Effect of vinegar supplementation on patients with esophageal lesions lightly stained with Lugol’s iodine solution: Prospective single-centre trial

doi:10.4253/wjge.v16.i5.259

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World Journal of Gastrointestinal Endoscopy

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Prospective Study

World J Gastrointest Endosc. May 16, 2024; 16(5): 259-272
Published online May 16, 2024. doi: 10.4253/wjge.v16.i5.259

Table 1 Characteristics of patients and lesions (intention-to-treat population), n (%)

Characteristics	Experimental group	Conventional group	P value
No. of participants	86	80
Age, mean ± SD, yr	59.84 ± 8.40	59.75 ± 9.21	0.949¹
BMI, mean ± SD, kg/m²	23.89 ± 3.35	23.49 ± 2.29	0.372¹
Sex			0.798²
Male	51 (59.30)	49 (61.25)
Female	35 (40.70)	31 (38.75)
Basic diseases
Diabetes	9 (10.47)	8 (10.00)	0.921²
Hypertension	14 (16.28)	6 (7.50)	0.083²
Coronary heart disease	4 (4.65)	4 (5.00)	0.916²
Family history of esophageal cancer or stomach cancer			0.800²
No	67 (77.91)	61 (76.25)
Yes	19 (22.09)	19 (23.75)
Smoking			0.899²
No-smoker	46 (53.49)	42 (52.50)
Smoker	40 (46.51)	38 (47.50)
Smoking index			0.618²
≤ 200	15 (17.44)	11 (13.75)
200-400	14 (16.28)	13 (16.25)
≥ 400	11 (12.79)	14 (17.50)
Alcohol drinking			0.712²
No-drinker	39 (45.35)	34 (42.50)
Drinker	47 (54.65)	46 (57.50)
Alcohol ingestion, g/d			0.833²
≤ 20	23 (26.74)	20 (25.00)
20-60	13 (15.12)	13 (16.25)
≥ 60	11 (12.79)	13 (16.25)
Prefer hot dishes/hot tea			0.459²
No	50 (59.14)	51 (63.75)
Yes	36 (41.86)	29 (36.25)
Prefer spicy food			0.227²
No	76 (88.37)	75 (93.75)
Yes	10 (11.63)	5 (6.25)
Prefer pickled dishes			0.095²
No	77 (89.53)	77 (96.25)
Yes	9 (10.47)	3 (3.75)
Multiple Lugol’s voiding lesions			0.208²
No	52 (65.00)	57 (75.00)
Yes	28 (35.00)	19 (25.00)
Lesion location			0.197²
Upper thoracic esophagus	12 (13.95)	8 (10.00)
Middle thoracic esophagus	44 (51.16)	52 (65.00)
Lower thoracic esophagus	30 (34.88)	20 (25.00)
Maximum diameter			0.134²
Lesion size ≤ 0.5 cm	65 (75.58)	54 (67.50)
Lesion size > 0.5 cm	21 (24.42)	26 (32.50)
Morphology			0.324²
Quasi circular	31 (36.05)	30 (37.50)
Bar-type	3 (3.49)	7 (8.75)
Irregular shape	52 (60.47)	43 (53.75)
Biopsy pathology			0.506²
Squamous epithelial hyperplasia	77 (89.53)	74 (92.50)
Low grade intraepithelial neoplasia	9 (10.47)	6 (7.50)
Follow-up time	28.92 ± 6.04	30.48 ± 5.88	0.0958¹

¹Student’s t-test.

²Chi-squared test.

Multiple Lugol’s voiding lesions: ≥ 10 Lugol’s voiding lesions per endoscopic field of vision. Smoking index = length of smoking (year) × daily cigarette consumption. Alcohol ingestion = daily alcohol consumption (mL) × alcohol concentration × 0.8.

Table 2 Characteristics of patients and lesions (per-protocol population), n (%)

Characteristics	Experimental group	Conventional group	P value
No. of participants	80	76
Age, mean ± SD, yr	59.69 ± 8.47	59.32 ± 9.22	0.793¹
BMI, mean ± SD, kg/m²	23.93 ± 3.43	23.49 ± 2.28	0.070¹
Sex			0.535²
Male	49 (61.25)	47 (61.84)
Female	31 (38.75)	29 (38.16)
Basic diseases
Diabetes	9 (11.25)	8 (10.53)	0.545²
Hypertension	13 (16.25)	6 (7.89)	0.143²
Coronary heart disease	3 (3.75)	4 (5.26)	0.949²
Family history of esophageal cancer or stomach cancer			0.984²
No	62 (77.50)	59 (77.63)
Yes	18 (22.50)	17 (22.37)
Smoking			0.863²
No-smoker	41 (51.25)	40 (52.63)
Smoker	39 (48.75)	36 (47.37)
Smoking index			0.687²
≤ 200	14 (17.50)	10 (13.16)
200-400	14 (17.50)	13 (17.11)
≥ 400	11 (13.75)	13 (17.11)
Alcohol drinking			0.836²
No-drinker	35 (45.75)	32 (42.11)
Drinker	45 (56.25)	44 (57.89)
Alcohol ingestion, g/d			0.936²
≤ 20	21 (26.25)	19 (25.00)
20-60	13 (16.25)	13 (17.11)
≥ 60	11 (13.75)	12 (15.79)
Prefer hot dishes/hot tea			0.287²
No	46 (57.50)	50 (65.79)
Yes	34 (42.50)	26 (34.21)
Prefer spicy food			0.210²
No	70 (8.75)	71 (93.42)
Yes	10 (12.50)	5 (6.58)
Prefer pickled dishes			0.087²
No	71 (88.75)	73 (96.05)
Yes	9 (11.25)	3 (3.95)
Multiple Lugol’s voiding lesions			0.3018²
No	54 (67.50)	57 (75.00)
Yes	26 (32.50)	19 (25.00)
Lesion location			0.194²
Upper thoracic esophagus	12 (15.00)	8 (10.53)
Middle thoracic esophagus	39 (48.75)	48 (63.16)
Lower thoracic esophagus	29 (36.25)	20 (26.32)
Maximum diameter			0.379²
Lesion size ≤ 0.5 cm	60 (75.00)	52 (68.42)
Lesion size > 0.5 cm	20 (25.00)	24 (31.58)
Morphology			0.518²
Quasi circular	29 (36.25)	28 (36.84)
Bar-type	3 (3.75)	6 (7.89)
Irregular shape	48 (60.00)	42 (55.26)
Biopsy pathology			0.477²
Squamous epithelial hyperplasia	71 (88.75)	70 (92.11)
Low grade intraepithelial neoplasia	9 (11.25)	6 (7.89)
Follow-up time	29.53 ± 5.73	31.00 ± 5.52	0.514¹

¹Student’s t-test.

²Chi-squared test.

BMI: Body mass index.

Table 3 Hazard ratio and 95%CI of clinical therapeutic outcomes (intention-to-treat population)

Therapeutic effect	HR (95%CI)	Multivariable adjusted HR (95%CI)¹
Endoscopic characteristics improved
Conventional group	1.00	1.00
Experimental group	2.183 (1.183, 4.028)^a	2.515 (1.318, 4.800)^b
Endoscopic characteristics deteriorate
Conventional group	1.00	1.00
Experimental group	0.791 (0.305, 2.048)	0.976 (0.920, 1.035)
Biopsy pathology improved
Conventional group	1.00	1.00
Experimental group	2.931 (1.212, 7.089)^a	2.710 (1.066, 6.891)^a
Biopsy pathology deteriorate
Conventional group	1.00	1.00
Experimental group	0.690 (0.230, 2.069)	0.983 (0.911, 1.060)
HGIN or early cancer
Conventional group	1.00	1.00
Experimental group	0.382 (0.079, 1.846)	0.833 (0.125, 5.560)

^aP 0.05.

^bP 0.01.

¹Adjusted by age, sex, lesion size, lesion location and biopsy characteristics.

HR: Hazard ratio; HGIN: High-grade intraepithelial neoplasia.

Table 4 Hazard ratio and 95%CI of clinical therapeutic outcomes (per-protocol population)

Therapeutic effect	HR (95%CI)	Multivariable adjusted HR (95%CI)¹
Endoscopic characteristics improved
Conventional group	1.00	1.00
Experimental group	2.307 (1.202, 4.426)^a	2.545 (1.282, 5.052)^b
Endoscopic characteristics deteriorate
Conventional group	1.00	1.00
Experimental group	0.793 (0.306, 2.055)	0.979 (0.923, 1.037)
Biopsy pathology improved
Conventional group	1.00	1.00
Experimental group	3.320 (1.295, 8.507)^a	3.186 (1.179, 8.605)^a
Biopsy pathology deteriorate
Conventional group	1.00	1.00
Experimental group	0.795 (0.259, 2.440)	0.969 (0.896, 1.048)
HGIN or early cancer
Conventional group	1.00	1.00
Experimental group	0.382 (0.079, 1.846)	0.750 (0.140, 4.015)

^aP 0.05.

^bP 0.01.

¹adjusted by age, sex, lesion size, lesion location and biopsy characteristics.

HR: Hazard ratio; HGIN: High-grade intraepithelial neoplasia.

Table 5 Subgroup analyses for endoscopic characteristics improved (intention-to-treat population)

Subgroup	Number (n)	Rate (%)	HR (95%CI)	P value
Male (n = 100)				0.008
Conventional group (n = 49)	7	14.29	1.00
Experimental group (n = 51)	19	37.25	3.232 (1.353, 7.719)
Female (n = 66)				0.542
Conventional group (n = 31)	9	29.03	1.00
Experimental group (n = 35)	10	28.57	1.324 (0.537, 3.263)
Age > 60 (n = 82)				0.008
Conventional group (n = 42)	7	16.67	1.00
Experimental group (n = 40)	15	37.50	3.425 (1.380, 8.497)
Age ≤ 60 (n = 84)
Conventional group (n = 38)	9	23.68	1.00	0.395
Experimental group (n = 46)	14	30.43	1.438 (0.622, 3.323)
Lesion size ≤ 0.5 cm (n = 119)				0.010
Conventional group (n = 54)	10	18.52	1.00
Experimental group (n = 65)	24	36.92	2.708 (1.263, 5.806)
Lesion size > 0.5 cm (n = 47)				0.794
Conventional group (n = 26)	6	23.08	1.00
Experimental group (n = 21)	5	23.81	1.181 (0.339, 4.119)
Lesion in upper thoracic esophagus (n = 20)				0.123
Conventional group (n = 8)	2	25.00	1.00
Experimental group (n = 12)	5	41.67	3.686 (0.701, 19.366)
Lesion in middle thoracic esophagus (n = 96)				0.245
Conventional group (n = 52)	12	23.08	1.00
Experimental group (n = 44)	13	29.55	1.596 (0.726, 3.506)
Lesion in lower thoracic esophagus (n = 50)				0.060
Conventional group (n = 20)	2	10.00	1.00
Experimental group (n = 30)	11	36.67	4.265 (0.943, 19.298)
Undergone esophageal ESD previously (n = 65)				0.078
Conventional group (n = 29)	5	17.24	1.00
Experimental group (n = 36)	12	33.3	2.386 (0.908, 6.267)
Not undergone esophageal ESD previously (n = 101)				0.076
Conventional group (n = 51)	11	21.57	1.00
Experimental group (n = 50)	17	34.00	2.100 (0.924, 4.772)
Lesion biopsy: Squamous epithelial hyperplasia (n = 151)				0.009
Conventional group (n = 74)	14	18.92	1.00
Experimental group (n = 77)	26	33.77	2.380 (1.238, 4.575)
Lesion biopsy: Low grade intraepithelial neoplasia (n = 15)				0.814
Conventional group (n = 6)	2	33.3	1.00
Experimental group (n = 9)	3	33.3	1.241 (0.206, 7.479)

HR: Hazard ratio; ESD: Endoscopic submucosal dissection.

Table 6 Subgroup analyses for biopsy pathology improved (intention-to-treat population)

Subgroup	Number (n)	Rate (%)	HR (95%CI)	P value
Male (n = 100)				0.043
Conventional group (n = 49)	4	8.16	1.00
Experimental group (n = 51)	11	21.57	3.285 (1.040, 10.375)
Female (n = 66)				0.227
Conventional group (n = 31)	3	9.68	1.00
Experimental group (n = 35)	6	17.14	2.356 (0.587, 9.449)
Age > 60 (n = 82)				0.035
Conventional group (n = 42)	4	9.52	1.00
Experimental group (n = 40)	9	22.50	3.609 (1.091, 11.933)
Age ≤ 60 (n = 84)				0.187
Conventional group (n = 38)	3	7.89	1.00
Experimental group (n = 46)	8	17.39	2.444 (0.648, 9.216)
Lesion size ≤ 0.5 cm (n = 119)				0.042
Conventional group (n = 54)	3	5.56	1.00
Experimental group (n = 65)	14	21.54	3.199 (1.042, 9.820)
Lesion size > 0.5cm (n = 47)				0.214
Conventional group (n = 26)	4	15.38	1.00
Experimental group (n = 21)	3	14.29	2.626 (0.573, 12.033)
Lesion in upper thoracic esophagus (n = 20)				0.440
Conventional group (n = 8)	1	12.50	1.00
Experimental group (n = 12)	2	16.67	2.610 (0.229, 29.702)
Lesion in middle thoracic esophagus (n = 96)				0.108
Conventional group (n = 52)	5	9.62	1.00
Experimental group (n = 44)	8	18.18	2.510 (0.817, 7.708)
Lesion in lower thoracic esophagus (n = 50)				0.112
Conventional group (n = 20)	1	5.00	1.00
Experimental group (n = 30)	7	23.33	5.485 (0.673, 44.705)
Undergone esophageal ESD previously (n = 65)				0.088
Conventional group (n = 29)	2	6.90	1.00
Experimental group (n = 36)	5	13.89	4.462 (0.799, 24.917)
Not undergone esophageal ESD previously (n = 101)				0.135
Conventional group (n = 51)	5	9.80	1.00
Experimental group (n = 50)	12	24.00	2.198 (0.783, 6.171)
Lesion biopsy: Squamous epithelial hyperplasia (n = 151)				0.056
Conventional group (n = 74)	5	6.76	1.00
Experimental group (n = 77)	11	14.29	2.820 (0.974, 8.161)
Lesion biopsy: Low grade intraepithelial neoplasia (n = 15)				0.342
Conventional group (n = 6)	2	33.33	1.00
Experimental group (n = 9)	6	66.67	2.184 (0.436, 10.936)

HR: Hazard ratio; ESD: Endoscopic submucosal dissection.

Citation: Gao Y, Ye LS, Li X, Yu B, Liao K, Xie J, Du J, Zhang QY, Hu B. Effect of vinegar supplementation on patients with esophageal lesions lightly stained with Lugol’s iodine solution: Prospective single-centre trial. World J Gastrointest Endosc 2024; 16(5): 259-272
URL: https://www.wjgnet.com/1948-5190/full/v16/i5/259.htm
DOI: https://dx.doi.org/10.4253/wjge.v16.i5.259