Original Contribution


Prophylactic Therapy of Cyclic Vomiting Syndrome in Children: Comparison of Amitriptyline and Cyproheptadine: A Randomized Clinical Trial

  • The American Journal of Gastroenterology volume 113, pages 135140 (2018)
  • doi:10.1038/ajg.2017.194
  • Download Citation




Cyclic vomiting syndrome (CVS) is a common functional gastrointestinal disorder characterized by recurrent episodes of nausea and vomiting. There is no definite treatment for the condition, although some medications are recommended. We aimed to compare the efficacy of amitriptyline and cyproheptadine in prophylactic therapy of CVS.


This is a single-blinded randomized clinical trial conducted during 2015–2016 in Isfahan, Iran. Sixty-four children who were 3–15 years old, with a diagnosis of CVS (based on Rome III criteria), were included in the study and were randomly divided into two groups of amitriptyline and cyproheptadine. They were followed for 6 months, looking for frequency and duration of attacks as the primary outcome.


The mean monthly frequency of attacks in the last 2 months of the study in the amitriptyline and cyproheptadine group were 0.38±0.55 and 0.59±0.71, respectively (P-value=0.197), after intervention. The mean duration of attacks between amitriptyline and cyproheptadine group were 1.41±2.86 and 1.81±2.22 h, respectively (P-value=0.212). In the amitriptyline group 65.6% of patients reported 100% remission, whereas in the cyproheptadine group 50% reported full remission (P-value=0.206).


There was no superiority of one of the medications over the other. We did not find any age-related effect on the efficacy of these medications as well.

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This study was funded by the vice-chancellor for research and technology of Isfahan University of Medical Sciences (grant number 292210 allocated to Dr Omid Yaghini). Dr Omid Yaghini has full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. We also thank Dr Marjan Mansourian for her help for data analysis and data interpretation.

Author information


  1. Faculty of Medicine, Najafabad Branch, Islamic Azad University, Najafabad, Iran

    • Negin Badihian
  2. Child Growth and Development Research Center, Research Institute for Primordial Prevention of Non-Communicable Disease, Isfahan University of Medical Sciences, Isfahan, Iran

    • Hossein Saneian
    • , Shervin Badihian
    •  & Omid Yaghini
  3. Students’ Research Center, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran

    • Shervin Badihian


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Competing interests

Guarantor of the article: Omid Yaghini, MD.

Specific author contributions: Omid Yaghini and Hossein Saneian had the main idea of the study, designed the study, conducted the study, contributed in data collection, data analysis and data interpretation, revised the manuscript critically, and approved the final manuscript as submitted. Negin Badihian and Shervin Badihian contributed in designing the study, conducted the study, collected data, analyzed and interpreted data, prepared the initial manuscript, and approved the final manuscript as submitted.

Financial support: This study was supported by the vice chancellor for Research and Development of Isfahan University of Medical Sciences, allocated to Dr Omid Yaghini (grant number: 292210).

Potential competing interests: None.

Corresponding author

Correspondence to Omid Yaghini.