MHGCJ – 2021

Mental Health: Global Challenges Journal

https://mhgcj.org ISSN 2612-2138

Dynamics of quality of life indicators in patients

with gastroesophageal reflux disease comorbid

with connective tissue dysplasia under the

influence of complex treatment

Iryna B. Romash, Ivan R. Romash

Ivano-Frankivsk National Medical University, Ukraine.

Abstract

Introduction. In the case of gastroesophageal reflux disease (GERD) on the background of

undifferentiated connective tissue dysplasia (UCTD) causes an even more significant deterioration

in the QOL, including sleep disturbances and the onset of excessive daytime sleepiness (EDS). Thus,

the study of the peculiarities of GERD on the background of connective tissue dysplasia and

determining the impact of comorbid pathology on the QOL of patients with GERD is a topical

issue in internal medicine. It has significant socio-economic significance. We believe that

monitoring the most important variables that affect the quality of life of patients with GERD can

help raise public awareness in this regard. In addition, it can guide the health care system to

address these issues.

Purpose. The purpose of the work is to increase the awareness of medical workers about the

scale of the problem and ways to solve it. to study the features of the dynamics of quality of life in

patients with gastroesophageal reflux disease comorbid with connective tissue dysplasia under

the influence of the proposed complex therapy.

Methodology. 120 patients were included: 65 men and 55 women. In 75 of them (Study Group)

GERD was in the background of UCTD, in 45 (Сomparison Group ) - developed as an independent

disease. The Study Group was divided into three groups. Сomparison Group - 45 patients with

GERD without UCTD, received basic standard therapy, which included PPI "Panocid" 40 mg once

a day and alginate-antacid formulation (Gaviscon Double Action Liquid) 20 ml, 3 times per day

after meals and before bedtime. I Group - 25 patients with GERD +UCTD, which to the standard

basic therapy was added "Magne-B6" for 2 tablets 3 times per day. II Group - 25 patients with

GERD +UCTD, which to the standard basic therapy was added "Calcium-D3 Nicomed" 1 tablet 3

times per day. III Group - 25 patients with GERD +UCTD, who used the drug "Magne-B6" 2 tablets

3 times per day and "Calcium-D3 Nicomed" 1 tablet 3 times per day on the background of

standard basic therapy. The Medical Outcomes Study 36-Item Short-Form Health Status (SF-36),

the Gastrointestinal Symptom Rating Scale (GSRS), and the scale of "Personal and social

performance" (PSP) - were used to study patients in detail. A comprehensive examination of

patients was performed twice: before and after 30 days of comprehensive treatment.

Results and Discussion. Under the influence of the basic therapy in Comparison Group the

General Health (GH) improved by 33.03%. While in the groups on the background of complex

treatment is increased by 42.52% in patients of the I Group, by 13.10% in patients of the II Group,

and 46.28% in patients of the III Group (p1, p2, p3 <0.05).Physical Functiong Scale (PF) improved

by 17.9% in patients of the Comparison Group (p <0.05) and by 30.38%; 27.47%, 29.17%,

respectively (p1, p2, p3 <0.05). Role Physical Scale (RP) scores improved by 25.14% in

Comparison Group (p <0.05) and by 33.6 %, 22.58% and 40.20% respectively (p1, p2, p3

<0.05). Dynamics of data in Body Pain (BP) scale improved by 21.84% in patients of the

Comparison Group (p <0.05) and by 37.28%, 25.46%, 35.92% (p1, p2, p3 <0.05).As can be seen

from it, under the influence of complex therapy, the values of the Vitality (VT) increased by 17.18%

in patients of Group I, by 21.93% – in Group II, by 37.87%– in Group III (p1, p2, p3 <0.05). Among

MHGCJ – 2021

Mental Health: Global Challenges Journal

https://mhgcj.org ISSN 2612-2138

patients of the Comparison Group, the influx of strength and energy felt 9.50% (p <0.05). Data of

Social Functioning Scale (SF) improved by 8.8% in patients of the Comparison Group (p <0 , 05)

and by 22.7%, 29.6%, 29.31%, respectively(p1, p2, p3 <0.05). Mental Health Scale (MH)

improved by 17.23% in patients of Group I, by 22.41% – in Group II, by 21.96% – in Group III (p1,

p2, p3 <0.05) and 14.22% - in the Comparison Group (p <0.05). Also in patients were positive

dynamics of the Role Emotional functioning scale (RE): by 27.37% in patients of Group I, by

12.36%– in Group II, by 15.7% – in the Group III (p1, p2, p3 <0.05) and 9.05% - in patients of the

Comparison Group (p < 0.05).

Conclusions. Thus, the inclusion in the standard therapy of gastroesophageal reflux disease in

patients with its development on the background of undifferentiated connective tissue dysplasia

of magnesium lactate dihydrate in combination with pyridoxine hydrochloride ("Magne -B6 ") and

calcium carbonate in combination with cholecalciferol ("Calcium-D3 Nicomed") contributed to

a significant improvement in their quality of life.

Keywords

quality of life, gastroesophageal reflux disease, comorbidity, connective tissue dysplasia, complex

treatment.

Address for correspondence:

Romash Iryna Bohdanіvna, MD, Ph.D., assistant of professor Department

propaedeutics of internal medicine, Ivano-Frankivsk National Medical University.

76010 Ivano-Frankivsk, Ukraine.e-mail: iromash@ukr.net;

iromash@ifnmu.edu.ua

This work is licensed under a Creative Commons Attribution-

NonCommercial 4.0 International License (CC BY-NC 4.0).

©Copyright: the Author(s), 2020

Licensee NDSAN (MFC- Coordinator of the NDSAN), Italy

doi: https://doi.org/10.32437/mhgcj.v4i2.127

Submitted for publication: 23

April 2021

Revised: 17 August 2021

Accepted for publication: 24

October 2021

Introduction

The problem of comorbid pathology in the

patient XXI century becomes the rule rather than

the exception. It causes significant costs for the

diagnosis and treatment of such patients, and

ultimately high disability and mortality.

Epidemiological studies in recent years have

shown that gastroesophageal reflux disease

(GERD) occupies a leading position among other

acid-dependent gastrointestinal diseases and is a

significant factor in health care costs. Depending

on the study population, its prevalence is in the

range of 10-30% and tends to increase (Charles

Hill et al. 2020). Over the past 40 years, the

incidence of GERD has increased significantly and

has become one of the main clinical problems in

gastroenterology. In North America, it is noted in

18.1-27.8%, in Europe - in 2.5-7.8%, in the Middle

East - in 8.7-33.2% of cases. GERD is also

increasingly found in Asians, where its prevalence

averages about 8%.

According to research by Gorczyca R et al.

(2019) and Iudici M et.al. (2017) already in patients

with GERD without concomitant pathology, the

quality of life deteriorates due to functional

limitations, emotional disorders, increased

frequency of reflux. Patients with GERD usually

suffer from a variety of symptoms, including acid

regurgitation, epigastralgia, non-cardiac chest

pain, chronic cough, asthma. Symptoms of

nocturnal acid regurgitation may interfere with

sleep. Therefore, patients with GERD may

experience a loss of quality of life (QOL) much

more often than the general population. (Salome

Satya Vani P et al., 2018). And this in turn affects

the ability of people to perform daily activities,

which closely affects the state of their well-being.

The urgency of the problem of GERD in addition

to a serious impact on QOL and social functioning

is the development of dangerous to the health

MHGCJ – 2021

Mental Health: Global Challenges Journal

https://mhgcj.org ISSN 2612-2138

and life of patients complications: esophageal

stricture, peptic ulcer, Barrett's esophagus,

adenocarcinoma. Therefore, early diagnosis of

the underlying disease and comorbid conditions is

important to prevent the above complications. By

the way, digestive disorders are increasingly

recognized as one of the leading causes of

disability worldwide. In 2019, these diseases took

third place after cardiovascular and cancer

diseases

In the case of GERD on the background of

undifferentiated connective tissue dysplasia

(UCTD) causes an even more significant

deterioration in the QOL, including sleep

disturbances and the onset of excessive daytime

sleepiness (EDS). This dependence is indicated by

our previous correlation analysis and the

establishment of a direct close relationship

between the indicator of pathological

acidification of the esophagus (acid exposure

time - AET) and EDS in both groups. In our previous

study, we found a significant decrease in QOL and

social functioning (Romash, 2019, 2020). In

particular, patients with a combination of GERD

and UCTD significantly more often worried about

heartburn, impaired quality of sleep, and life on

1.4 times (p <0.05). They increased the frequency

of gastroesophageal reflux with pH <4, increased

the number of acid reflux in the supine and

standing positions.

Thus, the study of the peculiarities of GERD on

the background of connective tissue dysplasia

and determining the impact of comorbid

pathology on the QOL of patients with GERD is a

topical issue in internal medicine. It has significant

socio-economic significance

We believe that monitoring the most important

variables that affect the quality of life of patients

with GERD can help raise public awareness in this

regard. In addition, it can guide the health care

system to address these issues

Purpose

The purpose of the work is to increase the

awareness of medical workers about the scale of

the problem and ways to solve it. to study the

features of the dynamics of quality of life in

patients with gastroesophageal reflux disease

comorbid with connective tissue dysplasia under

the influence of the proposed complex therapy.

Design/Methodology/Approach

120 patients have included 65 men and 55

women. In 75 of them (Stady Group) GERD was in

the background of UCTD, in 45 (Comparison

Group) - developed as an independent disease.

Depending on the treatment regimen, the

experimental group was divided into three.

Comparison Group consisted of 45 patients

with GERD without connective tissue disorders, who

received basic standard therapy, which included

PPI "Panocid" and alginate-antacid formulation

(Gaviscon Double Action Liquid) 20 ml 3 times per

day after meals and before bedtime.

I Group consisted of 25 patients with GERD in

combination with UCTD, which was added to the

basic therapy "Magne-B6" for 2 tablets 3 times per

day.

I Group consisted of 25 patients with GERD on

the background of UCTD, which was added to the

basic therapy "Calcium-D3 Nicomed" 1 tablet 3

times per day.

IІІ Group consisted of 25 patients with GERD in

combination with UCTD, which was added to the

basic therapy "Magne-B6" in 2 tablets. 3 times per

day and "Calcium-D3 Nicomed" 1 tablet 3 times

per day.

The Medical Outcomes Study 36-Item Short-

Form Health Status (SF-36), the Gastrointestinal

Symptom Rating Scale (GSRS), and the scale of

"Personal and social performance" (PSP) - were

used to study patients in detail.

A comprehensive examination of patients was

performed twice: before and after 30 days of

comprehensive treatment

The sample of patients was representative by

age and gender ( Table 1).

Table 1.

Distribution patients by age and sex

Indexes

Сomparison

Group

(n=45)

(n=25)

ІІІ

(n=25)

III

(n=25)

Age

46.2±3.03

36.2±3.03

32.2±3.03

29.2±3.03

MHGCJ – 2021

Mental Health: Global Challenges Journal

https://mhgcj.org ISSN 2612-2138

Gender

(abs. number,%)

Male

51.2

56.0

60.0

52.0

Female

48.8

44.0

40.0

48.0

After reviewing the examination procedure and

the principle of treatment, all patients voluntarily

signed written agreements following the protocol

of the clinical trial approved by the Bioethics

Commission of Ivano-Frankivsk National Medical

University. To assess the dynamics of quality of life

(QOL) of the examined patients under the

influence of complex treatment, each patient was

asked to fill out a short form of the questionnaire

Medical Outcomes Study 36-Item Short-Form

Health Status (SF-36) Ware et al. (1993) and the

Gastrointestinal Symptom Rating Scale (Svedlund

J, Dimenäs E, Wiklund I, 1995).

The SF-36 questionnaire consists of 36 questions

grouped into eight domains: physical functioning

(PF), social functioning (SF), role limitation related

to physical problems (RP), role limitation, gender

associated with emotional problems (RE), mental

health (MH), vitality (VT), body pain (VP) and

perception of general health (GH). The indicators

of each scale are compiled as follows: the higher

the value of the indicator (from 0 to 100), the better

the score on the selected scale. They form two

parameters that evaluate the eight concepts of

health: psychological and physical components.

The physical components are: GH - general

perception of health, PF - limitations in physical

activity due to health problems, RP - limitations in

normal role-playing activities due to physical

health problems, BP - physical pain. Mental

components include: SF - limitations in social

activity due to physical or emotional problems, MH

- general mental health (psychological distress

and well-being, RE - limitations in normal role

activity due to emotional problems, VT - viability

(energy and fatigue) The scores of each scale vary

between 0 and 100, where 100 is a completely

healthy, and the results are in the form of scores

compiled in such a way that a higher score

indicates a higher QOL level. The general

questionnaire is a general questionnaire that can

be used for patients with various pathologies as

well as for population-based studies. of 15

questions grouped into five clusters for a detailed

study of symptoms reflecting reflux, abdominal

pain, indigestion, diarrhea, and constipation. GSRS

has a seven-point Likert-type scale, where "1"

means no problem symptoms and "7" means no

very problematic symptoms. The reliability and

validity of this questionnaire are well documented,

the values of the norms for the general population

are available (Kulich et.al., 2008).

Results and Discussion

The dynamics of the physical components of

quality of life under the influence of the proposed

comprehensive treatment in our examined

patients is presented in Figure 1.

Under the influence of the basic therapy

among the patients of the Comparison Group the

General Health (GH) improved by 33.03%,

changing from 52.81 ± 0.98 to 78.86 ± 1.03 ( p

<0.05). While in the groups on the background of

complex treatment it increased by 42.52% (from

54.3 ± 0.97 to 94.5 ± 1.97) in patients of the first

group, by 13.10% (from 62 .01 ± 1.87 to 71.36 ±

0.61) – in II and 46.28% (from 50.81 ± 1.07 to 94.6

± 2.01) – in the III, respectively (p1 , p2, p3 <0.05).

MHGCJ – 2021

Mental Health: Global Challenges Journal

https://mhgcj.org ISSN 2612-2138

Fig. 1. Dynamics of quality of life indicators (physical component) in the examined patients

Note: * - (p <0,05) data are reliable for indicators before and after treatment.

Physical Functiong Scale (PF) improved by

17.9% under the influence of the prescribed

treatment (from 59.32 ± 0.97 to 72.3 ± 0, 61) in

patients of the Comparison Group (p <0.05) and

by 30.38% (from 61.12 ± 1.38 to 87.8 ± 2.09) – in

the I Group; 27.47% (from 57.01 ± 2.63 to 79.03

± 0.97) – in the II Group; 29.17% (from 61.12 ±

0.68 to 86.3 ± 1.16) – in the III Group, respectively

(p1, p2, p3 <0.05).

Role Physical Scale (RP) scores improved by

25.14% (from 58.31 ± 0.91 to 77.9 ± 1.12) in

Comparison Group (p <0.05) and by 33.6 % (from

61.24 ± 1.12 to 92.3 ± 2.07) in patients of the I

Group, by 22.58% (from 53.71 ± 0.76 to 69.38 ±

1.56) - in the II Group, by 40.20% (from 53.20 ±

0.13 to 89.12 ± 0.97) – in the III (p1, p2, p3 <0.05)

Dynamics of data in Body Pain (BP) scale under

the influence of the proposed therapy improved

by 21.84% (from 61.9 ± 0.89 to 79.2 ± 1.33) in

patients of the Comparison Group (p <0.05) and

by 37.28% (from 59.2 ± 0.86 to 94.4 ± 1.25) – in

the I Group, by 25.46% (from 58.36 ± 1.15 to 78.3

± 2.13) – in the II Group, by 35.92% (from 59 , 41

± 1.08 to 92.73 ± 1.05) – in the III Group (p1, p2,

p3 <0.05).

Dynamics of mental components of quality of

life under the influence of the offered complex

treatment at the patients examined by us is

presented in figure 2.

MHGCJ – 2021

Mental Health: Global Challenges Journal

https://mhgcj.org ISSN 2612-2138

Fig. 2. Dynamics of quality of life indicators (mental component) in the examined patients

Notes: 1. * - (p <0,05) data are reliable in relation to indicators before and after treatmen

Under the influence of complex therapy, the

values of the Vitality (VT) increased by 17.18%

(from 72.3 ± 1.62 to 87.3 ± 0.97) in patients of

Group I, by 21.93% (from 69.76 ± 1.32 to 89.36 ±

1.36) – in the Group II, in which the basic therapy

was added to the calcium drug; by 37.87% (from

59.86 ± 0.96 to 96.36 ± 2.31) – in the Group III, to

which both drugs were added to the basic therapy

(p1, p2, p3 <0.05). Among patients with GERD

without UCTD, who received basic therapy with PPIs

and alginate-antacid formulation, the influx of

strength and energy felt 9.50% (69.86 ± 0.32 to

77.2 ± 1.08), p <0.05.

Data of Social Functioning Scale (SF) under the

influence of the proposed therapy improved by

8.8% (from 74.36 ± 0.98 to 81.5 ± 1.64) in patients

of the Comparison Group (p <0 , 05) and by

22.7% (from 61.12 ± 0.81 to 79.1 ± 0.62) in

patients in the Group I, by 29.6% (from 59.36 ±

1.65 to 84.3 ± 1.31) – in the Group II, by 29.31%

(from 63.16 ± 0.38 to 89.36 ± 1.13) - in the Group

III (p1, p2, p3 <0.05).

Mental Health Scale (MH) improved by 17.23%

(from 71.26 ± 0.36 to 86.1 ± 1.95) in patients of

the Group I, by 22.41% (from 61.96 ± 0.68 to

MHGCJ – 2021

Mental Health: Global Challenges Journal

https://mhgcj.org ISSN 2612-2138

79.86 ± 1.07) – in the Group II, 21.96% (from 79.19

± 1.02 to 97.63 ± 2.03) – in the Group III (p1, p2,

p3 <0.05) and 14.22% (from 68.36 ± 0.35 to 79.7

± 1.04) - in the Comparison Group (p <0.05).

Also in the patients we treated there was a

positive dynamics of the scale Role Emotional

functioning (RE): by 27.37% (from 70.3 ± 1.16 to

96.8 ± 2.07) in patients of the Group I, by 12.36%

(from 73.26 ± 0.64 to 83.6 ± 1.35) – in the Group

II, by 15.7% (from 79.43 ± 0.38 to 94.3 ± 0.92 ) –

in the Group III (p1, p2, p3 <0.05) and 9.05% (from

69.3 ± 0.31 to 76.2 ± 0.82) - in patients of the

Comparison Group who received basic therapy (p

< 0.05).

Conclusions

Thus, the inclusion in the standard therapy of

gastroesophageal reflux disease in patients with its

development on the background of

undifferentiated connective tissue dysplasia of

magnesium lactate dihydrate in combination with

pyridoxine hydrochloride ("Magne -B6 ") and

calcium carbonate in combination with

cholecalciferol ("Calcium-D3 Nicomed")

contributed to a significant improvement in their

quality of life.

Conflict of interest

The authors declare that they have no conflict

of interest.

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