ABSTRACT
Aims and objectives: The primary objective of the study was to evaluate and document the evidence-based efficacy and safety of the study drug in lowering blood pressure (BP). The secondary objectives included efficacy of the study drug in improving symptoms, quality-of-life (QOL) and biochemical parameters including treadmill and Doppler echocardiography. Study design: Phase IV post-marketing/surveillance study. Material and methods: Thirty-five subjects with prehypertension and hypertension (Stage 1 and Stage 2), attending the OPDs and camps of Heart Care Foundation of India were enrolled for the nonplacebo-controlled prospective study. The subjects were given homeopathic combination BPA (study drug) in liquid dosage for 12 weeks. Baseline clinical and biochemical parameters, treadmill test and Doppler echocardiogram were compared with the same parameters at the end of 12 weeks. Sixteen subjects completed the study. Results: There was a mean fall in systolic BP (SBP) of 15.75 mmHg and mean fall in diastolic BP (DBP) of 10.31 mmHg without any side effects. This significant decline in BP was evident from 4th week onwards. There was an appreciable increase in the exercise tolerance as evident by the 8.6% increase in metabolic equivalents (METs) and 8.2% increase in exercise time. No significant changes were observed in systolic or diastolic function parameters on Doppler echocardiography at three months. There was decrease in blood sugar from 96.5 ± 13.938 at baseline to 92.56 ±12.329 at 12 weeks (p = 0.046). Serum uric acid levels also decreased from 5.681 ± 0.8998 at baseline to 6.031 ± 0.8822 at 12 weeks (p = 0.053) suggesting a beneficial effect of the combination on insulin resistance (IR). There were positive changes in the QOL as assessed by SF36 Questionnaire. The average Rand score improved from 54.53 ± 21.9991 to 77.55 ± 10.493 at 12 weeks (p < 0.001). All data are presented as mean ± standard deviation (SD). Conclusion: The results of the study showed that the study drug can be safely used as monotherapy in patients with prehypertension or hypertension with no complications.