Vaidya Balendu Prakash

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New Dimension in the Treatment of Migraine
through Ayurveda

• Vaidya Balendu Prakash
• Ayurvedic Consultant
• 919837028544
• balenduprakash_at_gmail.com
• www.ayrvedamigraineclinic.com
• www.ayurvedapancreatitisclinic.com

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Common Migraine

• Common primary episodic headache disorder
  characterized by various combination of
  neurologic, gastrointestinal and autonomic
  symptoms

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Migraine-Facts

• In India, prevalence stands at 15-20
• Effects women more than men, ratio 31

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World ATLAS of Migraine
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IHS Diagnostic Criteria for Migraine

• A. Idiopathic, recurrent headache (gt 5 attacks)
• B. 4-72 hours duration
• C. Pain characteristics (2/4)
• Unilateral location
• Pulsating quality
• Moderate to severe intensity
• Aggravation by routine physical activity
• D. During attack (1/2)
• Nausea and / or Vomiting
• Photophobia and phonophobia

children, sleep untreated or unsuccessfully
treated
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IHS Diagnostic Criteria for Migraine

• E. At least one of the following
• No secondary cause for headache
• Secondary cause suggested but ruled out by
  investigations
• Secondary cause present but migraine does not
  occur for the first time in close temporal
  relation to the disorder

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Severity of PainVisual Analog Scale (VAS)

• Assessment of severity of pain on a 10 point
  visual analog scale
• Should be used every 30 days for the evaluation
  of the severity of pain

Definition Score
No pain 0
Mild 1-3
Moderate 4-6
Severe 7-8
Worst possible 9-10

• Reference Amelia Wlliamsol, Barbara Hoggart
  Pain, a review of three commonly used pain rating
  scales. Journal of clinical nursing August 2005,
  volume 14 issue 7, 798-804

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Migraine Induced Disability Assessment Scale
(MIDAS)

• To evaluate the impact of migraine headache on
  ability to function at work, home and social
  situation
• Evaluated every 90 days

Grade Definition ScoreI
I Minimal 0-5
II Mild 6-10
III Moderate 11-20
IV Severe 21
Reference Stewart WF, Lipton RB et al An
international study to assess relaibility of
MIDAS Score, Neurology 1999, 53988-994
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Current Treatment of Migraine

• Abortive
  Prophylactic
• NSAIDs
  Beta blockers
• Analgesics
  Antidepressants
• (Along with antiemetics)
  Calcium antagonists
• Narcotics
• Ergot Alkaloids
• Triptans

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Concerns with Drug Therapy

• GI and Renal side effects with NSAIDs and Ergots
• 30 of patients fail to respond to a particular
  triptans (Headache 2005, Feb45
  (2)156-162)
• Triptans- potential risk in increasing blood
  pressure and mild and transient effects on
  coronary artery tone
• Triptans contraindicated in many diseases
• 
  (Am J Med
  2005 Mar 118 Suppl 1368-448)

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Transformed Migraine

• Chronic Migraine
• 4 hours /day for gt 15 days /month
• Evolution from episodic migraine to
  
• frequent migraine
• ? Medication overuse

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Working Hypothesis

• Shleshma-pitta vs Migraine
• Reference Madhav Nidan (Classical Ayurvedic
  text describing
• etio-pathogenesis and diagnosis of the diseases)

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Causes of Shleshma-pitta

• Irregular eating habits such as, wrong food
  combination, quantity and timings
• Long gap or intermittent eating pattern, crash
  dieting
• Stale, over salty, spicy, sour food items
• Over use of tea coffee, aerated drinks and
• deep fried food
• Arrestation of basic urges like sleep, hunger,
  urine, stool etc.
• Irregular life style, anxiety, worry and lack
  of exercises
• Use of certain drugs and diseases affecting the
  hepato-billiary system

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Innovation

• Migraine is an outcome of unregulated diet, life
  style and / or hepato-billiary disorder
• AcidAlkali imbalance causing physiological
  changes and reflexes in gastrointestinal tract
  causing symptoms of Shleshmapitta vs Migraine

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Mouth, Esophagus pH 6 - 7
Interhepatic bile pH 7.5
Gastric pH 1.8 3.5
Bile in gall bladder pH 7.6 8.6
Duodenum pH 5.5 6.5
Pancreatic juice pH 8.8
Ileum pH 6.5 7.5
Caecum pH 5.5 7.5
Rectum pH 6.1 7.5
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Ayurvedic Treatment Protocol (AYTP)

• Regulated diet (3 meals 3 snacks) 1600 calories
  / day
• Eight hour sleep
• Combination of five classical Ayurvedic
  Formulations (Herbo minerals)

• Narikel Lavana
• NUMAX
• Rasonvati
• Godanti Mishran

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Methodology

• IHS diagnostic Criteria for migraine without aura
• VAS and MIDAS scoring to access severity and
  impact at day 0, 30, 60 and 90
• Individual consent
• 120 days regular and paid treatment
• Long term follow up
• Collaborative experimental and clinical studies

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Observation and findings

• Retrospective 1985 to 2002
• Prospective I June 2002 to Dec 2004
  (Chandigarh)
• Prospective - II May 2005 till date (Karnataka,
  Maharashtra, Uttarakhand, Uttar Pradesh, Andhra
  Pradesh and Haryana)
• Prospective - III June 2007 till date (HQ
  Dehradun)
• Randomized controlled clinical trail on
  refractory and chronic migraine patients at
  AIIMS, New Delhi (2012-2014.ongoing)

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Poster Presented and Discussed at16th Migraine
Trust International Symposium,18 - 20 September
2006The Conference Centre, Kensington Town
Hall, London, UK 
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Poster Presented at 13th Congress on Headache
organized by International Headache Society,
28th June to 2nd July 2007, at Stockholm,
Sweden Poster abstract published in Cephalalgia,
2007, 27, 745
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Poster Presented at 52nd Meeting of the American
Headache Society, 24th 27th June 2010, at Los
Angeles, USA Poster abstract published in
Headache 2010 50 (Suppl 1) 53
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Research Paper on Response of Ayurvedic therapy
in the treatment of migraine without
aura Vaidya Balendu Prakash, S Raghavendra
Babu, K Suresh Kumar
Published in the International Journal of
Ayurveda Research, Publication of AYUSH,
Department of Health Family Welfare, Government
of India
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Case studies on prophylactic ayurvedic therapy in
migraine patients Vaidya Balendu Prakash, Nitin
Chandurkar, Tejashri Sanghavi
2012 / Volume 2 / Issue 2 / e17 TANG /
www.e-tang.org
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Acute and Sub acute safety studies on AYFs (OECD
guidelines)
Recommended Human Dose Rat (Daily Dose) Mice (Daily Dose)
7.3 gm/day 0.7 gm (Equivalent) 1.47 gm (Equivalent)
7.3 gm/day 2.23 gm (Three times) 3.04 gm (Two times)
7.3 gm/day 7.45 gm (Ten times) 6.48 gm (Four times)

• No LD50 at 5 gm (maximum) dose
• Well tolerated in all groups

Prakash et al. IJTPR 2010
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Sub Chronic Toxicity Studies in rats (OECD
guidelines) - 210 days
G I G II G III G IV G V
Control Normal Medium High Satellite
Animals (? ?) 20 20 20 20 20
Treatment (day) 180 180 180 180 180
Sacrifice (day) 181 181 181 181 211
Mortality 2 2
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Ongoing Research Progress

• Randomised controlled clinical trial to evaluate
  prophylactic properties of ayurvedic treatment
  protocol in refractory and chronic migraine
  patients
• Department of Neurology, AIIMS, New Delhi
• Investigators Prof (Dr) Manjari Tripathi (PI),
  Prof (Dr) A K Mahapatra, Vaidya Balendu Prakash
  (Co- PI)
• Date of commencement 1st April, 2012
• Funding Agency Ipca Laboratories Limited, Mumbai

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Baseline Characteristics (n70)
Particulars Particulars Ayu Gr ( 32 ) Conv Gr ( 38 )
Sex (Female/Male) Sex (Female/Male) 24/8 27/11
Age Group Age Group 18-51 18-52
History (In years) History (In years) 1-20 1-28
Frequency (monthly) 2-4 14 13
Frequency (monthly) gt 4 18 25
Intensity (VAS) Intensity (VAS) 7-10 5-10
MIDAS Score MIDAS Score 20-55 16-55
Headache Days Headache Days 1628 2139
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Baseline Characteristics - II
Particulars Ayu Gr ( 32 ) Conv Gr ( 38 )
Associate Symptoms Associate Symptoms Associate Symptoms
Nausea 27 34
Vomiting 24 31
Photophobia 26 35
Phonophobia 30 32
Relieving Factors Painkillers and Sleep Painkillers and Sleep
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Outcome after 120 days
Particulars Ayu Gr ( 13 ) Conv Gr ( 26 )
Moderate to Severe pain with need of Prophylaxis Rescue 0 26
Mild pain with no need of medication 10 0
Symptom free 2 0
VAS 97/24 ( 8.1 2 ) 111/213 ( 8.2 4.3 )
MIDAS 446 /103 ( 37.2 8.6) 889/656 ( 34.2 25.2)
Headache Days 726/100 ( 60.5 8.33) 1511/544 (58.1 20.9)
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Outcome after 120 days II
Particulars Ayu Gr ( 13) Conv Gr ( 26 )
Associate Symptoms Associate Symptoms Associate Symptoms
Nausea 11/4 23/25
Vomiting 10/0 20/6
Photophobia 13/5 24/24
Phonophobia 13/1 22/17
Lost to follow up 1 1
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Results VAS (Pain Intensity)

• Ayurvedic Group

• Conventional Group

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Results MIDAS

• Ayurvedic Group

• Conventional Group

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Observation

• Ayurveda group has significant and sustainable
  effect in the prevention of Migraine
• Ayurvedic treatment was well tolerated without
  any adverse event

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• Thank You