coronary heart disease
This systematic review/network meta-analysis assessed whether relaxation and stress management techniques are useful in reducing blood pressure in individuals with hypertension and prehypertension. The authors retrieved all studies published in English of adults with hypertension (blood pressure ≥140/90 mm Hg) or prehypertension (blood pressure ≥120/80 mm Hg but <140/90 mm Hg). Studies were considered that compared non- pharmacological interventions used to promote relaxation or reduce stress with each other, or with a control group (eg, no intervention, waiting list, or standard care). Studies were assessed with the risk of bias 2 tool (RoB2), and those at high risk of bias were excluded from the primary analysis. The certainty of the evidence was assessed with CINeMA (Confidence in Network Meta- Analysis).
A total of 182 studies were included (166 for hypertension and 16 for prehypertension). Results from a random effects network meta-analysis showed that, at short term follow- up (≤3 months), most relaxation interventions appeared to have a beneficial effect on systolic and diastolic blood pressure for individuals with hypertension. Between study heterogeneity was moderate (τ=2.62- 4.73). Compared with a passive comparator (ie, no intervention, waiting list, or usual care), moderate reductions in systolic blood pressure were found for breathing control (mean difference −6.65 mm Hg, 95% credible interval −10.39 to −2.93), meditation (mean difference −7.71 mm Hg, −14.07 to −1.29), meditative movement (including tai chi and yoga, mean difference −9.58 mm Hg, −12.95 to −6.17), mindfulness (mean difference −9.90 mm Hg, −16.44 to −3.53), music (mean difference −6.61 mm Hg, −11.62 to −1.56), progressive muscle relaxation (mean difference −7.46 mm Hg, −12.15 to −2.96), psychotherapy (mean difference −9.83 mm Hg, −16.24 to −3.43), and multicomponent interventions (mean difference −6.78 mm Hg, −11.59 to −1.99). Reductions were also seen in diastolic blood pressure. Few studies conducted follow-up for more than three months, but effects on blood pressure seemed to lessen over time. Limited data were available for prehypertension; only two studies compared short term follow- up of relaxation therapies with a passive comparator, and the effects on systolic blood pressure were small (mean difference −3.84 mm Hg, 95% credible interval −6.25 to −1.43 for meditative movement; mean difference −0.53 mm Hg, −2.03 to 0.97 for multicomponent intervention). The certainty of the evidence was considered to be very low based on the CINeMA framework, owing to the risk of bias in the primary studies, potential publication bias, and imprecision in the effect estimates.
The authors concluded that the results of our study indicated that many relaxation interventions show promise for reducing blood pressure in the short term but the longer term effects are unclear. Future studies in this area should include adequate follow-up to establish whether the effects on blood pressure persist over time, both while the relaxation interventions are ongoing and after they have been completed. Researchers should also use rigorous study methods and reporting to minimise the risk of bias in the results. Finally, we encourage researchers to assess all relevant outcomes, including cardiovascular events and adverse events, as well as blood pressure itself.
I was asked to provide a comment on this paper for a ‘Science Media Centre Roundup’ – here is what I wrote:
“This is a rigorous and important review. Its findings are eminently plausible: just like stress would increase blood pressure, so does relaxation decrease it. The problem, as I see it, might be compliance. Stressed people tend to be chronically pressed for time, and relaxation techniques take considerably more time than simply swallowing an antihypertensive pill.”
On this blog and elsewhere, we have many people doubting that COVID vaccinations were effective; some even claim that they were detrimental to our long-term health. In this context, cardiac conditions are often mentioned, as they constitute a significant category of potentially serious post-COVID conditions.
Perhaps these doubters will find this new analysis relevant. The objective of this systematic review was to synthesise the evidence on the factors associated with the development of post-COVID cardiac conditions, the frequency of clinical outcomes in affected patients, and the potential prognostic factors. A systematic review was conducted using the databases EBSCOhost, MEDLINE via PubMed, BVS, and Embase, covering studies from 2019 to December 2023. A total of 8343 articles were identified, and seven met the eligibility criteria for data extraction. The protective effect of vaccination stood out among the associated factors, showing a reduced risk of developing post-COVID cardiac conditions. Conversely, COVID-19 reinfections were associated with an increased risk of cardiovascular outcomes. Regarding the main outcomes in these patients, most recovered, although some cases persisted beyond 200 days of follow-up. The study included in the analysis of prognostic factors reported that the four children who did not recover by the end of the study were between two and five years old and had gastrointestinal symptoms during the illness.
The authors concluded that the present findings provide valuable contributions to a better understanding of the evolution of post-COVID cardiac conditions. Despite the limited number of eligible studies, this review offers insights that describe the progression of cardiac conditions, from their onset to medium-term follow-up of patients. The protection offered by the COVID-19 vaccination regimen was observed beyond the acute phase of the disease, reducing the risk of developing post-COVID cardiac conditions. Public policies encouraging vaccination should be promoted to prevent SARS-CoV-2 infections and reinfections. Given that both COVID-19 and heart diseases occupy a significant place on the global health agenda, post-COVID cardiac conditions deserve due attention. Although most patients recover in the short term, some require care for many months to prevent chronicity and complications, particularly in vulnerable groups such as children and older adults. COVID-19 emerged as a pandemic in 2020, and four years later, it continues to impact the entire planet. This study provides important evidence to guide government policies on post-COVID conditions surveillance, prevention, and targeted healthcare interventions. Although this review compiles the available evidence on the topic, it is clear that there is still much to learn about post-COVID cardiac conditions. Strengthening the research agenda by proposing and conducting primary studies on the subject is important. Additionally, this review should be regularly updated as new studies are published in the field.
I would be delighted to hear that this new analysis has persuaded some doubters that COVID vaccinations are, after all. helpful interventions – but (as always on such occasions) I will not hold my breath!
The year 2024 brought many disappointments. But let’s not dwell on those, lets get in the mood for tonights celebrations! And what could be more fitting for that than a review of the positive cardiovascular effects of wine drinking? After all wine involves both aromatherapy as well as antioxidants, botanical medicine and naturopathy! As luck would have it, we even have some recent evidence on this very subject.
The objectives of this systematic review and meta-analysis were:
- (i) to examine the association between wine consumption and cardiovascular mortality, cardiovascular disease (CVD), and coronary heart disease (CHD),
- (ii) to analyse whether this association could be influenced by personal and study factors, including the participants’ mean age, the percentage of female subjects, follow-up time and percentage of current smokers.
The searched several databases for longitudinal studies from their inception to March 2023.
A total of 25 studies were included in the systematic review, and 22 could be included the meta-analysis. The pooled risk ration (RR) for the association of wine consumption and the risk of CHD using the DerSimonian and Laird approach was 0.76 (95% CIs: 0.69, 0.84), for the risk of CVD was 0.83 (95% CIs: 0.70, 0.98), and for the risk of cardiovascular mortality was 0.73 (95% CIs: 0.59, 0.90).
The authors concluded that their research revealed that wine consumption has an inverse relationship to cardiovascular mortality, CVD, and CHD. Age, the proportion of women in the samples, and follow-up time did not influence this association. Interpreting these findings with prudence was necessary because increasing wine intake might be harmful to individuals who are vulnerable to alcohol because of age, medication, or their pathologies.
What, you suspect that this paper was sponsored by the wine industry?
No, you are mistaken! It was funded by FEDER funds, by a grant from the University of Castilla-La Mancha, and by a grant from the science, innovation and universities.
So, maybe just for tonight we put the worries about our livers aside and enjoy a (non-homeopathic) dose of wine.
Cheers!
An article entitled “The use of ayurvedic medicine in the management of hypertension” was recently published in the ‘Journal of Ayurveda and Naturopathy’ (no, I did not know either that this journal existed). Here I show you merely its conclusion, but encourage you to read the entire paper.
Hypertension, a significant risk factor for cardiovascular diseases, necessitates effective and sustainable management strategies. Ayurveda, with its holistic approach, offers a comprehensive framework for managing hypertension by addressing the underlying dosha imbalances through dietary and lifestyle modifications, herbal formulations, and therapeutic procedures. This review has highlighted the
efficacy of various Ayurvedic interventions, including the use of specific herbs like Ashwagandha, Arjuna, Brahmi, Gokshura, and Sarpagandha, which have demonstrated significant benefits in reducing blood pressure and improving overall health. Panchakarma therapies such as Virechana, Basti, Nasya, and Shirodhara have also been shown to detoxify the body, restore balance, and promote
long-term well-being.
Integrating Ayurvedic practices with modern medical approaches can enhance treatment outcomes, offering a more personalized and holistic approach to hypertension management. This synergy can potentially reduce the reliance on pharmaceuticals, minimize side effects, and improve patient compliance and quality of life. Future research should focus on rigorous clinical trials and the standardization of Ayurvedic formulations to further validate their efficacy and facilitate their integration into mainstream healthcare.
By embracing the principles of Ayurveda, individuals can achieve better control over hypertension, reduce the risk of associated complications, and enhance their overall health and well-being. This comprehensive approach not only addresses the symptoms but also tackles the root causes, promoting a sustainable and balanced lifestyle.
END OF QUOTE
Not only does the author, Dr. Zafar Siddiqa (from the Faculty of Natural Medicine and Holistic Sciences, Rajshahi Holistic Health College, Rajshahi, Bangladesh) re-write the current knowledge of hypertonology, he also provides no evidence for any of the far-reaching statements he makes in this paper. In particular, he cites no rigorous studies that “highlighted the efficacy of various Ayurvedic interventions” (most likely because such studies do not exist).
The autor is correct in the 1st sentence of his conclusion: “Hypertension, a significant risk factor for cardiovascular diseases, necessitates effective and sustainable management strategies”. But he is wrong in almost everything else! Because hypertension is such an important risk factor for stroke and ischaemic heart disease, we MUST treat it effectively.
Today, we fortunately have many conventional treatments that control hypertension well and with no or just minimal adverse effects. Advocating quackary or unproven therapies for managing hypertension is thus deeply unethical. It could contribute to the premature deaths of millions. I thus fear that the ‘Faculty of Natural Medicine and Holistic Sciences, Rajshahi Holistic Health College’ is in urgent need of taking a few courses in proper science and medical ethics.
Many patients seek Chinese herbal medicines (CHM) from traditional Chinese medicine (TCM) clinics. This study aimed to estimate the risk of major adverse cardiovascular events (MACEs) in adults diagnosed with obesity, with or without CHM.
Patients with obesity aged 18 to 50 years were identified using diagnostic codes from Taiwan’s National Health Insurance Research Database between 2008 and 2018. The researchers randomized 67,655 patients with or without CHM using propensity score matching. All patients were followed up from the start of the study until MACEs, death, or the end of 2018. A Cox proportional regression model was used to evaluate the hazard ratios of MACEs in the CHM and non-CHM cohorts.
During a median follow-up of 4.2 years, the CHM group had a higher incidence of MACEs than the non-CHM control cohort (9.35 versus 8.27 per 1,000 person-years). The CHM group had a 1.13-fold higher risk of MACEs compared with the non-CHM control (adjusted hazard ratio [aHR] = 1.13; 95% confidence interval [CI]: 1.07–1.19; p <0.001), especially in ischemic stroke (aHR = 1.18; 95% CI: 1.07–1.31; p <0.01), arrhythmia (aHR = 1.26; 95% CI: 1.14–1.38; p <0.001), and young adults aged 18 to 29 years (aHR = 1.22; 95%
CI: 1.05–1.43; p <0.001).
The authors concluded that, although certain CHMs offer cardiovascular benefits, young and middle-aged obese adults receiving CHM exhibit a higher risk of MACEs than those not receiving CHM. Therefore, TCM practitioners should be cautious when prescribing medications to young patients with obesity, considering their potential cardiovascular risks.
I am not sure why the authors concluded that “certain CHMs offer cardiovascular benefits”; their data do not support this statement and I am not aware of any such evidence either. The more valid result of this study is that the use of CHMs is a risk factor for cardiovascular health in obese people. I fear that this might also be true for non-obese individuals and could also apply to non-cardiovascular areas of health.
Just like any other form of herbal therapy, CHMs can contain toxic ingredients and might interact with prescribed medications. Unlike most other forms of herbal treatments CHMs are known to be often contaminated (e.g. with heaviy metals) and/or adulterated (e.g. with illegal amounts of synthetic drugs). as they typically contain a multitude of herbs, the risk of interactions is also increased. Our 2013 review shoed that “herbal medicinal products (HMPs) were adulterated or contaminated with dust, pollens, insects, rodents, parasites, microbes, fungi, mould, toxins, pesticides, toxic heavy metals and/or prescription drugs. The most severe adverse effects caused by these adulterations were agranulocytosis, meningitis, multi-organ failure, perinatal stroke, arsenic, lead or mercury poisoning, malignancies or carcinomas, hepatic encephalopathy, hepatorenal syndrome, nephrotoxicity, rhabdomyolysis, metabolic acidosis, renal or liver failure, cerebral edema, coma, intracerebral haemorrhage, and death. Adulteration and contamination of HMPs were most commonly noted for traditional Indian and Chinese remedies, respectively.”
My advice has therefore long been very clear and outspoken:
CHMs are best avoided!
This systematic review and meta-analysis aimed to evaluate the effectiveness of spiritually based interventions on blood pressure (BP) among adults. A systematic search was performed using the PubMed, Scopus, and Cochrane databases to identify studies evaluating spiritual interventions, including:
- meditation,
- transcendental meditation,
- mindfulness meditation,
- yoga,
for high BP among adults up to January 1, 2022.
The inclusion criteria were:
- (a) randomized controlled trials (RCTs),
- (b) studies in English or Persian,
- (c) studies conducted among adults (≥ 18 years),
- (d) studies reporting systolic or diastolic BP.
Given the high heterogeneity of these studies, a random effect model was used to calculate the effect sizes for the RCTs.
In total, the systematic review included 24 studies and the meta-analysis included 23 studies. As some of studies reported two or more outcome measurements, separate estimates of each outcome were extracted for that study (24 datasets). Fifteen trials reported the mean (SD) systolic blood pressure (SBP), and 13 trials reported the mean (SD) diastolic blood pressure (DBP). In addition, 13 studies reported means (SDs) and six trials reported mean changes in DBP. A significant decrease was found in systolic BP following intervention ((WMD (weighted mean difference) = − 7.63 [− 9.61 to − 5.65; P < 0.001]). We observed significant heterogeneity among the studies (I2 = 96.9; P < 0.001). A significant decrease was observed in DBP following the interventions (WMD = − 4.75 [− 6.45 to − 3.05; P < 0.001]).
The authors concluded that spiritually based interventions including meditation and yoga had beneficial effects in reducing both SBP and DBP. Reducing BP can be expected to reduce the risk of cardiovascular diseases.
Q: What do the RCTs of these interventions have in common?
A: They cannot normally be placebo-controlled because no adequate placebos exist for these therapies.
Q: What does that mean?
A: It means that patients could not be blinded and that patient expectations influenced the outcome.
In view of the fact that blood pressure is an endpoint that is extremely sensitive to expectation, I think, the conclusions of this paper might need to be re-formulated:
This analysis confirms that expectation can have beneficial effects in reducing both SBP and DBP. Reducing BP can be expected to reduce the risk of cardiovascular diseases.
It has been reported that 5 people who took a Japanese health supplement have died and more than 100 have been hospitalized as of Friday, a week after a pharmaceutical company issued a recall of the products, officials said. Osaka-based Kobayashi Pharmaceutical Co. came under fire for not going public quickly with problems known internally as early as January. Yet the first public announcement came only on 22 March. Company officials said 114 people were being treated in hospitals after taking products — including Benikoji Choleste Help meant to lower cholesterol — that contain an ingredient called benikoji, a red species of mold. Some people developed kidney problems after taking the supplements, but the exact cause was still under investigation in cooperation with government laboratories, according to the manufacturer.
“We apologize deeply,” President Akihiro Kobayashi told reporters last Friday, bowing for a long time to emphasize the apology alongside three other top company officials. He expressed remorse to those who have died and have been taken ill and to their families. He also apologized for the troubles caused to the entire health food industry and the medical profession, adding that the company was working to prevent further damage and improve crisis management.
The company’s products have been recalled — as have dozens of other products that contain benikoji, including miso paste, crackers, and a vinegar dressing. Japan’s health ministry put up a list on its official site of all the recalled products, including some that use benikoji for food coloring. The ministry warned the deaths could keep growing. The supplements could be bought at drug stores without a prescription from a doctor, and some may have been purchased or exported before the recall, including by tourists who may not be aware of the health risks.
Kobayashi Pharmaceutical had been selling benikoji products for years, with a million packages sold over the past 3 fiscal years, but a problem crept up with the supplements produced in 2023. Kobayashi Pharmaceutical said it produced 18.5 tons of benikoji last year. Some analysts blame the recent deregulation initiatives, which simplified and sped up approval for health products to spur economic growth.
________________________
Anouther source reported that Japanese authorities on Saturday raided a drug factory after a pharmaceutical company reported at least five deaths and 114 hospitalizations possibly linked to a health supplement. About a dozen Japanese health officials walked into the Osaka plant of the Kobayashi Pharmaceutical Co., as seen in footage of the raid widely telecasted on Japanese news. The health supplement in question is a pink pill called Benikoji Choleste Help. It is said to help lower cholesterol levels. A key ingredient is benikoji, a type of red mold. The company has said it knows little about the cause of the sickness, which can include kidney failure. It is currently investigating the effects in cooperation with Japan’s government.
___________________________
More recent reports update the figure of affected individuals: Japanese dietary supplements at the center of an expanding health scare have now been linked to at least 157 hospitalizations, a health ministry official said Tuesday.The figure reflects an increase from the 114 hospitalization cases that Kobayashi Pharmaceutical said on Friday were linked to its products containing red yeast rice, or beni kōji.
A Kobayashi Pharmaceutical spokeswoman confirmed the latest hospitalization cases without elaborating further.
Benikoji is widely sold and used; not just in Japan. It comes under a range of different names:
- red yeast rice,
- red fermented rice,
- red kojic rice,
- red koji rice,
- anka,
- angkak,
- Ben Cao Gang Mu.
It is a bright reddish purple fermented rice which acquires its color from being cultivated with the mold Monascus purpureus. Red yeast rice is used as food and as a medicine in Asian cultures, such as Kampo and TCM.
It contains lovastatin which, of course, became patented and is marketed as the prescription drug, Mevacor. Red yeast rice went on to become a non-prescription dietary supplement in the United States and other countries. In 1998, the U.S. FDA banned a dietary supplement containing red yeast rice extract, stating that red yeast rice products containing monacolin K are identical to a prescription drug, and thus subject to regulation as a drug.
Microplastics are tiny polymer fragments that range from less than 0.2 inch to 1/25,000th of an inch. Smaller particles are called nanoplastics and are measured in billionths of a metre. Microplastics and nanoplastics (MNPs) are emerging as a potential risk factor for human health and for cardiovascular disease in particular. However, direct evidence that this risk extends to humans has so far been lacking. This investigation is a first step towards filling the gap.
The researchers conducted a prospective, multicenter, observational study involving patients who were undergoing carotid endarterectomy for asymptomatic carotid artery disease. The excised carotid plaque specimens were analyzed for the presence of MNPs with the use of pyrolysis–gas chromatography–mass spectrometry, stable isotope analysis, and electron microscopy. Inflammatory biomarkers were assessed with enzyme-linked immunosorbent assay and immunohistochemical assay. The primary end point was a composite of myocardial infarction, stroke, or death from any cause among patients who had evidence of MNPs in plaque as compared with patients with plaque that showed no evidence of MNPs.
A total of 304 patients were enrolled in the study, and 257 completed a mean (±SD) follow-up of 33.7±6.9 months. Polyethylene was detected in carotid artery plaque of 150 patients (58.4%), with a mean level of 21.7±24.5 μg per milligram of plaque; 31 patients (12.1%) also had measurable amounts of polyvinyl chloride, with a mean level of 5.2±2.4 μg per milligram of plaque. Electron microscopy revealed visible, jagged-edged foreign particles among plaque macrophages and scattered in the external debris. Radiographic examination showed that some of these particles included chlorine. Patients in whom MNPs were detected within the atheroma were at higher risk for a primary end-point event than those in whom these substances were not detected (hazard ratio, 4.53; 95% confidence interval, 2.00 to 10.27; P<0.001).
The authors concluded that, in this study, patients with carotid artery plaque in which MNPs were detected had a higher risk of a composite of myocardial infarction, stroke, or death from any cause at 34 months of follow-up than those in whom MNPs were not detected.
This is an impressive study – so much so that I report it here even though it has no connection to so-called alternative medicine, the focus of my blog. The fact that 58% of all plaques contained MNPs seems alarming. The finding that the presence of these MNPs is associated with a poor cardiovascular prognosis seems even more concerning.
MNPs have been found in every environmental compartment on earth. They are ingested not just by humans but by most animals as well. Even though research into these issues is most active, their effects are so far still under-researched and not fully understood.
The authors of the new investigation are rightly cautious: “Our data must be confirmed by other studies and on larger populations,” said Marfella, professor of internal medicine and director of the department of medical and surgical sciences at the University of Campania Luigi Vanvitelli in Naples, Italy. “However, our study convincingly highlights the presence of plastics and their association with cardiovascular events in a representative population affected by atherosclerosis.”
Of course, many questions are as yet unanswered but the subject is as worrying as it is important, e.g.:
- Should exposure to MNPs be considered a cardiovascular risk factor?
- What organs in addition to the heart may be at risk?
- How can we reduce exposure?”
I wish I knew the ansers.
These days – 11 years after the closure of my department at Exeter – it is not often that I co-author a peer-reviewed paper. All the more reason, I think, to celebrate when it does happen:
Our review was aimed at determining the effectiveness of meditation, primarily mindfulness-based interventions (MBIs) and transcendental meditation (TM), for the primary and secondary prevention of CVD.
We searched CENTRAL, MEDLINE, Embase, three other databases, and two trials registers on 14 November 2021, together with reference checking, citation searching, and contact with study authors to identify additional studies. We included randomised controlled trials (RCTs) of 12 weeks or more in adults at high risk of CVD and those with established CVD. We explored four comparisons: MBIs versus active comparators (alternative interventions); MBIs versus non-active comparators (no intervention, wait list, usual care); TM versus active comparators; TM versus non-active comparators. We used standard Cochrane methods. Our primary outcomes were CVD clinical events (e.g. cardiovascular mortality), blood pressure, measures of psychological distress and well-being, and adverse events. Secondary outcomes included other CVD risk factors (e.g. blood lipid levels), quality of life, and coping abilities. We used GRADE to assess the certainty of evidence.
We included 81 RCTs (6971 participants), with most studies at unclear risk of bias. MBIs versus active comparators (29 RCTs, 2883 participants) Systolic (SBP) and diastolic (DBP) blood pressure were reported in six trials (388 participants) where heterogeneity was considerable (SBP: MD -6.08 mmHg, 95% CI -12.79 to 0.63, I2 = 88%; DBP: MD -5.18 mmHg, 95% CI -10.65 to 0.29, I2 = 91%; both outcomes based on low-certainty evidence). There was little or no effect of MBIs on anxiety (SMD -0.06 units, 95% CI -0.25 to 0.13; I2 = 0%; 9 trials, 438 participants; moderate-certainty evidence), or depression (SMD 0.08 units, 95% CI -0.08 to 0.24; I2 = 0%; 11 trials, 595 participants; moderate-certainty evidence). Perceived stress was reduced with MBIs (SMD -0.24 units, 95% CI -0.45 to -0.03; I2 = 0%; P = 0.03; 6 trials, 357 participants; moderate-certainty evidence). There was little to no effect on well-being (SMD -0.18 units, 95% CI -0.67 to 0.32; 1 trial, 63 participants; low-certainty evidence). There was little to no effect on smoking cessation (RR 1.45, 95% CI 0.78 to 2.68; I2 = 79%; 6 trials, 1087 participants; low-certainty evidence). None of the trials reported CVD clinical events or adverse events. MBIs versus non-active comparators (38 RCTs, 2905 participants) Clinical events were reported in one trial (110 participants), providing very low-certainty evidence (RR 0.94, 95% CI 0.37 to 2.42). SBP and DBP were reduced in nine trials (379 participants) but heterogeneity was substantial (SBP: MD -6.62 mmHg, 95% CI -13.15 to -0.1, I2 = 87%; DBP: MD -3.35 mmHg, 95% CI -5.86 to -0.85, I2 = 61%; both outcomes based on low-certainty evidence). There was low-certainty evidence of reductions in anxiety (SMD -0.78 units, 95% CI -1.09 to -0.41; I2 = 61%; 9 trials, 533 participants; low-certainty evidence), depression (SMD -0.66 units, 95% CI -0.91 to -0.41; I2 = 67%; 15 trials, 912 participants; low-certainty evidence) and perceived stress (SMD -0.59 units, 95% CI -0.89 to -0.29; I2 = 70%; 11 trials, 708 participants; low-certainty evidence) but heterogeneity was substantial. Well-being increased (SMD 0.5 units, 95% CI 0.09 to 0.91; I2 = 47%; 2 trials, 198 participants; moderate-certainty evidence). There was little to no effect on smoking cessation (RR 1.36, 95% CI 0.86 to 2.13; I2 = 0%; 2 trials, 453 participants; low-certainty evidence). One small study (18 participants) reported two adverse events in the MBI group, which were not regarded as serious by the study investigators (RR 5.0, 95% CI 0.27 to 91.52; low-certainty evidence). No subgroup effects were seen for SBP, DBP, anxiety, depression, or perceived stress by primary and secondary prevention. TM versus active comparators (8 RCTs, 830 participants) Clinical events were reported in one trial (201 participants) based on low-certainty evidence (RR 0.91, 95% CI 0.56 to 1.49). SBP was reduced (MD -2.33 mmHg, 95% CI -3.99 to -0.68; I2 = 2%; 8 trials, 774 participants; moderate-certainty evidence), with an uncertain effect on DBP (MD -1.15 mmHg, 95% CI -2.85 to 0.55; I2 = 53%; low-certainty evidence). There was little or no effect on anxiety (SMD 0.06 units, 95% CI -0.22 to 0.33; I2 = 0%; 3 trials, 200 participants; low-certainty evidence), depression (SMD -0.12 units, 95% CI -0.31 to 0.07; I2 = 0%; 5 trials, 421 participants; moderate-certainty evidence), or perceived stress (SMD 0.04 units, 95% CI -0.49 to 0.57; I2 = 70%; 3 trials, 194 participants; very low-certainty evidence). None of the trials reported adverse events or smoking rates. No subgroup effects were seen for SBP or DBP by primary and secondary prevention. TM versus non-active comparators (2 RCTs, 186 participants) Two trials (139 participants) reported blood pressure, where reductions were seen in SBP (MD -6.34 mmHg, 95% CI -9.86 to -2.81; I2 = 0%; low-certainty evidence) and DBP (MD -5.13 mmHg, 95% CI -9.07 to -1.19; I2 = 18%; very low-certainty evidence). One trial (112 participants) reported anxiety and depression and found reductions in both (anxiety SMD -0.71 units, 95% CI -1.09 to -0.32; depression SMD -0.48 units, 95% CI -0.86 to -0.11; low-certainty evidence). None of the trials reported CVD clinical events, adverse events, or smoking rates.
We concluded that despite the large number of studies included in the review, heterogeneity was substantial for many of the outcomes, which reduced the certainty of our findings. We attempted to address this by presenting four main comparisons of MBIs or TM versus active or inactive comparators, and by subgroup analyses according to primary or secondary prevention, where there were sufficient studies. The majority of studies were small and there was unclear risk of bias for most domains. Overall, we found very little information on the effects of meditation on CVD clinical endpoints, and limited information on blood pressure and psychological outcomes, for people at risk of or with established CVD. This is a very active area of research as shown by the large number of ongoing studies, with some having been completed at the time of writing this review. The status of all ongoing studies will be formally assessed and incorporated in further updates.
Some people will say that meditation is not a form of so-called alternative medicine (SCAM) but rather an aspect of lifestyle used for relaxation and well-being. As such, it should not be scrutinized like a therapy. This might be partly true, but as soon as proper health claims are made for meditation or similar modalities, they do need to be tested like any other therapy, in my view.
As our review demonstrates, meditation and similar treatments are not nearly as well supported by evidence as their proponents try to make us believe. In other words, the often-voiced claims that such therapies are effective for the primary and secondary prevention of cardiovascular disease are largely unfounded.
This study investigated whether Tongxinluo,a traditional Chinese medicine compound that has shown promise in in vitro, animal, and small human studies for myocardial infarction, could improve clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI). The randomized, double-blind, placebo-controlled clinical trial was conducted among patients with STEMI within 24 hours of symptom onset from 124 hospitals in China. Patients were enrolled from May 2019 to December 2020; the last date of follow-up was December 15, 2021.
Patients were randomized 1:1 to receive either Tongxinluo or placebo orally for 12 months. A loading dose of 2.08 g was given after randomization, followed by the maintenance dose of 1.04 g, 3 times a day, in addition to STEMI guideline-directed treatments. The primary end point was 30-day major adverse cardiac and cerebrovascular events (MACCEs), a composite of cardiac death, myocardial reinfarction, emergent coronary revascularization, and stroke. Follow-up for MACCEs occurred every 3 months to 1 year.
Among 3797 patients who were randomized, 3777 (Tongxinluo: 1889 and placebo: 1888; mean age, 61 years; 76.9% male) were included in the primary analysis. Thirty-day MACCEs occurred in 64 patients (3.4%) in the Tongxinluo group vs 99 patients (5.2%) in the control group. Individual components of 30-day MACCEs, including cardiac death, were also significantly lower in the Tongxinluo group than the placebo group. By 1 year, the Tongxinluo group continued to have lower rates of MACCEs and cardiac death. There were no significant differences in other secondary end points including 30-day stroke; major bleeding at 30 days and 1 year; 1-year all-cause mortality; and in-stent thrombosis. More adverse drug reactions occurred in the Tongxinluo group than the placebo group, mainly driven by gastrointestinal symptoms.
The authors concluded that in patients with STEMI, the Chinese patent medicine Tongxinluo, as an adjunctive therapy in addition to STEMI guideline-directed treatments, significantly improved both 30-day and 1-year clinical outcomes. Further research is needed to determine the mechanism of action of Tongxinluo in STEMI.
Tongxinluo is mixture of various active ingredients, including
- ginseng,
- leech,
- scorpion,
- Paeonia lactiflora,
- cicada slough,
- woodlouse bug,
- centipede,
- sandalwood.
With chaotic mixtures of this type, it is impossible to name all the potentially active ingredients, list their actions, or identify the ones that are truly relevant. According to the thinking of TCM proponents, this would also be the wrong way to go about it – such mixtures work as a whole, they would insist.
Tongxinluo is by no means a mixture that has not been studied before.
A previous systematic review of 12 studies found that Tongxinluo capsule is superior to conventional treatment in improving clinical overall response rate and hemorheological indexes and is relatively safe. Due to the deficiencies of the existing studies, more high-quality studies with rigorous design are required for further verification.
A 2022 meta-analysis indicated that the mixture had beneficial effects on the prevention of cardiovascular adverse events, especially in TVR or ISR after coronary revascularization and may possibly lower the incidence of first or recurrent MI and HF within 12 months in patients with CHD, while insufficient sample size implied that these results lacked certain stability. And the effects of TXLC on cardiovascular mortality, cerebrovascular events, and unscheduled readmission for CVDs could not be confirmed due to insufficient cases. Clinical trials with large-sample sizes and extended follow-up time are of interest in the future researches.
A further meta-analysis suggested beneficial effects on reducing the adverse cardiovascular events without compromising safety for CHD patients after PCI on the 6-month course.
Finally, a systematic review of 10 studies found that the remedy is an effective and safe therapy for CHD patients after percutaneous coronary interventions.
So, should we believe the new study with its remarkable findings? On the one hand, the trial seems rigorous and is reported in much detail. On the other hand, the study (as all previous trials of this mixture) originates from China. We know how important TCM is for that country as an export item, and we know how notoriously unreliable Chinese research sadly has become. In view of this, I would like to see an independent replication of this study by an established research group outside China before I recommend Tongxinluo to anyone.
Let’s not forget:
if it sound too good to be true, it probably is!
