Clinical trial NCT04296500: A Development of Inflammatory Bowel Disease Pattern Identification Algorithm Using Case Series Data
Official title: Herbal Medicine for Inflammatory Bowel Diseases: a Development of Pattern Identification Algorithm by Retrospective Analysis of Case Series Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Keywords: Herbal prescription
Herbal medicine
Pattern identification
Algorithm
Decision tree
TF-IDF
Lead sponsor: Kyunghee University
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 67
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had been diagnosed with IBD by gastroenterologist and achieved clinical remission after treatment with herbal medicine prescriptions

Brief summary: This study aimed to identify inflammatory bowel disease (IBD) patterns based on presenting symptoms and to suggest algorithms for determining pattern and herbal prescriptions for corresponding patterns. The investigators collected symptom data of 67 IBD patients who achieved and maintained clinical remissions after they had taken herbal medicine prescriptions. Prescriptions were categorised into 5 patterns, which were named after main features and symptoms of included patients. Associations between presenting symptoms and patterns were visualised using a term frequency inverse document frequency (TF-IDF) method. Determining IBD patterns from symptoms of patients was analysed and charted by decision tree modeling.

Detailed description: Herbal prescriptions are one of the most sought complementary and alternative medicine treatment strategies for inflammatory bowel disease patients. However, variability in pattern identification of Traditional Chinese Medicine (TCM)/Traditional East Asian Medicine (TEAM) has been criticised. Using data of patients who achieved and maintained clinical remission after TCM/TEAM herbal medicine prescription, the investigators aimed to develop treatment algorithms refined by identified pattern and key symptoms which practitioners can easily discriminate.

Based on herbal prescriptions which induced clinical remission, IBD patients were divided into 5 patterns, i.e., Large intestine type, Water-dampness type, Respiratory type, Upper gastrointestinal (GI) tract type, and Coldness type. By term frequency-inverse document frequency (TF-IDF) method, the association between 22 symptoms that were described as indications of the herbal medicine prescriptions and 5 patterns were analysed. Decision tree modeling was used for prediction of relevant patterns from symptoms.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of IBD by gastroenterologist
* Patients have achieved and maintained clinical remission of IBD symptoms after they took herbal prescriptions
* Patients have provided written informed consent

Exclusion Criteria:

* Details regarding any of 25 symptoms were omitted

Primary outcomes:
measure: Accuracy of pattern identification algorithm
timeFrame: Oct 2015
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Acupuncture & Meridian Science Research Centre
Study officials:
affiliation: Kyunghee University
name: Hyangsook Lee, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bernstein CN, Fried M, Krabshuis JH, Cohen H, Eliakim R, Fedail S, Gearry R, Goh KL, Hamid S, Khan AG, LeMair AW, Malfertheiner, Ouyang Q, Rey JF, Sood A, Steinwurz F, Thomsen OO, Thomson A, Watermeyer G. World Gastroenterology Organization Practice Guidelines for the diagnosis and management of IBD in 2010. Inflamm Bowel Dis. 2010 Jan;16(1):112-24. doi: 10.1002/ibd.21048.
citation: Panaccione R, Rutgeerts P, Sandborn WJ, Feagan B, Schreiber S, Ghosh S. Review article: treatment algorithms to maximize remission and minimize corticosteroid dependence in patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2008 Sep 15;28(6):674-88. doi: 10.1111/j.1365-2036.2008.03753.x.
citation: Abitbol V, Lahmek P, Buisson A, Olympie A, Poupardin C, Chaussade S, Lesgourgues B, Nahon S. Impact of complementary and alternative medicine on the quality of life in inflammatory bowel disease: results from a French national survey. Eur J Gastroenterol Hepatol. 2014 Mar;26(3):288-94. doi: 10.1097/MEG.0000000000000040.
citation: Lee MS, Lee JA, Alraek T, Bian ZX, Birch S, Goto H, Jung J, Kao ST, Moon SK, Park B, Park KM, You S, Yun KJ, Zaslawski C. Current research and future directions in pattern identification: Results of an international symposium. Chin J Integr Med. 2016 Dec;22(12):947-955. doi: 10.1007/s11655-014-1833-3. Epub 2014 Jun 18.
citation: Yu F, Takahashi T, Moriya J, Kawaura K, Yamakawa J, Kusaka K, Itoh T, Morimoto S, Yamaguchi N, Kanda T. Traditional Chinese medicine and Kampo: a review from the distant past for the future. J Int Med Res. 2006 May-Jun;34(3):231-9. doi: 10.1177/147323000603400301.
citation: Liu B, Zhou X, Wang Y, Hu J, He L, Zhang R, Chen S, Guo Y. Data processing and analysis in real-world traditional Chinese medicine clinical data: challenges and approaches. Stat Med. 2012 Mar 30;31(7):653-60. doi: 10.1002/sim.4417. Epub 2011 Dec 9.