Shenzhu Guanxin Recipe Granules (参术冠心方颗粒) for Improving Exercise Tolerance in Patients with Stable Angina (SERIES Trial):A Protocol of Multicenter,Randomized,Double-Blind,Placebo Parallel Controlled Clinical Trial
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摘要
Background: Many patients with chronic angina experience anginal episodes despite successful recanalization, antianginal and antiischemic medications. Empirical observations suggested that Shenzhu Guanxin Recipe Granules(参术冠心方颗粒, SGR), a Chinese herbal compound, exerted potential impacts on increased treadmill exercise performance and angina relieve. However, there has been no systematic study to clarify the impact of SGR on exercise tolerance in patients with stable angina. The SERIES(ShEnzhu guanxin Recipe for Improving Exercise tolerance in patients with Stable angina) trial is designed to determine the effects of SGR on exercise duration, electrocardiographic(ECG) evidence of myocardial ischemia, and incidence of major adverse cardiac events(MACE) in stable anginal patients. Methods: A total of 184 eligible patients with stable angina will be randomly assigned to receive placebo or SGR(10 g/day for 12 weeks) in a 1:1 ratio. The primary outcome will be the change from baseline in total exercise tolerance duration, time to onset of angina and ECG ischemia during exercise treadmill testing performed over a 12-week study period. The secondary outcome will include ECG measures, the occurrence and composite of MACE and the Seattle Angina Questionnaire score. Moreover, the coronary microcirculation will be evaluated to explore the possible effects in response to treatment of SGR. After the procedure, all participants will be followed up by interview at 3 and 6 months, enquiring about any cardiac events, hospitalizations, cardiac functional level and medication usage. Additionally, the occurrence of adverse events will be evaluated at each follow-up. Discussion: This study may provide novel evidence on the efficacy of SGR in improving exercise tolerance and potentially reducing clinical adverse events.
Background: Many patients with chronic angina experience anginal episodes despite successful recanalization, antianginal and antiischemic medications. Empirical observations suggested that Shenzhu Guanxin Recipe Granules(参术冠心方颗粒, SGR), a Chinese herbal compound, exerted potential impacts on increased treadmill exercise performance and angina relieve. However, there has been no systematic study to clarify the impact of SGR on exercise tolerance in patients with stable angina. The SERIES(ShEnzhu guanxin Recipe for Improving Exercise tolerance in patients with Stable angina) trial is designed to determine the effects of SGR on exercise duration, electrocardiographic(ECG) evidence of myocardial ischemia, and incidence of major adverse cardiac events(MACE) in stable anginal patients. Methods: A total of 184 eligible patients with stable angina will be randomly assigned to receive placebo or SGR(10 g/day for 12 weeks) in a 1:1 ratio. The primary outcome will be the change from baseline in total exercise tolerance duration, time to onset of angina and ECG ischemia during exercise treadmill testing performed over a 12-week study period. The secondary outcome will include ECG measures, the occurrence and composite of MACE and the Seattle Angina Questionnaire score. Moreover, the coronary microcirculation will be evaluated to explore the possible effects in response to treatment of SGR. After the procedure, all participants will be followed up by interview at 3 and 6 months, enquiring about any cardiac events, hospitalizations, cardiac functional level and medication usage. Additionally, the occurrence of adverse events will be evaluated at each follow-up. Discussion: This study may provide novel evidence on the efficacy of SGR in improving exercise tolerance and potentially reducing clinical adverse events.
Background: Many patients with chronic angina experience anginal episodes despite successful recanalization, antianginal and antiischemic medications. Empirical observations suggested that Shenzhu Guanxin Recipe Granules(参术冠心方颗粒, SGR), a Chinese herbal compound, exerted potential impacts on increased treadmill exercise performance and angina relieve. However, there has been no systematic study to clarify the impact of SGR on exercise tolerance in patients with stable angina. The SERIES(ShEnzhu guanxin Recipe for Improving Exercise tolerance in patients with Stable angina) trial is designed to determine the effects of SGR on exercise duration, electrocardiographic(ECG) evidence of myocardial ischemia, and incidence of major adverse cardiac events(MACE) in stable anginal patients. Methods: A total of 184 eligible patients with stable angina will be randomly assigned to receive placebo or SGR(10 g/day for 12 weeks) in a 1:1 ratio. The primary outcome will be the change from baseline in total exercise tolerance duration, time to onset of angina and ECG ischemia during exercise treadmill testing performed over a 12-week study period. The secondary outcome will include ECG measures, the occurrence and composite of MACE and the Seattle Angina Questionnaire score. Moreover, the coronary microcirculation will be evaluated to explore the possible effects in response to treatment of SGR. After the procedure, all participants will be followed up by interview at 3 and 6 months, enquiring about any cardiac events, hospitalizations, cardiac functional level and medication usage. Additionally, the occurrence of adverse events will be evaluated at each follow-up. Discussion: This study may provide novel evidence on the efficacy of SGR in improving exercise tolerance and potentially reducing clinical adverse events.
引文
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2.Lozano R,Naghavi M,Foreman K,Lim S,Shibuya K,Aboyans V,et al.Global and regional mortality from 235causes of death for 20 age groups in 1990 and 2010:a systematic analysis for the Global Burden of Disease Study2010.The Lancet 2012;380:2095-2128.
3.Serruys PW,Unger F,Sousa F.Comparison of coronaryartery bypass surgery and stenting for the treatment of multivessel disease.ACC Curr J Rev 2001;10:85.
4.Holubkov R,Laskey WK,Haviland A,Slater JC,Bourassa MG,Vlachos HA,et al.Angina 1 year after percutaneous coronary intervention:a report from the NHLBI Dynamic Registry.Am Heart J 2002;144:826-833.
5.Thadani U.Current medical management of chronic stable angina.J Cardiovasc Pharmacol Ther 2004;9:S11.
6.Kones R.Recent advances in the management of chronic stable anginaⅡ.Anti-ischemic therapy,options for refractory angina,risk factor reduction,and revascularization.Vasc Health Risk Manag 2010;6:749-774.
7.Qiu Y,Xu H,Shi D.Traditional Chinese herbal products for coronary heart disease:an overview of cochrane reviews.Evid-Based Complement Alternat Med 2012;2012:417387.
8.Mao S,Wang L,Ouyang W,Zhou Y,Qi J,Guo L,et al.Traditional Chinese medicine,Danlou Tablets alleviate adverse left ventricular remodeling after myocardial infarction:results of a double-blind,randomized,placebo-controlled,pilot study.BMC Complement Altern Med 2016;16:447.
9.Yu L,Qin Y,Wang Q,Zhang L,Liu Y,Wang T,et al.The efficacy and safety of Chinese herbal medicine,Rhodiola formulation in treating ischemic heart disease:a systematic review and meta-analysis of randomized controlled trials.Complement Ther Med 2014;22:814-825.
10.Mao S,Wang L,Zhao X,Shang H,Zhang M,Hinek A.Sodium tanshinoneⅡA sulfonate for reduction of periprocedural myocardial injury during percutaneous coronary intervention(STAMP trial):rationale and design.Int J Cardiol 2015;182:329-333.
11.Ruan X,Jiang W,Lin Y.Clinical efficacy of treatment for regulating Pi and protecting Xin in treating patients after coronary artery bypass grafting and its effect on patients'quality of life.Chin J Integr Tradit West Med(Chin)2006;26:28-32.
12.Wu H,Xu D,Luo W.Retrospective cohort study on the improvement of the prognosis of patients after coronary artery bypass grafting operation treated by the method for regulating Pi(Spleen)and protecting Xin(Heart).Jilin JTradit Chin Med(Chin)2009;29:27-29.
13.Xu D,Wu H,Lan T,Wang X,Sheng X,Lin Y,et al.Effect of Shenzhu Guanxin Recipe on patients with angina pectoris after percutaneous coronary intervention:a prospective,randomized control ed trial.Chin J Integr Med 2015;21:408-416.
14.Xu D,Wang X,Sheng X,Lin Y,Li S,Zheng C.Doubleblind,randomized,controlled clinical trial of Shenzhu Guanxin Prescription for treatment of stable angina due to cronary heart disease.J Guangzhou Univ Tradit Chin Med(Chin)2014;31:173-182.
15.Xu D,Wu H.Effect of Shenshu Guanxin Granules on coronary circulation in rats with myocardial infarction.Chin J Pathophysiol(Chin)2014;30:438-443.
16.Fraker TD,Fihn SD,Members WC,Gibbons RJ,Abrams J,Chatterjee K,et al.2007 chronic angina focused update of the ACC/AHA 2002 guidelines for the management of patients with chronic stable angina.J Am Col Cardiol 2007;50:2264-2274.
17.Chen KJ.Blood stasis syndrome and its treatment with activating blood circulation to remove blood stasis therapy.Chin J Integr Med 2012;18:891-896.
18.Thygesen K,Alpert JS,Jaffe AS,Simoons ML,Chaitman BR,White HD,et al.Third universal definition of myocardial infarction.J Am Coll Cardiol 2012;60:2264-2274.
19.Spertus JA,Winder JA,Dewhurst TA,Deyo RA,Prodzinski J,Mc Donell M,et al.Development and evaluation of the Seattle Angina Questionnaire:a new functional status measure for coronary artery disease.J Am Coll Cardiol 1995;25:333-341.
20.Gibbons RJ,Balady GJ,Bricker JT,Chaitman BR,Fletcher GF,Froelicher VF,et al.ACC/AHA 2002 guideline update for exercise testing:summary article:a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines(committee to update the 1997 exercise testing guidelines).J Am Coll Cardiol 2002;40:1531-1540.
21.Munzel T,Meinertz T,Tebbe U,Schneider HT,Stalleicken D,Wargenau M,et al.Efficacy of the long-acting nitro vasodilator pentaerithrityl tetranitrate in patients with chronic stable angina pectoris receiving anti-anginal background therapy with beta-blockers:a 12-week,randomized,doubleblind,placebo-controlled trial.Eur Heart J 2014;35:895-903.
22.McInnis KJ,Balady GJ,Weiner DA,Ryan TJ.Comparison of ischemic and physiologic responses during exercise tests in men using the standard and modified Bruce protocols.Am J Cardiol 1992;69:84-89.
23.Kume T,Akasaka T,Kawamoto T,Yoshitani H,Watanabe N,Neishi Y,et al.Assessment of coronary microcirculation in patients with takotsubo-like left ventricular dysfunction.Circ J 2005;69:934-939.
24.Gaibazzi N,Rigo F,Lorenzoni V,Molinaro S,Bartolomucci F,Reverberi C,et al.Comparative prediction of cardiac events by wall motion,wall motion plus coronary flow reserve,or myocardial perfusion analysis:a multicenter study of contrast stress echocardiography.JACC Cardiovasc Imag 2013;6:1-12.
25.Fox K,Garcia MA,Ardissino D,Buszman P,Camici PG,Crea F,et al.Guidelines on the management of stable angina pectoris:executive summary:the task force on the management of stable angina pectoris of the European Society of Cardiology.Eur Heart J 2006;27:1341-1381.
26.Thanigaraj S,Nease RF Jr.,Schechtman KB,Wade RL,Loslo S,Perez JE.Use of contrast for image enhancement during stress echocardiography is cost-effective and reduces additional diagnostic testing.Am J Cardiol 2001;87:1430-1432.
27.Huqi A,He A,Klas B,Paterson I,Thompson R,Irwin M,et al.Myocardial deformation analysis in contrast echocardiography:first results using two-dimensional cardiac performance analysis.J Am Soc Echocardiogr 2013;26:1282-1289.
28.Shah BN,Chahal NS,Bhattacharyya S,Li W,Roussin I,Khattar RS,et al.The feasibility and clinical utility of myocardial contrast echocardiography in clinical practice:results from the incorporation of myocardial perfusion assessment into clinical testing with stress echocardiography study.J Am Soc Echocardiogr 2014;27:520-530.
2.Lozano R,Naghavi M,Foreman K,Lim S,Shibuya K,Aboyans V,et al.Global and regional mortality from 235causes of death for 20 age groups in 1990 and 2010:a systematic analysis for the Global Burden of Disease Study2010.The Lancet 2012;380:2095-2128.
3.Serruys PW,Unger F,Sousa F.Comparison of coronaryartery bypass surgery and stenting for the treatment of multivessel disease.ACC Curr J Rev 2001;10:85.
4.Holubkov R,Laskey WK,Haviland A,Slater JC,Bourassa MG,Vlachos HA,et al.Angina 1 year after percutaneous coronary intervention:a report from the NHLBI Dynamic Registry.Am Heart J 2002;144:826-833.
5.Thadani U.Current medical management of chronic stable angina.J Cardiovasc Pharmacol Ther 2004;9:S11.
6.Kones R.Recent advances in the management of chronic stable anginaⅡ.Anti-ischemic therapy,options for refractory angina,risk factor reduction,and revascularization.Vasc Health Risk Manag 2010;6:749-774.
7.Qiu Y,Xu H,Shi D.Traditional Chinese herbal products for coronary heart disease:an overview of cochrane reviews.Evid-Based Complement Alternat Med 2012;2012:417387.
8.Mao S,Wang L,Ouyang W,Zhou Y,Qi J,Guo L,et al.Traditional Chinese medicine,Danlou Tablets alleviate adverse left ventricular remodeling after myocardial infarction:results of a double-blind,randomized,placebo-controlled,pilot study.BMC Complement Altern Med 2016;16:447.
9.Yu L,Qin Y,Wang Q,Zhang L,Liu Y,Wang T,et al.The efficacy and safety of Chinese herbal medicine,Rhodiola formulation in treating ischemic heart disease:a systematic review and meta-analysis of randomized controlled trials.Complement Ther Med 2014;22:814-825.
10.Mao S,Wang L,Zhao X,Shang H,Zhang M,Hinek A.Sodium tanshinoneⅡA sulfonate for reduction of periprocedural myocardial injury during percutaneous coronary intervention(STAMP trial):rationale and design.Int J Cardiol 2015;182:329-333.
11.Ruan X,Jiang W,Lin Y.Clinical efficacy of treatment for regulating Pi and protecting Xin in treating patients after coronary artery bypass grafting and its effect on patients'quality of life.Chin J Integr Tradit West Med(Chin)2006;26:28-32.
12.Wu H,Xu D,Luo W.Retrospective cohort study on the improvement of the prognosis of patients after coronary artery bypass grafting operation treated by the method for regulating Pi(Spleen)and protecting Xin(Heart).Jilin JTradit Chin Med(Chin)2009;29:27-29.
13.Xu D,Wu H,Lan T,Wang X,Sheng X,Lin Y,et al.Effect of Shenzhu Guanxin Recipe on patients with angina pectoris after percutaneous coronary intervention:a prospective,randomized control ed trial.Chin J Integr Med 2015;21:408-416.
14.Xu D,Wang X,Sheng X,Lin Y,Li S,Zheng C.Doubleblind,randomized,controlled clinical trial of Shenzhu Guanxin Prescription for treatment of stable angina due to cronary heart disease.J Guangzhou Univ Tradit Chin Med(Chin)2014;31:173-182.
15.Xu D,Wu H.Effect of Shenshu Guanxin Granules on coronary circulation in rats with myocardial infarction.Chin J Pathophysiol(Chin)2014;30:438-443.
16.Fraker TD,Fihn SD,Members WC,Gibbons RJ,Abrams J,Chatterjee K,et al.2007 chronic angina focused update of the ACC/AHA 2002 guidelines for the management of patients with chronic stable angina.J Am Col Cardiol 2007;50:2264-2274.
17.Chen KJ.Blood stasis syndrome and its treatment with activating blood circulation to remove blood stasis therapy.Chin J Integr Med 2012;18:891-896.
18.Thygesen K,Alpert JS,Jaffe AS,Simoons ML,Chaitman BR,White HD,et al.Third universal definition of myocardial infarction.J Am Coll Cardiol 2012;60:2264-2274.
19.Spertus JA,Winder JA,Dewhurst TA,Deyo RA,Prodzinski J,Mc Donell M,et al.Development and evaluation of the Seattle Angina Questionnaire:a new functional status measure for coronary artery disease.J Am Coll Cardiol 1995;25:333-341.
20.Gibbons RJ,Balady GJ,Bricker JT,Chaitman BR,Fletcher GF,Froelicher VF,et al.ACC/AHA 2002 guideline update for exercise testing:summary article:a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines(committee to update the 1997 exercise testing guidelines).J Am Coll Cardiol 2002;40:1531-1540.
21.Munzel T,Meinertz T,Tebbe U,Schneider HT,Stalleicken D,Wargenau M,et al.Efficacy of the long-acting nitro vasodilator pentaerithrityl tetranitrate in patients with chronic stable angina pectoris receiving anti-anginal background therapy with beta-blockers:a 12-week,randomized,doubleblind,placebo-controlled trial.Eur Heart J 2014;35:895-903.
22.McInnis KJ,Balady GJ,Weiner DA,Ryan TJ.Comparison of ischemic and physiologic responses during exercise tests in men using the standard and modified Bruce protocols.Am J Cardiol 1992;69:84-89.
23.Kume T,Akasaka T,Kawamoto T,Yoshitani H,Watanabe N,Neishi Y,et al.Assessment of coronary microcirculation in patients with takotsubo-like left ventricular dysfunction.Circ J 2005;69:934-939.
24.Gaibazzi N,Rigo F,Lorenzoni V,Molinaro S,Bartolomucci F,Reverberi C,et al.Comparative prediction of cardiac events by wall motion,wall motion plus coronary flow reserve,or myocardial perfusion analysis:a multicenter study of contrast stress echocardiography.JACC Cardiovasc Imag 2013;6:1-12.
25.Fox K,Garcia MA,Ardissino D,Buszman P,Camici PG,Crea F,et al.Guidelines on the management of stable angina pectoris:executive summary:the task force on the management of stable angina pectoris of the European Society of Cardiology.Eur Heart J 2006;27:1341-1381.
26.Thanigaraj S,Nease RF Jr.,Schechtman KB,Wade RL,Loslo S,Perez JE.Use of contrast for image enhancement during stress echocardiography is cost-effective and reduces additional diagnostic testing.Am J Cardiol 2001;87:1430-1432.
27.Huqi A,He A,Klas B,Paterson I,Thompson R,Irwin M,et al.Myocardial deformation analysis in contrast echocardiography:first results using two-dimensional cardiac performance analysis.J Am Soc Echocardiogr 2013;26:1282-1289.
28.Shah BN,Chahal NS,Bhattacharyya S,Li W,Roussin I,Khattar RS,et al.The feasibility and clinical utility of myocardial contrast echocardiography in clinical practice:results from the incorporation of myocardial perfusion assessment into clinical testing with stress echocardiography study.J Am Soc Echocardiogr 2014;27:520-530.
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