Clinical Evaluation of Himcocid Suspension in Patients with Non-ulcer Dyspepsia

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1 [The Antiseptic (21): (98), 11, ] Clinical Evaluation of Himcocid Suspension in Patients with Non-ulcer Dyspepsia Upadhyaya, B.N., Reader and Head, and Khagen Basumathy, Junior Resident Department of Kayachikitsa,Institute of Medical Sciences, Banaras Hindu University, Varanasi, U.P., India. [Corresponding author: Dr. Kala Suhas Kulkarni, M.D., Medical Advisor, R&D Center, The Himalaya Drug Company, Makali, Bangalore, India] ABSTRACT Fifty with confirmed non-ulcer dyspepsia were enrolled in the study. They consisted of 32 males and 18 females aged between 18-8 years. They were dispensed Himcocid Suspension twice daily for 45 days. The result showed that all the symptoms of non-ulcer dyspepsia were reduced from week 2 onwards, which was evident when the scaling of the symptoms was considered. Initially the symptom score of epigastric, heartburn, nausea, vomiting, belching, flatulence, fullness in stomach and abdominal distention ranged from.38 ±.73 to 2.24 ±.84. After 2 weeks, it ranged from.1 ±.3 to 1.58 ±.67. After 4 weeks it reduced from ± to.84 ±.37. At the end of the study all the symptoms were relieved and the symptoms scored was (). No untoward incidents were seen in any of the. INTRODUCTION The term Dyspepsia refers to complex symptoms like epigastric, heartburn, nausea, vomiting, belching, flatulence, postprandial fullness in and abdominal that has its origin in the upper gastrointestinal tract and is localised to the upper abdomen. The symptoms also include pain, which suggests peptic ulcer disease and thus, it is almost impossible to make an accurate diagnosis. Therefore it is now a standard clinical practice to consider them together and label them as either peptic ulcer on non-ulcer dyspepsia only after performing upper gastrointestinal endoscopic examination. Also, the symptoms like gaseous in abdomen, early satiety and nausea cause confusion with gastro-oesophageal reflux disease and giardiasis, pancreatic and biliary diseases. Most with dyspepsia do not have peptic ulceration or other disease 1-4. In recent times eradication of H. pylori is mandatory for treating non-ulcer dyspepsia. However, a few large trials have rigorously evaluated the role of H. pylori eradication in dyspepsia and the results are conflicting 5,6. The herbs present in Himcocid include Varatika, which has been advocated for treatment of symptoms of non-ulcer dyspepsia 7. Studies have shown that gastric and duodenal ulcers have been treated with a herb which is present in Himcocid known as Yasthimadhu. The other

2 ingredients which are helpful in treating non-ulcer dyspepsia include Dugdhapashna and Moutika Sukti 7,8. MATERIAL AND METHODS Table 1: Incidence of age and sex in 5 cases of non-ulcer dyspepsia Selection of : Fifty of Male Female both sex and varying age with Age Total Total complaints of epigastric, (years) heartburn, nausea, vomiting, belching, flatulence, fullness in and abdominal were selected from the O.P.D. of S.S. Hospital, Institute of Medical Sciences, Banaras Hindu University, Varanasi for the clinical trial. Total Administration of drug: Himcocid suspension was administered at a dose of two teaspoonfuls, twice daily after meals for a period of 1½ months. Diet: Patients were kept under normal diet. Spicy diet was restricted. OBSERVATION AND RESULTS i) Incidence of age and sex in 5 cases of non-ulcer dyspepsia: The study of sex incidence in 5 cases of non-ulcer dyspepsia revealed that maximum number of were males 32 (64) and females 13 (36). Regarding the age incidence maximum number of were in the age group of 18-3 years (28) followed by 31-4 years (26) (Table 1). ii) The incidence of symptoms in relation to grade in 5 cases of non-ulcer dyspepsia: Incidence of clinical symptomatology in 5 cases of non-ulcerdyspepsia related that the maximum number of 49 (98) were having heartburn and flatulence followed by epigastric 92, fullness in, 84 belching 8, nausea 66, vomiting Table 2: Incidence of symptoms in relation to grade in 5 cases of non-ulcer dyspepsia Severe (3) Moderate (2) Mild (1) Total No symptom () Heartburn Nausea Vomiting Belching Flatulence

3 3 and abdominal 24. In relation to the grade, maximum symptoms were found in moderate grade except nausea and vomiting, which are, in the mild grade. In semi-grade, maximum had epigastric (21 cases); in moderate maximum had heartburn (43 cases) followed by flatulence (41 cases) and in mild-grade Heartburn Nausea Vomiting Belching Flatulence Table 3: Response of Himcocid on symptoms observed Before treatment (BT) 2.24 ± ± ± ± ± ± ± ±.73 maximum had nausea (19 cases) followed by fullness in (18 cases) (Table 2). F ± ± ±.48.6 ± ±.5.98 ± ±.66.1 ±.3 BT-F1 t=11 t=3.33 p<.1 t=7.25 t=4.66 t=12.66 t=15.33 t=1 t=4 F2.84 ± ± ± ± ±.42.2 ±.14 BT-F2 t=15 t=17.75 t=8.54 t=4.85 t=11.6 t=21.71 t=11.2 t=4 F3 BT-F3 t=2.36 t=34.66 t=8.54 t=13.42 t=12 t=32 t=12.18 t=3.8

4 (iii) Response of Himcocid on symptoms observed: Regarding epigastric, the data shows (Table 3) that, initial mean and SD is 2.24 ±.84 and after the first followup (F1) in 21 weeks treatment, F2 (4 weeks treatment) and F3 (6 weeks treatment) reduced to 1.58 ±.67,.84 ±.37 and. ±. respectively. The improvement in epigastric is statistically highly significant () in all the three observations. Initial mean ± SD of heartburn is 2.8 ±.44; nausea is.94 ±.79, vomiting.94 ±.55; belching 1.32 ±.79; flatulence 1.92 ±.48; fullness in 1.34 ±.77 and abdominal.38 ±.73 and in 6 weeks of treatment reduced to. ±.. The improvement of symptoms in all the complaints are statistically highly significant (). REFERENCES 1. Talley, NJ, Colin-Jones, D, Koch, KL, Koch, M, Nyren, O and Stanghellini V. (1991) Functional dyspepsia. A classification with guidelines for diagnosis and management. Gastroenterol Int, 4, Table 4: Clinical assessment of Himcocid suspension in 5 cases of non-ulcer dyspepsia Heartburn Nausea Vomiting Belching Flatulence Pre-treatment 1 st follow-up (2 weeks) 2 nd follow-up (4 weeks) 3 rd follow-up (6 weeks) Mean SD SE Mean SD SE Mean SD SE Mean.94.6 SD SE Mean SD SE Mean SD SE Mean SD SE Mean SD SE Bernersen, B, Johnsen, R, Bostad, L, Straume, B, Sommer, AI and Burhol, PG. (1992) Is Helicobacter pylori the cause of dyspepsia? BMJ, 34, Armstong, D. (1996) Helicobacter pylori infection and dyspepsia. Sacnd J Gastroenterol, 31(Suppl 215), Bytzer P. (1996) Diagnosing dyspepsia any controversies left? Gastroenterology, 11, Blum, A, Talley, NJ, O Morain, C, et al. (1998) Lack of effect of treating Helicobacter pylori infection in with nonulcer dyspepsia. The New England Journal of Medicine, 26, Trespi, E, Broglia, F, Villani, L, Luinetti, O, Fiocca, R and Solcia, E. (1994) Distinct profiles of gastritis in dyspepsia subgroups. Their different clinical responses to

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