Trials | Hypothesis tested | Population | Modification of the power of the placebo effect | Treatments | Endpoints |
---|---|---|---|---|---|
Kam‐Hansen et al (2014) 25 | Additive model and interactive model | 66 chronic migraine patients | Oral information on the treatment administered | Treatment group (razatriptan) and placebo in minimized, neutral or maximized situation | Relief 2 h after onset of migraine symptoms and number of subjects without pain at 2.5 h |
Walach et al (2009) 26 | Placebo effect depending on a nonlocal correlation with response to treatment | 75 healthy volunteers | Oral information on the treatment administered | Treatment group (caffeine) and placebo in maximized or neutral situation | Objective parameters (SAT, DAT, CF, reaction time) and subjective parameters (calm, mood and alertness) |
Hammami et al (2016) 27 | Interactive model | 480 healthy volunteers | Oral information on the treatment administered | Treatment group (hydroxyzine) and placebo in minimized, neutral or maximized situation | Drowsiness and dry mouth, self‐assessed by the participants during the 7 h following treatment |
De Craen et al (2001) 16 | Interactive model | 112 chronic pain patients | Written information on the treatment administered | Treatment group (tramadol) and placebo in maximized or neutral situation | Primary endpoint: pain reduction on self‐assessing VAS |
Hammami et al (2010) 28 | Interactive model and pharmacokinetic modification of the placebo effect | 180 healthy volunteers | Oral information on the treatment administered | Treatment group (caffeine) and placebo in maximized or minimized situation | Subjective self‐assessed (energy, fatigue, nausea) and objective parameters (systolic blood pressure) |
Bjorkedal et al (2011) 29 | Interactive model: variation of treatment activity according to adverse effects | 20 healthy volunteers | Oral information that a powerful painkiller was administered (in fact, caffeine) | Treatment (caffeine) and placebo groups in maximized or minimized situations | Wakefulness, stress, pain, expectations and laser‐evoked potentials |
Mitchell et al (1996) 30 | Interactive model | 40 healthy volunteers | Oral information on the treatment administered | Treatment group (d‐amphetamine) and placebo in maximized or minimized situation | Different scales of drug response (ARCI, DEQ, POMS) |
Alasken et al (2015) 10 | Interactive model: inversion of treatment effects by means of information | 142 healthy volunteers | Oral information that analgesic or hyperalgesic cream was going to be administered | Treatment group (EMLA cream) and placebo in minimized or maximized situation | Endpoints evaluated after painful stimulus, including pain, stress and blood pressure |
Lund et al (2014) 31 | Interactive model, being of more import with powerful placebo effect | 46 healthy volunteers | Oral information on the treatment administered | Treatment group (lidocaine) and placebo in minimized or maximized situation | Self‐assessed pain duration and its maximal intensity after painful stimulus by IM injection |
Butcher et al (2012) 32 | Variation of the placebo effect according to gender | 20 healthy volunteers | Oral information on the treatment administered | Treatment group (ibuprofen) and placebo in minimized or maximized situation | Self‐assessed pain after painful electric stimulus |
Berna et al (2017) 33 | Interactive model: activity variation according to adverse effects | 100 healthy volunteers | Oral information that an analgesic yielding a dry mouth would be administered (in fact, it was atropine) | Treatment group (diclofenac) and placebo in minimized or maximized situation | Analgesia evaluated by VAS after painful thermal stimulus |
Flaten et al (1999) 34 | Interactive model | 66 healthy volunteers | Oral information on the treatment administered | Treatment group (carisoprodol) and placebo in minimized, neutral or maximized situation | Eyeblink reflex, skin conductance, self‐assessment of level of stress and drowsiness |
Flaten et al (2004) 35 | Interactive model | 94 healthy volunteers | Oral information on the treatment administered | Treatment group (carisoprodol), caffeine and placebo in minimized, neutral or maximized situation | Eyeblink reflex, self‐assessment of level of wakefulness and calm, skin conductance, cardiac rhythm, arterial tension |
Brandwhaite et al (1981) 36 | Interactive model | 835 women presenting with chronic headaches | Oral information provided on the “brand” of treatment administered | Treatment group (aspirin) and placebo in minimized or maximized situation | Pain self‐assessment 30 min and 1 h after headaches |
Atlas et al (2012) 37 | Interactive model | 14 healthy volunteers | Oral information on the treatment administered | Treatment group (remifentanil) and placebo in minimized or maximized situation | Self‐assessed pain after painful thermal stimulus |
Kirsch et al (1993) 38 | Interactive model | 100 healthy volunteers | Oral information on the treatment administered | Treatment group (caffeine) and placebo in minimized or maximized situation | Level of alertness and stress, systolic and diastolic tension and cardiac rhythm at 15, 30 and then 45 min after ingestion |
Penick et al (1965) 39 | Interactive model | 14 healthy volunteers | Oral information on the treatment administered |
Treatment group (epinephrine) and placebo in minimized or maximized situation Endpoints: l |
Level of perceived stress, glucose and free fatty acid concentration and cardiac rhythm |
Schenk et al (2013) 40 | Interactive model | 34 healthy volunteers | Oral information provided on the treatment administered | Treatment group (lidocaine) and placebo in minimized or maximized situation | Self‐assessment of pain on VAS after painful thermal stimulus |
Faasse et al (2016) 41 | Additive model | 87 patients presenting with chronic headaches | Oral information provided on the treatment brand administered | Treatment group (ibuprofen) and placebo in minimized or maximized situation | Home self‐assessment of pain following headache episodes and reported adverse effects |
Wise et al (2009) 42 | Interactive model | 601 poorly controlled asthmatics | Oral information provided on the treatment administered, its brand and its colour | Treatment group (montelukast) and placebo in neutral or maximized situation | Improvement at 4 wk of peak expiratory flow, improvement of pulmonary functions evaluated by spirometry and asthma control evaluated by four self‐assessment scales |
Kemeny et al (2007) 43 | Variation of the placebo effect and its determinants | 55 poorly controlled asthmatics | Oral information provided on the treatment administered | Treatment group (salmeterol) and placebo in maximized or neutral situation | Concentration of methacholine needed to induce a 20% FEV1 decrease |
Rose et al (2001) 44 | Interactive model | 53 healthy volunteers | Oral and written information on the treatment administered | Treatment group (melatonin) and placebo in minimized or maximized situation | Subjective sleep evaluated by a 12‐question assessment scale |
Ross et al (1962) 19 | Interactive model | 80 healthy volunteers | Hidden administration of treatments to minimize their effect | Treatment group (d‐amphetamine) and placebo in the same neutral or minimized situations | Mood swings (Clyde mood scale) and level of performance (tapping task and H‐bar test) |
Levine et al (1984) 45 | Placebo effect independent of the means of administration | 96 patients having undergone dental extraction | Hidden administration of treatments, manually or by a machine | Treatment group (naloxone) and placebo in minimized, neutral or maximized situation | Self‐assessment of pain 50 min after treatment administration |
Uhlenhuth et al (1959) 7 | Interactive model | 52 psychiatric patients suffering from anxieties | Neutral or positive attitude concerning the treatments administered | Treatment group (meprobamate or phenobarbital) and placebo in neutral or maximized situation | Improvement perceived by patients, assessment by a psychiatrist and a scale grouping together 45 symptoms |
Uhlenhuth et al (1966) 46 | Interactive model | 138 patients referred to psychiatric clinic | Neutral or positive attitude concerning the treatments administered | Treatment group (meprobamate) in neutral or maximized situations and placebo in the same situations | Modifications on different scales |
Mathews et al (1983) 47 | Interactive model | 48 couples presenting with sexual disorders | Frequency of administration and number of therapists | Treatment group (testosterone) and placebo with weekly or monthly administration and at least one therapist | Improvement of symptoms evaluated by an outside investigator and the couples themselves |
Van Der Molen et al (1988) 48 | Hyperventilation in the event of lactate injection or stressful information | 13 healthy volunteers | Oral information provided on the treatment administered | Treatment group (lactate) and placebo in minimized (relaxing information) and maximized (stressful information) situations | Anxiety, pCO2 and respiratory rate |
Lyerly et al (1964) 49 | Interactive model | 90 veterans and 90 young employees | Oral information provided on the treatment administered | Treatment group (amphetamine and chloral hydrate) versus placebo in minimized, neutral or maximized situation | Mood swings (Clyde mood scale) and level of performance (tapping task and H‐bar test). |
Bergmann et al (1994) 9 | Interactive model | 49 cancer patients | Oral information provided or not on the study procedure | Treatment group (500 mg of naproxen) and placebo in neutral or maximized situation | Self‐assessment of pain on VAS up to 3 h after administration |
Detailed study characteristics. A minimized situation corresponds to less placebo effect power compared to a neutral or maximized situation.
Abbreviations: ARCI, addiction research center inventory; CF, cognitive function; DAT, direct antiglobulin test; DEQ, drug effect questionnaire; EMLA, eutectic mixture of local anaesthetics; FEV1, forced expiratory volume in 1 second; IM, intramuscular; pCO2, partial pressure of carbon dioxide; POMS, profile of mood states; SAT, spontaneous awakening trials; VAS, visual analogue scale.