Effect of Botox Injection on Depression in Chronic Migraine
Effect of Botox Injection on Depression in Chronic Migraine
Objective. The current study retrospectively evaluated patient reported outcomes (PROs) collected before and after at least 2 sessions of onabotulinumtoxinA (onabot) injections for chronic migraine. Depression was assessed by the Patient Health Questionnaire-9.
Method. Chronic migraineurs receiving onabot were identified. In addition to the Patient Health Questionnaire-9 (PHQ9), the European Quality of Life (QOL), 5-Dimension (EQ-5D) (QOL), Headache Impact Test (HIT6), and Pain Disability Index (PDI) were reviewed across ≥2 consecutive onabot injections for 6–12 months. Paired t-tests on patient's questionnaire scores before and after treatment were performed. Analysis of the PHQ9 was restricted to patients with pretreatment scores ≥ 10 (moderate to severe depression). Change in PHQ9 was the primary outcome, and other PROs were also evaluated.
Results. Four hundred twenty-nine patients met the inclusion criteria, and data were gathered from 2010 to 2014. Average age was 45 years, with 85.5% female, and 92.1% Caucasian. There were 127 patients with PHQ9 scores ≥10 at baseline. Their PHQ9 scores improved from 14.4 (high-moderate) pre-onabot to 11.3 (low-moderate) post-onabot (P <.0001, 95% CI = −4.2 to −2.1); PDI improved from 4.3 to 3.8 (P = .0078, 95% CI = −0.7 to −0.1); EQ-5D improved from 0.74 to 0.77 (P = .0078; 95%CI = 0.01 to 0.04); HIT6 improved from 63.3 to 60.5 (P <.0001, 95%CI = −3.4 to −2.2). For comparison, in the PREEMPT onabot regulatory trials, HIT6 changed from 66 to 61.2 after 5 onabot injections at 24 weeks, P < .001.
Conclusion. Onabot injections in chronic migraine patients statistically improved depression scores in patients beginning with at least moderate depression and improved scores in headache and quality of life. Onabot injections also decreased impact of headache on daily life.
Migraine is a common primary headache disorder, with a 1-year prevalence rate of 10%, ranging from 4.5–6% in men and 14.5–18% in women. Furthermore, it is associated with mood disorders including depression, which may have a similar genetic basis. Both migraine and depression cause a large economical and emotional burden for the individual and the society. Estimates from the World Health Organization (WHO) suggest that depression will be the leading cause of disease burden after ischemic heart disease by 2020. Lipton noted in 2009 that one of the major risk factors for worsening and transforming episodic migraine to chronic daily headache is the presence of psychiatric conditions such as depression.
As chronic migraine (CM) is often accompanied by clinical depression, the current study investigated the changes in depression when CM patients are treated with onabot injections. The study was performed at a large tertiary referral Headache Center in the US. In this institution, patient reported outcome (PRO) measures are routinely collected via a data capture system called the Knowledge Program (KP). Prior to each visit, patients complete a questionnaire and validated outcome measures on either an electronic tablet or computer. The outcome measures obtained in the KP are disease-specific to each center in the institution. For headache, the KP includes the Patient Health Questionnaire (PHQ9), Headache Impact Test (HIT6), Pain Disability Index (PDI), and European Quality of Life 5 Dimensions (EQ-5D). These measures are collected at each visit and are used to evaluate quality of care over time.
PHQ9 is the KP outcome measure collected for depression measurement and is a shorter and more clinically oriented version of the historical Primary Care Evaluation of Mental Disorders (PRIME-MD). PHQ9 serves to detect and measure depression and its severity in the clinical setting. PHQ9 was validated by Spitzer in 3000 primary care patients in eight different clinics and 3000 obstetrics/gynecology patients in seven different clinics in 1999 and 2000, respectively. PHQ9 scores range from 0 to 27. Kroenke et al described how to interpret the scores: 0–4: no depression, 5–9: mild depression, 10–14: moderate depression, 15–19: moderately severe depression, and 20–27: severe depression. Löwe et al reported that a change of 5 points is a clinically meaningful change in depression and hence a significant response to treatment.
HIT6 is a screening and monitoring tool that was designed to provide a global measure of headache impact in 6 domains. The impact domains evaluated include social functioning, vitality, cognition, psychological distress, and severity of headache. HIT6 scores range from 36–78. Scores ≤49 represent little or no headache impact, scores between 50 and 55 represent some impact, scores between 56 and 59 represent substantial impact, and scores ≥60 indicate severe impact. HIT6 has good internal consistency and test-retest reliability. Ware et al validated the HIT6 for 624 migraine patients between ages 18 and 39. In this study, 6.4% had CM, 42.1% had episodic migraine (EM), and 51.5% had other types of headaches. The test–retest reliability was 0.77, and the internal consistency reliability among migraine sufferers was between 0.82 and 0.9. Rendas-Baum et al validated HIT6 specifically for CM using over 1300 patients. Again, the test–retest reliability ranged between 0.76 and 0.8.
EQ-5D encompasses 5 dimensions including mobility, self-care, usual/general activity, pain or discomfort, anxiety/depression, as well as general health of the patient. The health status is presented as an index from 0 to 1, where 1 is the best quality of life (QOL). In a study by Xu et al, EQ-5D was determined to have a statistically and clinically significant decrement for patients experiencing mild, moderate, and severe levels of headache. It was generally observed to correspond well with clinical ratings for migraine pain severity.
PDI was developed by Pollard in the 1980s for elucidating the degree with which pain interferes with functioning of an individual in 7 broad areas. It measures 2 factors. Factor 1 is for voluntary activities (items 1–5: family/home responsibilities, recreation, social activity, occupation, and sexual behavior) and Factor 2 is for obligatory activities (items 6 and 7: self-care and life support activity). In the PDI, each item ranges from 0 (no interference) to 10 (total interference), totaling to 70 points (most pain disability). The PDI has a strong internal consistency (Factor 1, Cronbach α = 0.85; Factor 2, Cronbach α = 0.70). Tait et al reviewed 2 studies to examine the reliability and validity of PDI. One study contained 444 subjects and the second study included 46 patients, which was a subset of the initial study that included patients who were admitted to the inpatient ward. They found that PDI is a valid and reliable measure of pain-related disability.
We analyzed data from the KP questionnaire for CM patients who came to our center for onabotulinumtoxinA (onabot) injections (BOTOX, Allergan, Irvine, CA, USA). We hypothesized that PROs would improve after onabot treatment. As our primary outcome we evaluated change in depression after onabot treatment for CM.
Abstract and Introduction
Abstract
Objective. The current study retrospectively evaluated patient reported outcomes (PROs) collected before and after at least 2 sessions of onabotulinumtoxinA (onabot) injections for chronic migraine. Depression was assessed by the Patient Health Questionnaire-9.
Method. Chronic migraineurs receiving onabot were identified. In addition to the Patient Health Questionnaire-9 (PHQ9), the European Quality of Life (QOL), 5-Dimension (EQ-5D) (QOL), Headache Impact Test (HIT6), and Pain Disability Index (PDI) were reviewed across ≥2 consecutive onabot injections for 6–12 months. Paired t-tests on patient's questionnaire scores before and after treatment were performed. Analysis of the PHQ9 was restricted to patients with pretreatment scores ≥ 10 (moderate to severe depression). Change in PHQ9 was the primary outcome, and other PROs were also evaluated.
Results. Four hundred twenty-nine patients met the inclusion criteria, and data were gathered from 2010 to 2014. Average age was 45 years, with 85.5% female, and 92.1% Caucasian. There were 127 patients with PHQ9 scores ≥10 at baseline. Their PHQ9 scores improved from 14.4 (high-moderate) pre-onabot to 11.3 (low-moderate) post-onabot (P <.0001, 95% CI = −4.2 to −2.1); PDI improved from 4.3 to 3.8 (P = .0078, 95% CI = −0.7 to −0.1); EQ-5D improved from 0.74 to 0.77 (P = .0078; 95%CI = 0.01 to 0.04); HIT6 improved from 63.3 to 60.5 (P <.0001, 95%CI = −3.4 to −2.2). For comparison, in the PREEMPT onabot regulatory trials, HIT6 changed from 66 to 61.2 after 5 onabot injections at 24 weeks, P < .001.
Conclusion. Onabot injections in chronic migraine patients statistically improved depression scores in patients beginning with at least moderate depression and improved scores in headache and quality of life. Onabot injections also decreased impact of headache on daily life.
Introduction
Migraine is a common primary headache disorder, with a 1-year prevalence rate of 10%, ranging from 4.5–6% in men and 14.5–18% in women. Furthermore, it is associated with mood disorders including depression, which may have a similar genetic basis. Both migraine and depression cause a large economical and emotional burden for the individual and the society. Estimates from the World Health Organization (WHO) suggest that depression will be the leading cause of disease burden after ischemic heart disease by 2020. Lipton noted in 2009 that one of the major risk factors for worsening and transforming episodic migraine to chronic daily headache is the presence of psychiatric conditions such as depression.
As chronic migraine (CM) is often accompanied by clinical depression, the current study investigated the changes in depression when CM patients are treated with onabot injections. The study was performed at a large tertiary referral Headache Center in the US. In this institution, patient reported outcome (PRO) measures are routinely collected via a data capture system called the Knowledge Program (KP). Prior to each visit, patients complete a questionnaire and validated outcome measures on either an electronic tablet or computer. The outcome measures obtained in the KP are disease-specific to each center in the institution. For headache, the KP includes the Patient Health Questionnaire (PHQ9), Headache Impact Test (HIT6), Pain Disability Index (PDI), and European Quality of Life 5 Dimensions (EQ-5D). These measures are collected at each visit and are used to evaluate quality of care over time.
PHQ9 is the KP outcome measure collected for depression measurement and is a shorter and more clinically oriented version of the historical Primary Care Evaluation of Mental Disorders (PRIME-MD). PHQ9 serves to detect and measure depression and its severity in the clinical setting. PHQ9 was validated by Spitzer in 3000 primary care patients in eight different clinics and 3000 obstetrics/gynecology patients in seven different clinics in 1999 and 2000, respectively. PHQ9 scores range from 0 to 27. Kroenke et al described how to interpret the scores: 0–4: no depression, 5–9: mild depression, 10–14: moderate depression, 15–19: moderately severe depression, and 20–27: severe depression. Löwe et al reported that a change of 5 points is a clinically meaningful change in depression and hence a significant response to treatment.
HIT6 is a screening and monitoring tool that was designed to provide a global measure of headache impact in 6 domains. The impact domains evaluated include social functioning, vitality, cognition, psychological distress, and severity of headache. HIT6 scores range from 36–78. Scores ≤49 represent little or no headache impact, scores between 50 and 55 represent some impact, scores between 56 and 59 represent substantial impact, and scores ≥60 indicate severe impact. HIT6 has good internal consistency and test-retest reliability. Ware et al validated the HIT6 for 624 migraine patients between ages 18 and 39. In this study, 6.4% had CM, 42.1% had episodic migraine (EM), and 51.5% had other types of headaches. The test–retest reliability was 0.77, and the internal consistency reliability among migraine sufferers was between 0.82 and 0.9. Rendas-Baum et al validated HIT6 specifically for CM using over 1300 patients. Again, the test–retest reliability ranged between 0.76 and 0.8.
EQ-5D encompasses 5 dimensions including mobility, self-care, usual/general activity, pain or discomfort, anxiety/depression, as well as general health of the patient. The health status is presented as an index from 0 to 1, where 1 is the best quality of life (QOL). In a study by Xu et al, EQ-5D was determined to have a statistically and clinically significant decrement for patients experiencing mild, moderate, and severe levels of headache. It was generally observed to correspond well with clinical ratings for migraine pain severity.
PDI was developed by Pollard in the 1980s for elucidating the degree with which pain interferes with functioning of an individual in 7 broad areas. It measures 2 factors. Factor 1 is for voluntary activities (items 1–5: family/home responsibilities, recreation, social activity, occupation, and sexual behavior) and Factor 2 is for obligatory activities (items 6 and 7: self-care and life support activity). In the PDI, each item ranges from 0 (no interference) to 10 (total interference), totaling to 70 points (most pain disability). The PDI has a strong internal consistency (Factor 1, Cronbach α = 0.85; Factor 2, Cronbach α = 0.70). Tait et al reviewed 2 studies to examine the reliability and validity of PDI. One study contained 444 subjects and the second study included 46 patients, which was a subset of the initial study that included patients who were admitted to the inpatient ward. They found that PDI is a valid and reliable measure of pain-related disability.
We analyzed data from the KP questionnaire for CM patients who came to our center for onabotulinumtoxinA (onabot) injections (BOTOX, Allergan, Irvine, CA, USA). We hypothesized that PROs would improve after onabot treatment. As our primary outcome we evaluated change in depression after onabot treatment for CM.
Source...