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

Chinese studies

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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.

Chinese researchers evaluated the effect of Chinese medicine (CM) on survival time and quality of life (QoL) in patients with small-cell lung cancer (SCLC). They conducted an exploratory and prospective clinical observation. Patients diagnosed with SCLC receiving CM treatment as an add-on to conventional cancer therapies were included and followed up every 3 months. The primary outcome was overall survival (OS), and the secondary outcomes were progression-free survival (PFS) and QoL.

A total of 136 patients including 65 limited-stage SCLC (LS-SCLC) patients and 71 extensive-stage SCLC (ES-SCLC) patients were analyzed. The median OS of ES-SCLC patients was 17.27 months, and the median OS of LS-SCLC was 40.07 months. The survival time was 16.27 months for SCLC patients with brain metastasis, 9.83 months for liver metastasis, 13.43 months for bone metastasis, and 18.13 months for lung metastasis. Advanced age, pleural fluid, liver, and brain metastasis were risk factors, while longer CM treatment duration was a protective factor. QoL assessment indicated that after 6 months of CM treatment, scores increased in function domains and decreased in symptom domains.

The authors concluded that CM treatment might help prolong OS of SCLC patients. Moreover, CM treatment brought the trend of symptom amelioration and QoL improvement. These results provide preliminary evidence for applying CM in SCLC multi-disciplinary treatment.

Sorry, but these results provide NO evidence for applying CM in SCLC multi-disciplinary treatment! Even if the findings were a bit better than those reported for SCLC in the literature – and I am not sure they are – it is simply not possible to say with any degree of certainty what effect the CM had. For that, we would obviously need a proper control group.

The study was supported by the National Natural Science Foundation of China (No. 81673797), and Beijing Municipal Natural Science Foundation (No. 7182142). In my view, this paper is an example for showing how the relentless promotion of dubious Traditional Chinese Medicine by Chinese officials might cost lives.

I feel that it is time to do something about it.

But what precisely?

Any ideas anyone?

 

Acupuncture is a veritable panacea; it cures everything! At least this is what many of its advocates want us to believe. Does it also have a role in supportive cancer care?

Let’s find out.

This systematic review evaluated the effects of acupuncture in women with breast cancer (BC), focusing on patient-reported outcomes (PROs).

A comprehensive literature search was carried out for randomized controlled trials (RCTs) reporting PROs in BC patients with treatment-related symptoms after undergoing acupuncture for at least four weeks. Literature screening, data extraction, and risk bias assessment were independently carried out by two researchers. The authors stated that they followed the ‘Preferred Reporting Items for Systematic Review and Meta-Analyses’ (PRISMA) guidelines.

Out of the 2, 524 identified studies, 29 studies representing 33 articles were included in this meta-analysis. The RCTs employed various acupuncture techniques with a needle, such as hand-acupuncture and electroacupuncture. Sham/placebo acupuncture, pharmacotherapy, no intervention, or usual care were the control interventions. About half of the studies lacked adequate blinding.

At the end of treatment (EOT), the acupuncture patients’ quality of life (QoL) was measured by the QLQ-C30 QoL subscale, the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES), the Functional Assessment of Cancer Therapy–General/Breast (FACT-G/B), and the Menopause-Specific Quality of Life Questionnaire (MENQOL), which depicted a significant improvement. The use of acupuncture in BC patients lead to a considerable reduction in the scores of all subscales of the Brief Pain Inventory-Short Form (BPI-SF) and Visual Analog Scale (VAS) measuring pain. Moreover, patients treated with acupuncture were more likely to experience improvements in hot flashes scores, fatigue, sleep disturbance, and anxiety compared to those in the control group, while the improvements in depression were comparable across both groups. Long-term follow-up results were similar to the EOT results. Eleven RCTs did not report any information on adverse effects.

The authors concluded that current evidence suggests that acupuncture might improve BC treatment-related symptoms measured with PROs including QoL, pain, fatigue, hot flashes, sleep disturbance and anxiety. However, a number of included studies report limited amounts of certain subgroup settings, thus more rigorous, well-designed and larger RCTs are needed to confirm our results.

This review looks rigorous on the surface but has many weaknesses if one digs only a little deeper. To start with, it has no precise research question: is any type of acupuncture better than any type of control? This is not a research question that anyone can answer with just a few studies of mostly poor quality. The authors claim to follow the PRISMA guidelines, yet (as a co-author of these guidelines) I can assure you that this is not true. Many of the included studies are small and lacked blinding. The results are confusing, contradictory and not clearly reported. Many trials fail to mention adverse effects and thus violate research ethics, etc., etc.

The conclusion that acupuncture might improve BC treatment-related symptoms could be true. But does this paper convince me that acupuncture DOES improve these symptoms?

No!

Qigong can be described as a mind-body-spirit practice that improves one’s mental and physical health by integrating posture, movement, breathing technique, self-massage, sound, and focused intent. But does it really improve health?

The purpose of this review was to evaluate the effectiveness of Qigong in improving the quality of life and relieving fatigue, sleep disturbance, and cancer-related emotional disturbances (distress, depression, and anxiety) in women with breast cancer.

The PubMed, Cochrane Central Register of Controlled Trials, Web of Science, Sinomed, Wanfang, VIP, and China National Knowledge Infrastructure databases were searched from their inceptions to March 2020 for controlled clinical trials. Two reviewers selected relevant trials that assessed the benefit of Qigong for breast cancer patients independently. A methodological quality assessment was conducted according to the criteria of the 12 Cochrane Back Review Group for risk of bias independently. A meta-analysis was performed using Review Manager 5.3.

A total of 17 trials were found in which 1236 cases were enrolled. The quality of the included trials was generally low, as only 5 of them were rated high quality. 14 studies were conducted in China. The types of qigong included Baduanjin Qigong (9 trials), Chan-Chuang Qigong (1 trial), Goulin New Qigong (2 Trials), Tai Chi Qigong (2 Trials), and Kuala Lumpur Qigong (1 trial). The course of qigong ranged from 21 days to more than 6 months. Four trials compared qigong to no treatment, one sham Qigong, seven compared to other types of exercise, and 6 to usual care.

The results showed significant positive effects of Qigong on quality of life (n = 950, standardized mean difference (SMD), 0.65, 95 % confidence interval (CI) 0.23–1.08, P =  0.002). Depression (n = 540, SMD = −0.32, 95 % CI −0.59 to −0.04, P =  0.02) and anxiety (n = 439, SMD = −0.71, 95 % CI −1.32 to −0.10, P =  0.02) were also significantly relieved in the Qigong group. There was no significant benefit on fatigue (n = 401, SMD = −0.32, 95 % CI  0.71 to 0.07, P = 0.11) or sleep disturbance relief compared to that observed in the control group (n = 298, SMD = −0.11, 95 % CI  0.74 to 0.52, P = 0.73).

The authors concluded that this review shows that Qigong is beneficial for improving quality of life and relieving depression and anxiety; thus, Qigong should be encouraged in women with breast cancer.

No, this review does not show that Qigong is beneficial for improving quality of life and relieving depression and anxiety!

Why?

  1. Most primary studies were of very poor quality.
  2. Most were from China, and we know (and have often discussed) that such trials are most unreliable.
  3. No trial even attempted to control for placebo effects.

A better conclusion would therefore be something like this:

Even though most trials conclude positively, the value of Qigong can, for a range of reasons, not be determined on the basis of the evidence available to date.

Thread embedding acupuncture therapy (TEAT) involves the insertion of thread at specific points on the body surface. The claim is that TEAT provides a sustained stimulation of acupoints and is therefore superior to needle acupuncture. Initially, TEAT was used in China to treat obesity, today it is employed to treat many conditions, including musculoskeletal conditions such as ankle sprain, shoulder pain, lumbar intervertebral disc herniation, and plantar fasciitis. Its effectiveness is, however, doubtful and so is its safety.

This review evaluated the safety of thread embedding acupuncture therapy (TEAT) and discuss the prevention and treatment of some adverse events (AEs).

Databases, including China National Knowledge Infrastructure (CNKI), CBMdisc, Wanfang, VIP databases and PubMed, MEDLINE, EMBASE, and Web of Science, were searched from their inception to January 2020. Included were randomized controlled trials (RCTs) and case reports in which AEs with TEAT were reported. Cochrane Collaboration’s tool and RevMan V.5.3.3 software were used to evaluate the quality of the studies.

A total of 61 articles (45 RCTs and 16 case reports) with a total of 620 cases of AEs were included in this review. These studies were published in two countries: China and South Korea. Twenty-eight kinds of AEs were noted. The most common AEs were induration, bleeding and ecchymosis, redness and swelling, fever, and pain. They accounted for 75.35% of all AEs.  Most AEs were mild.; The rarest AEs were epilepsy, irregular menstruation, skin ulcer, thread malabsorption, and fat liquefaction, with 1 case each. Not all of them had a clear causal relationship with TEAT. Most of the AEs were local reactions and systemic reactions accounted for only 1.27%. Although the included studies showed that AEs were very commonly encountered (11.09%), only 5 cases of severe AEs reported from 2013 to 2017 (0.1%) by using catgut thread, which is rarely employed nowadays with new absorbable surgical suture being more popular. All of the patients with severe AEs were recovered after symptomatic treatment with no sequelae.

The authors concluded that the evidence showed that TEAT is a relatively safe and convenient therapy especially since application of new absorbable surgical suture. Improving practitioner skills, regulating operations, and paying attention to the patients’ conditions may reduce the incidence of AEs and improve safety of TEAT.

TEAT was initially used in China only but recently it has become popular elsewhere as well. Therefore the question about its risks has become relevant. The present paper is interesting in that it demonstrates that AEs do occur with some regularity. The authors’ conclusion that TEAT is “relatively safe” is, however, not justified because:

  1. the total sample size was not large enough for a generalizable conclusion;
  2. only RCTs and case reports were included, whereas case series and case-control studies (which would provide more relevant data) were excluded or might not even exist;
  3. RCTs of acupuncture often fail to mention or under-report AEs;
  4. acupuncture papers from China are notoriously unreliable.

So, all we can conclude from the evidence presented here is that AEs after TEAT do occur and do not seem to be all that rare. As the efficacy of TEAT has not been shown beyond doubt, this must inevitably lead to the conclusion that the risk-benefit balance of TEAT is not positive. In turn, that means that TEAT cannot be recommended as a treatment for any condition.

 

The Chinese have made several attempts to persuade us that their traditional remedies are effective for COVID-19 infections. Here is yet another one. This review summarised the evidence of the therapeutic effects and safety of Chinese herbal medicine (CHM) used with or without conventional western therapy for COVID-19. All clinical studies of the therapeutic effects and safety of CHM for COVID-19 were included. The authors

  • summarized the general characteristics of included studies,
  • evaluated the methodological quality of the randomized controlled trials (RCTs) using the Cochrane risk of bias tool,
  • analyzed the use of CHM,
  • used Revman 5.4 software to present the risk ratio (RR) or mean difference (MD) and their 95% confidence interval (CI) to estimate the therapeutic effects and safety of CHM.

A total of 58 clinical studies were identified including;

  • 10 RCTs,
  • 1 non-randomized controlled trials,
  • 11 retrospective studies with a control group,
  • 12 case-series,
  • 24 case-reports.

All of the studies had been performed in China. No RCTs of high methodological quality were identified. The most frequently tested oral Chinese patent medicine, Chinese herbal medicine injection, or prescribed herbal decoction were:

  • Lianhua Qingwen granule/capsule,
  • Xuebijing injection,
  • Maxing Shigan Tang.

The pooled analyses showed that there were statistical differences between the intervention group and the comparator group (RR 0.42, 95% CI 0.21 to 0.82, six RCTs; RR 0.38, 95% CI 0.23 to 0.64, five retrospective studies with a control group), indicating that CHM plus conventional western therapy appeared to be better than conventional western therapy alone in reducing aggravation rate.

In addition, compared with conventional western therapy, CHM plus conventional western therapy had the potential advantages in increasing the recovery rate and shortening the duration of fever, cough, and fatigue, improving the negative conversion rate of nucleic acid test, and increasing the improvement rate of chest CT manifestations and shortening the time from receiving the treatment to the beginning of chest CT manifestations improvement.

For adverse events, the pooled data showed that there were no statistical differences between the CHM and the control groups.

The authors concluded that current low certainty evidence suggests that there maybe a tendency that CHM plus conventional western therapy is superior to conventional western therapy alone. The use of CHM did not increase the risk of adverse events.

One of the principles to remember here is this: RUBBISH IN, RUBBISH OUT. If you meta-analyze primary data that are rubbish, your findings can only be rubbish as well.

All one needs to know about the primary data entered into the present analysis is that there were no rigorous RCTs… not one! That means the evidence is, as the authors rightly but modestly conclude of LOW CERTAINTY. My conclusions would have been a little different:

  1. In terms of safety, the dataset is too small and unreliable to make any judgment.
  2. In terms of efficacy, there is no sound data that CHM has a positive effect.
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