Effect of “Pistacia atlantica” Resin (Baneh) on Functional Dyspepsia: A Double-Blind, Randomized Clinical Study

AUTHORS

Mahdiyehsadat Eftekharafzali 1 , Mitra Mehrabani 2 , Haleh Tajadini 1 , 3 , Bijan Ahmadi 4 , Mohammad Javad Zahedi 4 , *

1 Department of Traditional Medicine, School of Traditional Medicine, Kerman University of Medical Sciences, Kerman, Iran

2 Herbal and Traditional Medicines Center, Kerman University of Medical Sciences, Kerman, Iran

3 Neuroscience Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran

4 Gastroenterology and Hepatology Research Center, Kerman University of Medical Sciences, Kerman, Iran

How to Cite: Eftekharafzali M, Mehrabani M, Tajadini H, Ahmadi B, Zahedi M J. Effect of “Pistacia atlantica” Resin (Baneh) on Functional Dyspepsia: A Double-Blind, Randomized Clinical Study, Iran Red Crescent Med J. 2018 ; 20(7):e63822. doi: 10.5812/ircmj.63822.

ARTICLE INFORMATION

Iranian Red Crescent Medical Journal: 20 (7); e63822
Published Online: May 31, 2018
Article Type: Research Article
Received: November 6, 2017
Revised: January 19, 2018
Accepted: February 24, 2018
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Abstract

Background: Functional dyspepsia (FD) is one of the most common problems around the world. Pistacia atlantica has beneficial effects in gastrointestinal disorders and is used for treating functional dyspepsia in Persian Medicine.

Objectives: The aim of this study was to assess the effect of “Pistacia atlantica” (Baneh) on functional dyspepsia.

Methods: This randomized, double-blind, placebo-controlled trial was carried out on 119 patients (18 to 60 years old) with functional dyspepsia based on Rome III criteria. Subjects were randomly divided to intervention (n = 61) and placebo (n = 58) groups. Participants received capsules twice daily (500 mg capsules containing 350 mg Pistacia atlantica resin plus 150 mg sugar in the intervention group, and 500 mg capsules containing 350 mg starch powder plus 150 mg sugar in the placebo group) for four weeks and they were followed up for one month. The intensity and frequency of gastrointestinal symptoms, such as fullness, bloating, nausea, pain, and burning were assessed using the questionnaire on arrival, two and four weeks, and one month after the intervention.

Results: Fifty-three patients in the Pistacia atlantica group and 48 patients in the placebo group completed the study. The severity and frequency of gastrointestinal symptoms, such as early satiation nausea, pain, and burning were significantly decreased in the Pistacia atlantica group. For example, severity of early satiation was 1.67 ± 0.13 in pistacia and 2.54 ± 0.17 in placebo groups in eight weeks (P > 0.001) and frequency of this symptom was 2.39 ± 0.27 and 4.41 ± 0.34 in Pistacia and placebo groups, respectively, in eight weeks (P > 0.001), which was significantly decreased in the Pistacia group. No serious adverse effects were reported.

Conclusions: This study revealed that Pistacia atlantica is significantly effective in functional dyspepsia symptoms.

Keywords

Dyspepsia Medicinal Medicine Pistacia Plant Traditional

Copyright © 2018, Author(s). This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/) which permits copy and redistribute the material just in noncommercial usages, provided the original work is properly cited

1. Background

Functional dyspepsia (FD) with an approximate prevalence of 20% is one of the most common problems around the world (1-3). The prevalence of FD in Iran ranges from 2.2% to 29.9% (4-6). However, FD is not life-threatening and it generally persists lifelong, resulting in significant personal and economic costs and influences quality of life (2, 7-10). Pharmacological treatment includes acid inhibitory drugs or prokinetics, anxiolytics, and antidepressants (11). According to the Rome III criteria, functional dyspepsia is defined as the presence of early satiation, postprandial fullness, epigastric pain, or epigastric burning for the last three months, with symptom onset at least six months prior to diagnosis and in the absence of organic or structural evidence (including in upper endoscopy) (12, 13). Functional dyspepsia is subdivided to epigastric pain syndrome (EPS), which is characterized by epigastric pain or burning, and postprandial distress syndrome (PDS), which is characterized by postprandial fullness and early satiation (3, 13, 14). The pathophysiology of FD is poorly understood (15, 16). However, several treatments are recommended for FD yet therapeutic options remain limited and provided in most cases just as symptomatic (3). Therefore, other treatment methods, such as complementary and alternative medications, such as herbal medicine, are suggested (17-21). In Persian Medicine, stomach and its disorders are very important (22-25). Several herbal remedies, such as Apium graveolens, Trachyspermum copticom (26), and Pistacia atlantica have been introduced as a treatment for FD in Persian Medicine (27, 28). The genus Pistacia belongs to the family Anacardiaceae (29). Pistacia atlantica (from Pistacia species) is called Baneh in Iran and its resin has beneficial effects in gastrointestinal disorders (27, 30-32).

2. Objectives

The aim of this study was to assess the effect of “Pistacia atlantica mutica” (Baneh) on functional dyspepsia.

3. Methods

3.1. Setting

This single center, randomized, double-blind, placebo-controlled trial was carried out from May 2016 to September 2016 on patients referred to the research center of gastroenterology and hepatology of Afzalipour Hospital, affiliated with Kerman University of Medical Sciences of Iran. This hospital was a governmental and referral center.

3.2. Study Participants

Patients (18 to 60 years old) with functional dyspepsia based on Rome III criteria were enrolled and randomly divided to intervention and placebo groups. This study was registered at Iranian Registry of Clinical Trials with code IRCT2016031327033N1.

3.3. Inclusion Criteria

Inclusion criteria for this trial were as follows: The presence of early satiation, postprandial fullness, epigastric pain, or epigastric burning for the last three months with symptom onset at least six months prior to diagnosis. Participants stopped taking herbal or chemical drugs for two weeks before the intervention (washout period).

3.4. Exclusion Criteria

The exclusion criteria for this study were as follows: Organic or structural evidence (including upper endoscopy), history of peptic ulcer or reflux, underlying disease, including heart failure, renal failure, cirrhosis, diabetes, hypothyroidism, and history of abdominal surgeries after evaluation of a gastroenterologist. It is noteworthy to mention that participants using herbal, and chemical drugs, and those drinking alcohol, and abusing opiates were also excluded. Furthermore, pregnant and lactating females were also excluded.

3.5. Preparation of Pistacia atlantica mutica Capsules

The drug used in this study was the resin of Pistacia atlantica mutica that was obtained from Rabor county of Kerman Province in Iran with herbarium code KF1136-3. Pistacia atlantica mutica resin after drying and microbial cultures and standardization was powdered and prepared as 500-mg capsules (containing 350 mg Pistacia atlantica mutica resin plus 150 mg sugar). Also, 500-mg capsules containing 350 mg starch powder plus 150 mg sugar (as a placebo) with taste and flavor similar to the target group was prepared.

3.6. Randomization and Intervention

In this clinical trial, treatment assignment was done with simple randomization using random numbers (Random digit number).

Participants received capsules twice daily (one after lunch, and one after dinner) for four weeks and they were followed up for one month. Primary and secondary symptoms of patients were assessed on arrival, 4-weeks, and 1-month after the intervention.

3.7. Safety Evaluation

Patients were assessed for possible side effects in each visit, and if present, symptoms were documented in a form. Routine physical examinations were also done at every visit.

3.8. Statistical Analyses

Both demographic characteristics and symptom scores were normally distributed, so we have presented them using symptoms mean ± SE. Independent t-test and Chi-square were used to compare quantitative and qualitative variables between two groups respectively. In order to compare DSS score, the two-way repeated measures ANOVA test was used for three consecutive 0, 2nd and 4th week. Independent t-test after Bonferroni correction was used to compare the DSS score in each of the above time intervals, We used the Per Protocol method for data analysis, therefore, had no missing values during statistical analyses.

In this study the software, SPSS Statistics for Windows, version 21.0 (IBM Corp., Armonk, N.Y., USA) were utilized and P values < 0.05 were considered statistically significant.

3.9. Sample Size

The sample size was calculated based on a 30% decreased in mean symptom score in the treatment group and considerably a = 0.05 and power of 80% to be 47 in each group.

3.10. Measurement Tools

In this study, the Rome III diagnostic questionnaire was used to evaluate the symptom score of patients (33). Dyspeptic symptoms, such as postprandial fullness, early satiation, epigastric pain, epigastric burning, belching, nausea, vomiting, and bloating was graded and scored on a Likert scale, according to its severity as follows: Absent = 0, mild = 1, moderate = 2 (diverting from but not urging modifications in daily activities), and severe = 3 (influencing daily activities markedly enough to urge modifications). The frequency of each symptom was also graded as follows: 1, occurring < 1 day (d)/month (m); 2, occurring 1 d/m; 3, occurring 2 - 3 d/m; 4, occurring 1 d/week; 5, occurring > 1 d/week; and 6, occurring every day. The score for a single dyspeptic symptom was an aggregate of frequency and severity ratings, ranging from 0 to 9. Dyspeptic symptoms score (DSS) was assessed by summing the score of eight dyspepsia symptoms (33). Validity and reliability of the questionnaire was confirmed in the Persian language (26, 34, 35).

3.11. Ethics

The ethics committee of Kerman University of Medical Sciences approved this study (IR.KMU.AH.REC.1395.10). All patients were fully aware of the objectives and details of the study through an information form, and a signed written consent form was obtained.

4. Results

Initially, 142 patients were enrolled, 23 subjects, who did not have the inclusion criteria were excluded and 119 patients were recruited and randomized to two groups. 18 patients were lost to follow-up: Eight in the Pistacia group and ten in the placebo group. The main reason was due to lack of regular drug use or concurrent use of herbal medicine or other chemicals (six patients in the drug and eight in the placebo group). Four patients had side effects and discontinued medication (in Pistacia atlantica group, one was due to severe bloating and irritation, and was one due to bloating and constipation, and in the placebo group one because of severe diarrhea and one due to severe pain). 53 patients in the Pistacia atlantica group and 48 patients in the placebo group completed the study (Figure 1). The mean age for subjects in the Pistacia atlantica group was 38.30 ± 12.57 and for subjects in the placebo group was 44.85 ± 13.08 years. There was no significant difference between the study groups in terms of age (P = 0.66). In both groups, females dominated males (34 females and 19 males in the Pistacia atlantica group and 35 females and 13 males in the placebo group) and there was no significant difference between them (P = 0.34).

The baseline characteristics regarding chief complaint and provocation factors of these patients are shown in Tables 1 and 2. There were no relevant differences between the groups. The severity of FD in some symptoms, such as early satiation, nausea, pain, and burning had significantly decreased in the Pistacia atlantica group (Table 3). There were significant differences in the mean score of the frequency of dyspeptic symptoms (except vomiting) during the second and fourth week’s trial period and also one-month follow-up in Pistacia atlantica and placebo groups (P ≤ 0.001) (Table 4). Epigastric pain or burning (EPS) diminished in 43 subjects (81.1%) of the Pistacia atlantica group yet only 21 patients (43.8%) with EPS had been improved in the placebo group in the fourth week (P ≤ 0.001). Postprandial fullness and early satiation (PDS) was improved in 41 (77.4%) patients in the Pistacia atlantica group yet only 18 patients (37.5%) with PDS improved in the placebo group by the fourth week (P ≤ 0.001). Mean symptom score during the 2nd and 4th week trial and one month follow-up period significantly decreased in the Pistacia atlantica group (Figure 2).

Table 1. Demographic Characteristics of Patientsa
Demographic CharacteristicsPistacia atlantica” (Baneh) Group, 53Placebo Group, 48P Value
Age38.30 ± 12.5744.85 ± 13.080.66
Sex
Female34 (64.2)35 (72.9)0.34
Male19 (35.8)13 (27.1)
Marital status9 (17.0)0.09
Single2 (4.2)
Married42 (79.2)45 (93.8)
Divorced2 (3.8)1 (2.1)
BMI24.67 ± 4.7527.04 ± 24.690.49

aValues are expressed as No. (%).

Table 2. Baseline Clinical Characteristics and Confounding Factora
VariablesPistacia atlantica” (Baneh) Group, 53Placebo Group, 48P Value
Chief complaint0.491
Postprandial fullness1 (1.9)3 (6.3)
Bloating16 (30.2)15 (31.3)
Nausea1 (1.9)3 (6.3)
Pain33 (62.3)24 (50.0)
Burning2 (3.8)3 (6.3)
Provocation factors0.142
Fasting4 (7.5)8 (16.7)
Stress30 (56.6)22 (45.8)
Eating16 (30.2)18 (37.5)
Other cases3 (5.7)0 (0.0)

aValues are expressed as No. (%).

Table 3. Comparison of Mean (Standard Error) Scores of Severity of FD Between Baneh and Placebo Group Across the Study Period
SymptomBanehPlacebo
Baseline2 Week4 Week8 WeekBaseline2 Week4 Week8 WeekP Value
Early satiation3.09 (0.17)2.01 (0.15)1.41 (0.13)1.67 (0.13)3.10 (0.20)2.41 (0.17)2.45 (0.17)2.54 (0.17)> 0.001
Bloating3.45 (0.12)2.28 (0.14)1.52 (0.10)2.00 (0.11)3.33 (0.14)2.52 (0.14)2.43 (0.13)2.56 (0.13)0.321
Fullness3.03 (0.14)2.18 (0.12)1.64 (0.09)1.60 (0.09)2.35 (0.14)2.04 (0.13)2.04 (0.13)2.20 (0.13)0.505
Belching2.07 (0.16)1.47 (0.09)1.16 (0.05)1.28 (0.07)2.39 (0.16)1.87 (0.13)1.91 (0.13)1.91 (0.13)0.107
Nausea2.15 (0.15)1.43 (0.10)1.09 (0.04)1.15 (0.07)1.83 (0.15)1.41 (0.09)1.50 (0.12)1.50 (0.11)> 0.001
Vomiting1.26 (0.93)1.11 (0.05)1.00 (0.00)1.11 (0.06)1.33 (0.10)1.18 (0.08)1.29 (0.11)1.16 (0.06)0.055
Pain3.26 (0.13)2.28 (0.13)1.64 (0.11)1.98 (0.14)3.00 (0.14)2.56 (0.14)2.47 (0.15)2.54 (0.13)> 0.001
Burning2.45 (0.16)1.90 (0.12)1.47 (0.09)1.50 (0.09)2.14 (0.17)1.66 (0.13)1.79 (0.14)1.93 (0.14)> 0.001
Table 4. Comparison of Mean (Standard Error) Scores of Frequency of FD Between Baneh and Placebo Group During the Study Period
SymptomBanehPlacebo
Baseline2 Week4 Week8 WeekBaseline2 Week4 Week8 WeekP Value
Early satiation4.90 (0.29)3.52 (0.29)1.96 (0.24)2.39 (0.27)4.79 (0.35)4.25 (0.33)4.33 (0.33)4.41 (0.34)> 0.001
Bloating5.26 (0.17)3.81 (0.26)2.20 (0.22)2.77 (0.22)5.00 (0.21)4.39 (0.23)4.25 (0.23)4.45 (0.21)> 0.001
Fullness4.35 (0.23)3.52 (0.27)2.24 (0.21)2.58 (0.22)3.43 (0.23)3.33 (0.24)3.14 (0.22)3.12 (0.22)> 0.001
Belching3.33 (0.31)2.30 (0.25)1.66 (0.19)1.67 (0.19)3.91 (0.30)3.20 (0.29)3.08 (0.27)3.41 (0.28)> 0.001
Nausea3.16 (0.29)1.83 (0.20)1.28 (0.11)1.35 (0.14)2.91 (0.30)2.43 (0.27)2.12 (0.24)2.16 (0.23)> 0.001
Vomiting1.67 (0.22)1.05 (0.05)1.07 (0.05)1.20 (0.11)1.60 (0.20)1.31 (0.15)1.39 (0.15)1.37 (0.14)0.031
Pain5.01 (0.18)3.58 (0.25)2.16 (0.20)2.60 (0.23)4.75 (0.25)4.10 (0.25)3.79 (0.27)4.14 (0.24)> 0.001
Burning4.00 (0.27)2.75 (0.26)1.86 (0.20)2.32 (0.24)3.18 (0.30)2.68 (0.27)2.75 (0.28)3.06 (0.26)> 0.001
Mean symptom Score during the second and fourth week of trial and one month follow-up period in Pistacia atlantica mutica and placebo groups
Figure 2. Mean symptom Score during the second and fourth week of trial and one month follow-up period in Pistacia atlantica mutica and placebo groups

5. Discussion

Nowadays, functional dyspepsia is a common disorder (1, 2) with unsatisfactory treatments (2). The current study showed that Pistacia atlantica improved gastrointestinal symptoms in patients with functional dyspepsia and it had no significant side effects. Only a short paper was found about the effect of Pistacia atlantica on functional dyspepsia. In a clinical study, Afrasiabian et al. assessed the effect of Pistacia atlantica kurdica gum on the eradication of Helicobacter pylori in patients with dyspepsia. Their study showed that Pistacia atlantica kurdica significantly led to the treatment of dyspepsia symptoms and H. pylori eradication (36). Their results, similar to that of the current study, showed medicinal plants improved FD symptoms. However, their intervention period was shorter than the current study, as two weeks. In another clinical trial, Dabos et al. investigated the effect of Chios mastic gum capsule on functional dyspepsia for three weeks. Patients were assessed one month later for adverse effects. This herb significantly improved symptoms of functional dyspepsia (37). The intervention period of this trial was shorter than that of the current study, yet the follow-up period was similar. Both studies showed an significant efficacy of medicinal plants on FD. In another study, the efficacy of Ocimum basilicum was studied. Their results showed that Ocimum basilicum could relieve symptoms of functional dyspepsia, especially in female and young patients with dysmotility (38). This study and the current trial both showed the significant efficacy of medicinal herbs without any serious adverse events. However, in the current study, there were no differences in efficacy of Pistacia atlantica based on age or genus. Mohtashami et al. assessed the efficacy and safety of honey-based formulation of Nigella sativa seed oil in functional dyspepsia. Their Results showed that sativa could cause significant symptomatic improvement in patients with functional dyspepsia no serious adverse event was reported (39). Their intervention period was longer than that of the current study at eight weeks. Both studies had no serious adverse effects. Babaeian et al. investigated the efficacy of Mentha longifolia in patients with postprandial distress syndrome. Their results showed a significant improvement in the mean severity scales of FD symptoms (P < 0.001) (40). Compared with the current study, their follow up period was longer. Pasalar et al. in a clinical trial study showed that jollab (a mixture of rose water, saffron, white rock candy, and water) was effective on FD without any complicated side effects (41). This natural compound was effective and had no serious side effects, similar to the current study. This study had several strengths and limitations. One of the strengths of this trial was the use of domestic and safe medication. The authors did not find any clinical study about the effect of the Pistacia atlantica on FD, thus it seems the present study was the first clinical trial to evaluate the effect of Pistacia atlantica in FD. The current study had some limitations, such as short follow-up period, single-center study, and small sample size. Due to the fact that standard treatment for this disease has not been documented, as well as the complications of chemical drugs, based on the sources of Iranian medicine, a new drug was selected, which, in addition to the patient’s complexity and therapeutic properties, was less complicated and more stable than other drugs. The authors suggest another clinical study with longer follow-up period.

5.1. Conclusion

This study showed that Pistacia atlantica is significantly effective on functional dyspepsia in comparison with the placebo. The authors suggest another clinical study with longer follow-up period in the future.

Acknowledgements

Footnotes

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