ADD-ON EFFECT OF SELECTED AYURVEDIC TREATMENT PROTOCOL IN FOCAL SEIZURES EVOLVING TO GENERALIZED SEIZURES – A NON-RANDOMIZED CONTROLLED TRIAL

ADD-ON EFFECT OF SELECTED AYURVEDIC TREATMENT PROTOCOL IN FOCAL SEIZURES EVOLVING TO GENERALIZED SEIZURES - A NON-RANDOMIZED CONTROLLED TRIAL

Vidhya M. Sanker * and M, Jithesh

ManoVigyan Avum Manasroga, VPSV Ayurveda College, Kottakkal, Kerala India.

ABSTRACT: Epilepsy is a chronic non-communicable disease that affects 50 million people worldwide. AEDs play a vital role in controlling seizures but are not a permanent solution. For a large percentage of Persons with Epilepsy, seizures happen even with the intake of AEDs. Apasmāra is more or less compared to epilepsy. The majority of studies conducted on Apasmāra were śamana therapies and suggested śodhana therapy for better results. A non-randomized controlled trial on the Add-on effect of Selected Ayurvedic Treatment Protocol in Focal Seizures Evolving to Generalized seizures was conducted to assess and compare the selected protocol's add-on effect, including śodhana and śamana in secondary generalized seizures. In the trial group, 10 diagnosed subjects with secondarily generalized seizures on Anti-Epileptic Drugs were included and given the intervention. In control, group 10 diagnosed subjects with secondarily generalized seizures on Anti-Epileptic Drugs were observed for the same period. The treatment's effect was assessed using the Epilepsy severity assessment chart. Assessments were done on 0th day, 15th day, 30th day, 45th day, 60th day and on 75th day and Quality of life by QOLIE-10p questionnaire before and after treatment. The control group was also assessed, and the results were compared. The selected protocol was found to have a significant add-on effect in reducing severity, frequency, duration, and post-ictal features compared to the control group and improving the Quality of life compared to the control group.

Keywords: Snehapāna, śodhana, Virecana, Apasmāra, Secondary generalized seizures

INTRODUCTION: Epilepsy is a chronic non communicable disease that affects 50 million people of all ages worldwide. The global burden report estimates that about 13 million Disability Adjusted Life Years are due to epilepsy each year ¹. Due to the ongoing epidemiological transition from communicable to non-communicable disease, mental and neurological disorders are increasingly indicated as a public health concern ².

A person with epilepsy had difficulties in emotional and physical domains that limited their activities and resulted in poor social interactions, decreased energy levels and feelings of social isolation ³. Presentation of seizures varies from brief lapses of attention or muscle jerks to severe and prolonged convulsions with a varying frequency from less than one per year to several times per day ⁴.

As per WHO's data, an estimated 25% epilepsy cases are preventable, and up to 70% of people living with epilepsy could become seizure-free with appropriate use of anti-seizure medicines ⁵. But for a large percentage of PWE (Person with Epilepsy), seizures do happen even with the intake of AEDs. The missing dose is reported as a major trigger. Intractable epilepsies may not respond to AEDs. The persistence of these problems highlighted the need for effective management. These conditions are more or less compared to Apasmāra in our classics which primarily presented with impairment or alteration in memory ⁶. Well explained treatment modalities were included as Apasmāra pratiṣeda upāyas in our classics ⁷. Though Śodhanas are the primary line of treatment in Samhitas, studies reported mainly focused on Samana and recommended Śodhana for better results.

METHODOLOGY:

Aim: To explore the scope of Sodhana therapy in epilepsy.

Objectives:

Primary Objective: To compare the effect of selected Ayurvedic treatment protocol with the control group in focal seizures evolving to generalized seizures.

Secondary Objective: To compare the Quality of life in both groups.

Study Design: Non-Randomized controlled trial.

Settings:

• Control group – OPD, PVS Hospital, Calicut.
• Trial group - IPD, VPSV Ayurveda College Hospital, Kottakkal and IPD, Govt Ayurveda Research Institute for Mental Diseases, Kottakkal

Sample Siz: Considering the dropouts, N is fixed as 10.

Sampling Procedure: Convenience sampling Inclusion criteria.

• Age Group: 18 – 50 years.
• Diagnosed cases of focal seizures evolving to generalized seizures.
• Participants on AED (AntiEpileptic Drugs) for the last one year, with at least one seizure in a month, for the previous three months.
• Those who are fit for snehapāna and śodhana.

Participants were willing to give written consent.

Exclusion criteria:

• With a recent history of alcoholism or drug abuse.
• Pregnancy or lactation.
• With symptoms of any other progressive brain disordersorco-morbidpsychiatric disorders.
• Cardio-vascular diseases, chronic hepatic diseases, renal dysfunction, thyroids function and status epilepticus.

MATERIALS:

• Epilepsy Assessment charts ⁸.
• QOLIE–questionnaire (Quality of Life in Epilepsy-10p) ⁹.
• Samyak snigdha assessment chart ¹⁰.
• Samyakrukșana assessment chart ¹¹.
• Consent form and Participant information sheets.
• Case record from
• Takra ¹²
• Vaiśwānaracūṛna¹³
• Kūșmandaswarasaghrita¹⁴
• Dhanvantaram taila¹⁵

Avipathicūrna ¹⁶ (Medicines purchased from a GMP certified company)

Methods of Preparation: Takrapāna– Takra 1.5L+Vaiśvānara Cūrna 5 gm.

Intervention in Trial Group.

Rukșana:

• Time of intake: intake frequently to the maximum of 1.5 lina day.
• Duration: up to samyakrukșana lakșana / 3 days.
• Drugs: Takra and vaiswānara cūrna.
• Dose: 1.5 Ltakra and 5 gm of vaiswānara cūrna.

Snehapāna:

• Time of intake: 6.00 am.
• Duration: up to samyaksnig dhalakșana / 7days.
• Drug: Kūșmandaswarasa ghrita.
• Dose: Arohanamatra as per Agni and Koșta (Starting from 30ml).
• Abhyanga and ushma sweda– Abhyanga with dhanwantharam taila followed by ușmasweda - 3 days -20 minutes.
• Virecana– Avipathi cūrna -1 day (30gm)-8.00 am.
• Samana Kūșm and aswarasa ghrita 20 mlin 2 divided doses for one-month.

Control Group-Observation ¹⁰: Participants on AEDs for the last year with at least one seizure in a month for the last three months satisfy the inclusion criteria. Settings: OPD, PVS Hospital, Calicut Outcome measurement. The treatment's effect was assessed using the Epilepsy severity assessment chart –Assessing on the 0th day, 15th day, 30th day, 45th day, 60th day, and on 75th day and Quality of life by QOLIE-10p questionnaire before and after treatment. The control group was also assessed these days, and the results were Compared. Ethical committee clearance. The dissertation work, case record form and consent form were placed before the Institutional Ethical Committee (IEC No: IEC/Cl/14/19, dated 02/05/2019) of VPSV Ayurveda. College, Kottakkal. After the various levels of scrutiny and Subsequent modification, the final acceptance was gained, and ethical clearance was obtained for the dissertation work. CTRI Registration Number: CTRI/2021/01/030168

Observation and Analysis: Each group included ten diagnosed subjects of Focal seizures evolving to generalized seizures. Data collected using case record forms were entered into Microsoft excel spreadsheet2010and the results were represented as Mean + Standard Deviation. As the data failed to follow a normal distribution, Friedman’s test was done, followed by Wilcoxon’s signed-rank test for multiple comparisons. The effect of treatment between groups was assessed using Mann–the Whitney U test.

The selected protocol has a statistically significant result within the trial group and when compared to the control group in reducing the severity, frequency, duration and post-ictal feature (p< 0.001-Friedmans test) and also in improving the Quality of life (p<0.01- Wilcoxon signed-rank test). Domains of Mental health, Role functioning, and epilepsy distress show significant changes (p<0.001).

TABLE 1: SEVERITY OF SEIZURES

DISCUSSION: The protocol selected for the Study includes rúksana, snehapāna, abhyangauṣ masweda, virecana, and śamana. It’s hard to differentiate the role of each therapy in the effect of treatment. Overall, the selected protocol is significantly effective in reducing the symptoms. As purvakarma of snehapana to avoid snehavyāpath, rukṣana ¹⁷ is indicated. Rukṣana being pacana ¹⁸ may have acted on the Vyādhi directly and it creates a suitable condition for snehapāna. This may be because of its laghuguna (laghava or ropana ¹⁹) along with uṣnaguna (pācanaschaviseṣata ¹⁹) as it corrects the impaired agni. Snehapana provides vātanulomata and agnidīpti ²⁰ which have a negative action on the precipitating factors like indigestion; constipation ²¹ etc and may initiate the koṣtagati of doṣa (vridhiabhishyandanāt ²²). In bahudoṣāvasta, śodhana is the only line of treatment ²³ and the choice in apasmara. Virecana being the primary line of treatment in pitta and pittanubhandha dosha ²⁴ its action can be justified in apasmāracikitsa as the involvement of pitta in apasmārasamprapti was explained by Harita ²⁵. Apasmara being an achronic disease after śodhana, Śamana like therapies are needed. For samanasnehapāna medicated ghee was used, and the medication included will certainly have a role in the action (samskarasyānuvartini ²⁶) along with the effect of ketogenic diet ²⁷. The drug used has an evident role in the reduction of seizures. As apasmāra is primarily associated with impairments in memory, the selected formulation acts as medhya 28 and helps reduce the symptoms. A previous experimental study shows that the drug possesses a neuroprotective effect against lithium bicarbonate – pilocarpin induced status epileptic us ²⁹.

CONCLUSION: The selected protocol was found to have a significant add-on effect in reducing the severity, frequency, duration, and post-ictal features when compared to the control group and also have a significant add-on effect in improving the Quality of life when compared to the control group. AEDs do play a vital role in controlling seizures. Still, in this particular study, as per the inclusion criteria, the selected participants had at least one seizure in a month, even after the intake of AEDs. And the selected protocol was found to have a significant add-on effect in reducing the seizures and improving the Quality of life compared to the control.

ACKNOWLEDGEMENT: Expressing sincere gratitude and respect to my guide, co-guides, and all other teachers and staff of VPSV Ayurveda College Kottakkal, Kerala, for their continuous support and guidance.

CONFLICTS OF INTEREST: No potential conflicts of interest.

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    How to cite this article:

    Sanker VM and Jithesh M: Add-on effect of selected ayurvedic treatment protocol in focal seizures evolving to generalized seizures - a non-randomized controlled trial. Int J Pharm Sci & Res 2022; 13(11): 4636-40. doi: 10.13040/IJPSR.0975-8232.13(1).4636-40.

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