Angiographic Findings after Supplementation with Heracleum persicum Extract: Results of a Randomized Controlled Trial.

BACKGROUND: Heracleum persicum is a common dietary spice with several traditional medicinal properties important for cardiovascular health including antioxidant, hypolipidemic, and anti-inflammatory effects. This study explored the effects of supplementation with H. persicum fruit on the angiographic findings of patients with minimal coronary artery disease (CAD).
METHODS: Subjects who were diagnosed with <50% stenosis in any of their coronary arteries by angiography were selected for this trial and randomly assigned to H. persicum hydroalcoholic fruit extract (n = 15; 300 mg/day) or placebo (n = 12) for 6 months. At the end of the trial, participants underwent a second coronary angiography in order to evaluate the progression of their disease.
RESULTS: Posttrial angiography did not reveal any improvement in the number of stenosed vessels after consumption of H. persicum extract versus placebo (P > 0.05). Similarly, there was no significant difference between the study groups in terms of disease progression and chest pain score (P > 0.05).
CONCLUSIONS: The present results do not support any clinically significant benefit of supplementation with H. persicum extract on the angiographic findings of in patients with minimal CAD.

RCT Entities:   Population Interventions Outcomes

INTRODUCTION

Coronary artery disease (CAD) is the most common type of cardiovascular disease and results in the reduction of cardiac blood flow because of atherosclerotic plaque formation and subsequent arterial narrowing.[1] CAD accounts for a considerable burden of mortality as well as tremendous health care cost.[2] Numerous evidence from epidemiological surveys has shown an inverse association between consumption of diets rich in vegetables and fruits, and the occurrence of CAD and its complications.[3] Plants contain a multitude of bioactive phytochemicals that can synergistically modify several cardiovascular risk factors including inflammation, dyslipidemia, hypertension, insulin resistance, and adiposity.[456]

Heracleum persicum (Persian hogweed) is a perennial herb belonging to the family Apiaceae. This plant is endemic to Iran and is known with the vernacular name “Golpar.” Fruits of H. persicum are commonly consumed in the Persian cuisine as a dietary spice.

H. Persicum fruits are reputed in Iranian traditional medicine for treating various ailments. In addition, modern pharmacological research has unveiled different activities of H. persicum, including anti-inflammatory,[7] antioxidant,[8] and lipid-modifying effects.[9] These activities are important for the prevention of atherosclerosis and promotion of cardiovascular health. However, no study has yet evaluated the efficacy of supplementation with H. persicum in CAD patients. The present pilot study aimed to investigate this issue in subjects with minimal CAD.

METHODS

This study was designed as a randomized, double-blind, and placebo-controlled trial. Included subjects were selected from those with symptoms of stable angina pectoris who were referred to the Cardiology Clinic at the Baqiyatallah Hospital (Tehran, Iran) for coronary angiography. Subjects had myocardial ischemia according to the findings of the exercise test, thallium single photon emission computed tomography or dobutamin stress echocardiography. Coronary angiography was performed using routine procedures and angiograms were interpreted offline by a blinded cardiologist.

For this trial, only subjects with minimal CAD (defined as <50% stenosis in any of the coronary arteries) were selected. Candidates of coronary artery bypass grafting and coronary angioplasty, as well as those subjects with >50% reduction of coronary artery diameter, unstable angina, acute coronary syndrome, systemic diseases and malignancies were excluded from the trial. Eligible subjects (n = 27) were randomly allocated to receive H. persicum hydroalcoholic extract (n = 15; 300 mg/day) or matching placebo (n = 12) for a period of 6 months. All patients were receiving standard of care treatments for controlling comorbidities such as dyslipidemia and hypertension. At the end of the trial, participants underwent a second coronary angiography in order to evaluate the progression of their disease.

RESULTS

The groups were comparable at baseline regarding age, gender, anthropometric parameters, ejection fraction, the number of diseased vessels, history of cardiovascular disease and drug therapy (P > 0.05). Similarly, there was no significant difference in the frequencies of smoking, dyslipidemia and hypertension between the study groups (P > 0.05) [Table 1].

Table 1

Baseline characteristics of the study groups

Posttrial angiography did not reveal any improvement in the number of stenosed vessels after consumption of H. persicum extract versus placebo, apart from a significant difference in the number of subjects with normal angiographic findings in the left circumflex artery (P < 0.001), and a borderline difference in the number of subjects with normal posterior descending artery (P = 0.070). There was no significant difference between the study groups in terms of disease progression and chest pain score (P > 0.05) [Table 2].

Table 2

Frequency of coronary arteries with normal angiographic finding at baseline and study end

CONCLUSIONS

The above results do not support any clinically significant benefit of supplementation with H. persicum extract in patients with minimal CAD. Previous studies have shown that H. persicum is rich in phytochemicals such as flavonoids and furanocoumarins,[1011] and have been shown to possess anti-atherosclerotic and cardioprotective properties.[12] Furthermore, our previous trial demonstrated the efficacy of H. persicum extract as adjunct to low-dose atorvastatin in lowering serum total cholesterol and low-density lipoprotein cholesterol concentrations,[9] but the impact of this plant extract on the formation and progression of atherosclerotic plaques has not yet been reported.

In light of the present results, H. persicum extract is unlikely to have any significant plaque-regressing effect because of the futility of this extract in reducing luminal narrowing of coronary arteries. In spite of this negative finding, it must be noted that the present trial investigated the impact of short-term supplementation with H. persicum extract and the number studied was small. That long-term consumption of this extract can improve angiographic findings remains open to question, and merits further investigation.