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Clinical Study on Retinitis Pigmentosa

Effect of Ayurvedic Therapies and Medicines in Retinitis Pigmentosa

– A Clinical Study

Late Dr. N. P. P. Namboothiri
Dr. Sreekanth P. Namboothiri
Dr. Darpan Gangil
Priyanka Paul
Smitha S. Nair
Midhu N.N.

ABSTRACT

A clinical study of 50 cases of Retinitis Pigmentosa was conducted at Sreedhareeyam Ayurvedic Eye Hospital & Research Centre, Koothattukulam, Ernakulam District, Kerala, India, to evaluate the effect of Ayurvedic Therapies and Medicines ware scheduled for 1 year. Follow up was done and the results were encouraging. The disease progression was stopped and the disease became stable.

Key Words: Retinitis Pigmentosa, Ayurvedic Management

INTRODUCTION

RETINITIS PIGMENTOSA (RP) is a hereditary condition with an incidence of 1 in 4000. It is very heterogeneous, both phenotypically and genetically. No effective approach for prevention, stabilization or reversal exists for the majority of RP cases. More than 70 different genetic defects (27 identified genes1) have been identified including autosomal recessive (16%), autosomal dominant (22%), and X-linked (9%), with the remaining cases being simplex (with no known inheritance pattern). Actually, many in the simplex RP group are likely to have hereditary causes as has been shown in a number of genetic studies (fully 20% of simplex males have X-linked RP, according to several studies). Retinitis Pigmentosa is a degenerative process of the retina primarily affecting the rod photoreceptors and retinal pigment epithelium (RPE). Although the rod photoreceptors appear to be the primary target of the disease, there is histological and functional evidence for cone photoreceptor damage that is likely secondary to the rod degeneration. In most cases, patients show an early night blindness and loss of peripheral field of vision but central vision is generally preserved until the late stages of the disease.

Ayurveda, the earliest known medical system in the world was the first to describe and treat eye diseases separately. In Susrutha Samhitha, one of the oldest textbooks of Ayurveda has described 72 eye diseases and their treatment with both medicinal and surgical methods. Among these are mentioned diseases like Kapha vidagdha drushti and Pitha vidagdha drushti, which closely resemble RP in their symptomatology. Ayurveda relies it treatment efficacy on the basis of Tridosha (roughly translated as three humours) namely Vata, Pitha and Kapha. A treatment programme for the above-said diseases can slightly vary based on the predominant dosha condition. As per the Ayurvedic Concepts, the signs and symptoms of the disease Retinitis pigmentosa can be compared with Kaphaja Drishty gata rogas.

The disease can be classified into four stages:

       1.Kapha vishama drishty (Stage-I):

In Kapha Vishama drishty, patients do recognize, this condition progresses significantly and include difficulty with night vision as well as loss of peripheral vision.

      2. Kapha vidagdha drishty (Stage-II):

In kapha Vidagdha drishty, the disease progresses and the patient is unable to see in dim light and darkness.

      3. Kapha-Pitha vidagdha drishty (Stage-III):

In kapha Pitha Vidagdha drishty the disease progress into the next patala. In this stage, the vision is often worse in bright light with or without colour discrimination.

      4. Sannipathika Drishtyandyam (Stage-IV):

 In the fourth stage, the disease gets progressed into the fourth patala, where a complete visual loss occurs. Sreedhareeyam is an Ayurvedic Hospital that specializes in ophthalmic diseases follows knowledge imparted through the generation of practice in Ayurvedic ophthalmic treatment.

AETIOLOGY

 Retinitis Pigmentosa is a solitary manifestation of several genetically determined disorders characterized by loss of dark adaption and progressive reduction of the peripheral visual field early in the disease, leading eventually to impairment of central vision. It is likely that each disease entity within this family of disorders has a different fundamental defect.

In the beginning, there is degeneration of the rods and cones along with the pigment epithelium and migration of the pigment into the retina particularly around the blood vessels of the retina. Later on, the ganglion cells and their axons also degenerate and they are replaced by neuralgia tissue. The blood vessels become attenuated and the disc assumes a waxy yellow colour due to consecutive atrophy.

NEED FOR ALTERNATIVE THERAPIES

The current line of treatment is not found satisfactory because of an incomplete relief from the disease.

MATERIALS & METHODS

Aim & Objects:

The Present study is aimed at establishing the clinical and therapeutic efficacy of Ayurvedic Therapies and Medicines in the cases of Retinitis Pigmentosa. An attempt has been made to observe the incidence of age, gender, occupation and role of aetiological factors in relation to the causation of the condition.

SELECTION OF MEDICINES:

Internal Medicines

  • Kashayam (Decoction)
  • Gritham(Medicated ghee)
  • Choornam (Powder)
  • Gulika (Tablet)

Therapeutic Medicines
Retinitis Pigmentosa


Procedur
e to be used:

      Systemic therapies

  • Virechanam: Medicated Pergation
  • Nasyam: Application of medicine through the nose
  • Sirodhara – Application of continuous stream of oil on the forehead
  • Thakradhara- Application of continuous stream of a decoction prepared with buttermilk on the forehead
  • Siro Vasthi
  • Pichu
  • Thalam
  • Vasthi

      Specific applications on the eye

  • Nethradhara (Sekam)
  • Aschyothanam
  • Anjanam
  • Tharpanam
  • Putapakam
  • Pindi
  • Vidalaka

Criteria for Selection:

  • Age criteria between 7-70 years will be selected irrespective of gender, occupation, religion and socio-economic status.
  • Patients clinically diagnosed as Retinitis Pigmentosa.

Criteria for Exclusion:

  • Complete loss of vision
  • Associated with complicated cataract and Glaucoma.
  • Systemic  diseases   like   Type1   or   Type2   Diabetes   Mellitus, Systemic Hypertension, Hypercholesterolemia
  • Known cases of renal diseases and Livers disorders

Criteria for Assessment:

  • Optical Coherence Tomography changes.
  • Visual Acuity as assessed by Snellen’s cha
  • Changes in Perimetry at every inpatient vis
  • Symptomatic changes as assessed by symptom score.

The criteria for assessment were based on presenting sign and symptoms and their alleviation on a linear scale.

The symptoms will be assessed by means of a linear scale from 0 to 3 where

0 = symptom absent
1= mildly affected by the symptom
2 = moderately affected by the symptom
3 = severely affected by the symptom.

The least score possible will be 0 and the maximum score will be 24.

Linear Scale
Retinitis Pigmentosa

 

RESULTS

Total 50 cases of both genders and aged between 7-70 yrs. were studied. A summary of subject disposition is provided in Table-I. 50 subjects were taken for the observational study. 37 subjects who completed 2 IP visits were considered for efficacy evaluation and were deemed as “evaluable subjects”. Table I has details of the population analyzed.

Table I. Populations for Analysis
Retinitis Pigmentosa

Observation in Table-II indicates that 19 (38%) cases were female and 31 (62%) were male. The maximum numbers of cases (15) were between the age group of 30-40 yrs., Consanguinity was absent in 44 (88%) cases and preseant only in 6 (12%) cases. Dietary habits were about the same. Family history was absent in 35 (70 %) and present in 15 (30%) cases. 10 (20%) cases were of Kapha Vishama Dristi (Stage-I), 31 (63%) case were of Kapha Vidagdha Dristi (Stage-II), 7 (14%) cases were of Kapha-Pitha Vidagdha Dristi (Stage-III) and only 1 (2%) case was of Sannipathika Drishtyandyam (Stage-IV). The maximum number of cases (31) was of Kapha Vidagdha Dristi (Stage-II).

Table II. Demographics and baseline characteristics (Safety set)

Retinitis Pigmentosa

Observation in Table-III & Table-IV indicates that the primary analysis performed was a comparison between changes in visual function under treatment and the natural course of Retinitis Pigmentosa, considering that this natural course entails a gradual deterioration of visual function. The rate of this deterioration is estimated to be about 15–17% in a year loss for Visual Field and about 3–5% annual loss for Visual Acuity. Assuming a 5% annual rate of decrease in logMAR as the natural course of disease, treatment resulted in 6% increase in logMAR, viz. improvement in Visual Acuity at normal illumination. Even though the result was not significant at 95% confidence interval (p=0.097), the result was significant at 90% confidence interval. It should be underlined that these modest improvements in Visual Acuity are significant considering the natural course of the disease, which is a gradual deterioration of Visual Acuity. Symptom scores were indicators as to the improved quality of life in patients as well as perceived changes from Ayurveda point of view over repeated treatments. There was a significant reduction in mean symptom scores of 17% from Visit 1 to Follow up 2 (p<0.05).

Table III. Efficacy Results – Visual Acuity

Descriptive StatisticsRetinitis Pigmentosa
Paired Samples Test
Retinitis Pigmentosa
Table IV. Efficacy Results – Symptom Score

Descriptive Statistics
Retinitis Pigmentosa

Paired Samples Test
Retinitis Pigmentosa

Adverse Events

No significant adverse effects were seen in participants while they were on treatment. Burning sensation in eyes and tearing of eyes was the most commonly reported AE after Tharpanam. The symptoms had receded without any treatment.7 patients reported Rhinitis after Shirodhara. These symptoms were reduced by internal medications

Evaluation of Intra Ocular pressure

Descriptive StatisticsRetinitis PigmentosaPaired Samples Test
Retinitis Pigmentosa

 

DISCUSSION OF CONCLUSION

Clinical experience of physician’s at Sreedhareeyam had suggested a beneficial effect of Ayurvedic treatment on Retinitis Pigmentosa cases which has prompted this study. As mentioned above, the aim of the study was to assess the efficacy of Ayurvedic treatment principles in RP patients and not to understand the efficacy of any therapy in particular.

The study confirmed that Ayurvedic treatment was safe and effective to a significant extent in reducing subjective symptoms of RP thereby improving the quality of life of the patients.

There is weak evidence in favour of a positive effect of treatment in preserving and improving Visual Acuity in patients with RP. As explained above, it slightly improved Visual Acuity at normal illumination level, although this was not statistically significant. The non-significant results may be due to lack of enough power to detect such an effect and/or confounding by delayed effect of treatment. It should be underlined that there are modest improvements in Visual Acuity in comparison with the natural course of the disease, which is a gradual deterioration of Visual Acuity. When compared to an expected decline due the natural course of the disease; a marginally significant benefit has to be considered positively.

The log visual field area, finally, did show a beneficial effect of treatment and the gradual loss of visual field was significantly arrested. Even though Perimetry findings were available it was premature to use it in this publication. It will be published in the next assessment of the study which is ongoing.

Our results support a positive difference in the Visual Acuity of Retinitis Pigmentosa patients taking Ayurvedic treatment and improve their quality of life. However, due to the small sample size of the study, it is difficult to judge the generalizability of these results, yet it will not be wrong to believe that they may apply to most patients with Retinitis Pigmentosa. The design of the study is observational and lack of a comparison group may have caused unintended biases which can be rectified by future studies that are interventional and comparative in nature.

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