Abstract
This parallel, randomized, double blind clinical trial was designed to compare allopathic drugs [a combination of metronidazole + diloxanide furoate (MDF)] with Endemali (herbal product) for therapeutic cure rate and side effects in order to find out the most suitable drug for this killer disease. This double blind randomized clinical trial was conducted in two areas of Karachi, Pakistan after approval from ethical committee of Hamdard University. All those confirmed for Entamoeba histolytica were included in the study. One hundred and seventy one patients selected for the study were randomly allocated to two arms of 86 and 85 for allopathic and herbal treatment, respectively. However 78 in allopathic and 75 in herbal group completed the study. Main outcome variable was treatment success or failure. Secondary outcome measures included side effects and association with age and sex. No significant difference was observed in the socio economic and demographic variables at the baseline. No significant difference was found between the cure rate of MDF and Endemali; hence both drugs were equally effective in treating amoebiasis. Significant differences were reported for the side effects observed among the two groups and the price. The failure rate for the two drugs was 28.7%. It is concluded that both Endemali and MDF are equally effective in treating amoebiasis. However, Endemali has fewer side effects than MDF. New drugs need to be researched for the treatment of E. histolytica because of high failure rate of the two drugs against this killer organism. Key words: Comparison, Entamoeba histolytica, amoebiasis, herbal, Endemali, metronidazole, diloxanide furoate, clinical trial, double blind, parallel.
Highlights
IntroductionPakistan, where literacy rate is 34% and only 20%
Mode of action: Antitumor, antioxidant, antidiarrheal, astringent, antibacterial, anti-inflammatory, sweetening agents and excipients q.s. This randomized, double blind clinical trial was conducted to compare herbal medicine Endemali and a combination of allopathic preparation, metronidazole and diloxanide furoate (MDF) in order to evaluate the effectiveness of these medicinal preparation for the treatment of amoebiasis
A total of 78 in allopathic and 75 in herbal group completed their study (Figure 1). Both groups were compared for the basic characteristics and there was no significant difference between the two with respect to age, weight, height, sex, marital status, body mass index (BMI), race, occupation etc. at alpha level 5%, P < 0.05
Summary
Pakistan, where literacy rate is 34% and only 20%. Population has access to safe water supply and sanitation and even lesser in the rural area, the prevalence of parasitic infection is a common problem (Iliyas, 2006) which requires effective treatment. Many options exist for the treatment of parasitic infection including herbal medicine, which are said to be more cost effective with less side effects (Dans, 2007; Shahab-uddin, 2006; Al-Habbal, 1984; Calzada, 2005). Some work has been done regarding the prevalence of HIPP in Pakistan but there were few studies conducted to compare allopathic and herbal modalities for the treatment of amoebiasis (Khan, 2008; Ranque, 2004)
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