A Randomized Clinical Trial of Elemental Zinc Add-On Therapy on Clinical Outcomes of Patients with Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP)

Document Type : Research article

Authors

1 Department of Otolaryngology, Head and Neck Surgery, Loghman Hakim Educational Hospital, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

2 Hearing Disorders Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Abstract

Recent studies suggest a relationship between zinc deficiency and inflammation. In the present study, we studied the effect of oral zinc supplementation on clinical improvement of chronic rhinosinusitis with nasal polyposis. In this single-blind randomized controlled trial, 44 patients with chronic rhinosinusitis with polyposis referring to ENT clinic of the Loghman Hakim hospital during 2013-2014 were randomly allocated in two groups. The treatment group (n = 28) was treated with a four-drug fixed-dose regimen (FD_FDR) consisting of oral dexamethasone (0.02 mg/kg), fluticasone nasal spray, fexophenadine 60 mg daily, montelukast 10 mg daily plus 220mg zinc sulfate capsules containing 55 mg elemental zinc, b.d., and the control group (n = 16) received the FD_FDR without supplemental zinc, for six weeks. After sixth week, two groups were compared regarding clinical outcomes based on theSNOT20 (Sinonasal outcome test) questionnaire, the general health questionnaire (SF12), the Lund-Mackay, and the Lund-Kennedy scoring systems. In the treatment group, serum zinc levels were significantly increased compared to those at the baseline (1.33 fold-increase; p = 0.0002). Within groups analysis revealed a significant reduction (p < 0.01) in LM and LK in both treatment (55% LM; 50% LK) and control groups (45% LM; 53% LK). Incontrast, between groups analysis revealed no significant differences in the LM and LK. The treatment group showed a mild superiority in general health improvement compared to that of the control group. Add-on therapy with supplemental zinc sulfate was not associated with significant improvement in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP). The advantage of zinc supplementation on the general health improvement of the patients with CRSwNP requires further assessments.

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References
Figure 2. Comparison of SNOT20 before and after treatment in both groups.
Figure 3. Comparison of SF12 before and after treatment in both groups.
Figure 3. Comparison of SF12 before and after treatment in both groups.
Figure 2. Comparison of SNOT20 before and after treatment in both groups.
Figure 3. Comparison of SF12 before and after treatment in both groups.
(a) (b)
Nasal polyposis and sinusitis. Bachert C and Van
Cauwenberge P. )eds). Sanders Publishers (2003) 58:
176–91.
Moss A and Parsons V. Current estimates from the
National Health Interview Survey. United States,
1985. Vital Health Stat. 10 (1986) 160: 1-182.
Kaliner MA, Osguthorpe JD, Fireman P, Anon J,
Georgitis J, Davis ML, Naclerio R and Kennedy D.
(1)
(2)
(3)
The effect of Zinc therapy in patients with CRSwNP
1601
Sinusitis: bench to bedside: current findings, future
directions. J. Allergy Clin. Immunol. (1997) 99: 829-48.
Meltzer EO, Hamilos DL, Hadley JA, Lanza DC,
Marple BF, Nicklas RA, Bachert C, Baraniuk J,
Baroody FM, Benninger MS, Brook I, Chowdhury
BA, Druce HM, Durham S, Ferguson B, Gwaltney
JM Jr, Kaliner M, Kennedy DW, Lund V, Naclerio
R, Pawankar R, Piccirillo JF, Rohane P, Simon R,
Slavin RG, Togias A, Wald ER, Zinreich SJ; American
Academy of Allergy, Asthma and Immunology;
American Academy of Otolaryngic Allergy; American
Academy of Otolaryngology-Head and Neck
Surgery; American College of Allergy, Asthma and
Immunology; and American Rhinologic Society.
Rhinosinusitis: establishing definitions for clinical
research and patient care. J. Allergy Clin. Immunol.
(2004) 114: 155-212.
Slavin RG, Spector SL, Bernstein IL, Workgroup
SU, Kaliner MA, Kennedy DW, Virant FS, Wald ER,
Khan DA and Blessing-Moore J. The diagnosis and
management of sinusitis: a practice parameter update.
J. Allergy Clin. Immunol. (2005) 116: 13-47.
Lamblin C, Gosset P, Salez F, Vandezande LM, Perez
T, Darras J, Janin A, Tonnel AB and Wallaert B.
Eosinophilic airway inflammation in nasal polyposis.
J. Allergy Clin. Immunol. (1999) 104: 85-92.
Mygind N, Dahl R and Bachert C. Nasal polyposis,
eosinophil dominated inflammation, and allergy.
Thorax (2000) 55: 79-83.
Benninger MS, Ferguson BJ, Hadley JA, Hamilos
DL, Jacobs M, Kennedy DW, Lanza DC, Marple BF,
Osguthorpe JD and Stankiewicz JA. Adult chronic
rhinosinusitis: definitions, diagnosis, epidemiology,
and pathophysiology. Otolaryngol. Head Neck Surg.
(2003) 129: 1-32.
Kern EB, Sherris D, Stergiou AM, Katz LM, Rosenblatt
LC and Ponikau J. Diagnosis and treatment of chronic
rhinosinusitis: focus on intranasal Amphotericin B.
Ther. Clin. Risk Manag. (2007) 3: 319.
Sadeghi N, Oveisi MR, Jannat B, Hajimahmoodi M,
Behfar A, Behzad M, Norouzi N, Oveisi M and Jannat
B. Simultaneous measurement of zinc, copper, lead
and cadmium in baby weaning food and powder milk
by DPASV. Iran. J. Pharm. Res. (2014) 13: 345-9.
Navaei-Nigjeh M, Gholami M, Fakhri-Bafghi
MS, Baeeri M and Abdollahi M. Molecular and
biochemical evidences for beneficial effects of zinc
oxide nanoparticles in modulation of chlorpyrifos
toxicity in human lymphocytes. Iran. J. Pharm. Res.
(2018) 17: 927-39.
Bao B, Prasad AS, Beck FW, Snell D, Suneja A,
Sarkar FH, Doshi N, Fitzgerald JT and Swerdlow
P. Zinc supplementation decreases oxidative stress,
incidence of infection, and generation of inflammatory
cytokines in sickle cell disease patients. Transl. Res.
(2008) 152: 67-80.
Prasad AS, Beck FW, Bao B, Fitzgerald JT, Snell DC,
Steinberg JD and Cardozo LJ. Zinc supplementation
decreases incidence of infections in the elderly: effect
of zinc on generation of cytokines and oxidative stress.
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
(12)
(13)
This article is available online at http://www.ijpr.ir
Am. J. Clin. Nutr. (2007) 85: 837-44.
Sharma GD, Doershuk CF and Stern RC. Erosion of
the wall of the frontal sinus caused by mucopyocele in
cystic fibrosis. J. Pediatr. (1994) 124: 745-7.
Ünal M, Tamer L, Pata YS, Kilic S, Degˇirmenci
U, Akbaş Y, Görür K and Atik U. Serum levels of
antioxidant vitamins, copper, zinc and magnesium in
children with chronic rhinosinusitis. J. Trace Elem.
Med. Biol. (2004) 18: 189-92.
Fokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I,
Baroody F, Cohen N, Cervin A, Douglas R, Gevaert P,
Georgalas C and Goossens H. EPOS 2012: European
position paper on rhinosinusitis and nasal polyps.
Rhinology (2012) 50: 1-12.
Jones ML, Piccirillo JF, Haiduk A and Thawley SE.
Functional endoscopic sinus surgery: do ratings of
appropriateness predict patient outcomes? Am. J.
Rhinol. (1998) 12: 249-55.
Hopkins C, Browne JP, Slack R, Lund V and Brown
P. The Lund-Mackay staging system for chronic
rhinosinusitis: how is it used and what does it predict?
Otolaryngol. Head Neck Surg. (2007) 137: 555-61.
Psaltis AJ, Li G, Vaezeafshar R, Cho KS and Hwang
PH. Modification of the lund‐kennedy endoscopic
scoring system improves its reliability and correlation
with patient‐reported outcome measures. Laryngoscope
(2014) 124: 2216-23.
Yanagisawa H. Zinc deficiency and clinical practice.
Japan Med. Assoc. J. (2004) 47: 359-64.
Chow SC, Wang H and Shao J. Sample size calculations
in clinical research. 1st ed. CRC Press (2007) 237-8.
Julious SA. Sample sizes for clinical trials with normal
data. Stat. med. (2004) 23: 1921-86.
Adelson RT and Adappa ND. What is the proper role
of oral antibiotics in the treatment of patients with
chronic sinusitis? Curr. Opin. Otolaryngol. Head Neck
Surg. (2013) 21: 61-8.
Harvey R, Hannan SA, Badia L and Scadding G.
Nasal saline irrigations for the symptoms of chronic
rhinosinusitis. Cochrane Database Syst. Rev. (2007)
2007: 183-6.
Suh JD and Kennedy DW. Treatment options for
chronic rhinosinusitis. Proc. Am. Thorac. Soc. (2011)
8: 132-40.
Gulani A and Sachdev HS. Zinc supplements for
preventing otitis media. Cochrane Database Syst. Rev.
(2012) 2012: 134-9.
Lamberti LM, Walker CLF, Chan KY, Jian WY and
Black RE. Oral zinc supplementation for the treatment
of acute diarrhea in children: a systematic review and
meta-analysis. Nutrients (2013) 5: 4715-40.
Lazzerini M and Ronfani L. Oral zinc for treating
diarrhoea in children. Cochrane Database Syst. Rev.
(2012) 2012: 211-5.
Sazawal S, Black RE, Bhan MK, Bhandari N, Sinha
A and Jalla S. Zinc supplementation in young children
with acute diarrhea in India. N. Engl. J. Med. (1995)
333: 839-44.