European Journal of Cardiovascular Medicine

Irritable bowel syndrome (IBS) is a functional bowel disorder characterized by abdominal pain or discomfort along with change in frequency and consistency of bowel habits. Abdominal distension, bloating and altered bowel habits are common clinical presentations. IBS affects around 3% to 15% of the population.(1) IBS is functional gastrointestinal disease defined by symptom-based diagnostic criteria, in the absence of any detectable etiology (2)

Birmingham Questionnaire(BQ) can be completed by the patients and is known to have, external validity, good reliability and is responsive to changes in health status.(3) The questionnaire is validated for its use in research. However, it has been observed the language is difficult to understand for the Indian population. This makes it difficult to be accepted in the Indian setting. So we need to modify the Birmingham Questionnaire (BQ), which can be easily comprehended by the Indian patients. No studies have been done till now to modify and validate the BQ for the Indian healthcare setup.(4)

It has been observed that studies available using BQ, FBDSI are only from western countries. There are no similar studies published in the Indian context. Also, the reproducibility of BQ and FBDSI in the Indian setting has not been looked into. With this rationale, the present study was taken to validate Birmingham Questionnaire (BQ) in assessing symptoms in IBS patients in the South Indian scenario. 

AIMS & OBJECTIVES:

1. To validate Birmingham Questionnaire(BQ) in assessing symptoms in IBS patients in South Indian scenario 
2. Use of Functional Bowel Disease Severity Index (FBDSI) in assessing the severity of IBS patients 
3. To correlate BQ with FBDSI in assessing the outcomes with respect to the severity of IBS 

Study Design and Study Site:
This study was an analytical, longitudinal, single-centre, questionnaire-based study done in the gastrointestinal OPD of a medical college hospital.
Ethical Considerations:
The study was initiated after obtaining permission from the Institutional Ethics Committee (IEC) and the IEC approval number for this study was 052/IHEC/FEB 2020.
Study population:
The study was conducted among IBS patients attending the gastro medicine OPD at a tertiary care hospital. During the study, duration participants were recruited using the convenience sampling technique. Eligibility criteria were as follows:
1. Inclusion criteria:
• Patients who fulfil the ROME 4 criteria mentioned below
1. Recurrent abdominal pain, on average, at least one day per week in the last 3 months,
2. Related to defecation
3. Associated with a change in stool frequency
4. Associated with a change in stool form (appearance)
• Age group 18 to 50 years
2. Exclusion criteria:
• Patients with IBD, DCLD, IDA, Macrocytic anemia
Study duration:

100 participants were included in the study among which, 71 males and 29 were females. The gender distribution of the study participants is depicted in Table 1A. The minimum age of the study participants were 18 years while maximum age was 57 years.

Table 2 shows the variable food habits of study participants. More than half of the patients (52%) were non-vegetarians, 39% of the people were vegetarians. 50% of the people preferred mild consumption while 37% of the study population was intolerant to milk consumption. Around half of the study participants (51%) had habit of eating spicy food.

Table 3 represents the effect of IBS on general behaviour and personal life. 59% of the people complained of easy irritability while another 55% of the study participants mentioned that they are stressed out in their daily life. Morning fatigue was seen in around 52% of the study population.

The gastrointestinal complaints arising due to IBS have been summarized in Table 4. Abdominal pain was the chief complaint among the study population with 90% of the people suffering from it. This was followed by bloating, incomplete evacuation of stools and abdominal discomfort, encountered in 71%, 65% and 63% of the patients respectively.

Table 5 represents the descriptive statistics for the biochemical parameters of the study participants. The mean for all the blood parameters was well within the normal limits. Fetal calprotectin levels were elevated in few patients, the mean for which was 10.34 Few patients did not gave any history of myalgia, while the maximum duration of myalgia in one patient was 3 years.

Table 6A and 6B show the correlation of pre-treatment Birmingham questionnaire (BSQ) with FBDSI score. Modified BSQ questionnaire used in this study is designed to assess different symptoms of IBS. The correlation of different questions pertaining to specific symptoms of IBS with the diseases severity has been computed below. Pain, abdominal fullness, fatigue, behavioural symptoms like anxiety and stress, diarrhoea and constipation were assessed with FBDSI. Since both the FBDSI and pre-treatment BSQ followed a non-parametric distribution, a spearman correlation was carried out. None of the BSQ scores for the above mentioned symptoms were found to be significant with FBDSI scores. p value for all the correlations was above the 0.05 level of significance.
Table 6: Correlation of the IBS symptoms with pre-medication BQ with FBDSI score

Table 7 shows the correlation between the pre-treatment BQ and the post-treatment BQ depicting the effect of treatment on the symptoms of IBS as experienced by the patients. Both the pre-treatment and post-treatment BQ followed a non-parametric distribution, thus spearman correlation was used to assess the relationship between the two scores. The post-treatment mean scores for all the individual symptoms of IBS, like pain, abdominal fullness, fatigue, behavioural symptoms including anxiety and stress, along with diarrhoea and constipation were less as compared to the pre-treatment scores. The mean difference of the BQ scores for all the symptoms was significantly different as indicted with a p value of <0.001
Table 7: Correlation between IBS symptoms of pre-treatment BQ with post-treatment BQ in the study participants:

IBS is observed more in women than men, and typically noted people below the age of 50 (5). According to diagnostic standards such as the Rome criteria, the generality of IBS is associated to be between 5 and 15% of the global population. (6) Based on these findings, it has been advocated to avoid certain food stuffs known to be notorious for precipitation of the symptoms of IBS. These findings were consistent with the patients in our study, where around 45 percent of the individuals were non-vegetarians and 51 percent of the people admitted to consuming spicy food in their diet on a regular basis. Aside from that, 37 percent of the research group was lactose intolerant, and more than half of the respondents consumed outside food on a regular basis. (7,8) Our studies showed over half of the patients had a disrupted home life, were stressed out, and shown indicators of easy irritation. These findings were comparable to those of Magdalena et al, who discovered that persons with IBS had substantially poorer IBS-QOL scores than the control group. They also found that the QOL scores and the overall pain scores were lower in females with IBS compared to males. (9) Management of the patients with IBS demands prompt evaluation so as to ensure optimum clinical benefit with respect to the gastrointestinal symptoms and overall health of the patients. Assessment of IBS involves identification of the disease related symptoms, responsible for morbidity in daily activities in patient’s life. In this regard, several questionnaires and scoring systems for qualitative and quantitative estimation of the symptoms have been made available. The questionnaires which are used by the practising physicians can be broadly classified into four different categories of instruments: (10)

We included two multi-item, 22 multi-dimensional gastrointestinal symptom questionnaires, the Birmingham IBS symptom questionnaire (BSQ) and the Functional Bowel Disease Severity Index, among the above-mentioned categories (FBDSI). The BSQ was created to assess IBS patients symptoms. The questionnaire have been shown to be reliable, externally valid, and sensitive. (11) The Birmingham IBS symptom score questionnaire is made up of 11 questions that are based on the frequency of IBS symptoms. The replies to the questions are graded on a six-point Likert scale ranging from 0 (never) to 5 (always) (all of the time). The fundamental aspects of the questionnaire include abdominal pain (3 items), diarrhoea (5 items), and constipation (3 items), with lower scores suggesting less severe symptom.
However, unlike the pre-validated BSQ that has been used for assessment of severity of the symptoms of IBS, we decided to modify the questionnaire as per the symptoms that were frequently encountered in the Indian subpopulation. The original Birmingham questionnaire is designed to evaluate 3 major symptom domains, namely: constipation, diarrhoea, and abdominal pain in patients suffering from IBS. The amended questionnaire now included items on stomach fullness, weariness, and behavioural symptoms such as worry and easy irritability, in addition to abdominal pain, diarrhoea, and constipation. The modified Birmingham questionnaire employed in our study is unique in its use, not only in India but also internationally. This is the first study of its type to analyse IBS symptoms other than stomach pain, diarrhoea, and constipation to characterise the complete clinical picture of IBS patients.
Since the Birmingham symptom questionnaire was modified, a pilot study was performed to ensure test-retest validity of the questionnaire. This gave the Cronbach’s alpha value of 0.74, of the entire questionnaire. This finding was consistent with the Cronbach’s value of 0.74 for abdominal pain, in accordance with the standard Birmingham questionnaire. (3) In our investigation, FBDSI was administered to patients before to treatment beginning to quantify IBS symptoms, whereas the BSQ was employed both before and after treatment to determine the prevalent symptoms and their trend regarding the recommended medication. The FBDSI score suggested that most of the patients had severe severity of symptoms, whereas the BSQ assisted in identifying the most often encountered IBS symptoms in the research participants.
We performed a correlation analysis between FBDSI and BSQ, to identify the possible relationship between the two scores. The correlation between the 2 baseline scores came out to be insignificant in our study, indicating that the presence of a particular symptom did not necessarily significantly correlate with the severity of symptoms, the patient is suffering from (12). One possible reason for this is that the bulk of the patients (99 percent of the sample size) were classed as having a severe degree of disease according to the FBDSI. However, the post-treatment BSQ differed considerably from the pre-treatment BSQ, showing a significant change in the presence of IBS-related symptoms following treatment commencement. All individual symptom categories were found to be significant, including behavioural alterations such as increased anxiety and irritation. Because the BSQ scores in the post-treatment phase were significantly lower than the pre-treatment scores, this demonstrated a good reliability of BSQ in correctly predicting the clinical improvement of IBS patients following treatment, indicating a definitive reduction in IBS symptoms as depicted by clinical improvement.
In addition to diarrhoea and constipation, as well as abdominal pain, the modified BSQ used in our study enabled us to identify behavioural symptoms such as generalised fatigue and irritability, as well as abdominal fullness, which can be efficiently targeted with pharmacotherapy and counselling, thereby improving overall recovery of IBS patients. The modified BSQ employed in our study aided in understanding the clinical development of IBS patients and how treatment response may be anticipated using these multidimensional questionnaires. Therefore, assessment tools in the form of uni-dimensional and multi-dimensional scoring systems and questionnaires for symptoms or for a group of symptoms relating to a particular disease condition play a vital role in the management of the patient not only in terms of clinical benefit over time, but they also aid to identify the pattern and periods of symptom appearance and disappearance, so that appropriate and timely medical measures can be undertaken.

There was a good correlation between the pre-treatment and post-treatment Birmingham symptom questionnaire scores. This has definitely helped to monitor the clinical response once the treatment was initiated. Our study failed to show a significant difference comparing the pre-treatment BQ with the FBDSI.

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