An Open-Label Study of the Efficacy and Safety of a Herbal Secretolytic Preparation as a Sole Therapy in Patients with Sinusitis

Abstract

This is an open-label, non-comparative controlled study of the efficacy and safety of a herbal secretolytic preparation (Sinupret®) as a single therapy in patients with sinusitis. The study was conducted at the Department of Otolaryngology, Siriraj Hospital, Bangkok, during the period January - December 2000. Thirty-nine patients with symptoms and signs of sinusitis, which were confirmed by abnormal endoscopic findings and abnormal radiological findings, were included. All patients received Sinupret®, two sugar-coated tablets orally three times a day for 21 days. Symptoms and signs were evaluated on three occasions; the first (day 0, V1) before the treatment started, the second (V2) on day 14, and the third (V3) on day 21. There were no other additional adjunctive treatments. Primary outcome measures were the change in the percentage of patients who had three main symptoms (i.e. nasal obstruction, nasal discharge and sinus headache), abnormal endoscopic findings (i.e. mucosal swelling and nasal secretion), and abnormal radiological findings (i.e. air-fluid level, opacification, and mucoperiosteal thickening). Global assessment was rated by the patients using a visual analogue scale (VAS). The clinical response was classified as cure, improvement, failure, and relapse. Treatment success was defined as cure or improvement. Adverse events were also recorded.
     There were 14 males and 25 females, with a mean age of 39.7 ± 14.1 years (16-75). Twenty three patients had chronic sinusitis (CS) and 16 patients had acute sinusitis (AS). The duration of symptoms in the CS group was 16.4 ± 25.6 months (1-96), and in the AS group was 21.3 ± 9.4 days (7-30). At V1, 34 patients (87.2%) had nasal discharge, 26 patients (66.7%) had obstruction, and 25 patients (64.1%) had sinus headache. At V3, the percentages of patients who had symptoms decreased signifiantly to 64.1%, 41.0% and 38.5% for these three symptoms respectively. The same was true for the percentage of patients who had abnormal endoscopic findings. The percentage of patients showing radiological evidence of improvement was 61.5% (33.3% normal, 28.2% improvement), with no change in 38.5% of patients, Treatment success was recorded in 31 out of 39 patients (79.4% : cure 23.0%, improvement 56.4%). In four patients (10.3%) treatment failed and in four other patients (10.3%) there was a relapse in symptoms and signs. Adverse events were reported in 4 patients (10.3%), which were mikd and resolved spontaneously.
     This study shows the efficacy and safety of a 3-week course of a herbal secretolytic preparation (Sinupret®) in the treatment of sinusitis, either acute or chronic. The incidence of adverse events was low and they were tolerated by the patients. The use of this herbal secretolytic preparation as a sole treatment is effective in most cases of uncomplicated sinusitis. This can decrease the risk of adverse drug reactions from antibiotic therapy and is a cheaper treatment.