The use of Acyclovir and Prednisone in the

The use of Acyclovir and Prednisone in the treatment of Bell’s Palsy Department of Emergency Medicine University of Pennsylvania Health System Kristi Artz MD January 13, 2004

Clinical Studies l l l Austin JR, et al. Idiopathic Facial Nerve Paralysis: A Randomized Double Blind Controlled Study of Placebo Versus Prednisone. Laryngoscope. 103: 1326 -1333 1993. Adour KK, et al. Bell’s Palsy Treatment with Acyclovir and Prednisone Compared with Prednisone Alone: A Double-Blind, Randomized, Controlled Trial. Ann Otol Rhinol Laryngol. 105: 371 -378 1996. De Diego JI, et al. Idiopathic Facial Paralysis: A Randomized, Prospective, and Controlled Study Using Single-Dose Prednisone Versus Acyclovir Three Times Daily. Laryngoscope. 108: 573 -575 1998.

Austin et al. l l A RCT out of the University of Southern California Los Angeles County Medical Center Inclusion criteria: age>16 yrs, onset of facial paralysis <5 days, no prior treatment from a physician, no confounding predisposing factors for facial nerve paralysis (e. g. middle ear dz, trauma, autoimmune dz, known prior Ramsay Hunt syndrome), no contraindication to use of steroids (e. g. PUD, pregnancy, HTN, DM, TB)

Austin et al. l l l 107 patients enrolled, 76 completed study (31 lost to follow-up) 37 women, 39 men Facial paralysis on right in 37 cases, on left in 39 cases 35 patients received prednisone; 41 received placebo Patients followed regularly during treatment phase and until 6 months after recovery

Austin et al. l Evaluation: – House and Brackmann facial nerve grading system (gr. I normal gr. VI. total paralysis) – Nerve excitability using max stimulation test (MST) followed by electroneurography (ENOG) if MST<25% normal side; significant denervation with its sequelae (e. g. synkinesis) occurs with MST<10% – **similar testing used in all 3 studies presented**

Results: Austin et al. l l l No significant difference in mean time to resolution (prednisone 51. 4 days vs. placebo 69. 3 days) No significant difference in number of patients that developed denervation (prednisone 5. 7% vs. placebo 19. 5%) A significant difference was found for final grade at resolution, with the placebo group having a higher proportion of poor outcome (gr III or less) (17% vs. 0%, p<0. 01)

Adour et al. A RCT from the Cranial Nerve Research Clinic in Oakland, California. Patients referred from primary care offices and emergency departments in the San Francisco Bay area. l Inclusion criteria: age >18 yrs old, onset of Bell’s palsy <3 days, no contraindication to steroids or acyclovir use, negative pregnancy test l

Adour et al. 119 patients enrolled, 99 completed study l 53 received acyclovir-prednisone, 46 received placebo-prednisone l Doses: prednisone tapered dose over 5 days starting at 1 mg/kg; acyclovir 400 mg 5 x/day for 10 days l Followed at regular intervals during treatment and until resolution l

Results: Adour et al. l l Return of full volitional facial muscle use was significantly better in the acyclovir-prednisone vs. placebo-prednisone group (92% vs. 76%, p=0. 02) Prevention of neural degeneration was significantly better in the acyclovir group (87% vs. 70%, p=0. 05) A non-significant trend toward less synkinesis in the acyclovir group Only mild GI symptoms were more frequently reported in the acyclovir group

De Diego et al. A RCT out of La Paz Hospital in Madrid, Spain l 113 patients enrolled, 101 patients completed (12 patients lost to follow-up) l Age range 14 -85 yrs l 56 men, 45 women l 47 received prednisone (1 mg/kg/d x 10 days then tapered over 6 days), 54 received acyclovir (800 mg tid x 10 days) l

De Diego et al. Inclusion criteria – Onset <3 days, no contraindications to use of prednisone or acyclovir, negative pregnancy test l Patients followed at regular intervals until recovery or a minimum of 3 months l

Results: De Diego et al. Significantly greater return of facial nerve function in the prednisone group (93% vs. 77%, p=0. 001) l A non-significant trend toward a greater degree of impairment on EMG testing in acyclovir group l No significant difference in number of patients with sequelae between the 2 groups l

HUP ism The use of prednisone and acyclovir is beneficial in the treatment of patients with Bell’s palsy who present within the first 3 -5 days of symptom onset. l Doses vary but these studies suggest: – 10 days of treatment with acyclovir at a dose of 1000 -2000 mg/day – Prednisone doses starting at 1 mg/kg for 5 days then tapered over approximately 5 days l