-New Haven Hospital, New Haven, USA |
R: pregnant women with low back pain and posterior pelvic pain P: acupuncturist |
Intervention (true AT): (i) Method: auricular acupuncture with Seirin Pyonex ear needles (ii) Duration: one week Control 1 (sham AT): auricular acupuncture at nonspecific points Control 2: no treatment |
True AT: shenmen, kidney, analgesia Sham AT: shoulder, wrist, extra-auricular point |
Transient ear tenderness (n = 4) Outcome: resolved spontaneously |
(1) Not reported (2) Not reported (3) Adequate (4) Adequate (5) Not reported (6) Not reported (7) Partially adequate |
|
| |||||
| Harding et al., 2008 [33] Non-RCT (N = 60) James Cook University Hospital, Middlesbrough, UK |
R: hot flushes in prostate cancer patients with LHRH agonist treatment P: not reported |
Intervention (AT): (i) Method: auricular acupuncture with 0.20 g sterile single-use needles (ii) Duration: weekly treatment (40 minutes) for 10 weeks Control: not applicable |
Shenmen, liver, lung, autonomic, kidney | Transient exacerbation of vasomotor symptoms (n = 2) Outcome: resolved spontaneously (lasted only seconds) |
(1) Adequate (2) Not reported (3) Not reported (4) Not reported (5) Not reported (6) Adequate (7) Partially adequate |
|
| |||||
| Courbasson et al., 2007 [34] Non-RCT (N = 305) The Jean Tweed Centre, Toronto, Ontario, Canada |
R: women with concurrent substance use problems and anxiety and depressive symptoms P: acupuncturist |
Intervention (AT + usual treatment): (i) Method: auricular acupuncture (details not described) (ii) Duration: three treatments weekly (45 minutes per treatment) (length of treatment not mentioned) Control: usual treatment |
Not reported | Experiencing pain from needles (not reported) Outcome: not reported |
(1) Not reported (2) Inadequate (3) Not reported (4) Partially adequate (5) Not reported (6) Inadequate (7) Not reported |
|
| |||||
| Wu et al., 2007 [35] RCT (N = 131) Smoking Cessation Clinics, Taipei Veterans General Hospital, Taiwan |
R: smoking cessation P: acupuncturist |
Intervention (true AT): (i) Method: auricular acupuncture with 36 gauge 0.5 inch ear-piercing needles (ii) Duration: weekly treatment for 8 weeks Control (sham AT): auricular acupuncture at nonspecific points |
True AT: shenmen, lung, mouth, sympathetic Sham AT: eye, elbow, shoulder, knee |
Hematoma (n = 1) Feeling of residual needling (n = 24) Tenderness sensation (n = 50) Minor bleeding (n = 3) Minor infection (n = 1) Nausea (n = 2) and dizziness (n = 4) Outcome: gradually declined |
(1) Adequate (2) Not reported (3) Adequate (4) Adequate (5) Adequate (6) Inadequate (7) Adequate |
|
| |||||
| Usichenko et al., 2007 [36] RCT (N = 120) Ambulatory Orthopedic Surgery Center of the Ernst Moritz Arndt University, Greifswald, Germany |
R: postoperative pain P: acupuncturist |
Intervention (true AT + analgesia): (i) Method: auricular acupuncture with indwelling steel needles (0.22 × 1.5 mm) (ii) Duration: inserted before surgery and kept until the following morning Control (sham AT + analgesia): auricular acupuncture at nonacupuncture points |
True AT: shenmen, lung, knee joint Sham AT: nonacupuncture points located on the helix ipsilateral to the site of surgery |
Dizziness and nausea (n = 1) Pain at insertion and sleep disturbance (n = 1) Outcome: (i) Disappeared after withdrawal of the needles (for dizziness and nausea) (ii) Not reported (for pain and sleep disturbance) |
(1) Not reported (2) Not reported (3) Not reported (4) Not reported (5) Partially adequate (6) Partially adequate (7) Adequate |
|
| |||||
| Kunz et al., 2007 [37] RCT (N = 109) Clinic of Psychiatry and Psychotherapy Bethel, Bielefeld, Germany |
R: alcohol withdrawal P: psychiatrists or mental-health nurses |
Intervention (AT + usual treatment): (i) Method: auricular acupuncture with stainless-steel acupuncture needles (0.2 × 0.15 mm) (ii) Duration: daily treatment (45 minutes) for 5 consecutive days Control: aromatherapy + usual treatment |
Shenmen, sympathetic, kidney, liver, lung |
Pain and mild bleeding (n = 6) Outcome: not reported |
(1) Not reported (2) Not reported (3) Not reported (4) Adequate (5) Partially adequate (6) Inadequate (7) Adequate |
|
| |||||
| Usichenko et al., 2005 [38] RCT (N = 61) Department of Anesthesiology and Orthopedic Surgery, University of Greifswald, Germany |
R: postoperative pain P: acupuncturist |
Intervention (true AT + analgesia): (i) Method: auricular acupuncture with permanent press steel needles (0.22 × 1.5 mm) (ii) Duration: inserted the evening before surgery and kept for 3 days after surgery Control (sham AT + analgesia): auricular acupuncture at nonacupuncture points |
True AT: shenmen, lung, thalamus, hip joint Sham AT: nonacupuncture points on the auricular helix |
Pain at the needling site (n = 3) Minor bleeding at the needling site (n = 2) Headache (n = 1) Hip pain after needle withdrawal (n = 2) Outcome: (i) One withdrew, not reported for another 2 (for pain) (ii) Recovery after treatment (for bleeding) (iii) Recovery after surgery (for headache) (iv) Not reported (for hip pain) |
(1) Not reported (2) Not reported (3) Not reported (4) Not reported (5) Inadequate (6) Adequate (7) Inadequate |
|
| |||||
| Berman et al., 2004 [39] RCT (N = 158) Two Medium-Security Institutions (Jails), Sweden |
R: drug use problem, psychological symptoms, and physical discomfort in prison inmates P: acupuncturist |
Intervention (true AT): (i) Method: auricular acupuncture with stainless-steel disposable needles (0.22 × 0.13 mm) (ii) Duration: a total of 14 treatments (40 minutes per treatment) for 4 weeks Control (sham AT): auricular acupuncture at nonspecific points |
True AT: shenmen, lung, liver, kidney, sympathetic Sham AT: nonspecific points on the auricular helix |
Pain at insertion (n = 44) Outcome: forty-two dropped out and 2 completed treatment even though they found it painful |
(1) Adequate (2) Adequate (3) Adequate (4) Adequate (5) Partially adequate (6) Inadequate (7) Adequate |
|
| |||||
| Bier et al., 2002 [40] RCT (N = 141) Arizona, USA |
R: smoking cessation and cigarette consumption P: acupuncturist |
Intervention 1 (true acupuncture + education): (i) Method: auricular acupuncture with 36 gauge 0.5 inch needles (ii) Duration: five treatments weekly (30 minutes per treatment) for 4 weeks Intervention 2 (true acupuncture) Control (sham acupuncture + education): auricular acupuncture at nonacupuncture points |
True AT: shenmen, lung, liver, kidney, sympathetic Sham AT: nonacupuncture points located within 5 mm of the true points |
Infrequent minor bleeding upon needle removal (not reported) Outcome: not reported |
(1) Not reported (2) Not reported (3) Not reported (4) Adequate (5) Not reported (6) Inadequate (7) Not reported |
|
| |||||
| Gurevich et al., 1996 [41] Non-RCT (N = 77) North Shore University Hospital at Glen Cove, USA |
R: substance-abuse problem P: psychiatrist and nurses |
Intervention (receiving AT for 5 or more times): (i) Method: auricular acupuncture with sterile disposable needles (ii) Duration: daily treatment (20–40 minutes) Control: receiving AT for 4 or fewer times |
Shenmen, lung, liver, kidney, sympathetic | Minor local bleeding (not reported) Local pain (not reported) Outcome: (i) Treatment was not required (for bleeding) (ii) Stopped AT temporarily or had less frequent treatments (for local pain) |
(1) Partially adequate (2) Inadequate (3) Partially adequate (4) Not reported (5) Not reported (6) Partially adequate (7) Not reported |
|
| |||||
| Washburn et al., 1993 [42] RCT (N = 100) The Bayview-Hunters Point Foundation, San Francisco, USA |
R: heroin addiction P: acupuncturist |
Intervention (true AT + support service): (i) Method: auricular acupuncture with single-use disposable needles (ii) Duration: twenty-one days (20–45 minutes per treatment) Control (sham AT + support service): auricular acupuncture at nonacupuncture points |
True AT: shenmen, lung, kidney, sympathetic Sham AT: nonacupuncture points located close to the true points |
Slight bleeding at insertion (not reported) Mild nausea and dizziness (not reported) Outcome: relief when the needles were removed |
(1) Not reported (2) Inadequate (3) Partially adequate (4) Not reported (5) Not reported (6) Inadequate (7) Not reported |
|
| |||||
| Zhang and Fan, 1986 [43] Non-RCT (N = 179) TCM Academy of Shanxi Province, China |
R: cholecystolithiasis P: TCM practitioner |
Intervention (AT): (i) Method: auricular acupuncture for main points and auricular acupressure for adjunct points (details were not described) (ii) Duration: not reported Control: not applicable |
Liver, gallbladder, stomach, duodenum, shenmen, sympathetic, lung | Dizziness, upper limb numbness, and minor nausea (not reported) Outcome: disappeared after removing stimulation on acupoint “sympathetic” |
(1) Not reported (2) Not reported (3) Not reported (4) Not reported (5) Not reported (6) Inadequate (7) Not reported |
|
| |||||
| Studies on auricular acupressure | |||||
| Vas et al., 2014 [44] RCT (N = 265) Ten Primary Healthcare Centres, Seville, Spain |
R: chronic nonspecific spinal pain P: doctors and nurses with AT training |
Intervention (true AT): (i) Method: auricular acupressure using auricular plaster with vaccaria seeds (ii) Duration: weekly treatment (seeds kept for 7 days) for 8 weeks Control (placebo AT): auricular acupressure using auricular plaster with inactive black plastic discs |
Main acupoints: shenmen, thalamus Adjunct acupoints: not reported |
Pressure ulcers in the pinna (n = 18) Worsened symptoms (n = 8) Outcome: (i) Healed within 10 days of removal (for pressure ulcers) (ii) Not reported (for worsened symptoms) |
(1) Adequate (2) Adequate (3) Not reported (4) Adequate (5) Inadequate (6) Inadequate (7) Partially adequate |
|
| |||||
| Li et al., 2014 [45] RCT (N = 99) Elderly Residential Care Home, Hong Kong |
R: constipation P: not reported |
Intervention (true AT): (i) Method: auricular acupressure using auricular plaster with magnetic pellets (ii) Duration: ten days Control 1 (placebo AT): auricular acupressure using auricular plaster with vaccaria seeds Control 2 (usual care): auricular acupressure using auricular plaster only |
Large intestine, rectum, San Jiao, spleen, lung, sympathetic, subcortex | Minor local itchiness (n = 27) Minor dizziness (n = 2) Outcome: (i) Spontaneously subsided after AT (25) and 2 withdrew (for itchiness) (ii) Spontaneously subsided after AT (1) and 1 withdrew (for dizziness) |
(1) Partially adequate (2) Partially adequate (3) Adequate (4) Not reported (5) Inadequate (6) Adequate (7) Partially adequate |
|
| |||||
| Zhang et al., 2013 [46] RCT (N = 43) RMIT University, Australia |
R: smoking cessation P: acupuncturist |
Intervention (true AT): (i) Method: auricular acupressure with stainless-steel press-pellet tapes (ii) Duration: weekly treatment for 8 weeks Control (sham AT): auricular acupressure at nonspecific points |
True AT: shenmen, lung, mouth, extra, liver Sham AT: helix 2, shoulder, clavicle, occiput, tooth |
Mild to moderate local discomfort (n = 5) Slight headache and dizziness (n = 1) Outcome: (i) All AEs were resolved without any medical intervention (for both) (ii) One subject withdrew (for ear discomfort) |
(1) Adequate (2) Adequate (3) Not reported (4) Adequate (5) Inadequate (6) Adequate (7) Partially adequate |
|
| |||||
| Kong, 2012 [47] RCT (N = 60) Foshan Hospital of TCM, Foshan, China |
R: postoperative pain P: not reported |
Intervention (AT + intravenous analgesia): (i) Method: auricular acupressure using auricular plaster with vaccaria seeds (ii) Duration: one treatment (5 hours after surgery), seeds kept for 3 days Control: intravenous analgesia only |
Shenmen, liver, kidney, heel, lesser occipital nerve, great auricular nerve | Mild skin irritation (n = 2) Outcome: no obvious discomfort and AT continued |
(1) Adequate (2) Partially adequate (3) Not reported (4) Adequate (5) Partially adequate (6) Inadequate (7) Inadequate |
|
| |||||
| Yeh et al., 2012 [48] RCT (N = 10) A Large Children's Hospital, Taiwan |
R: chemotherapy-induced nausea and vomiting P: therapist |
Intervention (true AT + standard care): (i) Method: auricular acupressure using auricular plaster with plant seeds (ii) Duration: one treatment, seeds kept for 7 days Control (sham AT + standard care): auricular acupressure at nonspecific points |
True AT: Shenmen, sympathetic, cardia, stomach, digestive subcortex Sham AT: external knee point, vision, shoulder joint, eye |
Local itchiness (n = 3) Outcome: continued to complete the study |
(1) Not reported (2) Not reported (3) Not reported (4) Not reported (5) Not reported (6) Inadequate (7) Not reported |
|
| |||||
| Li et al., 2012 [49] RCT (N = 39) Elderly Residential Care Home, Hong Kong |
R: constipation P: not reported |
Intervention (true AT): (i) Method: auricular acupressure using auricular plaster with magnetic pellets (ii) Duration: three weeks Control (placebo AT): auricular acupressure using auricular plaster with vaccaria seeds |
Large intestine, rectum, San Jiao, spleen, lung, sympathetic, subcortex | Mild, tolerable, and short-term itchiness of the ears (n = 7) Outcomes: not reported |
(1) Not reported (2) Not reported (3) Not reported (4) Partially adequate (5) Not reported (6) Inadequate (7) Not reported |
|
| |||||
| Jin et al., 2012 [50] RCT (N = 80) Cangnan TCM Hospital of Zhejiang Province, Cangnan, China |
R: severe insomnia P: TCM practitioner |
Intervention (AT): (i) Method: auricular acupressure using auricular plaster with magnetic pellets (ii) Duration: one treatment, seeds kept for 7 days Control: standardized medication |
Main acupoints: shenmen, occiput, subcortex, sympathetic Adjunct acupoints: (based on TCM syndrome) heart, spleen, kidney, liver, stomach |
Local redness at the taped site (n = 2) Outcome: recovery after treatment |
(1) Inadequate (2) Not reported (3) Not reported (4) Adequate (5) Not reported (6) Inadequate (7) Not reported |
|
| |||||
| Kung et al., 2011 [51] Non-RCT (N = 45) Taipei Veterans General Hospital, Taiwan |
R: women with postmenopausal insomnia P: acupuncturist |
Intervention (AT): (i) Method: auricular acupressure using auricular plaster with magnetic pellets (ii) Duration: daily treatment (every night before sleep) for 4 weeks Control: not applicable |
Shenmen, kidney, heart, brainstem, subcortex | Sensation of auricular tenderness (n = 2) Outcome: not reported |
(1) Not reported (2) Not reported (3) Not reported (4) Not reported (5) Not reported (6) Inadequate (7) Not reported |
|
| |||||
| Xia et al., 2011 [52] RCT (N = 60) Baoan Hospital Affiliated to South Medical University, Shenzhen, China |
R: low back pain caused by lumbar strain P: not reported |
Intervention (AT + Chinese medicine plaster): (i) Method: auricular acupressure using auricular plaster with vaccaria seeds (ii) Duration: two treatments weekly for 2 weeks Control: Chinese medicine plaster only |
Ashi point, kidney, liver, lumbosacral vertebrae, shenmen, subcortex | Obvious pain at the taped site when receiving AT for the first time (n = 5) Outcome: completed the study by reducing pressing frequency and intensity |
(1) Adequate (2) Not reported (3) Partially adequate (4) Partially adequate (5) Not reported (6) Inadequate (7) Not reported |
|
| |||||
| Xue et al., 2011 [53] RCT (N = 63) Two Metropolitan RMIT Campus in Melbourne, Australia |
R: persistent allergic rhinitis P: acupuncturist |
Intervention (true AT): (i) Method: auricular acupressure using auricular plaster with stainless-steel pellets (ii) Duration: eight weeks Control (sham AT): auricular acupressure at nonspecific points |
True AT: shenmen, internal nose, lung, wind stream Sham AT: adrenal gland, helix 2, shoulder, clavicle, occiput, teeth |
Mild to moderate local and short-term discomfort (n = 30) Sore ear (n = 9) Ear itch (n = 7) Outcome: well tolerated |
(1) Not reported (2) Not reported (3) Not reported (4) Partially adequate (5) Not reported (6) Inadequate (7) Inadequate |
|
| |||||
| Ji et al., 2010 [54] RCT (N = 73) Shuguang Hospital Affiliated to Shanghai University of TCM, Shanghai, China |
R: functional constipation P: nurse |
Intervention (AT + usual care): (i) Method: auricular acupressure using auricular plaster with Liu Shen Wan (for excess syndrome) or magnetic pellets (for deficiency syndrome) (ii) Duration: one month Control: usual care |
Main acupoints: large intestine, small intestine, rectum Adjunct acupoints: Lung, San Jiao, stomach (for excess syndrome), spleen, kidney, endocrine (for deficiency syndrome) |
Mild redness and skin breakdown at the taped site (n = 1) Outcome: recovery two days later after using entoiodine |
(1) Adequate (2) Not reported (3) Not reported (4) Adequate (5) Not reported (6) Inadequate (7) Not reported |
|
| |||||
| Wing et al., 2010 [55] RCT (N = 70) Outpatient Clinics and The Community, Hong Kong |
R: smoking cessation P: not reported |
Intervention (true AT + hand acupressure): (i) Method: auricular acupressure using auricular plaster with hard beads (ii) Duration: three weeks Control (sham AT + sham hand acupressure): auricular acupressure at nonmeridian points |
True AT: shenmen, lung, month, brain Nonmeridian points: away from those selected for the treatment group |
Skin irritation (allergy) at the site of the adhesive tapes (n = 3) Outcome: withdrawal |
(1) Adequate (2) Partially adequate (3) Not reported (4) Not reported (5) Not reported (6) Adequate (7) Partially adequate |
|
| |||||
| Sun, 2010 [56] RCT (N = 173) Department of TCM, Xuzhou First Hospital of Jiangsu Province, Xuzhou, China |
R: insomnia P: not reported |
Intervention (AT + psychological support): (i) Method: auricular acupressure using auricular plaster with vaccaria seeds (ii) Duration: twenty days Control: AT only |
Main acupoints: shenmen, sympathetic, endocrine, heart, subcortex Adjunct acupoints: liver, stomach, spleen, kidney, pancreas and gallbladder, heart of dorsal surface |
Skin irritation (allergy) at the site of the adhesive tapes (n = 5) Outcome: changed to desensitization tapes and treatment continued |
(1) Not reported (2) Not reported (3) Not reported (4) Not reported (5) Not reported (6) Inadequate (7) Not reported |
|
| |||||
| Peng, 2009 [57] Non-RCT (N = 30) Hanguang Hospital of Handan City, Handan, China |
R: neurasthenia P: not reported |
Intervention (AT): (i) Method: auricular acupressure using auricular plaster with magnetic pellets (ii) Duration: three days per treatment, 20 treatments in total (60 days) Control: not applicable |
Main acupoints: shenmen, subcortex, endocrine, anterior ear lobe Adjunct acupoints: (based on TCM syndrome) liver, gallbladder, San Jiao, stomach, lung, heart |
Skin allergy and itchiness of the ear (not reported) Outcome: symptom disappeared after changing magnetic pellets to vaccaria seeds |
(1) Not reported (2) Not reported (3) Not reported (4) Not reported (5) Not reported (6) Inadequate (7) Not reported |
|
| |||||
| Chen et al., 2009 [58] RCT (N = 180) TCM Hospital of Hainan Province, Haikou, China |
R: vascular dementia P: TCM practitioner |
Intervention (AT): (i) Method: auricular acupressure using auricular plaster with vaccaria seeds (ii) Duration: daily treatment for 12 weeks Control: standardized medication |
Shenmen, brain, kidney, occiput | Severe skin allergy and itchiness at the taped site (n = 2) Outcome: withdrawal |
(1) Adequate (2) Partially adequate (3) Not reported (4) Inadequate (5) Not reported (6) Adequate (7) Not reported |
|
| |||||
| Wang et al., 2007 [59] RCT (N = 198) People's Hospital of Baoshan City, Baoshan, China |
R: myopia P: not reported |
Intervention (AT): (i) Method: auricular acupressure using auricular plaster with vaccaria seeds (ii) Duration: four weeks for one treatment Control: standardized medication |
Apex of ear, kidney, liver, eye, eye 2, spleen, |
Skin allergy and local redness at the taped site (n = 2) Outcome: not reported |
(1) Adequate (2) Not reported (3) Not reported (4) Not reported (5) Not reported (6) Inadequate (7) Not reported |
|
| |||||
| Ding et al., 2006 [60] RCT (N = 200) TCM Hospital of Hebei Province, Shijiazhuang, China |
R: motion sickness P: acupuncturist |
Intervention (AT + Neiguan acupressure): (i) Method: auricular acupressure using auricular plaster with magnetic pellets (ii) Duration: not reported Control: standardized medication |
Stomach, occiput, shenmen, sympathetic | Itchiness at the taped site (n = 2) Outcome: not reported |
(1) Adequate (2) Not reported (3) Not reported (4) Not reported (5) Not reported (6) Inadequate (7) Not reported |
|
| |||||
| Studies on auricular electroacupuncture | |||||
| Schukro et al., 2013 [61] RCT (N = 56) Department of Special Anesthesia and Pain Management at the Medical University of Vienna, Vienna, Austria |
R: obesity in female patients P: not reported |
Intervention (AT + diet based on TCM): (i) Method: auricular acupuncture with electrical stimulation using P-stim electroacupuncture device (needle: 27 gauge, 3 mm length) (ii) Duration: 4-day treatment per week for 6 weeks Control (placebo AT + diet based on TCM): auricular acupuncture with a P-stim dummy |
Hunger, stomach, colon |
mild skin irritations behind the ear caused by the adhesive patch of the P-stim/placebo device (n = 8) Outcome: resolved immediately after the end of application |
(1) Adequate (2) Not reported (3) Not reported (4) Not reported (5) Not reported (6) Inadequate (7) Not reported |
|
| |||||
| Fritz et al., 2013 [62] RCT (N = 125) St. Louis Veterans Affairs Medical Center, USA |
R: smoking cessation P: registered nurse |
Intervention (AT): (i) Method: auricular acupuncture with the Stim Flex 400A Transcutaneous Electrical Nerve Stimulation Unit (active, 80 Hz) (ii) Duration: weekly treatment (20 minutes per treatment) for 5 consecutive weeks Control (sham AT): auricular acupuncture with the Stim Flex 400A Transcutaneous Electrical Nerve Stimulation Unit (inactive, 0 Hz) |
Lung, shenmen, nicotine, point zero, palate | Auricle discomfort without redness or swelling (n = 1) Outcome: not reported |
(1) Adequate (2) Not reported (3) Not reported (4) Partially adequate (5) Not reported (6) Partially adequate (7) Partially adequate |
|
| |||||
| Bernateck et al., 2008 [63] RCT (N = 44) Outpatient Clinic of the Department of Rheumatology, Hannover Medical School, Hannover, Germany |
R: rheumatoid arthritis P: doctor with profound acupuncture experience |
Intervention (AT): (i) Method: auricular acupuncture with electrical stimulation using P-stim device (needle: 27 gauge, 3 mm length) (ii) Duration: weekly treatment (48 hours per treatment) for 6 weeks Control: autogenic training |
Shenmen, cushion, an individual point depending on the main pain spots |
Pain and discomfort at the needling site (n = 1) Outcome: not reported |
(1) Not reported (2) Not reported (3) Not reported (4) Not reported (5) Not reported (6) Inadequate (7) Not reported |
|
| |||||
| Studies on auricular bloodletting therapy | |||||
| Yuan and Qiao, 1998 [64] Non-RCT (N = 170) Chinese PLA 34260 Hospital, Xiangfan, China |
R: acute tonsillitis P: not reported |
Intervention (AT): (i) Method: auricular bloodletting therapy with three-edged needle (ii) Duration: not applicable Control: not applicable |
Helix 6 (Ashi point) | Minor infection at the needling site (n = 2) Outcome: not reported |
(1) Not reported (2) Not reported (3) Not reported (4) Not reported (5) Not reported (6) Inadequate (7) Not reported |
AT: auricular therapy, AE: adverse event, RCT: randomized controlled trial, R: reason for AT, PTSD: posttraumatic stress disorder, P: practitioner, LHRH: luteinizing hormone releasing hormone, and TCM: traditional Chinese medicine.
△ The CONSORT Recommendation for AEs: (1) report of data on harms in the title or abstract, (2) report of AT-related harms in the introduction section, (3) prespecification of potential adverse events of AT (clinical and/or laboratory), (4) specification of approach for collecting harms-related information, (5) description of plans for presenting and analyzing adverse events of AT, (6) description of participant withdrawals due to adverse events of AT, and (7) report of the particular denominators for analyses on AT-related harms. Quality grades for each item: adequate—item was properly described in detail in the article or in the study protocol; partially adequate—item was properly described but only in a brief format; inadequate—item failed to be properly described; not reported—item was not described.
#Happened in one participant who did not disclose a history of rheumatoid arthritis (one of the exclusion criteria for that study).