Salvia mirzayanii Rech. f. & Esfand as adjunctive therapy for Helicobacter pylori eradication: a randomized controlled trial

doi:10.19852/j.cnki.jtcm.2025.02.009

Abstract

Abstract:

OBJECTIVE: To evaluate the effect of this plant as adjunctive therapy on Helicobacter pylori (H. pylori) eradication.

METHODS: The plant capsules were prepared and their physicochemical properties were assessed. In this clinical trial, 99 patients with H. pylori infection were randomized to receive Salvia mirzayanii Rech. f. & Esfand (S. mirzayanii) or placebo capsules for two weeks. All the patients in both groups received clarithromycin-based triple therapy. Both intention to treat and per protocol analyses were performed. Eradication rates, treatment side effects, and medication compliance were evaluated in both groups.

RESULTS: H. pylori eradication rate of all the randomized participants was 59.59%. The eradication rate of H. pyloriwas significantly higher in S. mirzayanii group compared with that in the placebo group for per protocol analysis (84.62%, P = 0.026) but not for intention to treat one (65.31%, P = 0.252). There were no significant differences between the two groups regarding the frequencies of the medications side effects and the patients with poor compliance.

CONCLUSION: The use of S. mirzayanii as adjunctive therapy to 14-day clarithromycin-based triple therapy might improve H. pylorieradication rate.

Key words: helicobacter pylori, clarithromycin-based triple therapy, Salvia mirzayanii Rech. f. &, Esfand, resistance

Nima Vaziri, Gholamreza Dehghannoudeh, Fariba Sharififar, Fatemeh Dabaghzadeh, Farhad Sarafzadeh, Bizhan Ahmadi. Salvia mirzayanii Rech. f. & Esfand as adjunctive therapy for Helicobacter pylori eradication: a randomized controlled trial[J]. Journal of Traditional Chinese Medicine, 2025, 45(2): 437-442.

Figures/Tables 3

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Variables		S. mirzayanii group (n = 49)	Placebo group (n = 50)	P value^a
Age (years)		37±10	34±10	0.232^b
Sex (n)	Male Female	17 32	23 27	0.252
Smoking [n (%)]		7 (14.28)	9 (18.00)	0.616
Alcohol consumption [n (%)]		4 (7.16)	6 (12.00)	0.526
Tea consumption [n (%)]		49 (100.00)	50 (100.00)	-
Other herbal teas consumption [n (%)]		10 (20.41)	9 (18.00)	0.761
Drug history [n (%)]	NSAIDs Antibiotics Anticoagulant Bisphosphonate None	23 (46.93) 3 (6.12) 1 (2.04) 1 (2.04) 21 (42.86)	18 (36.00) 1 (2.00) 1 (2.00) 0 30 (60.00)	0.381
Medical history [n (%)]	Cardiovascular diseases Respiratory diseases Psychiatric disorders Musculoskeletal disorders Others None	3 (6.12) 2 (4.08) 2 (4.08) 1 (2.04) 7 (14.28) 34 (69.38)	6 (12.00) 2 (4.00) 6 (12.00) 2 (4.00) 7 (14.00) 27 (54.00)	0.531

Variables		S. mirzayanii group (n = 49)	Placebo group (n = 50)	P value^a
Age (years)		37±10	34±10	0.232^b
Sex (n)	Male Female	17 32	23 27	0.252
Smoking [n (%)]		7 (14.28)	9 (18.00)	0.616
Alcohol consumption [n (%)]		4 (7.16)	6 (12.00)	0.526
Tea consumption [n (%)]		49 (100.00)	50 (100.00)	-
Other herbal teas consumption [n (%)]		10 (20.41)	9 (18.00)	0.761
Drug history [n (%)]	NSAIDs Antibiotics Anticoagulant Bisphosphonate None	23 (46.93) 3 (6.12) 1 (2.04) 1 (2.04) 21 (42.86)	18 (36.00) 1 (2.00) 1 (2.00) 0 30 (60.00)	0.381
Medical history [n (%)]	Cardiovascular diseases Respiratory diseases Psychiatric disorders Musculoskeletal disorders Others None	3 (6.12) 2 (4.08) 2 (4.08) 1 (2.04) 7 (14.28) 34 (69.38)	6 (12.00) 2 (4.00) 6 (12.00) 2 (4.00) 7 (14.00) 27 (54.00)	0.531

P value^a	Placebo group (n = 50)	S. mirzayanii group (n = 49)	Side effect
0.307	9	13	Taste alteration
0.495	0	1	Skin rash
0.505	1	0	Loss of appetite
0.242	0	2	Weakness
0.505	1	0	Nausea
0.495	0	1	Flushing
0.253	2	0	Diarrhea

P value^a	Placebo group (n = 50)	S. mirzayanii group (n = 49)	Side effect
0.307	9	13	Taste alteration
0.495	0	1	Skin rash
0.505	1	0	Loss of appetite
0.242	0	2	Weakness
0.505	1	0	Nausea
0.495	0	1	Flushing
0.253	2	0	Diarrhea

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