Adv Pharm Bull, 2019, 9(2), 321-324

doi: 10.15171/apb.2019.038 https://apb.tbzmed.ac.ir

1Maragheh University of Medical Sciences, Maragheh, Iran. 2Liver and Gastrointestinal Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. 3Road Traffic Injury Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. 4Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. 5Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.

Received: 30 Oct. 2018 Revised: 21 Jan. 2019 Accepted: 14 Apr. 2019 epublished: 1 June 2019

1. • Zingiber officinale
2. • Ginger
3. • Helicobacter pylori
4. • Dyspepsia
5. • Gastric motility

Purpose: The present study aimed to assess the effect of ginger (Zingiber officinale) powder supplementation on Helicobacter pylori eradication and improvement of dyspeptic symptoms in patients with H. pylori positive functional dyspepsia (FD).

Methods: During this pilot study 15 patients with H. pylori positive FD received 3 g/d ginger powder as three 1-g tablets for 4-weeks. Dyspepsia symptoms were asked before and after the intervention using a questionnaire based on the Rome III criteria. H. pylori eradication was also assessed by a non-invasive stool antigen (HpSAg) test.

Results: Ginger consumption accompanied by significant H. pylori eradication rate of 53.3% (P = 0.019) and the odds ratio (95% CI) was 8 (1.07 to 357.14). Moreover, our results showed significant changes in most of the dyspepsia symptoms after ginger supplementation.

Conclusion:According to our findings, Z. officinale can be considered as a useful complementary therapy for FD. However, due to the small number of clinical trials in this area, further welldesigned clinical trials are needed to explicitly talk about its effectiveness especially about the eradication of H. pylori.

Functional dyspepsia (FD) is manifested by different gastrointestinal (GI) symptoms like gastric fullness, early satiety, nausea and vomiting, belching, bloating, heartburn and epigastric pain. It was previously known as non-ulcer dyspepsia or idiopathic dyspepsia.1,2

The pathophysiology of FD is not well understood, however, some factors like GI motor abnormalities, gastric hypersensitivity, psychosocial factors and Helicobacter pylori infection play important role.2-4

FD is a common public health problem around the world with prevalence rate of 11-30% based on the different definitions of it (Rome criteria I, II, III).2 Although FD is not a life threatening condition, it is accompanied by poor quality of life and experience of various medications and herbs.5 Since there is not yet any verified medical protocol to treat FD, the consumption of medicinal plants is increasing.

The rhizome of ginger(Zingiber officinaleRoscoe, family Zingiberaceae) is one of the most popular medicinal plants worldwide. It has long been used as a remedy for different diseases including GI ailments like belching, bloating,

vomiting, indigestion and constipation.6,7

There are also some scientific evidences regarding its gastro-protective effects like improving the dyspeptic symptoms.7-11 Moreover, based on the results of some experimental studies ginger treatment seems to inhibit H. pylori growth12-16and prevent the gastric ulceration.17

However, to the best of our knowledge, the effect of ginger consumption alone (not in combination with other herbs) on H. pylori eradication has not yet been assessed in any clinical trial. Accordingly, the present study aimed to assess the effect of ginger powder supplementation on H. pylori eradication and improvement of dyspeptic symptoms in patients with H. pylori positive FD.

The present pilot study was conducted as a before-after clinical trial on patients with H. pylori positive FD who were referred to endoscopy unit of Imam Reza hospital (Tabriz, Iran). The exclusion criteria were age under 18 or over 65, clinically diagnosed peptic ulcer during endoscopy, negative urease test, hepatobiliary disease,

*Corresponding Author: Alireza Ostadrahimi, Tel: +98 41 33352292, Fax: +98 41 33363430, Email: [email protected]

© 2019 The Author (s). This is an Open Access article distributed under the terms of the Creative Commons Attribution (CC BY), which permits unrestricted use, distribution, and reproduction in any medium, as long as the original authors and source are cited. No permission is required from the authors or the publishers.

irritable bowel syndrome and gastric cancer, having severe anorexia or vomiting, history of gastric surgery, taking antibiotics and nonsteroidal anti-inflammatory drugs, smoking and being hypersensitive to ginger.

Accordingly, a total of 15 patients were recruited voluntarily of more than 80 subjects who were initially assessed (Figure 1).

Dried rhizomes of ginger (Z. officinale Roscoe, Chinese yellow ginger) were purchased from a local market in Tabriz. The ginger rhizomes were finely ground and then prepared as tablets containing 1-g ginger powder in each (Pharmaceutics laboratory, Faculty of Pharmacy, Tabriz University of Medical Science). The tablets were placed in the identical bottles. Subjects were asked to take 3 tablets per day with meals for 4 weeks.

Dyspepsia symptoms were asked before and after the intervention using a questionnaire based on the symptoms of Rome III criteria, including gastric fullness, early satiety, nausea, vomiting, belching, epigastric pain and heartburn which were graded through the visual analog scales (0– 10 scores). Moreover, H. pylori eradication assessment after ginger treatment was performed by the stool antigen test (HpSAg) in an accredited laboratory since it

was impossible to do the endoscopy (rapid urease test) again at the end of intervention. It should be mentioned that HpSAg has >95% sensitivity, >94% specificity, and correlation to endoscopy of 95.5%.18

Data were analyzed using SPSS software, version 21.0 (IBM Corp., Armonk, NY, USA). Results were reported as mean (SD) and median (IQR). The eradication rate of H. pylori was assessed using the chi-square and McNemar tests. The Wilcoxon signed rank test was also used to assess the differences of GI symptoms before and after ginger supplementation. The significance level was set at P = 0.05.

The baseline characteristics of the participants are shown in Table 1. According to Table 2, after 4 weeks of ginger supplementation the eradication rate of H. pylori was 53.3 % which was statistically significant (P= 0.019) and the eradication rate was eight to one based on the presented odds ratio (95% CI).

Ginger supplementation was also accompanied by some improvements in dyspepsia symptoms. In the present study, gastric fullness, nausea, belching and gastric pain were more prevalent than other symptoms in patients with FD. Regarding the non-parametric feature of

Figure 1. Flow diagram of study participant.

The gastro-protective effect of ginger

1. Table 1. Basic characteristics of study subjects (n = 15)
2. Table 2. The eradication rate of H. pylori after ginger supplementation in patients with functional dyspepsia
3. Table 3. Comparison of the dyspepsia symptoms before and after ginger supplementation

dyspepsia symptoms’ scores, the median and IQR (25th, 75th percentiles) was presented for each variable in Table 3. Moreover, the mean (SD) was also reported for better understanding of changes. Based on the Wilcoxon signed rank test, there were significant changes in gastric fullness (P= 0.018), early satiety (P= 0.039), nausea (P= 0.018), belching (P= 0.016), gastric pain (P= 0.003) and gastric burn (P= 0.039) scores after ginger consumption.

Helicobacter pylori infection plays important role in the pathogenesis of different gastro-duodenal diseases including gastritis, ulcers and carcinoma.19 Nowadays, the triple or quadruple therapy is used for the eradication of H. pylori. However, their eradication rate is not 100% due to resistance to antibiotics and patients’ poor compliance.20

According to our results, ginger supplementation caused significant H. pylori eradication. Ginger rhizome seems to have anti H. pylori activity through its different phenolic compounds (e.g., gingerol, shogaol, zingerone and phenolic acids like gallic acid and cinnamic acid).1215 Results of Siddaraju and Dharmesh indicated that a hydrolysed phenolic fraction of ginger had better

Before After

P valuea Median (IQR) Mean (SD) Median (IQR) Mean (SD)

Fullness 1 (1,7) 3.27 (2.89) 1 (1,2) 1.67 (1.95) 0.018 Early satiety 1 (1,4) 2.47 (2.58) 1 (1,1) 1.60 (1.59) 0.039 Nausea 1 (1,6) 3.13 (2.97) 1 (0,1) 1.40 (2.06) 0.018 Vomiting 1 (1,1) 1.47 (1.55) 1 (1,1) 0.87 (0.35) 0.180 Belching 2 (1,3) 2.67 (2.61) 1 (0,1) 1.27 (1.71) 0.016 Gastric pain 2 (1,4) 2.73 (1.53) 1 (0,1) 0.73 (0.88) 0.003 Gastric burn 1 (1,3) 2.40 (2.29) 1 (1,1) 1.07 (0.88) 0.039

a Based on Wilcoxon signed rank test.

Advanced Pharmaceutical Bulletin, 2019, Volume 9, Issue 2 323

needed to explicitly talk about its effectiveness especially for eradication of H. pylori.

The study was approved by the Ethics Committee of Tabriz University of Medical Science (reference number 9199) and registered in Iranian Registry of Clinical Trials website (identifier: IRCT201211182017N9). A written consent form was taken prior to the intervention.

Conflict of Interest There is no conflict of interest.