Study | Reason for exclusion |
---|---|
Abbot 1995 | The 'placebo intervention' was 'compressed air with freon' which, sprayed on skin, lowers temperature: impure placebo. |
Abikoff 1985 | All patients underwent a placebo run‐in period and only those not responding were included: not relevant participants. |
Allen 1987 | Dropout was > 50%. |
Allen 1996 | Randomisation was not described in the original paper. In a subsequent correspondence the authors described the method of randomisation: 'put three pieces of paper into a hat, each with the number 1, 2 or 3 and then drew a number each time a subject arrived and then assigned them accordingly '. There was no concealment of allocation. The number of patients in the placebo group was 105, in the no‐treatment group 75. |
Amanzio 1999 | Pain was induced experimentally. |
Amanzio 2001 | Not explicitly a randomised trial. |
Archer 1992 | Not a randomised study. |
Arnett 1990 | Inclusion of patients to no‐treatment groups started later than inclusion to active/placebo. |
Avis 2008 | Patients received payment. |
Babizhayev 2001 | No explicit randomisation between placebo and no‐treatment. |
Barrett 1999 | Low self‐esteem is not regarded a clinical problem. |
Beck 2002 | Male nursing home residents were not randomised, but 'assigned to the groups'. The proportion of males differed between the compared groups from 10% to 24%. |
Benedetti 1998 | Allocation to placebo and no‐treatment was not explicitly random. |
Benedetti 1999b | Pain was induced experimentally. |
Benedict 1989 | The outcome in this study of chronic schizophrenia was reaction‐time which we regard not clinically relevant. |
Bennet 2001 | The outcome was not clinical. |
Benton 1988 | The trial studied the impact of vitamin supplements on the intelligence of normal schoolchildren, not regarded a clinical study. |
Bergmann 1994 | No untreated group. |
Beutler 1988 | The 'placebo' intervention consisted in 'paranormal healing at a distance', directed at a patient behind a screen, however the patients in the no treatment group also sat behind a screen, so the patient in both groups experienced the same: unacceptable no treatment group. |
Bierman 1997 | The outcome in this alcohol addiction trial was 'sleep quality': regarded not clinically relevant. |
Björkstén 1986 | Randomisation not mentioned. |
Blackwell 1972 | Participants were 'medical students': not a clinical study. |
Blanchard 1978 | 6/30 patients were reallocated after randomisation. |
Borden 1989 | The clinically relevant outcomes (parents' and teachers' ratings) were not blinded. |
Borkovec 1975 | The participants were college students screened by group test program and receiving research credit for participation: not a clinical setting. |
Bornstein 1973 | The accumulated weight loss of the patients in the placebo group was 'positively reinforced': impure placebo. |
Bouchet 1996 | The participants were normal subjects. |
Brown 1999 | Pain was induced experimentally. |
Buckalew 1972 | The participants were normal subjects. |
Bullock 1999 | Drop out rate > 50%. |
Bush 1985 | Allocation of participants to the different groups of the trial was not concealed. |
Butler 1984 | The placebo intervention consisted in ordering difficult tasks for social phobics and practicing these tasks in ascending order: impure placebo. |
Carlson 1993 | The outcomes were 1) a questionnaire assessing the boys' attributions and 2) performance at an experimental word puzzle test: regarded not clinically relevant. |
Carpenter 1994 | Subjects were paid for participation. |
Chambless 1984 | Drop‐out rate > 50%. |
Chen 1999 | Unclear wether the trial was randomised. Authors contacted by e‐mail for clarification but did not respond. |
Cole 1983 | Randomisation not stated. |
Corletto 1999 | Placebo group got active treatment after 40 days. |
Corson 1994 | The placebo intervention implied pain inducing needle sticks: not a pure placebo intervention. |
Cottraux 1986 | Placebo group received not only a placebo intervention but also advice to reduce alcohol intake which is associated with smoking: impure placebo. |
Cram 1980 | The no treatment group sessions ('chart headaches only' ) also included discussions of 'situational themes': unacceptable no treatment group. |
Cristofalo 1999 | Normal subjects (athletes with no diagnosis of asthma). |
Cullhed 1961 | Allocation by day of admission. |
Dahlquist 1986 | Placebo group children were removed from parents. This was probably in itself anxiety inducing: impure placebo. |
Daley 2007 | According to the protocol patients received money for entering the trial. |
Diamond 1995 | The placebo used was saline. It is likely that saline has a physiological effect on congested nose, and is sold 'over the counter' in Denmark for this purpose: impure placebo. |
Disney 1988 | Not explicitly a randomised trial. |
Dobia 1985 | The 'placebo intervention' was relaxation therapy which was an integrated part of the experimental intervention: not a relevant placebo procedure. |
Dundee 1988 | Patients allocated by day of admittance. |
Egbert 1964 | The 'placebo' intervention in post‐operative patients having had intra‐abdominal surgery included instructions concerning pain modulating behaviour, e.g. how actively to relax abdominal muscles: impure placebo. |
Eickholz 2002 | Split mouth design. Teeth were randomised, not patients or treatment periods. |
Elkin 1985 | No untreated group. |
Feather 1972 | A non‐clinical experimental setting where pain was induced by heat. |
Fevery 1990 | The trial was designed to measure outcome after 6, 12 and 24 months. The placebo intervention was only comparable to the no treatment group the first 8 weeks: not a relevant comparison. |
Fillmore 1992 | A non‐clinical experimental setting with normal subjects. |
Fillmore 1994 | A non‐clinical experimental setting with normal subjects. |
Fillmore 1994b | A non‐clinical experimental setting with normal subjects. |
Flor 1983 | Untreated group received co‐intervention not given to the placebo group. |
Fuller 1986 | No untreated group. |
Gam 1998 | The placebo group received massage and exercise, the no treatment group did not: differential co‐intervention. |
Gelfand 1963 | The subjects in this non‐clinical experimental pain trial were nursing students. |
Goodale 1990 | No clear indication in the trial report that 'the reading group' constituted a placebo group. |
Gowdey 1967 | 'Normal subjects': not a clinical problem. |
Gregorio 1996 | The trial was designed to measure outcome after 6, 12 and 18 months. The placebo intervention was only comparable to the no treatment group the first 6 weeks: not a relevant comparison. |
Gregory 1983 | The study was 'designed to investigate whether elderly hospitalized people can improve their performance if they are permitted a second attempt at the Set Test, a verbal fluency task': not a therapeutical clinical study. |
Gryll 1978 | The allocation of participants was not explicitly stated to be random. |
Haake 2007 | No no‐treatment group. The group receiving acupuncture was not treated with conventional treatment given to the no‐acupuncture group. |
Hale 1986 | Allocation of participants was done in 'orderly sequence' following randomisation of the first patient. |
Hall 1994 | 'Subjects reimbursed $20 at weeks 3 and 8 and $35 at week 12': participants paid. |
Hargreaves 1983 | This laboratory study was an uncontrolled trial. |
Hayden 1996 | The placebo used was saline. It is likely that saline has a physiological effect on congested nose, and is sold 'over the counter' in Denmark for this purpose: impure placebo. |
Herth 2000 | Placebo not explicitly mentioned. |
Hogarty 1973 | No untreated group. |
Huber 1986 | The clinician who decided to remove the placenta knew which patients were in the untreated group: not blindly assessed. |
Jensen 1991 | The trial was a 'laboratory study' with normal subjects: not a clinical study. |
Kalman 1998 | The placebo group received dietary advice which was withheld from the no‐treatment group. |
Kanner 1999 | The placebo treatment included 'intensive smoking‐cessation sessions' which was withheld from the the no‐treatment group. |
Kelley 1976 | Subjects were normal children: not a clinical study. |
Khandwala 1997 | According to personal communication with trial report authors, the vehicle was under suspicion of having an effect that was not only due to placebo and is actually sold 'over the counter' in the USA: impure placebo. |
Klosko 1990 | Patients in the untreated group continued on anxiolytic medication. Patients in the placebo group discontinued their medication. The groups in this anxiety trial are not comparable. |
Korner 1982 | No randomisation to placebo and untreated. |
Lasagna 1954 | The study was not randomised. |
Levine 1980 | The outcome was test anxiety which is not considered a clinically relevant outcome. |
Liberman 1964 | Not a randomised study. |
Lopez 1999 | Randomisation was conducted 'with due precaution to avoid differences among the subgroups in the children's mean ages and IQs'. |
Lorr 1962 | Drop‐out rate > 50%. |
Lujan 1992 | The headache was induced: an experimental setting. |
Lynn 1983 | The placebo procedure is described as being of 'an active nature': impure placebo. |
Manner 1987 | 7/20 placebo treated patients receive sedative anticholinergic premedication (glycopyrrolate) compared to 0/18 untreated patients. Also unclear whether the untreated patients were part of the randomization: differential co‐intervention. |
Marchand 1993 | Patients were allocated through 'pseudo‐random assignment'. Contact to the authors clarified that this meant that randomisation was based on drawing pieces of paper with group assignments from a hat. There was no concealment of allocation. |
McGrath 1988 | Suggestions to reduce impact of possible triggers in 'untreated group': unacceptable no treatment group. |
Meehan 1985 | The no treatment group took prescribed and escape analgesics, the placebo group only escape analgesics. |
Montgomery 1996 | A non‐clinical experimental study with normal subjects. |
Nikolaou 1998 | Not a randomised trial. |
Peart 1977 | No randomisation to untreated and placebo. |
Penman 1956 | Post‐randomisation reallocations took place. |
Pollo 2001 | Allocation to placebo and no‐treatment was not explicitly random. |
Price 1999 | Healthy volunteers. Pain was induced experimentally. |
Rampes 1997 | Drop‐out rate 33/58=56% [> 50%]. |
Reich 1990 | The participants were normal older subjects: not a clinical study. |
Robertson 1991 | 'All subjects were paid'. |
Rodriguez 1997 | Post randomisation patient re‐allocation took place: 69 patients were randomised to the untreated group and but results were collected from 78 patients. |
Roehrich 1993 | This alcohol study had neuropsychological and psychological test variables as outcomes: regarded not clinically relevant. |
Roelofs 2000 | Paid healthy volunteers. Pain was induced experimentally. |
Roos 1969 | The placebo intervention was designed to include active components: not a pure placebo. |
Roth 1986 | Normal subjects. |
Rustøen 1998 | Placebo not explicitly mentioned. |
Sarles 1977 | Not a randomised trial. |
Sartor 1980 | Not properly randomised. |
Shaw 1974 | The placebo intervention consisted of listening to 'audiotapes designed to help persons cope with everyday fears and anxieties': not a pure placebo. |
Sheikh 1986 | The participants were older 'normal' volunteers with 'age associated memory impairment' : not a clinical study. |
Silvestri 1977 | Anxiety is the only outcome considered clinically relevant in this trial of the effect of implosive therapy for emotionally disturbed retardates, however, anxiety was not recorded in the no treatment group. |
Skovlund 1991 | No untreated group. |
Smith 2002 | The so‐called 'no treatment' group (but not the placebo group) received advice about changes in diet and the use of vitamin B6. |
Spanos 1988 | 'All were paid $15 for their participation'. |
Staats 1998 | Pain induced by 'hand exposure to ice water': not a clinical study. |
Stanley 1989 | Not blindly assessed. |
Suchman 1992 | Not blindly assessed. |
Tashkin 1977 | Not a randomised trial. |
Taylor 1977 | Anti‐hypertensive drugs were given at variable dose as co‐intervention. More patients in the placebo group than in the untreated group were increased in dose: differential co‐intervention. |
Vacc 1980 | The investigation studied the effect of various interventions on maladaptive behaviour of otherwise normal children: not regarded a clinical study. |
Van Damme 1998 | Healthy volunteers. |
Volweider 1981 | Placebo procedure included physical exercise: not a pure placebo. |
Weber 1975 | Averaged Electroencephalic audiometry (AEA) thresholds was the outcome in this study of CNS stimulant medication on children with minimal brain damage: outcome regarded not clinically relevant. |
Weintraub 1992 | The placebo period (week 160 to 190) was followed by the untreated period (week 190 to 210), (no randomisation). |
Windle 2001 | Allocation of patients by alternation. |
Winnan 1982 | The Bernstein test is a diagnostic test. Pain was induced by infusion of acid: not a therapeutic clinical study. |
Worner 1992 | Drop out rate > 50%. |
Zeisset 1968 | The outcome was 'interview anxiety' which was not considered clinically relevant as a measure for general anxiety. |
Impure placebos: interventions with clearly specified contents or procedures that have an effect which, with considerable likelihood, goes beyond the effect of the treatment ritual. Such interventions are mostly 1) physical or pharmacological vehicles (see, e.g., Khandwala 1997), or 2) psychological 'placebos' with clear behavioural‐cognitive therapeutical elements (see, e.g., Bornstein 1973) or direct health related advice (see, e.g., Cottraux 1986).