The Characteristics of TCM Clinical Trials: A Systematic Review of ClinicalTrials.gov

Chen, Junchao; Huang, Jihan; Li, Jordan V; Lv, Yinghua; He, Yingchun; Zheng, Qingshan

doi:10.1155/2017/9461415

Cited by 32 publications

(23 citation statements)

References 21 publications

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“…Approximately 56% of TCM studies uploaded on clinicaltrials.gov constitute a sample size of fewer than 100 subjects or lack statistical power. Furthermore, these studies are prone to statistical type 2 errors [24], therefore less likely to reject a wrong null hypothesis [25]: this imprecision in study design can lead to serious misinformation regarding e.g. clinical endpoints measured in interventional trials.…”

Section: Quantitative and Qualitative Analysis Of Tcm Publicationsmentioning

confidence: 99%

“…Despite rising registration rates in ClinicalTrials.gov to more than 10 entries/month and over 570 studies completed (45% of all entries), only 50 TCM studies, a total of 9% have reported results [24]. In contrast, more than 50% of conventional drug trials marked as completed on ClinicalTrials.gov reported results [26,27].…”

Section: Quantitative and Qualitative Analysis Of Tcm Publicationsmentioning

confidence: 99%

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A critical examination of the main premises of Traditional Chinese Medicine

Eigenschink

Dearing

Dablander

et al. 2020

Wien Klin Wochenschr

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Traditional Chinese Medicine (TCM) consists of a plethora of therapeutic approaches aiming to both characterize and treat diseases. Its utilization has gained significant popularity in the western world and is even backed by the World Health Organization's decision to include TCM diagnostic patterns into the new revision of the International Classification of Diseases code, the global standard for diagnostic health information. As these developments and potentially far-reaching decisions can affect modern healthcare systems and daily clinical work as well as wildlife conservation, its underlying factual basis must be critically examined. This article therefore provides an overview of the evidence underlying the basic TCM concepts, such as Qi, meridians, acupuncture, pulse and tongue diagnostics as well as traditional herbal treatments. Moreover, it discusses whether scientific literature on TCM reflects the current standard for evidence-based research, as described in good scientific practice and good clinical practice guidelines. Importantly, misinformation regarding the therapeutic efficacy of animal-derived substances has lead and currently leads to problems with wildlife preservation and animal ethics. Nevertheless, the (re-)discovery of artemisinin more than 50 years ago introduced a novel development in TCM: the commingling of Eastern and Western medicine, the appreciation of both systems. The need for more rigorous approaches, fulfilment of and agreement to current guidelines to achieve highquality research are of utmost relevance. Thereby, ancient knowledge of herbal species and concoctions may serve as a possible treasure box rather than Pandora's box.

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Section: Quantitative and Qualitative Analysis Of Tcm Publicationsmentioning

confidence: 99%

Section: Quantitative and Qualitative Analysis Of Tcm Publicationsmentioning

confidence: 99%

A critical examination of the main premises of Traditional Chinese Medicine

Eigenschink

Dearing

Dablander

et al. 2020

Wien Klin Wochenschr

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“…Acupuncture is a therapeutic method from Traditional Chinese Medicine (TCM), and its benefits are especially observed in musculoskeletal diseases 6 . The points in acupuncture are based on meridian theory, a network system linked by the so‐called ‘Qi’ (energy) streaming.…”

Section: Introductionmentioning

confidence: 99%

“…Although acupuncture has been widely performed globally, robust scientific evidence regarding the effectiveness of acupuncture is still considered small, primarily regarding TMD 6,8 . Systematic reviews on acupuncture and TMD highlight the gaps in evidence quality and the absence of conclusive results because available studies show significant limitations 9 .…”

Section: Introductionmentioning

confidence: 99%

Acupuncture for pain, mandibular function and oral health‐related quality of life in patients with masticatory myofascial pain: A randomised controlled trial

Salles‐Neto

Paula²,

Romero

et al. 2020

J of Oral Rehabilitation

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Background Masticatory myofascial pain is the most prevalent muscular temporomandibular disorders (TMD). It primarily affects masseter and temporal muscles. Several treatments, including acupuncture, have been recommended. However, systematic reviews have highlighted gaps in studies and absence of conclusive results. Objectives We performed a randomised controlled clinical trial to evaluate the effectiveness of acupuncture in improving pain, mandibular function and oral health‐related quality of life in women with masticatory myofascial pain. Methods Thirty‐six patients diagnosed with masticatory myofascial pain according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) were divided into the following two groups: acupuncture and control (non‐penetrating acupuncture).Treatment was performed weekly for 5 weeks, and pain, mandibular function and oral health‐related quality of life were evaluated one week before treatment, one week after treatment and one month after treatment. Non‐parametric and parametric tests were used for comparisons between times and treatment groups (significance level of P ≤ .05). Results The acupuncture group showed a significant reduction in pain (P ≤ .01), which was not observed in the control group. Pain intensity was reduced by 61% and 84% at 1 week and 1 month after treatment, respectively. Both groups showed significant improvements in mandibular function and oral health‐related quality of life over time (P ≤ .01). Statistical analysis did not show a significant difference between the groups for any other evaluated outcome (P > .05). Conclusion Although acupuncture was effective in pain reduction, non‐specific factors may have influenced mandibular function and oral health‐related quality of life improvements in both groups, and this needs to be further addressed.

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“…Based on the registered clinical trial data, we have successfully researched for the sample sizes for clinical trials investigating the dosage, 13 reviewed the clinical trials on ginseng, 14 and studied the characteristics of TCM clinical trials. 15 Although Zhang et al analyzed the clinical trials, their study period ended on February 12, 2020, and only 87 intervention trials were studied. 16 The number of COVID-19 clinical trials registered with ClinicalTrials.gov and ChiCTR has grown considerably over the past 3 months.…”

Section: Introductionmentioning

confidence: 99%

<p>Characteristics of COVID-19 Clinical Trials in China Based on the Registration Data on ChiCTR and ClinicalTrials.gov</p>

Huang¹,

He²,

Su³

et al. 2020

DDDT

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This study aimed to evaluate the fundamental characteristics of coronavirus disease (COVID-19) clinical trials registered in China. Methods: COVID-19 clinical trials registered in China were analyzed from databases on ChiCTR and ClinicalTrials.gov. The study designs, samples, primary end points, and intervention measures were evaluated. Results: In total, 262 intervention clinical trials were retrieved on March 10, 2020. Overall, 181 (69.1%) trials involved two groups, 200 (76.3%) trials were randomized parallel trials, 24 (9.2%) trials were double blind, and 60.3% of trials included ≤100 participants. Sixty (22.9%) trials considered symptom improvement as the primary endpoint and 43 (16.4%) trials considered the rate or time at which the subjects became virus-free as the primary endpoint. Of 262 intervention studies, chemical drugs and biological products were studied in 105 (40.1%) intervention studies, of which antiviral drugs accounted for 15.3% and malaria drugs accounted for 8.4% of the studies. Among all trials, 27.9% of the studies used traditional Chinese medicine (TCM), 10.3% used cell therapy, and 5.0% used plasma therapy. Conclusion: This study is the first snapshot of the landscape of COVID-19 clinical trials registered in China and provided the basic features of clinical trial designs for the treatment and prevention of COVID-19 to offer useful information to guide future clinical trials on COVID-19 in other countries.

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The Characteristics of TCM Clinical Trials: A Systematic Review of ClinicalTrials.gov

Cited by 32 publications

References 21 publications

A critical examination of the main premises of Traditional Chinese Medicine

A critical examination of the main premises of Traditional Chinese Medicine

Acupuncture for pain, mandibular function and oral health‐related quality of life in patients with masticatory myofascial pain: A randomised controlled trial

<p>Characteristics of COVID-19 Clinical Trials in China Based on the Registration Data on ChiCTR and ClinicalTrials.gov</p>

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