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A randomized trial to compare the efficacy and tolerability of sodium picosulfate-magnesium citrate solution vs. 4 L polyethylene glycol solution as a bowel preparation for colonoscopy

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International Journal of Colorectal Disease Aims and scope Submit manuscript

Abstract

Purpose

The purpose of this study is to compare the efficacy and acceptability of an evening-before regimens of sodium picosulfate/magnesium citrate (SPMC) and polyethylene glycol (PEG) as bowel cleansers and to explore the results of a same-day regimen of SPMC.

Methods

Multicenter, randomized, observer-blinded, parallel study carried out in subjects who were 18–80 years old and were undergoing diagnostic colonoscopy for the first time. The primary outcome was treatment success, which was a composite outcome defined by (1) the evaluation of the overall preparation quality as “excellent” or “good” by two blinded independent evaluators with the Fleet® Grading Scale for Bowel Cleansing and (2) a subject’s acceptability rating of “easy to take” or “tolerable.” The primary outcome was analyzed using a logistic regression with site, gender, and age group (age ≥65 years and <65 years) as factors.

Results

Four hundred ninety subjects were included in the efficacy evaluation. Although treatment success was significantly higher in subjects assigned to the evening-before regimen of SPMC vs. subjects assigned to the evening-before PEG, when evaluating the two individual components for treatment success, there were significant differences in the ease of completion but not in the quality of preparation. The same-day SPMC regimen was superior to both the evening-before regimen of SPMC and PEG in terms of the quality of preparation, especially regarding the proximal colon.

Conclusions

An evening-before regimen of SPMC is superior to an evening-before regimen of PEG in terms of subject’s acceptability. The same-day SPMC regimen provides better cleansing levels in the proximal colon.

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Acknowledgments

The authors would like to thank Dr. Fernando Rico-Villademoros (APICES, Madrid, Spain) for the support given in Medical Writing of the manuscript, Ángel Callejo (APICES, Madrid, Spain) for coordinating all tasks performed by the different parties during the study conduction, and Dr. José Luis Lledó and Dr. Guillermo Cacho (Madrid, Spain) for the independent blinded evaluations.

The authors also thank to the investigators who participated in this study: Federico Argüelles-Arias (Sevilla, Spain), Lidia Argüello (Valencia, Spain), Raquel Barranco (Valdemoro, Spain), Susana Basterra (Bilbao, Spain), Mª Rosa Briz (Valdemoro, Spain), Ángel José Calderón (Bilbao, Spain), Almudena Calvache (Valdemoro, Spain), Henry R. Cordova (Barcelona, Spain), Joan Dot (Barcelona, Spain), Rosario Fernández (Oviedo, Spain), Raquel García Arcones (Majadahonda, Spain), Blas José Gómez-Rodríguez (Sevilla, Spain), Cecilia González (Madrid, Spain), Ángel González (Córdoba, Spain), Lander Hijona (Bilbao, Spain), Josep Llach (Barcelona, Spain), Oscar Nogales (Madrid, Spain), Akiko Ono (Murcia, Spain), María Antonia Palacio (Oviedo, Spain), Virginia Pertejo (Valencia, Spain), Marta Ponce (Valencia, Spain), Cesar Prieto de Frías (Pamplona, Spain), Enrique Quintero (La Laguna, Spain), María Rodríguez (Oviedo, Spain), Juan Ruíz (Málaga, Spain), Teresa Sala (Valencia, Spain), Luis Vázquez (Málaga, Spain), and Paz Zaballa (Oviedo, Spain).

Compliance with ethical standards

ᅟ

Funding

This study was fully funded by Laboratorios Casen-Fleet S.L.U. (currently Casen Recordati S.L.)

Conflict of interest

The authors declare that they have no competing interests.

Research involving human participants and/or animals

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This article does not contain any studies with animals performed by any of the authors. Informed consent was obtained from all individual participants included in the study.

Author information

Author notes

  1. Adolfo Parra-Blanco

    Present address: School of Medicine of Pontificia, Universidad Católica de Chile, Santiago, Chile

Authors and Affiliations

  1. Instituto de Investigación Sanitaria de Navarra (Idisna), Clínica Universidad de Navarra, Pamplona, Spain

    Miguel Muñoz-Navas & Cristina Carretero

  2. Department of Gastroenterology, IDIPHIM, Hospital Universitario Puerta de Hierro, Joaquin Rodrigo 2, Majadahonda, 28222, Madrid, Spain

    José Luis Calleja & Luis Esteban Abreu

  3. Hospital Infanta Elena Valdemoro, Madrid, Spain

    Guillermo Payeras

  4. Hospital General Universitario Reina Sofía, Córdoba, Spain

    Antonio José Hervás

  5. Hospital Basurto, Bilbao, Spain

    Víctor Orive

  6. Hospital General Universitario Gregorio Marañón, Madrid, Spain

    Pedro L. Menchén

  7. Hospital Clínic de Barcelona, Barcelona, Spain

    José María Bordas

  8. Hospital Universitari Vall d’Hebrón, Barcelona, Spain

    José Ramón Armengol

  9. Hospital Universitari i Politècnic la Fe, Valencia, Spain

    Vicente Pons Beltrán

  10. Hospital Universitario de Canarias, La Laguna, Spain

    Inmaculada Alonso-Abreu

  11. Hospital Regional Universitario Carlos Haya, Málaga, Spain

    Román Manteca

  12. Hospital Universitario Central de Asturias, Oviedo, Spain

    Adolfo Parra-Blanco

  13. Hospital Universitario Virgen de la Arrixaca, Murcia, Spain

    Fernando Carballo

  14. Hospital Virgen Macarena, Sevilla, Spain

    Juan Manuel Herrerías

  15. Laboratorios Casen Recordati S.L., Zaragoza, Spain

    Carlos Badiola

Authors
  1. Miguel Muñoz-Navas
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  2. José Luis Calleja
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  5. Luis Esteban Abreu
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  6. Víctor Orive
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  7. Pedro L. Menchén
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  11. Vicente Pons Beltrán
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  12. Inmaculada Alonso-Abreu
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  13. Román Manteca
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  14. Adolfo Parra-Blanco
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  17. Carlos Badiola
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Corresponding author

Correspondence to José Luis Calleja.

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Muñoz-Navas, M., Calleja, J.L., Payeras, G. et al. A randomized trial to compare the efficacy and tolerability of sodium picosulfate-magnesium citrate solution vs. 4 L polyethylene glycol solution as a bowel preparation for colonoscopy. Int J Colorectal Dis 30, 1407–1416 (2015). https://doi.org/10.1007/s00384-015-2307-6

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  • DOI: https://doi.org/10.1007/s00384-015-2307-6

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