International Journal of Life Sciences 9 (5) : 2015; 108 - 112 Founded 2007 An Independent, Open Access, Peer Reviewed, Non-Profit Journal International Journal of InternationalInternational JournalJournal ofof LifeLife SciencesSciences ISSN 2091-0525 website: http://nepjol.info/index.php/IJLS/index ifeSciences LCopyright © International Journal of Life Sciences
Research Article Comparison of the Plant Plantago Major and the Drug Colofac on Clinical Symptoms in IBS Patients Mostafa Salehi Nagafabadi1, Shahram Aghah2, Seyde Sedighe Yousefi3, Mohammad Kamalinejad4, Farzane Mahdaviyan5, Ali Akbar Jafarian6*
1Department of Iranian Traditional Medicine, School of Iranian Traditional Medicine, Tehran University of Medical Sciences 2Associate Prof. of Gastroenterology, Gastroenterology Research Center, Iran University of Medical Sciences & Health services 3Traditional and Complementary Medicine Research Center, Mazandaran University of Medical Sciences, Sari, Iran 4Department of Pharmacognosy, School of Pharmacy Shaheed Beheshti University of Medical Sciences, Tehran, Iran. 5School of Medicine,Shahid Sadughi University of Medical Sciences,Yazd, Iran 6Assistant Professor of anesthesia and critical care medicine , School of Medicine, Iran University of Medical Sciences, Tehran
Article Information ABSTRACT Key words: Background and Aim: Despite the frequency with which IBS is encountered in clinical practice, it Irritable Bowel remains an important medical problem for both health care providers and patients. Unfortunately, so Syndrome; far no single treatment option has been effective for managing IBS. Therefore we decided to Plantago Major; Comparison of the plant Plantago major and the drug Colofac on clinical symptoms in IBS patients. Colofac Method of investigation: This study was done as a double-blinded clinical trial in Aug 2014 until Nov 2014. 51 patients (male and female) were included in the study after considerations of inclusion and exclution criteria. Diagnosis of IBS was based on Rome II Criteria and organic causes were ruled out. Patients were divided randomly into the two groups, A and B. In the first visit, all patients were observed for two weeks without any medication. Patients in group A were given a 4.5 g dose of powdered plantago plant per day in two administrations, (2 hours before eating lunch and dinner) in the form of an oral capsule. Patients in Group B received a Colofac capsule (200 mg) morning and night for 3 months. Patients in both groups were visited for an examination to evaluate their condition in terms of diarrhea, constipation, number of defecations. Visits and examinations were made every week in the first month and every two weeks in the second month plus one at the end of the third month. Data were further analyzed by SPSS-17 software and statistical test of chi-square was done, and a repeated measure. Findings: Evaluations for number of days of diarrheal defecation per day show significant difference at each visit in repeated measurements; however, average of the descending trend for number of days of diarrheal defecation showed no significant difference between the two therapeutic methods. The effectiveness of plantago in reducing numbers of diarrheal defecations in a day was higher than that of Colofac. number of defecations per week showed no significant difference in relation to each of the visits in repeated measures. However, there was no significant difference between the two treatments in terms of the mean of descending trend of number of defecations during a week, although the effectiveness of plantago in for reducing the number of defecations per week was greater than that of Colofac. Conclusion: The present study is the clinical trial to Comparison of the plant Plantago major and the drug Colofac on clinical symptoms in IBS patients. Our study demonstrated that two therapeutic methods are effective in the management of IBS symptoms, although the effectiveness of plantago was greater than that of Colofac.
INTRODUCTION changes in bowel movements (1-5). No particular organ has been identified causing of the disease. Several IBS is a functional bowel disorder characterized by systems are involved, and it seems that its pathobiology is abdominal pain, malaise, bloating, bowel disorders, and associated with multiple factors. Visceral hyper-
*Corresponding author Email address: [email protected]
Copyright reserved © International Journal of Life Sciences DOI:dx.doi.org/10.3126/ijls.v9i5.12708 International Journal of Life Sciences 9 (5) : 2015; 108 - 112 sensitivity and abnormal bowel movements, bowel such as cramps and abdominal colic pain, non-specific microbial factors, immune disorder and inflammation, diarrhea and bloating (12, 13). Recommended Colofac genetic predisposition, abnormal gas handling in the consumption is three times a day, 20 min before each bowel, psychosocial factors, bowel infection, the central meal. This medication has no common side effects. In rare nervous system, and serotonin are all factors associated cases, it has caused skin rash and hives and its potential with the development of IBS (2, 6, 7, 8, 9). Patients side effects include dizziness, headache, bradycardia, suffering from IBS have a poor quality of life (2, 10, 11) nausea and vomiting. and research has shown that 37% of such patients develop depression as a result of the disorder. Furthermore, it is significant that 38% of those with IBS MATERIALS AND METHODS attempted suicide because of symptoms of the disease (12). This study was done as a double-blinded clinical trial in the specialized clinic of liver and digestion in Rasul A variety of drugs are commonly recommended to treat Akram Hospital between the beginning of Aug 2014 until the condition, they include tricyclic antidepressants (10), Nov 2014. 80 patients with IBS were examined, and a antispasmodics (12, 13), 5-hydroxytriptamin-3 receptor total of 51 patients (male and female) were included in (5-HT3) antagonists, 5-HT4 agonists (14), antibiotics the study after considerations of inclusion and exclution (15), probiotics (16), melatonin (17), selective serotonin criteria. Diagnosis of IBS was based on Rome II Criteria reuptake inhibitor (11). Colofac is an antispasmodic and organic causes were ruled out. Diagnosis included drug, commonly indicated as a common therapy for IBS. the following symptoms: 1 - abdominal pain experienced during the previous 12 weeks, presented constantly or Involvement of numerous factors in the pathophysiology periodically over the previous 12 months. 2 - abdominal and evidence of the placebo effect means that treatment pain or discomfort that improved by defecation and when of this disease is highly complex (18), and considering the its onset presented itself as a change in the number of disappointing results of common treatments, alternative defecations or in stool consistency. and traditional treatments are suitable options for many patients. So far, 11 to 43% of patients suffering from Conditions for inclusion in the study were as follows: digestive disorders use alternative or complementary approaches. Although herbal medicine is used by many 1. Diagnosis of IBS by ruling out organic causes using people to treat or prevent digestive disorders, there is colonoscopy and stool tests. little research available on the subject (19-21). 2. Normal results of the last examination over the Plantago major is a durable plant from the Planta- previous 5 years (colonoscopy in patients over the age of ginaceae family. Novel pharmaceutical research has 55 and sigmoidoscopy in others). indicated that this plant has been widely used all over the world to treat a number of diseases such as skin diseases, Exclusion criteria included existence of any active problems associated with the digestive system, digestive disease, major psychiatric disease (either in the respiratory, reproductive, and blood circulation system past or present), pregnancy or breast-feeding, under any diseases; it is also used against infections and tumors and other treatment at the beginning of participation in the to mitigate pain and fever. It has traditionally been used to plan or during it, and any abnormal test laboratory treat diarrhea in many parts of the world yet little results. research has been done on its effectiveness (22). The aim of this study was to compare the effect of the plant A written testimonial was taken from each patient plantagel, a herbal plant with that medication in the form included in the study. Each patient was identified by a of Colofac capsules for treating diarrhea-predominant code. Patients were divided randomly into two equal irritable bowel syndrome. Mebevirine hydrochloride, is groups (plantago and Colofac) and thus each patient had marketed under the trade name of Colofac; it is an a 50% chance of entry into either group. Patients were antispasmodic drug available in the form of a coated divided randomly into the two groups, A and B. In the first tablet (135 mg) and Cap Colofac Retard (200 mg). visit, all patients were observed for two weeks without Mebevirine acts as a musculotropic antispasmodic that any medication. The aim of this stage was to cancel out directly affects smooth myocytes in the digestive system effects of any other medication recently consumed by the and dispels spasm without affecting natural bowel patient. Patients in group A were given a 4.5 g dose of movement or causing hypotony. Mebevirine is rapidly powdered plantago plant per day in two administrations, absorbed in the intestine. It is hydrolyzed in the body and (2 hours before eating lunch and dinner) in the form of an secreted in the urine. It is recommended for treating IBS oral capsule. Patients in Group B received a Colofac and similar conditions including chronic irritable colon, capsule (200 mg) morning and night for 3 months. spastic constipation, mucous colitis and spastic colitis. In Patients in both groups were visited for an examination addition, Colofac is effective for treating other symptoms to evaluate their condition in terms of diarrhea,
109 International Journal of Life Sciences 9 (5) : 2015; 108 - 112 constipation, number of defecations. Visits and There were 24 persons in each group 31 (64.6%) of examinations were made every week in the first month which were female and the rest were male. Means of age and every two weeks in the second month plus one at the for each group were 36.1 ± 12.02 and 37.88 ± 8.9 for the end of the third month. The results were then recorded on plantago and Colofac groups respectively, indicating no the relevant forms. Data were further analyzed by SPSS- significant difference (p value=0.535). 17 software and statistical test of chi-square was done, and a repeated measure. In this study, an evaluation of Mean duration of course of the disease was 7.3 years in p<0.05 was considered as significant difference. patients in both groups with a standard deviation of 5.19. Furthermore, minimum and maximum ages of participants were 19 and 62 years, respectively, and the RESULTS minimum and maximum numbers of years for duration of the disease were 1 and 20, years respectively. In this study, 80 cases were investigated. With respect to inclusion and exclusion criteria, 51 patients were Table 1. Shows demographic information on mean age and course of the disease based on each treatment. enrolled and Data related to 51 patients were subjected to statistical analysis. 25 patients from the group taking plantago and 26 patients from that taking Colofac where excluded from the plan, together with one patient from the plantao group and two patients from Colofac group due to lack of access to the patient during the course of treatment. Table 2. Shows frequency for symptoms of diarrhea and constipation in both groups under treatment before intervention.
Table 3. Shows mean of dependent variables investigated at different stages of intervention.
Diarrhea: In the table above, mean of numbers of diarrhea defecation is shown per day, recorded on each of the 6 visits. Records are shown individually for each of the two intervention methods. Based on the Repeated Measure Test, evaluations for number of days of diarrheal defecation per day show significant difference at each
110 International Journal of Life Sciences 9 (5) : 2015; 108 - 112 visit in repeated measurements (p<0.001, F=23.1); Similarly, the above table shows number of days with however, average of the descending trend for number of constipated defecation in a week recorded in each of the 6 days of diarrheal defecation showed no significant visits for both interventions. According to the Repeated difference between the two therapeutic methods (p=0.2, Measure Test, there was significant difference between F=1.49). The effectiveness of plantago in reducing each of the visits in repeated measures in terms of numbers of diarrheal defecations in a day was higher number of days with constipated defecation per week than that of Colofac. (P=0.001, F=38.2). However, the mean of the descending trend of this number shows no significant difference The trend of diarrheal defecations per day, for plantago between the two interventions (P=0.3, F=1.06). and Colofac therapeutic interventions was determined separately.
Number of defecations per week: DISCUSSION In addition, the above table summarizes means of number of defecations per week at each of the 6 visits for Despite high prevalence of IBS in societies, this disease both interventions, separately. According to the Repeated has remains a challenge for health organizations and Measure test, number of defecations per week showed no patients. Despite availability of various medications, each significant difference in relation to each of the visits in of which affects one symptom of the disease, these are repeated measures (P<0.001, F=18.3). However, there sometimes ineffective and their consumption has not was no significant difference between the two treatments been continued because of increased cost or onset of in terms of the mean of descending trend of number of serious side effects, patients have turned their attention defecations during a week (P=0.5, F=0.37), although the to the use of herbal medicines (5). effectiveness of plantago in for reducing the number of defecations per week was greater than that of Colofac. In this study, the therapeutic effect of the plant plantago was compared with that of Colofac for treating symptoms Diagram showing number of defecations per week in of irritable bowel syndrome. In this comparison, it was Colofac and plantago treatments. observed that both of the mentioned medications effectively reduced number of defecations. Results show that plantago had a greater impact in terms of reducing the number of defecations and that difference between the two methods was significant. Moreover, significant difference was determined between the two treatments in terms of reducing the number of diarrheal defecation occurrences compared with pre-treatment conditions. However, the two treatments were determined as significantly different, although some diagrams indicated that plantago was the more effective. The present study has demonstrated that consumption of the plant plantago major was more effective than taking Colofac capsules to control symptoms of diarrhea in IBS patients.
Constipation The effect of various herbs has been investigated for The following diagram demonstrates values for number treating this disease in other studies, but results are not of constipated defecations per week. Records show that in accordance with one another. In a study done in 2006 numbers reduced in both treatments, but the reduction on Aloe Vera, no significant difference was observed in was greater in the group that took plantago. improving symptoms in patients compared with the placebo (23).
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