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Randomised clinical trial: the efficacy of prucalopride in patients with chronic intestinal pseudo-obstruction--a double-blind, placebo-controlled, cross-over, multiple n = 1 study.

Emmanuel AV, Kamm MA, Roy AJ, Kerstens R, Vandeplassche L - Aliment. Pharmacol. Ther. (2011)

Bottom Line: Three discontinued, two due to study length, and one on prucalopride due to unrelated malnutrition and bronchopneumonia.Four patients (three visceral myopathy and one visceral neuropathy) completed the study; prucalopride significantly improved pain in three of four patients, nausea in two, vomiting in one, bloating in four and analgesic intake.Bowel function was not changed substantially. n = 1 studies in rare conditions allow drug efficacy assessment.

View Article: PubMed Central - PubMed

Affiliation: University College, London, UK.

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Related in: MedlinePlus

Proportion of days with symptoms (dark) vs. no symptoms (light) for (a) pain, (b) nausea, (c) vomiting and (d) bloating for each of the four patients completing the study. Each number (pair of bars) represents a different patient, for whom all days on placebo and active drug have been summed. *Statistically significant reduction (P < 0.05) of symptoms with prucalopride vs. placebo. Pru, Prucalopride; Pla, Placebo.
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fig01: Proportion of days with symptoms (dark) vs. no symptoms (light) for (a) pain, (b) nausea, (c) vomiting and (d) bloating for each of the four patients completing the study. Each number (pair of bars) represents a different patient, for whom all days on placebo and active drug have been summed. *Statistically significant reduction (P < 0.05) of symptoms with prucalopride vs. placebo. Pru, Prucalopride; Pla, Placebo.

Mentions: Figure 1 and Table 3 show the distribution of the proportion of days with and without symptoms (pain, vomiting, nausea and bloating) for each of the four patients who completed the study, during placebo- and prucalopride- treatment days. One subject (3006) reported very few days with the presence of symptoms during both placebo and prucalopride treatment, hence there was little room for improvement. All the other subjects showed an improvement in at least one of the symptoms with active treatment.


Randomised clinical trial: the efficacy of prucalopride in patients with chronic intestinal pseudo-obstruction--a double-blind, placebo-controlled, cross-over, multiple n = 1 study.

Emmanuel AV, Kamm MA, Roy AJ, Kerstens R, Vandeplassche L - Aliment. Pharmacol. Ther. (2011)

Proportion of days with symptoms (dark) vs. no symptoms (light) for (a) pain, (b) nausea, (c) vomiting and (d) bloating for each of the four patients completing the study. Each number (pair of bars) represents a different patient, for whom all days on placebo and active drug have been summed. *Statistically significant reduction (P < 0.05) of symptoms with prucalopride vs. placebo. Pru, Prucalopride; Pla, Placebo.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3298655&req=5

fig01: Proportion of days with symptoms (dark) vs. no symptoms (light) for (a) pain, (b) nausea, (c) vomiting and (d) bloating for each of the four patients completing the study. Each number (pair of bars) represents a different patient, for whom all days on placebo and active drug have been summed. *Statistically significant reduction (P < 0.05) of symptoms with prucalopride vs. placebo. Pru, Prucalopride; Pla, Placebo.
Mentions: Figure 1 and Table 3 show the distribution of the proportion of days with and without symptoms (pain, vomiting, nausea and bloating) for each of the four patients who completed the study, during placebo- and prucalopride- treatment days. One subject (3006) reported very few days with the presence of symptoms during both placebo and prucalopride treatment, hence there was little room for improvement. All the other subjects showed an improvement in at least one of the symptoms with active treatment.

Bottom Line: Three discontinued, two due to study length, and one on prucalopride due to unrelated malnutrition and bronchopneumonia.Four patients (three visceral myopathy and one visceral neuropathy) completed the study; prucalopride significantly improved pain in three of four patients, nausea in two, vomiting in one, bloating in four and analgesic intake.Bowel function was not changed substantially. n = 1 studies in rare conditions allow drug efficacy assessment.

View Article: PubMed Central - PubMed

Affiliation: University College, London, UK.

Show MeSH
Related in: MedlinePlus