Comparison of two purification products of shankha bhasma: A prospective randomized control trial

BACKGROUND: Shankha bhasma is widely used in the treatment of gastroesophageal reflux disease (GERD) patients. AIM: To compare the efficacy of two purification methods of shankha bhasma in relieving GERD symptoms. In method A, purification was done with lemon juice and method B with sour gruel. MATERIALS AND METHODS: Patients with heartburn since at least four days/week but who did undergo endoscopy to assess esophageal mucosa could participate. In this single-phase, single-center, prospective, randomized control trial, the patients were randomized to receive either shankha bhasma purified by method A or by method B. The primary efficacy variable was the proportion of patients with resolution of heartburn at week 4 and week 8. DESIGN: Single-phase, single-center, prospective, randomized control trial in a hospital setting. RESULTS: Of the total 70 patients who received samples A and B in a randomized double-blind manner, 65% of the patients showed resolution of symptoms in sample A and 28% in sample B at the end of four weeks, whereas, 71% of the patients showed resolution of symptoms in sample A and 31% in sample B at the end of eight weeks; P value was statistically significant for resolution of symptoms (P <0.005). CONCLUSION: Purification of shankha bhasma by lemon juice method is better than sour gruel method in terms of clinical outcome in GERD patients and is hence recommended.