Table 1

Studies, protocol approval and funding, interventions in the active treatment and sham arms, and adverse events

AuthorProtocol approval/funding (commercial, non-commercial)Invasive procedure/indicationSham interventionAdverse events related to procedure, active treatmentAdverse events related to procedure, sham
Leon et al34Food and Drug Administration/NCPercutaneous myocardial laser revascularisation/intractable angina pectorisLaser turned on but no procedure performedMAE in hospital (high dose): 4.1%MAE in hospital: 0
Salem et al33Ethics committee/NCNo procedural AE
Sihvonen et al48Review board/NCArthroscopic partial meniscectomy/degenerate meniscal tearRoutine arthroscopy, simulation of meniscectomy by manipulation etcNo MAE
mAE: 6.6%mAE: 2.9%
Moseley et al47Review board/NCArthroscopic debridement/knee osteoarthritisSimulated arthroscopy preparation, intravenous anaesthesia, skin incisions, no instruments entered knee, knee manipulatedNo procedural AE
Pham et al35Review board/NCHyaluronic acid/knee osteoarthritisIntra-articular injection of saline solutionNo MAE
Any mAE: 81.7%Any mAE: 1.2%
Altman et al36Ethics committee/CNo MAE
mAE: 12.8%mAE: 8%
Chevalier et MAE
mAE: 35.8%mAE: 33.8%
Kallmes et al38Review board/NCPercutaneous vertebroplasty with PMMA cement injection/vertebral compression fractureConscious sedation + local anaesthaesia, pressure put on spine, simulation of odour with mixing of PMMA to imitate the smell during the active procedureNo MAE
mAE: 14%mAE: 16%
Buchbinder et al39Ethics committee at each participating center/NCConscious sedation + local anaesthaesia, needle inserted to rest on the lamina, PMMA container opened to imitate the smell during the active procedureNo procedural AE
Cohen et al41Review board/NCEpidural injection of corticosteroids/sciatica2 mL sterile water at 1–2 injection sites, transforaminal approachNo MAE
mAE:36%mAE: 20%
Arden et al42Ethics committee/NC2 mL saline into interspinous ligamentNo MAE
mAE: 9%mAE: 10%
Valat et al43Ethics committee/NC2 mL saline into epidural space, interlaminar approachNo MAE
mAE: 6%mAE: 8%
Iversen et al40Ethics committee/NCSubcutaneous injection of 2 mL saline superficial to the sacral hiatusNot reported
Freeman et al45Ethics committee/CIDET/discogenic low back pain17-gauge introducer needle inserted into disc under fluoroscopic guidance, catheter inserted but not connected to generator, both subject and surgeon blindedNo MAE
mAE: 11%mAE: 5%
Pauza et al44Review board/NC17-gauge needle introduced onto the outer annulus, mock electrode passage shown on monitor, generator noises producedNot reported
Kvarstein et al46Ethics committee/NCPIRFT/discogenic low back pain17-gauge canula and RF probe inserted into annulus, no RF current appliedNot reported
Olanow et al49Review board/NCFetal nigral transplantation, 4 donors/Parkinson’s diseaseScalp incisions, partial thickness burr holes, no cell transplantation, 6 months low-dose cyclosporineNo MAE
mAE (rate/patient day: 0.66mAE (rate/patient day: 0.39
Marks et al50Review board/CGene delivery of AAV2-neurturin/Parkinson’s diseaseScalp incisions, partial thickness burr holes, no intracranial injectionsMAE: 4MAE: 0
Most frequent mAE: headache: 68%Most frequent mAE: headache: 50%
Gross et al51Review board/CTransplantation of human retinal pigmental cells/Parkinson’s diseaseScalp incisions, partial thickness burr holes, no cell transplantation1 death0 deaths
MAE: 23%MAE: 0
LeWitt et al52Review board/CInsertion of AAV-GAD gene into subthalamic nucleus/Parkinson’s diseaseInsertion of catheter caudal to nucleus, infusion of salineNo MAE
mAE (probably related to procedure): 56%mAE (probably related to procedure): 14%
Dowson et al53Ethics committee/CPatent foramen ovale closure with STARFlex Septal Repair Implant/migraineGeneral anaesthesia, skin incision in the groinMAE (possibly or probably related to procedure): 11%MAE (possibly or probably related to procedure): 4%
  • AAV2, adeno-associated; C, commercial; GAD, glutamic acid decarboxylase; IDET, intradiscal electrothermal therapy; MAE, major adverse events; mAE, minor adverse events; NC, non-commerical; PIRFT, percutaneous intradiscal radiofrequency thermocoagulation; PMMA, polymethylmethacrylate.