Septilin Versus Actifed in Chronic Non-specific Pharyngitis

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1 [The Indian Practitioner (2001): (54), 7, ] Septilin Versus Actifed in Chronic Non-specific Pharyngitis Nehru, V., Associate Professor, Department of ENT, Postgraduate Institute of Medical Education and Research, Chandigarh, India. (Correspondence to: Kala Suhas Kulkarni, Medical Advisor, R&D Center, The Himalaya Drug Company, Makali, Bangalore, India) ABSTRACT A double blind, placebo controlled clinical trial was conducted in 50 patients with chronic non-specific pharyngitis to assess the efficacy of Septilin in comparison to Actifed, an antihistamine-decongestant formula. Based on the clinical assessment and patient s self-assessment score at the end of three months, Septilin was found effective in 68% of the cases compared to Actifed, which was effective in 40% of the cases. Septilin was well tolerated and no side effects were observed. Key words: Non-specific pharyngitis, Septilin, Chronic sinusitis, Decongestant, Halitosis INTRODUCTION Chronic non-specific pharyngitis is a long-standing indolent inflammation of the pharynx. Primarily, it manifests as a persistent discomfort in the throat accompanied by painful swallowing. These patients have been treated extensively in the past with antibiotics and supportive therapy. However, the results have not been satisfactory due to the development of resistance to antimicrobial drugs. Clinically, the patients have islands of hypertrophic lymphoid tissue and/or diffuse congestion in the posterior pharyngeal wall. Laboratory tests such as the throat swab for culture and sensitivity may be useful for diagnosis. Septilin is a combination of herbs and minerals, chemically distinct from antibiotics. Its antibacterial and anti-inflammatory properties have been proved in experimental animals 5 demonstrated inhibition of Gram-positive and Gram-negative organisms with oral administration of Septilin in human clinical trials. The present study was planned to evaluate the efficacy of Septilin in chronic non-specific pharyngitis. MATERIAL AND METHODS Fifty patients of chronic non-specific pharyngitis, who attended the ENT Outpatient Service Department, were included in this study. Twenty one males and 29 females with age ranging between 18 and 49 years were randomly divided into two groups of 25 each, ensuring equal distribution on the basis of age and sex. Care was also taken to include those subjects into two groups whose symptoms were more or less uniformly manifested. A complete history

2 was recorded and a general physical and ENT examination performed before starting the therapy. The patients with a history of tuberculosis, leprosy, syphilis rhinoscleroma, dental caries, chronic tonsillitis, diabetics, ischaemic heart disease, patients on steroid therapy, allergy to drugs or with known renal or hepatic disease, were excluded from the study. A pre-treatment Clinical Assessment Score was self-assigned. No symptoms 0 Symptoms present but not troublesome 1 Symptoms troublesome but not interfering with normal activities 2 Symptoms interfering with normal activities 3 This was a randomised double-blind trial comparing the efficacy of Septilin with Actifed. Group I received Septilin 2 tablets three times daily. Group II received Actifed 2 tablets twice daily. The duration of therapy was three weeks in both the groups. No other therapy was used concurrently. At the end of three weeks a comparison was made on the outcome of treatment in the two groups. The response was categorised as "Good", "Satisfactory", "Poor" and "No response". RESULTS Sore throat The incidence of sore throat was 24 (96%) in Group I and 23 (92%) in The difference between the groups was not statistically significant. (Chi square = 0.02, df=1, NS). Improvement in sore throat occurred in 17 patients in Group I, and in 12 patients in The difference between the groups was not significant. (Chi square = 0.86, df=1, NS). Discomfort in swallowing The incidence of difficulty in swallowing was 19 (76%) in Group I and 21 (84%) in The difference between the groups was not statistically significant (Chi square = 0.10, df=1, NS). Improvement in sore throat and swallowing was observed in 10 patients in Group I and 9 in The difference between the groups was not significant. (Chi square = 0.05, df=1, NS). Halitosis The incidence of halitosis was 7 (28%) in Group I and 9 (36%) in The difference between the groups was not statistically significant (Chi square = 0.25, df=1, NS).

3 Improvement in halitosis was noticed in 4 patients in Group I and 2 patients in The difference between the groups was not significant. (Chi square = 0.66, df=1, NS). Hypertrophy of lymphoid tissue The incidence of hypertrophy of lymphoid tissue was 22 (88%) in Group I and 20 (80%) in The difference between groups was not statistically significant (Chi square = 0.25, df=1, NS). Improvement in lymphoid hypertrophy occurred in 13 patients in Group I and 9 patients in The difference between the groups was not significant. (Chi square = 0.73, df=1, NS). Congestion of mucosa The incidence of mucosal congestion was 22 (88%) in Group I and 19 (76%) in The difference between the groups was not statistically significant (Chi square = 0.22, df=1, NS). Improvement in mucosal congestion occurred in 13 patients in Group I and 16 patients in The difference between the groups was not significant. (Chi square = 0.31, df=1, NS). Pre-treatment clinical score The M (SD) pre-treatment clinical score was 2.16 (0.75) in Group I and 2.20 (0.71) in The difference between the groups was not statistically significant (t=0.19, df=48, NS). The M (SD) post-treatment clinical score was 1.20 (1.19) in Group I and 1.72 (1.06) in The difference between the groups was not statistically significant (t=1.63, df=48, NS). The groups were thus socio-demographically and symptomatically similar at baseline. The age-wise distribution of males and females amongst Group I and II is shown in Table 1. Two groups did not differ significantly in age. Females were more than males. Table 1: Distribution of Age groups Age (Years) Group I Group II Chi-square = 0.37, df=2, NS. The two groups did not differ significantly in age. Sex The sex distribution was as follows: Group I: Males =12 (48%), Females = 13 (52%). Group II: Males =10 (40%), Females = 15 (60%). The groups did not differ significantly in sex distribution Chi-square = 0.02, df=1, NS. There was uniform occurrence of symptoms in the two groups of patients, as assessed before they entered the study. The predominant features were persistent sore throat and the presence of follicles on the posterior pharyngeal wall in more than 90% of the cases. Halitosis occurred in 28% and 36% in Group I and II, respectively (Table 2).

4 The outcome was equivocal in the both the groups. Forty four percent of the patients in Group I and 48% in Group II had the above symptoms, only 36% in both the groups had severe symptoms resulting into interference with daily routine activities (Table 3). Table 2: Pre treatment Clinical Assessment Symptom Group I Group II Persistent sore throat Discomfort in swallowing Halitosis 7 9 Hypertrophy of lymphoid tissue Congestion of mucosa Table 3: Pre treatment Clinical Score Assessment Criterion Score Group I Group II No symptoms (0) 0 0 Symptoms present but not troublesome (1) 5 (20%) 4 (16%) Symptoms troublesome but not interfering with normal activities (2) 11 (44%) 12 (48%) Symptoms interfering with normal activities (3) 9 (36%) 9 (36%) The response with regard to Table 4: Post treatment clinical assessment persistent sore throat in Group I Symptom Group I Group II was 70% as against 52% in Persistent sore throat 7 11 A better response in Discomfort in swallowing 9 12 Actifed group was seen with Halitosis 3 7 regard to congestion of mucosa Hypertrophy of Lymphoid Tissue 9 11 i.e. 84% as compared to 50% in Congestion of Mucosa 9 3 the Septilin group. The response to halitosis was significantly better in Group I, i.e. 57% as compared to 22% in With regard to other symptoms, the results were marginally better in Group I (Table 4). Sixty eight percent of patients had a successful outcome in Group I and 40% in About one fourth of the patients in either group continued to have symptoms that interfered with their routine activities. The response was rated as poor in 8% in Group I and 32% in Group II (Table 5). Table 5: Post treatment clinical score Assessment Criteria Score Group I Group II No symptoms (Good) 9 (36%) 4 (16%) Symptoms present but not troublesome (Satisfactory) 8 (32%) 6 (24%) Symptoms troublesome, but not interfering with normal activities (Poor) 2 (8%) 8 (32%) Symptoms interfering with normal activities (No Response) 6 (24%) 7 (28%) No adverse effects were observed with the use of Septilin. Nine patients on Actifed complained of significant sedation.

5 DISCUSSION Chronic non-specific pharyngitis continues to be a common problem in practice of Otolaryngology. Environmental pollution, dietary habits, allergies, occupation and climatic conditions may also play an important role. As the rationale of expecting this condition to respond to antibiotic therapy appears doubtful, it was thought to attempt to treat this with an indigenous drug called Septilin. It appears to be a justified attempt because it has been widely claimed that there are no side/adverse effects of consequence with this drug. On clinical assessment, the symptoms of chronic non-specific pharyngitis were uniformly distributed amongst the two groups making them reasonably comparable. On the whole, 68% of the patients treated with Septilin reported a successful outcome whereas in the Actifed group this figure was 40%. There were 36% of patients in each group with symptoms interfering with their normal activities before they entered this study. At the end of the trial, about one fourth continued to be equally bad in either group; however response was rated as 'poor' in 8% of patients in Septilin group and in 32% of patients in Actifed group. With regard to relief of congestion, the Actifed group performed better with 84% as against 40% with Septilin. Both the drugs were tolerated well. However no side effects were reported with Septilin and a significant sedation occurred with Actifed in 9 patients. Septilin boosts the natural body defences and exerts an effect similar to the naturally occurring adrenocorticotropic hormone and thus helps overcome inflammation 1. A specific local effect on the mucosa has also been suggested. Several authors have mentioned antibacterial properties of Septilin 2-5. Both the drugs were equally effective in this trial, but Septilin does not produce sedation and thus could be a useful alternative in ambulatory patients suffering from chronic non-specific pharyngitis. ACKNOWLEDGEMENT We sincerely thank Dr. Rangesh Paramesh, M.D (Ay) for his kind help to conduct the study, and The Himalaya Drug Company for providing drug samples. REFERENCES 1. Roy S. Clinical Evaluation of Septilin in Allergic Rhinitis. Probe 1992; 2: Aggarwal S.R. and Saxena, A.K. Septilin - A study of its efficacy in patients with chronic suppurative otitis media. The Antiseptic 1980; 9: Garga M.K. Clinical determination of Septilin in chronic sinusitis. Probe 1980; 1: Ross D.K. The anti-infective and anti-bacterial efficacy of Septilin. Probe 1984; 2: Vishwakarma S.K. Septilin in ear, nose and throat infections. Probe 1979; 2: 85.