PMID- 21435214
OWN - NLM
STAT- MEDLINE
DCOM- 20110628
LR  - 20211020
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 12
DP  - 2011 Mar 24
TI  - Adverse events associated with acupuncture: three multicentre randomized 
      controlled trials of 1968 cases in China.
PG  - 87
LID - 10.1186/1745-6215-12-87 [doi]
AB  - BACKGROUND: In order to evaluate the safety of acupuncture in China objectively, 
      we investigated the adverse events associated with acupuncture based on three 
      multicentre randomized controlled trials (RCTs) to assess the safety of 
      acupuncture, identifying the common types of acupuncture adverse events, and 
      analysing the related risk factors for their occurrence. METHODS: This 
      observational study included patients who received acupuncture from three 
      multicentre RCTs respectively for migraine, functional dyspepsia and Bell's 
      palsy. The 1968 patients and their acupuncturists documented adverse events 
      associated with acupuncture after treatment. We collected data about adverse 
      events due to acupuncture treatment from their case report forms. We analysed the 
      incidence and details of the adverse effects, and studied the risk factors for 
      acupuncture adverse events with non-conditional logistic regression analysis. 
      RESULTS: Among the 1968 patients, 74 patients (3.76%) suffered at least one 
      adverse event throughout the treatment period. We did not observe the occurrence 
      of serious adverse events. 73 patients with adverse events recovered within 2 
      weeks through effective treatment such as physiotherapy or self-treatment. A 
      total of 3 patients withdrew because of adverse events. There were 9 types of 
      adverse events related to acupuncture, including subcutaneous haematoma, 
      bleeding, skin bruising and needle site pain. Subcutaneous haematoma and 
      haemorrhage in the needling points were the most common adverse events. Age and 
      gender were related to the occurrence of acupuncture adverse events. The older 
      the patients were, the higher the risk of adverse events was. In addition, male 
      patients had slightly higher risk of an adverse event than female patients. 
      CONCLUSIONS: Acupuncture is a safe therapy with low risk of adverse events in 
      clinical practice. The risk factors for adverse events (AEs) were related to the 
      patients' gender and age and the local anatomical structure of the acupoints. AEs 
      could be reduced and mitigated by improving the medical environment, ensuring a 
      high technical level of the acupuncture practitioners and establishing a good 
      relationship of mutual trust between doctor and patient. TRIAL REGISTRATION: 
      ClinicalTrials.gov: NCT00599586, NCT00599677, NCT00608660.
FAU - Zhao, Ling
AU  - Zhao L
AD  - College of Acupuncture and Massage, Chengdu University of TCM, Chengdu, Sichuan 
      610075, China.
FAU - Zhang, Fu-wen
AU  - Zhang FW
FAU - Li, Ying
AU  - Li Y
FAU - Wu, Xi
AU  - Wu X
FAU - Zheng, Hui
AU  - Zheng H
FAU - Cheng, Lin-hao
AU  - Cheng LH
FAU - Liang, Fan-rong
AU  - Liang FR
LA  - eng
SI  - ClinicalTrials.gov/NCT00599586
SI  - ClinicalTrials.gov/NCT00599677
SI  - ClinicalTrials.gov/NCT00608660
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20110324
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
SB  - IM
MH  - Acupuncture Therapy/*adverse effects
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Bell Palsy/*therapy
MH  - China
MH  - Dyspepsia/*therapy
MH  - Female
MH  - Humans
MH  - Logistic Models
MH  - Male
MH  - Middle Aged
MH  - Migraine Disorders/*therapy
MH  - Risk Assessment
MH  - Risk Factors
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC3072923
EDAT- 2011/03/26 06:00
MHDA- 2011/06/29 06:00
PMCR- 2011/03/24
CRDT- 2011/03/26 06:00
PHST- 2010/09/10 00:00 [received]
PHST- 2011/03/24 00:00 [accepted]
PHST- 2011/03/26 06:00 [entrez]
PHST- 2011/03/26 06:00 [pubmed]
PHST- 2011/06/29 06:00 [medline]
PHST- 2011/03/24 00:00 [pmc-release]
AID - 1745-6215-12-87 [pii]
AID - 10.1186/1745-6215-12-87 [doi]
PST - epublish
SO  - Trials. 2011 Mar 24;12:87. doi: 10.1186/1745-6215-12-87.