INVESTIGATION OF THE EFFECT OF DIABETIC NEUROPATHIC PAIN ON DEPRESSION AND QUA- LITY OF LIFE

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1 Acta Medica Mediterranea, 2018, 34: 643 INVESTIGATION OF THE EFFECT OF DIABETIC NEUROPATHIC PAIN ON DEPRESSION AND QUA- LITY OF LIFE MSC. SIBEL GÖKMEN 1, ASSOC PROF. DR.ELIF UNSAL AVDAL 2, ASIST PROF. DR.BERNA NILGUN ÖZGURSOY URAN 3 ¹Izmir Katip Çelebi University Ataturk Research Hospital, İzmir, Turkey - 2,3 Izmir Katip Çelebi University, Faculty of Health Sciences ABSTRACT Introduction and aim: One of the most common and long-lasting complications in uncontrolled diabetes is diabetic neuropathy. The aim of this study was to investigate the effect of diabetic neuropathic pain on depression and quality of life. Material and methods: The study was designed as cross-sectional and descriptive study and was conducted between February and April of 2016 with 40 diabetic individuals diagnosed with diabetic neuropathy. Data were collected using the Diabetes Individual Identification Form, Leeds Assessment of Neuropathic Symptom and Signs Scale, Beck s Depression Inventory and the EORTC QLQ- C30 Quality of Life Questionnaire. Verbal and written consent was obtained and the data were analyzed with the SPSS program. Results: 25 women and 15 men participated in this study. It was determined that 50% of the individuals participating in the study had had diabetes for 6-10 years, 55% had received insulin treatment and 25% had only received oral anti-diabetic (OAD) treatment. The mean score for the LANSS pain scale of diabetic subjects was 9.83, the mean score for the BECK s Depression Inventory was and the mean score for the EORTC Quality of Life Questionnaire was 612. The correlation coefficient between the LANSS pain scale and the EORTC Quality of Life Questionnaire was significant for individuals with diabetic neuropathic pain. There was a positive correlation between the two scales (r=0.671, p=0.000 <α=0.05.). There was a positive but weak relationship between the LANSS Pain Scale and the BECK Depression Inventory, while no significant relationship was found between the BECK Depression Inventory and the EORTC Quality of Life Questionnaire for individuals with neuropathic pain (r=0.097, p=0.551>α=0.05.) rs=0.312, p=0.050 =α=0.05). Conclusion: Diabetic neuropathic pain seriously affects the quality of life and increases susceptibility to psychological problems such as depression. When using a patient-specific treatment approach for diabetes, taking into account the data on depression and quality of life will increase the patient's participation in the treatment process and the success of the treatment. Keywords: diabetetes, neuropathic pain, depression, life quality. DOI: / _2018_3_99 Received November 30, 2017; Accepted January 20, 2018 Introduction Diabetes mellitus (DM) is a chronic and complicated disease that relies on glycemic control and requires continuous medical care which aims to reduce its multifactorial risks. Nowadays diabetes, because of its frequency and complications, is a growing health problem across the world. Concurrent with changes in lifestyle, its prevalence in all populations, particularly the prevalence of type 2 DM, is rapidly increasing. As of 2013, the number of diabetic patients in the world was 382 million and this was predicted to increase by 55% by 2035, reaching 592 million (1-3). According to the findings of Turkish Diabetes Epidemiology (TURDEP-I) study conducted in Turkey between , the prevalence of type 2 DM was 7.2%, while it rose to 13.7% in the TUR- DEP-II study published in 2011 (4, 5). Uncontrolled diabetes causes hyperglycemia leading to chronic complications affecting in all bodily systems, primarily in the cardiovascular system, the kidney, the eye, and the nervous system, in which it causes neuropathy (1).

2 644 Sibel Gökmen, Elif Unsal Avdal et Al The prevalence, incidence and mortality rates of cardiovascular diseases are 2-8 times higher in diabetic individuals than in their non-diabetic peers (6, 7). Diabetes is the most common cause of kidney failure and neuropathy-induced amputation in the world. Neuropathy, one of the most common long-term complications of diabetes, is a major cause of morbidity and mortality (1, 3). Painful diabetic neuropathy leads to feelings of inadequacy and it has been shown in a variety of studies that it has a negative influence on the emotional states of diabetic individuals, especially in the long term (8, 9). Since diabetic neuropathic pain requires complex and long treatment, it affects the quality of life of the individual, both physically and psychologically. Diabetic individuals may face psychiatric problems throughout their lives, with various psychological, physical and social impacts. One of the most common psychiatric problems is depression. Depression leads to problems such as a reluctance to engage in daily activities, an inability to enjoy life, and feelings of grief, pessimism, sadness, guilt, unhappiness and despair. This negatively affects the individual at a biopsychosocial level (1, 10, 11). Depression negatively affects the management of the blood sugar in diabetic individuals, eventually causing the patient to develop resistance to insulin. This condition can lead to many complications in the diabetic individual. In the literature, some studies have demonstrated that depression causes a rise in the complications found in diabetic individuals, and, at the same time, that depressive symptoms are greater in those with complications. With the development of diabetes-associated complications, obstacles accumulate in the daily life of the patient, resulting in a lower quality of life and difficulties managing the patient s illness (1, 10). Despite the fact that diabetic neuropathic pain affects the rate of depression and quality of life, there has been no research about this situation in Turkey. This study was planned to ensure that individuals with diabetic neuropathic pain are treated with a holistic approach during treatment and that they have a better quality of life. The aim of this study was to investigate the effect of diabetic neuropathic pain on depression and quality of life. Materials and methods Study overview and participants This cross-sectional and descriptive study was conducted between February and April of 2016 in the Clinic of Internal Medicine and Endocrinology of a Training and Research Hospital in Izmir, Turkey. The number of patients treated for diabetic neuropathic pain in the endocrine polyclinic of the hospital was between eight and nine per month. In addition, four diabetes nurses in the hospital regularly conducted diabetes education in the clinic through group and individual education. During this education, diabetic individuals diagnosed with neuropathy were placed under a doctor s supervision. Based on the information obtained from the nonresearched data, the total number of patients with diabetic neuropathy referred to the hospital was determined as 15 per month on average. A total of 40 patients who voluntarily agreed to participate in the study for three months constituted the sample of the study. All participants provided written informed consent and the study protocol was approved by the ethics committee of the hospital (Izmir, Turkey). Data Collection Forms In order to obtain information on the sociodemographic and disease status of participating individuals, a 14-item Diabetic Individual Identification Form, which was developed by the researcher based on the literature, was used. In addition to this form, LANSS (Leeds Assessment of Neuropathic Symptom and Signs) scale,which was previously used by Bennett to clinically differentiate neuropathic pain from nociceptive pain (12), Beck s Depression Inventory and, lastly, the EORTC QLQ-C30 Quality of Life Questionnaire (13) were used for data collection. The Turkish validity and reliability study of the LANSS pain scale was conducted by Yücel et al. in When compared with clinical diagnosis it displays a sensitivity of between 82 and 91% and a specificity of around 80-94% (14).The Beck s Depression Inventory is a scale developed by Beck (15), adapted to Turkish by Hisli, and the Cronbach s alpha coefficient of the Turkish validity and reliability study was found to be 0.80 (16). The EORTC QLQ-C30 Quality of Life Questionnaire was developed by EORTC (13), and a validity and reliability study of its scope was conducted by Beşer and Öz. In the Turkish adaptation, the Cronbach s alpha coefficient was calculated as The EORTC QLQ-C30 is a widely used quality of life questionnaire for chronic patients worldwide (17).

3 Investigation of effect of diabetic neuropathic pain on depression and quality life 645 Data Analysis The statistical package for social science (SPSS) program was used to analyze the data from the diabetic subjects participating in the study. The Mann Whitney U-Test was used to evaluate the study data because the distribution between the groups was not normal, and descriptive statistical methods were also used. The Kruskal Wallis H-Test was used for the comparison of more than one group. The Anderson-Darling Test Statistic was used for the normality test in the analyses. The Spearman correlation coefficient analysis was used for relationship exploratory analyses in the study data. An expert statistician was consulted while assessing the statistical analyses in this study. felt uneasy was 42.5% and the percentage who went for a routine health check-up once every 6 months was 30%. Sociodemographic Characteristics N % Age Sex Marital Status Female Male v Never married 2 5 Married Divorced 6 15 Widow 0 0 Estranged 6 15 Ethics of the research Written ethical approval was obtained from Ethics Committee of the Training and Research Hospital in the province of Izmir where the research was carried out. Written institutional permission for the hospital was granted by the General Secretariat of the Public Hospitals Union. Oral and written consent was obtained from the diabetic individuals participating in the research after the purpose of the research had been explained. Results Education Level Economic Status Other 0 0 Illiterate Primary school Junior High High school College 2 5 Good Moderate Bad 6 15 Social Security Authority Information about the frequencies and percentages of the socio-demographic characteristics of individuals with diabetic neuropathic pain is given in Table 1. In the study, which was conducted with 40 individuals with diabetic neuropathic pain, 57.5% of the individuals were between the ages of 44-54, while 62.5% were women and 65% were married. 47.5% of the participants were primary school graduates, 60.0% had a moderate economic status and 52.5% had insurance from the Social Security Organization for Artisans and the Self- Employed (Bağkur). The distribution of disease-related characteristics of the subjects covered in this study is shown in Table 2. According to the table, 50.0% of the individuals had been diagnosed with diabetes for 6-10 years, 55.0% received insulin treatment, 85.0% had a family history of diabetes and 55.9% of those with a family history of diabetes confirmed that the disease was present in members of their immediate family such as their mother, father or siblings. The percentage of diabetic individuals who went to a health facility for diabetes monitoring when they Health Insurance Retirement Fund of Civil Servants Social Security Organization for Artisans and Self-Employed Private Insurance 0 0 Other 0 0 None 0 0 Table 1: Sociodemographic characteristics of individuals with diabetic neuropathic pain. Descriptive statistics for the LANSS Pain Scale, Beck s Depression Inventory and EORTC Quality of Life Questionnaire, which were all applied to participants in the study, are shown in Table 3. The mean value of the LANSS pain scale for diabetic individuals was 9.83, the lowest score being 0, while the highest was 16. This indicates that the average value of the LANNS pain scale was above the median value. The mean score of the Beck s Depression Inventory of the diabetic subjects was 18.03; the lowest score was 0 and the highest was 49, which was above the median value,

4 646 Sibel Gökmen, Elif Unsal Avdal et Al too. The average score of the EORTC Quality of Life Questionnaire for diabetic individuals was 612, with the lowest score being and the highest Duration of Having Diabetes Treatment Method for Diabetes Disease Related Features N % Less than 1 year years years years and more Oral Antidiabetic (OAD) 4 10 Insulin Previously OAD but now Insulin 0 0 Exercise and Diet 2 5 Exercise, Diet and OAD 2 5 Only Diet 0 0 Oral Antidiabetic Drugs (OAD) and Insulin Beck s Depression Inventory and EORTC Quality of Life Questionnaire were always lower than the mean values, resulting in the distribution of scores not being symmetrical but rather skewed to the right. Table 4 demonstrates statistics and the calculated p values of the Anderson-Darling normality test for the scores achieved from the LANSS Pain Scale, the Beck s Depression Inventory and the EORTC Quality of Life Questionnaire. The null hypothesis for the normality test was established as H0: distribution of scores fits normal distribution and the alternative hypothesis was H1: distribution of scores does not fit normal distribution. H0 was rejected because the individual p-values shown in the Table 4 were smaller than the significance level, p=0.05. Accordingly, it was confirmed that the distribution of the scores obtained from these three scales did not fit the normal distribution, and therefore non-parametric tests were used in the analysis of these three scales. Diabetes in Family History Degree of Relativeness with Diabetic Individual Yes No 6 15 First degree relative Second degree relative Total When felt uneasy Once a month 0 0 Anderson-Darling Test Statistic p - value LANNS BECK EORTC QLQ Table 4: Normality test analysis of scores obtained from the lanss pain scale, beck s depression inventory and eortc quality of life questionnaire. Frequency of Going a Health Facility for Diabetes Control Once in 2 months 0 0 Once in 3 months 2 5 Once in 6 months Once a year Table 2: Descriptive characteristics of individuals with diabetic neuropathic pain. N Ss Median Minimum Maximum LANNS BECK EORTC QLQ Table 3: Descriptive statistics of the lanss pain scale, beck s depression inventory and eortc quality of life questionnaire in individuals with diabetic neuropathic pain. In this questionnaire, the median value was below the average. The median values of all the scores obtained from the LANSS Pain Scale, Duration of Diabetes LANNS BECK EORTC QLQ years years years and more Kruskal-Wallis Test Statistic 15.56* * (p-value) Table 5: Analysis of the scores of lanss pain scale, beck s depression inventory and eortc quality of life questionnaire in comparison with diabetes time in individuals with diabetic neuropathic pain. When Table 5 was examined, it was observed that the scores of individuals with diabetic neuropathic pain obtained from the LANSS Pain Scale and EORTC Quality of Life Questionnaire were not homogeneous regarding the duration of having diabetes (p <0.05). In the analyses assessed at 95% confidence interval, the difference between the mean scores of the LANSS Pain Scale and the

5 Investigation of effect of diabetic neuropathic pain on depression and quality life 647 EORTC Quality of Life Questionnaire were significant in subjects with diabetic neuropathic pain. According to this result, both the LANSS values and EORTC values of individuals exclusively diagnosed with diabetes for over 11 years were higher than those who had had diabetes for different lengths of time. No statistically significant difference was found between the scores for the Beck s Depression Inventory of individuals with diabetic neuropathic pain regarding the duration of diabetes (p> 0.05). Diabetes Treatment Method Oral Antidiabetic Drugs (OAD) LANNS BECK EORTC QLQ Insulin Physical exercise and Diet Physical exercise, Diet and OAD OAD and Insulin Kruskal-Wallis Test Statistic 11.05* (p-value) Table 6: Analysis of the scores of lanss pain scale, beck s depression inventory and eortc quality of life questionnaire in comparison with diabetes treatment method in individuals with diabetic neuropathic pain. In Table 6, when the LANSS Pain Scale scores of the diabetic neuropathic pain patients was evaluated, there was a significant difference found between the mean scores obtained from the LANSS pain scale and the treatment type (p <0.05). According to this, the LANSS values of the individuals who were on insulin treatment specifically were higher than those on other methods of treatment. There was no statistically significant difference between the Beck s Depression Inventory and the EORTC Quality of Life Questionnaire (p> 0.05). BECK EORTC QLQ-30 LANNS rs= (p=0.050) rs=0.671* (p=0.000) BECK rs=0.097 (p=0.551) Table 7: Analysis of the correlation between the lanss pain scale, beck s depression inventory and eortc quality of life questionnaire in individuals with diabetic neuropathic pain. Since the scores obtained from the scales were not normally distributed, in Table 7 instead of the Pearson correlation coefficient, the Spearman nonparametric correlation coefficient (rs) was used to compare scale scores and the correlation coefficients. In line with this, there was a positive and strong correlation between the LANSS pain scale and the EORTC Quality of Life Questionnaire in the individuals with diabetic neuropathic pain (rs = 0.671, p = 0.000). Furthermore, there was no significant relationship between the Beck s Depression Inventory and the EORTC Quality of Life Questionnaire in the individuals with neuropathic pain (rs = 0.097, p = 0.551), yet there was a positive but weak correlation between the LANSS Pain Scale and the Beck s Depression Inventory (rs = 0.312, p = 0.050). Discussion In this study, the mean value of the LANSS pain scale for the diabetic subjects was found to be 9.83 (Table 3). In a study on diabetic individuals conducted by Gül et al. (2015), it was reported that the mean value for the LANSS pain scale was found to be 16.7 (18). The LANSS pain scale score in our study was not parallel to the study mentioned above. In the literature, the LANSS pain scale is evaluated as follows: a score below 12 is considered as nociceptive pain, while 12 points and above indicate neuropathic pain (14). According to this information, the pain of individuals with diabetes in our study could be considered as nociceptive (28,29,30). The reasons for this are that the researcher did not obtain pain values from the diabetic participants at their first admission to the hospital and that the LANSS pain scores of the diabetic individuals who began treatment immediately decreased over time. The mean score of the Beck s Depression Inventory for diabetic participants was and the average score of the EORTC Quality of Life Questionnaire was 612. Based on these values, the depression level of the diabetic individuals was concluded to be mild to moderate and the quality of life to be low (Table 3). There was a statistically significant difference (p <0.05) between the LANSS pain scale and the EORTC Quality of Life Questionnaire scores when compared to the duration of diabetes in the individuals with diabetic neuropathic pain (Table 5). In particular, diabetics whose disease had lasted for 11 years or more had higher LANSS pain scores, while

6 648 Sibel Gökmen, Elif Unsal Avdal et Al their EORTC Quality of Life scores were lower than the scores of those whose diabetes had lasted different lengths of time (Table 5). In the literature, as in our research, a significant difference was reported between quality of life and the duration of diabetes. As the duration increased, the quality of life decreased (19). On the other hand, in the study of Sönmez (2013), no significant difference was stated between the general quality of life of diabetic individuals and the duration of diabetes (20). Regarding the literature, it is possible that in diabetes which is chronic, several other complications may arise as a result of poor prognosis. Complications cause restrictions to diabetic individuals lives, and anxiety and worry about the future consequently negatively affect the quality of life (1). This information was in line with our results. There was no significant difference found between the duration of diabetes and the Beck s Depression Inventory scores of the subjects with diabetic neuropathic pain (p> 0.05) (Table 5). In the study of Gülseren (2001), although anxiety disorder was seen after the first diagnosis of diabetes, depressive disorder was seen more frequently as the disease developed and had a prolonged duration due to the effects of chronic fluctuations of blood sugar on the central nervous system (21). In a study conducted by Bahar (2006) which is comparable to ours, there was no significant relationship reported between the duration of the illness and depression in diabetic individuals (10). In the light of this information found in the literature, it is believed that diabetic individuals may experience different levels of depression at every stage of their illness. In our study, a statistically significant difference was found between the mean scores of the diabetic neuropathic pain patients for the LANSS pain scale and the diabetes treatment method (p <0.05). In particular, the LANSS values of individuals treated with insulin were higher than for the other treatment regimens (Table 6). No resource on this subject was found in the literature. In conclusion, we can note that the pain scores of the diabetic individuals in our study were higher because of the fact that glycemic control had not been successfully achieved in the diabetic subjects receiving insulin therapy and their neuropathic complications were more severe (1). There was no statistically significant difference between the Beck s Depression Inventory and the EORTC Quality of Life Questionnaire with respect to the treatment methods of the diabetic subjects participating in the study (Table 6) (p> 0.05). In a review of the literature it was found that diabetic individuals using insulin had more features of depression than those who only used oral antidiabetic drugs (22). In another study, diabetic individuals using both insulin and oral antidiabetic therapy were found to be more likely to develop depression (23). In a study by Yüksek (2007) it was also shown that individuals with diabetes using insulin had a higher quality of life than diabetic subjects using other therapies (24). The differences observed in the types of treatment for diabetes originate from the fact that the treatment approaches of doctors differ from each other (25). Treatment methods prescribed to diabetic individuals can affect depression and quality of life in a positive or negative way (1). As a result of the correlation analysis of the LANSS pain scale and the EORTC Quality of Life Questionnaire for individuals with diabetic neuropathic pain, a slightly positive correlation was found between the two scales (p <0.05) (Table 7). In the same analysis, although no positive relationship was found between the Beck s Depression Inventory and the EORTC Quality of Life Questionnaire for the individuals with diabetic neuropathic pain, there was a positive but weak relationship found between the LANSS Pain Scale and the Beck s Depression Inventory (Table 7). On the basis of this result, we can report that as the pain scores of individuals with diabetic neuropathic pain rise, the quality of life falls, while the tendency to experience depression increases. In reviewing the literature studies were found indicating similar results with regard to the negative effects of diabetic neuropathic pain on depression and its general effects on life (23, 28,29,30). Neuropathic pain, pain-associated depression, sleep and eating disorders can also negatively contribute to the quality of life of diabetic individuals (1). We can note that the results of our study concur with this information found in the literature. Conclusions and Recommendations Diabetic neuropathic pain seriously influences the individual s quality of life and increases their susceptibility to psychological problems such as depression. Although it is not only depression that affects the quality of life of diabetic individuals, their likelihood of depression increases as their pain increases.

7 Investigation of effect of diabetic neuropathic pain on depression and quality life 649 In the management of peripheral neuropathic pain, the Turkish Society of Endocrinology and Metabolism (TEMD), in line with the evidencebased guidelines of American and European diabetes associations, recommends the use of antidepressant derivatives alone or in combination with other medicines for the treatment of painful diabetic neuropathy (Level of evidence A) (27). The results of our study also concur with this evidence-based statement. On this basis, the following suggestions can be offered to the patients and health workers: The addition of the symptom of neuropathic pain to individual diagnosis forms for diabetes in all public and private hospitals and an increased awareness of this issue in diabetes care teams The establishment of psychoeducation support groups for individuals with diabetes in all public and private hospitals, meeting regularly in order to raise awareness of this issue. 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8 650 Sibel Gökmen, Elif Unsal Avdal et Al 23) Turhan H. Tip 2 diabetes mellitus lu hastalardatedavi şekline ve hastalik süresine göre depresyon veanksiyete.master Thesis. İstanbul, 2007; ) Yüksel S. Tip 1 ve Tip 2 diyabetik hastalarin uyku kalitesi,anksiyete, depresyon ve yaşam kalitesinindeğerlendirilmesi. İç Hastalıkları Hemşireliği Yükseklisans Tezi. Afyon 2007; ) Hamilton MA. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960; 23; ) İrem A. Tip 1 ve Tip 2 diyabetik hastalarin uyku kalitesi, anksiyete, depresyon ve yaşam kalitesinin değerlendirilmesi. Yükseklisans Tezi. Afyonkarahisar Kocatepe Üniversitesi Sağlık Bilimleri Enstitüsü 2007; ) Türkiye Endokrin ve Metabolizma Derneği (TEMD). Diabetes mellitus ve komplikasyonlarinin tani, tedavi ve izlem kilavuzu [Internet]. 28) Cragg JJ, Noonan VK, Noreau L, Borisoff JF, Kramer JK. Neuropathic pain, depression, and cardiovascular disease: a national multicenter study. Neuroepidemiology. 2015; 44(3): doi: / ) Dziemidok P, Dąbrowski M, Makara-Studzińska M. Relationship between diabetic neuropathy and occurrence of depression among diabetic patients. Psychiatr Pol. 2016; 50(2): doi: /PP/OnlineFirst/ ) Johnny-Wei Bai, Leif E. Lovblom, Marina Cardinez, Alanna Weisman, Mohammed A. Farooqi,et.al. Neuropathy and presence of emotional distress and depression in longstanding diabetes: Results from the Canadian study of longevity in type 1 diabetes. Journal of Diabetes and Its Complications 31 (2017) Corresponding author ELIF UNSAL AVDAL Assoc. Professor, Dr Izmir Katip Çelebi University Faculty of Health Sciences Izmir (Turkey)