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New Dimension in the Treatment of Migraine through Ayurveda. Vaidya Balendu Prakash Ayurvedic Consultant +919837028544 balenduprakash@gmail.com www.ayrvedamigraineclinic.com www.ayurvedapancreatitisclinic.com. Common Migraine.
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New Dimension in the Treatment of Migraine through Ayurveda VaidyaBalenduPrakash Ayurvedic Consultant +919837028544 balenduprakash@gmail.com www.ayrvedamigraineclinic.com www.ayurvedapancreatitisclinic.com
Common Migraine • Common primary episodic headache disorder characterized by various combination of neurologic, gastrointestinal and autonomic symptoms
Migraine-Facts • In India, prevalence stands at 15-20% • Effects women more than men, ratio 3:1
IHS Diagnostic Criteria for Migraine • A. Idiopathic, recurrent headache (=> 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
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
Severity of Pain[Visual 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 • 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
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 Reference:Stewart WF, Lipton RB et al An international study to assess relaibility of MIDAS Score, Neurology 1999, 53:988-994
Current Treatment of Migraine Abortive Prophylactic NSAIDs Beta blockers Analgesics Antidepressants (Along with antiemetics) Calcium antagonists Narcotics Ergot Alkaloids Triptans
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, Feb;45 (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 1:368-448)
Transformed Migraine • Chronic Migraine • 4 hours /day for > 15 days /month • Evolution from episodic migraine to • frequent migraine • ? Medication overuse
Working Hypothesis Shleshma-pitta vs Migraine Reference: Madhav Nidan (Classical Ayurvedic text; describing etio-pathogenesis and diagnosis of the diseases)
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
Innovation • Migraine is an outcome of unregulated diet, life style and / or hepato-billiary disorder • Acid–Alkali imbalance causing physiological changes and reflexes in gastro–intestinal tract causing symptoms of Shleshma–pitta vs Migraine
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
Ayurvedic Treatment Protocol (AYTP) • Narikel Lavana • NUMAX* • Rasonvati • Godanti Mishran • Regulated diet (3 meals + 3 snacks) 1600 calories / day • Eight hour sleep • Combination of five classical Ayurvedic Formulations (Herbo – minerals)
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
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)
Poster Presented and Discussed at16th Migraine Trust International Symposium,18 - 20 September 2006The Conference Centre, Kensington Town Hall, London, UK
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
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
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
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
Acute and Sub acute safety studies on AYFs (OECD guidelines) • No LD50 at 5 gm (maximum) dose • Well tolerated in all groups Prakash et al. IJTPR 2010
Sub Chronic Toxicity Studies in rats (OECD guidelines) - 210 days
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
Results – VAS (Pain Intensity) Ayurvedic Group Conventional Group
Results – MIDAS Ayurvedic Group Conventional Group
Observation • Ayurveda group has significant and sustainable effect in the prevention of Migraine • Ayurvedic treatment was well tolerated without any adverse event