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Efficacy of Viola Odorata Flower Decoction in Chronic Rhinosinusitis

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Efficacy of Viola Odorata Flower Decoction in Chronic Rhinosinusitis Original Article Medical Journal of Islamic World Academy of Sciences Basic Sciences-Unani doi: 10.5505/ias.2019.08379 2019;27(3): 77-84 Efficacy of Viola odorata flower decoction in chronic rhinosinusitis Imamuddin MULLA1, Mariyam ROQAIYA2, Mohd Imran KHAN3 1 Department of Moalajat, Luqman Unani Medical College Hospital and Research Centre Bijapur, Karnataka, India 2 Department Niswan Wa Qabala, Luqman Unani Medical College Hospital and Research Centre Bijapur, Karnataka, India 3 Department of Pharmacology, National Institute of Unani Medicine Bengaluru, Karnataka, India Correspondence Mariyam ROQAIYA Department of Niswan Wa Qabala, Luqman Unani Medical College Hospital and Research Centre Bijapur, Karnataka, India e-mail: [email protected] ABSTRACT Chronic rhinosinusitis (CRS) is one of the most frequent otorhinolaryngologic diseases encountered in daily practice with an estimated prevalence of 14% of the global population. This study aimed to explore the efficacy of Viola odorata flower decoction against CRS. In this prospective randomized controlled trial, 30 patients with CRS were randomly assigned to receive either test drug (10 g of V. odorata flower in the form of decoction administered orally empty stomach in the morning daily) or active control drug (single nasal spray of fluticasone propionate 50 µg/spray in each nostril daily) for 30 days. The primary outcome measure was an improvement in sinonasal symptoms assessed using a 22-item sinonasal outcome questionnaire (SNOT-22). Reduction in absolute eosinophil count (AEC) and improvement in x-ray paranasal sinus were secondary outcome measures. The significance level was kept as 5%. After completing the therapy, the SNOT-22 score was significantly low in the test group compared with the control group and a significant difference was found in AEC between the groups. Also, the SNOT-22 score remained significantly low after completion of the treatment on the 45th and 60th days compared with the control drug. Changes in x-ray paranasal sinuses were not significant between the groups. These results suggested thatV. odorata flower was effective in reducing the symptoms of CRS. Trial Registration No. Clinical Trial Registry of India CTRI/2017/09/009788 (01/09/2016) Key words: Flower; herbal medicine; quality of life; sinonasal; Viola odorata INTRODUCTION Rhinosinusitis is a group of disorders characterized [1]. Surgery is usually considered as a last option for by inflammation of the nasal mucosa and the mucosa of patients not responding to medical management. Re- the paranasal sinuses [1]. The inflammation of the nasal currence has been noted with surgical treatment and and sinus mucosa often coexists in this condition, and is often not successful. Therefore, no effective medical hence the term “rhinosinusitis” has been given [2]. Rhi- or surgical treatment is available to provide complete nosinusitis is considered as chronic when symptomatic cure for CRS. So, alternative therapeutic strategies need inflammation of the nasal and sinus mucosa persists for to be explored for the same [6]. more than >12 weeks, with or without exacerbations Viola odorata, popularly known as “Banafsha” in [1-4]. Chronic rhinosinusitis (CRS) is one of the most Asia [7] and frequently recognized as wood violet, sweet frequent otorhinolaryngologic diseases encountered in violet, English violet, common violet, florist's violet, or daily practice [3] with an estimated prevalence of 14% garden violet [7-10], is cultivated and grows spontane- of the global population [5]. ously on six continents with Mediterranean and tem- In the medical management of CRS, topical admin- perate climates [11]. In India, it is distributed in Kashmir, istration of corticosteroids is considered as the first-line Western Himalayan region, at an altitude of 1500–1800 therapy. Nasal irritation, mucosal bleeding, and crust- m [12]. According to Unani literature, Viola odorata flow- ing have been found to be associated with the daily ers (gulebanafsha) possess anti-inflammatory, analgesic, use of topical nasal steroids. Further long-term systemic blood-purifying, and expectorant properties [13,14]. It steroid use is associated with significant side effects is a remedy for respiratory problems such as bronchitis, 77 78 Mulla, Roqaiya, Khan cough, and asthma [13,15]. Several experimental stud- pain/pressure/fullness, or reduced sense of smell were ies have been conducted showing its anti-inflammatory, observed, besides inflammation documented by one or antimicrobial, sedative, and pre-anesthetic properties. more of the findings of purulent mucus or edema in the In clinical studies, the adjuvant use of violet syrup with middle meatus or anterior ethmoid region, polyps in the short-acting b-agonist was found to enhance cough nasal cavity or the middle meatus, and/or radiographic suppression in children with intermittent asthma [16]. imaging showing inflammation of the paranasal sinuses. Also, the frequencies of tonsillitis and peritonsillar ab- Patients were excluded if they had known systemic and scess reduced with the administration of decoction of metabolic diseases, external injuries, nasal polyps, and V. odorata flowers [17]. The objective of this study was to nasal growth. Pregnant and lactating women were also investigate the effect of V. odorata flowers in reducing excluded. Patients were randomized as 1:1 into the test the symptoms of CRS. or control group, 15 patients in each group, using an open list of random numbers produced from an online MetHODOLOGY randomization list generator (www.randomization.com). Study design The sequence of random numbers was concealed from This randomized controlled trial was conducted the researcher collecting the data until the interventions in the Department of Moalajat, Luqman Unani Medi- were assigned to each patient. cal College (LUMC) Hospital and Research Center, Vi- Intervention jaypur, Karnataka, from November 2016 to March 2018 The gule banafsha (V. odorata flower) was pur- conforming to the tenets of the Declaration of Helsinki. chased from a local drug market of Vijaypur city and The study protocol was approved by the Institutional identified and authenticated by Professor Syed Sal- Ethical Committee (IEC), LUMC, Vijaypur, under.IEC No: eemuddin Ahmed, Department of Pharmacology. The BJP/LUMC/PG/IEC/2015-16/01/MOALAJAT/02. The trial voucher specimen has been stored in the laboratory of was registered by the Clinical trial Registry of India with the Department of Pharmacology, LUMC Hospital and registration number CTRI/2017/09/009788. All patients Research Center, Vijayapur, Karnataka. Small sachets were required to sign a consent form before participat- were made, each containing 10 g dried gule banafsha. ing in the trial. Patients were instructed to prepare a decoction by add- Sample size estimation ing each sachet in 250 mL of water, followed by boiling The sample size of this study was calculated by tak- it for 5 min, sieving it, and use it empty stomach in the ing assumptions needed to demonstrate a difference by morning daily for 30 days. In the control group, a single a new treatment in terms of costs and risks: assumed ef- nasal spray of fluticasone propionate (50 µg/spray) in fect size of 9 and assumed standard deviation of 8.44. each nostril in the morning daily was given for 30 days. Based on these assumptions, a sample containing 28 Compliance was assessed at every follow-up by exam- participants, 14 in each group, was found to be sufficient ining the lock bags in which the medication was dis- to rule out a clinically important difference of 9 between pensed at the previous visit. the 2 groups in reducing 22-item sinonasal outcome Study procedure questionnaire (SNOT-22) score, assuming a standard deviation of 8.44 and using a two-tailed t test of the dif- During the first visit, a detailed history, including ference between means with 80% power and a 5% level the onset and duration of nasal blockage, running nose, of significance. After considering 10% as a dropout rate, sneezing, facial pain, decreased sense of smell, ear pain, the sample size required was approximately 30 (15 in ear fullness, history of allergy, and any previous treat- each group). ment, was taken, and a complete physical examination was done. Systemic examination of Central Nervous Participant selection and criteria System (CNS), Cardiovascular System (CVS), and Respi- The male and female patients aged 18–50 years ratory System (RS), and abdominal examination was fulfilled the diagnostic criteria for CRS of theA merican performed in each patient. Following the evaluation, Academy of Otolaryngology-Head and Neck Surgery. Ac- the patients were advised to go for necessary investi- cording to this criteria, a patient was diagnosed with CRS gations, including absolute eosinophil count (AEC) and if 12 weeks or longer of two or more of signs and symp- x-ray (Water’s view). Serum Glutamic-Ocaloacetic Trans- toms of mucopurulent drainage, nasal obstruction, facial aminase (SGOT), Serum Glutamic Pyruvic Transaminase Medical Journal of Islamic World Academy of Sciences 2019; 27(3): 77-84 Efficacy of Viola odorata Flower Decoction in Chronic Rhinosinusitis 79 (SGPT), blood urea, and serum creatinine levels were RESULts also determined to assess the safety of the drug. Pa- Participant selection tients meeting the inclusion criteria were provided A total of 151 patients were screened; 19 patients an information sheet containing details regarding the denied to participate in the study, and 132 were sub- nature of the study. Patients were given enough time jected to investigation. Of these, 102 patients were ex- and opportunity to read and understand the details cluded from the study and 30 patients were randomly of the study mentioned in the information sheet and allocated (Figure 1). ask any questions. They were given the right to deny or withdraw the treatment during any part of the study Baseline characteristics without sharing any reason. After obtaining the will- At baseline, patients were assessed for different ingness, they were asked to take part in the study and variables such as age sex, diet, occupation, and socio- sign the consent form.
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