Adverse event reporting in acupuncture clinical trials focusing on pain

Research output: Contribution to journalArticle

Abstract

OBJECTIVES: To review the quality of adverse event reporting for published randomized controlled trials (RCTs) focusing on acupuncture for pain reduction. With the release of the Consolidated Standards of Reporting Trials (CONSORT) in 2001, the quality of published RCTs has improved. To improve reporting on adverse events, CONSORT expanded the section on harms (adverse events) in 2004. This paper evaluates whether the updated harms guidelines have been implemented in RCTs evaluating acupuncture for pain relief. METHODS: Systematic searches were conducted using the following databases: MEDLINE, Allied & Complementary Medicine, Cumulative Index to Nursing & Allied Health Literature, and All EBM Reviews. Each database was searched from 2005 through 2008, corresponding to the availability of the updated harms guideline. RESULTS: Ten studies met the inclusion criteria of this review. Six of the 10 studies mentioned or discussed adverse events. Four of the 6 studies did not detail how adverse events were collected. Only 2 studies discussed how adverse events were assessed. DISCUSSION: On the basis of our findings, acupuncture clinical trials for pain reduction have yet to comprehensively meet CONSORTs guidelines for adverse event reporting. Acupuncture is commonly used by patients experiencing pain and although typically viewed as a benign and minimally invasive therapy, serious adverse events have been reported in the literature. To effectively and comprehensively document and understand these events, routine reporting according to ONSORT s harms guidelines should become the norm. Both science and patients are served by accuately evaluating the safety of acupuncture for patient populations experiencing pain.

Original languageEnglish (US)
Pages (from-to)43-48
Number of pages6
JournalClinical Journal of Pain
Volume26
Issue number1
DOIs
StatePublished - Jan 2010

Fingerprint

Acupuncture
Clinical Trials
Pain
Guidelines
Randomized Controlled Trials
Databases
Patient Safety
Complementary Therapies
MEDLINE
Nursing
Health
Population

Keywords

  • Acupuncture
  • Adverse event
  • CONSORT
  • Pain
  • RCT
  • STRICTA

ASJC Scopus subject areas

  • Anesthesiology and Pain Medicine
  • Clinical Neurology

Cite this

Adverse event reporting in acupuncture clinical trials focusing on pain. / Capili, Bernadette; Anastasi, Joyce; Geiger, Jenna N.

In: Clinical Journal of Pain, Vol. 26, No. 1, 01.2010, p. 43-48.

Research output: Contribution to journalArticle

@article{73272c63357c41fd97a4c75a72432391,
title = "Adverse event reporting in acupuncture clinical trials focusing on pain",
abstract = "OBJECTIVES: To review the quality of adverse event reporting for published randomized controlled trials (RCTs) focusing on acupuncture for pain reduction. With the release of the Consolidated Standards of Reporting Trials (CONSORT) in 2001, the quality of published RCTs has improved. To improve reporting on adverse events, CONSORT expanded the section on harms (adverse events) in 2004. This paper evaluates whether the updated harms guidelines have been implemented in RCTs evaluating acupuncture for pain relief. METHODS: Systematic searches were conducted using the following databases: MEDLINE, Allied & Complementary Medicine, Cumulative Index to Nursing & Allied Health Literature, and All EBM Reviews. Each database was searched from 2005 through 2008, corresponding to the availability of the updated harms guideline. RESULTS: Ten studies met the inclusion criteria of this review. Six of the 10 studies mentioned or discussed adverse events. Four of the 6 studies did not detail how adverse events were collected. Only 2 studies discussed how adverse events were assessed. DISCUSSION: On the basis of our findings, acupuncture clinical trials for pain reduction have yet to comprehensively meet CONSORTs guidelines for adverse event reporting. Acupuncture is commonly used by patients experiencing pain and although typically viewed as a benign and minimally invasive therapy, serious adverse events have been reported in the literature. To effectively and comprehensively document and understand these events, routine reporting according to ONSORT s harms guidelines should become the norm. Both science and patients are served by accuately evaluating the safety of acupuncture for patient populations experiencing pain.",
keywords = "Acupuncture, Adverse event, CONSORT, Pain, RCT, STRICTA",
author = "Bernadette Capili and Joyce Anastasi and Geiger, {Jenna N.}",
year = "2010",
month = "1",
doi = "10.1097/AJP.0b013e3181b2c985",
language = "English (US)",
volume = "26",
pages = "43--48",
journal = "Clinical Journal of Pain",
issn = "0749-8047",
publisher = "Lippincott Williams and Wilkins",
number = "1",

}

TY - JOUR

T1 - Adverse event reporting in acupuncture clinical trials focusing on pain

AU - Capili, Bernadette

AU - Anastasi, Joyce

AU - Geiger, Jenna N.

PY - 2010/1

Y1 - 2010/1

N2 - OBJECTIVES: To review the quality of adverse event reporting for published randomized controlled trials (RCTs) focusing on acupuncture for pain reduction. With the release of the Consolidated Standards of Reporting Trials (CONSORT) in 2001, the quality of published RCTs has improved. To improve reporting on adverse events, CONSORT expanded the section on harms (adverse events) in 2004. This paper evaluates whether the updated harms guidelines have been implemented in RCTs evaluating acupuncture for pain relief. METHODS: Systematic searches were conducted using the following databases: MEDLINE, Allied & Complementary Medicine, Cumulative Index to Nursing & Allied Health Literature, and All EBM Reviews. Each database was searched from 2005 through 2008, corresponding to the availability of the updated harms guideline. RESULTS: Ten studies met the inclusion criteria of this review. Six of the 10 studies mentioned or discussed adverse events. Four of the 6 studies did not detail how adverse events were collected. Only 2 studies discussed how adverse events were assessed. DISCUSSION: On the basis of our findings, acupuncture clinical trials for pain reduction have yet to comprehensively meet CONSORTs guidelines for adverse event reporting. Acupuncture is commonly used by patients experiencing pain and although typically viewed as a benign and minimally invasive therapy, serious adverse events have been reported in the literature. To effectively and comprehensively document and understand these events, routine reporting according to ONSORT s harms guidelines should become the norm. Both science and patients are served by accuately evaluating the safety of acupuncture for patient populations experiencing pain.

AB - OBJECTIVES: To review the quality of adverse event reporting for published randomized controlled trials (RCTs) focusing on acupuncture for pain reduction. With the release of the Consolidated Standards of Reporting Trials (CONSORT) in 2001, the quality of published RCTs has improved. To improve reporting on adverse events, CONSORT expanded the section on harms (adverse events) in 2004. This paper evaluates whether the updated harms guidelines have been implemented in RCTs evaluating acupuncture for pain relief. METHODS: Systematic searches were conducted using the following databases: MEDLINE, Allied & Complementary Medicine, Cumulative Index to Nursing & Allied Health Literature, and All EBM Reviews. Each database was searched from 2005 through 2008, corresponding to the availability of the updated harms guideline. RESULTS: Ten studies met the inclusion criteria of this review. Six of the 10 studies mentioned or discussed adverse events. Four of the 6 studies did not detail how adverse events were collected. Only 2 studies discussed how adverse events were assessed. DISCUSSION: On the basis of our findings, acupuncture clinical trials for pain reduction have yet to comprehensively meet CONSORTs guidelines for adverse event reporting. Acupuncture is commonly used by patients experiencing pain and although typically viewed as a benign and minimally invasive therapy, serious adverse events have been reported in the literature. To effectively and comprehensively document and understand these events, routine reporting according to ONSORT s harms guidelines should become the norm. Both science and patients are served by accuately evaluating the safety of acupuncture for patient populations experiencing pain.

KW - Acupuncture

KW - Adverse event

KW - CONSORT

KW - Pain

KW - RCT

KW - STRICTA

UR - http://www.scopus.com/inward/record.url?scp=74049146218&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=74049146218&partnerID=8YFLogxK

U2 - 10.1097/AJP.0b013e3181b2c985

DO - 10.1097/AJP.0b013e3181b2c985

M3 - Article

VL - 26

SP - 43

EP - 48

JO - Clinical Journal of Pain

JF - Clinical Journal of Pain

SN - 0749-8047

IS - 1

ER -