Randomized Controlled Trial
Copyright ©The Author(s) 2015.
World J Gastroenterol. Jan 7, 2015; 21(1): 351-359
Published online Jan 7, 2015. doi: 10.3748/wjg.v21.i1.351
Table 1 Characteristics of patients n (%)
PAC groupPAM groupSequentialConcomitantP value
(n = 170)(n = 170)(n = 170)(n = 170)
Age, yr55.6 ± 13.657.4 ± 12.858.3 ± 12.355.8 ± 12.60.1031
Gender0.0602
Male102 (60.0)107 (62.9)110 (64.7)106 (62.4)
Female68 (40.0)63 (37.1)60 (35.3)64 (37.7)
Diagnosis0.5532
Gastric ulcer81 (47.7)77 (45.3)86 (50.6)78 (45.9)
Duodenal ulcer36 (21.2)28 (16.5)32 (18.8)27 (15.9)
Gastritis53 (31.2)65 (38.2)52 (30.6)65 (38.2)
Table 2 First-line eradication rates of Helicobacter pylori
Achieved/analyzed patients (n)Eradication rate, (95%CI)P value1P value2
Per protocol0.001
PAC (n = 143)109/14376.2% (69.3-83.2)< 0.001
PAM (n = 139)117/13984.2% (78.1-90.2)0.016
Sequential (n = 141)119/14184.4% (78.4-90.4)0.018
Concomitant (n = 143)135/14394.4% (90.6-98.2)-
Intent-to-treat0.001
PAC (n = 170)109/17064.1% (58.8-73.0)0.007
PAM (n = 170)117/17068.8% (66.3-79.2)0.285
Sequential (n = 170)119/17070.7% (65.0-78.5)0.169
Concomitant (n = 170)135/17079.4% (74.6-86.5)-
Table 3 Second-line eradication rates of Helicobacter pylori
Achieved/analyzed patients (n)Eradication rate (95%CI)P value1
Per protocol0.351
PAC (n = 31)27/3187.1% (75.3-98.9)
PAM (n = 24)22/2491.7% (80.6-100)
Sequential (n = 25)20/2580.0% (64.3-95.9)
Concomitant (n = 10)7/1070.0% (34.8-93.3)
Intent-to-treat0.657
PAC (n = 36)27/3675.0% (60.9-89.1)
PAM (n = 27)22/2781.5% (66.8-96.1)
Sequential (n = 25)20/2580.0% (64.3-95.9)
Concomitant (n = 11)7/1163.6% (35.2-92.1)
Table 4 Third-line eradication rates of Helicobacter pylori
Achieved/analyzed patients (n)Eradication rate (95%CI)P value1
Treatment group0.052
PAC (n = 4)3/475.0 (19.4-99.4)
PAM (n = 2)2/2100.0 (15.8-100)
Sequential (n = 5)1/520.0 (0.5-71.6)
Concomitant (n = 3)0/30.0 (0.0-70.8)
Table 5 Factors affecting eradication of Helicobacter pylori n (%)
FactorsEradicatedNotCrude OR(95%CI)P valueaAdjust OR(95%CI)P value1
Age56.8 ± 12.957.6 ± 11.90.9960.632
(0.978-1.014)
Gender
Male29434----
(61.25)(39.53)
Female186520.4140.080
(38.75)(60.47)(0.259-0.662)
Diagnosis
Gastric ulcer225381.1210.663
(46.88)(44.19)(0.673-1.869)
Duodenal ulcer86161.0180.896
(17.92)(18.60)(0.529-1.957)
Gastritis16932--
(35.21)(37.21)
Treatment Group
PAC10934----
(22.71)(39.53)
PAM117221.6590.4301.7380.559
(24.38)(25.58)(0.914-3.012)(0.948-3.187)
Sequential119221.6870.4781.6360.386
(24.79)(25.58)(0.930-3.062)(0.894-2.997)
Concomitant13585.2640.0015.2870.001
(28.13)(9.3)(2.341-11.838)(2.335-11.973)
Alcohol Intake
Yes165271.1450.591
(34.38)(31.4)(0.699-1.874)
No31559--
(65.63)(68.6)
Smoking
Smoker127181.3590.281
(26.46)(20.93)(0.778-2.374)
Non-smoker35368--
(73.54)(79.07)
BMI22.7 ± 2.722.2 ± 2.91.0730.107
(0.985-1.169)
Total Cholesterol188.2 ± 39.9188.8 ± 35.11.0000.914
(0.993-1.007)
LDL Cholesterol107.3 ± 32.5109.8 ± 31.80.9980.601
(0.989-1.007)
Table 6 Incidence of adverse drug reactions n (%)
PACPAMSequentialConcomitantP value1
(n = 170)(n = 170)(n = 170)(n = 170)
Patients with side effect86 (50.6)82 (48.2)70 (41.2)69 (40.6)0.158
(43.07, 58.10)(40.72, 55.75)(33.78, 48.57)(33.21, 47.97)
Total side effects (n)101938396
Side effect
Abdominal bloating2 (1.18)5 (2.94)0 (0.00)0 (0.00)7 (1.03)
Abdominal pain8 (4.71)11 (6.47)0 (0.00)0 (0.00)19 (2.79)
Bitter taste28 (16.47)10 (5.88)11 (6.47)16 (9.41)65 (9.56)
Constipation0 (0.00)6 (3.53)0 (0.00)1 (0.59)7 (1.03)
Dizziness4 (2.35)3 (1.76)3 (1.76)1 (0.59)11 (1.62)
Dyspepsia5 (2.94)15 (8.82)13 (7.65)13 (7.65)46 (6.76)
Epigastric pain6 (3.53)0 (0.00)11 (6.47)21 (12.35)38 (5.59)
General weakness2 (1.18)3 (1.76)2 (1.18)2 (1.18)9 (1.32)
Halitosis0 (0.00)0 (0.00)1 (0.59)1 (0.59)2 (0.29)
Headache4 (2.35)3 (1.76)3 (1.76)4 (2.35)14 (2.06)
Loose stool24 (14.12)2 (1.18)17 (10.00)19 (11.18)62 (9.12)
Loss of appetite6 (3.53)3 (1.76)1 (0.59)0 (0.00)10 (1.47)
Nausea12 (7.06)32 (18.82)20 (11.76)15 (8.82)79 (11.62)
Oral ulcer0 (0.00)0 (0.00)1 (0.59)0 (0.00)1 (0.15)
Skin eruption0 (0.00)0 (0.00)1 (0.59)0 (0.00)1 (0.15)
Sleeping tendency0 (0.00)0 (0.00)0 (0.00)1 (0.59)1 (0.15)
Vomiting0 (0.00)0 (0.00)3 (1.76)3 (1.76)6 (0.88)