MD, PhD, MAE, FMedSci, FRSB, FRCP, FRCPEd.

Chinese studies

1 2 3 8

Even though most people do not think about it in this way, tea is a herbal remedy. We know that it is pleasant, but is it also effective?

This study explored the associations between tea drinking and the incident risk of type 2 diabetes mellitus(T2 DM). A dynamic prospective cohort study among a total of 27 841 diabetes-free permanent adult residents randomly selected from 2, 6, and 7 rural communities between 2006-2008, 2011-2012, and 2013-2014, respectively. Questionnaire survey, physical examination, and laboratory test were carried out among the participants. In 2018, the researchers conducted a follow-up through the electronic health records of residents. Cox regression models were applied to explore the association between tea drinking and the incident risk of T2 DM and estimate the hazard ratio(HR), and its 95%CI.

Among the 27 841 rural community residents in Deqing County, 10 726(39%) were tea drinkers, 8215 (77%) of which were green tea drinkers. A total of 883 new T2 DM incidents were identified until December 31, 2018, and the incidence density was 4.43 per 1000 person-years (PYs). The incidence density was 4.07/1000 PYs in those with tea drinking habits and 4.71/1000 PYs in those without tea drinking habits. The incidence density was 3.79/1000 PYs in those with green tea drinking habits. After controlling for sex, age, education, farming, smoking, alcohol consumption, dietary preference, body mass index, hypertension, impaired fasting glucose, and family history of diabetes, the risk of T2 DM among rural residents with tea drinking habits was 0.79 times higher than that among residents without tea drinking habits(HR=0.79, 95%CI 0.65-0.96), and the risk of T2 DM among residents with green tea drinking habits was 0.72 times higher than that among residents without tea drinking habits(HR=0.72, 95%CI 0.58-0.89). No significant associations were found between other kinds of tea and the risk of T2 DM, nor the amount of green tea-drinking.

The authors concluded that drinking green tea may reduce the risk of T2 DM among adult population in rural China.

Epidemiological studies of this nature resemble big fishing expeditions that can bring up all sorts of rubbish and – if lucky – also some fish. The question thus is whether this study identified an interesting association or just some odd rubbish.

A quick look into Medline seems to suggest great caution. Here are the conclusions from a few further case-control studies:

Thus the question of whether tea drinking might prevent diabetes remains open, in my view.

Yet, the paper might teach us two important lessons:

  1. Case-control studies must be taken with a pinch of salt.
  2. Correlation is not the same as causation.

Earlier this year, I started the ‘WORST PAPER OF 2022 COMPETITION’. As a competition without a prize is no fun, I am offering the winner (that is the lead author of the winning paper) one of my books that best fits his/her subject. I am sure this will overjoy him or her.

And how do we identify the winner? I will continue blogging about nominated papers (I hope to identify about 10 in total), and towards the end of the year, I let my readers decide democratically.

In this spirit of democratic voting, let me suggest to you ENTRY No 8 (it is so impressive that I must show you the unadulterated abstract):

Introduction

Female sexual dysfunction (FSD) seriously affects the quality of life of women. However, most women do not have access to effective treatment.

Aim

This study aimed to determine the feasibility and effectiveness of the use of acupuncture in FSD treatment based on existing clear acupuncture protocol and experience-supported face-to-face therapy.

Methods

A retrospective analysis was performed on 24 patients with FSD who received acupuncture from October 2018 to February 2022. The Chinese version of the female sexual function index , subjective sensation, sexual desire, sexual arousal, vaginal lubrication, orgasm, sexual satisfaction, and dyspareunia scores were compared before and after the treatment in all 24 patients.

Main Outcome Measure

A specific female sexual function index questionnaire was used to assess changes in female sexual function before and after the acupuncture treatment.

Results

In this study, the overall treatment improvement rate of FSD was 100%. The Chinese version of the female sexual function index total score, sexual desire score, sexual arousal score, vaginal lubrication score, orgasm score, sexual satisfaction score, and dyspareunia score during intercourse were significantly different before and after the treatment (P < .05). Consequently, participants reported high levels of satisfaction with acupuncture. This study indicates that acupuncture could be a new and effective technique for treating FSD. The main advantages of this study are its design and efficacy in treating FSD. To the best of our knowledge, this is the first study to evaluate the efficacy of acupuncture in the treatment of FSD using the female sexual function index scale from 6 dimensions. The second advantage is that the method used (ie, the nonpharmacological method) is simple, readily available, highly safe with few side effects, and relatively inexpensive with high patient satisfaction. However, limitations include small sample size and lack of further detailed grouping, pre and post control study of patients, blank control group, and pre and post control study of sex hormones.

Conclusion

Acupuncture can effectively treat FSD from all dimensions with high safety, good satisfaction, and definite curative effect, and thus, it is worthy of promotion and application.

My conclusion is very different: acupuncture can effectively kill any ability for critical thinking.

I hardly need to list the flaws of this paper – they are all too obvious, e.g.:

  • there is no control group; the results might therefore be due to a host of factors that are unrelated to acupuncture,
  • the trial was too small to allow far-reaching conclusions,
  • the study does not tell us anything about the safety of acupuncture.

The authors call their investigation a ‘pilot study’. Does that excuse the flimsiness of their effort? No! A pilot study cannot draw conclusions such as the above.

What’s the harm? you might ask; nobody will ever read such rubbish and nobody will have the bizarre idea to use acupuncture for treating FSD. I’m afraid you would be wrong to argue in this way. The paper already got picked up by THE DAILY MAIL in an article entitled “Flailing libido? Acupuncture could help boost sex drive, scientists say” which was as devoid of critical thinking as the original study. Thus we can expect that hundreds of desperate women are already getting needled and ripped off as we speak. And in any case, offensively poor science is always harmful; it undermines public trust in research (and it renders acupuncture research the laughing stock of serious scientists).

 

Should Acupuncture-Related Therapies be Considered in Prediabetes Control?

No!

If you are pre-diabetic, consult a doctor and follow his/her advice. Do NOT do what acupuncturists or other self-appointed experts tell you. Do NOT become a victim of quackery.

But the authors of a new paper disagree with my view.

So, let’s have a look at the evidence.

Their systematic review was aimed at evaluating the effects and safety of acupuncture-related therapy (AT) interventions on glycemic control for prediabetes. The Chinese researchers searched 14 databases and 5 clinical registry platforms from inception to December 2020. Randomized controlled trials involving AT interventions for managing prediabetes were included.

Of the 855 identified trials, 34 articles were included for qualitative synthesis, 31 of which were included in the final meta-analysis. Compared with usual care, sham intervention, or conventional medicine, AT treatments yielded greater reductions in the primary outcomes, including fasting plasma glucose (FPG) (standard mean difference [SMD] = -0.83; 95% confidence interval [CI], -1.06, -0.61; P < .00001), 2-hour plasma glucose (2hPG) (SMD = -0.88; 95% CI, -1.20, -0.57; P < .00001), and glycated hemoglobin (HbA1c) levels (SMD = -0.91; 95% CI, -1.31, -0.51; P < .00001), as well as a greater decline in the secondary outcome, which is the incidence of prediabetes (RR = 1.43; 95% CI, 1.26, 1.63; P < .00001).

The authors concluded that AT is a potential strategy that can contribute to better glycemic control in the management of prediabetes. Because of the substantial clinical heterogeneity, the effect estimates should be interpreted with caution. More research is required for different ethnic groups and long-term effectiveness.

But this is clearly a positive result!

Why do I not believe it?

There are several reasons:

  • There is no conceivable mechanism by which AT prevents diabetes.
  • The findings heavily rely on Chinese RCTs which are known to be of poor quality and often even fabricated. To trust such research would be a dangerous mistake.
  • Many of the primary studies were designed such that they failed to control for non-specific effects of AT. This means that a causal link between AT and the outcome is doubtful.
  • The review was published in a 3rd class journal of no impact. Its peer-review system evidently failed.

So, let’s just forget about this rubbish paper?

If only it were so easy!

Journalists always have a keen interest in exotic treatments that contradict established wisdom. Predictably, they have been reporting about the new review thus confusing or misleading the public. One journalist, for instance, stated:

Acupuncture has been used for thousands of years to treat a variety of illnesses — and now it could also help fight one of the 21st century’s biggest health challenges.

New research from Edith Cowan University has found acupuncture therapy may be a useful tool in avoiding type 2 diabetes.

The team of scientists investigated dozens of studies covering the effects of acupuncture on more than 3600 people with prediabetes. This is a condition marked by higher-than-normal blood glucose levels without being high enough to be diagnosed as diabetes.

According to the findings, acupuncture therapy significantly improved key markers, such as fasting plasma glucose, two-hour plasma glucose, and glycated hemoglobin. Additionally, acupuncture therapy resulted in a greater decline in the incidence of prediabetes.

The review can thus serve as a prime example for demonstrating how irresponsible research has the power to mislead millions. This is why I have often said that poor research is a danger to public health.

And what can be done about this more and more prevalent problem?

The answer is easy: people need to behave more responsibly; this includes:

  • trialists,
  • review authors,
  • editors,
  • peer-reviewers,
  • journalists.

Yes, the answer is easy in theory – but the practice is far from it!

The US Food and Drug Administration created the Tainted Dietary Supplement Database in 2007 to identify dietary supplements adulterated with active pharmaceutical ingredients (APIs). This article compared API adulterations in dietary supplements from the 10-year time period of 2007 through 2016 to the most recent 5-year period of 2017 through 2021. Its findings are alarming:

  • From 2007 through 2021, 1068 unique products were found to be adulterated with APIs.
  • Sexual enhancement and weight-loss dietary supplements are the most common products adulterated with APIs.
  • Phosphodiesterase-5 inhibitors are commonly included in sexual enhancement dietary supplements.
  • A single product can include up to 5 APIs.
  • Sibutramine, a drug removed from the market due to cardiovascular adverse events, is the most included adulterant API in weight loss products.
  • Sibutramine analogues, phenolphthalein (which was removed from the US market because of cancer risk), and fluoxetine were also included.
  • Muscle-building dietary supplements were commonly adulterated before 2016, but since 2017 no additional adulterated products have been identified.

The authors concluded that the lack of disclosure of APIs in dietary supplements, circumventing the normal procedure with clinician oversight of prescription drug use, and the use of APIs that are banned by the Food and Drug Administration or used in combinations that were never studied are important health risks for consumers.

The problem of adulterated supplements is by no means new. A similar review published 4 years ago already warned that “active pharmaceuticals continue to be identified in dietary supplements, especially those marketed for sexual enhancement or weight loss, even after FDA warnings. The drug ingredients in these dietary supplements have the potential to cause serious adverse health effects owing to accidental misuse, overuse, or interaction with other medications, underlying health conditions, or other pharmaceuticals within the supplement.”

These papers relate to the US where supplement use is highly prevalent. The harm done by adulterated products is thus huge. If we focus on Chinese or Ayurvedic supplements, the problem might even be more serious. In 2002, my own review concluded that adulteration of Chinese herbal medicines with synthetic drugs is a potentially serious problem which needs to be addressed by adequate regulatory measures. Twenty years later, we seem to be still waiting for effective regulations that protect the consumer.

Progress in medicine, they say, is made funeral by funeral!

 

Ischemic heart disease (IHD) related to cardiovascular or cerebrovascular disease is the leading cause of mortality and an important issue of public health worldwide. The cost of long-term healthcare for IHD patients may result in a huge financial burden. This study analyzed the medical expenditure incurred for and survival of IHD patients treated with Chinese herbal medicine (CHM) and Western medicine.

Subjects were randomly selected from the National Health Insurance Research Database in Taiwan. The Cox proportional hazards regression model, Kaplan–Meier estimator, logrank test, chi-square test, and analysis of variance were applied. Landmark analysis was used to assess the cumulative incidence of death in IHD patients.

A total of 11,527 users were identified as CHM combined with Western medicine and 11,527 non-CHM users. CHM users incurred a higher medical expenditure for outpatient care within 1 (24,529 NTD versus 18,464 NTD,  value <0.0001) and 5 years (95,345 NTD versus 60,367 NTD,  value <0.0001). However, CHM users had shorter hospitalizations and lower inpatient medical expenditure (7 days/43,394 NTD in 1 year; 11 days/83,141 NTD in 5 years) than non-CHM users (11 days/72,939 NTD in 1 year; 14 days/107,436 NTD in 5 years).

The CHM group’s adjusted hazard ratio for mortality was 0.41 lower than that of the non-CHM group by Cox proportional hazard models with time-dependent exposure covariates. Danshen, Huang qi, Niu xi, Da huang, and Fu zi were the most commonly prescribed Chinese single herbs; Zhi-Gan-Cao-Tang, Xue-Fu-Zhu-Yu-Tang, Tian-Wang-Bu-Xin-Dan, Sheng-Mai-San, and Yang-Xin-Tang were the five most frequently prescribed herbal formulas in Taiwan.

The authors concluded that combining Chinese and Western medicine can reduce hospital expenditure and improve survival for IHD patients.

Why, you will ask, do I think that this study deserves to be in the ‘worst paper cometition’?

It is not so bad!

It is an epidemiological case-control study with a large sample size that generates interesting findings.

Agreed!

But, as a case-control study, it cannot establish a causal link between CHM and the outcomes. You might argue that the conclusions avoid doing this – “can … improve survival” is not the same as “does improve survival”. This may be true, yet the title of the article leaves little doubt about the interpretation of the authors:

Chinese Herbal Medicine as an Adjunctive Therapy Improves the Survival Rate of Patients with Ischemic Heart Disease: A Nationwide Population-Based Cohort Study

I find it difficult not to view this as a deliberate attempt of the authors, editors, and reviewers to mislead the public.

Looking at the details of the study, it is easy to see that the two groups were different in a whole range of parameters that were measured. More importantly, they most likely differ in a range of variables that were not measured and had significant influence on IHD survival. It stands to reason, for instance, that patients who elected to use CHM in addition to their standard care were more health conscious. They would thus have followed a healthier diet and lifestyle. It would be foolish to claim that such factors do not influence IHD survival.

The fact that the authors fail even to mention this possibility, interpret an association as a causal link, and thus try to mislead us all makes this paper, in my view, a strong contender for my

WORST PAPER OF 2022 COMPETITION

 

 

Yes, Today is ‘WORLD SLEEP DAY‘ and you are probably in bed hoping this post will put you back to sleep.

I’ll do my best!

This study aimed to synthesise the best available evidence on the safety and efficacy of using moxibustion and/or acupuncture to manage cancer-related insomnia (CRI).

The PRISMA framework guided the review. Nine databases were searched from its inception to July 2020, published in English or Chinese. Randomised clinical trials (RCTs) of moxibustion and or acupuncture for the treatment of CRI were selected for inclusion. The methodological quality was assessed using the method suggested by the Cochrane collaboration. The Cochrane Review Manager was used to conduct a meta-analysis.

Fourteen RCTs met the eligibility criteria; 7 came from China. Twelve RCTs used the Pittsburgh Sleep Quality Index (PSQI) score as continuous data and a meta-analysis showed positive effects of moxibustion and or acupuncture (n = 997, mean difference (MD) = -1.84, 95% confidence interval (CI) = -2.75 to -0.94, p < 0.01). Five RCTs using continuous data and a meta-analysis in these studies also showed significant difference between two groups (n = 358, risk ratio (RR) = 0.45, 95% CI = 0.26-0.80, I 2 = 39%).

The authors concluded that the meta-analyses demonstrated that moxibustion and or acupuncture showed a positive effect in managing CRI. Such modalities could be considered an add-on option in the current CRI management regimen.

Even at the risk of endangering your sleep, I disagree with this conclusion. Here are some of my reasons:

  • Chinese acupuncture trials invariably are positive which means they are as reliable as a 4£ note.
  • Most trials were of poor methodological quality.
  • Only one made an attempt to control for placebo effects.
  • Many followed the A+B versus B design which invariably produces (false-) positive results.
  • Only 4 out of 14 studies mentioned adverse events which means that 10 violated research ethics.

Sorry to have disturbed your sleep!

On 27 January 2022, I conducted a very simple Medline search using the search term ‘Chinese Herbal Medicine, Review, 2022’. Its results were remarkable; here are the 30 reviews I found:

  1. Zhu, S. J., Wang, R. T., Yu, Z. Y., Zheng, R. X., Liang, C. H., Zheng, Y. Y., Fang, M., Han, M., & Liu, J. P. (2022). Chinese herbal medicine for myasthenia gravis: A systematic review and meta-analysis of randomized clinical trials. Integrative medicine research11(2), 100806.
  2. Lu, J., Li, W., Gao, T., Wang, S., Fu, C., & Wang, S. (2022). The association study of chemical compositions and their pharmacological effects of Cyperi Rhizoma (Xiangfu), a potential traditional Chinese medicine for treating depression. Journal of ethnopharmacology287, 114962.
  3. Su, F., Sun, Y., Zhu, W., Bai, C., Zhang, W., Luo, Y., Yang, B., Kuang, H., & Wang, Q. (2022). A comprehensive review of research progress on the genus Arisaema: Botany, uses, phytochemistry, pharmacology, toxicity and pharmacokinetics. Journal of ethnopharmacology285, 114798.
  4. Nanjala, C., Ren, J., Mutie, F. M., Waswa, E. N., Mutinda, E. S., Odago, W. O., Mutungi, M. M., & Hu, G. W. (2022). Ethnobotany, phytochemistry, pharmacology, and conservation of the genus Calanthe R. Br. (Orchidaceae). Journal of ethnopharmacology285, 114822.
  5. Li, M., Jiang, H., Hao, Y., Du, K., Du, H., Ma, C., Tu, H., & He, Y. (2022). A systematic review on botany, processing, application, phytochemistry and pharmacological action of Radix Rehmnniae. Journal of ethnopharmacology285, 114820.
  6. Mutinda, E. S., Mkala, E. M., Nanjala, C., Waswa, E. N., Odago, W. O., Kimutai, F., Tian, J., Gichua, M. K., Gituru, R. W., & Hu, G. W. (2022). Traditional medicinal uses, pharmacology, phytochemistry, and distribution of the Genus Fagaropsis (Rutaceae). Journal of ethnopharmacology284, 114781.
  7. Xu, Y., Liu, J., Zeng, Y., Jin, S., Liu, W., Li, Z., Qin, X., & Bai, Y. (2022). Traditional uses, phytochemistry, pharmacology, toxicity and quality control of medicinal genus Aralia: A review. Journal of ethnopharmacology284, 114671.
  8. Peng, Y., Chen, Z., Li, Y., Lu, Q., Li, H., Han, Y., Sun, D., & Li, X. (2022). Combined therapy of Xiaoer Feire Kechuan oral liquid and azithromycin for mycoplasma Pneumoniae pneumonia in children: A systematic review & meta-analysis. Phytomedicine : international journal of phytotherapy and phytopharmacology96, 153899.
  9. Xu, W., Li, B., Xu, M., Yang, T., & Hao, X. (2022). Traditional Chinese medicine for precancerous lesions of gastric cancer: A review. Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie146, 112542.
  10. Wang, Y., Greenhalgh, T., Wardle, J., & Oxford TCM Rapid Review Team (2022). Chinese herbal medicine (“3 medicines and 3 formulations”) for COVID-19: rapid systematic review and meta-analysis. Journal of evaluation in clinical practice28(1), 13–32.
  11. Chen, X., Lei, Z., Cao, J., Zhang, W., Wu, R., Cao, F., Guo, Q., & Wang, J. (2022). Traditional uses, phytochemistry, pharmacology and current uses of underutilized Xanthoceras sorbifolium bunge: A review. Journal of ethnopharmacology283, 114747.
  12. Liu, X., Li, Y., Bai, N., Yu, C., Xiao, Y., Li, C., & Liu, Z. (2022). Updated evidence of Dengzhan Shengmai capsule against ischemic stroke: A systematic review and meta-analysis. Journal of ethnopharmacology283, 114675.
  13. Chen, J., Zhu, Z., Gao, T., Chen, Y., Yang, Q., Fu, C., Zhu, Y., Wang, F., & Liao, W. (2022). Isatidis Radix and Isatidis Folium: A systematic review on ethnopharmacology, phytochemistry and pharmacology. Journal of ethnopharmacology283, 114648.
  14. Tian, J., Shasha, Q., Han, J., Meng, J., & Liang, A. (2022). A review of the ethnopharmacology, phytochemistry, pharmacology and toxicology of Fructus Gardeniae (Zhi-zi). Journal of ethnopharmacology, 114984. Advance online publication.
  15. Wong, A. R., Yang, A., Li, M., Hung, A., Gill, H., & Lenon, G. B. (2022). The Effects and Safety of Chinese Herbal Medicine on Blood Lipid Profiles in Placebo-Controlled Weight-Loss Trials: A Systematic Review and Meta-Analysis. Evidence-based complementary and alternative medicine : eCAM2022, 1368576.
  16. Lu, C., Ke, L., Li, J., Wu, S., Feng, L., Wang, Y., Mentis, A., Xu, P., Zhao, X., & Yang, K. (2022). Chinese Medicine as an Adjunctive Treatment for Gastric Cancer: Methodological Investigation of meta-Analyses and Evidence Map. Frontiers in pharmacology12, 797753.
  17. Niu, L., Xiao, L., Zhang, X., Liu, X., Liu, X., Huang, X., & Zhang, M. (2022). Comparative Efficacy of Chinese Herbal Injections for Treating Severe Pneumonia: A Systematic Review and Bayesian Network Meta-Analysis of Randomized Controlled Trials. Frontiers in pharmacology12, 743486.
  18. Zhang, L., Huang, J., Zhang, D., Lei, X., Ma, Y., Cao, Y., & Chang, J. (2022). Targeting Reactive Oxygen Species in Atherosclerosis via Chinese Herbal Medicines. Oxidative medicine and cellular longevity2022, 1852330.
  19. Zhou, X., Guo, Y., Yang, K., Liu, P., & Wang, J. (2022). The signaling pathways of traditional Chinese medicine in promoting diabetic wound healing. Journal of ethnopharmacology282, 114662.
  20. Yang, M., Shen, C., Zhu, S. J., Zhang, Y., Jiang, H. L., Bao, Y. D., Yang, G. Y., & Liu, J. P. (2022). Chinese patent medicine Aidi injection for cancer care: An overview of systematic reviews and meta-analyses. Journal of ethnopharmacology282, 114656.
  21. Liu, H., & Wang, C. (2022). The genus Asarum: A review on phytochemistry, ethnopharmacology, toxicology and pharmacokinetics. Journal of ethnopharmacology282, 114642.
  22. Lin, Z., Zheng, J., Chen, M., Chen, J., & Lin, J. (2022). The Efficacy and Safety of Chinese Herbal Medicine in the Treatment of Knee Osteoarthritis: An Updated Systematic Review and Meta-Analysis of 56 Randomized Controlled Trials. Oxidative medicine and cellular longevity2022, 6887988.
  23. Yu, R., Zhang, S., Zhao, D., & Yuan, Z. (2022). A systematic review of outcomes in COVID-19 patients treated with western medicine in combination with traditional Chinese medicine versus western medicine alone. Expert reviews in molecular medicine24, e5.
  24. Mo, X., Guo, D., Jiang, Y., Chen, P., & Huang, L. (2022). Isolation, structures and bioactivities of the polysaccharides from Radix Hedysari: A review. International journal of biological macromolecules199, 212–222.
  25. Yang, L., Chen, X., Li, C., Xu, P., Mao, W., Liang, X., Zuo, Q., Ma, W., Guo, X., & Bao, K. (2022). Real-World Effects of Chinese Herbal Medicine for Idiopathic Membranous Nephropathy (REACH-MN): Protocol of a Registry-Based Cohort Study. Frontiers in pharmacology12, 760482.
  26. Zhang, R., Zhang, Q., Zhu, S., Liu, B., Liu, F., & Xu, Y. (2022). Mulberry leaf (Morus alba L.): A review of its potential influences in mechanisms of action on metabolic diseases. Pharmacological research175, 106029.
  27. Yuan, J. Y., Tong, Z. Y., Dong, Y. C., Zhao, J. Y., & Shang, Y. (2022). Research progress on icariin, a traditional Chinese medicine extract, in the treatment of asthma. Allergologia et immunopathologia50(1), 9–16.
  28. Zeng, B., Wei, A., Zhou, Q., Yuan, M., Lei, K., Liu, Y., Song, J., Guo, L., & Ye, Q. (2022). Andrographolide: A review of its pharmacology, pharmacokinetics, toxicity and clinical trials and pharmaceutical researches. Phytotherapy research : PTR36(1), 336–364.
  29. Zhang, L., Xie, Q., & Li, X. (2022). Esculetin: A review of its pharmacology and pharmacokinetics. Phytotherapy research : PTR36(1), 279–298.
  30. Wang, D. C., Yu, M., Xie, W. X., Huang, L. Y., Wei, J., & Lei, Y. H. (2022). Meta-analysis on the effect of combining Lianhua Qingwen with Western medicine to treat coronavirus disease 2019. Journal of integrative medicine20(1), 26–33. https://doi.org/10.1016/j.joim.2021.10.005

The amount of reviews alone is remarkable, I think: more than one review per day! Apart from their multitude, the reviews are noteworthy for other reasons as well.

  • Their vast majority arrived at positive or at least encouraging conclusions.
  • Most of the primary studies are from China (and we have often discussed how unreliable these trials are).
  • Many of the primary studies are not accessible.
  • Those that are accessible tend to be of lamentable quality.

I fear that all this is truly dangerous. The medical literature is being swamped with reviews of Chinese herbal medicine and other TCM modalities. Collectively they give the impression that these treatments are supported by sound evidence. Yet, the exact opposite is the case.

The process that is happening in front of our very eyes is akin to that of money laundering. Unreliable and often fraudulent data is being white-washed and presented to us as evidence.

The result:

WE ARE BEING SYSTEMATICALLY MISLED!

This systematic review examined the efficacy of acupressure on depression. Literature searches were performed on PubMed, PsycINFO, Scopus, Embase, MEDLINE, and China National Knowledge (CNKI). Randomized clinical trials (RCTs) or single-group trials in which acupressure was compared with various control methods or baseline (i.e. no treatment) in people with depression were included. Data were synthesized using a random-effects or a fixed-effects model to analyze the impacts of acupressure treatment on depression and anxiety in people with depression. The primary outcome measures were depression symptoms quantified by various means. Subgroups were created, and meta-regression analyses were performed to explore which factors are relevant to the greater or lesser effects of treating symptoms.

A total of 14 RCTs (1439 participants) were identified. Analysis of the between-group showed that acupressure was effective in reducing depression [Standardized mean differences (SMDs) = -0.58, 95%CI: -0.85 to -0.32, P < 0.0001] and anxiety (SMD = -0.67, 95%CI: -0.99 to -0.36, P < 0.0001) in participants with mild-to-moderate primary and secondary depression. Subgroup analyses suggested that acupressure significantly reduced depressive symptoms compared with different controlled conditions and in participants with different ages, clinical conditions, and duration of intervention. Adverse events, including hypotension, dizziness, palpitation, and headache, were reported in only one study.

The authors concluded that the evidence of acupressure for mild-to-moderate depressive symptoms was significant. Importantly, the findings should be interpreted with caution due to study limitations. Future research with a well-designed mixed method is required to consolidate the conclusion and provide an in-depth understanding of potential mechanisms underlying the effects.

I think that more than caution is warranted when interpreting these data. In fact, it would have been surprising if the meta-analyses had NOT generated an overall positive result. This is because in several studies there was no attempt to control for the extra attention or the placebo effect of administering acupressure. In most of the trials where this had been taken care of (i.e. patient-blinded, sham-controlled studies), there were no checks for the success of blinding. Thus it is possible, even likely that many patients correctly guessed what treatment they received. In turn, this means that the outcomes of these trials were also largely due to placebo effects.

Overall, this paper is therefore a prime example of a biased review of biased primary studies. The phenomenon can be aptly described by the slogan:

RUBBISH IN, RUBBISH OUT!

Lian gong (LG), also called Lian Gong Shi Ba Fa, is a form of so-called alternative medicine (SCAM) from China.  More specifically, it is a set of stretching, breathing exercises, and self-massaging techniques aimed at preventing and relieving stress as well as acute pains around the neck, shoulders, back, hips, legs, joints, and connective tissues.  Even though it is relatively new, it is based on old Chinese stretching, breathing, and warm-up exercises dating back more than 1,000 years, including the Eight Silk Brocade (八段錦).  Lian gong has spread rapidly from China to other countries, especially to Japan and Brazil.

Lian Gong was developed by Dr. Zhuang Yuan Ming (1919- ), a traditional Chinese medical doctor, who started conducting a series of clinical trials around 1974 in a Shanghai hospital on patients suffering from a variety of stress-related conditions. Lian Gong is now being promoted as “massage in motion”.

One of the few controlled clinical studies of Liam gong aimed to evaluate the effects of LG on the impact of dizziness on the quality of life and fear of falling in primary health care patients. It was designed as a randomized clinical trial with 36 patients with dizziness not caused by central changes. The participants were randomly assigned to 3 groups:

  • the Liam gong (LG) group ( n = 11),
  • the vestibular rehabilitation (VR) group ( n = 11),
  • the control group ( n = 14).

The treatments were carried out over a period of 12 weeks.

Lian gong reduced the influence of dizziness on the quality of life in physical (1.8 points, 95% confidence interval [CI]: 0.2-3.4), functional (4.0 points, 95% CI: 2.1-5.9), and emotional domains of quality of life (4.4 points, 95% CI: 1.7-7.2), with no differences, compared with VR.

The authors concluded that Lian gong was shown to be an effective balance rehabilitation strategy to reduce the impact of dizziness on quality of life, with similar results to those of VR.

Unfortunately, this study has many flaws – not least its minute sample size. Therefore, the conclusions seem more than a little over-optimistic. I would not be all that surprised to learn that these exercises can have beneficial effects for a range of conditions. What seems doubtful in my view, however, is whether it is superior to more conventional exercise therapies.

This multicenter, randomized, sham-controlled trial was aimed at assessing the long-term efficacy of acupuncture for chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Men with moderate to severe CP/CPPS were recruited, regardless of prior exposure to acupuncture. They received sessions of acupuncture or sham acupuncture over 8 weeks, with a 24-week follow-up after treatment. Real acupuncture treatment was used to create the typical de qi sensation, whereas the sham acupuncture treatment (the authors state they used the Streitberger needle, but the drawing looks more as though they used our device) does not generate this feeling.

The primary outcome was the proportion of responders, defined as participants who achieved a clinically important reduction of at least 6 points from baseline on the National Institutes of Health Chronic Prostatitis Symptom Index at weeks 8 and 32. Ascertainment of sustained efficacy required the between-group difference to be statistically significant at both time points.

A total of 440 men (220 in each group) were recruited. At week 8, the proportions of responders were:

  • 60.6% (95% CI, 53.7% to 67.1%) in the acupuncture group
  • 36.8% (CI, 30.4% to 43.7%) in the sham acupuncture group (adjusted difference, 21.6 percentage points [CI, 12.8 to 30.4 percentage points]; adjusted odds ratio, 2.6 [CI, 1.8 to 4.0]; P < 0.001).

At week 32, the proportions were:

  • 61.5% (CI, 54.5% to 68.1%) in the acupuncture group
  • 38.3% (CI, 31.7% to 45.4%) in the sham acupuncture group (adjusted difference, 21.1 percentage points [CI, 12.2 to 30.1 percentage points]; adjusted odds ratio, 2.6 [CI, 1.7 to 3.9]; P < 0.001).

Twenty (9.1%) and 14 (6.4%) adverse events were reported in the acupuncture and sham acupuncture groups, respectively. No serious adverse events were reported. No significant difference was found in changes in the International Index of Erectile Function 5 score at all assessment time points or in peak and average urinary flow rates at week 8.

The authors concluded that, compared with sham therapy, 20 sessions of acupuncture over 8 weeks resulted in greater improvement in symptoms of moderate to severe CP/CPPS, with durable effects 24 weeks after treatment.

Previous studies of acupuncture for CP/CPPS have been unconvincing. Our own systematic review of 2012 included 9 RCTs and all suggested that acupuncture is as effective as a range of control interventions. Their methodologic quality was variable; most were associated with major flaws. Only one RCT had a Jadad score of more than 3. We concluded that the evidence that acupuncture is effective for chronic prostatitis/chronic pelvic pain syndrome is encouraging but, because of several caveats, not conclusive. Therefore, more rigorous studies seem warranted.
This new study looks definitely more rigorous than the previous ones. But is it convincing? To answer this question, we need to consider a few points.

The study was sponsored by the China Academy of Chinese Medical Sciences and the National Administration of Traditional Chinese Medicine. The trialists originate from the following institutions:

  • 1Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China (Y.S., B.L., Z.Q., J.Z., J.W., X.L., W.W., R.P., H.C., X.W., Z.L.).
  • 2Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China (Y.L.).
  • 3ThedaCare Regional Medical Center – Appleton, Appleton, Wisconsin (K.Z.).
  • 4Hengyang Hospital Affiliated to Hunan University of Chinese Medicine, Hengyang, China (Z.Y.).
  • 5The First Hospital of Hunan University of Chinese Medicine, Changsha, China (W.Z.).
  • 6Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, China (W.F.).
  • 7The First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, China (J.Y.).
  • 8West China Hospital of Sichuan University, Chengdu, China (N.L.).
  • 9China Academy of Chinese Medical Sciences, Beijing, China (L.H.).
  • 10Yantai Hospital of Traditional Chinese Medicine, Yantai, China (Z.Z.).
  • 11Shaanxi Provincial Hospital of Traditional Chinese Medicine, Xi’an, China (T.S.).
  • 12The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China (J.F.).
  • 13Beijing Fengtai Hospital of Integrated Traditional and Western Medicine, Beijing, China (Y.D.).
  • 14Xi’an TCM Brain Disease Hospital, Xi’an, China (H.S.).
  • 15Dongfang Hospital Beijing University of Chinese Medicine, Beijing, China (H.H.).
  • 16Luohu District Hospital of Traditional Chinese Medicine, Shenzhen, China (H.Z.).
  • 17Guizhou University of Traditional Chinese Medicine, Guiyang, China (Q.M.).

These facts, together with the previously discussed notion that clinical trials from China are notoriously unreliable, do not inspire confidence. Moreover, one might well wonder about the authors’ claim that patients were blinded. As pointed out above, the real and sham acupuncture were fundamentally different: the former did generate de qi, while the latter did not! A slightly pedantic point is my suspicion that the trial did not test the efficacy but the effectiveness of acupuncture, if I am not mistaken. Finally, one might wonder what the rationale of acupuncture as a treatment of CP/CPPS might be. As far as I can see, there is no plausible mechanism (other than placebo) to explain the effects.

So, is the evidence that emerged from the new study convincing?

No, in my view, it is not!

In fact, I am surprised that a journal as reputable as the Annals of Internal Medicine published it.

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