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Case Series to evaluate role of Nutool Therapy on Headache frequency, MIDAS (Migraine Disability Assessment Score) headache intensity by VAS in diagnosed cases of Shaqiqa (Migraine) in Delhi

1. PG Scholar, Tahaffuzi wa Samaji Tib, SUMER, Jamia Hamdrad, New Delhi, India

3. Assistant Professor/Medical Officer Unani, A&U Tibbia College Karol Bagh Directorate of AYUSH, GNCT, Delhi, India

4. Assistant Professor, Tahaffuzi wa Samaji Tib, SUMER, Jamia Hamdard, New Delhi, India

Article Info:

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Article History:

Received 23 December 2021

Reviewed 17 January 2022

Accepted 21 January 2022

Published 28 January 2022

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Cite this article as:

Adil M, Anjum R, Wani P, Perveen A, Case Series to evaluate role of Nutool Therapy on Headache frequency, MIDAS (Migraine Disability Assessment Score) headache intensity by VAS in diagnosed cases of Shaqiqa (Migraine) in Delhi, Journal of Drug Delivery and Therapeutics. 2022; 12(1):143-148

DOI: http://dx.doi.org/10.22270/jddt.v12i1.5204

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*Address for Correspondence:

Dr. Paras Wani, Assistant Professor/Medical Officer Unani, A&U Tibbia College Karol Bagh Directorate of AYUSH, GNCT, Delhi, India

ORCID ID: orgid.org/0000-0001-5802-3633

Abstract

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Almost all Unani physicians have advocated Nutool therapy in the management of migraine (Shaqiqa), particularly with or without medicated oil or liquid, but unfortunately these have not evaluated on scientific parameters. Despite the fact that, this therapy is in the practice of Unani physician and a large number of patients have been treated successfully; this regimen still requires scientific validation to generalize their popularity and acceptability. Present paper is the case series of diagnosed migraine patients to assess the effect of Nutool therapy on headache intensity, MIDAS scale and Pain intensity. The present study entitled “Case Series to evaluate role of Nutool Therapy on Headache frequency (from the daily headache diary),MIDAS (migraine disability assessment score) headache intensity by VAS in diagnosed cases of Shaqiqa (Migraine) in patients attending HAHU and SUMER ,Jamia Hamdard Delhi was conducted in the Department of Tahaffuzi-wa-samaji Tib, SUMER, Jamia Hamdard, New Delhi during the period of September 2020 to Nov 2020 in Psychiatric OPD of HAHC Hospital, Jamia Hamdard, New Delhi on diagnosed Patients of Migraine as per ICHD^3rd (International classification of headache disorders) Criteria. Nutool with Rogan Gul was done for 30 minutes for 12 sittings. The analysis of Nutool therapy on intensity of pain was done and it was found that Nutool therapy reduced the intensity of pain, and it was found statistically significant P<.005 (ANOVA of repeated measures) Freidman statistic Fr =17.76. Nutool therapy also reduced the MIDAS (migraine disability assessment score) and was statistically significant (P<.0047).and was effective on intensity of headache and found statistically significantly P<.0001. Further studies need to be carried out so that it can be advocated on large scale in management of migraine effectively.

Keywords: Migraine, Nutool, Rogan-e-Gul, MIDAS, VAS, Pain.

Shaqiqa (migraine) is a complex disorder characterized by recurrent attacks or episodes of headache, most often unilateral, accompanied by other neurologic and gastrointestinal symptoms.¹ It is the most common headache that leads to medical attentions.² Migraine is one of the oldest medical condition afflicting mankind. It is a form of primary headache derived from term “hemicrania”.^34,35 Its historical background dates back to Mesopotamian era but first written documentation was done by Buqrat (Hippocrates), also further description about its location and cause was given by Jalinoos (Galen).^34,35,36Migraine presentation is multifaceted with symptoms emanating from multiple systems, including vascular, neurologic, gastrointestinal, endocrine and visual.¹ Ancient people held the myth that headache was a sign of evil spirits, and its evidence along with ancient remedies to relieve what was thought to be head pain can be traced 7000 years back.³⁷

The core features of migraine include recurrent headache that is often unilateral, gastrointestinal symptoms such as nausea, or vomiting, and hyperaesthesia manifested by photophobia and phonophobia. The headache generally has a pulsatile and throbbing quality, and the pain is exacerbated by routine physical activity involving movements of the head.¹This disorder is typified as much by nausea and photophobia as it is by pain because of the severity of pain associated with migraine.²

In Unani literature, shaqiqa (migraine) has been described under the heading of suda (headache) in most of the classical Unani text as a disease entity.^21,22,24 The term shaqiqa has been derived from an Arabic word ‘shaq’ which means a part or a side, hence it has been named as shaqiqa.²⁴ It is called hemicrania in Greek.^30,31,33 The English counterpart of shaqiqa is migraine.³² Hippocrates(460-377BC), was the first to described a collection of symptoms which comprises aura, pain and vomiting as part of a singular disorder.^28,29,30,31 Hippocrates, released shaqiqa (migraine) from the realm of the supernatural by attributing it to vapors rising from stomach to the head He proposed that headache can be triggered by exercise or intercourse, and vomiting could partially relieve the pain of headache.²⁷

Ilaj bit Tadbeer (regimental therapy) is one among the four modes of treatment in Unani system of medicine. Nutool (Irrigation) is one among various regimenal therapies.It is useful for various types of chronic ailments and various lifestyle disorders.^1,2

Unani system of medicine claims to possess possible treatment for migraine without aura and offers a number of drugs and therapy including (including Nutool) for this purpose. Almost all Unani physicians have advocated Nutool therapy in the management of migraine (Shaqiqa), particularly with or without medicated oil or liquid, but unfortunately these have not evaluated on scientific parameters. Despite the fact that, this therapy is in the practice of Unani physician and a large number of patients have been treated successfully; this regimen still requires scientific validation to generalize their popularity and acceptability.

Present paper is the case series of diagnosed migraine patients to assess the effect of Nutool therapy on headache intensity, MIDAS scale and Pain intensity.

The present study entitled “Case Series to evaluate role of Nutool Therapy on Headache frequency (from the daily headache diary),MIDAS (migraine disability assessment score) headache intensity by VAS in diagnosed cases of Shaqiqa (Migraine) in patients attending HAHU and SUMER ,Jamia Hamdard Delhi was conducted in the Department of Tahaffuzi-wa-samaji Tib, SUMER, Jamia Hamdard, New Delhi during the period of September 2020 to Nov 2020 in Psychiatric OPD of HAHC Hospital, Jamia Hamdard, New Delhi on diagnosed Patients of Migraine as per ICHD^3rd (International classification of headache disorders) Criteria.

The subjects fulfilling the inclusion criteria were informed in detail regarding the nature of study, method of Nutool (Irrigation) and the procedure involving the subjects. A printed sheet containing the information was used for this purpose (see annexure). Subjects who could read or their family members who could read were provided this sheet or its vernacular translation. They were given the opportunity to ask any question and if they agreed to participate in the study, they were asked to sign the informed consent sheet.

Follow ups on alternate days for first two weeks followed by twice weekly next two weeks.

On the basis of above criteria patients were selected from psychiatry opd, HAHC hospital, Jama Hamdard New Delhi and subjected for further evaluation, enrolled after explaining the study in detail and receiving the informed consent form.

Patients fulfilling the inclusion criteria were enrolled in the present study. The patients were assessed clinically by the relevant history taking, general physical examination, systemic examination of nervous system and other acquired parameters. Socioeconomic status was assessed by Kuppuswamy’s socioeconomic status scale modified for 2017. All the information was recorded in the case record form designed for the study. After through evaluation of patients by history and clinical examination. Patients were enrolled in the study after obtaining written voluntary informed consent.

The assessment of the efficacy of Nutool with Roghan-e-Gul was based on subjective and objective parameter.

Headache location (unilateral or bilateral & pulsating or non-pulsating quality) nausea, vomiting, photophobia and phonophobia.

These were assessed before and after treatment. But subjective parameter was assessed on every 0-day, 15^th day, 30^th day and 45 day by simple asking patients either presence or absence of subjective parameter.

Grade 0 (None), Grade 1 (Mild 1-3), Grade 2 (Moderate 4-6), Grade 3 (Severe 7-10)

Nutool Therapy with Roghan-e-gul manufactured by ‘Hamdard Laboratories’ will be done on forehead for 30 minutes on alternate days for 2 weeks followed by twice a week for 2 weeks.

Before starting the therapy, eyes were protected by keeping a cotton swab soaked in plain water over the closed eye lids. Medicated oil continuously poured by Nutool apparatus in rhythmic stream from a distance of approx. 65cm over forehead of patient lying in supine position.

The mean age of the patients was 28±6.85 and all the participants were females (100%). Majority of the patients were Hindus (66%) and 33% were Muslims and. More than half of the patients were 66% were married and from middle class. All the patients had unilateral headache. Almost all had chronic migraine with duration ranging from four years to nineteen years. Only one patient had migraine form 2-3 years. Headache was pulsating in all the cases and five out of six had moderate intensity headache while only one had mild intensity pain. Four patients had aggravated headache with sunlight exposure. In majority of the patients Vomiting (50%), Nausea (75%), Photophobia (75%), Phonophobia (50%) was associated with migraine. Most of the patients were vegetarian and had strong family history of migraine (4). No addiction and comorbidity was found. The analysis of Nutool therapy on intensity of pain was done and it was found that Nutool therapy reduced the intensity of pain and it was found statistically significant P<.005 (ANOVA of repeated measures) Freidman statistic Fr =17.76. (Table 1, Figure 1). Analysis of Nutool therapy on MIDAS (migraine disability assessment score) was analysed and it was found that Nutool therapy reduced the MIDAS (migraine disability assessment score) and was statistically significant (P<.0047). (Table-2, Figure-2). The analysis of Nutool therapy was assessed on intensity of headache and was found that Nutool therapy reduced the intensity of pain and it was found statistically significantly P<.0001. q>4.076. The analysis of effect of Nutool therapy on vomiting was seen and was found statistically significant p<0.0211. There was decrease in other symptoms as well as photophobia, phonophobia, nausea and vomiting.

Inference: The analysis of Nutool therapy on intensity of pain was done and it was found statistically significant P<.005 (ANOVA of repeated measures) Freidman statistic Fr=17.76.

Inference: Analysis of Nutool therapy on MIDAS was analysed and it was found statistically significant P<.0047.

Nutool is very effective mode of regimental therapy for various types of chronic ailments and various lifestyle disorders including migraine. Nutool therapy (Irrigation therapy) works on the principle of Taḥlīl (resolution), Taskīn (sedation), Tartīb (moistness) and Tadīl-i-Mizaj (temperamental rejuvenation).^3,4,5,6

Rogan e gul is a, nervine tonic, analgesic, aperient¹⁸, murattib¹⁷, Mufatteh, musakkin e dard¹⁷, musakkin e hararat e safra¹⁷, radeh, muhallil, muhallil e auram.^17,20 For Tabreed, Talaiyun e amma¹⁹, Mudammi e quru, musakkin e qumar, qateh bah.¹⁷

A 2006 study in the journal of ethnopharmacology elucidated its antispasmodic effect. In this study, researchers found a potent relaxant effect of R. Damascene oil on the tracheal chains of laboratory animals.¹⁶

In 2007 university of central Lancashire in UK demonstrated anti-anxiety effect of rose oil in laboratory animals exposed to the scent of rose oil.¹⁶

Nutool therapy is effective in Migrane as it induces relaxation similar to that in medication which is reflected by decreased heart rate, bradycardia, lowered sympathetic tone, slowing of alpha waves on EEG, decreased tidal volume and CO2 excretion. The effect of Nutool therapy on migrane is due to its functions as Musakkin e alam (analgesic), Mukhaddir (sedative), Murattib (emollient), Mubarrid (cold), Munavvim(hypnotic) &Muqawi e dimagh(brain tonic properties)^7-10

Uebeba et.al declared that the neuro-physiological mechanism of the consequences of irrigation on the psycho-physiological changes is also associated with the tactile stimulation of the skin or hair follicles innervated by the primary branch of the trigeminal nerve nerves.¹¹Nutool, if done on forehead has been proved to own psycho-neuroimmunology effects that additionally ends up in anxiolysis. organic chemistry changes embrace suppression of nor vasoconstrictive, decrease of PMN/lymphocyte magnitude relation and alpha receptors that recommend a sympathetic suppression instead of parasympathetic activation.¹² The impulses from the forehead cause a stimulation of the trigeminus and additionally a somato-autonomic reflexes and changes in levels of varied neurotransmitters as well as monoamine neurotransmitter and hormone, leading to sympathetic suppression and physio immunologic changes of peripheral circulation and natural killer T cell activity. ^11,12

The perennial stimuli area unit required for consolidation of this data that desires 5-10 minutes and concerning one hour for stronger consolidation. this can be logic and rationalization of completing Nutool for concerning 30-45 minutes. Regular or continuous pressure input generates continuous impulse to the central system thereby endlessly stimulating central nervous system. active this procedure frequently for 15days might cause long lasting stimulation of central nervous system. ^2,11,13

The Nutool therapy has been proved to induce a sense of relaxation. The oils and decoctions in Nutool medical care, absorbed through skin, have curative edges and therapeutic effects area unit achieved by the utilization of specific medicine. several studies are disbursed to grasp the efficaciousness of varied oils utilized in Nutool medical care. ^2,14

Nutool, if done on forehead has been proven to have psycho-neuroimmunology effects which also leads to anxiolysis. Biochemical changes include suppression of nor adrenaline, decrease of PMN/lymphocyte ratio and alpha receptors which suggest a sympathetic suppression rather than parasympathetic activation.¹² The impulses from the forehead cause a stimulation of the trigeminal nerve and also a somato-autonomic reflexes and changes in levels of various neurotransmitters including serotonin and catecholamine, resulting in sympathetic suppression and physio immunologic changes of peripheral circulation and natural killer cell activity.^2,11

A similar study conducted by Umar Fazal et.al 2021 in NIUM Bangalore has yielded similar results. This was a open, single-arm, exploratory clinical study was conducted in 30 patients of chronic migraine selected by convenient sampling method. One litre decoction prepared with 12 g each of Astragalus hamosus L. (Iklilul malik), Matricaria chamomilla L. (Babuna), Artemisia absinthium L. (Afsanteen), Origanum vulgare L. (Marznjosh) and Trigonella foenum graecum L. (Hulba) was poured over painful side of head for 45 minutes on every alternate day for a period of 30 days (15 sittings). The patients, thereafter, were followed untill 90^th day of the study for various outcome measures comprising headache intensity, headache frequency, Migraine Disability Assessment Scale (MIDAS), and rescue medication. The reduction in headache frequency, MIDAS score and use of rescue medication was significant (p < 0.001) after the treatment. Reduction in headache intensity at 30th day, 60th day and 90^th day was significant as compared with baseline values (p < 0.001) but not statistically significant at 90^thday with respect to 60^th day (p > 0.05). Statistical analysis was done using parametric (paired t-test) and non-parametric tests (Wilcoxan sign ranked test, Freidman with Dunn’s multiple comparison tests). Hot irrigation with medicated decoction was found effective in the treatment of chronic migraine which is in accordance with present study.

It can be concluded that the Nutool therapy has been proven to induce a feeling of relaxation and has effectively reduced the intensity of Pain, MDAS in shaqiqa (Migraine). The oils and decoctions in Nutool therapy, absorbed through skin, have curative benefits and therapeutic effects are achieved by the use of specific drugs. Further studies need to be carried out to establish the role of Nutool in Migraine and this regimental therapy can be advocated with conventional medicines too which will help to decrease the drug dependency in migraine patients.

Acknowledgement: Thanks to Dr. Rashmi Prakash psychiatry OPD HIMSR for giving patients and we are thankful to patients without which this study could not have been possible.

HEADACHE FREQUENCY
Day 0	DAY 15	DAY 30	DAY 45
3	2	1	0
5	3	1	0
10	8	5	2
4	3	1	0
9	6	6	3
6	4	2	0

HEADACHE INTENSITY
DAY 0	DAY 15	DAY 30	DAY 45
4	1	0	0
6	3	1	0
6	5	4	1
3	0	0	0
6	3	4	1
5	2	0	0

MIDAS
DAY 0	DAY15	DAY 30	DAY 45
6	3	1	1
11	11	6	2
16	12	5	2
5	2	1	1
12	11	11	5
12	6	3	1