A comparative study of Bilvadi Yoga Ashchyotana and eye drops in Vataja Abhishyanda (Simple Allergic Conjunctivitis).

Simple allergic conjunctivitis is the most common form of ocular allergy (prevalence 5 - 22 %). It is a hypersensitivity reaction to specific airborne antigens. The disease Vataja Abhishyanda, which is due to vitiation of Vata Pradhana Tridosha is comparable with this condition. The management of simple allergic conjunctivitis in modern ophthalmology is very expensive and it should be followed lifelong and Ayurveda can provide better relief in such manifestation. This is the first research study on Vataja Abhishyanda. Patients were selected from the Outpatient Department (OPD), Inpatient Department (IPD), of the Shalakya Tantra Department and were randomly divided into two groups. In Group-A Bilvadi Ashchyotana and in Group-B Bilvadi eye drops were instilled for three months. Total 32 patients were registered and 27 patients completed the course of treatment. Bilvadi Ashchyotana gave better results in Toda, Sangharsha, Parushya, Kandu and Ragata as compared with Bilvadi Eye Drops in Vataja Abhishyanda.

RCT Entities:   Population Interventions Outcomes

Introduction

Abhishyanda is the root cause of almost all the eye disorders and must be treated as soon as possible, otherwise its complications will become severe and difficult to save the eye sight.[1-4] If Abhishyanda takes a chronic course it may lead to Vataja Adhimantha, Hatadimantha, Akshipakatyaya, Avranashukla, and so on.[1]

Vataja Abhishyanda is characterized by Toda (Pricking pain), Sangharsha (foreign body sensation), Achchashruta (watery discharge), Alpa Shopha (mild chemosis), Vishushka Bhava (feeling of dryness), Parushya (dryness),[5] and so on, which are very similar to most of the signs and symptoms of Simple Allergic Conjunctivitis. Based on the similarities of signs and symptoms, Vataja Abhishyanda can be co-related with Simple Allergic Conjunctivitis. The prevalence is 5 – 22% in the general population and recurrence found in 41 – 62% of the cases.[67]

Simple allergic conjunctivitis is the most common form of ocular allergy. It is a hypersensitivity reaction to specific airborne antigens.[8] Basically it is an urticarial reaction.[6] Although serious sequels as a result of corneal involvement are rare, the distressing signs and symptoms may cause extreme discomfort to the patients, it can disturb the patient's routine life.[9] Jamnagar and the surrounding areas are famous for industrial pollution and a good number of patients with simple allergic conjunctivitis are being reported to the OPD of the Shalakya Tantra Department, I.P.G.T. and R.A., Jamnagar.

Drugs have multiple pharmacological mechanisms of actions, such as — histamine H1 receptor antagonists, mast cell stabilizers, inhibit infiltration, activation and degranulation of eosinophils, and other late phase reactions, such as, the effect of platelet activating factors, which are useful in the treatment of simple allergic conjunctivitis.[10] There are expensive, may settle in developing ADRs and possibilities of relapses are also present.

Moreover these drugs are to be used lifelong to keep the condition under control. Hence, there is scope to search for a better remedy from the rich heritage of ophthalmic preparations available in Ayurveda.

Among various formulations prescribed for the treatment of Vataja Abhishyanda by different Acharyas, Bilvadi Yoga,[11] which is indicated in the treatment of Vataja Abhishyanda has been selected. All the ingredients [Bilva (Aegle marmelos Corr.), Agnimantha (Clerodendrum phlomidis Linn.), Aralu (Ailanthus excelsa Roxb.), Patala (Stereospermum suaveolens DC.), Gambhari (Gmelina arborea Linn), Eranda (Ricinus communis Linn), Brihati (Solanum indicum Linn.) and Madhu Shigru (Morianga olifera)] have the Vata Shamaka effect. Moreover all the ingredients are known for their anti-inflammatory and antibacterial activities.[12-19]

However, Ashchyotana is the foremost procedure indicated in all ocular ailments.[20] Nevertheless, due to certain limitations, like being a time consuming procedure, dose variation, and the chance of due to non compliance of aseptic precautions, the Ashchyotana procedure is not much in practice.

Eye drops is the most common form in ophthalmic practice, because the standard dose of the eye drops is maintained and patients can easily carry it with them and instill it whenever required. Considering this, eye drop formulation has been choosen as an alternative to Ashchyotana Kriya Kalpa.

Looking in to all these, a study is planned to evaluate the comparative efficacy of Bilvadi Yoga as Ashchyotana and eye drops.

Aims and objectives

The present study has been undertaken with the following aim and objective:

To evaluate the comparative efficacy of Bilvadi Aschyotana and Bilvadi eye drops in the patients of Vataja Abhishyanda.

Material and Methods

Source of data: Patients with Vataja Abhishyanda, fulfilling the inclusion criteria attending the OPD of the Shalakya Tantra Department of I.P.G.T. and R.A., G.A.U., Jamnagar. A detailed research proforma was prepared as per the modern and Ayurvedic points. After taking ophthalmic and systemic history, a detailed conjunctival examination was carried out by torch light and slit lamp, before and after the treatment.

Preparation of drug

The trial drug, Bilvadi Yoga was used in two methods, (The traditional method of Ashchyotana and the modified method of eye drops). For Ashchyotana, Yavakuta Churna was prepared in the Pharmacy, Gujarat Ayurved University, and Kwatha was prepared. For the eye drop formulation, the distillation process was carried out in the Pharmaceutical Chemistry Laboratory, I.P.G.T. and R.A., packed in sterile containers by taking aseptic precautions at Indiana Ophathalmic, Surendranagar.

Inclusion criteria

Age in between 16 – 60 years

Patients with signs and symptoms of Vataja Abhishyanda.

Exclusion criteria

Age less than 16 and more than 60 years

Patients with any other ocular pathology like Bacterial conjunctivitis corneal opacity, etc.

The study was approved by Institutional Ethics Committee. Written consent was taken from the patients.

Investigations

Routine hematological, urine (routine and microscopic), random blood sugar, and serum cholesterol were done to rule out associated systemic pathology. Absolute Eosinophil Count was carried out before and after treatment to identify the status of eosinophils in the blood. Conjunctival smear examination was carried out (10 patients: Group A-7 patients, Group B-3 patients), in which Leishman's Stain was used to differentiate the white cells — especially Eosinophils and Neutrophils, and Gram Stain was used for confirmation of allergic origin.

Grouping

Group A: Ten drops of Bilvadi Yoga Ashchyotana was instilled thrice a day for three months.

Group B: One drop of Bilvadi eye drops was instilled thrice a day for three months.

The assessment of Bilvadi Ashchyotana and eye drops on Vataja Abhishyanda, was done by subjective and objective parameters.

Subjective parameters: It was assessed by relief in the signs and symptoms of the Vataja Abhishyanda.

Objective parameters: It was assessed by decrease in Absolute Eosinophil Count (AEC) and decrease in the number of eosinophils and neutrophils in the conjunctival smear examination.

For feasibility of statistical analysis, according to the severity of the symptoms, a score was given individually for all subjective symptoms and signs from 0–4.

The obtained data was subjected to statistical analysis in terms of mean, standard deviation, and standard error with the help of unpaired ‘t’ test and paired ‘t’ test.

Observations and Results

It was observed that, 31.25% patients were from the age group of 21-30 years, 65.62% were female, 81.25% were from Hindu community, 37.25% were house wives, 28.12% were graduates, 75% were married, 40.62% were from upper middle class, 90.62% from urban area, 78.12% are vegetarian, 71.87% were addicted to tea/coffee and 40.62% patients have Ruksha - Sheeta Sparsha [Table 1].

Table 1

General observation of the patients

All patients (100%) had Kandu, Achchhashruta, Ragata, and Toda, while 81.25% of the patients have Alpa Shopha, 71.87% of the patients had Sangharsha, 62.50% of the patients had Shishirashruta and Alpa Dushika, 46.87% of the patients had Vishushkabhava, 43.75% of the patients had Parushya, and 37.50% of the patients had Shushka Dushika, while 09.37% of the patients had Nimeshonmeshana Krichchhrata. The 43.75% patients had Shirobhitapa as an associated symptom [Table 2].

Table 2

Chief and associated complaints of the patients in brief

In the present study 28.12% patients had a history of allergic rhinitis and 15.62% patients had dandruff on the scalp. Chronicity of 6 to 12 months was noticed in 40.62% patients, recurrent history of conjunctivitis was noted in 65.62% patients. Dust and smoke reported as the aggravating factor in 65.62% patients [Table 3].

Table 3

Details related to the disease Vataja Abhishyanda

Effect of therapy

In Group A statistically significant relief was observed in Toda (pricking pain) (82.10%, < 001), Sangharsha (foreign body sensation) (77.00%, < 0.001), Parushya (dryness) (100%, < 0.01), Vishushkabhava (feeling of dryness) (78.00%, < 0.01), Shishirashruta (cold lacrimation) (64.00%, < 0.001), Achchhashruta (clean / watery discharge) (73.00%, < 0.001), Alpa Shopha (mild chemosis) (64.00%, < 0.001), Shushka Dushika (dry discharge) (75.00%, < 0.01), Alpa Dushika (scanty discharge) (70.00%, < 0.01), Ragata (congestion) (72.00%, < 0.001), and Kandu (itching) (78.00%, < 0.001). In associated symptom, statistically significant results were observed in Shirobhitapa (66.70%, < 0.001) and Nasanaha (80.00%, < 0.01). Statistically significant results were observed in AEC (33.80%, < 0.01) [Table 4].

Table 4

The effect of therapy on various clinical symptoms, AEC, and conjunctival smear examination

In Group B (Bilvadi eye drops) statistically significant results were observed in Toda (68.00%, < 0.001), Sangharsha (33.00%, < 0.05), Parushya (88.00%, < 0.001), Vishushkabhava (71.00%, < 0.01), Shishirashruta (60.00%, < 0.01), Achchhashruta (78.00%, < 0.001), Alpa Shopha (86.00%, < 0.01), Shushka Dushika (80.00%, < 0.001), Alpa Dushika (81.00%, < 0.001), Ragata (65.00%, < 0.001), Kandu (71.00%, < 0.001), and in associated complaints like Shirobhitapa (77.80%, < 0.01) and Nasanaha (67.00%, < 0.05). Statistically significant results were observed in AEC (30.40%, < 0.02) [Table 4].

Effect of therapies on conjunctival smear

The eosinophils of the right eye were reduced by 66.70% (< 0.001) and the neutrophils of the right eye were reduced by 44.00% (< 0.05); the eosinophils of the left eye were reduced by 56.00% (< 0.05) and neutrophils of the left eye were reduced by 43.00% (< 0.05). All the results were statistically significant [Table 4].

In both the groups none of the patients were cured or remained unchanged. In Group A marked improvement was observed in 42.85%, moderate improvement in 50.00%, and mild improvement in 07.14% of the patients. In Group B marked improvement was observed in 23.07%, moderate improvement in 76.92%, and mild improvement in 07.14% of the patients [Table 5].

Table 5

Overall effect of therapies on 27 patients of Vataja Abhishyanda

Discussion

Highly polluted environment, has an effect on lifestyle. Simple allergic conjunctivitis is one of the outcomes of this changing lifestyle, food habits, and polluted environment.

Simple allergic conjunctivitis has an equal distribution, more or less, throughout the world, without any exception to the developed and under-developed countries.[7]

Probable mode of action of and eye drops

According to Ayurveda the instilled medicine will penetrate into the Akshikosha Srotas, Shira Srotas, Ghrana Srotas, and Mukha Srotas of the Urdhvanga Bhaga and remove the Mala present there.[21] This happens because of the basic properties of Bilvadi Yoga, that is, Vata Shamaka, Vedana Sthapana, Vrana Ropana, and Ushna Virya.

Pharmacokinetics of and eye drops

Most of the ophthalmic medications are formulated to be applied topically. The classical pharmacokinetic theory based on the studies of systemically administered drugs does not fully apply to all ophthalmic drugs. However, similar principles of absorption, distribution, metabolism, and excretion are applicable to the drug disposition in the eye.[22] Possible absorption pathways of an ophthalmic drug, following the topical application to the eye, are shown schematically in Figure 1.

Figure 1

Possible absorption pathways of an ophthalmic drug following topical application to the eye (Solid black arrows represent the corneal route, dashed black arrows represent the conjunctival / scleral route)

After absorption, Bilvadi Ashchyotana and Bilvadi eye drops may undergo systemic distribution primarily by nasal mucosa absorption and possibly by local ocular distribution by transcorneal / transconjunctival absorption, and metabolism by various enzymes.

Hence, after instillation of Bilvadi Ashchyotana and Bilvadi eye drops, these fluids undergo absorption, distribution, and metabolism. Thus, the effect of Bilvadi Ashchyotana and Bilvadi eye drops are local as well as systemic.

Conclusion

Among all the Nidana of Netra Roga, Raja Sevana, Dhuma Sevana, and Ritu Viparyaya can be considered as specific Nidana for Vataja Abhishyanda.

Among all the symptoms of Vataja Abhishyanda, Toda can be correlated with pricking pain, Achchhashruta can with watery discharge, and Sangharsha with foreign body sensation in simple allergic conjunctivitis.

Bilvadi Ashchyotana gives better results in the symptoms of Toda, Sangharsha, Parushya, Kandu and Ragata in Vataja Abhishyanda.

Bilvadi Ashchyotana and Bilvadi eye drops give significant results in all the symptoms like, Toda, Sangharsha, Kandu, Achchashruta, Parushya, Vishushakabhava, Shishirasruta, Alpa Shopha, Shushka Dushika, Alpa Dushika, Ragata, and the absolute eosinophils counts of Vataja Abhishyanda.

Although the Ashchyotana formulation is time consuming procedure for today's busy lifestyle; yet it is more effective than the eye drops.

This study has established the significant effect of Bilvadi Ashchyotana in clinical symptoms of Vataja Abhishyanda. The results obtained in Bilvadi eye drops are also encouraging. Thus, in patients who cannot come for the Ashchyotana procedure, eye drops can be an alternative treatment modality.

No adverse effects were found during the study in both the groups.