Approach to Study the Efficacy and Safety of New Complementary and Alternative Medicine Formulations: Lesson during COVID-19 from Sri Lanka.

COVID-19 affected Sri Lanka from early 2020, a time of considerable ignorance accompanied by wide media coverage of a devastating epidemic in Italy and Europe. Many were attracted to complementary and alternative medicine (CAM) or traditional medicine (TM) in this desperate situation. Several preparations were claimed to be effective against COVID-19 globally. Dammika Bandara Syrup© was one such preparation promoted for preventing and treating SARS-CoV-2 infection. It was based on bees' honey, pericarp and mace of Myristica fragrans (nutmeg), the seed of Foeniculum vulgare and fresh rhizome of Zingiber officinale, all believed to have anti-viral properties. Following an unpublished clinical study claiming efficacy, Dammika Bandara Syrup© gained wide media publicity and political patronage. The producer claimed of Goddess Kali revealing the formula added an anthropological, cultural, and religious complexity to the issue. The demand for the product increased rapidly as a debate raged both in public and in the parliament on utilizing such products in combating COVID-19. The Department of Ayurveda, which is statutorily responsible for regulating CAM/TM had to respond to the situation. The legislation to regulate such indigenous medicinal products was weak, and the crisis deepened as thousands converged to the production facility, defying mobility restrictions introduced to control COVID-19. This led to the Ministry of Health requesting academics to form a team and conduct a clinical trial to prove its efficacy. This paper outlines the process and issues faced during the regulatory approval for the trial in a polarized political environment. Some health professionals accused the researchers of bowing to political pressure and questioned the scientific justification for the trial. However, the team considered this as an opportunity to streamline a path for research into CAM/TM therapies in situations such as COVID-19. Several processes were identified and addressed, such as the provisional registration of CAM preparations, assessing the potential efficacy of a CAM product, confirmation of authenticity and safety, standardization and supervision of production respecting cultural identities, obtaining approval for human use, choice of comparators, and ethical issues. We believe the study has helped set standards and a benchmark for CAM and TM research in Sri Lanka.

In vivo anticancer effects of Momordica charantia seed fat on hepatocellular carcinoma in a rat model.

BACKGROUND: Momordica charantia or bitter melon is a well-known vegetable with a number of therapeutic actions in Ayurvedic medicine. Alpha-eleostearic acid, a conjugated trienoic fatty acid present in bitter melon is proven to have anticancer properties. Crude seed oil from local bitter melon varieties could be an effective and economical anticancer therapy. OBJECTIVE(S): The study was conducted to evaluate the anticancer effect of the crude oil from the seeds of Matale green variety of bitter melon on a hepatocellular carcinoma-induced rat model. MATERIALS AND METHODS: Hepatocellular carcinoma (HCC) was experimentally induced in Wistar rats. Crude seed oil of Matale green bitter melon (MGBM) was supplemented to one treatment group in concurrence with carcinoma induction and to another treatment group after the development of carcinoma. After 168 days, gross morphological, histopathological, biochemical, hematological and gene-expression analysis of treated and control groups were performed. RESULTS: Oral supplementation of MGBM seed oil showed a statistically significant reduction (p < 0.05) in the average number, diameter and area of hepatic dysplastic nodules and a reduction in the size of histopathological neoplastic lesions in both treatment groups compared to the non-treated control group. The expression of tumor suppressor gene p53 and anti-apoptotic gene Bcl-2 were significantly increased while the expression of apoptotic gene caspase 3 was significantly reduced in the treatment group when MGBM supplementation was in concurrence with carcinogenesis (p < 0.05). CONCLUSION: Crude seed oil from the MGBM has anticancer effects against experimentally induced HCC in Wistar rats, specially when supplemented in concurrence with carcinoma induction.

Bartter syndrome-like phenotype in a patient with diabetes: a case report.

BACKGROUND: Bartter's syndrome is a rare genetic tubulopathy affecting the loop of Henle leading to salt wasting. It is commonly seen in utero or in early neonatal period. Rare cases of acquired Bartter's syndrome are reported in association with infections like tuberculosis, granulomatous conditions like sarcoidosis, autoimmune diseases, and drugs. The mainstay of management includes potassium, calcium, and magnesium supplementation. CASE PRESENTATION: We report the case of a 62-year-old Sri Lankan Sinhalese man with diabetes and hypertension presenting with generalized weakness with clinical evidence of proximal myopathy. He was severely hypokalemic with high urinary potassium excretion and hypochloremic metabolic alkalosis. He poorly responded to intravenously administered potassium supplements. A diagnosis of idiopathic Bartter-like phenotype was made. He responded well to spironolactone and indomethacin. CONCLUSIONS: Patients presenting with body weakness need serum potassium estimation. Acquired Bartter's syndrome although rare, should be ruled out in those with hypokalemia and metabolic alkalosis with increased urinary potassium loss with poor response to potassium replacement.

Is oral penicillin an effective chemoprophylaxis against leptospirosis? A placebo controlled field study in the Kandy District, Sri Lanka.

Leptospirosis poses a severe threat to the lives of farmers in Sri Lanka, thus, development of an effective chemoprophylaxis is deemed essential. We tested oral penicillin as chemoprophylaxis against leptospirosis in high transmission areas in central Sri Lanka in October 2005. Eight hundred active farmers were randomly assigned to take either oral penicillin (500 mg bid) or a similar looking placebo over a month during active farming season. The primary study point was the incidence of serologically confirmed leptospirosis. Data were available for 602 subjects of whom 319 (152 taking penicillin and 167 taking placebo) had good compliance, shown by tablet count. Of 5 subjects hospitalized with fever, 3 had serological evidence of leptospirosis, all of whom belonged to the placebo group. Therefore, oral penicillin may be effective chemoprophylaxis against leptospirosis.