Treatment of Helicobacter pylori in surgical practice: A randomised trial of triple versus quadruple therapy in a rural district general hospital

Table 1 Inclusion criteria and exclusion criteria

Criteria
Inclusion criteria	Dyspeptic symptoms
	Has recent OGD (duodenal ulcer; gastric ulcer; gastritis or non-ulcer dyspepsia)
	Positive for H pylori on histology and culture or CLO test or 13C-urea breath test
Exclusion criteria	Age less than 18 or above 75 yr
	Symptomatic gallstones
	Treated with antibiotic or bismuth-containing drugs during the month prior to inclusion
	Treated with proton pump inhibitor during the week prior to inclusion
	Disturbed gastrointestinal physiology (gastric surgery; vagotomy; Zollinger-Ellison syndrome; chronic ingestion of NSAIDs)
	Concomitant serious disease
	Concomitant medications that may adversely interact with the study drugs (e.g. warfarin, anti-epileptics)
	Pregnancy and breast-feeding
	Childbearing age without adequate contraception
	Allergy to drugs used in the study
	Mental illness
	Heavy drinking or abuse of drugs

Table 2 Regimens used in the trial

Triple therapy regimen (LAC)	Quadruple therapy regimen (LMBT)
Lansoprazole (30 mg b.d.)	Lansoprazole (30 mg b.d.)
Amoxycillin (1 g b.d.)	Metronidazole (400 mg t.d.s.)
Clarithromycin (500 mg b.d.)	Bismuth subcitrate (240 mg b.d.)
	Tetracycline chloride (500 mg q.d.s.)

Table 3 Patient characteristics

	Therapy
	LAC (n = 50)	LMBT (n = 44)
Age	55.2 ± 10.9	53.7 ± 11.4
Gender (male: female)	26:24	27:17
Active smoking	10 (20%)	16 (36%)
NSAID use	4 (8%)	3 (7%)
Ethanol abuse (> 14 U/wk)	4 (8%)	3 (7%)
Previous therapy with antacids	4 (8%)	8 (18%)
Time between treat-ment and UBT (mo)	2.2 ± 0.7	2.1 ± 0.5
Gastric ulcer	1	1
Duodenal ulcer	3	1
Gastritis	36	33
Duodenitis	6	8
Diagnosis of H pylori infection (Urease: Culture: Biopsy)	42:29:45	37:27:44

NSAID: Non-steroidal anti-inflammatory drug; UBT: Urea breath test.

Table 4 Incidence of side effects n (%)

	Therapy		P-value
	LAC (n = 50)	LMBT (n = 44)
Nausea	11 (22)	20 (45)	< 0.05
Vomiting	0 (0)	9 (20)	< 0.01
Diarrhoea	14 (28)	25 (57)	< 0.01
Headache	12 (24)	19 (44)
Dizziness	9 (18)	11 (25)
Blurred vision	5 (10)	6 (14)
Itching	5 (10)	5 (11)
Rash	1 (2)	2 (5)
Dry mouth	27 (54)	19 (43)
Sore mouth	4 (8)	0 (0)
Glossitis	2 (4)	1 (2)
Black tongue	6 (12)	6 (14)
Black stool	5 (10)	35 (80)	< 0.01
Taste disturbance	23 (46)	14 (32)
Arthralgia	3 (6)	1 (2)

Table 5 Severity of side-effects (n)

	Therapy
Severity	LAC	LMBT
None	5	2
Mild	17	19
Moderate	25	13
Severe	3	10
Total	50	44

Severity score: 1 = mild, does not cause any concern; 2 = moderate, but not bad enough to discontinue treatment; 3 = severe or incapacitating, forced to discontinue treatment.

Table 6 ¹³C-urea breath test results n (%)

	Therapy		P-value
	LAC (n = 50)	LMBT (n = 44)
Returned for UBT	50 (100)	44 (100)	-
Completed therapy	50 (100)	38 (86)	< 0.01
UBT result	46 negative, 4 positive	37 negative, 1 positive
Not completed therapy	0 (0%)	6 (14)	< 0.01
UBT result	-	3 positive, 3 negative	-
Intention-to-treat cure rate	92% (46/50)	91% (40/44)
Per-protocol cure rate	92% (46/50)	97%(37/38)

UBT: Urea breath test.

Table 7 Symptomatic outcome at 6-mo follow-up n (%)

	Therapy
	LAC (n = 50)	LBMT (n = 44)
Follow-up at 6 mo	46 (92)	40 (91)
Persistent symptoms	4 (8)	7 (16)
Recurrent symptoms	17 (34)	9 (20)
Repeat eradication therapy	1 (2)	1 (2)
Long-term acid-reduction therapy	17 (34)	14 (32)