Assessment of clinical treatments for hypercholesterolemic patients with lower extremity arterial disease based on their quality of life *
(Portuguese
PDF version)
Carla Aparecida Faccio Bosnardo,1 Ana Terezinha Guillaumon2
1.
M.Sc., Physician, Department of Surgery, Hospital das Clínicas, Universidade Estadual de Campinas (UNICAMP), Campinas, São Paulo, Brazil. Scientific supervisor of the residency program in vascular surgery, Santa Casa de Misericórdia de Limeira, São Paulo, Brazil.
2. Ph.D., Professor, Department of Surgery, Faculdade de Ciências Médicas, Universidade Estadual de Campinas (UNICAMP). Chief of the Laboratory of Microprocedures and Vascular Research, Center of Medicine and Experimental Surgery, Faculdade de Ciências Médicas, UNICAMP. Supervisor of the Endovascular Surgery Reference Center, UNICAMP, Campinas, São Paulo, Brazil.
* Article based on the M.Sc. thesis of the first author, presented at Faculdade de Ciências Médicas da UNICAMP, São Paulo, Brazil.
Correspondence:
Carla Aparecida Faccio Bosnardo
Rua Vasco Fernandes Coutinho, 555
CEP 13075-235 - Campinas, São Paulo
Brazil
Phone: +55 (19) 3241.6685/323.2919/8131.9969
E-mail: carlabosnardo@aol.com
ABSTRACT
Objective:
To assess different treatments for hypercholesterolemic patients
with arterial disease based on their quality of life.
Method: From May to December 1999, 30 patients randomly divided
into three groups were followed. All of them were claudicant and
presented with arterial disease. There were 19 males (63.3%) and
11 females (36.6%) with an average age of 59.9 years. Each group
was prescribed a different treatment. Group I was prescribed low
cholesterol diet and physical therapy. Group II was prescribed low
cholesterol diet, physical therapy and simvastatin administration
at 10 mg/day. Group III was prescribed free diet, physical therapy
and simvastatin administration at 10 mg/day. Each patient answered
questionnaires about their quality of life before and after treatment.
Results: Improvements in total cholesterol levels and its
fractions and in the patients' quality of life were observed in
all groups.
Conclusion: Treatment was more effective, leading to a greater
improvement in terms of quality of life, for patients who were in
group II.
Key-words:
quality of life, hypercholesterolemia, intermittent claudication.
Palavras-chave: qualidade de vida, hipercolesterolemia,
claudicação intermitente.
J
Vasc Br 2004;3(3):238-46
It is widely known that chronic infrainguinal occlusive disease, whose major cause is atherosclerosis,1 commonly results in amputations. Its treatment, whether clinical or surgical, is well established. However, early diagnosis is fundamental in order to reduce its complications.
Based on this fact, the present study aims at assessing three different clinical treatments for hypercholesterolemia and control of chronic infrainguinal occlusive disease, observing which approach is the most well-accepted by patients based on the improvement in their of quality of life. Our method included blood tests, assessments of quality of life (through pre-established questionnaires) and statistical analysis.2
CASES AND METHOD
Patients who had been previously followed at the Outpatient Clinic of Vascular Surgery of Hospital e Maternidade Celso Piêrro of Faculdade de Ciências Médicas of Pontifícia Universidade Católica de Campinas (PUCCAMP) were asked (through telephone or mail) to return to our clinic. Following the requirements of the committee on research ethics of UNICAMP, patients were previously informed about our research purposes.
Of all patients who came, 30 hypercholesterolemic patients with arterial disease were selected, comprising 19 males and 11 females, with an average age of 59.9 years (ranging from 25 to 80). Were considered to be hypercholesterolemic patients who presented total cholesterol level surpassing 200 mg/dl, according to criteria available in the literature.3 Were considered to have arterial disease patients who presented with occlusion of infrainguinal arteries with limited intermittent claudication, pain at rest, amputation due to lower extremity ischemic disease and those who had undergone peripheral revascularization.
Patients were randomly divided into three groups, followed for 6 months (from May to December 1999) and, besides baseline measures, they underwent new tests at 1, 3 and 6 months after the beginning of follow-up; appointments were scheduled whenever results of these tests were available.3 Patients in all groups presented with ankle-brachial indices ranging from 0.6 to 0.9.
Group
I
Ten patients underwent a dietary therapy with low cholesterol diet consisting of no fried foods or saturated fats and controlled ingestion of carbohydrates, along with physical therapy. The average ankle-brachial index was 0.73.
Group
II
Ten patients underwent treatment with low cholesterol diet, doses of simvastatin (a hypocholesterolemic drug) at 10 mg/day, along with physical therapy, independently of the weight of the patient. The average ankle-brachial index was 0.69.
Group
III
Ten patients underwent treatment with normal cholesterol diet, in which all nutritional components were included, but in reduced quantities. Thus, fatty food intake was allowed once a day at a rate of two to three times a week, saturated fat intake was allowed at a rate of three to four times a week and carbohydrate intake was allowed every day. Patients in this group also received daily doses of 10 mg of simvastatin, along with physical therapy. Anamnesis was included, with special attention to symptoms related to infrainguinal arterial disease, such as intermittent claudication, pain at rest, trophic lesions and/or amputations. General and specific clinical examinations were performed in order to screen for vascular alterations; such procedure included inspection, palpation and auscultation, special attention given to dilations, pulsation, thrills and bruits. Non-invasive vascular evaluation was performed with portable continuous-wave ultrasound equipment. The average ankle-brachial index was 0.70.
Patients in all groups answered two questionnaires, so that it was possible to assess the difference between the quality of life in the beginning and in the end of the prescribed treatment. The first questionnaire was the Quality of Life Questionnaire of Centro de Tratamento Bezerra de Menezes,4 which assesses the patient in social, emotional, professional and health aspects. The second questionnaire was the Wisconsin Brief Pain Questionnaire,5 which assesses functional aspects concerning pain.
Answers to the questionnaires in the beginning of treatment were obtained in each patient's medical record and through interviews with parents and relatives. Answers after the end of treatment were obtained through interview with the patient him/herself.
RESULTS
Analysis
of covariance evidenced that there were differences among the three
groups. The value of P (0.0070) showed that the result of the
prescribed treatments was statistically significant. Figure 1 displays
the curves of total cholesterol level adjusted for the covariate during
the study. Note that interactions among group, time and cholesterol
levels were not statistically significant.
 Figure
1 - Mean total cholesterol level estimated for groups, adjusted for the
covariate.
In relation
to HDL, analysis of covariance was also performed because, similarly
to total cholesterol levels, initial HDL levels were different for each
group; and P for initial values was 0.0003. If it had not been
adjusted for, P for final values could have been altered.
In this case, P value was 0.0539 (Figure 2), evidencing the predisposition
of group II to behave differently from groups I and III in terms of
HDL levels.
Figure
2 - Mean HDL level estimated for the groups, adjusted for the covariate.
Analysis
of covariance was also performed for LDL levels because initial values
for LDL were different, with a significant P value of 0.0294.
After adjusting for the covariate, P value was 0.0186, evidencing
a decrease in LDL levels in all groups (Figure 3).
Figure
3 - Mean LDL levels estimated for the groups, adjusted for the covariate.
In terms of indices of quality of life, Wilcoxon test was applied to the responses of the Questionnaire of Quality of Life of Centro de Tratamento Bezerra de Menezes. Table 1A displays the results for this questionnaire.
Table
1A - Measures of position and dispersion of indices of quality of life
for each group
 |
| Group
|
Moment
quadrant |
n |
Mean
|
Standard
deviation |
Minimum
|
Median
|
Maximum |
|
| I
|
BQ1
|
10
|
11 |
5 |
0 |
13
|
14 |
|
BQ2 |
10 |
8 |
3 |
1 |
10
|
10 |
|
BQ3 |
10 |
4 |
2 |
0 |
5 |
7 |
|
BQ4 |
10 |
4 |
2 |
0 |
5 |
6 |
|
AQ1 |
10 |
11 |
4 |
2 |
13 |
14 |
|
AQ2 |
10 |
9 |
2 |
5 |
10 |
10 |
|
AQ3 |
10 |
4 |
2 |
0 |
5 |
7 |
|
AQ4 |
10 |
8 |
3 |
3 |
9 |
11 |
| II
|
BQ1 |
10 |
11 |
3 |
4 |
12 |
13 |
|
BQ2 |
10 |
8 |
2 |
4 |
10 |
10 |
|
BQ3 |
10 |
3 |
2
|
-1 |
4 |
6 |
|
BQ4 |
10 |
3 |
2 |
-1 |
3 |
6 |
|
AQ1 |
10 |
11 |
3 |
4 |
12
|
14 |
|
AQ2 |
10 |
10 |
1 |
6 |
10 |
10 |
|
AQ3 |
10 |
4 |
2 |
-1 |
4 |
6 |
|
AQ4 |
10 |
5 |
3 |
-1 |
6 |
8 |
| III
|
BQ1 |
10 |
7 |
7 |
-4
|
11
|
15 |
|
BQ2 |
10 |
7 |
3 |
3 |
8 |
10 |
|
BQ3 |
10 |
1 |
3 |
-3 |
2 |
5 |
|
BQ4 |
10 |
5 |
3 |
-1 |
5 |
9 |
|
AQ1 |
10 |
8 |
7 |
-4
|
11
|
15 |
|
AQ2
|
10 |
8 |
3 |
3
|
10
|
10 |
|
AQ3 |
10 |
2 |
3 |
-3 |
4 |
5 |
|
AQ4 |
10 |
8 |
3 |
3 |
7 |
12 |
|
B
= before; A = after.
Results
show that all four quadrants (social, emotional, professional and health
aspects) presented significant alterations between the two assessments
(before and after treatment) (P < 0.005). The most significant
change occurred in quadrant 4, group I, when taken alone (Table 1B).
Table
1B - Descriptive levels of Wilcoxon tests: comparison of answers before
and after treatment for each group
|
| Variable |
P for group I |
P
for group II |
P
for group III |
|
| Q1
|
1.0000
|
0.5000
|
0.1250 |
| Q2
|
0.2500
|
0.2500
|
0.2500 |
| Q3 |
- |
0.2500
|
0.1250 |
| Q4
|
0.0039
|
0.0156
|
0.0440 |
|
Q
= quadrant.
Kruskal-Wallis test, which allows comparing each quadrant before and after treatment considering all groups, was also applied. Table 1C displays such values.
Table
1C - Descriptive levels for Kruskal-Wallis tests: comparison of indices
of quality of life considering the three groups
|
| Variable
|
P
before |
P
after |
|
| Q1
|
0.0982
|
0.4965 |
| Q2
|
0.6897
|
0.7437 |
| Q3
|
0.0953
|
0.3527 |
| Q4 |
0.1719 |
0.0448
(group II is different from groups I and III) |
|
Q
= quadrant.
When Kruskal-Wallis
test was applied for comparing the groups, difference also appeared
in quadrant 4 for group II. In contrast to groups I and III, this was
the group which presented the greatest improvement (P < 0.0448).
The Wisconsin Brief Pain Questionnaire5 was divided into two parts. The first was related to pain and the second was related to the way pain interferes with the life of the patient. Statistical results for the first part of this questionnaire are displayed in Tables 2A and 2B.
Table
2A - Measures of position and dispersion of indices of the Wisconsin Brief
Pain Questionnaire for each group
|
| Group
|
Moment
question |
n |
Mean
|
Standard
deviation |
Minimum
|
Median
|
Maximum |
|
| I
|
BQ1
|
10 |
8 |
1 |
5 |
9 |
9 |
| |
BQ2 |
10 |
7 |
1 |
4 |
7 |
8 |
| |
BQ3 |
10 |
7 |
2 |
4 |
8 |
9 |
| |
BQ4
|
10 |
7 |
1 |
5 |
7 |
8 |
| |
BQ5 |
10 |
7 |
2 |
4 |
8 |
9 |
| |
BQ6 |
10 |
8 |
2 |
4 |
9 |
9 |
| |
BQ7
|
10 |
8 |
2 |
5 |
9 |
10 |
| |
AQ1 |
10 |
3 |
1 |
0 |
3 |
5 |
| |
AQ2 |
10 |
3 |
1 |
1 |
2 |
4 |
| |
AQ3 |
10 |
3 |
1 |
1 |
3 |
4 |
| |
AQ4 |
10 |
3 |
1 |
1 |
2 |
5 |
| |
AQ5 |
10 |
3 |
1 |
2 |
3 |
5 |
| |
AQ6 |
10 |
2 |
1 |
0 |
2 |
5 |
| |
AQ7 |
10 |
2 |
1 |
0 |
2 |
4 |
| II |
BQ1 |
10 |
8 |
1 |
6 |
9 |
10 |
| |
BQ2 |
10 |
7 |
1 |
5 |
8 |
9 |
| |
BQ3 |
10 |
7 |
1 |
5 |
8 |
10 |
| |
BQ4 |
10 |
7 |
2 |
3 |
8 |
10 |
| |
BQ5 |
10 |
7 |
2 |
4 |
8 |
9 |
| |
BQ6 |
10 |
8 |
2 |
4 |
8 |
9 |
| |
BQ7 |
10 |
7 |
2 |
4 |
8 |
10 |
| |
AQ1 |
10 |
3 |
1 |
1 |
3 |
5 |
| |
AQ2 |
10 |
4 |
1 |
1 |
4 |
5 |
| |
AQ3 |
10 |
3 |
1 |
1 |
3 |
4 |
| |
AQ4 |
10 |
3 |
1 |
1 |
4 |
5 |
| |
AQ5 |
10 |
3 |
1 |
1 |
4 |
5 |
| |
AQ6 |
10 |
3 |
1 |
1 |
3 |
5 |
| |
AQ7 |
10 |
3 |
1 |
1 |
3 |
5 |
| III |
BQ1 |
10 |
8 |
2 |
3 |
9 |
10 |
| |
BQ2 |
10 |
8 |
2 |
3 |
9 |
10 |
| |
BQ3 |
10 |
9 |
2 |
3 |
3 |
10 |
| |
BQ4 |
10 |
8 |
2 |
3 |
3 |
10 |
| |
BQ5 |
10 |
9 |
2 |
3 |
10 |
10 |
| |
BQ6 |
10 |
9 |
2 |
3 |
10 |
10 |
| |
BQ7 |
10 |
9 |
2 |
3 |
10 |
10 |
| |
AQ1 |
10 |
4 |
2 |
0 |
4 |
8 |
| |
AQ2 |
10 |
4 |
3 |
0 |
3 |
9 |
| |
AQ3 |
10 |
4 |
2 |
0 |
4 |
9 |
| |
AQ4 |
10 |
4 |
2 |
0 |
4 |
8 |
| |
AQ5 |
10 |
4 |
2 |
0 |
4 |
9 |
| |
AQ6 |
10 |
4 |
2 |
0 |
4 |
9 |
| |
AQ7 |
10 |
4 |
2 |
0 |
4 |
9 |
|
B
= before; A = after.
Table
2B - Descriptive levels of Wilcoxon tests: comparison of answers before
and after treatment for each group. Wisconsin Brief Pain Questionnaire, part
I
|
| Variable
|
P
for group I |
P
for group II |
P
for group III |
|
| Question
1 |
0.0020
|
0.0020
|
0.0020 |
| Question
2 |
0.0020 |
0.0078 |
0.0020 |
| Question
3 |
0.0156
|
0.0117
|
0.0039 |
| Question
4 |
0.0039
|
0.0078
|
0.0039 |
|
Concerning the application of Kruskal-Wallis test to the first part of the questionnaire, comparing the answers of the three groups to each question before and after treatment, it was observed that, although groups started from different situations, they achieved similar improvement levels at the end of treatment, as displayed in Table 2C.
Table
2C - Descriptive levels of Kruskal-Wallis tests: comparison of indices
of quality of life of the three groups. Wisconsin Brief Pain Questionnaire,
part I
|
| Variable
|
P
before |
P
after |
|
| Question
1 |
0.0255
(group I is different from groups II and III) |
0.4953 |
| Question
2 |
0.2998
|
0.2968 |
| Question
3 |
0.3502
|
0.1179 |
| Question
4 |
0.0204
(group I is different from group III) |
0.1022 |
|
Tables 3 and 4 display results of Wilcoxon test and Kruskal-Wallis test for the second part of the questionnaire. Wilcoxon test did not evidence significant alterations, unlike Kruskal-Wallis test, which showed differences among the groups.
Table
3 - Descriptive levels of Wilcoxon tests: comparison of answers before
and after treatment for each group. Wisconsin Brief Pain Questionnaire, part
II
|
| Variable
|
P
for group I |
P
for group II |
P
for group III |
|
| Question
1 |
0.0020
|
0.0020
|
0.0020 |
| Question
2 |
0.0020
|
0.0020
|
0.0020 |
| Question
3 |
0.0020
|
0.0020
|
0.0020 |
| Question
4 |
0.0020
|
0.0020
|
0.0020 |
| Question
5 |
0.0020
|
0.0020
|
0.0020 |
| Question
6 |
0.0020
|
0.0020
|
0.0020 |
| Question
7 |
0.0020
|
0.0020
|
0.0020 |
|
Table
4 - Descriptive levels of Kruskal-Wallis tests: comparison of indices
of quality of life of the three groups. Wisconsin Brief Pain Questionnaire,
part II
|
| Variable
|
P
before |
P after |
|
| Question
1 |
0.9495
|
0.1104 |
| Question
2 |
0.0762
|
0.1356 |
| Question
3 |
0.0271
group III is different groups I and II |
0.1105 |
| Question
4 |
0.0651
|
0.1312 |
| Question
5 |
0.0199
group III is different from groups I
and II |
0.2253 |
| Question
6 |
0.1582 |
0.0384
group I is different from groups II
and III |
| Question
7 |
0.1020 |
0.0421
group I is different from groups II
and III |
|
DISCUSSION
The etiology
of atherosclerosis is not clear yet. Several factors may contribute
to its occurrence and progression, among which are heredity, smoking,
hypertension, diabetes mellitus, hypothyroidism, stress, sedentary
lifestyle and obesity.6,7
The present study compared three treatments for hypercholesterolemic patients with arterial disease, and its aim was to assess the clinical improvement of patients in terms of their quality of life after the prescribed treatment.
Comparing our results with those available in literature, it was observed that our patients achieved clinical improvement when serum cholesterol levels lowered.8-10
Furthermore, it was observed that a low cholesterol diet is the first step for controlling hypercholesterolemia,3 but it is not enough to lower serum low density lipoprotein levels (LDL).11 There are several classes of drugs used for lowering LDL levels.12 In our study, the one chosen was simvastatin; evaluation of other drugs was not included.
Concerning the analysis of each group, it was observed that, in the end of treatment, all groups presented decreased serum total cholesterol levels. However, such decrease was not only due to lowered LDL levels. In groups I (low cholesterol diet and physical therapy) and III (normal diet, simvastatin administration and physical therapy), a decrease in HDL levels was also observed, which is not beneficial to the patient given that HDL has a crucial role in reducing the risk of coronary artery disease and, unlike LDL, does not form deposits in arterial wall when found in high concentrations. An increase in HDL levels and a decrease in LDL levels was only observed in group II (low cholesterol diet, simvastatin administration and physical therapy), which is a crucial fact, since a decrease in LDL levels and an increase in HDL levels leads to a more efficient control of atherosclerosis.3 Studies show that a low cholesterol diet is the first step for controlling hypercholesterolemia.
Despite the fact that all patients explicitly mentioned a significant improvement after treatment,13-15 it was difficult to make an objective evaluation of their actual progress. Given that the initial and final measures of the ankle-brachial index (which is a quantitative method) did not present significant differences, patients were evaluated in terms of their quality of life, contrasting their statuses in the beginning and end of treatment.
Several reports mention that, when risk factors for diseases are controlled, patients enjoy a better quality of life.4,5,16-18. After considering the method adopted in each of these reports for quantifying their patients' quality of life, the Quality of Life Questionnaire4 of Centro de Tratamento Bezerra de Menezes - Ciclo de Educação em Saúde Mental (which assesses patients in social, emotional, professional and health aspects) and the Wisconsin Brief Pain Questionnaire5 (which assesses functional aspects concerning pain) were chosen. Answers to the questionnaires before treatment started were obtained in each patient's medical record and through interviews with parents and relatives. Answers after the end of treatment were obtained through interview with the patient him/herself.
Literature shows that patients assessed in different quadrants (such as psychological, emotional and functional) and in different moments present significant and reliable variations.2 Following such finding, in the present study, patients were assessed in two different moments (beginning and end of treatment) through the Wisconsin and Bezerra de Menezes questionnaires.
In the beginning of treatment, many patients were found to consider that their disease was the end of their life expectancy, finding which agrees with those available in literature.19 However, as the patients adhered to the treatment and started to improve, such perception of their disease changed. Even those who were in worse initial clinical situations realized their improvement as they contrasted their statuses before and after treatment.20
It is relevant to mention that family support played a crucial role in this process. Furthermore, medical follow-ups were also important, given that patients would feel relieved as they perceived their clinical improvement after every new appointment.
Some authors compared patients with limb ischemia who underwent surgical treatment, ranging from revascularization to primary amputation.15,21-25 All of them agreed that quality of life improves when clinical progress occurs,26,27 and reported that patients who underwent revascularization felt less pain and, thus, had a better quality of life.
In our study, as treatment advanced and questionnaires were answered, patients were progressively more welcomed by their families and by society and presented improvement in quality of life, independently of the group to which they belonged.19 Analysis of answers to Bezerra de Menezes questionnaire revealed that improvements related to health quadrant were numerically superior and statistically significant in the three groups, while those related to social, emotional and professional quadrants, despite having numerical difference between first (before treatment) and second (after treatment) assessments, did not present statistically significant differences according to Kruskal-Wallis test (when groups were considered altogether).
Comparing each group in relation to health aspects before and after treatment, Wilcoxon test revealed that group I presented the best statistical result. However, considering that the initial values of group II were lower, one can affirm that, after treatment, this was the group which presented the greatest improvement in quality of life in terms of health aspects. The rating of group III concerning this aspect was lower because its initial situation was similar to group I but it did not achieve end values similar to group I.
As for the Wisconsin Brief Pain Questionnaire, answers to its first part evidenced that after treatment all patients, independently of the group to which they belonged, achieved improvement (numerically and statistically significant according to Wilcoxon test). Based on the analysis of answers of all groups before and after treatment with Kruskal-Wallis test, one can conclude that there was improvement; however, such result was not statistically significant. Even patients whose initial situation was worse achieved results similar to those of other patients.
Concerning the second part of the Wisconsin questionnaire, which assesses to which extent pain interferes with the life of the patient, there were numerically (but not statistically) significant differences among the groups when their statuses before and after treatment were separately compared with Wilcoxon test. Analysis of the three groups before and after treatment using Kruskal-Wallis test evidenced that, in relation to questions 3 (walking ability) and 5 (relations with other people), initial situation of patients in group III was worse than those in groups I and II; however, after treatment, their values were similar to those of other groups, not presenting statistically significant difference in relation to other groups. Concerning questions 6 (sleep) and 7 (enjoyment of life), group I presented statistically significant results. Observing numerically, groups II and III also presented improvement in this aspect, despite group I having had the greatest improvement.
CONCLUSION
Based on the results of the present study, we can affirm that low cholesterol diet along with simvastatin administration and physical therapy is the best approach to treating claudicant hypercholesterolemic patients with arterial disease. Isolated therapies do not manage to achieve the final goal, which is improving the patient's quality of life. Family support during treatment is also crucial for a positive final result.
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