Case studies on prophylactic ayurvedic therapy in migraine patients

Abstract

Ayurveda is a nearly 3000 years old traditional medical system of India. Most of the time, people turn to ayurvedic physicians in desperate conditions. Here clinical practices of Ayurveda were initially found effective in the management of migraine among few patients. Later, it was developed as an ayurvedic treatment protocol (ATP) which consists of four herbo-mineral formulations (HMF), three meals and three snacks in a day with eight hours sleep at night. ATP brought significant relief in reducing the frequency, intensity of pain and associated symptoms in the migraine patients. IHS diagnostic criteria was followed to establish the diagnosis of migraine and uniform ATP was prescribed to each patient who were primarily treated by the ayurvedic physicians at their respective clinics. Such observations were presented at appropriate international forums. In an effort to validate the above, the present study carries the details of nine migraine patients who were first diagnosed and treated for migraine by a leading headache expert at Mumbai in India and were then referred to receive ATP. A total number of nine subjects volunteered to this program. Out of those, seven subjects completed 120 days of ATP. Five subjects reported significant improvement in overall symptoms of migraine. All subjects were followed up periodically for four years. No Grade II side effects were observed in any treated case. HMF has also been proved to be safe in experimental studies. Further pharmacological and randomized controlled clinical studies are in progress at the respective departments of a premier medical institute in India.

Full text

TANG / www.e-tang.org 2012 / Volume 2 / Issue 2 / e17
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Case Report
Case studies on prophylactic ayurvedic therapy in migraine patients
Vaidya Balendu Prakash1, Nitin Chandurkar2, Tejashri Sanghavi3
1Padaav-Specialty ayurvedic Treatment Centre, Ipca Traditional Remedies Pvt. Ltd, 142 AB, Kandivli Industrial Estate, Kandivli
West, Mumbai 400067, India; 2Clinical Research and Development, Ipca laboratories limited, 102 Kadivli Industrial Estate,
Kandivli West, Mumbai 400067, India; 3Counselling and Nutrition, Padaav-Specialty ayurvedic Treatment Centre, Ipca Traditional
Remedies Pvt. Ltd, 142 AB Kandivli Industrial Estate, Kandivli West, Mumbai 400067, India
ABSTRACT
Ayurveda is a nearly 3000 years old traditional medical system of India. Most of the time, people turn to
ayurvedic physicians in desperate conditions. Here clinical practices of Ayurveda were initially found
effective in the management of migraine among few patients. Later, it was developed as an ayurvedic
treatment protocol (ATP) which consists of four herbo-mineral formulations (HMF), three meals and
three snacks in a day with eight hours sleep at night. ATP brought significant relief in reducing the
frequency, intensity of pain and associated symptoms in the migraine patients. IHS diagnostic criteria was
followed to establish the diagnosis of migraine and uniform ATP was prescribed to each patient who were
primarily treated by the ayurvedic physicians at their respective clinics. Such observations were presented
at appropriate international forums. In an effort to validate the above, the present study carries the details
of nine migraine patients who were first diagnosed and treated for migraine by a leading headache expert
at Mumbai in India and were then referred to receive ATP. A total number of nine subjects volunteered to
this program. Out of those, seven subjects completed 120 days of ATP. Five subjects reported significant
improvement in overall symptoms of migraine. All subjects were followed up periodically for four years.
No Grade II side effects were observed in any treated case. HMF has also been proved to be safe in
experimental studies. Further pharmacological and randomized controlled clinical studies are in progress
at the respective departments of a premier medical institute in India.
Keywords migraine, ayurveda, herbo-mineral formulations, IHS diagnostic criteria, prophylaxis
INTRODUCTION
Migraine is a global health problem that affects productivity of
an individual at work, home and social levels (Lipton et al.,
2003) There are many theories towards the diagnosis, treatment
(Diamond, 1989) and prophylaxis (Ivan and Jerry, 2006) of
migraine. Studies now indicate that in certain categories of
patients, prolonged use of medicines for treating migraine may
lead to severe side effects including medication-overuse
headaches (Prakash et al, 2006). Such chronic migraineurs (CM)
turned to complementary and alternative medicine (CAM) to
find relief without getting any side effects. In India, Ayurveda
is the oldest system of medicines (Gogtay et al., 2002). It has
laid down certain principles for the diagnosis, prevention and
treatment of diseases. Ayurveda is largely practiced in India as
a parallel system of medicine along with conventional western
medical system. Patients can approach or attend to any
registered ayurvedic physician for their respective treatment
(Malik, 1984). The present approach towards the prophylaxis
of migraine is an outcome of such an ayurvedic clinical
practice.
The past studies led to a discussion on the response of
ayurvedic treatment in the prevention of migraine during the
proceedings of 16th Migraine Trust International Symposium
held in London in the year 2006 (Prakash et al., 2006). A
uniform ayurvedic treatment protocol (ATP) comprising of four
classical herbo-mineral formulations (HMFs), along with
regulated diet and life style had significantly reduced the pain
intensity, frequency and associated symptoms in fair number of
patients. Later, ATP was followed by few ayurvedic physicians
in their respective clinics in southern India. The multi-centred
observations were presented at the 13th International Headache
Congress held at Stockholm, Sweden in June 2007 (Prakash et
al., 2007). These findings could bring an understanding
between the two streams of medicine (Ayurveda and modern
medicine) and led to the genesis of the present study.
MATERIALS AND METHODS
In the present study, nine cases were first diagnosed and treated
for migraine using conventional prophylaxis and rescue
treatment at the headache and migraine clinic of Dr. K
Ravishankar in Mumbai. Due to the limitation of conventional
treatment in the management of their migraine symptoms and
related side effects, these patients were counselled to undertake
ATP as prophylaxis. The treatment was carried out as a pilot
observation study to validate the stated efficacy of ATP in the
prophylaxis of migraine for four years.
Subject
Each subject gave a written consent prior to undergoing ATP.
These subjects were screened using the International Headache
Society (IHS) diagnostic criteria (Michel et al., 1993) and were
*Correspondence: Vaidya Balendu Prakash
Email: balenduprakash@gmail.com
Received March 12, 2012; Accepted May 24, 2012; Published May
31, 2012
doi: http://dx.doi.org/10.5667/tang.2012.0009
©2012 by Association of genuine traditional medicine

Case studies on prophylactic ayurvedictherapy in migraine patients
TANG / www.e-tang.org 2012 / Volume 2 / Issue 2 / e17
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evaluated for primary parameters like frequency of attacks,
associated symptoms, pain intensity (VAS) (Prakash et al.,
2010), and disability (MIDAS score) (Stewart et al., 2001).
Subjects were also asked questions on the migraine-assessment
of current treatment (ACT) (Pascual et al., 2007).
A total number of nine subjects (5 males, 4 females) in the
age range from between 13 to 54 years received ATP and were
observed from November 2007 to June 2011. All the presented
subjects had been suffering with well-established migraine for
several years (average duration of six years). Subjects had a
frequency of attacks for more than four times in a month except
in one subject (2-4 times a month). Each subject had minimum
two or more associated symptoms like nausea, vomiting,
photophobia or phonophobia during the migraine attack.
Subjects received conventional prophylactic and rescue
treatment under an acclaimed headache specialist (Table 1).
Out of the nine subjects, only one subject was found to be
satisfied on the migraine ACT questionnaire. Seven subjects
had severe pain intensity (VAS > 7) and two subjects had
moderate (VAS 4 - 6). Similarly, six subjects reported grade IV
MIDAS (score > 21) and two subjects had grade I MIDAS
prior to the ATP. Subjects had a median duration of 70
headache days (in last 90 days) prior to ATP (Table 2).
Subjects were advised to take three meals and three snacks
during the day with an uninterrupted eight hours sleep at night.
Subjects were uniformly dispensed ayurvedic medicines
Table 1. Details of conventional treatment*
S.n
CRF no.
Details of conventional treatment
Prophylaxis
Rescue
Name
Dose
(mg)
Frequency
Name
Dose (mg)
Frequency
Propanolol
20
bid
Naratriptan
1
od
Co-enzyme
10
bid
Tizanidine
2
od
1
4
Domeperidone + Paracetamol
combination
10 + 500
od
Naproxen + Domeperidone
Combination
250 + 10
od
Topiramate
50
bid
Sumatriptan
25
od
Naratriptan
7
od
2
5
Rizatripatan Benzoate
10
bid
Naproxen + Domeperidone
Combination
250 + 10
od
Divalproex
500
tid
Rizatriptan
10
od
Methysergide
2
bid
Naproxen
250
bid
Tizanidine
6
od
3
8
Verapamil
120
bid
Naproxen
10
od
Propanol
25
bid
Sumatriptan
25
od
Verapamil
120
od
Lithium Carbonate
150
od
Methysergide
2
od
Tizanidine
6
od
4
11
Amitryptyline
10
od
Naproxen + Domeperidone
Combination
250 + 10
od
Divalproex
500
bid
Rizatripatan
5
od
Tizanidine
2
bid
Topiramate
25
bid
Amitryptyline
10
od
5
26
Naproxen + Domeperidone
Combination
250 + 10
od
Naproxen + Domeperidone
Combination
250 + 10
od
Amitryptyline
10
od
Naratriptan
1
od
Naproxen + Domeperidone
Combination
250 + 10
od
Tizanidine
2
od
6
51
Domeperidone + Paracetamol
combination
10 + 500
od
Naproxen + Domeperidone
Combination
250+ 10
od
Propanol
50
bid
Naratriptan
7
od
7
53
Rizatripatan Benzoate
10
bid
Naratriptan
1
od
Propanol
40
bid
Naratriptan
2.5
od
Topiramate
25
od
Tramadol + paracetamol
37.5 +
325
od
8
55
Amitryptyline
50
od
Naproxen + Domeperidone
Combination
250 + 10
od
Divalproex
500
bid
Tizanidine
2
bid
Naproxen + Domeperidone
Combination
250 + 10
od
Topiramate
25
bid
9
57
Amitryptyline
10
od
Nasal Spray
(Dihydroergotamine Mesylet)
2
od
*Prescribed by Dr. K Ravishankar, MD, Consultant in Charge at the Headcahe and Migraine Clinics in Jaslok Hospital & Research Centre and
Lilawati Hospital Research Centre, Mumbai, India.

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namely Narikela lavana (1000 mg BD), (Shastry et al, 1948),
Numax (500 mg BD), (Prakash et al., 2000), Rason vati (1000
mg TDS) (Yadav ji and Tikram ji, 1935) and Godanti Mishran
(250 mg HS). (Yadav ji and Tikram Ji, 1935) These are
classical Ayurvedic HMFs, prepared at Bharat Bhaishajaya
Shala Pvt. Ltd. under Good Manufacture Practice (GMP)
certificate and ayurvedic medicines manufacturing license
issued by the federal government of Uttarakhand, India.
Subjects were asked to avoid tea, coffee, aerated drinks,
reheated, deep fried, and canned food in their diets during the
entire duration of ATP. They were evaluated for all primary
parameters at 30, 60, 90, 120 days and later randomly over the
telephone or in person. Subjects were advised to stop all other
prophylaxis treatment during ATP. However, subjects were
advised to take conventional rescue treatment as in case of
emergency. Each subject was periodically monitored and all
relevant details were noted on a case record form (CRF) from
the start, during and at the end of ATP.
RESULTS
Out of the nine patients, five patients reported marked
improvement in overall symptoms of migraine after receiving
ATP. They are now living a normal life without the need of any
prophylaxis or rescue treatment. The remission period ranges
from forty-one months (first enrolment) to nine months (last
enrolment). No relapse was reported by any of these patients
except for mild headaches occasionally in extraordinary
situations. However, such mild headaches were devoid of other
symptoms of migraines. Two patients discontinued ATP after
eighty and forty days respectively. One patient received ATP
for 120 days and did not respond. ATP was recommended for
120 days to all the cases, except in one patient, who has been is
receiving ATP for the last 300 days. He does not require
conventional prophylaxis and the quantity of rescue treatment
has dropped significantly. However, he still gets a phobia of
migraine and the number of headache days almost remains the
same after taking ATP. No side effects have been reported or
observed in any of the treated patients (Table 3). There was a
substantial reduction in mean pain intensity from VAS 8 ± 0.77
to 0.2 ± 0.20, median MIDAS score from 60 to 1 and median
headache days from 75 to 1 in five respondents after the
completion of 120 days of ATP. One patient showed marginal
changes in VAS, MIDAS, and headache days after continuing
ATP for 300 days (Table 4).
DISCUSSION
Ayurveda has laid its own principles for the cause, diagnosis,
prevention and treatment of diseases. The ATP for the
prophylaxis of migraine is based on the classical diagnosis of
Shleshma-Pitta (Shastry and Madhavkar, 1937). The symptoms
Table 2. Baseline disease characteristics
Symptoms
VAS
MIDAS
No of
headache
ACT*
S. n
Age
Sex
CRF
no.
History
(in years)
Frequency
(no/month)
Nausea
Vomiting
Photophobia
Phonophobia
Pre
ATP
Pre ATP
Pre ATP
Conventional
prophylaxis
treatment
Yes
No
Relieving
factor
1
13
M
4
6
> 4
×
×
√
√
5
81
70
Yes
3
1
Analgesics
2
46
F
5
3
> 4
√
×
√
√
6
25
25
Yes
4
0
Analgesics
3
35
M
8
6
> 4
√
×
√
√
8
32
70
Yes
0
4
Analgesics
4
42
M
11
10
> 4
×
×
√
√
10
3
75
Yes
0
4
Analgesics
5
54
F
26
1
> 4
×
×
√
√
9
0
20
Yes
0
4
Analgesics
6
28
F
51
2
> 4
√
√
√
√
9
60
75
Yes
1
3
Analgesics
7
47
M
53
30
> 4
×
×
√
√
9
55
55
Yes
1
3
Analgesics
8
44
F
55
20
> 4
√
√
√
√
8
0
90
Yes
0
4
Analgesics
9
33
M
57
25
> 2- 4
√
√
√
√
9
107
90
Yes
0
4
Analgesics
* Assessment of Current Treatment (Dowson et al., 2004)
Table 3. Outcome of ATP
S.n
CRF
no.
Date Of enrolment
Duration of ATP
(Days)
Outcome of ATP
Symptom free period after ATP till
03/01/2012
1
4
01/11/2007
123
Symptom free
41 months
2
5
02/11/2007
120
No change
Dropped out
3
8
23/11/2007
80
Lost to follow up
LTF
4
11
03/03/2008
40
Stopped ATP : using pacemaker
Dropped out
5
26
18/03/2009
125
Symptom free
27 months
6
51
05/06/2010
120
Symptom free
15 months
7
53
09/09/2010
227
Partial improvement in all
symptoms
On ATP (no conventional prophylaxis)
8
55
02/11/2010
90
Symptom free
11 months
9
57
18/01/2011
120
Symptom free
9 month

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described in this book are quite similar to IHS diagnostics
criteria of migraine without aura. HMFs are also well described
in various ayurvedic texts and are being used individually for
many ailments. However, for the first time, these HMFs have
been converted into a uniform ATP for the prophylaxis of
migraine. ATP is based on a hypothesis that episodic attacks of
migraines might be an outcome of a functional disorder of
hepato-bilary system and gastrointestinal tract. ATP is aimed to
restore acid-alkaline balance and to normalise peristalsis in the
gastrointestinal tract. On the other hand, it strengthens the
nervous system. HMFs used in this study did not show any
direct analgesic activity in experimental animal studies.
Though, it brings significant and sustainable relief to migraine
patients (Eadie, 2003). This approach is quite similar to Samuel
August Tissot, who in 1783, ascribed migraine as supra–orbital
neuralgia provoked by the reflexes of the stomach, gall bladder
or uterus (Eadie, 2003).
HMFs are modified classical ayurvedic formulations,
primarily used to cure digestive tract related disorders. The
earlier observations have shown significant prophylactic effect
of HMFs along with regulated diet and life style in migraine
patients. The findings were reported by respective ayurvedic
physicians, who used IHS diagnostic criteria and ATP for the
diagnosis and treatment of migraine. The present study might
be a repetitive exercise, but is different in a way that the
existing cases were first diagnosed and treated by a
conventional headache expert, and subsequently by an
ayurvedic physician. The joint effort is a step forward towards
the validation of the earlier findings. Summarized results of
these cases reconfirm the relevance of ATP in the prophylaxis
of migraine. At this juncture, it will be difficult to draw any
generalisations as the sample size is too small. But this opens
portals towards the diagnosis and treatment of migraine using
one of the oldest CAM therapies of the world.
CAM therapies have certain merits and de-merits regarding
safety and efficacy (Tabish, 2008), (Komper, 2001), which can
be developed for mass use by adopting a rational approach and
principles of reverse pharmacology. It is quite evident that ATP
has strong prima facie evidence in the prophylaxis of migraine.
Nevertheless, many queries should be answered following
modern scientific methodologies and techniques such as
chemistry of HMFs and finished formulations. These will be a
pre-requisite to assure the reproducibility. HMFs have been
subjected to acute, sub-acute and sub-chronic toxicity studies
following OECD guidelines and proved to be safe (Prakash et
al., 2010). But the reason behind the stated efficacy is not
understood. Hence, experimental pharmacological studies and
confirmatory clinical trials on adequate sample size have been
designed in accordance with experts in the field of
pharmacology and neurology at a leading academic medical
institute in India.
The data generated from this case series might be
considered for scientific scrutiny of ayurvedic principles and
therapy towards the diagnosis and prophylaxis for migraine
with a pragmatic approach. A randomized controlled
multicenter clinical trial with an adequate sample size is also
desirable to substantiate the findings of this study.
FUNDING
This research received no specific grant from any funding
agency in the public, commercial, or not-for-profit sectors. All
the patients paid for their treatment.
ACKNOWLEDGEMENTS
Authors are grateful to Dr K Ravishankar M.D, Head
consultant of Headache and Migraine clinic at Jaslok and
Lilawati Hospital, Mumbai for referring the diagnosed cases of
migraine to undergo prophylaxis ayurvedic treatment protocol
and to all patients and their family members for participating in
the program. Special thanks to to Mr. Prem Chand Godha,
M.D., Ipca laboratories Ltd., Mumbai for providing
infrastructure and logistic support for the documentation,
treatment and follow up of these patients. Authors are also
thankful to Bharat Bhaishajaya Shala Pvt. Ltd., Dehradun for
supplying all the herbo-minerals ayurvedic formulations
required for this study.
CONFLICT OF INTERESTS
The authors declare that there is no conflict of interest.
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