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Comparison of preference and safety of powder and liquid lactulose in adult patients with chronic constipation.

Barish CF, Voss B, Kaelin B - Clin Exp Gastroenterol (2010)

Bottom Line: Chronic constipation is an important clinical condition which can result in serious discomfort and even require hospitalization.More patients preferred powder compared with liquid lactulose and the products were equally safe.These findings may impact patient compliance, and therefore may affect clinical outcome.

View Article: PubMed Central - PubMed

Affiliation: Wake Research Associates, Raleigh, North Carolina, USA;

ABSTRACT

Background: Chronic constipation is an important clinical condition which can result in serious discomfort and even require hospitalization. Powder and liquid lactulose are designated as clinically equivalent for the treatment of constipation, but there are significant differences in the taste, consistency, and portability of the products, which may affect patient compliance and therefore clinical outcome.

Aim: To evaluate patient preference between powder and liquid lactulose in terms of overall preference, taste, consistency, and portability, and safety in terms of adverse events.

Methods: Three sites randomized patients (total n = 50) to powder or liquid lactulose for seven days with crossover. Patient preference was assessed by a questionnaire, and the occurrence of adverse events was monitored.

Results: Of those expressing a preference, 44% and 57% more patients preferred the taste and consistency, respectively, of powder over liquid lactulose. More than six times as many patients preferred the portability of powder compared with liquid lactulose and, overall, 77% more patients preferred powder over liquid lactulose. There was no difference between treatment groups in terms of adverse events (P = 0.635).

Conclusions: More patients preferred powder compared with liquid lactulose and the products were equally safe. These findings may impact patient compliance, and therefore may affect clinical outcome.

No MeSH data available.


Related in: MedlinePlus

Study randomization and design.Note: *Or within 7 days of day 14 of the study.
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f1-ceg-3-153: Study randomization and design.Note: *Or within 7 days of day 14 of the study.

Mentions: Patients were randomized in a 1:1 ratio to receive powder or liquid lactulose first for seven days (dose determined by treating physician, range for powder = 10–20 g/day, range for liquid = 15–30 mL/day), and then the patients crossed over to the alternative treatment for the following seven days (dose again determined by treating physician, Figure 1). Patients returned to the study site on study day 6 or 7 to pick up the formulation of lactulose which they were scheduled to cross over to for the remainder of the study (Figure 1). Sealed envelopes containing the patient randomization scheme were provided to the study sites. Powder lactulose (Kristalose®, Cumberland Pharmaceuticals Inc., Nashville, TN, USA) was provided in 10 g pouches and liquid lactulose syrup (Generlac, Morton Grove Pharmaceuticals Inc., Morton Grove, IL, USA) was provided in a 473 mL (pint) bottle. Patient preference was assessed on a questionnaire administered by study staffin the days following completion of the study. Both treatment groups received both drugs in a crossover design (drug sequence determined by randomization), and then preference was evaluated after patients had been exposed to both treatments in this prospective study. The study sponsor developed the patient questionnaire and two versions were developed and utilized equally to avoid bias. One version of the questionnaire listed powder first as an answer selection for all of the questions, while the other listed liquid first as an answer selection for all of the questions. Each question on the questionnaire had three possible answers, ie, liquid, powder, or no preference. Spanish translations of the questionnaire and other study documents were made available at the request of the Brooklyn, NY site. Upon completion of the study, patients were allowed a seven-day window (total study duration including questionnaire visit = 21 days) to return to the study site and complete the questionnaire, and adverse events were monitored throughout the entire study period (Figure 1).


Comparison of preference and safety of powder and liquid lactulose in adult patients with chronic constipation.

Barish CF, Voss B, Kaelin B - Clin Exp Gastroenterol (2010)

Study randomization and design.Note: *Or within 7 days of day 14 of the study.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3108673&req=5

f1-ceg-3-153: Study randomization and design.Note: *Or within 7 days of day 14 of the study.
Mentions: Patients were randomized in a 1:1 ratio to receive powder or liquid lactulose first for seven days (dose determined by treating physician, range for powder = 10–20 g/day, range for liquid = 15–30 mL/day), and then the patients crossed over to the alternative treatment for the following seven days (dose again determined by treating physician, Figure 1). Patients returned to the study site on study day 6 or 7 to pick up the formulation of lactulose which they were scheduled to cross over to for the remainder of the study (Figure 1). Sealed envelopes containing the patient randomization scheme were provided to the study sites. Powder lactulose (Kristalose®, Cumberland Pharmaceuticals Inc., Nashville, TN, USA) was provided in 10 g pouches and liquid lactulose syrup (Generlac, Morton Grove Pharmaceuticals Inc., Morton Grove, IL, USA) was provided in a 473 mL (pint) bottle. Patient preference was assessed on a questionnaire administered by study staffin the days following completion of the study. Both treatment groups received both drugs in a crossover design (drug sequence determined by randomization), and then preference was evaluated after patients had been exposed to both treatments in this prospective study. The study sponsor developed the patient questionnaire and two versions were developed and utilized equally to avoid bias. One version of the questionnaire listed powder first as an answer selection for all of the questions, while the other listed liquid first as an answer selection for all of the questions. Each question on the questionnaire had three possible answers, ie, liquid, powder, or no preference. Spanish translations of the questionnaire and other study documents were made available at the request of the Brooklyn, NY site. Upon completion of the study, patients were allowed a seven-day window (total study duration including questionnaire visit = 21 days) to return to the study site and complete the questionnaire, and adverse events were monitored throughout the entire study period (Figure 1).

Bottom Line: Chronic constipation is an important clinical condition which can result in serious discomfort and even require hospitalization.More patients preferred powder compared with liquid lactulose and the products were equally safe.These findings may impact patient compliance, and therefore may affect clinical outcome.

View Article: PubMed Central - PubMed

Affiliation: Wake Research Associates, Raleigh, North Carolina, USA;

ABSTRACT

Background: Chronic constipation is an important clinical condition which can result in serious discomfort and even require hospitalization. Powder and liquid lactulose are designated as clinically equivalent for the treatment of constipation, but there are significant differences in the taste, consistency, and portability of the products, which may affect patient compliance and therefore clinical outcome.

Aim: To evaluate patient preference between powder and liquid lactulose in terms of overall preference, taste, consistency, and portability, and safety in terms of adverse events.

Methods: Three sites randomized patients (total n = 50) to powder or liquid lactulose for seven days with crossover. Patient preference was assessed by a questionnaire, and the occurrence of adverse events was monitored.

Results: Of those expressing a preference, 44% and 57% more patients preferred the taste and consistency, respectively, of powder over liquid lactulose. More than six times as many patients preferred the portability of powder compared with liquid lactulose and, overall, 77% more patients preferred powder over liquid lactulose. There was no difference between treatment groups in terms of adverse events (P = 0.635).

Conclusions: More patients preferred powder compared with liquid lactulose and the products were equally safe. These findings may impact patient compliance, and therefore may affect clinical outcome.

No MeSH data available.


Related in: MedlinePlus