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Introduction

Previous studies have demonstrated that the Chinese population has a more stringent interpretation of “normal” defecation. The symptom spectrum of Chinese constipated patients remains unknown.

Aims & Methods

To systematically investigate the symptom spectrum of Chinese constipated patients, and to evaluate the clinical applicability of Rome IV criteria in this distinct population.

Non-selective outpatients (aged ≥16 years) self-identified with “constipation” were enrolled and given the Rome IV questionnaire. Data on demographics, defecation frequency, stool forms, defecation symptoms, and abdominal symptoms were collected. Non-constipated controls were recruited from outpatients’ family members for demographics and defecation pattern data. Descriptive analysis was performed to contrast distribution differences between constipated and normal individuals, and to determine the abnormal defecation symptom thresholds. The consistency of Rome IV criteria with respondents’ self-assessments was evaluated, and modifications of Rome IV criteria were proposed based on these thresholds.

Results

The study enrolled 6364 constipated individuals and 1432 normal controls. In constipated individuals, the prevalent symptoms included straining (97.29%), sensation of incomplete evacuation (96.07%), hard stools (95.21%), sensation of anorectal obstruction (93.22%), reduced defecation frequency (91.67%), bloating or abdominal distension (87.13%), abdominal pain (76.71%), laxative-assisted defecation (23.98%), and manipulation-assisted defecation (21.51%).
Descriptive analysis has substantiated that constipated patients exhibit inter-individual symptom heterogeneity, validating the clinical utility of Rome IV's symptom cluster-based diagnostic paradigm. However, Rome IV criteria manifested poor consistency with self-assessment (Kappa=0.24, P<0.01), with high specificity (98.81%) but low sensitivity (47.30%). This discrepancy reflects stricter perceptions of normal defecation among the Chinese.
As for normal controls, the mean defecation frequency was 7.09±2.03/week, with the 90th percentile cutoff (4/week) stricter than Rome IV's 3/week benchmark. This quantitative analysis yielded six constipation diagnostic thresholds: defecation frequency = 4 times a week, hard stools =30%, straining =30%, sensation of incomplete evacuation =20%, sensation of anorectal obstruction or blockage =10%, and manipulation-assisted defecation =10%.
We compared five diagnostic approaches to determine the optimal symptom count for constipation diagnosis. As illustrated in the Table, the diagnostic approach with the presence of ≥2 abnormal symptoms had an excellent consistency (Kappa value =0.80, P < 0.01), high specificity (95.46%), and high sensitivity (92.94%).

Diagnostic Approach	Kappa Value	Specificity/%	Sensitivity/%
Rome IV Criteria	0.24	98.81	47.30
Two-Symptom Criteria	0.80	95.46	92.94
Three-Symptom Criteria	0.66	98.60	84.43
Four-Symptom Criteria	0.50	99.72	73.29
Five-Symptom Criteria	0.32	99.93	56.46
Six-Symptom Criteria	0.01	100.00	2.44

Conclusion

Rome IV criteria demonstrate suboptimal performance in consistency and sensitivity, mainly attributable to the stricter threshold for defecation frequency in China. After modifications, the novel dual-symptom diagnostic framework significantly improves consistency and sensitivity, offering a more tailored approach for diagnosing constipation in Chinese population. These findings underscore the necessity for region-specific adaptations of Rome IV criteria across diverse populations.

References

1. Chu H, Hou X. Understanding of constipation symptoms and the diagnosis and management of constipation in Chinese physicians. PLoS One. 2016 Mar 31;11(3):e0152801. https://pubmed.ncbi.nlm.nih.gov/27031865/
2. Mearin F, Lacy BE, Chang L, Chey WD, Lembo AJ, Simren M, Spiller R. Bowel disorders. Gastroenterology. 2016 Feb 18;150(6):1393-1407. https://pubmed.ncbi.nlm.nih.gov/27144627/
3. Zhu SR, Tian Y, Bai T, Hou XH. The defecation habits of people in Central China: a cross-sectional survey and a literature review. Neurogastroenterol Motil. 2020 Mar;32(S1):274. https://webofscience.clarivate.cn/wos/woscc/full-record/WOS:000521974900269

MODIFICATIONS OF ROME IV DIAGNOSTIC CRITERIA BASED ON DEFECATION SYMPTOM SPECTRUM IN CHINESE

Qing Huang 1, Yurong Huang 2, Siran Zhu 3, Yuen Tian 3, Tao Bai 3, Xiaohua Hou 3, Jie Yang 2

1 Chongqing Medical University, Chongqing, China

2 The Affiliated Hospital of Guizhou Medical University, Guiyang, China

3 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China

Conference

UEG Week Berlin 2025

Topics

Colorectal

Submission format

Abstract

Session

Constipation and defaecatory disorders (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

Table. Proportions of pts (n [%]) achieving endpoints at Wk 12 and Wk 52 in GLADIATOR (nonresponder imputation)^a	Endpoint	Placebo (N=60)	Etrasimod 2 mg (N=127)	% difference from placebo^b (95% CI)	Difference from placebo p value^c
Wk 12 Wk 12 completers: Placebo: 56 (93.3)^d Etrasimod: 122 (96.1)^e	Clinical remission^f	7 (11.7)	36 (28.3)	15.6 (4.3, 26.9)	0.0068
	EI^g	12 (20.0)	56 (44.1)	23.3 (9.8, 36.9)	0.0007
	EIHR^h	8 (13.3)	37 (29.1)	15.0 (3.2, 26.8)	0.0128
Wk 52 Wk 52 completers: Placebo: 28 (46.7)ⁱ Etrasimod: 76 (59.8)^j	Clinical remission^f	11 (18.3)	33 (26.0)	7.4 (-5.2, 19.9)	0.2524
	EI^g	14 (23.3)	41 (32.3)	8.2 (-5.2, 21.7)	0.2302
	EIHR^h	9 (15.0)	32 (25.2)	9.6 (-2.1, 21.3)	0.1089
	CS-free clinical remission^k	10 (16.7)	32 (25.2)	8.5 (-3.7, 20.7)	0.1726
Wk 12 and Wk 52	Sustained clinical remission^l	3 (5.0)	21 (16.5)	11.2 (2.6, 19.8)	0.0104
^aAll randomised pts who received ≥1 dose of study treatment with baseline MMS 4–6, baseline ES ≥2 and baseline RBS ≥1 were included in the primary analysis set for efficacy analysis. All pts with missing data were treated as nonresponders in the primary analysis. ^bEstimated common risk difference using the Mantel–Haenszel weighted method, stratified by naïve to biologic/JAKi therapy at trial entry (yes/no) and baseline CS use (yes/no). ^cFrom Mantel–Haenszel test and not adjusted for multiplicity. ^dIn the placebo group, prior to Wk 12, the following reasons for discontinuation were reported: AE (n=2 [3.3%]); withdrawal by pt (n=2 [3.3%]). ^eIn the etrasimod group, prior to Wk 12, the following reasons for discontinuation were reported: AE (n=3 [2.4%]); withdrawal by pt (n=1 [0.8%]); disease worsening (n=1 [0.8%]). ^fClinical remission was defined as SFS=0 or 1 (and no greater than baseline), RBS=0 and ES ≤1 (excluding friability). ^gEI was defined as ES ≤1. ^hEIHR was defined as ES ≤1 with histologic remission measured by Geboes Index score <2.0. ⁱIn the placebo group, after Wk 12, the following reasons for discontinuation were reported: disease worsening (n=26 [43.3%]); withdrawal by pt (n=2 [3.3%]). ^jIn the etrasimod group, after Wk 12, the following reasons for discontinuation were reported: disease worsening (n=33 [26.0%]); withdrawal by pt (n=5 [3.9%]); AE (n=4 [3.1%]); physician decision (n=2 [1.6%]); lack of efficacy (n=1 [0.8%]); study termination by sponsor (n=1 [0.8%]). ^kCS-free clinical remission was defined as clinical remission at Wk 52 and CS free for ≥12 wks immediately prior to Wk 52. ^lSustained clinical remission was defined as clinical remission at both Wk 12 and Wk 52. AE, adverse event; CI, confidence interval; CS, corticosteroid; EI, endoscopic improvement; EIHR, endoscopic improvement-histologic remission; ES, endoscopic subscore; JAKi, Janus kinase inhibitor; MMS, modified Mayo score; N, number of pts in cohort; pt, patient; RBS, rectal bleeding subscore; SFS, stool frequency subscore; wk, week.

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