| Traditional Chinese Medicine (TCM) is one of the more effective methods in the prevention and treatment of hypertension. Not only is it effective in regulating blood pressure, it significantly alleviates clinical symptoms and prevents the onset of future complications. TCM decoctions are often thought to be the most ideal form of TCM. However, due to the fact that hypertension is a chronic medical condition, and often require long periods of medicating, using tradition decocting pieces to prepare the decoctions may prove impractical. Thus, the usage of TCM formulated granules, as an alternative to traditional herbal decocting pieces, are becoming increasingly common. Whether there is significant difference between the effectiveness of formulated granules and decocting pieces has always been a point of controversy. While most literature proves that fomulated granules of a certain formulae is effective or equally effective compared to its decoction counterpart, there are still evidence that shows otherwise. This experiment was based on syndrome type differentiation using TCM, and designed to compare the difference, in terms of clinical effectiveness, between treating hypertension with TCM formulated granules and decocting pieces.Objective:To compare the clinical effectiveness of TCM formulated granules and traditional herbal decocting pieces in the treatment of stage1-2primary hypertension, in order to prove that TCM formulated granules are not inferior in terms of effectiveness compared to traditional herbal decocting pieces.Methodology:A multicenter randomized trial of non-inferiority was performed, with traditional herbal decocting pieces as the control.227patients from9medicinal clinical trial organizations including Xiyuan Hospital, China Academy of Traditional Chinese Medicine, were selected to participate in the experiment, their age ranging from18-65years old. The diagnosis of the participating patients in terms of conventional western medicine is:stage1-2primary hypertension, with the additional criteria of having a TCM syndrome type of "Ascendant hyperactivity of liver yang" or "Deficiency of the heart and liver". Patients in the experimental group were treated with TCM formulated granules for a period of4weeks; patients in the control group were treated with traditional herbal decocting pieces manufactured from the same batch and quality of Traditional Chinese Medicine as the TCM formulated granules for4weeks. Observations were made with regards to the clinical effectiveness of both groups, the results compared using the following set of criteria:Blood pressure (systolic blood pressure, diastolic blood pressure, mean difference of blood pressure before and after treatment, percentage of patients who reached the target blood pressure, distribution of patients for different stages of hypertension. Symptoms-difference of TCM symptom scores, therapeutic index of TCM symptom scores and therapeutic level. Data management was done using Epidata3.0, and the collected data was analysed with SAS.Results:A total of227patients were selected to participate in the trial,2patients were eliminated from the trial,24exprematurely,201patients completed the trail, with99patients in the experimental group and102patients in the control group.1. Differences in blood pressure:In the experimental group, the mean difference of the patients’systolic blood pressure is14.06±12.52mmHg, the mean difference of the patients’ diastolic blood pressure is7.28±8.55mmHg; in the control group, the mean difference of the patients’ systolic blood pressure is13.14±13.04mmHg, the mean difference of the patients’ diastolic blood pressure is8.24±7.63mmHg, there is significant difference between the two groups for the non inferiority test(P<0.05).2. Percentage of patients who reached the target blood pressure:In the experimental group, there were85patients whose blood pressure reached the target blood pressure, with a percentage of80.19%; in the control group, there were75patients whose blood pressure reached the target blood pressure, with a percentage of75.00%, there is significant difference between the two groups for the non inferiority test(P<0.05).3. Distribution of patients for different stages of hypertension:In the experimental group, there were22patients whose blood pressure returned to normal,71patients with borderline hypertension,21patients with Level1Hypertension,0patient with Level2Hypertension,1patient with Level3Hypertension. In the control group, there were18patients whose blood pressure returned to normal,66patients with borderline blood pressure,25patients with Level1Hypertension,1patient with Level2Hypertension, and0patient with Level3Hypertension. There is no significant difference between the two groups (P>0.05).4. Difference between symptom scores:The difference between symptom scores for the experimental group is11.38±8.65, while that of the control group is10.12±8.08, there is no significant difference between the two groups(P=0.29).5. Therapeutic Level:The rate of effectiveness for the experimental group is65.22%, with the rate of significant effectiveness at23.48%, rate of moderate effectiveness at36.52%, rate of full recovery at5.22%, rate of non-effectiveness at34.78%. The rate of effectiveness for the control group is65.45%, with the rate of significant effectiveness at21.82%, rate of moderate effectiveness at37.27%, rate of full recovery at6.36%, rate of non-effectiveness at34.55%, there is no significant difference between the two groups(P=0.98).Conclusion:The rate of effectiveness for treating Level1-2hypertension, syndrome type:hyperactivity of liver yang or deficiency of heart and liver, is similar for TCM formulated granules and Traditional herbal decocting pieces with regards to lowering blood pressure and alleviation of symptoms. Moreover, TCM granulated granules are more convenient for patients with hypertension to prepare for the long term, hence an effective alternative for patients unable to prepare traditional decoctions. |
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