A COMPARATIVE STUDY TO EVALUATE THE EFFICACY OF AGNIKARMA AND SHADBINDU TAILA NASYA IN VATAJA SHIRASHOOLA

INTRODUCTION

Tension headache is a psychosomatic disease which can be compared with Vataja Shirashoola described in Ayurvedic texts. Shiras in Ayurveda is explained as uttamanga. Being the seat of life, intellect and sense organs, it is also one among the three major marmas² . All three doshas are located in the head with the predominance of kapha. Ayurveda suggests main causes of vataja shiroroga as sandharana, divaswapna, ratrijagarana, uchaibhashya, upavasa, bashpa, shoka, bhaya, trasa etc³ . So prime importance should be given to protect the Shiras from all sorts of diseases.

According to allopathic science, headache is an extremely common phenomenon, experienced by most people, particularly in settings of stress and fatigue⁴ . Their mode of treatment includes analgesics. Use of analgesic drugs regularly, induces headache, known as analgesic headache. Which disappears after the regular medication is stopped. But the disadvantage is initial complaint may re-occur⁵ .

Hence there is need for an optimum therapy where by at least the duration is reduced, Intensity is decreased, Frequency is delayed which may give a long better relief to the patients.

In this connection, an effort has been made to evaluate the efficacy of classical therapeutic procedures in combating this clinical condition.

For Vataja Shirashoola various treatment measures are described in Ayurvedic science. Agnikarma is one among them⁶ .Agnikarma is emphasized in Sushrutha Samhitha that, those diseases which are not curable by Shastra, Ksharaand Bheshaja can beneficially be treated by Agnikarma. Such successfully treated diseases have no recurrence⁷ .

Nasya is effective in treatment of Shirorogas, where the medicine administered through the nose goes into the Shiras and expels out the vitiated Doshas since Nasika being the doorway of Shira⁸ . Shadbindu Taila Nasya is the one which is indicated in all Shiro rogas⁹ .

Agnikarma being Ushna chikitsa pacifies Vata so pain gets relieved immediately after Agnikarma and most of the ingredients of Shadbindu Taila are having Vata Shamaka and Vedanahara property which act effectively in relieving Vataja shirashoola. So here in this present clinical study Agnikarma is being evaluated or compared with Nasyakarma.

OBJECTIVE OF THE STUDY

1. To evaluate the comparative effects of Agnikarma and Nasyakarmain Vataja Shirashoola.

MATERIALS AND METHODS

Drug source

Raw drugs required were identified and selected from the local market and Shadbindu Taila was prepared in the Alva's Pharmacy, Mijar, as per the literature reference.

Sample source

40 patients diagnosed with Vataja Shirashoola were taken for this study from the OPD and IPD of the Alva's Ayurveda Medical College Hospital, Moodbidri and also from other available sources.

Method of collection of data

40 patients fulfilling the inclusion criteria of either sex were randomly selected. They were assigned into two equal groups A & B of 20 patients each.

a) Diagnostic criteria

Classical symptoms of Vataja Shirashoola as mentioned in classical texts like Animittaja Shirashoola, Teevram Nishi cha Atimatram, Banda Upatapascha Prashamanam & Pain in forehead, frontal and temporal region radiating to occipital region, bilaterally.

b) Inclusion criteria

1. Patients between 20-60 years of age irrespective of sex, religion, occupation and socio-economic status were taken into the study.

2. Patients with signs and symptoms of Vataja Shirashoola as mentioned in classical texts.

3. Average headache frequency of more than 15 days per month for more than 6 months.

c) Exclusion criteria

1. Patients contraindicated for Agnikarma and Nasya as per classics.

2. Patients with secondary headaches due to intra cranial tumor, hematoma, meningitis, ocular causes, nasal sinusitis, dental caries.

d) Procedure

Group A: Agnikarma was done on 20 patients of Group A. 

Materials used: Pancha loha shalaka (probe), Madhu, Ghritha, Ushna Jala, cotton, gauze stow, eye pack.

Site: Bhru, Shankha, Lalata (Avoiding vital parts)

Purva karma: Patient's consent to undergo Agni karma treatment was taken. Patient's eyes were covered with eye pack. Brhu, Shankha, Lalata Pradesha of both sides is gently cleansed with a swab dipped in Ushnajala and dried. The site of Agnikarma is marked.

Pradhana karma: Initially Pancha loha shalaka is heated on stow. The heating of Shalaka is continued until it becomes red hot. The Tapta Shalaka is slowly touched on the selected sites, in maximum tender points for a moment in Bindu Akrithi (4- 8 dots) till Twakdagdha lakshana as per classical reference were observed and then Panchaloha Shalaka was removed.

Paschat karma: The burnt part is gently applied with Goghrita and Madhu. Patient was asked to be in supine position for a period of 10 minutes.

Duration of treatment-One day.

DETAILS OF THE SHALAKA USED IN THE STUDY:

Component metals are as follows: Tamra (Copper)-45%, Loha (Iron)- 35%, Yashada (Zinc)- 10%,Vanga (Tin) - 5%, Rajata (Silver)- 5%

Diameter of the Tip of the Shalaka: 1mm-pointed.

Weight of the Shalaka :100 grams.

Group B: Standard procedure of Nasyakarma with Shadbindu Taila was done for 20 patients of Group B.

Materials used: Shadbindu Taila, Tila Taila, Dhumavarti.

Duration of treatment: 7 days

Study period: Study period was for about 28 days.

Investigations

• Hb%, TC, DC, ESR
• RBS

(These investigations were done only for the purpose of selection of patients)

e) Interventions: 

Group A: 1^st day – Agnikarma

2^nd – 28^th day- Observation period Group B: 1^st – 7^th day

Nasya Karma

7^th – 28^th day -Observation period.

Assessment was done before and after the procedure, and weekly once (7^th , 14^th , 21^st and 28^th day) for both the groups.

Follow Up: Once in 15 days for one month after study duration.

f) Assessment criteria: Effect of treatment was assessed on the basis of gradation of suitable parameters before and after treatment. 

• Teevram nishi cha ati-matram. 
• Severity of headache 
• Frequency of headache / week
• Duration of headache in hrs./day

Statistical Analysis:

Mean, S.D, 't'value and 'p' value were calculated. 'Paired t' test was used for calculating the 't' value for pre and post test. Unpaired t- test was applied to compare between two groups.

ASSESSMENT OF THE TOTAL EFFECT OF THE THERAPY

Assessment of the total effect of therapy made by analyzing the data statistically as follows:

1. Cured- Complete relief in the signs and symptoms.

2. Markedly improved- Patients showing more than 76% relief.

3. Moderately improved - Relief between 75-51% in signs and symptoms.

4. Partially improved - Relief between 50-25% in signs and symptoms.

5. No Change - Either no change or less than 25% relief.

OBSERVATION

In this study it was found that the incidence was highest in the age group of 20-30 years constituting 47.5% of patients, 62.5% were females. Maximum number of patients were house wives (50%), 62.5% patients were Hindus, Majority of patients belonged to the middle class (85%), Majority of patients were married (82.5%),Maximum number of patients were Literates (80%), 55% of the patients had a chronicity of more than 1 year, and 45% had less than 1year. In the present study, all patients (100%) had gradual onset of headache. 90% of the patients had disturbed sleep and 10% had sound sleep pattern. 67.5% of the patients had 6-12 hrs of duration of headache per day, while 17.5% had 3-6 hrs of headache per day, 12.5% had > 12 hrs of duration per day and 2.5% had 1-3hrs/day. According to frequency 60% of the patients had headache for more than 3 times per week, 32.5% had headache thrice per week and 7.5% of the patients had headache twice per week. According to severity 62.5% of the patients had severe headache, 25% of the patients had moderate type of headache and 12.5% of the patients had very severe type of headache.

RESULTS

The change that occurred with the treatment is greater than would be expected by chance; there was a statistically high significant change at P<0.001 in both Group A and Group B for all the symptoms: Nishi cha atimatram, Severity, Frequency and Duration of headache.

The difference in the mean values of the two groups in symptom like Nishi cha Atimatram and in Severity, Frequency and Duration of headache is not great enough to reject the possibility that the difference is due to random sampling variability. There is not a statistically significant difference between the two groups at >0.05.

COMPARATIVE PERCENTAGE RELIEF OF GROUP A AND GROUP B

This indicates that on Severity and Frequency of headache better results shown by Agnikarma and on Nishi cha Atimatram and on Duration of headache better results shown by Shadbindu Taila Nasya.

FOLLOW UP:

The improvements noted in the study period persisted as such in course of follow-up, in most of the patients in both the groups. But in Group A, 7 patients and in Group B, 3 patients complained about reoccurrence of pain.

COMPLICATIONS

No complications were noted after the treatment in both the groups.

Discussion On Agnikarma

For Agnikarma, Pancha loha shalaka was selected though other substances mentioned in the text because it is most convenient to maintain constant temperature and once it is heated it can produce a range of 10-12 Bindus. Thickness of Shalaka plays an important role to maintain constant temperature hence Pancha loha shalaka having 100 gram weight was used for Agnikarma. End of the Shalaka was pointed to create Bindu dahana vishesa. To achieve better result Samyak twak dagdha vrana was made. Dagdha vrana was completely healed within two weeks. Color of the scar became normal with surrounding tissue within one month.

Probable Mode of Action of Agnikarma

Heat is often used to relieve pain in many disorders and diseases however the exact of its action and mechanism is not clearly understood. During Agnikarama, Agni is transferred from the Shalaka to the Dushya Dhatu. Agnikarma is considered as the most preferred therapy to pacify Vata & Kapha Dosha, by virtue of the properties that Agni possesses viz. Ushna, Tikshna, Sukshma, Ashukari Guna. These Gunas are opposite to the properties of Vata & Kapha. The heat which is transferred to Tvak Dhatu by agnikarmamay act in three ways i.e.

1. Due to Ushna, Tikshna, Sukshma, Ashukari Guna it removes the Srotavarodha and pacifies the vitiated Vata Doshaand maintains equilibrium.

2. It increases the blood circulation to the affected site. More blood circulation flushes away the pain producing substances and patient gets relief from symptoms.

3. The therapeutic heat also increases the Dhatvagni, which cause Amapachana.

Heat has also been claimed to act as a “counter irritant”. Such responses are due to the effect on the pain gate (pain gate control theory) where the transmission of thermal sensation takes precedence over nociceptive impulses.

Agnikarma may work on following principles:

• According to scientist Dr. Ven Hanff, in the heat burns places the local tissue metabolism improves, thus various metabolic and rejuvenating changes takes place at the site of heat burns, thus it leads to increased demand of oxygen and nutrient of the tissues at the site of heat burn. It also excretes the unwanted metabolites and toxins.
• Due to increased local metabolism, the waste products (metabolites) which are produced get excreted, which normalize the blood circulation thus resulting in reduction in intensity of pain.
• Provided that the heating is not excessive, it appears to reduce the excitability (quick response to stimuli) of nerves.
• Rise in temperature induces relaxation of muscles and hence muscles spasm with inflammation and pain gets reduced.
• ·Skin is one of the places of Vayu; Agnikarma is performed to release the Sangha of Vayu.
• Pain is caused any where in the body is due to Vata, Agnikarma being Ushna chikitsa pacifies Vata and thus the pain is relieved immediately after Agnikarma.
• In our body there are large amounts of nerve cells and nerve pathways. These allow the brain to send signals to the body and the body to send signals to the brain. One of these signals is pain. Agnikarma works by interrupting the signals for pain, keeping us from feeling it.
• It also activates the body to produce endrophins. Endrophins are chemicals that act as our body's natural pain killers and are more powerful than morphine.

So the mode of action of Agnikarma based on “STIMULATE PAIN TO CONQUER PAIN”

Discussion on Nasya Karma

Probable Mode of Action of Nasya Karma

In Sushruta Samhita while explaining the importance of Indriya Pancha Panchaka, Panchabhibhoota Dhamanis have been told. This phenomenon tells about the Gandhajnana by NasaIndriya. These Dhamanis are porus structures, which perceive the objects. These can be considered for the ciliary bed or the transneural area of the nasal mucosa where absorption of the drug takes place.

It is stated in Ayurvedic literatures that, there is a very close relation between Nasa and Shiras. The medicine administered will reach the Shringataka Marma (sira marma) and spreads to the Siras of eye, ear and throat etc and to the head (Murdha). Even according to modern science the nasal mucosa is the only location in the body provides a direct connection between central nervous system to the exterior

.Drugs administered to nasal cavity rapidly transverse through the cribriform plate into the CNS by 3 routes: Directly by olfactory neurons, Through supporting cells and the surrounding capillary bed, Directly into the CSF.

DISCUSSION ON SHADBINDU TAILA NASYA

Shadbindu Taila is a formulation from Bhaishajya Ratnavali, Shiro Roga Chikitsa Prakaranam – 65/81-83 mentioned for Nasya. It is indicated in all types of Shirorogas. Most of the ingredients of Shadbindu Taila are possessing Vatahara and Vedanasthapaka property. So the formulation Shadbindu Taila is subjected for clinical trial in Vataja Shirashoola.

Shadbindu Taila containing Ajadugda, Bhringaraja and Tila Taila is a classical recipe mentioned for Nasya in all Shirorogas. Kshira (Milk) possesses good Rasayana action and Vatahara property too. Bhringaraja possesses VataKaphahara dosha karma, Vedana Sthapaka and Vatahara guna. Most of the Kalka dravyas possess Vatahara and Vedanasthapaka property. Taila by its nature itself considered as best Vatahara drug. Because of above said properties it showed significant action on all symptoms of Vataja Shirashoola.

CONCLUSION

• In the study both Agnikarma & Shadbindu Taila Nasya showed significant results in all the symptoms of Vataja Shirashoola.
• Agnikarma showed greater results in reducing Severity and Frequency of headache when compared to Shadbindu Taila Nasya.
• Shadbindu Taila Nasya showed greater results in reducing the symptoms like Nishi cha Atimatram and Duration of headache when compared to Agnikarma.
• During the follow up period the study showed the recurrence of Signs and symptoms of Vataja Shirashoola in few patients.
• None of the patients were showed any untoward effects in this study.
• In Vataja Shirashoola Agnikarma provides an immediate result over pain. Shadbindu Taila Nasya has a gradual and long term effect. Hence Agnikarma can be practiced in Vataja Shirashoola to obtain immediate relief from pain and Shadbindu Taila Nasya can be administered to get sustained effect.