title: Adverse event reporting in studies of penetrating acupuncture during pregnancy: a systematic review.
abstract: BACKGROUND
  Acupuncture within pregnancy has frequently been investigated, often finding this to be more effective than standard care. However, the adverse event severity, types and occurrence are unclear.
  
  
  OBJECTIVE
  To investigate the quality of reporting adverse events and to attempt to identify occurrence, type and severity of adverse events in acupuncture and non-acupuncture groups.
  
  
  METHODS
  MEDLINE, CINAHL, Allied and Complementary Medicine Database, and Physiotherapy Evidence Database (PEDro) were searched for relevant studies between 2000 and 2014.
  
  
  METHODS
  Seventeen studies using penetrating acupuncture and making comment on adverse events experienced were included. Quality appraisal of the selected publications was performed using either the PEDro scale or the Downs and Black checklist. Quality of reporting was evaluated against STRICTA and CONSORT guidelines, with data on adverse events extracted in accordance with CONSORT and Good Clinical Practice adverse event guidelines.
  
  
  RESULTS
  Overall quality of reporting of adverse events was poor, with information describing the adverse events often lacking in detail. A number of trends were noted: adverse events occurring within a treatment session was 3-17% in the acupuncture groups and 4-25% in the non-acupuncture groups. The percentage of women affected by an adverse event was between 14 and 17% in the acupuncture groups and between 15 and 19% in non-acupuncture groups.
  
  
  CONCLUSIONS
  Adverse event reporting within acupuncture trials is generally poor. The trends noted were that adverse events do occur, but would appear to be largely minor and comparable to non-acupuncture-related interventions.
authors.affiliation: Department of Sport, Exercise and Rehabilitation, Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, UK.
authors.forename: Carl E
authors.initials: CE
authors.lastname: Clarkson
authors.forename: Deborah
authors.initials: D
authors.lastname: O'mahony
authors.forename: Diana E
authors.initials: DE
authors.lastname: Jones
mesh_terms: D015670:Acupuncture Therapy / Q000009:adverse effects*; D005260:Female; D006801:Humans; D011247:Pregnancy; D011248:Pregnancy Complications / Q000453:epidemiology* / Q000628:therapy*; D012107:Research Design
keywords: Acupuncture; adverse events; harms; pregnancy; safety; systematic review