Placebo and Placebo Effect: Their Impact on the Evaluation of Drug Response in Patients

Dobrilla, G; Scarpignato, Carmelo

doi:10.1159/000171471

Cited by 20 publications

(11 citation statements)

References 28 publications

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“…Our effects in the placebo group may be caused by the regular checkups, encouragement and reminders by the same investigator (NP). This effect has been shown in other studies [34][35][36]. Therefore, we suggest that the placebo effect is very important, even in trials studying effects on morphology.…”

Section: Discussionsupporting

confidence: 76%

The effects of candesartan on diabetes glomerulopathy: a double-blind, placebo-controlled trial

2008

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Our objective was to study the effects of candesartan on diabetic glomerulopathy in young normoalbuminuric and normotensive patients with type 1 diabetes in a double-blind, placebo-controlled trial. In 13 patients aged 24 years at baseline, we evaluated blood pressure, kidney biopsies and kidney function tests at baseline and after 5 years of treatment. Kidney biopsies were examined with light and electron microscopy, glomerular filtration rate and effective renal plasma flow determined with inulin and para-aminohippuric acid clearances. Two patients in the placebo group needed antihypertensive treatment because they developed microalbuminuria and/or hypertension, but no patient in the candesartan group did. A significant reduction in mesangial matrix volume and mesangial volume occurred in the candesartan group, although changes in morphological parameters were similar between groups. Office blood pressure was significantly lower in the candesartan group at follow-up than in the placebo group. Deterioration in morphological parameters observed in earlier studies of our patients did not become worse during treatment with candesartan or placebo. The effects of candesartan, with reduction in morphological parameters and lowering of blood pressure, might influence future treatment of glomerulopathy in type 1 diabetes patients.

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Section: Discussionsupporting

confidence: 76%

The effects of candesartan on diabetes glomerulopathy: a double-blind, placebo-controlled trial

2008

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“…Since placebo-controlled trials are the only objective way of accurately assessing drug response in patients 16 , any factor contributing to the placebo response will affect the outcome of the study. In general, the positive placebo response in vasomotor trials has been reported to occur in about 20-50% of patients 8,[17][18][19] . The placebo response in the present study was somewhat higher (56.3% reduction in MSVS) than reported in most vasomotor trials.…”

Section: Discussionmentioning

confidence: 99%

Perimenopausal women in estrogen vasomotor trials: contribution to placebo effect and efficacy outcome

Simon

Stevens²,

Ayres³

et al. 2001

Climacteric

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Perimenopausal women contributed to a higher placebo response, compared with the rate of response previously reported in clinical studies of estrogen replacement in postmenopausal women. Including perimenopausal women in future vasomotor symptom trials will require study populations of sufficient size to maintain the statistical power to demonstrate a difference between therapeutic response to active or placebo treatment.

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“…Several authors have commented that randomized controlled trials in duodenal ulcer have given substantially different placebo healing rates [ 7–9]. It has not been postulated that in duodenal ulcers the frequency of placebo administration might influence the healing process.…”

Section: Introductionmentioning

confidence: 99%

Placebo effect in the treatment of duodenal ulcer

Craen¹,

Moerman

Heisterkamp³

et al. 1999

Brit J Clinical Pharma

107

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Aims To assess whether frequency of placebo administration is associated with duodenal ulcer healing. Methods A systematic literature review of randomized clinical trials was undertaken. 79 of 80 trials that met the inclusion criteria. The pooled 4 week placebo healing rate of all duodenal ulcer trials that employed a four times a day regimen was compared with the rate obtained from trials with a twice a day regimen. Results The pooled 4 week healing rate of the 51 trials with a four times a day regimen was 44.2% (805 of 1821 patients) compared with 36.2% (545 of 1504 patients) in the 28 trials with a twice a day regimen (difference, 8.0% [equal effects model]; 95% confidence interval, 4.6% to 11.3%). Depending on the statistical analysis, the rate difference ranged from 6.0% (multivariable random effects model) to 8.0% (equal effects model). A number of sensitivity analyses showed comparable differences between the two regimens. Most of these sensitivity analyses were not significant, probably because a number of trials were excluded resulting in a loss of power. Conclusions We found a relation between frequency of placebo administration and healing of duodenal ulcer. We realize that the comparison was based on nonrandomized data. However, we speculate that the difference between regimens was induced by the difference in frequency of placebo administration. A better knowledge of various placebo effects is required in order to make clinically relevant assessments of treatment effects derived from placebo-controlled trials.

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Placebo and Placebo Effect: Their Impact on the Evaluation of Drug Response in Patients

Cited by 20 publications

References 28 publications

The effects of candesartan on diabetes glomerulopathy: a double-blind, placebo-controlled trial

The effects of candesartan on diabetes glomerulopathy: a double-blind, placebo-controlled trial

Perimenopausal women in estrogen vasomotor trials: contribution to placebo effect and efficacy outcome

Placebo effect in the treatment of duodenal ulcer

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