Issues with Tissues: Trends in Tissue-Engineered Products in Clinical Trials in the European Union.

Tissue-engineered products (TEPs) consist of engineered cells or tissues produced to regenerate, repair, or replace a dysfunctional, diseased, or absent human tissue. TEPs make up <5% of all advanced therapeutic medicinal products (ATMPs) in clinical trials and received 5.1% of ATMP-designated funding in trials in the European Union (EU) in 2019, highlighting the relatively low proportion of TEPs being developed.

CARE guidelines for case reports: explanation and elaboration document.

Background: Well-written and transparent case reports (1) reveal early signals of potential benefits, harms, and information on the use of resources; (2) provide information for clinical research and clinical practice guidelines, and (3) inform medical education. High-quality case reports are more likely when authors follow reporting guidelines. During 2011-2012, a group of clinicians, researchers, and journal editors developed recommendations for the accurate reporting of information in case reports that resulted in the CARE (CAse REport) Statement and Checklist.

Proposal for publishing and parallel reporting of case reports on adverse drug reactions to authorities by physicians.

For the safe use of medicinal products, it is important that physicians publish adverse experiences with a medicinal product-particularly regarding side effects-in the scientific literature. However, when searching applicable publications, we determined that adverse drug reactions (ADRs) are often published several months after their occurrence. In the context of patient safety, this is rather questionable as new and important information on ADRs is not available quickly enough to be considered in pharmacovigilance systems.

Is autologous chondrocyte implantation (ACI) an adequate treatment option for repair of cartilage defects in paediatric patients?

Cartilage lesions in the knee of juvenile patients require an effective repair to regain life-long functional activity of the joint. Autologous chondrocyte implantation (ACI) is discussed to be advantageous over other methods for cartilage repair regarding long-term outcome. ACI has successfully been applied in juvenile patients, although currently recommended for patients ≥18 years of age.

A Homeopathic Arnica Patch for the Relief of Cellulitis-derived Pain and Numbness in the Hand.

Objectives: Arnica montana, belonging to the Compositae family, is a plant with a longstanding tradition of relieving pain and/or inflammation in muscles and joints and may thus represent an alternative to nonsteroidal antiinflammatory drugs, which are often ineffective or lead to a number of adverse effects. A homeopathic arnica patch (3X dilution according to the Homeopathic Pharmacopoeia of the United States) was developed to alleviate pain symptoms in the back and neck muscles and joints.

Case Presentation: The present case report describes the treatment outcome after administration of the arnica patch in a 55-year-old female patient with pain in the right hand and numbness in the fourth finger after cellulitis in the palmar area.

Case reports on cancer therapies: the urgent need to improve the reporting quality.

Current guidelines for certain cancer therapies mainly provide recommendations for therapy options treating the primary tumors. However, first-choice treatments for advanced or metastasizing tumors are described only rarely if at all. In such cases, one or more individual treatment options are chosen by the physician depending on the medical need of the patient and considering the acceptance of this treatment by the patient.

One-Year Clinical and Radiological Results of a Prospective, Investigator-Initiated Trial Examining a Novel, Purely Autologous 3-Dimensional Autologous Chondrocyte Transplantation Product in the Knee.

Background: The 3-dimensional autologous chondrocyte transplantation (ACT3D) comprises isolation of chondrocytes from cartilage biopsies, cultivation to spheroids, and transplantation into the cartilage defect.

Objectives: To evaluate the patients' general health and functionality and to assess the defect repair after ACT3D with spheroids by MRI and MOCART scoring.

Methods: Thirty-seven patients with isolated chondral lesions of the knee underwent ACT3D with spheroids through medial arthrotomy.

Coherence and health care cost--RCA actuarial study: a cost-effectiveness cohort study.

Chronic stress is among the most costly health problems in terms of direct health costs, absenteeism, disability, and performance standards. The Reformed Church in America (RCA) identified stress among its clergy as a major cause of higher-than-average health claims and implemented HeartMath (HM) to help its participants manage stress and increase physiological resilience. The 6-week HM program Revitalize You! was selected for the intervention including the emWave Personal Stress Reliever technology.

A series of case reports: clinical evaluation of a complex homeopathic injection therapy in the management of pain in patients after breast cancer treatment.

Objective: In breast cancer patients, posttreatment pain often appears after several months and strongly impairs health-related quality of life. Conventional methods of pain reduction are often ineffective. Injection therapy with Traumeel (Heel GmbH, Baden-Baden, Germany), a medication with analgesic properties used in homotoxicology for treatment of the pain associated with trauma as well as a mediator of inflammation, was proposed as an innovative approach for pain relief after breast cancer treatment.

Effects of the special extract ERr 731 from Rheum rhaponticum on estrogen-regulated targets in the uterotrophy model of ovariectomized rats.

A recent clinical study with a two-year application of the extract ERr 731 from Rheum rhaponticum demonstrated its efficacy and potentially suggested it safety regarding unwanted endometrial side effects. The aim of the present study is to provide experimental proof for the latter observation in a preclinical experimental animal model by assessing dose-dependent effects of ERr 731 - either alone or in combination with estradiol (E2) - on growth and proliferation in the uterus of ovariectomized (ovx) rats. ERr 731 was given in a dose corresponding to human therapeutic application and additionally in three pharmacologically relevant doses.

Confirmation of the efficacy of ERr 731 in perimenopausal women with menopausal symptoms.

Objective: In a previous study, the special extract ERr 731 of Rheum rhaponticum significantly reduced vasomotor and other menopausal symptoms associated with perimenopause. This trial was conducted to confirm the efficacy of ERr 731.

Design: A multicenter, randomized, placebo-controlled, clinical trial with 112 perimenopausal women with menopausal symptoms receiving either 1 enteric-coated tablet of ERr 731 (n = 56) or placebo (n = 56) daily for 12 weeks.

Efficacy of the special extract ERr 731 from rhapontic rhubarb for menopausal complaints: a 6-month open observational study.

Background: The special extract ERr 731 from the roots of rhapontic rhubarb has been in widespread use in Germany since 1993, and the current regulations have required an evaluation of its risk:benefit ratio in daily use.

Objective: To demonstrate the efficacy and tolerability ofERr 731 in menopausal women in everyday practice.

Design: Three hundred sixty-three menopausal women with menopausal symptoms were enrolled at 70 German gynecological practices and received ERr 731 for 6 months.

Long-term efficacy and safety of the special extract ERr 731 of Rheum rhaponticum in perimenopausal women with menopausal symptoms.

Objective: To investigate the long-term efficacy and safety of ERr 731 in perimenopausal women with menopausal symptoms.

Design: This was a multicenter, prospective, 48-week observational study (OS) (OS I) followed by a 48-week OS II in perimenopausal women with menopausal symptoms taking ERr 731. Of 109 women participating in a previous randomized, placebo-controlled trial (RCT), 39 women receiving ERr 731 and 41 women receiving placebo participated in OS I.

Subtype-specific activation of estrogen receptors by a special extract of Rheum rhaponticum (ERr 731), its aglycones and structurally related compounds in U2OS human osteosarcoma cells.

The special extract ERr 731 from the roots of Rheum rhaponticum is the major constituent of Phytoestrol N which is used for the alleviation of menopausal symptoms. Recently, we demonstrated that ERr 731 and its aglycones trans-rhapontigenin and desoxyrhapontigenin as single test substances do not activate the estrogen receptors-alpha (ERalpha) in human endometrial adenoarcinoma cells. However, these substances together with the structurally related hydroxystilbenes cis-rhapontigenin, resveratrol and piceatannol activated the ERbeta-dependent reporter gene activity.

Activation of estrogen receptor-beta by a special extract of Rheum rhaponticum (ERr 731), its aglycones and structurally related compounds.

The special extract ERr 731 from the roots of Rheum rhaponticum is the major constituent of Phytoestrol N which is used for the treatment of climacteric symptoms in menopausal women. However, the molecular mode of action of ERr 731 was unknown. For the first time, ERr 731 and its aglycones trans-rhapontigenin and desoxyrhapontigenin were investigated with regard to the activation of the estrogen receptor-alpha or estrogen receptor-beta (ERalpha, ERbeta).

Efficacy of a complex homeopathic medication (Sinfrontal) in patients with acute maxillary sinusitis: a prospective, randomized, double-blind, placebo-controlled, multicenter clinical trial.

Background: There is a demand for clinical trials that demonstrate homeopathic medications to be effective and safe in the treatment of acute maxillary sinusitis (AMS).

Objective: The objective of this clinical trial was to demonstrate the efficacy of a complex homeopathic medication (Sinfrontal) compared with placebo in patients with AMS confirmed by sinus radiography.

Design: A prospective, randomized, double-blind, placebo-controlled, phase III clinical trial was conducted for a treatment period of 22 days, followed by an eight-week posttreatment observational phase.

The special extract ERr 731 of the roots of Rheum rhaponticum decreases anxiety and improves health state and general well-being in perimenopausal women.

Objective: To investigate the efficacy of the special extract ERr 731 from the roots of Rheum rhaponticum compared with placebo on anxiety, health state, and general well-being in perimenopausal women.

Design: This study is a multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial, in which 109 perimenopausal women with climacteric complaints and anxiety received either 1 enteric coated tablet of ERr 731 (n=54) or placebo (n=55) daily for 12 weeks. The Hamilton Anxiety Scale, the Menopause Rating Scale II, the Women's Health Questionnaire, and the Psychological General Well-Being Index were used to measure anxiety, health state, and subjective psychological well-being.

Efficacy and safety of a special extract of Rheum rhaponticum (ERr 731) in perimenopausal women with climacteric complaints: a 12-week randomized, double-blind, placebo-controlled trial.

Objective: To investigate the efficacy and safety of the special extract ERr 731 from the roots of Rheum rhaponticum compared to placebo in perimenopausal women with climacteric complaints.

Design: A multicenter, prospective, randomized, double-blind, placebo-controlled, clinical trial in which 109 women with climacteric complaints received either one enteric-coated tablet of ERr 731 (n = 54) or placebo (n = 55) daily for 12 weeks. Primary outcome criterion for efficacy was the change in Menopause Rating Scale II (MRS II) total score after 12 weeks.