Efficacy and safety of a supplement combination for hand osteoarthritis pain: protocol for an internet-based randomised placebo-controlled trial (The RADIANT study)

Liu, Xiaoqian; Robbins, Sarah R; Eyles, Jillian; Федорова, Т. А.; Virk, Sonika; Deveza, Leticia A; McLachlan, Andrew J.; Hunter, David J.

doi:10.1136/bmjopen-2019-035672

Cited by 5 publications

(13 citation statements)

References 47 publications

(51 reference statements)

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“…Thirty‐five trials reported durations that ranged from 1 month to 13 years (median 11 mo). The lead investigators of over half (30) of the trials were based in North America, 18–47 11 were in the UK, 48–58 3 in other European countries 59–61 and 1 in Australia 62 . Most trials (40) included participants only in the country of the lead investigator; however, 4 trials included participants in 2 countries, 33,39,46,50 and 1 reported participants in more than 2 countries (11 countries, 5 continents) 24 …”

Section: Resultsmentioning

confidence: 99%

“…12 tested dietary supplements 19,21,[27][28][29]32,34,49,[58][59][60]62 or herbal medicines; 6 tested licensed medicines for new or extended indications [43][44][45][46]52,55 ; and 6 tested not yet licensed medicines. 20,26,30,38,56,61 Of the remainder, there were 3 device trials, [40][41][42] 3 screening trials 36,37,51 and 1 trial testing a methodological intervention (remote set-up of mobile health technology for a longitudinal cohort study).…”

Section: Description Of Included Trialsmentioning

confidence: 99%

“…20,46,47 None of the incomplete trials (n = 16) was assessed as being at a high risk of bias. We evaluated 3 as being at low risk of bias, 54,61,62 while the remaining 14 presented some concerns, primarily due to limited available information.…”

Section: Risk Of Biasmentioning

confidence: 99%

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A systematic review of methods used to conduct decentralised clinical trials

Rogers

Paoli

Subbarayan

et al. 2022

Brit J Clinical Pharma

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Aims: To evaluate, using quantitative and qualitative approaches, published data on the design and conduct of decentralised clinical trials (DCTs).Methods: We searched MEDLINE, EMBASE, CENTRAL, PsycINFO, ProQuest Dissertations and Theses, ClinicalTrials.gov, OpenGrey and Google Scholar for publications reporting, discussing, or evaluating decentralised clinical research methods. Reports of randomised clinical trials using decentralised methods were included in a focused quantitative analysis with a primary outcome of number of randomised participants.All publications discussing or evaluating DCTs were included in a wider qualitative analysis to identify advantages, disadvantages, facilitators, barriers and stakeholder opinions of decentralised clinical trials. Quantitative data were summarised using descriptive statistics, and qualitative data analysed using a thematic approach.Results: Initial searches identified 19 704 articles. After removal of duplicates, 18 553 were screened, resulting in 237 eligible for full-text assessment. Forty-five trials were included in the quantitative analysis; 117 documents were included in the qualitative analysis. Trials were widely heterogeneous in design and reporting, precluding meta-analysis of the effect of DCT methods on the primary recruitment outcome. Qualitative analysis formulated 4 broad themes: value, burden, safety and equity. Participant and stakeholder experiences of DCTs were incompletely represented. Conclusion:DCTs are developing rapidly. However, there is insufficient evidence to confirm which methods are most effective in trial recruitment, retention, or overall cost. The identified advantages, disadvantages, facilitators and barriers should inform the development of DCT methods. We recommend further research on how DCTs are experienced and perceived by participants and stakeholders to maximise potential benefits.

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Section: Resultsmentioning

confidence: 99%

Section: Description Of Included Trialsmentioning

confidence: 99%

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A systematic review of methods used to conduct decentralised clinical trials

Rogers

Paoli

Subbarayan

et al. 2022

Brit J Clinical Pharma

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“…The bioavailability of curcumin is a major challenge because it is inherently low in humans, but new formulations have enhanced the therapeutic efficacy of curcumin [ 142 , 143 ]. Furthermore, the use of curcumin in combination with other natural products, such as Boswellia serrate , gingerly, and pipeline, are being studied in several clinical trials to investigate whether their therapeutically synergy enhances their performance in OA treatment but the results showed no significant difference between each component separately or in combination [ 144 , 145 , 146 ].…”

Section: Natural-compound-based Treatments For Oa Therapymentioning

confidence: 99%

Emerging Natural-Product-Based Treatments for the Management of Osteoarthritis

et al. 2021

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Osteoarthritis (OA) is a complex degenerative disease in which joint homeostasis is disrupted, leading to synovial inflammation, cartilage degradation, subchondral bone remodeling, and resulting in pain and joint disability. Yet, the development of new treatment strategies to restore the equilibrium of the osteoarthritic joint remains a challenge. Numerous studies have revealed that dietary components and/or natural products have anti-inflammatory, antioxidant, anti-bone-resorption, and anabolic potential and have received much attention toward the development of new therapeutic strategies for OA treatment. In the present review, we provide an overview of current and emerging natural-product-based research treatments for OA management by drawing attention to experimental, pre-clinical, and clinical models. Herein, we review current and emerging natural-product-based research treatments for OA management.

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“…Отмечалось 34 несерьезных нежелательных явления в группе комбинированной терапии (кожные реакции и обострения боли, связанные с физической нагрузкой). Позже этот же авторский коллектив в РКИ RADIANT показал отсутствие эффекта от приема пищевых растительных добавок на симптомы ОА кистей [35][36][37].…”

Section: преимущества топических нпвп содержащих диклофенакunclassified

Local anti-inflammatory therapy for osteoarthritis with high comorbidity

2021

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Osteoarthritis (OA) is a widespread disease, the leading symptom of which is pain in the load-bearing joints, and the incidence increases with age. Many patients with OA have several comorbidities, such as arterial hypertension, coronary heart disease, diabetes mellitus, gastric and duodenal ulcers. Currently, there are different approaches to the treatment of OA with and without comorbidity. In particular, oral non-steroidal anti-inflammatory drugs (NSAIDs) are not recommended for OA with high comorbidity. The literature review discusses the prospects and popularity of the use of local forms of NSAIDs associated with their equal analgesic efficacy relative to oral drugs, but with a smaller number of adverse events. Data on transcutaneous forms of diclofenac are analyzed, which can provide at least oral equivalent analgesia, improved physical function and reduced stiffness in osteoarthritis of the hands and knee joints, while showing fewer systemic adverse events. This feature of topical NSAIDs allows them to be considered as an effective first-line treatment option, especially in elderly patients and those with severe comorbidity. Topical medications containing diclofenac as the main active ingredient are popular among both patients and doctors, and their use has an extensive evidence base. Diclofenac ethylenediamine salt has advantages over sodium salt in its penetrating properties, and the form of an emulsion gel containing a hydrophobic phase that slows down the drying of the substance applied to the skin provides ease of use and improves the consumer properties of agents for local antiinflammatory therapy of osteoarthritis.

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Efficacy and safety of a supplement combination for hand osteoarthritis pain: protocol for an internet-based randomised placebo-controlled trial (The RADIANT study)

Cited by 5 publications

References 47 publications

A systematic review of methods used to conduct decentralised clinical trials

A systematic review of methods used to conduct decentralised clinical trials

Emerging Natural-Product-Based Treatments for the Management of Osteoarthritis

Local anti-inflammatory therapy for osteoarthritis with high comorbidity

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