Non-specific effects of acupuncture and sham acupuncture in clinical trials from the patient's perspective

Background Previous clinical trials have demonstrated that both acupuncture and sham acupuncture exert significant, non-specific effects on treatment outcomes when compared to no-treatment controls. A recently developed framework (mechanisms in orthodox and complementary and alternative medicine—MOCAM) suggests that the non-specific effects of acupuncture originate from multiple domains (e.g. patient characteristics, acupuncturist skill/technique, the patient–acupuncturist relationship, and the acupuncture environment). However, it remains to be determined precisely how these domains influence the non-specific effects of treatment among patients receiving acupuncture and sham acupuncture in clinical trials. Therefore, we conducted a systematic review to synthesize existing qualitative evidence on how trial participants randomized to acupuncture and sham acupuncture groups experience non-specific effects, regardless of the types of medical condition investigated. Methods This systematic review included primary qualitative studies embedded in randomized controlled trials designed to investigate acupuncture or sham acupuncture interventions. Eligible studies published in English were derived from a search of five international databases. The methodological quality of included studies was evaluated using the Critical Appraisal Skills Programme (CASP) tool. Using a framework synthesis approach, the identified MOCAM framework was adapted based on the synthesis of the available qualitative evidence. Results A total of 20 studies of high methodological quality were included. Our proposed model indicated that the effects of acupuncture may be increased by maintaining a professional status, applying a holistic treatment approach, practicing empathy, and providing patients with an appropriate explanation of the theory behind acupuncture and sham acupuncture. From the patient’s perspective, the efficacy of treatment can be increased by following the lifestyle modification advice provided by acupuncturists, maintaining a positive attitude toward treatment efficacy, actively engaging with acupuncturists during consultation, and making behavioral changes based on experience gained during the trial. Conclusion The results of this study may provide a basis for improving and standardizing key components of non-specific effects in acupuncture treatment, and for improving the isolation of specific effects in future clinical trials involving acupuncture and sham acupuncture.

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Review: Acupuncture Analgesia in Clinical Trials

The American Journal of Chinese Medicine ◽

10.1142/s0192415x09006679 ◽

2009 ◽

Vol 37 (01) ◽

pp. 1-18 ◽

Cited By ~ 46

Author(s):

Jaung Geng Lin ◽

Wei Liang Chen

Keyword(s):

Clinical Trials ◽

Back Pain ◽

Lower Back Pain ◽

Placebo Effect ◽

Chronic Headache ◽

Sham Acupuncture ◽

Osteoarthritis Of The Knee ◽

Specific Effects ◽

Lower Back ◽

Almost All

Acupuncture treatment has been accepted worldwide. Many clinical trials have been conducted especially in analgesia. The present review includes almost all the important trials since 1970. Among all the pain conditions, postoperative pain, lower back pain, osteoarthritis of the knee and chronic headache are the most popular topics. We found that there are diverse conclusions in each condition; however, most trials agree that acupuncture is an effective therapeutic strategy for analgesia. As with regard to the placebo effect, there is no consensus. In chronic headache treatment, the placebo effect of acupuncture seems to be large. However, in osteoarthritis, the placebo effect is minimal. Another issue is the non-specific physiologic response to piercing the skin. We believe that this effect produces analgesia in some heterogeneous syndrome such as lower back pain. However, this effect is not superior to the specific therapeutic effect of acupuncture based on TCM theory in all the pain conditions reviewed here. We also notice that the design of the sham acupuncture or the placebo has great impact on the result. Rigorous design can minimize the non-specific and placebo effects of acupuncture. Therefore, the real effect of acupuncture can be investigated well. We conclude that acupuncture is a proven treatment for relieving pain. This conclusion is based on specific effects of acupuncture rather than placebo.

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Preclinical evaluation of eltrombopag in a PDX model of myelodysplastic syndromes

Leukemia ◽

10.1038/s41375-021-01327-w ◽

2021 ◽

Author(s):

Nanni Schmitt ◽

Johann-Christoph Jann ◽

Eva Altrock ◽

Johanna Flach ◽

Justine Danner ◽

...

Keyword(s):

Clinical Trials ◽

Myelodysplastic Syndromes ◽

Preclinical Study ◽

Preclinical Research ◽

Individual Level ◽

Specific Effects ◽

Pdx Model ◽

Whole Exome ◽

Thrombopoietin Receptor ◽

Therapeutic Concepts

AbstractPreclinical research of myelodysplastic syndromes (MDSs) is hampered by a lack of feasible disease models. Previously, we have established a robust patient-derived xenograft (PDX) model for MDS. Here we demonstrate for the first time that this model is applicable as a preclinical platform to address pending clinical questions by interrogating the efficacy and safety of the thrombopoietin receptor agonist eltrombopag. Our preclinical study included n = 49 xenografts generated from n = 9 MDS patient samples. Substance efficacy was evidenced by FACS-based human platelet quantification and clonal bone marrow evolution was reconstructed by serial whole-exome sequencing of the PDX samples. In contrast to clinical trials in humans, this experimental setup allowed vehicle- and replicate-controlled analyses on a patient–individual level deciphering substance-specific effects from natural disease progression. We found that eltrombopag effectively stimulated thrombopoiesis in MDS PDX without adversely affecting the patients’ clonal composition. In conclusion, our MDS PDX model is a useful tool for testing new therapeutic concepts in MDS preceding clinical trials.

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Antitumoral and Anti-inflammatory Roles of Somatostatin and Its Analogs in Hepatocellular Carcinoma

Analytical Cellular Pathology ◽

10.1155/2021/1840069 ◽

2021 ◽

Vol 2021 ◽

pp. 1-13

Author(s):

Argyrios Periferakis ◽

Georgios Tsigas ◽

Aristodemos-Theodoros Periferakis ◽

Ioana Anca Badarau ◽

Andreea-Elena Scheau ◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Clinical Trials ◽

Primary Liver Cancer ◽

Somatostatin Receptors ◽

Metastatic Potential ◽

Cancer Staging ◽

Complete Evaluation ◽

Specific Effects

Hepatocellular carcinoma (HCC) is the most common primary liver cancer and affects about 8% of cirrhotic patients, with a recurrence rate of over 50%. There are numerous therapies available for the treatment of HCC, depending on cancer staging and condition of the patient. The complexity of the treatment is also justified by the unique pathogenesis of HCC that involves intricate processes such as chronic inflammation, fibrosis, and multiple molecular carcinogenesis events. During the last three decades, multiple in vivo and in vitro experiments have used somatostatin and its analogs (SSAs) to reduce the proliferative and metastatic potential of hepatoma cells by inducing their apoptosis and reducing angiogenesis and the inflammatory component of HCC. Most experiments have proven successful, revealing several different pathways and mechanisms corresponding to the aforementioned functions. Moreover, a correlation between specific effects and expression of somatostatin receptors (SSTRs) was observed in the studied cells. Clinical trials have tested either somatostatin or an analog, alone or in combination with other drugs, to explore the potential effects on HCC patients, in various stages of the disease. While the majority of these clinical trials exhibited minor to moderate success, some other studies were inconclusive or even reported negative outcomes. A complete evaluation of the efficacy of somatostatin and SSAs is still the matter of intense debate, and, if deemed useful, these substances may play a beneficial role in the management of HCC patients.

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Diversity spectrum analysis identifies mutation-specific effects of cancer driver genes

Communications Biology ◽

10.1038/s42003-019-0736-4 ◽

2020 ◽

Vol 3 (1) ◽

Cited By ~ 2

Author(s):

Xiaobao Dong ◽

Dandan Huang ◽

Xianfu Yi ◽

Shijie Zhang ◽

Zhao Wang ◽

...

Keyword(s):

Clinical Trials ◽

Spectrum Analysis ◽

Driver Mutations ◽

Driver Gene ◽

Cancer Type ◽

Driver Genes ◽

Drug Responses ◽

Cancer Driver ◽

Specific Effects ◽

Cancer Driver Genes

AbstractMutation-specific effects of cancer driver genes influence drug responses and the success of clinical trials. We reasoned that these effects could unbalance the distribution of each mutation across different cancer types, as a result, the cancer preference can be used to distinguish the effects of the causal mutation. Here, we developed a network-based framework to systematically measure cancer diversity for each driver mutation. We found that half of the driver genes harbor cancer type-specific and pancancer mutations simultaneously, suggesting that the pervasive functional heterogeneity of the mutations from even the same driver gene. We further demonstrated that the specificity of the mutations could influence patient drug responses. Moreover, we observed that diversity was generally increased in advanced tumors. Finally, we scanned potentially novel cancer driver genes based on the diversity spectrum. Diversity spectrum analysis provides a new approach to define driver mutations and optimize off-label clinical trials.

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Controlling for non-specific effects of acupuncture in clinical trials

Clinical Acupuncture and Oriental Medicine ◽

10.1016/s1461-1449(03)00025-2 ◽

2003 ◽

Vol 4 (2-3) ◽

pp. 59-70 ◽

Cited By ~ 32

Author(s):

Stephen Birch

Keyword(s):

Clinical Trials ◽

Specific Effects

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Review of controlled clinical trials on acupuncture versus sham acupuncture in Germany

Journal of Traditional Chinese Medicine ◽

10.1016/s0254-6272(13)60187-9 ◽

2013 ◽

Vol 33 (3) ◽

pp. 403-407 ◽

Cited By ~ 12

Author(s):

Wei He ◽

Yuanyuan Tong ◽

Yingkai Zhao ◽

Li Zhang ◽

Hui Ben ◽

...

Keyword(s):

Clinical Trials ◽

Sham Acupuncture ◽

Controlled Clinical Trials

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Acupuncture for Managing Cancer-Related Insomnia: A Systematic Review of Randomized Clinical Trials

Integrative Cancer Therapies ◽

10.1177/1534735416664172 ◽

2016 ◽

Vol 16 (2) ◽

pp. 135-146 ◽

Cited By ~ 19

Author(s):

Tae-Young Choi ◽

Jong In Kim ◽

Hyun-Ja Lim ◽

Myeong Soo Lee

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Sleep Quality ◽

Randomized Clinical Trials ◽

Data Extraction ◽

Meta Analysis ◽

Sham Acupuncture ◽

Risk Of Bias ◽

The Other ◽

Level Of Evidence

Background. Insomnia is a prominent complaint of cancer patients that can significantly affect their quality of life and symptoms related to sleep quality. Conventional drug approaches have a low rate of success in alleviating those suffering insomnia. The aim of this systematic review was to assess the efficacy of acupuncture in the management of cancer-related insomnia. Methods. A total of 12 databases were searched from their inception through January 2016 without language restriction. Randomized controlled trials (RCTs) and quasi-RCTs were included if acupuncture was used as the sole intervention or as an adjunct to another standard treatment for any cancer-related insomnia. The data extraction and the risk of bias assessments were performed by 2 independent reviewers. Results. Of the 90 studies screened, 6 RCTs were included. The risk of bias was generally unclear or low. Three RCTs showed equivalent effects on the Pittsburgh Sleep Quality Index and 2 RCTs showed the similar effects on response rate to those of conventional drugs at the end of treatment. The other RCT showed acupuncture was better than hormone therapy in the numbers of hours slept each night and number of times woken up each night. The 3 weeks of follow-up in 2 RCTs showed superior effects of acupuncture compared with conventional drugs, and a meta-analysis showed significant effects of acupuncture. Two RCTs tested the effects of acupuncture on cancer-related insomnia compared with sham acupuncture. One RCT showed favourable effects, while the other trial failed to do so. Conclusion. There is a low level of evidence that acupuncture may be superior to sham acupuncture, drugs or hormones therapy. However, the number of studies and effect size are small for clinical significance. Further clinical trials are warranted.

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