RETRACTED: Artemisia annua and Artemisia afra tea infusions vs. artesunate-amodiaquine (ASAQ) in treating Plasmodium falciparum malaria in a large scale, double blind, randomized clinical trial

Munyangi, Jérôme; Cornet-Vernet, Lucile; Idumbo, Michel; Chen, Lü; Lutgen, Pierre; Perronne, Christian; Ngombe, Nadège Kabamba; Bianga, Jacques; Mupenda, Bavon; Lalukala, Paul; Mergeai, Guy; Mumba, Dieudonné; Towler, Melissa J.; Weathers, Pamela J.

doi:10.1016/j.phymed.2018.12.002

Cited by 35 publications

(44 citation statements)

References 23 publications

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“…Despite potential suboptimal levels of artemisinin present in the Artemisia annua used for the present study, both 60 and 90% alcohol extracts of Artemisia annua exhibited better activity against stationary phase B. burgdorferi compared to the control antibiotics cefuroxime and doxycycline. One explanation for these results could be that constituents other than artemisinin are important in providing antimicrobial effects, a finding supported by prior studies (59,87). Artemisia annua is generally considered safe provided that the product administered has minimal or no thujone and other terpene derivatives that are potentially neurotoxic (88).…”

Section: Discussionmentioning

confidence: 68%

“…The use of whole plant extracts instead of single constituents offers potential advantages including providing multiple mechanisms of action and synergistic effects that can reduce the risk of developing microbial resistance. An emerging example of this can be seen in malaria treatment where significant resistance has been reported with artemisinin-based combination therapy (ACT) (90,91), whereas preliminary studies show improved efficacy and reduced side-effects when treatment with the whole Artemisia plant is used (87,92).…”

Section: Discussionmentioning

confidence: 99%

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Evaluation of Natural and Botanical Medicines for Activity Against Growing and Non-growing Forms of B. burgdorferi

Feng

Leone

Schweig³

et al. 2020

Front. Med.

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Lyme disease is the most common vector-borne disease in the US and Europe. Although the current recommended Lyme antibiotic treatment is effective for the majority of Lyme disease patients, about 10-20% of patients continue to suffer from persisting symptoms. There have been various anecdotal reports on the use of herbal extracts for treating patients with persisting symptoms with varying degree of improvements. However, it is unclear whether the effect of the herb products is due to their direct antimicrobial activity or their effect on host immune system. In the present study, we investigated the antimicrobial effects of 12 commonly used botanical medicines and three other natural antimicrobial agents for potential anti-Borrelia burgdorferi activity in vitro. Among them, 7 natural product extracts at 1% were found to have good activity against the stationary phase B. burgdorferi culture compared to the control antibiotics doxycycline and cefuroxime. These active botanicals include Cryptolepis sanguinolenta, Juglans nigra (Black walnut), Polygonum cuspidatum (Japanese knotweed), Artemisia annua (Sweet wormwood), Uncaria tomentosa (Cat's claw), Cistus incanus, and Scutellaria baicalensis (Chinese skullcap). In contrast, Stevia rebaudiana, Andrographis paniculata, Grapefruit seed extract, colloidal silver, monolaurin, and antimicrobial peptide LL37 had little or no activity against stationary phase B. burgdorferi. The minimum inhibitory concentration (MIC) values of Artemisia annua, Juglans nigra, and Uncaria tomentosa were quite high for growing B. burgdorferi, despite their strong activity against the non-growing stationary phase B. burgdorferi. On the other hand, the top two active herbs, Cryptolepis sanguinolenta and Polygonum cuspidatum, showed strong activity against both growing B. burgdorferi (MIC = 0.03-0.06% and 0.25-0.5%, respectively) and non-growing stationary phase B. burgdorferi. In subculture studies, only 1% Cryptolepis sanguinolenta extract caused complete eradication, while doxycycline and cefuroxime and other active herbs could not eradicate B. burgdorferi stationary phase cells as many spirochetes were visible after 21-day subculture. Further studies are needed to identify the active constituents of the effective botanicals and evaluate their combinations for more effective eradication of B. burgdorferi in vitro and in vivo. The implications of these findings for improving treatment of persistent Lyme disease are discussed.

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Section: Discussionmentioning

confidence: 68%

Section: Discussionmentioning

confidence: 99%

Evaluation of Natural and Botanical Medicines for Activity Against Growing and Non-growing Forms of B. burgdorferi

Feng

Leone

Schweig³

et al. 2020

Front. Med.

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show abstract

“…A concept in botanical medicine postulates that using a whole plant extract offers several potential advantages over the use of a single constituent, including multiple mechanisms of action, synergism and, in some cases, improved bioavailability as well as less side effects. An example of the clinical benefit in using whole plant extracts over single constituents or analogues may be emerging from the current use of artemisinin-based combination therapy (ACT) for malaria where significant resistance has emerged (74, 75) whereas preliminary studies show improved efficacy and reduce side-effects compared to whole plant treatment (76, 77).…”

Section: Discussionmentioning

confidence: 99%

Evaluation of Natural and Botanical Medicines for Activity against Growing and Non-growing Forms ofB. burgdorferi

Feng

Leone²,

Schweig³

et al. 2019

Preprint

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Lyme disease is the most common vector-borne disease in the US. Although the current recommended Lyme antibiotic treatment can cure the majority of Lyme disease patients, about 10-20% patients continue to suffer from persisting symptoms. There have been various anecdotal reports on the use of herbal extracts for treating patients with persisting symptoms with varying degree of improvements. However, it is unclear whether the effect of the herb products is due to their direct antimicrobial activity or their effect on host immune system. In the present study, we investigated the antimicrobial effects of 12 commonly used botanical medicines and 3 other natural antimicrobial agents for potential anti-Borrelia burgdorferi activity in vitro. Primary criteria for selecting compounds for the present study included agents that had shown significant anti-borrelial effects in previous studies, have favorable safety profiles, and can be absorbed systemically. Among them, 9 natural product extracts at 1% were found to have good activity against the stationary phase B. burgdorferi culture compared to the control antibiotics doxycycline and cefuroxime. These active herbs include Cryptolepis sanguinolenta, Juglans nigra (Black walnut), Polygonum cuspidatum (Japanese knotweed), Artemesia annua (Sweet wormwood), Uncaria tomentosa (Cat’s claw), Cistus incanus, and Scutellaria baicalensis (Chinese skullcap). In contrast, Stevia rebaudiana, Andrographis paniculata, Grapefruit seed extract, colloidal silver, monolaurin, and antimicrobial peptide LL37 had little or no activity against stationary phase B. burgdorferi. The minimum inhibitory concentration (MIC) values of Artemesia annua, Juglans nigra, and Uncaria tomentosa were quite high for growing B. burgdorferi, despite their strong activity against the non-growing stationary phase B. burgdorferi cells. On the other hand, the top two active herbs, Cryptolepis sanguinolenta and Polygonum cuspidatum, showed strong activity against both growing B. burgdorferi (MIC=0.03%-0.06% and 0.25%-0.5% respectively) and non-growing stationary phase B. burgdorferi. In subculture studies, only 1% Cryptolepis sanguinolenta extract caused complete eradication, while current Lyme antibiotics doxycycline and cefuroxime and other active herbs including Polygonum cuspidatum, Artemesia annua, Juglans nigra and Uncaria tomentosa could not eradicate B. burgdorferi stationary phase cells as many spirochetes were visible after 21-day subculture. Further studies are needed to identify the active ingredients of the effective herbs and evaluate their combinations for more effective eradication of B. burgdorferi in vitro and in vivo. The implications of these findings for more effective treatment of persistent Lyme disease are discussed.

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“…[72][73][74][75][76] Such systems have the ability to interrogate multiple chemical components and their combinations simultaneously, without purification of individual constituents. 5,79 These novel, non-targeted platforms also have the advantage of generating strong, testable mechanism of action hypotheses without requiring assumptions or prior knowledge regarding those mechanisms. 77,78 These may include effects by constituents on each others' solubility (or other aspects of bioavailability) or toxicity.…”

Section: In Vitro Modelsmentioning

confidence: 99%

“…A growing number of recent efforts to elucidate the mechanisms of action of traditionally used NPs have reported finding a complex mixture of bioactive constituents that act at multiple targets. [2][3][4][5] Perhaps partly as a result of this still incompletely understood complexity, to date many NIH-supported clinical trials (CTs) a of complex NPs (NPCTs), in particular the majority of large, randomized, controlled clinical trials (RCTs), have failed to reject the "null hypothesis," that is, they detected no significant difference between the intervention and negative controls. [6][7][8] While CTs that fail to reject their null hypothesis can | 43 SORKIN et al still provide invaluable guidance, the results of such trials are often met with concerns that different design choiceswhether of product, dose, timing, participant eligibility criteria, outcomes, etc.-might have yielded a substantially different result.…”

Section: Introductionmentioning

confidence: 99%

Improving natural product research translation: From source to clinical trial

et al. 2019

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While great interest in health effects of natural product (NP) including dietary supplements and foods persists, promising preclinical NP research is not consistently translating into actionable clinical trial (CT) outcomes. Generally considered the gold standard for assessing safety and efficacy, CTs, especially phase III CTs, are costly and require rigorous planning to optimize the value of the information obtained. More effective bridging from NP research to CT was the goal of a Septe mber, 2018 trans disci plina ry workshop. Participants emphasized that replicability and likelihood of successful translation depend on rigor in experimental design, interpretation, and reporting across the continuum of NP research. Discussions spanned good practices for NP characterization and quality control; use and interpretation of models (computational through in vivo) with strong clinical predictive validity; controls for experimental artefacts, especially for in vitro interrogation of bioactivity and mechanisms of action; rigorous assessment and interpretation of prior research; transparency in all reporting; and prioritization of research questions. Natural product clinical trials prioritized based on rigorous, convergent supporting data and current public health needs are most likely to be informative and ultimately affect public health. Thoughtful, coordinated implementation of these practices should enhance the knowledge gained from future NP research. K E Y W O R D S clinical predictive validity, dietary supplements, model systems, rigor and replicability, value of information | 43 SORKIN et al.still provide invaluable guidance, the results of such trials are often met with concerns that different design choiceswhether of product, dose, timing, participant eligibility criteria, outcomes, etc.-might have yielded a substantially different result. Each interventional trial represents a substantial investment, with well-powered Phase III CTs typically consuming more than $10 million and many person-years. 9,10 Additionally, as time and funds are limited, and participant pools may also be constrained, a decision to invest in a CT often precludes pursuing other research questions, 11 which may provide more useful public health-relevant knowledge than an RCT with an insufficient evidence base.

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RETRACTED: Artemisia annua and Artemisia afra tea infusions vs. artesunate-amodiaquine (ASAQ) in treating Plasmodium falciparum malaria in a large scale, double blind, randomized clinical trial

Cited by 35 publications

References 23 publications

Evaluation of Natural and Botanical Medicines for Activity Against Growing and Non-growing Forms of B. burgdorferi

Evaluation of Natural and Botanical Medicines for Activity Against Growing and Non-growing Forms of B. burgdorferi

Evaluation of Natural and Botanical Medicines for Activity against Growing and Non-growing Forms ofB. burgdorferi

Improving natural product research translation: From source to clinical trial

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