Constipation, usually characterized by reduced number of bowel movements, high defecation effort (straining), and feeling of incomplete evacuation, has a negative impact on well-being and quality of life (QoL) [1]. Constipation is predominant in women and elderly, with an overall prevalence of 14 – 30% in Spain [2, 3].
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Perceived effectiveness and increased quality of life after Macrogol 4000 use in patients with constipation
Macrogol is an osmotic laxative. The osmotic gradient in the intestine caused by Macrogol draws water into the intestine causing hydration and increase in stool volume and thus resulting in peristaltic movements [1, 4, 5]. Macrogol is recommended for the relief of constipation symptoms, qualified as per Grading of Recommendations Assessment, Development and Evaluation Working Group (GRADE) [6].
A survey was conducted among individuals purchasing Macrogol 4000 (Dulcosoft®) at Spanish pharmacies [7]. Patients’ perception on treatment effectiveness of Macrogol (mode of use, perceptions on constipation relief, physical discomfort and well-being) and QoL (physical and psychosocial discomfort) was recorded.
The survey included individuals with signs of constipation such as incomplete evacuation, infrequent stools, and straining. Participants included 73 women and 27 men with a mean age of 47.3 ± 17.7 years and 48% of men and 59% of women being below 50 years of age. Participants reported that they had constipation symptoms for a minimum of three months. Most common treatments used were oral laxatives (54%), enemas (35%) and suppositories (27%), and some subjects used more than one treatment.
Participants filled in pre-validated questionnaires at treatment initiation and after 4, 8 and 14 days where they recorded the date, time and dose of product intake followed by the presence or absence of an effect at 24 h.
Subjective perception on the effectiveness of Macrogol
Treatment dosage was either Macrogol powder for an oral solution (1 – 2 sachets a day dissolved in liquid) or Macrogol oral solution (20 – 40 ml of solution per day, both equivalent to 10 – 20 g of Macrogol), preferably taken as a single dose in the morning. The measurement of health-related QoL was achieved by using both, generic and specific questionnaires that quantify 3 fundamental dimensions: physical, psychological-cognitive, and social functioning.
At day 14, physical (Fig. 1) and psychosocial discomfort affecting the quality of life improved with Macrogol use compared to prior treatment.
Fig. 1. Evolution of physical discomfort from before treatment to after treatment (at day 14) [7]
Based on the 13 variable-questionnaire, the data were organised into four blocks – mode of use, perceptions on constipation relief, physical discomfort and well-being. A significant improvement in level of agreement (completely and strongly agree) for ease of intake (p < 0.05) and all variables of perceptions on constipation relief (p < 0.05), physical discomfort (except facilitates evacuation without exertion/pain; p < 0.05) and well-being were reported on day 14 (Fig. 2 to 5). The majority of the patients (90%) reported that Macrogol allowed them to lead a normal life.
Fig. 2. Changes in patient-perceived effectiveness (mode of use) from before treatment to after treatment (at day 14) [7]
*Day 4 and day 14: p < 0.05 compared to baseline (baseline data not shown)
Fig. 3. Changes in patient-perceived effectiveness (constipation relief perceptions) from before treatment to after treatment (at day 14) [7]
*Day 14: p < 0.05 compared to baseline (baseline data not shown); ** empties the entire gastrointestinal system
Fig. 4. Changes in patient-perceived effectiveness (perceptions of physical discomfort) from before treatment to after treatment (at day 14) [7]
*Day 4 and day 14: p < 0.05 compared to baseline (baseline data not shown)
Fig. 5. Changes in patient-perceived effectiveness (perceptions of well-being) from before treatment to after treatment (at day 14) [7]
On day 4, 88% of the patients were satisfied or very satisfied with Macrogol use which improved gradually to 95% on day 14 and 88% of them felt that Macrogol was better than their previous treatments.
Summary
Treatment with Macrogol 4000 for constipation symptoms decreased physical and psychological discomfort after 14 days, while improving the perceived effectiveness of the treatment, specifically, the perceptions on constipation relief, physical discomfort and well-being. When measures such as lifestyle changes are not effective, the need for treatments capable of improving the QoL in patients with constipation is of quintessence.
Literature
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Acknowledgements: The authors thank Paula Fontanilla, PhD, for critically reviewing the manuscript for scientific content and Ashwitha A, an employee of Sanofi, for providing writing and editorial support.
Conflict of interest: G. Logusso has nothing to declare. N. Correia, A. Aran and M. Militao are employees of Sanofi.
Disclosure: This study was funded by Sanofi.
