PREDNISOLONE VERSUS PREDNISOLONE COMBINED WITH ACYCLOVIR FOR THE TREATMENT OF BELL ' S PALSY : A COMPARATIVE STUDY IN PERIPHERAL REFERRAL CENTRE Affiliation

Shrestha K, Shah RK, Sapkota S, Giri S. Prednisolone Verses Prednisolone Combined ith Acyclovir or he Treatment f Bell's Palsy A Comparative w f t o Study n Peripheral Referral Centre. BJHS 2018;3(2)6: 443-446 i * Corresponding Author Dr Karuna Shrestha Consultant Otorhinolaryngologist Department of Otorhinolaryngology Birat Medical College and Teaching Hospital Email: karunashrestha215@gmail.com ORCID: https://orcid.org/0000-0002-6332-9095 ORA 72 1* 2 3 3 Shrestha K , Shah RK , Sapkota S , Giri S


Objec ve
To evaluate whether a prednisolone with acyclovir provide a be er degree of facial muscle recovery outcomes than prednisolone alone in pa ent with Bell's palsy.

Methodology
This is a hospital based longitudinal cross sec onal study conducted in Birat Medical College and Teaching Hospital and Birat Hospital PVT LTD, Biratnagar, Nepal from January 2017 to May 2018. A total of 42 pa ent diagnosed with Bell's palsy are included in this study, where 21 pa ent are treated with prednisolone and remaining 21 pa ent treated with a combina on of prednisolone and acyclovir. The House-Brackmann grading scale is used for recording the ini al presenta on of pa ent with Bell's palsy and their early recovery on follow-up visit. The collected data was analysed using SPSS 18.0.

Results
The total number of pa ents included in this study was 42. Mean age of pa ents is 27.1±10 years. Among them 25 (59.5%) were male and 17(40.5%) were female where male and female ra o is 1.5:1. Prednisolone plus acyclovir given in combina on in Bell's palsy pa ents has as 76.2% recovery while prednisolone given alone has a 57.1% recovery P value <0.195, odds ra o 2.400 (95% confidence interval 0.638 -9.028).

Conclusions
Prednisolone and acyclovir, the combined therapy is effec ve than prednisolone alone in the treatment of Bell's palsy. It requires confirma on with randomized controlled trial.

INTRODUCTION
Bell's palsy is named a er the Bri sh physician Sir Charles Bell, who described the onset, physical findings, and course 1 of the disease in 1821. The incidence rate of 20 per 100,000 per year and equal in both genders. Bell's palsy can occur at any age but the median age is 40 and both sides may be 2 affected equally. Bell's palsy is defined as an idiopathic, 3 sudden onset peripheral facial nerve palsy.
The exact causes of Bell's palsy remains unclear, although ischaemic neuropathy, viral infec on usually herpes simplex virus, and autoimmune disorders like sarcoidosis 4 are proposed as a causes of Bell's palsy.
The pathophysiology of Bell's palsy involves inflamma on and compression of seventh cranial nerve around the area where it exists the skull via stylomastoid foramen. The facial nerve travels through the fallopian canal and then enters the paro d gland where it divides into five terminal branches that are responsible for innerva ng the muscles of facial expression.The oedema and inability to expand beyond the inelas c bony fallopian canal leads to pressure effect and demyelina on of axon, resul ng in weakness or 5 paralysis of everything that it innervates.
Many viruses including Herpes simplex virus type 1 (HSV-1), Herpes simplex virus type 2 (HSV-2), Human herpes virus, Varicella zoster virus (VZV), Adeno virus, influenza B virus, Coxsackie virus and Epstein-Barr virus (EBV) have been linked to the development of Bell's palsy but it is believed that HSV-1 is the one that is responsible for idiopathic facial 6 palsy. HSV may remains latent at the geniculate ganglia and increasing evidence implies that Bell's palsy is caused by the latent HSV being reac vated from the cranial nerve 7,8,9 ganglion and causes inflamma on of facial nerve.
The majority of pa ents with Bell's palsy recover completely without interven on. Complete recovery typically occur within 6 months. Approximately 30% of pa ents do not recover completely and gets residual symptoms such as 10 contracture, synkinesis and paresis.
Due to its unknown e ology, treatment of Bell's palsy remains controversial, frequently debated and variable. Steroid and an viral are main two types of pharmacological 3 treatment that have been used for Bell's palsy. The ra onal for these treatment is based on the presumed pathophysiology of Bell's palsy, the use of steroids to counteract the inflammatory process and an virals is aimed at eradica on 4,11 of virus such as HSV-1, an viral therapy seems logical.
Most surgeon would advocate a combina on of steroid and an viral drugs. The usual recommended regime is oral prednisolone 1mg\kg\day for 7 days followed by ten days taper and oral acyclovir 200-400mg 5 mes daily for 7 days.

METHODOLOGY
This is a hospital based longitudinal cross sec onal study. A total of 42 pa ent diagnosed with Bell's palsy who visited OPD of Otorhinolaryngology of Birat Medical College and Teaching Hospital and Birat Hospital PVT LTD, Biratnagar, Nepal from January 2017 to May 2018 are included in this study. The permission to conduct this study was taken from the ins tu on. All pa ent with Bell's palsy age of more than 10 years and of either sex were enrolled in the study.
All pa ents were randomly divided into two group. The first Group A of 21 pa ent were treated with prednisolone and remaining Group B of 21 pa ent were treated with a combina on of prednisolone and acyclovir. In Group A oral prednisolone 1mg\kg\day was given for 7 days followed by ten days taper and Group B were treated with a combina on of oral prednisolone 1mg\kg\day and oral acyclovir 400mg five mes per day for 7 days.
Pa ent with facial palsy due to Ramsey Hunt syndrome, chronic suppura ve o s media, systemic infec on, th vasculopathy, secondary causes of 7 nerve palsy, sensi vity to acyclovir, Bell's palsy with >3 days of symptom onset, other cranial nerve paralysis, pa ents who are lost to follow up are excluded. This is therefore the compara ve study on recovery outcomes in pa ents with Bell's palsy treated either with prednisolone alone or with a combina on of prednisolone and acyclovir.
The treatment of the pa ents with Bell's palsy depends on a number of variables. Steroid treatment has been shown to 17,18 be effec ve in many studies of pa ent with Bell's palsy. However adding an viral drugs to the treatment of Bell's palsy is to eradicate the virus while steroid reduced swelling 19 and inflamma on of nerve. Use of an an viral agent in addi on to steroid in the treatment of Bell's palsy has been shown to improve the recovery of facial func on when 20,21 compared to cor costeroid treatment alone.
Kawagachi et al. showed that the recovery rate in pa ents with combina on of prednisolone and valacyclovir were 7 significantly greater than prednisolone alone. de Almeida JR et al suggested that combina on of an viral and glucocor coid treatment reduced risk of unfavourable recovery as compared with glucocor coid treatment 22 alone. Lockhart P et al showed that treatment with an viral agents alone were unsa sfactory, while the combina on of cor costeroid and acyclovir therapy were 20 significantly be er. Hato et al study, which reported a significant benefit of adding valaciclovir and showed that the benefit of valaciclovir was greater in pa ents with severe facial paralysis at presenta on than in those with 23 moderate paralysis. Minnerop et al performed a subgroup analysis of pa ents who presented with severe facial muscle paralysis (House-Brackmann grade of 5 or 6) and found significantly be er recovery in pa ents who received famciclovir plus steroids than in those on steroids alone 24 (72% v 47%, respec vely, achieved normal func on.
In a double blind, placebo-controlled, randomized study, early treatment with prednisolone significantly improved Bell's palsy. However, no significant advantage was found 25 for acyclovir alone or in combina on with prednisolone. Steroids are effec ve in pa ents whose Bell's palsy is started recently, and that an viral therapy does not significantly 26 improved the facial nerve func on. The recovery rate with combina on therapy increases only slightly as compared to trea ng with prednisolone alone, according to Numthavaj 27 et al Prednisolone is the basis of Bell's palsy treatment.
On the other hand, one of the most recently published trials, by Engstrom et al, is in opposi on to this argument. Pa ents in this trial had a median House-Brackmann grade of 4 at presenta on, and the authors convincingly showed 28 no benefit of adding valaciclovir to steroids .
However, other studies that underes mate the efficacy of treatment by adding acyclovir. In our study though the response seems to be be er with combined acyclovir and the prednisolone over prednisolone alone, the difference was found to be sta s cally insignificant.

CONCLUSION
The combina on therapy of prednisolone along with acyclovir is found to be be er than prednisolone alone yet sta s cally insignificant. For the confirma on of the finding we recommend a randomized controlled trial with larger sample size.

RECOMMENDATION
The study recommends the combined therapy of prednisolone and acyclovir as the effec ve treatment for Bell's palsy.

LIMITATION OF THE STUDY
In this study sample size was small therefore mul centre studies with large sample size are required.

ACKNOWLEDGEMENT
I would like to thanks all the faculty from department of Otorhinolaryngology of Birat Medical College and Teaching Hospital and others who are involved directly and indirectly to make this study a success and also the en re pa ents who were enrolled in this study.