|Year : 2019 | Volume
| Issue : 1 | Page : 76-79
An analgesic effect of Stachys lavandulifolia in patients with migraine: A double-blind randomised clinical trial study
Alireza Rezaei Ashtiani1, Ali Jadidi2, Ali Khanmohamadi Hezave3, Mehdi Safarabadi4, Seyed Mohamad Aghae Pour3, Keivan Ghassami1, Abolfazl Mohammadbeigi5
1 Department of Neurology, Vali-E-Asr Medical Center, Arak University of Medical Sciences, Arak, Iran
2 Department of Nursing, Hamadan University of Medical Sciences, Hamadan, Iran
3 Department of Nursing, School of Nursing and Midwifery, Arak School of Nursing and Midwifery, Arak University of Medical Sciences, Arak, Iran
4 Department of Nursing, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran
5 Neurology and Neurosciences Research Center, Qom University of Medical Sciences, Qom, Iran
|Date of Web Publication||4-Jan-2019|
Department of Neurology, Arak University of Medical Sciences, Arak
Source of Support: None, Conflict of Interest: None
Background and Aim: Headache is the most common clinical syndrome of pain, and it is estimated that more than half of the patients are visited by physicians due to headache. Stachys lavandulifolia is one of the medicinal herbs which are traditionally used to treat headache. Therefore, the present study aimed to investigate the therapeutic effect of this herb on pain relief among patients with migraine. Methods: In this study, 50 patients with migraine were assigned randomly by block randomisation to intervention and control groups. In addition to routine treatment, two grams of hot herbal tea was given to the intervention group twice a day and every time while control group took routine herbs and placebo. Pain intensity was measured using visual analogue scale 1 and 2 months after the beginning of treatment. The data were analysed by t-tests and repeated measures using SPSS software (Version 18.0, SPSS Inc., Chicago, USA). Results: The mean score of pain intensity was similar at baseline and after intervention reached to 4.21 ± 1.42 and 6.33 ± 1.55 for intervention and control groups, respectively. Based on the results of repeated measures, the mean score of pain intensity decreased in both groups, but the decreasing trend has more speed in intervention group. Moreover, the mean score of pain intensity decreased more 1 and 2 months after taking the medicinal herbs in intervention group compared to control group (P < 0.001). The mean score of decrease in pain intensity was statistically significant between two groups (4.21 ± 1.89 vs. 1.92 ± 1.41, P < 0.001). Conclusion: Mountain tea can be used as an auxiliary drug in the treatment of migraine patients due to its strong analgesic resources and the lack of significant side effects.
Keywords: Analgesic, headache, migraine, mountain tea, toclice
|How to cite this article:|
Ashtiani AR, Jadidi A, Hezave AK, Safarabadi M, Aghae Pour SM, Ghassami K, Mohammadbeigi A. An analgesic effect of Stachys lavandulifolia in patients with migraine: A double-blind randomised clinical trial study. Adv Hum Biol 2019;9:76-9
|How to cite this URL:|
Ashtiani AR, Jadidi A, Hezave AK, Safarabadi M, Aghae Pour SM, Ghassami K, Mohammadbeigi A. An analgesic effect of Stachys lavandulifolia in patients with migraine: A double-blind randomised clinical trial study. Adv Hum Biol [serial online] 2019 [cited 2020 Jun 6];9:76-9. Available from: http://www.aihbonline.com/text.asp?2019/9/1/76/243756
| Introduction|| |
Pain is one of the symptoms which is observed in most of the diseases and is prevalent in several syndromes. Headache is the most common clinical syndrome of pain in such a way that half of the patients due to headache refer to physicians. In categorising the causes of headache, migraine after the neural headache is ranked in the second place of prevalence. Migraines include 20%–25% of headache types. However, due to the degree of damage which afflicts people, its treatment and the reduction of frequency and intensity of migraine headaches are extremely important.,, Migraine is one of the most common types of headache in the world affecting about 12% of the total population., This disease is a neurovascular disorder of the parenchyma of the brain which is debilitating, progressive and chronic and plays an important role in individuals' life. The most common problems and costs associated with headache are disability, pain and suffering and loss of quality of life. Currently, various drugs including Tryptic medications, ergot, beta-blockers, calcium channel blockers, anticonvulsants, three-ring antidepressants and serotonergic agents are used to treat and prevent migraine. Most of these drugs have many side effects such as ovarian cysts, obesity, liver complications and interference in pregnancy.,,, For this reason, the tendency to use these drugs and herbal compounds has increased in recent years. The use of medicinal herbs for the treatment of diseases has a long history. Today, although a large part of drugs is synthetic, it is estimated that at least one-third of all products are herbal medicines or have been transformed after extraction of the plant.,, The mountain tea, known as Chay-e-Kouhi, or Toklijeh with scientific name of Stachys lavandulifolia is a kind of Pune which grows in mountain slopes of different regions of Iran. Its flowers are cotton-like and blue-purple spikes., The flower of this herb has a greater therapeutic effect including colic and rheumatic pain improvement, starting menstruation in women, removing urinary and biliary stones and increasing sexual power. Further, the studies indicated that this drug can prevent the production of prostaglandins, which act as pain mediators. Anti-inflammatory, antibacterial and analgesic effects of this plant were reported and its traditional use was confirmed for the treatment of pain and inflammation.,,, Although this herbal medicine has been used to relieve pain in animal models, it has been used less frequently in human studies. However, the use of this herbal medicine for relieving the symptoms of dysmenorrhea was reported in one study. Therefore, due to a high prevalence of migraine among the public population and its adverse consequences such as life quality reduction and absence from work, it is important to use a low-risk and safe drug in the prevention of migraine, especially in pregnant women who are suffering from this disease because many anti-migraine drugs have adverse effects in pregnancy. However, mountain tea is a healthy herbal medicine with minimal side effects which has not been used to treat migraine so far. Therefore, the present study aimed to investigate the effect of mountain tea on the treatment of migraine disease in clinical trial form.
| Methods|| |
The present study was conducted as a double-blind clinical trial among the patients referred to the Neurology Clinic of Arak University of Medical Sciences for 9 months during 2014–2016. The study population consisted of 50 patients with migraine headache who were diagnosed according to international headache society (IHS) criteria and suffered from the disease for at least 6 months and also had headache more than 3 times a month. Sample size was calculated based on the results of recent studies and the power of study as 80% and confidence interval as 95%. The patients were selected by the convenience sampling method, and then, the eligible patients were assigned randomly by block randomisation to intervention and control groups. The patients were voluntarily participated in the study and they were signed the informed consent form. Moreover, the Ethical Committee of Arak University of Medical Sciences approved the protocol of this study by IR.ARAKMU.REC.1394.369 code. In addition, this research was registered in Iranian Registry of Clinical Trials (IRCT) with number IRCT2016042626667N4. During the study, the patients who were reluctant to continue the study were excluded from the study. The patients were assigned randomly into intervention and control groups by block randomisation method and each group with 25 participants. The block size was 4. Patients in assigned groups and the research team were not aware about the treatment assignment, and the study was double blind.
The intervention group received treatment three times a day and each time 10 g of hot mountain tea in 200 cc of boiling water beside to the routine drugs. Patients in the control group were also prescribed routine drugs and placebo. Then, the visual analogue scale (VAS) was used to measure the pain intensity. Actually, the VAS is the same as the pain ruler with a horizontal line which was scaled from 0 for absolute analgesia to 10 for unbearable pain. In the present study, it is regarded as one of the pain grading scales. At the beginning of the study, the patients were trained how to use this scale, and then, their pain intensity was measured at three times of 0, 30 and 60 days after the intervention. Patients' pain was measured by a person other than the researcher who did not know the patient group. Then, the data were statistically analysed using SPSS software (Version 18.0, SPSS Inc., Chicago, USA). Chi-square test and independent sample t-test were used for assessing the relationship between qualitative and quantitative variables, respectively. In addition, analysis of variance for repeated measurements was used to evaluate the trend of pain intensity in each group and between two study groups.
| Results|| |
The mean age for the intervention and control groups was 36.08 ± 13.04 and 38.16 ± 8.8, respectively, and this difference was not statistically significant (P > 0.05). Overall, 96% of the participants in the intervention group and 76% of participants in the control group were male. Moreover, the participants in both groups were the same in terms of marital status, educational level and occupation (P > 05) as shown in [Table 1]. Based on the results, the pain intensity among the patients suffering from migraine in the intervention and control groups was significant at 30 and 60 days after the intervention [Table 2]. The mean score of pain intensity was similar at baseline and after intervention reached to 4.21 ± 1.42 and 6.33 ± 1.55 for intervention and control groups, respectively. Based on the results of repeated measures, the mean score of pain intensity decreased in both groups, but the decreasing trend has more speed in intervention group (P < 0.001). In addition, the pain intensity in each group showed a decreasing trend, and the decreasing trend between two groups was statistically significant by analysis of variance for repeated measurements. The baseline measurements showed that the pain intensity based on VAS index was similar before intervention (8.42 ± 1.40 vs. 8.25 ± 1.57, P = 0.667). Nevertheless, the mean of decrease in pain intensity was statistically significant between two groups (4.21 ± 1.89 vs. 1.92 ± 1.41, P < 0.001).
|Table 1: Demographic data based on quantitative and qualitative demographic variables in intervention and control groups|
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|Table 2: The mean comparison of visual analogue scale index (pain intensity) in control and intervention groups|
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| Discussion|| |
S. lavandulifolia is a native plant in Iran which is traditionally used in home remedy as sedative herbal tea to reduce anxiety and treat gastrointestinal disorders. In addition, mountain tea is widely used in some regions of Turkey as a natural tea for the treatment of gastrointestinal and respiratory disorders.,,, The results of the study indicated that the mean score of pain intensity based on the VAS was significantly different in three measurement times. The mean of pain intensity in the 1st and 2nd months after treatment was significantly different between the intervention and control groups, and the mean of pain intensity in the 1st and 2nd months after treatment in the intervention group was lower than that of the control group. In the phytochemical study of the extracts of mountain tea, two iridous glycosides, including flavonoid and phenylethanoid glycoside, have been identified. Further, qualitative tests related to flavonoids, alkaloids and sapiens on the plant extract were positive. The presence of flavonoids and iridous compounds in the extract of this plant has the antioxidant, anti-inflammatory and analgesic effects leading to the traditional use of this plant. The significant antioxidant activity of these plants confirms the presence of phenolic glycosylated compounds. The inhibitory effects of flavonoids on acute inflammation are related to the effect of signalling pathways including the activity of the nuclear factor of kappa B and phosphorylation of mitogen-activated protein kinase. In addition, flavonoids reduce the accumulation of floating lipids which are essential for signalling the pain phenomenon. Therefore, flavonoids can reduce chronic and acute inflammation by controlling the accumulation of receptors and signal cascade. These flavonoids are able to inhibit prostaglandin E2 and leukotriene C4 and can stop the production of thromboxane B2 in human platelets.
The cyclooxygenase enzymes catalyse the conversion of arachidonic acid to prostanoids such as prostaglandins and thromboxanes. Non-steroidal analgesic medications prevent the synthesis of prostaglandin E2 by inhibiting cyclooxygenase enzyme. Based on the results of the study conducted in Tehran in March 2005 on anti-inflammatory and analgesic effects of extract of aerial parts of S. lavandulifolia plant on rats, anti-inflammatory and analgesic effects of this plant were similar to the use of 5 mg/kg indomethacin above 50–100 mg/kg doses. In another study in Greece in February 2003 on the antioxidant effect of aromatic plants, it was found that mountain tea has antioxidant effect. Antioxidants can prevent the oxidation of arachidonic acid and ultimately the production of prostaglandins. This species is also from the family of S. lavandulifolia. Jenabi et al., in another study on the effect of mountain tea on primary dysmenorrhea, found that the S. lavandulifolia plant can reduce the pain intensity in patients, change the pain pattern and improve its tolerance. Rabbani et al. (2005) concluded that the anxiolytic effect of this medicinal herb is due to the content of flavonoids, phenylpropanoids or terpenoids. Rahzani et al., in another study in India, indicated that this medicinal herb has antioxidant and anti-inflammatory effects and its traditional use relieves the pain and inflammation. Işcan et al. demonstrated the potent antioxidant effects of this plant. Further, Rahzani et al. showed that mountain tea has specific oxidative anti-stress activity and can be used as a supplement to manage oxidative stress-related illnesses. The study results of Hajhashemi et al. confirmed the traditional use of this herb to treat disorders associated with pain and inflammation. Therefore, according to the results of this study, mountain tea can reduce and improve the pain intensity of patients with migraine.
| Conclusion|| |
According to our results, the mean score of pain intensity was lower than in patients of intervention group than the control group both 1 and 2 months after treatment. Moreover, the decreasing trend of pain intensity showed a speedy trend in intervention group. Therefore, S. lavandulifolia can be used as an auxiliary drug in the treatment of migraine patients due to its strong antioxidant resources and the lack of significant side effects.
Authors greatly appreciate the Deputy of Research and Technology of Arak University of Medical Sciences, Clinical Research Development Base of Vali-Asr Hospital, Department of Neurology and all patients who patiently participated in this project.
Financial support and sponsorship
This study was financially supported by Arak University of Medical Sciences.
Conflicts of interest
There are no conflicts of interest.
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