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The effectiveness of Ayurvedic oil based nasal instillation (Nasya) medicines for the treatment of facial paralysis (Ardita): a systematic review protocol

Source:

JBI Evidence Synthesis

December 2013, Volume :11 Number 12 , page 33 - 44 [Free]

Authors

  1. Vivera, Manuel Joseph
  2. Streak Gomersall, Judith Christine PhD
  3. Lisy, Karolina PhD

Abstract

Review question/objective: The objective of this review is to establish the effectiveness of oil based nasal instillation medicines in the treatment of Ardita (facial paralysis).

 

The question that will be asked in the review is:

 

Which of the commonly used Ayurvedic nasal instillation medicated oils is the most effective for treating Ardita either solely or in combination with other Ayurvedic medical interventions?

 

Background: Facial paralysis is a medical condition that disfigures or distorts the facial appearance.1 Besides causing asymmetry of the face, it limits the functioning of facial muscles of the sufferer. The condition could be congenital or could be caused as a result of infection, stroke, toxicity, physical trauma, neoplastic, iatrogenic or idiopathic aetiologies.2 Facial paralysis can be unilateral or bilateral. Among the causes of facial paralysis, Bell's palsy cases are the highest.3 The eponym Bell's palsy is used when the peripheral facial nerve paralysis is caused by idiopathic reasons.3,4 In certain cases facial paresis is caused as a result of the central nervous system disorder or brain injury, leading to facial paralysis. Bell's palsy, which as indicated above is paralysis disorder that is most common, affects men and women equally and can occur at any age, but it is rare before age of 15 or above the age of 60.5 It is estimated that bell's palsy constitutes 60 to 70% cases among all facial paralysis, followed by trauma and infection related ones.6 The condition is resultant of damage caused to the seventh cranial nerve which travels through the bony Fallopian canal in the skull, providing nerve impulse to the muscles on each sides of the face and tear glands. Additionally, the facial nerve also transmits taste sensations from the tongue.5

 

The Ayurvedic term for facial paralysis irrespective of the aetiology is Ardita.7

 

Cause-based classification of facial paralysis according to conventional medicine2, 8, 9 is:

 

Idiopathic: Bell's palsy, sarcoidosis, inherited Bell's palsy, myasthenia gravis, multiple sclerosis, temporal arteritis.

 

Infection: External otitis, varicella zoster, syphilis, otitis media, poliomyelitis, botulism, mastoiditis, coxsackievirus, tetanus, diptheria, HIV, cholesteatoma, Lyme disease.

 

Neoplastic: Schwannoma, teratoma, meningioma, von Recklinghausen's disease, hemangioma, parotid tumour, acoustic neuroma, sarcoma, carcinoma (metastatic).

 

Metabolic: Diabetes mellitus, Hypertension, Acute porphyria.

 

Congenital: Mobius syndrome, Dystrophia myotonica.

 

Autoimmune syndrome: Thrombotic thrombocytopenic purpure, Kawasaki disease, Guillian barre/Miller-Fisher syndrome.

 

Neurological: Opercular syndrome, Wernicke-Korsakoff syndrome, pseudo-tumour cerebri, lacunar infarct.

 

Iatrogenic: Post-immunisation, Antitetanus serum, Vaccine for rabies.

 

Trauma: Traumatic delivery, parotid surgery, mastoid surgery, forceps delivery, anaesthetic nerve block, mandible fracture, penetrating injury, scuba diving.

 

Toxins: Ethylene glycol, ethanol, Carbon monoxide, thalidomide.

 

Patho-physiological classification of facial paralysis is of two types namely supranuclear palsy and infranuclear palsy. The former is identified as the involvement of the central nervous system when the fibres of facial nerve proximal to facial nucleus in pons are involved. The causes are mainly due to cerebrovascular stroke, haemorrhage or tumour in the region. In infranuclear palsy, the involvement of peripheral nervous system is identified, when the facial nerve is affected after its nucleus in pons. Bell's palsy and parotid tumours are most common in this category.10

 

Evidence of knowledge of facial paralysis has been known since ancient times and has been transcribed in present day scientific literature. Ancient cultures like the Incas, Egyptians, Greeks and the Indians had a fair bit of understanding of this medical condition and attempted medical interventions available at that time.3 The great Indian sage Caraka, in his medical tome scripted in the second century BC describes the aetiology and management of Ardita. He describes clinical features of Ardita with symptoms manifested such as face, nose, eyebrows and jaws become distorted, food in mouth loses direction, tongue becomes crooked on trying to raise, voice becomes weak and hearing weakness.7, 11 Ayurvedic science identifies the psycho-physiological nature of a person on the bases of subtle bio-energies known as Doshas. Basically, there are three doshas, namely Vata, Kapha and Pitha. The simplest equivalence for Vata substrate in the human body is the nervous system.11, 11, 13 Caraka attributes the root-cause of Ardita to perturbed Vata dosha.7 However, other Ayurvedic experts like Sodhala classifies Ardita on doshic influence of Kapha and Pitha besides Vata.14

 

The renowned Ayurvedic surgeon of ancient times and father of discrete surgery Susruta who lived in the first century AD, describes medication for Ardita in his compendium - Susruta Samhita. His treatment protocol gives special emphasis to Nasya.15

 

Conventional medicine offers various treatments for facial paralysis according to the aetiology. In the management of facial paralysis which include Bell's palsy, acute measures are normally taken first. These typically include eye protection such as application of eye ointment or lubricant 16 and wearing watch-glass bandages17 to prevent dehydration of the cornea or from aberrations. Subsequently, Mime and physiotherapy including massage and relaxation may be advised to control the condition. Further, medication with steroids or antiviral agents may be prescribed. In some cases, acupuncture, transcutaneous electrical stimulation, transmastoid decompression, surgical methods such as Gold weight implant, facial nerve cable grafting, subperiostal facial suspension (face lifting),or Botulinum toxin injection are performed.18,19

 

The conventional medical treatment and management of facial paralysis has its own limitations. It has been reported that in some cases up to 10% of patients are reported to have no recovery from the condition.20 Some studies have found that the facial paralysis is treatable to a complete cure in the early stages of development of symptoms.19,21 However, there are no known definite recommendations favoring any specific medication that could be regarded as the best.18 In the light of this fact, availability of evidence based alternative medication would be of help to the patients.

 

The administration of nasal instillation medicine in Ayurveda is called Nasya which belongs to the 5-prong Ayurvedic treatment modality known as Panchakarma. Nasya is regarded as patient friendly because it can be done even in the comfort of patients' residence. Moreover, the use of Nasya medication has not been reported as causing any side effects. The usual dose varies between two to 10 drops in each nostril, once or twice daily.23

 

Currently there is a dearth of easy to access evidence on the prevalence of use of Nasya for treating facial paralysis as well as on the effectiveness of Nasya for treating facial paralysis. A search of leading databases of published medical studies, including PubMed, Cochrane and DHARA found no systematic review on either the prevalence of use of Nasya for treating facial paralysis or / and the effectiveness of different nasal instillation Ayurvedic medicines for treating facial paralysis. In the absence of a systematic review existing on the topic, the review will fill a knowledge gap and facilitate practitioners of Ayurveda and Integrative medicine using Nasya as an alternative treatment modality in a way that is informed by evidence.22

 

Article Content

Inclusion criteria

Types of participants

Adults (18-70 years of age) with Ardita (chronic or acute) are the participants to be included in this review. More specifically, the review will consider for inclusion studies that have examined the effectiveness of Naysa for treating acute or chronic Ardita in adults. An inclusive approach will be adopted with respect to geographical location of the participants with patients located in any country, and both rural and urban areas to be considered. Participants of any socio-economic status, both sexes and all ethnic origins will be considered.

 

Studies whose participants have been pregnant women, adults older than 70 years and patients with allergic rhinitis, fever, intracranial tumour/haemorrhage and bilateral facial palsy will be excluded from the review. The reason for the lower age limit of 18 is because oil based Nasya is not usually administered to children, according to the ancient textual source Astanga Hridaya Sootra Sthanna.23

 

Types of intervention(s) and comparator(s)

The review will include for consideration all quantitative studies conducted worldwide that have examined the effectiveness of nasal instillation of Ayurvedic oil-based herbal medicine. All studies that quantified the effectiveness of Nasya either administered by a therapist or by self administration in treating facial paralysis will be considered for inclusion. All dosages and frequencies of Nasya use will be considered and if possible how effectiveness varies with dosage and frequency of use will be detailed in the analysis.

 

All studies in which the comparator was conventional medical management or placebo will be considered for inclusion. However, studies of Ayurvedic Nasya medicine in conjunction with conventional medicine, if any, will be excluded. As the objective is not only to shed light on the effectiveness of Nasya for treating facial paralysis, but also the effectiveness of one kind of Nasya medicine compared to another, all studies that have compared the effectiveness of one Nasya instillation medicine compared to another will be considered.

 

Types of outcomes

The review will consider both Ayurvedic and Conventional medicine outcome assessment criterion as described in the research papers. With respect to the conventional medicine this will include, but not be limited to facial function as measured by the House-Brackmann grading24,25 of facial function measure. With respect to the Ayurvedic medicine approach this will include but not limited to Ayurvedic diagnostic scoring.14, 22

 

The House-Brackmann scale ranges between I (normal movement) and VI (no movement).25

 

Grade I

 

Normal symmetrical function

 

Grade II

 

Slight weakness noticeable only on close inspection

 

Complete eye closure with minimal effort

 

Slight asymmetry of smile with maximal effort

 

Synkinesis barely noticeable, contracture, or spasm absent

 

Grade III

 

Obvious weakness, but not disfiguring

 

May not be able to lift eyebrow

 

Complete eye closure and strong but asymmetrical mouth movement

 

Obvious, but not disfiguring synkinesis, mass movement or spasm

 

Grade IV

 

Obvious disfiguring weakness

 

Inability to lift brow

 

Incomplete eye closure and asymmetry of mouth with maximal effort

 

Severe synkinesis, mass movement, spasm

 

Grade V

 

Motion barely perceptible

 

Incomplete eye closure, slight movement corner mouth

 

Synkinesis, contracture, and spasm usually absent

 

Grade VI

 

No movement, loss of tone, no synkinesis, contracture, or spasm

 

The Ayurvedic facial function grading is done as follows, with a full score of 3 for complete, 2 for Half, 1 for Mild and a score of 0 for normal:22

 

1. Vaktrardhavakra:

 

Complete Mukhavakrata

 

Half Mukhavakrata

 

Mild Mukhavakrata

 

Normal

 

2. Vaksanga:

 

Complete Vaksanga

 

Pronouncing with great efforts

 

Pronouncing with less efforts

 

Normal speech (whistling)

 

3. Netravikriti:

 

Complete upward rolling of eye

 

Half of the upward rolling of eye

 

Partial upward rolling of eye

 

Normal

 

4. Lalasrava:

 

Constant (profuse) Lalasrava

 

Intermittent (moderate) Lalasrava

 

Partial (mild) Lalasrava

 

No Lalasrava

 

Types of studies

To answer the questions of whether Nasya is effective for treating facial paralysis in the population of interest and the relative effectiveness of the different Nasya that emerge as effective, the review will consider experimental and epidemiological study designs including randomized controlled trials, non-randomized controlled trials and quasi-experimental studies.

 

Search strategy

The search strategy aims to find both published and unpublished studies. A three-step search strategy will be utilized in the review. An initial limited search of MEDLINE and CINAHL will be undertaken followed by analysis of the text words contained in the title and abstract, and of the index terms used to describe articles. Second, a search using all identified keywords and index terms will then be undertaken, across all databases. Thirdly, the reference list of identified reports and articles will be searched for additional studies. If missing information in studies are found all efforts will be made to obtain them. A limitation of the proposal is that even though it is understood that there may be a number of studies that are published in languages besides English, only studies published in English will be considered. This is due to concerns about the cost and feasibility associated with translation.

 

The following databases will be searched to identify published studies:

 

PubMed

 

CINAHL

 

Cochrane (CENTRAL)

 

Scopus

 

Centre for Review and Dissemination databases

 

Turning Research into Practice TRIP

 

EMBASE

 

EBM Reviews

 

DHARA, DARE, AYUSH Research Portal (Govt of India) and HTA database.

 

To identify unpublished studies the following will be searched:

 

Google Scholar

 

Online clinical trials registers:

 

MedNar

 

ProQuest Dissertations

 

Theses

 

Studies published in English language will be considered for inclusion.

 

Examples of initial keywords that will be used in the exploratory stage of the search for studies in electronic databases are: Nasya, Ardita, Panchakarma and Ayurveda.

 

Informed by the findings from the initial exploratory searches in the range of databases to be covered, further key words will be identified and a detailed search strategy will be developed and implemented for each database.

 

Assessment of methodological quality

Papers selected for retrieval will be assessed by two independent reviewers for methodological validity prior to inclusion in the review using standardized critical appraisal instruments from the Joanna Briggs Institute Meta-Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI) (Appendix I). Any disagreements that arise between the reviewers will be resolved through discussion, or with a third reviewer.

 

Data collection

Data will be extracted from papers included in the review using the standardized data extraction tool from JBI-MAStARI (Appendix II). The data extracted will include specific details about the interventions, populations, study methods and outcomes of significance to the review question and specific objectives.

 

Data synthesis

Quantitative data will, where possible, will be pooled in statistical meta-analysis using JBI-MAStARI. All results will be subject to double data entry. Effect sizes expressed as odds ratio (for categorical data) and weighted mean differences (for continuous data) and their 95% confidence intervals will be calculated for analysis. Where statistical pooling is not possible the findings will be presented in narrative form. Tables and figures will be used to aid in data presentation where appropriate.

 

Conflicts of interest

There are no conflicts of interest to report.

 

Acknowledgements

The primary reviewer would like to thank Morne Scheepers, fellow Master of Clinical Science Student, for agreeing to assist with critical appraisal in the proposed review.

 

References

 

1. Schmidt KL, Cohn JF. Human facial expressions as adaptations: Evolutionary questions in facial expression research. American journal of physical anthropology.2001;(33): 3-24. [Context Link]

 

2. Malik V, Joshi V, Green KM, Bruce IA. 15 minute consultation: a structured approach to the management of facial paralysis in a child. Archives of disease in childhood Education and practice.2012; 97(3): 82-85. [Context Link]

 

3. Peitersen E. The spontaneous course of 2,500 peripheral facial nerve palsies of different etiologies. Acta oto-laryngologica Supplementum.2002; (549): 4-30. [Context Link]

 

4. Scully C, Langdon J, Evans J. Marathon of eponyms: 2 Bell palsy (idiopathic facial palsy). Oral diseases.2009; 15(4): 307-8. [Context Link]

 

5. National Institute of Neurological Disorders and Stroke; Bell's Palsy Fact Sheet. http://www.ninds.nih.gov/disorders/bells/detail_bells.htm.2003; April. [Context Link]

 

6. Nedio Atolini Junior JJJJ, Vinicius de Faria Gignon, Adriano Tomio Kitice LSdAP, Vania Gracia Wolff Santos. Facial Nerve Palsy: Incidence of Different Ethiologies in a Tertiary Ambulatory. Intl Arch Otorhinolaryngol.2009; 13(12): 167-71. [Context Link]

 

7. Valiyathan MS. The Legacy of Caraka. Chennai. Orient Longman (P)Ltd;2004. [Context Link]

 

8. Kosins AM, Hurvitz KA, Evans GR, Wirth GA. Facial paralysis for the plastic surgeon. The Canadian journal of plastic surgery = Journal canadien de chirurgie plastique.2007; 15(2): 77-82. [Context Link]

 

9. Aik Kah T AFH. A Systemic Approach to Facial Nerve Paralysis. Webmed Central Opthalmology.2011. [Context Link]

 

10. Al Kandari Q. Facial paralysis reconstructive surgery state of art. Egypt, J Plast Reconstr Surg.2011; 35(2): 317-24. [Context Link]

 

11. Hankey A. The scientific value of Ayurveda. Journal of alternative and complementary medicine.2005; 11(2): 221-5. [Context Link]

 

12. Hankey A. A test of the systems analysis underlying the scientific theory of ayurveda?s tridosha. The journal of alternative and complementary medicine.2005; 113: 385-90.

 

13. Joshi RR. A biostatistical approach to ayurveda: quantifying the tridosha. Journal of alternative and complementary medicine.2004; 10(5): 879-89. [Context Link]

 

14. Kumar VA. Ayurvedic clinical medicine. Delhi: Sri satguru publications, Delhi, India.1997. [Context Link]

 

15. Valiyathan MS. The Legacy of Susruta. Orient Longman (P) Ltd;2007. [Context Link]

 

16. Holland NJ, Weiner GM. Recent developments in Bell's palsy. Bmj.2004; 4;329(7465): 553-7. [Context Link]

 

17. Greco A, Gallo A, Fusconi M, Marinelli C, Macri GF, de Vincentiis M. Bell's palsy and autoimmunity. Autoimmunity reviews.2012; 12(2): 323-8. [Context Link]

 

18. Finsterer J. Management of peripheral facial nerve palsy. European archives of oto-rhino-laryngology: official journal of the European Federation of Oto-Rhino-Laryngological Societies. 2008; 265(7): 743 52. [Context Link]

 

19. Volk GF, Pantel M, Guntinas-Lichius O. Modern concepts in facial nerve reconstruction. Head & face medicine.2010: 6-25. [Context Link]

 

20. Lindsay RW, Robinson M, Hadlock TA. Comprehensive facial rehabilitation improves function in people with facial paralysis:a 5-year experience at the Massachusetts Eye and Ear Infirmary. Physical therapy.2010; 90(3): 391-7. [Context Link]

 

21. Anil G. Clinical Management of Ardita (Facial Palsy) Through Nasya and Shirobasti. Thesis - Rajiv Ganghi University of Health Sciences; Karnataka, Bangalore.2011. [Context Link]

 

22. Thanki KH, Joshi, N.P. and Shah, N.B. A comparative study of Anu taila and Mashadi taila nasya on Ardita (Facial Paralysis). AYU Journal.2009; 30(2): 201-4. [Context Link]

 

23. Deveraj T. The pancakarma treatment of ayurveda with kerala specialities. Chaukhambha orientalia.1998. [Context Link]

 

24. Reitzen SD, Babb JS, Lalwani AK. Significance and reliability of the House-Brackmann grading system for regional facial nerve function. Otolaryngology-head and neck surgery. official journal of American Academy of Otolaryngology-Head and Neck Surgery.2009; 140(2): 154-8. [Context Link]

 

25. House JW, Brackmann DE. Facial nerve grading system. Otolaryngology-head and neck surgery. official journal of American Academy of Otolaryngology-Head and Neck Surgery. 1985; 93(2): 146-7. [Context Link]

Appendix I: MAStARI critical appraisal checklist[Context Link]

Appendix II: MAStARI data extraction instrument[Context Link]

 

Keywords: Ayurveda; Nasya; Ardita; Facial paralysis; Vata

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