Evidence map›Paper›PMID 19420954›Full record

ArticleForschende Komplementarmedizin (2006)2009

Safety of acupuncture: results of a prospective observational study with 229,230 patients and introduction of a medical information and consent form.

Claudia M Witt, Daniel Pach, Benno Brinkhaus, Katja Wruck, Brigitte Tag, Sigrid Mank, Stefan N Willich

5 registry-linked trialsOpen access · bronzeAbstract read
PubMed Publisher
In one paragraph

Article in Forschende Komplementarmedizin (2006), 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 205 papers, 23 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
205citing papers in PubMed, 23 pooled it
64.4field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02491333 phase3completedstarted 2015, after this paper: background citation

The Effect of Acupuncture on Insulin Sensitivity of Women With Polycystic Ovary Syndrome and Insulin Resistance: a Randomized Controlled Trial

Ran2015Enrolled342Registered outcomes12Posted comparisons0ConditionsInsulin Resistance, Polycystic Ovary SyndromeArmsMetformin, placebo metformin, sham acupuncture, true acupuncture
PMID 21950959PMID 18364705PMID 12243370PMID 11602624PMID 9165656PMID 21121941PMID 22878886PMID 12900694PMID 15833138PMID 16684838PMID 16791967PMID 19494176other papers from this trial
Open the trial in the graph
NCT02976558 naterminatednot on this mapstarted 2016, after this paper: background citation

Prospective Open Randomized Monocentric Two-armed Controlled Clinical Trial in Parallel Groups to Investigate the Influence of Complementary Medicine (CAM) Interventions on Quality of Life and The Treatment Process of Patients Undergoing Allogenic Stem Cell Transplantation

TypeinterventionalSponsorUniversity of Erlangen-Nürnberg Medical SchoolRan2016 to 2019Enrolled104ConditionsHematological Neoplasm, Graft-Versus-Host Disease, Depression, Stem Cell Transplant ComplicationsArmsClown theatrical Performance, Acupuncture, Music Therapy TaKeTiNa
NCT03539588 nacompletednot on this mapstarted 2017, after this paper: background citation

Trigger Point Dry Needling vs Trigger Point Dry Needling With Intramuscular Electrical Stimulation for the Treatment of Sub-acute and Chronic Low Back Pain in a Military Population: A Randomized Crossover Design

TypeinterventionalSponsorWilliam Beaumont Army Medical CenterRan2017 to 2017Enrolled30ConditionsSub-acute and Chronic Low Back PainArmstrigger point dry needling, Electrical Stimulation
NCT03755960 nacompletednot on this mapstarted 2019, after this paper: background citation

Acupuncture in Symptomatic Diabetic Peripheral Neuropathy.

TypeinterventionalSponsorBenno BrinkhausRan2019 to 2021Enrolled62ConditionsDiabetic NeuropathyArmsacupuncture, routine care
NCT05232487 naunknown statusnot on this mapstarted 2023, after this paper: background citation

Comparison of Swiss Versus Standard Low Back Acupuncture in Patients With Chronic Low Back Pain. A Randomized, Controlled, Single-blind, Monocentric Clinical Study

TypeinterventionalSponsorLi YimingRan2023 to 2025Enrolled116ConditionsChronic Low-back PainArmsSwiss low back acupuncture (SLBA), Standard acupuncture (SA)
3 · Its place in the literature

Who cites it

205 citing papers in PubMed, 23 syntheses or guidelines pooled it, 505 citations in OpenAlex.

  1. Pooled it
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  5. Acupuncture for treating overactive bladder in adults.The Cochrane database of systematic reviews · 2022
    Pooled it
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  10. Acupuncture for polycystic ovarian syndrome.The Cochrane database of systematic reviews · 2019
    Pooled it
  11. Pooled it
  12. Acupuncture for symptomatic gastroparesis.The Cochrane database of systematic reviews · 2018
    Pooled it
  13. Acupuncture and acupressure for premenstrual syndrome.The Cochrane database of systematic reviews · 2018
    Pooled it
  14. Acupuncture for hip osteoarthritis.The Cochrane database of systematic reviews · 2018
    Pooled it
  15. Acupuncture for depression.The Cochrane database of systematic reviews · 2018
    Pooled it
  16. Acupuncture for acute hordeolum.The Cochrane database of systematic reviews · 2017
    Pooled it
  17. Pooled it
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  19. The safety of acupuncture during pregnancy: a systematic review.Acupuncture in medicine : journal of the British Medical Acupuncture Society · 2014
    Pooled it
  20. Pooled it

145 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 2 countries.

Claudia M WittInstitute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin, Germany. claudia.witt@charite.de
Daniel Pach
Benno Brinkhaus
Katja Wruck
Brigitte Tag
Sigrid Mank
Stefan N Willich
Charité - Universitätsmedizin Berlin · DEBerlin Institute of Health at Charité - Universitätsmedizin Berlin · DEUniversity of Zurich · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo evaluate the safety of acupuncture in a large number of patients receiving conventional health care and, based on these results, to develop a new medical consent form for acupuncture.

methodsThe prospective observational study included patients who received acupuncture treatment for chronic osteoarthritis pain of the knee or hip, low back pain, neck pain or headache, allergic rhinitis, asthma, or dysmenorrhoea. After treatment, all patients documented adverse events associated with acupuncture (defined as adverse effects). Patients who reported a need for treatment due to an adverse effect completed an additional standardised questionnaire on the most important adverse effect. Based on this data and considering ethical and legal aspects a new consent form was developed.

resultsA total of 229,230 patients received on average 10.2 +/- 3.0 acupuncture treatments. Altogether, 19,726 patients (8.6%) reported experiencing at least one adverse effect and 4,963 (2.2%) reported one which required treatment. Common adverse effects were bleedings or haematoma (6.1% of patients, 58% of all adverse effects), pain (1.7%) and vegetative symptoms (0.7%). Two patients experienced a pneumothorax (one needed hospital treatment, the other observation only). The longest duration of a side effect was 180 days (nerve lesion of the lower limb). The resulting medical consent form consists of five modules: Introduction to acupuncture and moxibustion, Risks of acupuncture treatment, Conditions which can increase the risk, Doctor's statement, and Consent.

conclusionAcupuncture provided by physicians is a relatively safe treatment and the proposed consent form could support both patients and professionals in the process of obtaining informed consent.

Indexed as

SafetyAcupuncture TherapyAdultAgedAutonomic Nervous SystemConsent FormsCross-Sectional StudiesFemaleHematomaHemorrhageHumansMaleMalpracticeMiddle AgedPainPatient Education as Topic

Identifiers

PMID19420954
OpenAlexW2118656217

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.