PHYTOTHERAPY RESEARCH Phytother. Res. 28: 412–415 (2014) Published online 9 May 2013 in Wiley Online Library (wileyonlinelibrary.com) DOI: 10.1002/ptr.4996 Comparison Between the Efficacy of Ginger and Sumatriptan in the Ablative Treatment of the Common Migraine Mehdi Maghbooli,* Farhad Golipour, Alireza Moghimi Esfandabadi and Mehran Yousefi Zanjan University Of Medical Sciences, VALI-e-ASR Hospital, Neurology Department, Zanjan, Iran Frequency and torment caused by migraines direct patients toward a variety of remedies. Few studies to date have proposed ginger derivates for migraine relief. This study aims to evaluate the efficacy of ginger in the ablation of common migraine attack in comparison to sumatriptan therapy. In this double-blinded randomized clinical trial, 100 patients who had acute migraine without aura were randomly allocated to receive either ginger powder or sumatriptan. Time of headache onset, its severity, time interval from headache beginning to taking drug and patient self-estimation about response for five subsequent migraine attacks were recorded by patients. Patients, satisfaction from treatment efficacy and their willingness to continue it was also evaluated after 1 month following intervention. Two hours after using either drug, mean headaches severity decreased significantly. Efficacy of ginger powder and sumatriptan was similar. Clinical adverse effects of ginger powder were less than sumatriptan. Patients’ satisfaction and willingness to continue did not differ. The effectiveness of ginger powder in the treatment of common migraine attacks is statistically comparable to sumatriptan. Ginger also poses a better side effect profile than sumatriptan. Copyright © 2013 John Wiley & Sons, Ltd. Keywords: common migraine; ginger; sumatriptan. Supporting information may be found in the online version of this article. 1–4% essential oil, 5–8% resin and mucilage (Langner INTRODUCTION et al., 1998; Shri, 2003; Mascolo et al., 1989; Mustafa et al., 1993, Awang, 1992). Migraine, a periodic chronic neurologic disorder, is one Ginger products have long been used in the manage- of the most common causes of pain syndromes with a ment of motion sickness, dyspepsia, articular pain, local prevalence rate of 12%. This disorder imposes exorbi- pains and vertigo (Grant and Lutz, 2000; Yarnell, 2002; tant expenditures and creates disadvantages on personal Holtmann et al., 1989; Riebenfeld and Borzone, 1999; function. These can vary from minimally disturbed Micklefield et al., 1999; Grøntved and Hentzer, 1986; activities of daily living to complete, although temporary, Altman and Marcussen, 2001). incapacitation requiring total rest. Unfortunately, the One of the most favorable aspects of ginger is that there wait-and-see approach often prolongs the symptoms are no serious or even frequent side effects reported with constituting the disease, while also decreasing the effec- its use. Anecdotal reports even indicate a therapeutic role tiveness of the treatment. for ginger in vomiting, flatulence and memory problems Despite continuous improvements in the field of (Ernst and Pittler, 2000; Yamahara et al., 1989). Pharma- migraine treatment, which has provided further opportuni- cologic studies have revealed its effectiveness in the ties to select more specific and effective remedies, many reduction of blood sugar, normalizing of blood pressure, patients prefer to relieve headaches by nonchemical strengthening of the overall cardiovascular system, inhib- (herbal) means or readily available over-the-counter itory effects on prostaglandins and platelet aggregation, (OTC) products. A part of this trend is a result of fears as well as lipid lowering properties and hyposecretion of associated with adverse drug reactions and apprehensions gastric acid (Bordia et al., 1997; Tjendraputra et al., of dependency. Patients often experience a loss of satisfac- 2001; Guh et al., 1995). tion from their usual medications which contributes to In a study performed by Cady et al., Gelstat (an OTC their unmet needs. Even the general chronic relapsing drug which contains ginger extract) alleviated migraine nature of migraine disease poses frustrations for sufferers headache completely in 48%, and partially in 34% of that lead them to seek out alternative remedies. patients within 2 h of taking the drug (Cady et al., 2005). Ginger is a native plant of southeastern Asia that has Aurora et al., performed a double-blinded placebo- been widely cultivated in Jamaica, China, India, Nigeria, controlled study demonstrating that the Gelstat-treated Sierra Leone, Haiti and Australia. These thick rhizomes, group also had a significantly higher pain relief rate 2 h in dehydrated form, contain 40–60% carbohydrate, 10% following proper drug use, at 65% versus 36%, p = 0.038 protein, 10% fat, 5% fiber, 6% minerals, 10% water, (Aurora et al., 2006). In a case report review, a 42 year old woman with classic * Correspondence to: Maghbooli Mehdi, Zanjan University of Medical migraine achieved headache subsidence within a 30 min Sciences, Vali-e-Asr University Hospital, Neurology ward, Zanjan, Iran. period of taking a 500–600 mg water-soluble ginger E-mail: m.maghbooli@zums.ac.ir powder upon onset of visual aura. Patients, who continued Received 09 September 2010 Revised 09 March 2013 Copyright © 2013 John Wiley & Sons, Ltd. Accepted 17 March 2013  MIGRAINE ABLATION BY GINGER VERSUS SUMATRIPTAN 413 consumption of ginger powder, every 4 h for a total of patients evaluated their overall satisfaction with regards four days, reported both diminished headache severity to treatment efficacy as well as their willingness to con- and frequency (Mustafa and Srivastava, 1990). tinue their respective treatments. All statistical analysis Given the high frequency, the variability in treatment was performed by using SPSS for windows (version 16) options, along with the diverse inclinations and satisfaction software. Means of quantitative variables were com- of the sufferer population, the purpose of this study is to pared by using student T-test between the two groups. determine the therapeutic effects of ginger powder on In the case of categorical variables, Chi-square test was the attacks of migraine without aura and compare it with applied. Headache severity in the study groups, before standard sumatriptan treatment. and after intervention, was assessed with a paired sam- ples T-test analysis. All P-values were two-tailed and a P-value < 0.05 was considered significant. METHODS AND MATERIALS This is a double-blinded randomized controlled clinical RESULTS trial comparing the efficacy of ginger to sumatriptan in the treatment of the common migraine. One hundred One hundred patients with common migraine were study participants who are sufferers of common migraine selected to take either sumatriptan or ginger (groups were enrolled after admission to the Neurology Clinic of equally proportioned). Zanjan Vali-e-Asr Hospital. Participants were assigned The mean age of patients was 35.1  6.2 years old in to two coequal groups by way of simple, random the sumatriptan group and 33.9  8.3 years old in the nonprobability sampling; one group was blindly given ginger group. Females comprised 68% (34 patients) ginger powder, while the other was given sumatriptan. sumatriptan subjects versus 74% (37patients) ginger. Inclusion criteria used (International Headache Soci- Average duration of migraine diagnosis was 7.3  4.5 ety Classification ICHD-II, Migraine, nd): (i) Confirmed years in sumatriptan and 7.2  4.6 years in ginger group. diagnosis of migraine without aura by a neurologist, Average number of headache attacks in sumatriptan based on IHS criteria (ICHD-II), (ii) Aged ≥18 years, and ginger-treated groups were 5.8  3.1 and 4.9  2.7 (iii) Education level high school diploma or higher, attack/month, respectively. This frequency was 4.6  0.9 (iv) Headache frequency between 2 and 10 days/month. attack/month during trial period in both groups. Exclusion criteria were: (i) History of biliary calculus or Average time interval from headache onset to drug peptic ulcer disease, (ii) Allergic reaction, (iii) Hemorrhagic intake was 24  15 min (median: 21 min) for sumatriptan diathesis or using anticoagulants, (iv) History of ischemic and 20  11 min (median: 20 min) for ginger patients. heart disease or Prinzmetal’s angina, (v) Pregnancy or Figure 1 represents changes of mean headache severity lactation, (vi) Headache after head trauma. in subsequent time intervals following consumption of After completion of an introductory questionnaire, either drug. one sealed box containing five capsulets (sumatriptan Before taking the medication, 22% of the sumatriptan or ginger powder) was randomly delivered to each group and 20% of the ginger group had severe headaches subject. Subjects were instructed to take only one (VAS ≥ 8); mean values were 56% versus 48% for moder- capsulet upon headache onset. Each ginger capsulet ate severity (5 ≤ VAS ≤ 7) in the two groups, respectively contained 250 mg powder of ginger rhizome, while each (P = 0.527). Imegraz capsulet contained 50 mg of sumatriptan. Frequency distribution of mean headache severity at All patients were committed to keeping up with their 2 h after drug use demonstrated similar effectiveness previous maintenance therapeutic regimens, and, with for sumatriptan and ginger groups (P = 0.116) (Table 1). each attack they were required to fill out a questionnaire Comparing mean headache severity before and 2 h after revealing: time of headache onset, headache severity treatment revealed a 4.7 unit reduction (according to (rated on a visual analog scale), timing of drug taking, VAS) in the sumatriptan group (P < 0.0001) and a 4.6 response self-assessments following 30, 60, 90,120 min unit reduction in the ginger group (P < 0.0001). and 24 h. Subjects also included any clinical adverse In this study, 70% of sumatriptan-treated and 64% of drug reactions within the questionnaire. This study was ginger-treated patients showed favorable relief (≥90% conducted for the duration of one month, at which point decrease in headache severity) at 2 h following drug Figure 1. Changes in mean headache severity after taking sumatriptan and Ginger during subsequent time intervals. This figure is available in colour online at wileyonlinelibrary.com/journal/ptr. Copyright © 2013 John Wiley & Sons, Ltd. Phytother. Res. 28: 412–415 (2014) 414 M. MAGHBOOLI ET AL. Table 1. Frequency of mean headache severity before each drug use and 2 h after its intake Headache severity Drug Free Mildb Moderatec Severed Sum Sumatriptan Before 0 22 (11) 56 (28) 22 (11) 100 (50) After 44 (22)a 48 (24) 8 (4) 0 100 (50) Ginger powder Before 0 32 (16) 48 (24) 20 (10) 100 (50) After 44 (22) 56 (28) 0 0 100 (50) Sum Before 0 27 (27) 52 (52) 21 (21) 100 (100) After 44 (44) 52 (52) 4 (4) 0 100 (100) a Digits outside and inside the brackets indicate percent and number of patients. b Headache severity as 1 ≤ VAS ≤ 4. c Headache severity as 5 ≤ VAS ≤ 7. d Headache severity as 8 ≤ VAS. P = 0.116. use. Frequency of favorable relief according to gender, Despite availability of multiple drugs specifically for age group, duration of migraine history and maintenance the abortion of migraine attacks (such as ergots and regimen was compared between the sumatriptan and triptans), as well as advances in pharmacologic and ginger groups and summarized in Table 2. These findings alternative therapies, problems including poor satisfac- indicated that both the sumatriptan and ginger signifi- tion of drug efficacy as well as varied side effects persist. cantly impressed on pain relief and no significant differ- Challenges also include the chronic and recurrent ences were demonstrated in the headache subsidence nature of the disease; these can cause patients to between the sumatriptan- and ginger-treated groups. constantly reevaluate their treatment needs, a delay or Subjective side effects arose from sumatriptan including interruption in self management, and a tendency to take dizziness, a sedative effect, vertigo and heartburn. OTC and herbal medications. The only reported clinical adverse effect of ginger was Anecdotally, oral ginger has been used for migraine dyspepsia. Prevalence rate of clinical complaints was headache, nausea and vomiting (Kemper, 1999). The es- sential oil of ginger has also been used topically as an an- 20% for sumatriptan in contrast with only 4% for ginger algesic (Srivastava and Mustafa, 1989). For migraine, (P = 0.028). 86% of subjects reported high or superior 500 mg ginger taken at onset, repeated every 4 h up to satisfaction from the sumatriptan-treated group as com- 1.5–2 g per day, for 3–4 days has been recommended pared to 88% in ginger group (P = 0.736). Eighty-eight (Mustafa and Srivastava, 1990). percent of sumatriptan users and 72% of ginger recipients Researchers at the city of London Migraine Clinic were inclined to continue their randomly assigned drug found that feverfew also eliminated about two-thirds for the abortion of migraine attacks (P = 0.139). of migraines in a selected group of headache patients, which is similar to the effectiveness of most migraine drugs. While some people experience a pronounced effect, others may have none at all (Hylands et al., DISCUSSION 1985; Murphy et al., 1988). The amount that has been shown to prevent migraine The current study reveals that both sumatriptan and attacks in research studies ranges from 50 to 114 mg per ginger powder decrease mean severity of common day. Though most practitioners use capsules containing migraine attacks in within 2 h of use. A comparison of 250 mg of a standardized potency feverfew. efficacy in headache alleviation and patients’ content- Mustafa et al. reported a 42-year-old woman, with a ment does not show any significant difference amongst 16 years history of migraines, experienced enormous the two drugs. However, subjective side effects due to relief after supplementing her diet with 1.5–2 g of dried ginger powder were significantly less than sumatriptan. ginger daily. Table 2. Frequency of ≥ 90% reduction in headache severity after 2 h following each drug use compared based on some features of subjects Drug Variable Sumatriptan Ginger powder PV Sex Male 68.8 (11)a 69.2 (9) 0.978 Female 70.6 (24) 62.2 (23) 0.453 Age group <35 72 (18) 61.3 (19) 0.400 ≥ 35 68 (17) 68.4 (13) 0.976 Duration of migraine history <5 73.3 (11) 62.5 (10) 0.519 ≥5 68.6 (24) 64.7 (22) 0.733 Maintenance therapy With 78.1 (25) 78.6 (22) 0.967 Without 55.6 (10) 45.5 (10) 0.525 a Digits outside and inside the brackets indicate percent and number of patients. Copyright © 2013 John Wiley & Sons, Ltd. Phytother. Res. 28: 412–415 (2014)  MIGRAINE ABLATION BY GINGER VERSUS SUMATRIPTAN 415 In double-blinded placebo-controlled study of Aurora CONCLUSION et al., Gelstat (ginger extract) relieved migraine headache more significantly than placebo within 2 h of taking the drug. There was no meaningful difference in relief rate Consequently, ginger products are a favorable choice of headache by Gelstat and placebo (19% versus 7% for treatment of acute migraine without aura when com- respectively). pared with sumatriptan. Therefore, it is recommended In the present study, ginger powder reduced mean for migrainous patients who are uneasy or poorly headache severity up to 4.6 units in relation to before responsive to other medications or in general simply taking drug. tend to use herbal remedies. It is suggested a more Cady et al. performed an open-label study enrolling extensive placebo-controlled study which can measure 30 patients that were treated in the mild pain phase with the effectiveness of various doses of ginger-based Gelstat Migraine (a combination of ginger and fever- medications with differing types and severities of migraine few).Two hours after treatment, 48% were pain-free is examined. with 34% reporting a headache of only mild severity. Twenty-nine percent reported a recurrence within 24 h. Side effects were minimal, and 59% of subjects were satisfied. 41% preferred Gelstat Migraine or felt it was Acknowledgements equal to their pre-study medication. In our study, 2 h We would like to thank all patients for participating in this study. We after ginger intake, 44% of subjects became pain free are also very grateful to pharmacy companies Goldaru and Razak with 56% reporting a headache of only mild severity. for providing Zintoma and Imegraz. Thanks are also extended to Clinical adverse reactions occurred in 4% of ginger Mrs. Manizhe Asemani, Head nurse of Vali-e-Asr neuroclinic, group, and 88% of patients rated headache relief as for her assistance in sample collection and patient follow-up. great or excellent, and 72% preferred this drug for This study was supported by a grant from Zanjan University of long-term therapy. Medical Sciences. 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