
| PMC full text: | Published online 2008 Apr 18. doi: 10.1007/s00586-008-0664-3
|
Table 1
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Imperfect Placebos Are Common In Low Back Pain Trials:
A Systematic Review Of The Literature
Characteristics of included trials
| 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