Response to Ayurvedic therapy in the treatment of migraine without aura

Abstract

Migraine patients who do not respond to conventional therapy, develop unacceptable side-effects, or are reluctant to take medicines resort to complementary and alternative medicines (CAM). Globally, patients have been seeking various non-conventional modes of therapy for the management of their headaches. An Ayurvedic Treatment Protocol (AyTP) comprising five Ayurvedic medicines, namely Narikel Lavan, Sootshekhar Rasa, Sitopaladi Churna, Rason Vati and Godanti Mishran along with regulated diet and lifestyle modifications such as minimum 8 h sleep, 30-60 min morning or evening walk and abstention from smoking/drinking, was tried for migraine treatment. The duration of the therapy was 90 days. Out of 406 migraine patients who were offered this AyTP, 204 patients completed 90 days of treatment. Complete disappearance of headache and associated symptoms at completion of AyTP was observed in 72 (35.2%); mild episode of headache without need of any conventional medicines in 72 (35.2%); low intensity of pain along with conventional medicines in 50 (24.5%); no improvement in seven (3.4%) and worst pain was noted in three (1.4%) patients, respectively. In 144 (70.5%) of patients marked reduction of migraine frequency and pain intensity observed may be because of the AyTP. Though the uncontrolled open-label design of this study does not allow us to draw a definite conclusion, from this observational study we can make a preliminary assessment regarding the effectiveness of this ayurvedic treatment protocol.

Full text

30 International Journal of Ayurveda Research | January-March 2010 | Vol 1 | Issue 1
Response to Ayurvedic therapy in the treatment of
migraine without aura
Prakash Balendu Vaidya, Babu S. R. Vaidya1, Sureshkumar K. Vaidya2
V C P Cancer Research Foundation (SIRO), Turner Road, Clement Town, Dehradun, 1Padaav, 13th Main Lakkasandra Extension, Bangalore,
2Padaav, 180 D, 12th Main, 11th Cross Saraswathipuram, Mysore, India.
INTRODUCTION
Migraine is a widespread, chronic and intermittently disabling
disorder characterized by recurrent headaches with or without
aura.[1] Recent studies estimate the prevalence of migraine at
about 6-8% in men and 12-15% in women. In terms of actual
numbers of attacks, combined fi gures from prevalence and
incidence studies suggest 3000 migraine attacks occur every
day for each million of the general population.[2] The rate
of migraine varies globally, and although there is a lack of
epidemiological data available in many countries at present,
recent anecdotal evidence suggests higher rates in certain
places like India.[3]
Pharmaceutical treatment of migraine is complex, with no
agreed upon guidelines. Most individuals often need medication
during acute attacks and some prophylactic measure to reduce
attacks.[2] Moreover, the uncertainty regarding treatment and
the need to perhaps trial patients on a variety of drugs adds to
the escalating costs. Some specifi c drugs such as Triptans and
ergotamine tartrate are often expensive and not commonly used
in resource-poor countries, resulting in a signifi cant amount of
pain and disability.[4] Another problem is the actual overuse of
such medications which causes ‘medication overuse headache’
(MOH), further complicating management strategies.[5]
A large percentage of patients do not respond to pharmacological
interventions for migraine headache, develop unacceptable
side-effects, or are reluctant to take medications[6]. As a
result many patients resort to many complementary and
alternative therapies like acupuncture,[7] biofeedback therapy,[8]
relaxation therapy, herbal remedies and vitamin or mineral
supplementation.[6] Recent studies have demonstrated the
effectiveness of acupuncture[9] and Yoga[10] in the reduction of
migraine headache. The use of complementary and alternative
medicine (CAM) in migraine is a growing phenomenon which,
though increasingly widespread, is poorly understood.[11]
Ayurveda is a traditional medical system used by a majority
of India’s 1.1 billion population.[12] The principal author in his
clinical practice fi rst observed that a judicious combination of
Migraine patients who do not respond to conventional therapy, develop unacceptable side-effects, or are reluctant to
take medicines resort to complementary and alternative medicines (CAM). Globally, patients have been seeking various
non-conventional modes of therapy for the management of their headaches. An Ayurvedic Treatment Protocol (AyTP)
comprising fi ve Ayurvedic medicines, namely Narikel Lavan, Sootshekhar Rasa, Sitopaladi Churna, Rason Vati and
Godanti Mishran along with regulated diet and lifestyle modifi cations such as minimum 8 h sleep, 30-60 min morning
or evening walk and abstention from smoking/drinking, was tried for migraine treatment. The duration of the therapy
was 90 days. Out of 406 migraine patients who were offered this AyTP, 204 patients completed 90 days of treatment.
Complete disappearance of headache and associated symptoms at completion of AyTP was observed in 72 (35.2%);
mild episode of headache without need of any conventional medicines in 72 (35.2%); low intensity of pain along with
conventional medicines in 50 (24.5%); no improvement in seven (3.4%) and worst pain was noted in three (1.4%)
patients, respectively. In 144 (70.5%) of patients marked reduction of migraine frequency and pain intensity observed
may be because of the AyTP. Though the uncontrolled open-label design of this study does not allow us to draw a
defi nite conclusion, from this observational study we can make a preliminary assessment regarding the effectiveness
of this ayurvedic treatment protocol.
Key words: Alternative therapy, Ayurveda, CAM, migraine
ABSTRACT
ORIGINAL ARTICLE
Address for correspondence:
Vaidya Balendu Prakash, Ipca Traditional Remedies Pvt. Ltd.,
142-AB Kandivli Industrial Estate, Kandivli (West), Mumbai - 400
067, India. E-mail: balenduprakash@gmail.com
DOI: 10.4103/0974-7788.59941
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International Journal of Ayurveda Research | January-March 2010 | Vol 1 | Issue 1 31
Vaidya, et al.: Ayurvedic therapy for migraine
fi ve Ayurvedic medicines can markedly reduced the migraine
frequency in some migraine patients. Later, an Ayurvedic
Treatment Protocol (AyTP) comprising these fi ve ayurvedic
medicines along with regulated diet and lifestyle modifi cations
was developed for migraine treatment. This AyTP was tried by
over 600 migraine patients.[13] The background work of this
AyTP was fi rst carried out in Dhanwamtari Ayurvedic College
and Hospital, Chandigarh from June 2002 to December 2004.
[13] In this series we report the analysis of the observational
prospective clinical study of this AyTP carried on 406 migraine
patients in nine major cities of south India.
MATERIALS AND METHODS
Study period
May 2005 to March 2007.
Settings
This study was carried out in the clinics of 17 Vaidyas in nine
major cities of South India, the details of which are given in
Table 1.
Treatment Protocol
The treatment protocol was derived from the Ayurvedic
concept of diagnosis of Amla-Pitta a state of acid-alkali
imbalance causing one of the symptoms of Shiro ruja
(headache). A uniform AyTP was developed which comprised
of a combination of fi ve ayurvedic formulations (Narikel Lavan
(NL), Sootshekhar Rasa (SR), Sitopaladi Churna (SC), Rason
Vati (RV) and Godanti Mishran (GM)[14,15] along with regulated
diet (three meals and three snacks providing adequate calories
and meals devoid of nicotine, caffeine, reheated food, aerated
drink), and lifestyle modifi cation included minimum 8 h sleep,
moderate exercise such as morning or evening walk for 30-60
min and abstention from smoking / drinking.
Composition
Narikela Lavan
Narikel shell - Cocus nucifera
Saindhava lavana - Rock salt
A fully-ripe coconut is taken, the shell is removed and a hole
is made at the top of the coconut. Powdered rock salt is put
through the hole till the water in the coconut rises to the level
of the hole. The coconut is then covered by clay smeared cloth
in three consecutive layers and dried. This is put into a puta of
10-15 cowdung cakes/ furnace. When cool, the charred coconut
Table 1: Study carried out in the clinics of 17
Vaidyas in nine major cities of South India
Place Name of Vaidya Patients
Enrolled
Aurangabad Vd. N Patil 7
Bengaluru
(Bangalore)
Vd. SS Hiremath, Vd. S Kulkarni, Vd. VM
Bhat Aroor, Vd. Prashanth MV, Vd,
R Babu
264
Bellary Vd. Shailaja HB, Vd. Hema Desai DN,
Vd. Savitha BP
37
Dharwad Vd. Sushma RH 10
Hyderabad Vd. Sangamesh Benne, Vd. Vijaysimha R 12
Mysore Vd. Prasanna Venkatesh TS,
Vd. K Suresh Kumar
31
Shimoga Vd. Chitralekha V Krishna 8
Tumkur Vd. Sunil Kumar K 31
Warangal Vd. Mallikarjun K 6
Table 2: Composition of Sootshekhar Rasa
Traditional name English / scientifi c name Proportion
Suddha Parada Processed cinnabar 1 part
Suddha Gandhaka Processed sulphur 1 part
Dalchini Cinnamomum zeylanica 1 part
Chhoti Elachi Elleteria cardamomum 1 part
Tej patta Cinnamomum tamala 1 part
Nagkesar Mesua jerrea 1 part
Shankh Bhasma Turbinella pyrum 1 part
Swarna makshika Bhasma Chalco pyrite 1 part
Ropya Bhasma Argentum 1 part
Tamra Bhasma Cuprum 1 part
Dhatura’s seed Datura metel 1 part
Suhaga Borax sodium borate 1 part
Saunti Zingiber offi cinale 1 part
Kali mircha Piper nigrum 1 part
Chhoti pippal Piper longum 1 part
Bhringraj swarasa Eclipta Alba Q.S (for
mardana)
Table 3: Composition of Sitopaladi Churna
Traditional name English / scientifi c name Proportion
Mishri Sugar candy 16 parts
Vanslochan Bambusa arumdimaceo 8 parts
Chhoti Pippali Piper longum 4 parts
Chhoti Elachi Ellettaria cardamomum 2 parts
Dalchini Cinnamomum zeylanica 1 part
Table 4: Composition of Rason Vati
Traditional name English / scientifi c name Proportion
Lasuna Allium sativum 1 part
Jiraka Cuminum cyminum 1 part
Saindhava lavana Rock salt 1 part
Gandhaka-suddha Processed sulphur 1 part
Sunthi Zingiber offi cinale 1 part
Marica Piper nigrum 1 part
Pippali Piper longum 1 part
Hingu Ferula foetida 1 part
Nimbu rasa Citrus medica juice QS for bhavana
Table 5: Composition of Godanti Mishran
Traditional name English / scientifi c name Proportion
Godanti bhasma Gypsum 8 parts
Jahar mohara pisti Serpentine 2 parts
Rasadi vati 2 parts
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32 International Journal of Ayurveda Research | January-March 2010 | Vol 1 | Issue 1
Vaidya, et al.: Ayurvedic therapy for migraine
containing salt is powdered in a khalva.
The composition of other medicines is given in Table 2-5.
Medicine dosage and duration
The daily recommended doses of these combined formulations
were 7.3 g per day (NL 2000 mg, SR 375 mg, SC 1425 mg,
RV 3000 mg, GM 500 mg). The treatment period was for 90
days. During AyTP the patients were not allowed to take any
other alternative medications.
Manufacturing of Medicine
The Ayurvedic medicines were prepared by Bharat Bhaishajaya
Shala Private Limited, Dehradun under the manufacturing
license issued by the Government of Uttarakhand, India. The
medicines are manufactured under the GMP guidelines and
following the stringent procedures as mentioned in the classical
texts of Ayurveda.
Subjects and Diagnosis
A total of 406 migraine patients (M:133; F:273) were offered
this AyTP. All the patients were chronic sufferers and had
earlier consulted a neurologist for their migraine.
Eligibility
Criteria for inclusion were: individuals of either gender, age
10 and above, meeting the International Classifi cation of
Headache Disorders (ICHD) criteria [16] for migraine without
aura [Table 6]. Exclusion criteria included marked depression,
anxiety or psychosis; more than two visits/month for mental
healthcare; more than one psychiatric medication; major
medical illness under treatment; pregnancy.
Screening, consent, and enrollment
Interested migraine patients who contacted Vaidyas in their
clinics were fi rst screened for eligibility. The patients then
underwent a baseline medical assessment, including a complete
medical history and physical examination. The abdomen of
all patients was especially examined. Patients having any
serious health problem or comorbid illness were not selected
for undergoing AyTP. Eligible patients were fi rst explained
the treatment procedure in detail. Patients who were willing
to follow the set norms of the AyTP were then enrolled for
the study after taking a written consent. Clinical details of the
patients were entered in a clinical record form (CRF), which
was updated after each visit.
Monitoring Progress of Patients
Eligible patients were instructed to maintain a daily headache
diary after the start of AyTP. Subjects had the option of
completing the diary either on paper / postcard and mailing it
to their respective Vaidyas. Alternatively, they could report via
telephone. However, all patients were asked to visit the clinics
at the start of therapy, then at Day 30, 60 and at stoppage of
therapy at Day 90. However, patients were advised to report
to the clinic in case of emergency.
Outcome Measures
The primary outcome variables for this study included
frequency and intensity of headache and self-perceived benefi t
of the intervention at Day 30, 60 and 90. Detailed description
of these variables follows:
Headache frequency
Determination from the daily headache diary the total number
of headache frequency the patient had after the start of therapy.
The subjects were also instructed to record the presence and
intensity of their headaches on a daily basis. Additionally,
the subjects were invited to comment on the nature of their
headache, the associated symptoms, and the suspected triggers.
Headache intensity
The visual analogue scale (VAS) and numeric rating scale
(NRS) was used to measure the intensity of pain. VAS from no
pain (= 0) to worst pain imaginable [=10 (or 100)] and the fi ve-
point categorical verbal rating scale (VRS) i.e., score 0 = none;
1-3 = mild; 4-6 = moderate; 7-8 = severe; 9-10 = worst. Guide
to grading headache intensity was included with each diary.
Headache-related disability: MIDAS
Disability, defi ned as the consequences of illness on the
ability to work and function, is measured using the Migraine
Disability Assessment Score (MIDAS).[17] Derived from the
Headache Impact Test, MIDAS is a seven-item questionnaire
that assesses the number of days during the previous three
months that respondents missed work or school, experienced
decreased productivity at work or home, or missed social
engagements because of headaches. The defi nition of various
grades is mentioned in Table 7.
Adverse events
Reports of adverse events were obtained from the patients
during their visit to the clinic, self-reports in the headache
diaries or by direct contact with patients via telephone.
Statistical Analysis
Kruskal Wallis test was used to compare the VAS score on day
30, day 60 and day 90 from the base line. Paired t-test was
used to compare the headache days. The level of signifi cance
was set at P<0.05. The statistical analysis was performed using
the Statistical Package for Social Sciences (SPSS 12.0).
RESULT
The prevalence of migraine was found to be higher in the
age group 20-50 years, with the highest ranging between
>30-<40 years [Figure 1]. Around 90% of the patients were
non-vegetarian and 155 (38%) patients had family history of
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International Journal of Ayurveda Research | January-March 2010 | Vol 1 | Issue 1 33
Vaidya, et al.: Ayurvedic therapy for migraine
headache. Details of the prior treatment of migraine patients
indicated that 231 (57%) patients were totally dependent
on allopathic medicine; 167 (41%) patients had tried both
allopathic and alternative medicine such as Homeopathy,
Unani / Siddha, Ayurveda and Naturopathy etc., and eight (2%)
patients were totally dependent on alternative medicine. It was
found that exertion, lack of sleep and hunger were the three
most important factors for aggravating migraine, and details
of other factors are given in Figure 2. History of headache
of migraine patients ranged from 1 to 60 years [Figure 3].
At the time of enrollment all the patients reported more than
fi ve attacks in a year from occasional, daily, alternate day
and fi ve to eight days in a month. The maximum patients
those who were enrolled had migraine attack once a week.
Maximum migraineurs complained of nausea, photo phobia,
phono phobia, and vomiting as associated symptoms [Figure
4]. Nearly 50% reported moderate to extreme fatigue besides
heartburn, belching, blurred vision, fl atus, constipation etc.
A total of 406 patients were offered this AyTP, however, after
30 days 129 (31.7%) and after 60 days 41(14.8%) patients
dropped out, respectively. A total of 204 (50.2%) patients
completed 90 days of therapy. Complete disappearance of
headache and associated symptoms at completion of AyTP was
observed in 72 (35.2%); mild episode of headache without need
of any conventional medicines in 72 (35.2%); low intensity
of pain along with conventional medicines in 50 (24.5%); no
improvement in seven (3.4%) and worst pain was noted in
three (1.4%) patients, respectively [Figure 5]. There was a
signifi cant reduction in the VAS score after the start of AyTP
[Table 8].
Figure 1: Agewise distribution of migraine patients
Figure 2: Various aggravating factors reported by migraine patients
Figure 3: History of headache of migraine patients
Table 6: Eligibility of subjects for observational
clinical study on AyTP for migraine
Inclusion Criteria Exclusion Criteria
Subject > 10 years of age
Either gender
Meet ICHD* criteria for migraine
Headache history > 2 years
Willing to follow the dietary
restriction
Willing to complete daily diary
Willing to take the medication
for 90 days
Marked depression, anxiety or
psychosis
Major medical illness under
treatment
Pregnancy
Clotting disorders
More than 2 visits/month for
mental healthcar
Use of any other alternative
medication during AyTP study
period
* International Classifi cation of Headache Disorders
Table 7: The defi nition of various grades
Grade Defi nition Score
I Minimal or infrequent disability 0-5
II Mild or infrequent disability 6-10
III Moderate disability 11-20
IV Severe disability 21+
Table 8: Effect of AyTP on VAS score of migraine
patients
VAS score N Mean SD P value
Day 0
204
3.56 0.72 ----
Day 30 2.15 1.11 <0.001
Day 60 1.40 1.08 <0.001
Day 90 1.0 0.93 <0.001
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34 International Journal of Ayurveda Research | January-March 2010 | Vol 1 | Issue 1
Vaidya, et al.: Ayurvedic therapy for migraine
Figure 4: Various associated symptoms with migraine
Figure 5: Overall response of Ayurvedic treatment protocol on
completion of 90 days of therapy
Figure 6: Impact of AyTP on days of occurrence of headache
To study the impact of the AyTP on headache days 166 patients
were randomly interviewed at the time of enrollment and after
completing 90 days of treatment. It was observed that there
was a highly signifi cant reduction in headache days among the
treated migraineurs [Figure 6]. Decrease in MIDAS score was
observed after 90 days of therapy. At the start of therapy the
number of patients assigned various grades of MIDAS were as
follows: Grade I -110 (27.0%); Grade II - 70 (17.2%); Grade
III - 100 (24.6%); Grade IV - 126 (31.0%), which changed after
the completion of therapy viz. Grade I - 171 (83.8%); Grade
II -18 (8.8%); Grade III - nine (4.4%), and Grade IV - four
(1.9%), respectively.
In 45 (11.0%) patients it was observed that the clinical
condition deteriorated after the start of AyTP, hence, the therapy
was stopped immediately. However, patients who responded to
this therapy and completed 90 days of treatment did not show
any noticeable side-effects.
DISCUSSION
Though Ayurvedic therapy is popular among migraine
sufferers, there are very few reports available on the effi cacy
and toxicity of these therapies. Moreover, classical Vaidyas
treat patients on the basis of presenting symptoms and
hence, there is quite a variation in the selection of Ayurvedic
medicines by different Vaidyas. However, for the present study
a uniform treatment protocol (AyTP) was fi rst designed and
the same was offered to all migraine patients. Generally, the
patients who visited the clinics for AyTP were not satisfi ed
with conventional therapy. Many wanted to try the AyTP on
an experimental basis. The fi rst author in his clinical practice
observed that the combination of fi ve Ayurvedic therapy can
reduce the migraine frequency and intensity of pain in some
patients and hence further collected suffi cient evidence to start
a clinical trial on 131 migraine patients in the Dhanwamtari
Ayurvedic College and Hospital, Chandigarh in 2002.[15]
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International Journal of Ayurveda Research | January-March 2010 | Vol 1 | Issue 1 35
Vaidya, et al.: Ayurvedic therapy for migraine
The results of the trial encouraged us to take up the present
investigation in a planned manner. This AyTP is now being
used by various Vaidyas in various places of India, especially
in the southern parts.
Migraine was distinguished from common headache by Tissot
in 1783 for the fi rst time who ascribed it to a supra-orbital
neuralgia provoked by refl exes from the stomach, gall bladder
or uterus. Later, migraine was classifi ed as a neurological
disorder. Our hypothesis is quite similar to Tissot's idea
on the pathogenesis of migraine, viz. that it usually arose
from stomach disturbance.[18] Incidentally, there is a close
correlation between the symptoms of migraine with those of
Amla-pitta (state of acid-alkali imbalance in the body) causing
symptoms such as: brahma (confusion), moorcha (fainting),
aruchi (anorexia), aalasya (fatigue), chardi (vomiting),
prasek (nausea), mukhmadhurya (sweetness in the mouth)
and shiroruja (headache). The correlation between the cause
and symptoms of Amla-pitta match the current diagnosis
criteria of migraine. It may be possible that the combination
of Narikel Lavan, Sootashekhara Rasa, Sitopaladi Churna,
Rason Vati and Godanti Mishran in conjunction with regulated
lifestyle and diet may have restored the acid-alkali balance, and
restored / strengthened the functioning of the gastrointestinal
system. A better acid-alkali balance in the body may have been
responsible for reducing the frequency of migraine.
The herbo-mineral Ayurvedic medicines used for the
migraine treatment contained Bhasma[19] of silver, copper
and mercury and many immunomodulatory medicinal herbs,
namely Alium sativum, Eclipta alba, Cinnmomum zeylanica,
Zingiber offi cinalis, Piper longum, Piper nigrum, Bambusa
arumdinaceae, Ellettaria cardamomum and Cinnamomum
cassia, Ferula northrax, Citrus acida etc. Some ingredients
used for medicine preparations are moderate to severely toxic
in the raw form (ashodhit). However, intrigue processing
(shodhan) converts these toxic materials to complex mineral
forms which are nontoxic. However, improper processing/
manufacturing of Ayurvedic medicines may result in
severe toxicity.[20] Hence, the safety profi le of the combined
formulations was fi rst established in animal models. It was
observed that mice feed four times and rats 10 times more the
daily equivalent human dose did not produce any toxicity .[21]
In this present study it was observed that in 11% of patients
the clinical conditions deteriorated after the start of the AyTP.
We are at this moment unable to explain what was the exact
cause for this; however, the Ayurvedic medicine was well
tolerated by other patients.
During the last few decades, plants have been increasingly
employed as a herbal remedy for migraine treatment and
prophylaxis,[22] examples include Feverfew (Tanacetum
parthenium),[23] Butterbur (Petasites hybridus),[24, etc.
Most surveys agree that herbal remedies are amongst the
most prevalent therapies and that headache/migraine is
one of the most frequent reasons for trying plant-derived
medications.[25] Complimentary and Alternative Medicine
(CAM) is often perceived by the public to be more helpful
than conventional care for the treatment of headache.[26]
Recent studies have indicated that Ayurvedic medicines can
be effective in treatment of tension-type headache.[27]
From this observational study we can make a preliminary
assessment regarding the effectiveness of this Ayurvedic
treatment protocol in migraine treatment. Baring a few, the
Ayurvedic medications were well tolerated by patients. Marked
reduction of migraine frequency and pain intensity observed in
patients with AyTP needs attention. However, to ascertain the
real effectiveness of this AyTP a properly controlled clinical
trial with a larger patient population is required.
ACKNOWLEDGEMENT
The authors like to thank Dr. Sanjoy Kumar Pal, Sr. Scientifi c
Manager, Ipca Traditional Remedies Pvt. Ltd. for drafting this
manuscript. Mr. Nitin Chandurkar and Mitesh Sharma from
Ipca Laboratories limited for data management and statistical
analysis.
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36 International Journal of Ayurveda Research | January-March 2010 | Vol 1 | Issue 1
Vaidya, et al.: Ayurvedic therapy for migraine
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Source of Support: Nil, Confl ict of Interest: None declared
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