Association Between Traditional Chinese Medicine and Medication Adherence in Hypertensive Patients in Mainland China: A Real-World Population-Based Cohort Study

doi:10.21203/rs.3.rs-3135231/v1

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Association Between Traditional Chinese Medicine and Medication Adherence in Hypertensive Patients in Mainland China: A Real-World Population-Based Cohort Study

https://doi.org/10.21203/rs.3.rs-3135231/v1

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Background: Hypertension and associated CVD are the major public health challenges in China. Medication adherence is the cornerstone for achieving hypertension control and reduce the risk of CVD and mortality. Considering that more and more people have turned on complementary and alternative medicine(CAM) , combined with pharmacotherapy for treating hypertension, including Traditional Chinese Medicine(TCM).However, the relationship between medication adherence and TCM usage remains unknown. This study aimed to assess the association between non-pharmacological therapies of TCM and adherence to anti-hypertensive medication in mainland China.

Methods: Data was extracted from the electronic health records of a Chinese medical hospital. A retrospective cohort study was conducted on hypertension patients enrolled between January 2016 and April 2021. Propensity score matching (PSM) was employed, resulting in 1179 patients in the TCM user group and 257 patients in the no TCM user group. Medication possession ratios (MPR) were used to measure medication adherence in the presence or absence of TCM. Generalized estimating equations (GEE) were applied to identify factors associated with adherence, including TCM exposure, age and sex.

Results: Medication compliance in the real world was generally low, at approximately 10%. The percentage of TCM exposure among differed significantly between the two groups throughout the follow-up period. The proportions of optimal adherence (MPR≥ 80) and continuous treatment rate showed no significant difference. GEE regression results indicated that TCM visits could improve medication adherence to anti-hypertensive drugs. Subgroup analysis revealed that TCM use had a positive impact on optimal adherence for male patients and patients aged 60 years and above (p<0.05). Conversely, there was no association between TCM use and MPR in female patients.

Conclusions: Notably, medication compliance was higher among TCM users compared to no TCM users. TCM exposure appeared to have a positive effect on medication adherence in hypertensive patients, suggesting its potential as a complementary approach to conventional Western drug therapy. This study provides important insights for integrating Chinese and Western medicine to enhance adherence to anti-hypertensive medications.

Hypertension

Medication possession ratios

Medication adherence

Generalized estimating equations

Traditional Chinese Medicine

Non-pharmacological therapies

Hypertension is a significant health concern in mainland China, with over 245 million patients and a continuously increasing number and prevalence rate[1]. It is estimated that the number of hypertensive patients in China will reach 352 million by 2030[2]. High systolic blood pressure and hypertension are widely recognized as major risk factors for cardiovascular disease (CVD), leading to over 25 million disability adjusted life years attributed to stroke. The economic burden of CVD in China amounts to 540.638-billion-yuan, accounting for 17.47% of the total cost of all diseases[3]. To reduce the CVD burden on Chinese population, it is imperative to prioritize public health initiatives focusing on the prevention and treatment of hypertension, aiming to reduce its prevalence and increase awareness, treatment, and control[4].

The current treatment for hypertension involves various classes of anti-hypertensive drugs, such as angiotensin-converting-enzyme (ACE) inhibitors, angiotensin receptor antagonists (ARB), β-blockers, calcium channel blockers (CCB), and diuretics[5]. However, pharmacotherapy can be associated with potential adverse events, including hepatic and renal dysfunction, and may have deficiencies in the treatment process. The effectiveness of medications in controlling high blood pressure (HBP) has been unsatisfactory. A study involving 50,171 subjects revealed a hypertension prevalence of 29.6% in China, with a control rate of only 27.4% among participants receiving treatment[6]. Poor adherence to pharmacotherapy posed a significant challenge, as nearly 50% of treated patients discontinue medication within one year[7, 8]. Inadequate adherence to treatment medication is a key factor contributing to uncontrolled blood pressure[9]. In reality, approximately 75% of hypertensive patients fail to achieve optimal blood pressure control due to poor medical adherence[10]. The substantial number of patients and the inadequate management of hypertension result in severe complications, placing a heavy burden on China's healthcare system[11].

Medication adherence refers to the extent to which patients adhere to the prescribed treatment regimens agreed upon with their physicians[12]. The World Health Organization (WHO) classifies barriers and factors related to medication non-adherence into categories such as patient characteristics, sociodemographic factors, the healthcare system, therapy, and condition-related factors[13]. The chronic nature of the disease and the long-term use of medications are significant contributors to poor adherence among patients with hypertension. Extensive evidence indicates that continuous treatment is associated with a reduced risk of CVD compared to treatment discontinuation[14]. Consequently, there is growing interest in holistic interventions that combine complementary and alternative medicine (CAM) to enhance health maintenance and outcomes for essential hypertension patients.

Traditional Chinese medicine (TCM), a form of CAM that includes Chinese herbs, acupuncture, tuina (Chinese therapeutic massage), and other modalities, has been suggested as a potential adjuvant therapy for various conditions, including hypertension [15]. Acupuncture, an integral part of TCM, has demonstrated blood pressure-lowering effects in numerous clinical trials[16–19]. Non-pharmacological TCM interventions, such as acupuncture and tuina, have shown positive effects as adjuvant treatments for hypertension, reducing pain and improving the quality of life for patients[20–22].Moreover, these interventions have advantages such as minimal side effects, low cost, and high patient acceptance[23, 24]. Despite this, the relationship between medical adherence and the use of TCM has not been thoroughly studied, with only a few studies suggesting a potential improvement in medication adherence for hormonal therapy with TCM use[25]. Accordingly, the aim of this study is to investigate the association between TCM exposure with medication MPR for hypertension patients in China.

Data collection

Data for this research was obtained from the hospital information system (HIS) of Nanjing hospital of Chinese Medicine, a prominent tertiary-grade level-A traditional Chinese Medicine hospital with 1500 regular hospital beds. A total of 4474 hypertension patients who fulfilled the inclusion criteria were included in the study, covering the period from January 2016 to April 2021. Institutional Review Board (IRB) of Nanjing hospital of Chinese Medicine approved the waiver of informed consent due to the use of thoroughly deidentified data, ensuring no direct or indirect link to individual participants. No minors were included in this study, and all protocols strictly adhered to ethical standards, particularly those outlined in the Declaration of Helsinki. We remain committed to the utmost ethical research practices and data transparency. The Research Ethics Committee of Nanjing Hospital of Chinese Medicine approved this study (approval number KY2021091).

Research subjects

Figure 1 displays the patients included in this study. The inclusion criteria were as follows: 1) adult patients (aged > 18 years) diagnosed with primary hypertension during the research period; 2) patients with complete personal information and electronic medical records; and 3) patients receiving clinical treatments and having regular prescription records. Patients were excluded if they met any of the following criteria: 1) absence of hypertension diagnosis records; 2) missing data regarding patients' characteristics or clinical information; 3) no records of hypertension prescriptions; and 4) patients with valvar heart disease, secondary hypertension, or other severe chronic illnesses such as cancer or hepatic diseases. Ultimately, a total of 4474 patients were enrolled in the study from January 2016 to April 2021.

TCM exposure

In our research, the TCM modalities referred to non-pharmacological therapies, primarily including acupuncture, acupressure, moxibustion, and massage. These modalities were used as part of the treatment approach, focusing on their therapeutic effects for hypertension patients.

Study designs

A retrospective cohort study was conducted on all enrolled patients from January 2016 to April 2021. Among these patients, 3125 individuals received combined treatment of chemical drugs and TCM modalities, while 1349 patients solely received chemical drugs. The enrollment time for patients in the study was determined as the time they experienced their first TCM event during the research period, provided that they had received chemo-drug therapy within the previous year and the following year. These patients were classified as TCM user patients. Similarly, eligible patients who did not use TCM were identified using the same criteria. Ultimately, there were 1757 patients in the TCM user group and 288 patients in the no TCM user group.

To account for potential confounding factors in patient characteristics that could influence treatment effects, propensity score matching (PSM) method was employed. Patients in a ratio of 5:1 were matched using PSM, aiming to address any potential imbalances between the two groups. The matched patient cohort included 1179 patients in the TCM user group (experimental group) and 257 patients in the no TCM user group (control group). Furthermore, within the TCM exposure group, further subdivisions were made based on the specific TCM modalities used, specifically acupuncture therapy and massage therapy.

Outcome assessment

The primary endpoints of this study focused on evaluating medication adherence to anti-hypertensive drugs. Medication possession ratios (MPR) were utilized to measure adherence, calculated as the number of days' supply of medication per year divided by the number of days the patient participated in follow-up during the study period. To assess medication adherence, MPR was determined every three months, resulting in quarterly MPR values. Non-adherence was defined as an MPR < 80%, while adherence was categorized as an MPR ≥ 80%. Additionally, the proportion of patients with an MPR ≥ 80% was analyzed at the 3rd, 6th, 9th, and 12th months during the follow-up period.

The secondary outcome analyzed in this study was the continuous treatment rate, which measured the proportion of patients who received anti-hypertensive medication treatment at the 3rd, 6th, 9th, and 12th months in relation to the total number of patients enrolled during the follow-up period. This outcome aimed to assess the rate of consistent and ongoing treatment among the study participants.

Statistical analysis

In the study, categorical variables were presented as numbers (percentages) and compared between groups using the Chi-square test. Propensity score matching (PSM) was employed to match hypertension patients using chemotherapy combined with TCM to those only using chemotherapy, in a ratio of 5:1. For each patient, a propensity score was estimated using a logistic regression model, with the use of anti-hypertensive drugs in the TCM group or the no TCM group as the dependent variable. Potential confounders, including age, sex, comorbidity, and the number and class of anti-hypertensive drugs at baseline, were controlled as covariates. Standardized mean differences were utilized to assess the balance in covariates between the two groups after matching, and a standardized difference of < 0.1 indicated an adequate match.

Since the primary outcomes and TCM usage varied over time, generalized estimating equations (GEE) were employed to estimate the association between medication adherence to anti-hypertensive drugs and TCM usage. GEE models accounted for the correlation between repeated measurements within the same subject. These models can be fitted even when data are incomplete or individuals lack observations at all time points. Two sets of models were performed: unadjusted and adjusted for age and sex.

To assess if the intervention effect differed statistically among subgroups, several subgroup analyses were conducted based on age (≤ 60 years old, > 60 years old), sex (male, female), and comorbidities (diabetes yes, diabetes no; chronic kidney disease (CKD) yes, CKD no).

Sensitivity analyses were conducted by changing the time interval to 60 days and 120 days to examine the effect of TCM exposure on the proportion of patients achieving medication adherence.

All statistical tests were two-sided, and statistical significance was set at p < 0.05. The statistical analysis and propensity score matching were performed using R version 4.2.1 (R Foundation, Vienna, Austria)

Clinical characteristics of patients

Table 1 presented the clinical characteristics of hypertension patients in both the original and matched cohorts during the period of January 2016 to April 2021. In the matched cohort, the baseline covariates between the two groups were adequately matched, as indicated by small standardized differences in sex, comorbidity, and numbers of anti-hypertensive drugs at baseline(all p > 0.05).

Compared TCM users with no TCM users younger than 60, it was observed that percentage of patients using diuretics was higher in the no TCM user group,while the percentage of patients using CCB was higher in the TCM user group.

Table 1

Clinical characteristics by groups in the original and propensity score matched (PSM) cohort
	Original cohort			Matched cohort (1:5 ratio)
	No TCM users (n = 288)	TCM users (n = 1757)	P	No TCM users (n = 257)	TCM users (n = 1179)	P
Men, n(%)	157(54.5)	886(50.4)	0.222	139(54.1)	620(52.6)	0.714
Age, n(%)
< 60	43(14.9)	12(0.7)	< 0.001	12(4.7)	12(1.0)	< 0.001
≥ 60	245(85.1)	1745(99.3)		245(95.3)	1167(99.0)
Comorbidity, n(%)
MI	1(0.3)	24(1.4)	0.242	1(0.4)	10(0.8)	0.711
Apoplexy	0(0.0)	10(0.6)	0.408	0(0.0)	3(0.3)	0.956
Diabetes	83(28.8)	674(38.4)	0.002	73(28.4)	341(28.9)	0.928
CKD	13(4.5)	238(13.5)	< 0.001	13(5.1)	77(6.5)	0.459
Class of anti-hypertensive medication, n(%)
ACEI	57(19.8)	423(24.1)	0.130	48(18.7)	189(16.0)	0.346
ARB	186(64.6)	996(56.7)	0.014	159(61.9)	606(51.4)	0.003
CCB	182(63.2)	1282(73.0)	0.001	163(63.4)	782(66.3)	0.414
α-blocker	5(1.7)	156(8.9)	< 0.001	4(1.6)	38(3.2)	0.218
β-blocker	91(31.6)	608(34.6)	0.352	79(30.7)	293(24.9)	0.061
Diuretics	25(8.7)	557(31.7)	< 0.001	19(7.4)	255(21.6)	< 0.001
Others	37(12.8)	509(29.0)	< 0.001	33(12.8)	192(16.3)	0.200
Numbers of antihypertensive medications, n(%)
1 medication	106(36.8)	453(25.8)	< 0.001	99(38.5)	441(37.4)	0.998
2 medications	106(36.8)	495(28.2)		96(37.4)	432(36.6)
≥ 3 medications	76(26.4)	809(46.0)		62(24.1)	306(26.0)

MI Miocardial infarction, CKD Chronic kidney disease, CCB Calcium channel blocker,

ACEI Angiotensin converting enzyme inhibitor, ARB Angiotensin receptor blocker

Influence of TCM on MPR to anti-hypertensive drugs

Figure 2a illustrates an increasing trend in medication possession ratio (MPR) to anti-hypertensive drugs in the TCM group. Starting from the sixth month, the MPR in the TCM group was higher than that in the no TCM group, with median MPR values of 62.22%, 64.44%, and 64.44% for the 9th, 12th, and 21st month, respectively. On the other hand, the no TCM group had median MPR values of 45.56%, 33.33%, and 41.11% for the 9th, 12th, and 21st month, respectively. Over time, the median MPR to anti-hypertensive drugs in the TCM group showed an upward trend, while the no TCM group showed a downward trend. There was a statistically significant difference between the two groups (p < 0.001).

In terms of optimal medication adherence (MPR ≥ 80%) to anti-hypertensive drugs (see Fig. 2b), TCM visits significantly increased the proportion of patients with optimal adherence, with 30.5% in the TCM user group compared to 15.7% in the no TCM user group in the first trimester. However, no statistical difference in the percentage of optimal adherence was observed between the two groups in the long term (from the 6th month onwards, p = 0.885). This suggests that TCM usage had short-term effects on medication adherence but not long-term effects.

The continuous treatment rate of the two groups (see Fig. 2c) showed that in the 3rd month, 41.2% of TCM users adhered to taking medications, but this proportion sharply declined to 13.7% in the 6th month. In the long term, there was no statistical difference between TCM visits and no TCM visits in terms of the percentage of patients who consistently took their anti-hypertensive drugs (p = 0.555). The proportion of patients adhering to medication was only 8.7% in the TCM user group and 12.9% in the TCM non-user group. This indicates that overall compliance among hypertensive patients was low, at around 10%, in the real world.

Multivariate Analysis of medication adherence in hypertension patients

The GEE regression analysis indicated that TCM user group had a higher proportion of optimal medication adherence (MPR ≥ 80%) compared to the no TCM user group, with an odds ratio (OR) of 1.453 (95% CI: 1.113–1.897, p = 0.006). The analysis also revealed a positive relationship between the proportion of optimal medication adherence and TCM visits. More TCM visits were associated with better improvement in medication adherence.

Regarding TCM type, acupuncture users had significantly higher optimal medication adherence compared to those who did not use TCM (p < 0.05). However, there was no significant difference in the percentage of optimal medication adherence between message visits and no visits over time. After adjusting for time-varying variables such as age and sex, the data supported the notion that TCM visits could improve medication adherence to anti-hypertensive drugs (see Fig. 3).

In Fig. 4, the subgroup analysis showed that within the subgroup of patients aged ≥ 60 years, optimal adherence was significantly associated with TCM exposure (CI: 1.100-1.893, p = 0.008). However, for patients < 60 years, there was no significant association with optimal adherence (CI: 0.322–6.515, p = 0.629). When stratifying by gender, there was no significant association between TCM visits and optimal adherence in female patients. However, male patients who used TCM had 1.655 times higher odds of optimal adherence compared to non-users (p = 0.005). In the stratified analyses of patients with comorbidities, the data showed that the TCM user group had a significant improvement in medication compliance for patients with diabetes and without diabetes, as well as for patients with CKD and without CKD.

Sensitivity analysis

After adjusting the time interval to 60 days and 120 days during the follow-up period, the association between TCM exposure and medication adherence remained positive (see Additional file 1). Additionally, higher TCM visits were associated with a higher proportion of optimal medication adherence. However, it was observed that the short-time interval TCM user group had a stronger association with optimal medication adherence compared to the long-time interval group. This suggests that frequent TCM visits within shorter intervals may have a more pronounced effect on improving medication adherence.

This study presents a retrospective analysis based on real-world data from a Chinese medicine hospital to investigate the association between non-pharmacological interventions and medication adherence in hypertension patients. The large-scale, long-term nature of our study, coupled with the utilization of the GEE analysis model, allowed for robust findings. Notably, a significant proportion of hypertension patients enrolled in our study incorporated non-pharmacological interventions as part of their hypertension control strategies.The utilization of TCM varied among patients due to cultural norms and the unique healthcare setting of the Chinese medicine hospital, which provided both TCM and Western medicine services. TCM services are deeply rooted in Chinese cultural heritage and are an essential component of the hospital's offerings[26, 27]. Moreover, TCM is an important part of Chinese healthy policy of “intergration of Chinese and western medicine” [26].

Our findings revealed a positive effect of TCM exposure on improving medication compliance in hypertension patients. This observation aligns with previous studies that reported no significant relationship between CAM use and medication non-adherence[28, 29].Age, sex, and education are recognized factors influencing adherence in hypertensive patients, while comorbidity has shown a lesser impact[30–33]. To account for these factors, we included age and sex as independent variables in our GEE model, confirming the consistency of our results. Importantly, we observed a direct association between TCM visits and the percentage of optimal medication adherence (defined as Medication Possession Rate ≥ 80%) during the follow-up period. However, this dose-dependent effect was not evident when the number of visits was less than six.

Further exploration of specific non-pharmacological therapies within TCM revealed that acupuncture exhibited a significant positive association with higher rates of optimal medication adherence, while the effect of massage was not statistically significant. Prior research has demonstrated the efficacy of acupuncture and massage, in conjunction with medication, in reducing systolic and diastolic blood pressure in hypertensive patients[18, 34]. These therapies have been recognized as viable complementary approaches for cardiovascular diseases, including hypertension and coronary artery disease(CAD)[35]. However, the relationship between non-pharmacological therapies and medication compliance has received limited attention in the literature. A study showed that acupuncture could alleviate the pain of breast cancer women although a large between-group difference was not detected. But, the improvements were clinically important for keeping women on their breast cancer drugs[36]. Another research also supported the potential advantage of TCM on breast cancer-associated mortality, whereas TCM use did not compromise medical adherence to HT[25]. Our study bridges this gap by showcasing the positive association between acupuncture exposure and optimal compliance, thereby highlighting the potential benefits of TCM interventions in improving medication adherence.

The observed association between TCM non-pharmacological therapy and medication adherence may be attributed, in part, to improved communication between physicians and patients during these interventions. In generally, patients’ evaluation of the degree and quality of education and/or guidance they received at the initial consultation was only 50% of what physicians considered they had provided[37]. TCM therapies offer opportunities for enhanced education and guidance on hypertension management, which likely contributes to better adherence. Moreover, the significance of patient-physician trust in medication adherence has been well-documented. Establishing trust fosters a therapeutic relationship characterized by effective communication and the addressing of patient concerns, leading to improved compliance[38–40]. Notably, trust in the physician has been identified as the strongest predictor of adherence to conventional therapy.

It is worth noting that adherence to conventional Western hypertensive medications declined over time, suggesting a short-term effect of acupuncture on adherence. Patients’ motivation decreased and they increasingly withdrew from following medical recommendations[30]. This observation aligns with previous clinical trials, which have demonstrated short-term reductions in blood pressure following acupuncture sessions, typically within hours or days[24].

When considering variables associated with TCM use, we identified gender differences among patients. TCM visits did not yield a statistically significant between-group difference in medication adherence among women, whereas a significant difference was observed among male patients. This finding may be attributed to the higher level of health acceptance exhibited by men compared to women, leading to greater compliance in maintaining target blood pressure values through continued communication during TCM follow-up visits[30].

Strength and limitations

While our study provides significant insights, certain limitations must be acknowledged. Firstly, the retrospective study design introduces the possibility of unmeasured confounding factors, such as income, education, disease severity, and other health behaviors like smoking, diet, and physical activity, which may introduce bias. Secondly, due to data limitations, we were unable to analyze the impact of different types of hypertensive drugs or patient medication structures on compliance. Both of these variables are known to influence patients' adherence. Therefore, the temporal relationship between improved medication adherence and TCM use cannot be fully established. Thirdly, the data were collected from a single hospital, and it is possible that patients also purchased anti-hypertensive drugs and received non-pharmacological therapies from other healthcare institutions. Furthermore, medication adherence was evaluated using the medication possession rate, which may not reflect actual medication compliance. As a result, a direct causal inference between TCM use and medication possession rate cannot be established.

Despite these limitations, our study contributes valuable insights by evaluating the effect of non-pharmacological interventions on medication adherence in hypertension patients using real-world data from a Chinese medicine hospital. The finding that TCM use may be associated with improved adherence is thought-provoking and suggests that healthcare practitioners should consider and acknowledge TCM use, thereby enhancing the therapeutic relationship in the management of chronic diseases[41].

The utilization of non-pharmacological therapies within TCM is highly prevalent among hypertensive patients. These therapies have the potential to provide valuable benefits and can serve as a complementary approach alongside conventional Western drug therapy in the management of hypertension. Future research should aim to confirm the association between TCM non-pharmacological therapies and medication adherence over an extended period of time. Additionally, investigating the factors influencing the utilization of TCM therapies is warranted. The findings of this study have significant implications for the “integration of Chinese and Western medicine” approach, highlighting its potential in improving adherence to anti-hypertensive medications.

TCM:Traditional Chinese Medicine; MPR:Medication possession ratios; CVD: Cardiovascular disease; CKD: Chronic kidney disease; CAD: Coronary artery disease; MI: Miocardial infarction; ACE: Angiotensin converting enzyme inhibitor; ARB:Angiotensin receptor blocker; CCB:Calcium channel blockers; HBP:High Blood Pressure; WHO:World Health Organization; CAM: Complementary and alternative medicine; HIS: Hospital information system; PSM: Propensity score matching; GEE:Generalized estimating equations; CI: confidence interval;OR:Odd Ratios.

Acknowledgements

We sincerely thank Nanjing Hospital of Chinese Medicine for providing data for this research. All authors approved the final version of the manuscript.

Authors' contributions

Jifang Zhou, Ning Gu and Aixia Ma contributed to design of the study. Yuqing Bao, Ruijian Huang, Desong Kong and Lili Shang were responsible for the data collection and data analysis. Lili Shang and Yan Cheng contributed to the interpretation of analysis. Lili Shang wrote the first draft. Jifang Zhou and Aixia Ma contributed to revise the manuscript. All authors read and approved the final manuscript.

Funding

Not applicable.

Availability of data and materials

The data that support the findings of this study are available from the corresponding author on reasonable request.

Ethics approval and consent to participate

This study was approved by the Research Ethics Committee of Nanjing Hospital of Chinese Medicine (approval number KY2021091). All methods were carried out in accordance with STROBE guidelines and regulations.

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests.

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Association Between Traditional Chinese Medicine and Medication Adherence in Hypertensive Patients in Mainland China: A Real-World Population-Based Cohort Study

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Background

Methods

Data collection

Research subjects

TCM exposure

Study designs

Outcome assessment

Statistical analysis

Results

Clinical characteristics of patients

Influence of TCM on MPR to anti-hypertensive drugs

Multivariate Analysis of medication adherence in hypertension patients

Sensitivity analysis

Discussion

Strength and limitations

Conclusion

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