Efficacy and safety of Syferol-IHP for the treatment of peptic ulcer disease: a pilot, double-blind randomized trial

Figures & data

Table 1 Baseline demographic and clinical characteristics of the participants

Parameter	CTT and Syferol-IHP (N=37) Frequency (%)	CTT and placebo (N=23) Frequency (%)	RR (95% CI)	P-value
Age (years)	45.7±3.9	44.8±4.1	ŧ 0.853	0.3976
Gender
Male	16 (43.2)	11 (47.8)	0.93 (0.62–1.40)	0.731
Female	21 (56.8)	12 (52.2)
Duration of symptoms (months)
<12	3 (8.1)	1 (4.3)
≥12	34 (91.9)	22 (95.7)	0.95 (0.84–1.09)	0.961
Previous PUD treatments
Treatment naive	0 (0.0)	0 (0.0)
Nontreatment naive	37 (100.0)	23 (100.0)	U	0.214

Notes: Values are expressed as number (%) of patients. U, infinity.

Abbreviations: CTT, conventional triple therapy; PUD, peptic ulcer disease.

Table 2 Mean values or frequencies and differences in improvement with overall P-values after treatment (repeated measures analysis)

Parameter	CTT and Syferol-IHP (N=37) Frequency (%)	CTT and placebo (N=23) Frequency (%)	RR (95% CI)	P-value
HB concentration (g/dL)
Baseline	11.9±2.1	12.9±2.8
After treatment	12.2±3.4	12.3±3.1	ŧ −0.1145	0.909
WBC count (mL)
Baseline	4170±423.0	4355±449.0
After treatment	4125±391.3	4320±407.7	ŧ −0.8998	0.372
Epigastric pain
Baseline	37 (100.0)	23 (100.0)
After treatment	6 (16.2)	10 (43.5)	0.532 (0.27–1.03)	0.021*
Endoscopic findings
Gastritis   Baseline   After treatment	33 (89.2) 5 (13.5)	21 (91.3) 9 (39.1)	0.510 (0.25–1.06)	0.024*
Duodenitis   Baseline   After treatment	2 (5.4) 0 (0.0)	5 (21.7) 2 (8.7)	0.000 (U)	0.327
Gastric ulcer   Baseline   After treatment	9 (24.3) 0 (0.0)	3 (13.0) 2 (8.7)	0.000 (U)	0.048*
Duodenal ulcer   Baseline   After treatment	6 (16.2) 1 (2.7)	6 (26.1) 3 (13.0)	0.400 (0.07–2.37)	0.241
Histology  H. pylori positive   Baseline   After treatment   Unknowna H. pylori	6 (16.2) 0 (0.0) 12 (32.4)	4 (17.4) 2 (8.7) 5 (21.7)	0.00 (U)	0.066
H. pylori negative   Baseline   After treatment   Unknowna H. pylori	19 (51.4) 25 (67.6) 12 (32.4)	14 (60.9) 16 (69.7) 5 (21.7)	1.24 (0.68–2.28)	0.483
Biochemical tests  Urea (mg/dL)   Baseline   After treatment	4.5±2.1 4.8±3.6	5.4±8.7 3.9±1.4	ŧ −1.143	0.258
Creatinine (mg/dL)   Baseline   After treatment	102.5±25.1 93.2±29.8	94.3±15.5 92.3±26.9	ŧ 0.118	0.907
AST (U/L)   Baseline   After treatment	11.2±5.1 9.9±4.2	12.1±5.1 9.1±3.0	ŧ −0.795	0.430
ALT (U/L)   Baseline   After treatment	10.7±4.8 9.0±5.6	10.7±4.8 7.6±3.8	ŧ –1.056	0.296
ALP (U/L)   Baseline   After treatment	38.4±14.2 37.8±13.6	43.4±15.0 34.1±9.2	ŧ −1.150	0.255
LDL (mmol/L)   Baseline   After treatment	3.3±0.9 3.3±1.2	3.3±0.9 3.5±1.1	ŧ 0.648	0.520
HDL (mmol/L)   Baseline   After treatment	1.3±0.2 1.8±1.1	1.3±0.2 1.7±0.9	ŧ −0.366	0.716

Notes: Values are expressed as number (%) of patients.

a Biopsy results were not available in these patients. U, infinity.

* Statistically significant.

Abbreviations: ALT, alanine transaminase; AST, aspartate transaminase; CTT, conventional triple therapy; HB, hemoglobin; HDL, high-density lipoprotein; H. pylori, Helicobacter pylori; LDL, low-density lipoprotein; WBC, white blood cell.

Figure 1 Flow chart of the patients.

Abbreviation: CTT, conventional triple therapy.

Figure 2 Special stain (Giemsa) ×400 showing Helicobacter pylori organisms (arrow) within the gastric gland.

Figure 3 Severe chronic gastritis ×100 magnification.

Note: Lymphocytic infiltrates (arrow) are seen forming follicle (pretreatment result).

Figure 4 Mild gastric chronic inflammation (posttreatment result).