PMC full text: | Published online 2008 Apr 18. doi: 10.1007/s00586-008-0664-3
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Table 1
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Imperfect Placebos Are Common In Low Back Pain Trials:
A Systematic Review Of The Literature
Study | Placebo intervention | Assessment of blinding and expectations | Strategies to facilitate blinding | |||
---|---|---|---|---|---|---|
Indistinguishability | Inert placebo | Equivalence | Naïve subjects | |||
Acupuncture | ||||||
Itoh et al. [74] | Mock insertion of a needle | 〈F〉 Belief in the insertion of needles: no significant differences between groups | ✓ | ✓ | ||
Inoue et al. [73] | Mock insertion of a needle | 〈F〉 Belief in the insertion of needles: no significant differences between groups | ✓ | ✓ | ||
Kerr et al. [85] | Detuned TENS | 〈F〉 Willingness to try the treatment again in future: no significant differences between groups | ✓ | ✓ | ||
Molsberger et al. [106] | Superficial needling at non-acu points | Not assessed | ✓ | ✓ | ✓ | |
Leibing et al. [95] | Superficial needling at non-acu points | Not assessed | ✓ | ✓ | ||
Sherman et al. [128] | Mock insertion of a needle | 〈B〉 Belief in the efficacy of acupuncture and 〈F〉 belief in the insertion of needles: no significant differences between groups; 〈F〉 Credibility scale: groups were different on item related to pain relief (P = 0.01) | ✓ | ✓ | ✓ | |
Carlsson and Sjölund [25] | Detuned TENS | Not assessed | ✓ | ✓ | ||
Macdonald et al. [99] | Detuned TENS | Not assessed | ✓ | |||
Duplan et al. [42] | Superficial needling at non-acu points | Not assessed | ✓ | ✓ | ||
Mendelson et al. [104] | Superficial needling at non-acu points | 〈B〉 Expectation of pain relief: change in pain in response to treatment was not correlated to expectation of pain relief (no data provided) | ✓ | ✓ | ||
Back school | ||||||
Chenard et al. [28] | Detuned TENS | Not assessed | ✓ | ✓ | ||
Bergquist-Ullman and Larsson [11] | Lowest intensity SWD | Not assessed | ||||
Behavioural | ||||||
Basler et al. [10] | Detuned US | Not assessed | ✓ | ✓ | ||
Snook et al. [130] | "Ineffective" exercises | Not assessed | ✓ | |||
Strong [132] | Health education video | 〈F〉 Credibility scale: no significant differences between groups | ✓ | ✓ | ||
Goossens et al. [62] | Group discussion | Not assessed | ✓ | ✓ | ||
Nicholas et al. [111] | Group discussion | 〈B; F〉 Expectation scale: no significant differences between groups at baseline; higher expectations in experimental group after treatment (P < 0.05) | ✓ | ✓ | ||
Stuckey et al. [133] | Encouragement to relax | Not assessed | ✓ | ✓ | ||
Bush et al. [21] | Biofeedback with "temperature tones" | Not assessed | ✓ | ✓ | ✓ | |
Electrotherapy | ||||||
Lee et al. [94] | Detuned PEMT | Not assessed | ✓ | ✓ | ||
Bertalanffy et al. [15] | Detuned TENS | Not assessed | ✓ | ✓ | ||
Jarzem et al. [77] | Detuned TENS | Not assessed | ✓ | ✓ | ✓ | |
Jarzem et al. [76] | Detuned TENS | 〈F〉 Evaluation of reported and actual use of TENS units: no significant differences between groups | ✓ | ✓ | ||
Topuz et al. [137] | Detuned TENS | Not assessed | ✓ | ✓ | ✓ | |
Sator-Katzenschlager et al. [122] | Needling without electrical stimulation | 〈F〉 Belief in provision of real stimulation: no significant differences between groups; 〈F〉 Willingness to repeat treatment if necessary: 87% of patients in experimental group and 0% in placebo group would repeat treatment | ✓ | ✓ | ||
Weiner et al. [143] | Needling without electrical stimulation | Not assessed | ✓ | |||
Glaser et al. [57] | TENS | 〈B; F〉 Expectation scale: no significant differences between groups | ✓ | ✓ | ||
Carlsson and Sjölund [25] | Detuned TENS | Not assessed | ✓ | ✓ | ||
Hackenberg et al. [63] | Lowest intensity radiotherapy | Not assessed | ✓ | ✓ | ✓ | |
Cheing and Hui-Chan [27] | Detuned TENS | Not assessed | ✓ | ✓ | ||
Basford et al. [8] | Inactive laser probes | Not assessed | ✓ | ✓ | ✓ | |
Ghoname et al. [50] | Needling without electrical stimulation | 〈F〉 Willingness to pay out-of-pocket for treatment: more patients in group receiving PENS therapy willing to pay compared to other groups (P < 0.02) | ✓ | ✓ | ||
Ghoname et al. [49] | Needling without electrical stimulation | 〈F〉 Willingness to pay out-of-pocket for treatment: more patients in group receiving electrical stimulation of 15–30 Hz willing to pay compared to other groups (P < 0.05) | ✓ | |||
Ghoname et al. [51] | Needling without electrical stimulation | Not assessed | ✓ | |||
Moore and Shurman [107] | Detuned TENS | 〈F〉 Choice of therapy among those who would continue treatment: 38% NMES/TENS; 25% none; 21% NMES; 8% TENS; 8% placebo | ✓ | ✓ | ✓ | |
Herman et al. [69] | Detuned TENS | Not assessed | ✓ | ✓ | ✓ | |
Klein and Eek [89] | Inactive laser probes | Not assessed | ✓ | ✓ | ✓ | |
Deyo et al. [37, 38] | Detuned TENS | 〈F〉 Perception that TENS units were functioning properly: 84% of patients in placebo group guessed they had functioning units (blinding reported as partially successful) | ✓ | ✓ | ✓ | |
Gibson et al. [54] | Detuned SWD | Not assessed | ✓ | ✓ | ||
Exercise | ||||||
Goldby et al. [59] | Educational booklet | Not assessed | ||||
Geisser et al. [48] | Nonspecific exercises/positioning without muscle energy | 〈F〉 Belief in provision of real treatment: no significant differences between groups | ✓ | |||
Tasleem et al. [136] | Lowest intensity SWD | Not assessed | ||||
Preyde [116] | Inactive laser probes | Not assessed | ✓ | ✓ | ||
Ghoname et al. [50] | Needling without electrical stimulation | 〈F〉 Willingness to pay extra money for therapy: no significant differences between groups receiving exercise and placebo | ✓ | ✓ | ||
Cherkin et al. [29] | Educational booklet | Not assessed | ||||
Spratt et al. [131] | Abdominal wrap/advice to walk/video | Not assessed | ✓ | ✓ | ||
Faas et al. [43] | US with lowest possible dose | Not assessed | ✓ | |||
Hansen et al. [67] | Semi hot pack/10% body weight traction | Not assessed | ✓ | ✓ | ||
Deyo et al. [37, 38] | Detuned TENS | 〈F〉 Perception that TENS units were functioning properly: 84% of patients in placebo group guessed they had functioning units (blinding reported as partially successful) | ✓ | ✓ | ||
Heatwrap therapy | ||||||
Nadler et al. [109] | Placebo tablets | Not assessed | ✓ | |||
Nadler et al. [110] | Placebo tablets | Not assessed | ✓ | |||
Insoles | ||||||
Shabat et al. [127] | Placebo insole | 〈F〉 Choice of therapy among those who would continue treatment: majority of patients would prefer the true insole (P < 0.05) | ✓ | ✓ | ✓ | |
Magnet therapy | ||||||
Collacott et al. [33] | Demagnetised device | Not assessed | ✓ | ✓ | ✓ | ✓ |
Massage | ||||||
Preyde [116] | Inactive laser probes | Not assessed | ✓ | ✓ | ||
Neuroreflexotherapy | ||||||
Kovacs et al. [93] | Epidermal implants in adjacent points | Not assessed | ✓ | ✓ | ✓ | |
Pharmaceutical (oral or topical) | ||||||
Muehlbacher et al. [108] | Matching placebo tablets | Not assessed | ✓ | ✓ | ✓ | |
Bannwarth et al. [7] | Matching placebo tablets | Not assessed | ✓ | ✓ | ✓ | |
Khoromi et al. [87] | Diphenhydramine tablets | Not assessed | ✓ | ✓ | ||
Ketenci et al. [86] | Placebo capsules | Not assessed | ✓ | ✓ | ✓ | |
Katz et al. [82] | Matching placebo tablets | Not assessed | ✓ | ✓ | ✓ | ✓ |
Brizzi et al. [20] | Drug-free hydroelectrophoresis | Not assessed | ✓ | ✓ | ✓ | |
Coats et al. [32] | Matching placebo tablets | Not assessed | ✓ | ✓ | ✓ | |
Hoiriis et al. [72] | Matching placebo tablets | 〈F〉 Belief in provision of real medication: no significant differences between groups | ✓ | ✓ | ✓ | |
Pallay et al. [112] | Matching placebo tablets | Not assessed | ✓ | ✓ | ✓ | |
Peloso et al. [114] | Matching placebo tablets | Not assessed | ✓ | ✓ | ✓ | |
Frerick et al. [47] | Matching placebo plaster | Not assessed | ✓ | ✓ | ✓ | |
Ruoff et al. [120] | Placebo tablets | Not assessed | ✓ | ✓ | ✓ | |
Birbara et al. [17] | Matching placebo tablets | Not assessed | ✓ | ✓ | ✓ | |
Dreiser et al. [41] | Placebo tablets | Not assessed | ✓ | ✓ | ✓ | |
Katz et al. [83] | Placebo tablets | Not assessed | ✓ | ✓ | ✓ | |
Dreiser et al. [40] | Placebo tablets | Not assessed | ✓ | ✓ | ✓ | |
Keitel et al. [84] | Matching placebo plaster | Not assessed | ✓ | ✓ | ✓ | |
Chrubasik et al. [30] | Matching placebo tablets | Not assessed | ✓ | ✓ | ✓ | |
Dickens et al. [39] | Matching placebo capsules | Not assessed | ✓ | ✓ | ✓ | |
Schnitzer et al. [124] | Placebo capsules | Not assessed | ✓ | ✓ | ✓ | |
Atkinson et al. [4] | Diphenhydramine tablets | Not assessed | ✓ | ✓ | ||
Chrubasik et al. [31] | Matching lactose tablets | Not assessed | ✓ | ✓ | ✓ | |
Atkinson et al. [5] | Matching placebo capsules | Not assessed | ✓ | ✓ | ✓ | |
Worz et al. [145] | Placebo tablets | Not assessed | ✓ | ✓ | ✓ | |
Weber et al. [142] | Matching placebo capsules | Not assessed | ✓ | ✓ | ✓ | |
Goodkin et al. [60] | Matching placebo tablets | Not assessed | ✓ | ✓ | ✓ | |
Marcel et al. [101] | Matching placebo tablets | Not assessed | ✓ | ✓ | ✓ | |
Schnebel and Simmons [123] | Matching lactose capsules | Not assessed | ✓ | ✓ | ✓ | |
Berry and Hutchinson [14] | Matching placebo tablets | Not assessed | ✓ | ✓ | ✓ | |
Berry and Hutchinson [13] | Matching placebo tablets | Not assessed | ✓ | ✓ | ✓ | |
Amlie et al. [2] | Matching placebo tablets | Not assessed | ✓ | ✓ | ✓ | |
Ginsberg and Famaey [55] | Massage with placebo ointment | Not assessed | ✓ | |||
Haimovic and Beresford [64] | Matching placebo tablets | Not assessed | ✓ | ✓ | ✓ | |
Dapas et al. [35] | Placebo tablets | Not assessed | ✓ | ✓ | ✓ | |
Jagemann [75] | Placebo tablets | Not assessed | ✓ | ✓ | ✓ | |
Pheasant et al. [115] | Atropine tablets | Not assessed | ✓ | ✓ | ✓ | |
Berry et al. [12] | Matching placebo tablets | Not assessed | ✓ | ✓ | ✓ | |
Alcoff et al. [1] | Placebo pills | Not assessed | ✓ | ✓ | ✓ | |
Ghosh et al. [52] | Matching placebo tablets | Not assessed | ✓ | ✓ | ✓ | |
Gold [58] | Placebo tablets | Not assessed | ✓ | ✓ | ✓ | |
Pharmaceutical (injection or infusion) | ||||||
Finckh et al. [45] | 0.9% saline infusion | Not assessed | ✓ | ✓ | ✓ | ✓ |
Arden et al. [3] | Normal saline injection | 〈F〉 Belief in the provision of real treatment: no significant differences between groups | ✓ | ✓ | ✓ | ✓ |
Korhonen et al. [92] | Saline infusion | Not assessed | ✓ | ✓ | ✓ | ✓ |
Wasan et al. [141] | Saline infusion | 〈B〉 Expectation scale: expectations for pain relief significantly correlated with pain outcomes (P < 0.05) | ✓ | ✓ | ✓ | |
Khot et al. [88] | Normal saline injection | Not assessed | ✓ | ✓ | ✓ | |
Tuzun et al. [139] | Placebo injection | Not assessed | ✓ | ✓ | ✓ | |
Mauro et al. [102] | Placebo injection | Not assessed | ✓ | ✓ | ✓ | |
Dechow et al. [36] | Normal saline injection | Not assessed | ✓ | ✓ | ✓ | |
Medrik-Goldberg et al. [103] | Normal saline infusion | 〈F〉 Belief in provision of real treatment: no significant difference between groups | ✓ | ✓ | ✓ | |
Tajiri et al. [135] | Physiologic saline injection | Not assessed | ✓ | ✓ | ✓ | |
Revel et al. [118] | Saline injection | Not assessed | ✓ | ✓ | ✓ | |
Carette et al. [23] | Isotonic saline injection | 〈F〉 Belief in the provision of a placebo injection: no significant differences between groups | ✓ | ✓ | ✓ | |
Ghozlan and Dropsy [53] | Isotonic saline injection/matching placebo tablets | Not assessed | ✓ | ✓ | ✓ | |
Babej-Dölle et al. [6] | Isotonic saline injection | Not assessed | ✓ | ✓ | ✓ | |
Fine et al. [46] | Isotonic saline infusion | Not assessed | ✓ | ✓ | ✓ | |
Szpalski and Hayez [134] | Placebo injection/matching placebo tablets | Not assessed | ✓ | ✓ | ✓ | |
Bush and Hillier [22] | Normal saline injection | Not assessed | ✓ | ✓ | ✓ | |
Carette et al. [24] | Isotonic saline injection | Not assessed | ✓ | ✓ | ✓ | ✓ |
Treves et al. [138] | Glucose infusion | Not assessed | ✓ | ✓ | ✓ | |
Lilius et al. [97] | Physiologic saline injection | Not assessed | ✓ | ✓ | ✓ | |
Ginsberg et al. [56] | Isotonic saline injection | Not assessed | ✓ | ✓ | ||
Klenerman et al. [90] | Normal saline injection | Not assessed | ✓ | ✓ | ✓ | ✓ |
Chapman and Brena [26] | Normal saline injection | Not assessed | ✓ | ✓ | ✓ | |
Hofferberth et al. [71] | Placebo injection | Not assessed | ✓ | ✓ | ✓ | |
Brena et al. [19] | Saline injection | Not assessed | ✓ | ✓ | ✓ | |
Spinal manipulative therapy | ||||||
Hall et al. [65] | Foot massage | 〈F〉 Belief in provision of real treatment: no significant differences between groups | ✓ | ✓ | ||
Geisser et al. [48] | Nonspecific exercises/positioning without muscle energy | 〈F〉 Belief in provision of real treatment: no significant differences between groups | ✓ | |||
Hawk et al. [68] | Up to 12N postero-anterior force applied lateral to spine/effleurage | 〈F〉 Perception of group assignment: patients in placebo group more likely to accurately perceive their group assignment. 〈B; F〉 Expectation of improvement: no significant differences between groups at baseline; patients in placebo group had lower expectations at visit 4 (P = 0.04) | ✓ | |||
Hoiriis et al. [72] | Positioning and light pressure | 〈F〉 Belief in provision of true chiropractic adjustments: more patients in chiropractic group believed real adjustments were provided (P < 0.001) | ✓ | ✓ | ||
Licciardone et al. [96] | Range of motion/light touch/simulated osteopathic techniques | Not assessed | ✓ | |||
Goodsell et al. [61] | Lying prone | Not assessed | ✓ | |||
Cherkin et al. [29] | Educational booklet | Not assessed | ||||
Wreje et al. [146] | Gluteus medius transverse friction | Not assessed | ✓ | |||
Sanders et al. [121] | Light touch | Not assessed | ✓ | ✓ | ✓ | |
Gibson et al. [54] | Detuned SWD | Not assessed | ✓ | |||
Jayson et al. [78] | Microwave with lowest setting | Not assessed | ✓ | |||
Bergquist-Ullman and Larsson [11] | Low intensity SWD | Not assessed | ||||
Traction | ||||||
Sherry et al. [129] | TENS | Not assessed | ✓ | |||
Beurskens et al. [16] | Traction up to 20% total body weight | 〈F〉 Belief in provision of real treatment: no significant differences between groups | ✓ | ✓ | ✓ | ✓ |
Reust et al. [117] | 5 kg traction | Not assessed | ✓ | ✓ | ✓ | ✓ |
〈B〉 Measure taken at baseline. 〈F〉 Measure taken at follow-up