Qom University of Medical Sciences Journal

Introduction
Some herbal drugs such as red sugar, black myrobalan (Terminalia chebula Retz.), fennel (Foeniculum vulgare) and mastic (Pistacia lentiscus) are prescribed in traditional Iranian medicine.  Black myrobalan fruit (Terminalia chebula Retz.) is widely used as a drug by the Iranian people to prevent and treat the coronavirus disease 2019 (COVID-19). This study aims to investigate the consumption pattern of this drug in Iran and the attitude of people towards this drug.
Methods
This descriptive-analytical study with cross-sectional design was conducted from May to July 2021 in Qom, Iran. After obtaining ethical approval from the Ethics Committee of Qom University of Medical Sciences (QUMS) (Code: IR.MUQ.REC.1400.005). Sampling was done from medical centers in Qom city using a convenience sampling method. The patients who were residents of Qom city, had age over 20 years old, and declared informed consent were included in this study. In this regard, 1077 patients were selected. They completed a demographic form a researcher-made questionnaire assessing the pattern and frequency of black myrobalan use and the users’ attitude towards this drug. Face validity of this tool was confirmed based on the opinions of 10 participants in terms of the comprehensibility of the items. Its content validity was determined according to the opinions of 8 faculty members by calculating content validity index (CVI) and content validity ratio (CVR). Waltz and Basel’s index was used to evaluate CVI. To calculate the CVR, the experts were asked to rate each items as 3 if necessary, 2 if useful, but not necessary, and 1 if not necessary. Then the CVR value was calculated for each item. According to Lawshe table, the cut-off point is 0.75 for CVR and any item with this value remains in the questionnaire. The reliability of the attitude subscale was assessed in a pilot study on 50 patients and a Cronbach’s alpha >0.7 was obtained. Collected data were analyzed in SPSS v. 20 software. To describe the variables, mean, standard deviation, frequency, and percentage were used. For analyzing the relationship between variables, chi-square or Fisher test, Spearman correlation test, and logistic regression analysis were used.


Results
Out of 1077 questionnaires, 1018 were completed (response rate: 94.5%). Among participants, 660 patients (64.8%) were familiar with black myrobalan drug and 491 (48.2%) had used it since the onset of the COVID-19 pandemic. Moreover, 180 (17.7%) had COVID-19 based on physician’s diagnosis or PCR test.
Of 409 participants who had used the drug for prevention of COVID-19, 88 (21.5%) were infected; out of 609 who did not use this drug for prevention, 92 (15.1%) had infected with COVID-19. The relationship between drug use and infection with COVID-19, which was assessed by Fisher test, was statistically significant (P=0.009, 95% CI=1.11-2.12, OR=1.54). Those who had experienced COVID-19 were more likely to use black myrobalan drug than those who had not experienced the COVID-19. The most common consumption pattern in people with no infection was three days in a row per month for three months or three days per month with an interval of 10 days for three months (n=132). Moreover, one teaspoon or one tablespoon was the most commonly used dose (n=237). There was no significant relationship between consumption pattern and prevention of infection (P=0.13)
Of 166 patients who had used the drug for the treatment of COVID-19, 123 (74.1%) had symptom reduction, 32 (19.3%) had no any change in symptoms, and 11 (6.6%) had worsened symptoms.  
The most common consumption pattern in these subjects was the daily use until symptoms disappear or three days in a row (n=131) and the most common consumption dose was one teaspoon or one tablespoon (n=132). The frequency of symptom reduction was significantly higher in those who had used the drug for longer periods (P<0.001). There was a positive and significant correlation between attitude towards the drug and the drug use (P<0.001) based on the results of Spearman correlation test (r=0.59).
Discussion
Several epidemiological studies have been conducted on the prevalence of herbal medicine use in Iran. Regarding the emerging diseases such as COVID-19, where there is not much information about how they respond to herbal medicines, it is important to conduct studies on the effectiveness and safety of interventions and provide more accurate information about this disease at the community level.
In the present study, the risk of infection with COVID-19 was significantly higher in those who had used black myrobalan drug. This indicates that the use of black myrobalan not only has no preventive effect on COVID-19, but also increases the risk of infection. This can be due to several reasons such as the lack of compliance with health protocols by consumers. More than 74% of those who had used the drug to treat the symptoms of COVID-19 reported a reduction in symptoms. In this study, were asked about the symptom reduction in general, and it was not assessed which symptoms were more reduced. Considering people’s positive attitude towards medicinal plants in Qom, it is necessary to develop a suitable method for informing them about these plants.
A significant percentage of people in Qom city use black myrobalan for prevention or treatment of COVID-19 and have a positive attitude towards its consumption. Although this drug have less side effects and reduce the symptoms of COVID-19 in most cases, it has no significant role in prevention of COVID-19. The evaluation of the efficacy and side effects of black myrobalan drug requires more detailed clinical studies.
Ethical Considerations
Compliance with ethical guidelines
This study has been approved by the research ethics committee of Qom University of Medical Sciences (QUMS) (Code: IR.MUQ.REC.1400.005).
Funding
This article is the result of an approved research project with the same title, which was carried out at the expense of Qom University of Medical Sciences (QUMS).
Authors contributions
Conceptualization: Fatemeh Tanesh and Atiyeh Elsadat Danesh; Methodology: Abolfazl Mohammad Beigi, Mohammad Ali Gol and Fataneh Hashem Dabaghian; Research: Fatemeh Tanzan, Atieh Al-Sadat Danesh and Mahmoud Shekohi-Tabar; Writing the original draft: Fataneh Hashem Dabaghian; Fundraising: Atiye Al-Sadat Danesh; Writing, review and editing and supervision: all authors.
Conflicts of interest
The authors declared no conflict of interest.
Acknowledgements
Hereby, the authors would like to thank the health care workers of health centers in Qom, especially Leila Qazvinian, a child health expert in Qom, who helped in sampling and completing the questionnaires.