Placebo effects in trials evaluating 12 selected minimally invasive interventions: a systematic review and meta-analysis

doi:10.1136/bmjopen-2014-007331

PMC full text:

BMJ Open. 2015; 5(1): e007331.

Published online 2015 Jan 30. doi: 10.1136/bmjopen-2014-007331

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Table 1

Return to: Placebo Effects In Trials Evaluating 12 Selected Minimally Invasive Interventions

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

Author	Protocol approval/funding (commercial, non-commercial)	Invasive procedure/indication	Sham intervention	Adverse events related to procedure, active treatment	Adverse events related to procedure, sham
Leon et al³⁴	Food and Drug Administration/NC	Percutaneous myocardial laser revascularisation/intractable angina pectoris	Laser turned on but no procedure performed	MAE in hospital (high dose): 4.1%	MAE in hospital: 0
Salem et al³³	Ethics committee/NC		Laser turned on but no procedure performed	No procedural AE
Sihvonen et al⁴⁸	Review board/NC	Arthroscopic partial meniscectomy/degenerate meniscal tear	Routine arthroscopy, simulation of meniscectomy by manipulation etc	No MAE
Sihvonen et al⁴⁸	Review board/NC	Arthroscopic partial meniscectomy/degenerate meniscal tear		mAE: 6.6%	mAE: 2.9%
Moseley et al⁴⁷	Review board/NC	Arthroscopic debridement/knee osteoarthritis	Simulated arthroscopy preparation, intravenous anaesthesia, skin incisions, no instruments entered knee, knee manipulated	No procedural AE
Pham et al³⁵	Review board/NC	Hyaluronic acid/knee osteoarthritis	Intra-articular injection of saline solution	No MAE
Pham et al³⁵	Review board/NC			Any mAE: 81.7%	Any mAE: 1.2%
Altman et al³⁶	Ethics committee/C			No MAE
Altman et al³⁶	Ethics committee/C			mAE: 12.8%	mAE: 8%
Chevalier et al³⁷	ClinicalTrials.org/C			No MAE
Chevalier et al³⁷	ClinicalTrials.org/C			mAE: 35.8%	mAE: 33.8%
Kallmes et al³⁸	Review board/NC	Percutaneous vertebroplasty with PMMA cement injection/vertebral compression fracture	Conscious sedation + local anaesthaesia, pressure put on spine, simulation of odour with mixing of PMMA to imitate the smell during the active procedure	No MAE
Kallmes et al³⁸	Review board/NC			mAE: 14%	mAE: 16%
Buchbinder et al³⁹	Ethics committee at each participating center/NC		Conscious sedation + local anaesthaesia, needle inserted to rest on the lamina, PMMA container opened to imitate the smell during the active procedure	No procedural AE
Cohen et al⁴¹	Review board/NC	Epidural injection of corticosteroids/sciatica	2 mL sterile water at 1–2 injection sites, transforaminal approach	No MAE
Cohen et al⁴¹	Review board/NC			mAE:36%	mAE: 20%
Arden et al⁴²	Ethics committee/NC		2 mL saline into interspinous ligament	No MAE
Arden et al⁴²	Ethics committee/NC		2 mL saline into interspinous ligament	mAE: 9%	mAE: 10%
Valat et al⁴³	Ethics committee/NC		2 mL saline into epidural space, interlaminar approach	No MAE
Valat et al⁴³	Ethics committee/NC		2 mL saline into epidural space, interlaminar approach	mAE: 6%	mAE: 8%
Iversen et al⁴⁰	Ethics committee/NC		Subcutaneous injection of 2 mL saline superficial to the sacral hiatus	Not reported
Freeman et al⁴⁵	Ethics committee/C	IDET/discogenic low back pain	17-gauge introducer needle inserted into disc under fluoroscopic guidance, catheter inserted but not connected to generator, both subject and surgeon blinded	No MAE
Freeman et al⁴⁵	Ethics committee/C			mAE: 11%	mAE: 5%
Pauza et al⁴⁴	Review board/NC		17-gauge needle introduced onto the outer annulus, mock electrode passage shown on monitor, generator noises produced	Not reported
Kvarstein et al⁴⁶	Ethics committee/NC	PIRFT/discogenic low back pain	17-gauge canula and RF probe inserted into annulus, no RF current applied	Not reported
Olanow et al⁴⁹	Review board/NC	Fetal nigral transplantation, 4 donors/Parkinson’s disease	Scalp incisions, partial thickness burr holes, no cell transplantation, 6 months low-dose cyclosporine	No MAE
Olanow et al⁴⁹	Review board/NC	Fetal nigral transplantation, 4 donors/Parkinson’s disease		mAE (rate/patient day: 0.66	mAE (rate/patient day: 0.39
Marks et al⁵⁰	Review board/C	Gene delivery of AAV2-neurturin/Parkinson’s disease	Scalp incisions, partial thickness burr holes, no intracranial injections	MAE: 4	MAE: 0
Marks et al⁵⁰	Review board/C	Gene delivery of AAV2-neurturin/Parkinson’s disease		Most frequent mAE: headache: 68%	Most frequent mAE: headache: 50%
Gross et al⁵¹	Review board/C	Transplantation of human retinal pigmental cells/Parkinson’s disease	Scalp incisions, partial thickness burr holes, no cell transplantation	1 death	0 deaths
Gross et al⁵¹	Review board/C			MAE: 23%	MAE: 0
LeWitt et al⁵²	Review board/C	Insertion of AAV-GAD gene into subthalamic nucleus/Parkinson’s disease	Insertion of catheter caudal to nucleus, infusion of saline	No MAE
LeWitt et al⁵²	Review board/C		Insertion of catheter caudal to nucleus, infusion of saline	mAE (probably related to procedure): 56%	mAE (probably related to procedure): 14%
Dowson et al⁵³	Ethics committee/C	Patent foramen ovale closure with STARFlex Septal Repair Implant/migraine	General anaesthesia, skin incision in the groin	MAE (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.