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Pain Medicine 2014; 15: 320–328 Wiley Periodicals, Inc.
HEADACHE & FACIAL PAIN SECTION Original Research Article A Satisfaction Survey of Current Medicines Used for Migraine Therapy in China: Is Chinese Patent Medicine Effective Compared with Western Medicine for the Acute Treatment of Migraine? Ning Luo, PhD,*†▲ Weiwei Qi, MD,*▲ Can Zhuang, PhD,† Wei Di, PhD,* Yonggang Lu, PhD,† Zongqing Huang, BD,‡ Yunguang Sun, MD,§ Aiwu Zhang, MD,* Xiaoliang Huang, BD,¶ Yuqian Tao, MD,* Yingting Zhu, MD,** Aidong Li, BD,‡ Zhonghua Jiang, BD,§ Mark W. Massing, MD, PhD,†† and Yannan Fang, PhD* *Department of Neurology, First Affiliated Hospital of Sun Yat-Sen University, Guangzhou; † Affiliated Liuzhou Hospital of Southern Medical University, Guangxi; ‡
Affiliated futian hospital of Guangdong medical college, Shenzheng; §
Liuzhou Hospital of Traditional Chinese Medicine, Guangxi; ¶
Pingguo County People’s Hospital, Guangxi;
**Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China; ††
The Carolinas Center for Medical Excellence, Cary, North Carolina, USA
Reprint requests to: Yannan Fang, PhD, Department of Neurology, First Affiliated Hospital, Sun Yat-Sen University, no. 58 Zhongshan Road 2, Guangzhou 510080, China. Tel: +86-20-87755766; Fax: +86-20-87335935; E-mail: [email protected].
Abstract Objective. To investigate the patient satisfaction with medications commonly used for migraine therapy in patients seen in headache clinic in China with emphasis on the evaluation of Chinese patent medicine (CPM) in relieving acute migraine attack. Methods. Patients admitted at headache clinics in the neurological departments of four hospitals during April to October 2011 were enrolled in the investigation. The questionnaire was designed based on the validation of a diagnostic questionnaire for a population-based survey in China in 2009. Results. Among 219 eligible patients, 58% had used CPM at the acute attack of migraine while the guideline-recommended treatments were seldom used. However, patients using CPMs were less satisfied than those using Western Medicines (WMs) in either single medication groups or mixed medication groups (P < 0.05). Conclusion. Fifty-eight percent of the eligible respondents in Guangdong and Guangxi Province had used CPM at the acute attack of migraine, but based on our data, the effect of CPM on treating migraine attack was poor with low satisfaction compared with WMs. However, many factors may bias or explain our findings. This suggests the need for accelerated research in understanding patient choice, treatment availability, and use of medications.
Disclosure: None. ▲
NingLuo and Weiwei Qi are co-first authors.
320
Key Words. Migraine; Western Medicine; Chinese Patent Medicine; Satisfaction Survey
Satisfaction of CPM at Acute Migraine Introduction Migraine is a recurrent paroxysmal disease. Epidemiologic population-based investigations have found that the migraineur has 1.8 migraine attacks per month on average [1]. Acute attack occurs even when regular prophylactic therapy is being taken, and according to a survey of migraine sufferers, 38% sought medical help for acute attacks because of the unbearable pain and its effects on daily life [2]. As is well known, the aims of treating an acute migraine attack are to relieve pain as soon as possible, eliminate concomitant symptoms, recover normal daily function, and prevent recurrence while avoiding the use of excess medications to limit side effects [3]. The characteristics of headache, concomitant symptoms, medication history, and other related factors should be comprehensively considered when choosing an appropriate medication.
Hospital, and the Liuzhou Hospital of Traditional Chinese Medicine) during April 2011 to October 2011. Consenting patients answered survey questions in a face-to-face interview. Inclusion and Exclusion Criteria Patients were diagnosed and classified according to the criteria suggested by the International Classification of Headache Disorders, 2nd edition, 2004 [14]. Male and female migraineurs aged 18–65 years (with or without aura), who had used medication during acute attacks of migraine and had not accepted prophylactic therapy for migraine, were enrolled into this study. Patients experiencing primary headache other than migraine or chronic migraine with headache more than 15 days a month were excluded. Questionnaire
Western medicines (WMs), such as non-steroidal antiinflammatory drugs (NSAIDs), triptans, calcium channel blockers, and others, are commonly used in the treatment of headache and migraine worldwide. The majority of WMs currently used in China are available as nonprescription over-the-counter (OTC) medications. In addition, the consultant rate in many areas is low. As a result, the population-level use and effectiveness of WM for the treatment of migraine in China is unknown. Chinese patent medicines (CPMs), as a clinically safe and effective formulation-fixed traditional medicine with stable and controllable quality, produced from Chinese medicinal herbs with a reliable technology have been widely used for headache and migraine for a long time in China. Most of the CPMs used to treating headache contain Ligusticum wallichii, Dahurian angelica root, and Gastrodia. elata, which have been believed to have the function of promoting blood circulation to remove meridian obstruction, dispelling “Feng” (the pathogenic force of nature in traditional Chinese medicine), and relieving pain [4–6]. Nevertheless, their effectiveness in rapidly resolving an acute migraine attack is controversial [7–13]. Little is known about the use of CPMs and WMs for acute attack of migraine and the satisfaction with these diverse treatments in China. This is a cross-sectional questionnaire-based study to determine the use of and patient satisfaction with CPM vs WM in the acute treatment of migraine in China. We report the survey results of migraine sufferers seen at hospital neurologic departments to assess their experiences with WM and CPM. Methods Survey Respondents Surveys were administered to patients seen at neurological department headache clinics in four hospitals (the First Affiliated Hospital of Sun-Yat-Sen University, the People’s Hospital of Shenzhen City, the Liuzhou Railway Central
The questionnaire was designed based on the validation of a diagnostic questionnaire for a population-based survey in China published by Yu et al. [15]. The satisfaction survey was evaluated in accordance with recently published methods related to medication satisfaction questionnaires [16–19]. The questionnaire included five parts: demographic assessment, screening questions, diagnostic questions, health care assessment, and medication use for acute migraine attack. The first four parts assessed the history, features, and prior treatments of the migraineurs. The fifth part assessed medication use during past acute migraine attacks. The medication assessment included these 10 questions: 1) Have you ever used CPM or WM during an acute migraine attack? If yes, name the CPMs and WMs you had used; 2) Was the CPM used in combination with a WM? If yes, name the WM used in combination; 3) Describe the preparation of the CPM (e.g., pills, tablets, powders, etc.); 4) How long have you been using CPM and/or WM for acute migraine attacks; 5) Identify who recommended the medications to you; 6) Describe the therapeutic effects of the medications used. Responses were classified as “no effect at all,” “stop headache in 2 hours,” “shorten the duration of headache,” “prevent recurrence,” “ease concomitant symptoms,” or “psychological comfort”; 7) Describe the efficacy of the therapeutic effects classified as “very effective,” “slightly effective,” “neither effective nor ineffective,” “ineffective,” and “completely ineffective”; 8) Describe the severity of medication side effects classified as “mild,” “moderate,” or “severe”; 9) Describe your satisfaction with the therapeutic effect classified as “very unsatisfied,” “unsatisfied,” “generally satisfied,” “satisfied,” and “very satisfied”; 10) Describe your willingness to continue using these medications, classified as “continuing to use it,” “stop using it,” “change to another CPM,” and “change to an WM.” Although our questionnaire collected large amounts of diverse data, we will focus just on data about medication use and consumer satisfaction, especially comparing CPM with WM. 321
Luo et al. Statistical Analysis The data were managed with EpiData 2.1a (EpiData Association, Odense, Denmark). Analyses were performed using SPSS 16.0 (SPSS Inc., Chicago, IL, USA) software. Univariate analyses were performed. Continuous data were described by means and standard deviations. Categorical variables were described by count and percentage. Statistical evaluation included the rank-sum test (ordinal variables) and the chi-square test (categorical variables). All statistical tests were two-sided, and statistical significance was defined as P < 0.05. All respondents signed an informed consent before answering the questionnaire. Results A total of 697 patients with history of headache participated in this survey. These included 354 patients diagnosed with tension-type headache, 248 patients with migraine, 42 patients with chronic headache, and 53 patients with other headache types. For this study, we excluded all but the 248 patients with migraine headache. We further excluded 15 patients reporting no medication use during acute migraine attack, 7 patients using medication for migraine prophylaxis, and 7 patients with medication overuse, which is defined as regularly using overdose of any kind of ergotamine, triptans, opium, and NSAIDs at least 10 days per month or using common dose of the above drugs in combination at least 15 days per month in past 3 months. After these exclusions, the data of 219 respondents were analyzed. Based on the typical medication usage scenarios observed in our data, we divided the patients into two groups for analysis: 1) single medication-type group (55.3%, 121/219) including single WM (42.0%, 92/219) and single CPM (13.3%, 29/219), and 2) mixed medication-type group with patients who had used either WMs or CPMs in different attacks of migraine (44.7%, 98/219) (Figure 1). Population Characteristics Characteristics of the 219 respondents included in this study are shown in Table 1 for the entire study population and stratified by single and mixed medication groups. About a quarter were male, and the sex distribution was not significantly different comparing single with mixed medication groups. The study population was about 40 years old on average, and this did not differ significantly comparing the single and mixed medication groups. Patients in the mixed medication group had longer average history of migraine, more frequent headache, longer duration of each headache attack, higher visual analogue scale (VAS) score, more influence on daily life, and tend to seek for medical help than patients in single medication group. Overall, 95.4% of respondents were evaluated as moderate to severe based on the VAS score [7–13]. 322
Characteristics of those in the single medication group are shown in Table 2. In this group, characteristics were not statistically different between CPM subgroup and WM subgroup except for the influence on daily life was severer in WM subgroup. Medication Assessment A total of 11 CPMs mainly containing L. wallichii, Dahurian angelica root, and G. elata were reported to treat migraine (Table 3). The WMs reported to treat migraine included aspirin, sibelium, paracetamol, ibuprofen, and compound preparation which contains aspirin, paracetamol, and caffeine. Most (93.7%) of the WMs used were nonprescription OTC drugs. The few prescription WM drugs reported included triptans, alprazolam, diazepam, and rotundine. WMs were used 190 person-times (61.1%), and CPMs were used 127 person-times (38.9%). For the 23 respondents enrolled from the Liuzhou Hospital of Traditional Chinese Medicine, the proportion of the three categories (single WM 47.8%, single CPM 17.4%, and WM and CPM taken separately in different attacks 34.8%) was not statistically different from respondents enrolled from the other three hospitals (42.4%, 11.7%, and 45.9%, respectively, P = 0.199). Single Medication Type Group Categories of Drugs Taken in Single Medicine Type Groups In single medication group, NSAIDs were mostly used (39.7%, 48/121), followed by CPMs (24.0%, 29/121), and triptans were rarely used (0.8%, 1/121). Most of the CPMs were prescription (55.2%, 16/29) followed by selfpurchased at drugstore (20.7%, 6/29). CPMs were recommended by family or friends in 13.8% of the instances (4/29) and recommended by staff of the drugstore in 10.3% (3/29). Satisfaction with the Medicines in Single Medication-Type Groups (Table 4) Satisfaction (“satisfied” and “very satisfied”) was higher with NSAIDs (60.4%, 29/48) and compound preparations (69.5%, 16/23) than with the other drugs in single medication-type group (P < 0.05). CPMs had the lowest satisfaction (27.6%, 8/29). No statistically significant difference was found among the satisfaction with CPM, NSAIDs + compound preparation, NSAIDs + sibelium, and sibelium groups. When asked about whether they would continue the usage of CPM to control migraine attack, 37.9% (11/29) gave positive answers, 24.1% (7/29) wanted to use another kind of CPM, 31.0% (9/29) intended to stop using CPM, and 7.0% (2/29) would change to WMs. Figure 2 compares overall satisfaction with WM compared with CPM aggregating all categories of WM and CPM
Satisfaction of CPM at Acute Migraine
Figure 1 The flow chart of data processing.
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Table 1
Demographic characteristics of the 219 migraineurs
Characteristic
Total (N = 219)
Single Medication Class Group (N = 121)
Mixed Medication Class Group (N = 98)
Female Age (mean ± SEM) Migraine history (mean ± SEM) Monthly headache frequency ≤2 3–5 >5 mean ± SEM Headache duration hours ≤12 13–24 >24 mean ± SEM VAS score 1–3 4–6 7–10 mean ± SEM Influence on daily life None Slight Severe Previous hospital attendance Yes
79.0% 39.8 ± 11.8 10.5 ± 10.0
80.2% 38.9 ± 12.0 9.7 ± 7.5
77.6% 40.8 ± 11.5 11.4 ± 9.2†
65.3% 14.2% 20.5% 4.0 ± 3.3
74.4% 12.4% 13.2% 3.0 ± 2.6
54.1% 16.3% 29.6% 5.2 ± 4.6†
46.1% 24.2% 29.7% 36.0 ± 17.5
52.9% 23.1% 24.0% 31.5 ± 11.4
37.8% 25.5% 36.7% 41.6 ± 14.1†
4.6% 33.3% 62.1% 7.2 ± 2.0
6.6% 41.3% 52.1% 6.6 ± 1.9
2.0% 23.5% 74.5% 7.8 ± 1.9‡
5.5% 67.1% 27.4%
5.8% 73.6% 20.6%
5.1% 59.2% 35.7%†
66.7%
58.7%
76.5%‡
†
P < 0.05;
‡
P < 0.01.
among the single medication users. Patients using any WM were more likely to be at least generally satisfied (58.7%) than persons using any CPM (27.6%). Remarkably, only a third or fewer of patients were not satisfied with medications.
When asked about whether they would continue to use the same CPM to control acute attack of migraine, 18.4% (18/98) gave positive answers, 20.4% (20/98) wanted to use another kind of CPM, 25.5% (25/98) intended to stop using CPM, and 35.7% (35/98) would change to WM.
Mixed Medication-Type Group Medicines Used in Mixed Medication-Type Groups Patients reporting the use of both CPM and WM were categorized into subgroups. CPM + NSAIDs was used mostly (40.8%, 40/98), followed by CPM + NSAIDs + compound preparation (23.5%, 23/98), and both strategies of CPM + triptans and CPM + triptans + NSAIDs were rarely chosen (4.1%, 4/98, respectively). In the mixed medication-type group, most of the CPMs were prescription (66.3%, 65/98), followed by self-purchased at drugstore (21.4%, 21/98), recommended by family or friends (10.2%, 10/98) and recommended by staff of the drugstore (2%, 2/98) in descending order. Satisfaction with Different Usages in Mixed Medication-Type Groups (Table 5) Satisfaction with CPM was lower compared with the intergroup WM in all mixed subgroups (P < 0.05) except for in the CPM + sibelium subgroup (P = 0.083) (Table 5). 324
Figure 2 compares overall satisfaction with WM compared with CPM aggregating all categories of WM and CPM among the mixed medication users. Patients using any WM along with a CPM were more likely to be at least generally satisfied (23.5%) with their WM than they were with the CPM (10.2%). Moreover, patients in the mixed medication group were less satisfied (33.7%) in general than those in the single medication group (51.2%) (P = 0.009). Discussion As migraine is a recurrent paroxysmal disease which is often manifested by an unbearable headache, most migraineurs seek medical help to terminate the attack. In a large population-based survey, 38% of migraine patients reported the need of medical care to deal with their moderate to severe symptoms. In our survey, only 33.3% attended the hospital for the first time, and 95.4% were evaluated as moderate to severe according to VAS scores. The higher consultation rate is probably the result of the selection
Satisfaction of CPM at Acute Migraine
Table 2 Characteristics of patients in single medication group
Characteristics
Chinese Patent Medicine (N = 29)
Female 86.2% Age years 41.6 ± 13.1 (mean ± SEM) Migraine history year 7.0 ± 6.6 (mean ± SEM) Monthly headache frequency ≤2 65.5% 3–5 13.8% >5 20.7% mean ± SEM 2.2 ± 0.7 Headache duration hours ≤12 51.7% 13–24 31.0% >24 17.3% mean ± SEM 31.6 ± 14.8 VAS score 1–3 10.3% 4–6 51.7% 7–10 38.0% mean ± SEM 6.0 ± 1.9 Influence on daily life None 13.8% Slight 75.9% Severe 10.3% Previous hospital attendance Yes 69.0% †
Western Medicine (N = 92) 78.3% 38.1 ± 11.6 10.6 ± 9.0
77.2% 11.9% 10.9% 2.3 ± 0.6 53.3% 20.6% 26.1% 31.5 ± 10.4 5.4% 38.1% 56.5% 6.8 ± 1.9 3.3% 72.8% 23.9%† 55.4%
P < 0.05.
bias as our patients were recruited from headache clinics where most patients come for medical care for the annoying pain. It is also possible that the pressing need for medical care may exaggerate the severity of the headache. It should be noted that our survey depended on the memory of patients with migraine. Therefore, some recall bias was inevitable. As is well known, the aim of treating acute migraine attack is to relieve headache as soon as possible, eliminate concomitant symptoms, and recover normal daily function [20]. These expectations have been commonly recognized as the important factors in evaluating patient satisfaction with the available medicines for treating acute migraine attack [21,22]. CPM has been widely used in China, especially in Guangdong and Guangxi province, but its effectiveness on controlling acute attack of migraine has not been studied. Through our analyses, we found that 58.0% of the eligible respondents had used one or more CPMs at the acute attack of migraine. Among these, 77.2% had also used WMs at different attacks of migraine. Forty-
two percent of patients had used WMs only to control acute attacks. The utilization ratio of CPM/WM was not different between respondents from Hospital of Traditional Chinese Medicine and the other three comprehensive hospitals. This suggested that clinical tradition may not have overly influenced physician recommendation and choice of medicine. Among the available WMs, nonprescription medicine (OTC medicine) and nonspecific medicine for migraine, the NSAIDs and compound preparation, were used extensively (93.7%, 178/190). However, the triptans were rarely used despite the fact that they have been confirmed to be a migraine-specific medicine in 2000 [23] and have been recommended as a best option of medicine for acute treatment of moderate to severe migraine in the current guideline for migraine treatment [7,20,22]. Most of our patients (95.4%) were evaluated as moderate to severe at the acute migraine attack according to their VAS scores. It should be noted that the small number of patients taking triptans make statistical interpretation questionable for this medication. Nevertheless, it is notable that a medication so highly recommended is used so infrequently in this population. One possible explanation is that the high price of the medicine limited the widespread use. Most patients could not afford 50–90 RMB for each pill of triptan. Future research is needed to determine whether this underutilization is due to patient choice or failure of physicians to comply with recommended guidelines. For the commonly used CPMs, medications controversial with respect to their therapeutic effect for migraine,
Table 3 use
Prevalence of self-reported medication
Chinese Patent Medicines (CPM) Gastrodia capsule Zhengtian pill Other Chinese patent medicine Lingyangjiao pills DouLiang soft capsule Yangxue Qingnao Granule Ershiwuwei Shanhu Wan Tongtian oral liquid Tablet of Corydalistuber for alleviating pain Seven Leaves Spirit Calmness Tablet Tou tongning-capsule Western medicines (WM) Paracetamol Compound preparation Ibuprofen Sibelium Paracetamol, aminophenazone, caffeine, and chlorphenamine maleate tablets Prescription drug Aspirin Others
N = 155 25.8% 21.3% 15.6% 8.4% 7.7% 7.7% 6.5% 3.2% 2.6% 0.6% 0.6% N = 190 29.5% 21.1% 20.0% 8.4% 7.9% 6.3% 3.7% 3.1%
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Table 4
Satisfaction with different medicines in single medication type group
Category
Very Unsatisfied + Unsatisfied
Generally Satisfied
Satisfied + Very Satisfied
NSAIDs NSAIDs + compound preparation Compound preparation NSAIDs + sibelium Sibelium NSAIDs + triptans CPM
16.7% (8/48) 16.7% (2/12) 4.3% (1/23) 50.0% (2/4) 25.0% (1/4) — 34.5% (10/29)
22.9% (11/48) 33.3% (4/12) 26.1% (6/23) 50.0% (2/4) 25.0% (1/4) — 37.9% (11/29)
60.4% (29/48) 50.0% (6/12) 69.5% (16/23) — 50.0% (2/4) 100% (1/1) 27.6% (8/29)
Table 5
Satisfaction with CPM and WM of mixed medication subgroups Very Unsatisfied + Unsatisfied
Generally Satisfied
Satisfied + Very Satisfied
Category
CPM
WM
CPM
WM
CPM
WM
P value
MGI MGII MGIII MGIV MGV MGVI
35.0% (14/40) 60.8% (14/23) 36.4% (4/11) 81.3% (13/16) 75.0% (3/4) 50.0% (2/4)
15% (6/40) 43.5 (10/23) — 43.8% (7/16) — —
52.5% (21/40) 34.8% (8/23) 54.5% (6/11) 12.5% (2/16) — 25.0% (1/4)
42.5% (17/40) 47.8% (11/23) 63.6% (7/11) 56.3% (9/16) 75.0% (3/4) 100% (4/4)
12.5% (5/40) 4.3% (1/23) 9.1% (1/11) 6.3% (1/16) 25.0% (1/4) 25.0% (1/4)
42.5% (17/40) 8.6% (2/23) 36.4 (4/11) — 25.0% (1/4) —
Pain Medicine 2014; 15: 320–328 Wiley Periodicals, Inc.
HEADACHE & FACIAL PAIN SECTION Original Research Article A Satisfaction Survey of Current Medicines Used for Migraine Therapy in China: Is Chinese Patent Medicine Effective Compared with Western Medicine for the Acute Treatment of Migraine? Ning Luo, PhD,*†▲ Weiwei Qi, MD,*▲ Can Zhuang, PhD,† Wei Di, PhD,* Yonggang Lu, PhD,† Zongqing Huang, BD,‡ Yunguang Sun, MD,§ Aiwu Zhang, MD,* Xiaoliang Huang, BD,¶ Yuqian Tao, MD,* Yingting Zhu, MD,** Aidong Li, BD,‡ Zhonghua Jiang, BD,§ Mark W. Massing, MD, PhD,†† and Yannan Fang, PhD* *Department of Neurology, First Affiliated Hospital of Sun Yat-Sen University, Guangzhou; † Affiliated Liuzhou Hospital of Southern Medical University, Guangxi; ‡
Affiliated futian hospital of Guangdong medical college, Shenzheng; §
Liuzhou Hospital of Traditional Chinese Medicine, Guangxi; ¶
Pingguo County People’s Hospital, Guangxi;
**Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China; ††
The Carolinas Center for Medical Excellence, Cary, North Carolina, USA
Reprint requests to: Yannan Fang, PhD, Department of Neurology, First Affiliated Hospital, Sun Yat-Sen University, no. 58 Zhongshan Road 2, Guangzhou 510080, China. Tel: +86-20-87755766; Fax: +86-20-87335935; E-mail: [email protected].
Abstract Objective. To investigate the patient satisfaction with medications commonly used for migraine therapy in patients seen in headache clinic in China with emphasis on the evaluation of Chinese patent medicine (CPM) in relieving acute migraine attack. Methods. Patients admitted at headache clinics in the neurological departments of four hospitals during April to October 2011 were enrolled in the investigation. The questionnaire was designed based on the validation of a diagnostic questionnaire for a population-based survey in China in 2009. Results. Among 219 eligible patients, 58% had used CPM at the acute attack of migraine while the guideline-recommended treatments were seldom used. However, patients using CPMs were less satisfied than those using Western Medicines (WMs) in either single medication groups or mixed medication groups (P < 0.05). Conclusion. Fifty-eight percent of the eligible respondents in Guangdong and Guangxi Province had used CPM at the acute attack of migraine, but based on our data, the effect of CPM on treating migraine attack was poor with low satisfaction compared with WMs. However, many factors may bias or explain our findings. This suggests the need for accelerated research in understanding patient choice, treatment availability, and use of medications.
Disclosure: None. ▲
NingLuo and Weiwei Qi are co-first authors.
320
Key Words. Migraine; Western Medicine; Chinese Patent Medicine; Satisfaction Survey
Satisfaction of CPM at Acute Migraine Introduction Migraine is a recurrent paroxysmal disease. Epidemiologic population-based investigations have found that the migraineur has 1.8 migraine attacks per month on average [1]. Acute attack occurs even when regular prophylactic therapy is being taken, and according to a survey of migraine sufferers, 38% sought medical help for acute attacks because of the unbearable pain and its effects on daily life [2]. As is well known, the aims of treating an acute migraine attack are to relieve pain as soon as possible, eliminate concomitant symptoms, recover normal daily function, and prevent recurrence while avoiding the use of excess medications to limit side effects [3]. The characteristics of headache, concomitant symptoms, medication history, and other related factors should be comprehensively considered when choosing an appropriate medication.
Hospital, and the Liuzhou Hospital of Traditional Chinese Medicine) during April 2011 to October 2011. Consenting patients answered survey questions in a face-to-face interview. Inclusion and Exclusion Criteria Patients were diagnosed and classified according to the criteria suggested by the International Classification of Headache Disorders, 2nd edition, 2004 [14]. Male and female migraineurs aged 18–65 years (with or without aura), who had used medication during acute attacks of migraine and had not accepted prophylactic therapy for migraine, were enrolled into this study. Patients experiencing primary headache other than migraine or chronic migraine with headache more than 15 days a month were excluded. Questionnaire
Western medicines (WMs), such as non-steroidal antiinflammatory drugs (NSAIDs), triptans, calcium channel blockers, and others, are commonly used in the treatment of headache and migraine worldwide. The majority of WMs currently used in China are available as nonprescription over-the-counter (OTC) medications. In addition, the consultant rate in many areas is low. As a result, the population-level use and effectiveness of WM for the treatment of migraine in China is unknown. Chinese patent medicines (CPMs), as a clinically safe and effective formulation-fixed traditional medicine with stable and controllable quality, produced from Chinese medicinal herbs with a reliable technology have been widely used for headache and migraine for a long time in China. Most of the CPMs used to treating headache contain Ligusticum wallichii, Dahurian angelica root, and Gastrodia. elata, which have been believed to have the function of promoting blood circulation to remove meridian obstruction, dispelling “Feng” (the pathogenic force of nature in traditional Chinese medicine), and relieving pain [4–6]. Nevertheless, their effectiveness in rapidly resolving an acute migraine attack is controversial [7–13]. Little is known about the use of CPMs and WMs for acute attack of migraine and the satisfaction with these diverse treatments in China. This is a cross-sectional questionnaire-based study to determine the use of and patient satisfaction with CPM vs WM in the acute treatment of migraine in China. We report the survey results of migraine sufferers seen at hospital neurologic departments to assess their experiences with WM and CPM. Methods Survey Respondents Surveys were administered to patients seen at neurological department headache clinics in four hospitals (the First Affiliated Hospital of Sun-Yat-Sen University, the People’s Hospital of Shenzhen City, the Liuzhou Railway Central
The questionnaire was designed based on the validation of a diagnostic questionnaire for a population-based survey in China published by Yu et al. [15]. The satisfaction survey was evaluated in accordance with recently published methods related to medication satisfaction questionnaires [16–19]. The questionnaire included five parts: demographic assessment, screening questions, diagnostic questions, health care assessment, and medication use for acute migraine attack. The first four parts assessed the history, features, and prior treatments of the migraineurs. The fifth part assessed medication use during past acute migraine attacks. The medication assessment included these 10 questions: 1) Have you ever used CPM or WM during an acute migraine attack? If yes, name the CPMs and WMs you had used; 2) Was the CPM used in combination with a WM? If yes, name the WM used in combination; 3) Describe the preparation of the CPM (e.g., pills, tablets, powders, etc.); 4) How long have you been using CPM and/or WM for acute migraine attacks; 5) Identify who recommended the medications to you; 6) Describe the therapeutic effects of the medications used. Responses were classified as “no effect at all,” “stop headache in 2 hours,” “shorten the duration of headache,” “prevent recurrence,” “ease concomitant symptoms,” or “psychological comfort”; 7) Describe the efficacy of the therapeutic effects classified as “very effective,” “slightly effective,” “neither effective nor ineffective,” “ineffective,” and “completely ineffective”; 8) Describe the severity of medication side effects classified as “mild,” “moderate,” or “severe”; 9) Describe your satisfaction with the therapeutic effect classified as “very unsatisfied,” “unsatisfied,” “generally satisfied,” “satisfied,” and “very satisfied”; 10) Describe your willingness to continue using these medications, classified as “continuing to use it,” “stop using it,” “change to another CPM,” and “change to an WM.” Although our questionnaire collected large amounts of diverse data, we will focus just on data about medication use and consumer satisfaction, especially comparing CPM with WM. 321
Luo et al. Statistical Analysis The data were managed with EpiData 2.1a (EpiData Association, Odense, Denmark). Analyses were performed using SPSS 16.0 (SPSS Inc., Chicago, IL, USA) software. Univariate analyses were performed. Continuous data were described by means and standard deviations. Categorical variables were described by count and percentage. Statistical evaluation included the rank-sum test (ordinal variables) and the chi-square test (categorical variables). All statistical tests were two-sided, and statistical significance was defined as P < 0.05. All respondents signed an informed consent before answering the questionnaire. Results A total of 697 patients with history of headache participated in this survey. These included 354 patients diagnosed with tension-type headache, 248 patients with migraine, 42 patients with chronic headache, and 53 patients with other headache types. For this study, we excluded all but the 248 patients with migraine headache. We further excluded 15 patients reporting no medication use during acute migraine attack, 7 patients using medication for migraine prophylaxis, and 7 patients with medication overuse, which is defined as regularly using overdose of any kind of ergotamine, triptans, opium, and NSAIDs at least 10 days per month or using common dose of the above drugs in combination at least 15 days per month in past 3 months. After these exclusions, the data of 219 respondents were analyzed. Based on the typical medication usage scenarios observed in our data, we divided the patients into two groups for analysis: 1) single medication-type group (55.3%, 121/219) including single WM (42.0%, 92/219) and single CPM (13.3%, 29/219), and 2) mixed medication-type group with patients who had used either WMs or CPMs in different attacks of migraine (44.7%, 98/219) (Figure 1). Population Characteristics Characteristics of the 219 respondents included in this study are shown in Table 1 for the entire study population and stratified by single and mixed medication groups. About a quarter were male, and the sex distribution was not significantly different comparing single with mixed medication groups. The study population was about 40 years old on average, and this did not differ significantly comparing the single and mixed medication groups. Patients in the mixed medication group had longer average history of migraine, more frequent headache, longer duration of each headache attack, higher visual analogue scale (VAS) score, more influence on daily life, and tend to seek for medical help than patients in single medication group. Overall, 95.4% of respondents were evaluated as moderate to severe based on the VAS score [7–13]. 322
Characteristics of those in the single medication group are shown in Table 2. In this group, characteristics were not statistically different between CPM subgroup and WM subgroup except for the influence on daily life was severer in WM subgroup. Medication Assessment A total of 11 CPMs mainly containing L. wallichii, Dahurian angelica root, and G. elata were reported to treat migraine (Table 3). The WMs reported to treat migraine included aspirin, sibelium, paracetamol, ibuprofen, and compound preparation which contains aspirin, paracetamol, and caffeine. Most (93.7%) of the WMs used were nonprescription OTC drugs. The few prescription WM drugs reported included triptans, alprazolam, diazepam, and rotundine. WMs were used 190 person-times (61.1%), and CPMs were used 127 person-times (38.9%). For the 23 respondents enrolled from the Liuzhou Hospital of Traditional Chinese Medicine, the proportion of the three categories (single WM 47.8%, single CPM 17.4%, and WM and CPM taken separately in different attacks 34.8%) was not statistically different from respondents enrolled from the other three hospitals (42.4%, 11.7%, and 45.9%, respectively, P = 0.199). Single Medication Type Group Categories of Drugs Taken in Single Medicine Type Groups In single medication group, NSAIDs were mostly used (39.7%, 48/121), followed by CPMs (24.0%, 29/121), and triptans were rarely used (0.8%, 1/121). Most of the CPMs were prescription (55.2%, 16/29) followed by selfpurchased at drugstore (20.7%, 6/29). CPMs were recommended by family or friends in 13.8% of the instances (4/29) and recommended by staff of the drugstore in 10.3% (3/29). Satisfaction with the Medicines in Single Medication-Type Groups (Table 4) Satisfaction (“satisfied” and “very satisfied”) was higher with NSAIDs (60.4%, 29/48) and compound preparations (69.5%, 16/23) than with the other drugs in single medication-type group (P < 0.05). CPMs had the lowest satisfaction (27.6%, 8/29). No statistically significant difference was found among the satisfaction with CPM, NSAIDs + compound preparation, NSAIDs + sibelium, and sibelium groups. When asked about whether they would continue the usage of CPM to control migraine attack, 37.9% (11/29) gave positive answers, 24.1% (7/29) wanted to use another kind of CPM, 31.0% (9/29) intended to stop using CPM, and 7.0% (2/29) would change to WMs. Figure 2 compares overall satisfaction with WM compared with CPM aggregating all categories of WM and CPM
Satisfaction of CPM at Acute Migraine
Figure 1 The flow chart of data processing.
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Table 1
Demographic characteristics of the 219 migraineurs
Characteristic
Total (N = 219)
Single Medication Class Group (N = 121)
Mixed Medication Class Group (N = 98)
Female Age (mean ± SEM) Migraine history (mean ± SEM) Monthly headache frequency ≤2 3–5 >5 mean ± SEM Headache duration hours ≤12 13–24 >24 mean ± SEM VAS score 1–3 4–6 7–10 mean ± SEM Influence on daily life None Slight Severe Previous hospital attendance Yes
79.0% 39.8 ± 11.8 10.5 ± 10.0
80.2% 38.9 ± 12.0 9.7 ± 7.5
77.6% 40.8 ± 11.5 11.4 ± 9.2†
65.3% 14.2% 20.5% 4.0 ± 3.3
74.4% 12.4% 13.2% 3.0 ± 2.6
54.1% 16.3% 29.6% 5.2 ± 4.6†
46.1% 24.2% 29.7% 36.0 ± 17.5
52.9% 23.1% 24.0% 31.5 ± 11.4
37.8% 25.5% 36.7% 41.6 ± 14.1†
4.6% 33.3% 62.1% 7.2 ± 2.0
6.6% 41.3% 52.1% 6.6 ± 1.9
2.0% 23.5% 74.5% 7.8 ± 1.9‡
5.5% 67.1% 27.4%
5.8% 73.6% 20.6%
5.1% 59.2% 35.7%†
66.7%
58.7%
76.5%‡
†
P < 0.05;
‡
P < 0.01.
among the single medication users. Patients using any WM were more likely to be at least generally satisfied (58.7%) than persons using any CPM (27.6%). Remarkably, only a third or fewer of patients were not satisfied with medications.
When asked about whether they would continue to use the same CPM to control acute attack of migraine, 18.4% (18/98) gave positive answers, 20.4% (20/98) wanted to use another kind of CPM, 25.5% (25/98) intended to stop using CPM, and 35.7% (35/98) would change to WM.
Mixed Medication-Type Group Medicines Used in Mixed Medication-Type Groups Patients reporting the use of both CPM and WM were categorized into subgroups. CPM + NSAIDs was used mostly (40.8%, 40/98), followed by CPM + NSAIDs + compound preparation (23.5%, 23/98), and both strategies of CPM + triptans and CPM + triptans + NSAIDs were rarely chosen (4.1%, 4/98, respectively). In the mixed medication-type group, most of the CPMs were prescription (66.3%, 65/98), followed by self-purchased at drugstore (21.4%, 21/98), recommended by family or friends (10.2%, 10/98) and recommended by staff of the drugstore (2%, 2/98) in descending order. Satisfaction with Different Usages in Mixed Medication-Type Groups (Table 5) Satisfaction with CPM was lower compared with the intergroup WM in all mixed subgroups (P < 0.05) except for in the CPM + sibelium subgroup (P = 0.083) (Table 5). 324
Figure 2 compares overall satisfaction with WM compared with CPM aggregating all categories of WM and CPM among the mixed medication users. Patients using any WM along with a CPM were more likely to be at least generally satisfied (23.5%) with their WM than they were with the CPM (10.2%). Moreover, patients in the mixed medication group were less satisfied (33.7%) in general than those in the single medication group (51.2%) (P = 0.009). Discussion As migraine is a recurrent paroxysmal disease which is often manifested by an unbearable headache, most migraineurs seek medical help to terminate the attack. In a large population-based survey, 38% of migraine patients reported the need of medical care to deal with their moderate to severe symptoms. In our survey, only 33.3% attended the hospital for the first time, and 95.4% were evaluated as moderate to severe according to VAS scores. The higher consultation rate is probably the result of the selection
Satisfaction of CPM at Acute Migraine
Table 2 Characteristics of patients in single medication group
Characteristics
Chinese Patent Medicine (N = 29)
Female 86.2% Age years 41.6 ± 13.1 (mean ± SEM) Migraine history year 7.0 ± 6.6 (mean ± SEM) Monthly headache frequency ≤2 65.5% 3–5 13.8% >5 20.7% mean ± SEM 2.2 ± 0.7 Headache duration hours ≤12 51.7% 13–24 31.0% >24 17.3% mean ± SEM 31.6 ± 14.8 VAS score 1–3 10.3% 4–6 51.7% 7–10 38.0% mean ± SEM 6.0 ± 1.9 Influence on daily life None 13.8% Slight 75.9% Severe 10.3% Previous hospital attendance Yes 69.0% †
Western Medicine (N = 92) 78.3% 38.1 ± 11.6 10.6 ± 9.0
77.2% 11.9% 10.9% 2.3 ± 0.6 53.3% 20.6% 26.1% 31.5 ± 10.4 5.4% 38.1% 56.5% 6.8 ± 1.9 3.3% 72.8% 23.9%† 55.4%
P < 0.05.
bias as our patients were recruited from headache clinics where most patients come for medical care for the annoying pain. It is also possible that the pressing need for medical care may exaggerate the severity of the headache. It should be noted that our survey depended on the memory of patients with migraine. Therefore, some recall bias was inevitable. As is well known, the aim of treating acute migraine attack is to relieve headache as soon as possible, eliminate concomitant symptoms, and recover normal daily function [20]. These expectations have been commonly recognized as the important factors in evaluating patient satisfaction with the available medicines for treating acute migraine attack [21,22]. CPM has been widely used in China, especially in Guangdong and Guangxi province, but its effectiveness on controlling acute attack of migraine has not been studied. Through our analyses, we found that 58.0% of the eligible respondents had used one or more CPMs at the acute attack of migraine. Among these, 77.2% had also used WMs at different attacks of migraine. Forty-
two percent of patients had used WMs only to control acute attacks. The utilization ratio of CPM/WM was not different between respondents from Hospital of Traditional Chinese Medicine and the other three comprehensive hospitals. This suggested that clinical tradition may not have overly influenced physician recommendation and choice of medicine. Among the available WMs, nonprescription medicine (OTC medicine) and nonspecific medicine for migraine, the NSAIDs and compound preparation, were used extensively (93.7%, 178/190). However, the triptans were rarely used despite the fact that they have been confirmed to be a migraine-specific medicine in 2000 [23] and have been recommended as a best option of medicine for acute treatment of moderate to severe migraine in the current guideline for migraine treatment [7,20,22]. Most of our patients (95.4%) were evaluated as moderate to severe at the acute migraine attack according to their VAS scores. It should be noted that the small number of patients taking triptans make statistical interpretation questionable for this medication. Nevertheless, it is notable that a medication so highly recommended is used so infrequently in this population. One possible explanation is that the high price of the medicine limited the widespread use. Most patients could not afford 50–90 RMB for each pill of triptan. Future research is needed to determine whether this underutilization is due to patient choice or failure of physicians to comply with recommended guidelines. For the commonly used CPMs, medications controversial with respect to their therapeutic effect for migraine,
Table 3 use
Prevalence of self-reported medication
Chinese Patent Medicines (CPM) Gastrodia capsule Zhengtian pill Other Chinese patent medicine Lingyangjiao pills DouLiang soft capsule Yangxue Qingnao Granule Ershiwuwei Shanhu Wan Tongtian oral liquid Tablet of Corydalistuber for alleviating pain Seven Leaves Spirit Calmness Tablet Tou tongning-capsule Western medicines (WM) Paracetamol Compound preparation Ibuprofen Sibelium Paracetamol, aminophenazone, caffeine, and chlorphenamine maleate tablets Prescription drug Aspirin Others
N = 155 25.8% 21.3% 15.6% 8.4% 7.7% 7.7% 6.5% 3.2% 2.6% 0.6% 0.6% N = 190 29.5% 21.1% 20.0% 8.4% 7.9% 6.3% 3.7% 3.1%
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Table 4
Satisfaction with different medicines in single medication type group
Category
Very Unsatisfied + Unsatisfied
Generally Satisfied
Satisfied + Very Satisfied
NSAIDs NSAIDs + compound preparation Compound preparation NSAIDs + sibelium Sibelium NSAIDs + triptans CPM
16.7% (8/48) 16.7% (2/12) 4.3% (1/23) 50.0% (2/4) 25.0% (1/4) — 34.5% (10/29)
22.9% (11/48) 33.3% (4/12) 26.1% (6/23) 50.0% (2/4) 25.0% (1/4) — 37.9% (11/29)
60.4% (29/48) 50.0% (6/12) 69.5% (16/23) — 50.0% (2/4) 100% (1/1) 27.6% (8/29)
Table 5
Satisfaction with CPM and WM of mixed medication subgroups Very Unsatisfied + Unsatisfied
Generally Satisfied
Satisfied + Very Satisfied
Category
CPM
WM
CPM
WM
CPM
WM
P value
MGI MGII MGIII MGIV MGV MGVI
35.0% (14/40) 60.8% (14/23) 36.4% (4/11) 81.3% (13/16) 75.0% (3/4) 50.0% (2/4)
15% (6/40) 43.5 (10/23) — 43.8% (7/16) — —
52.5% (21/40) 34.8% (8/23) 54.5% (6/11) 12.5% (2/16) — 25.0% (1/4)
42.5% (17/40) 47.8% (11/23) 63.6% (7/11) 56.3% (9/16) 75.0% (3/4) 100% (4/4)
12.5% (5/40) 4.3% (1/23) 9.1% (1/11) 6.3% (1/16) 25.0% (1/4) 25.0% (1/4)
42.5% (17/40) 8.6% (2/23) 36.4 (4/11) — 25.0% (1/4) —
