ABSTRACT
BACKGROUND: Using the database of the German Cartilage Registry (KnorpelRegister DGOU), this study aims to present patient- and joint-related baseline data in a large cohort of patients with cam-derived femoroacetabular impingement syndrome (FAI) and to detect symptom-determining factors. MATERIALS AND METHODS: Requiring cam morphology as the primary pathology, 362 patients were found to be eligible for inclusion in the study. The assessment of preoperative baseline data was performed using the patient-reported outcome measure-International Hip Outcome Tool (iHOT-33). Descriptive statistics were performed to present baseline data. Univariate and multiple regression with post hoc testing were used to identify patient- and joint-related factors that might affect the preoperative iHOT-33 and its subscores, respectively. RESULTS: The study collective's mean age was 36.71 ± 10.89 years, with 246 (68%) of them being male. The preoperative mean iHOT-33 total was 46.31 ± 20.33 with the subsection "sports and recreational activities" presenting the strongest decline (26.49 ± 20.68). The parameters "age," "sex," "body mass index" (BMI), and the confirmation of "previous surgery on the affected hip" were identified to statistically affect the preoperative iHOT-33. In fact, a significantly lower mean baseline score was found in patients aged > 40 years (p < 0.001), female sex (p < 0.001), BMI ≥ 25 kg/m2 (p = 0.002) and in patients with previous surgery on the affected hip (p = 0.022). In contrast, the parameters defect grade and size, labral tears, and symptom duration delivered no significant results. CONCLUSIONS: A distinct reduction in the baseline iHOT-33, with mean total scores being more than halved, was revealed. The parameters "age > 40 years," "female sex," "BMI ≥ 25," and confirmation of "previous surgery on the affected hip" were detected as significantly associated with decreased preoperative iHOT-33 scores. These results help to identify symptom-defining baseline characteristics of cam-derived FAI syndrome. TRIAL REGISTRATION: The German Cartilage Registry is conducted in accordance with the Declaration of Helsinki and registered at germanctr.de (DRKS00005617). Registered 3 January 2014-retrospectively registered. The registration of data was approved by the local ethics committees of every participating institution. Primary approval was given by the ethics committee at the University of Freiburg (No. 105/13). https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00005617.
Subject(s)
Femoracetabular Impingement , Adult , Aged , Arthroscopy , Cartilage , Data Analysis , Female , Femoracetabular Impingement/epidemiology , Femoracetabular Impingement/surgery , Hip Joint/surgery , Humans , Infant, Newborn , Male , Registries , Treatment OutcomeABSTRACT
Surgical principles for treatment of full-thickness cartilage defects of the knee include bone marrow stimulation techniques (i.e. arthroscopic microfracturing) and transplantation techniques (i.e. autologous chondrocyte implantation and osteochondral transplantation). On the basis of increasing scientific evidence, indications for these established therapeutical concepts have been specified and clear recommendations for practical use have been given. Within recent years, matrix-augmented bone marrow stimulation has been established as a new treatment concept for chondral lesions. To date, scientific evidence is limited and specific indications are still unclear. The present paper gives an overview of available products as well as preclinical and clinical scientific evidence. On the basis of the present evidence and an expert consensus from the "Working Group on Tissue Regeneration" of the German Orthopaedic and Trauma Society (DGOU), indications are specified and recommendations for the use of matrix-augmented bone marrow stimulation are given. In principle, it can be stated that the various products offered in this field differ considerably in terms of the number and quality of related studies (evidence level). Against the background of the current data situation, their application is currently seen in the border area between cell transplantation and bone marrow stimulation techniques, but also as an improvement on traditional bone marrow stimulation within the indication range of microfracturing. The recommendations of the Working Group have preliminary character and require re-evaluation after improvement of the study situation.
Subject(s)
Cartilage, Articular/injuries , Guided Tissue Regeneration/methods , Knee Injuries/surgery , Orthopedics , Societies, Medical , Germany , HumansABSTRACT
BACKGROUND: Various operative strategies have been introduced to restore the integrity of articular cartilage when injured. The frequency of revision surgery after cartilage regenerative surgery remains incompletely understood. PURPOSE/HYPOTHESIS: The purpose of this study was to identify the reasons for revision surgery after cartilage regenerative surgery of the knee. We hypothesized that in a large patient cohort, revision rates would differ from those in the current literature. STUDY DESIGN: Case-control study; Level of evidence, 3. METHODS: A total of 2659 complete data sets from the German Cartilage Registry were available for analyses. In brief, baseline data were provided by the attending physician at the time of index surgery. Follow-up data were collected using a web-based questionnaire inquiring whether patients had needed revision surgery during follow-up, which was defined as the endpoint of the present analysis. RESULTS: A total of 88 patients (3.3%) reported the need for revision surgery as early as 12 months postoperatively. Among the most common causes were arthrofibrosis (n = 27) and infection (n = 10). Female patients showed a significantly greater complication rate (4.5%) when compared with male patients (2.6%; P = .0071). The majority of cartilage lesions were located at the medial femoral condyle (40.2%), with a mean defect size of 3.5 ± 2.1 cm2. Neither the location nor defect size appeared to lead to an increased revision rate, which was greatest after osteochondral autografts (5.2%) and autologous chondrocyte implantation (4.6%). Revision rates did not differ significantly among surgical techniques. Chi-square analysis revealed significant correlations between the number of previous joint surgeries and the need for revision surgery (P = .0203). Multivariate regression analysis further confirmed sex and the number of previous surgeries as variables predicting the need for early revision surgery. CONCLUSION: The low early revision rates found in this study underline that today's cartilage repair surgeries are mostly safe. Although invasiveness and techniques differ greatly among the procedures, no differences in revision rates were observed. Specific factors such as sex and the number of previous surgeries seem to influence overall revision rates and were identified as relevant risk factors with regard to patient safety.
ABSTRACT
BACKGROUND: Pancreatic cancer has a dire prognosis and is associated with a high mortality. Palliative patients have special needs and often seek help in integrative oncological concepts (IO) that combine conventional and complementary therapies. Nevertheless there are few recommendations regarding IO in current cancer guidelines. The aims of this study were to report on implementation of IO in everyday palliative care and to analyze patient survival in advanced pancreatic cancer. METHODS: This multicenter observational study investigates the implementation of IO and length of survival of patients suffering from advanced pancreatic cancer (stage IV). We analyzed patient's survival by employing multivariable proportional hazard models using different parametric distribution functions and compared patients receiving chemotherapy only, a combination of chemotherapy and Viscum album (VA) treatment, and VA treatment only. RESULTS: Records of 240 patients were analyzed. Complementary therapy showed high acceptance (93 %). Most frequent therapy was VA treatment (74 %) that was often administered concomitantly to chemotherapy (64 %). Both therapies had positive effects on patient survival as they had significant negative effects on the hazard in our log-normal model. A second analysis showed that patients with combined chemotherapy and VA therapy performed significantly better than patients receiving only chemotherapy (12.1 to 7.3 month). Patients receiving only VA therapy showed longer survival than those receiving neither chemotherapy nor VA therapy (5.4 to 2.5 months). Our data demonstrates that IO can be implemented in the everyday care of patients without disregarding conventional treatment. Patients combining VA with chemotherapy showed longest survival. CONCLUSIONS: Our data demonstrate the importance and potential of health services research showing that IO treatment can be successfully implemented in the every-day care of patients suffering from advanced pancreatic cancer. Patients combining VA with chemotherapy showed longest survival. To address patients' needs adequately, future cancer guidelines might increasingly include comments on complementary treatment options in addition to conventional therapies. Further studies should investigate the effect of complementary treatments on survival and quality of life in more detail.
Subject(s)
Antineoplastic Agents/administration & dosage , Health Services Research/methods , Palliative Care/methods , Pancreatic Neoplasms/drug therapy , Plant Extracts/administration & dosage , Viscum album/chemistry , Aged , Aged, 80 and over , Antineoplastic Agents/therapeutic use , Combined Modality Therapy , Complementary Therapies , Drug Therapy , Female , Humans , Male , Pancreatic Neoplasms/pathology , Plant Extracts/therapeutic use , Proportional Hazards Models , Quality of Life , Survival Analysis , Treatment OutcomeABSTRACT
BACKGROUND: Concepts of integrative oncology (IO), as have been offered by anthroposophic medicine (AM) for decades, are gaining increasing interest and acceptance. Central aspects are multimodal therapeutic interventions, health-related quality of live, and patients' preference as well as therapeutic relationship and clinical outcome. Despite its broad application, IO lacks evaluation in clinical practice and complementary therapies are not monitored by any cancer registries. METHODS: To close this gap we established 'Network Oncology' (NO), a conjoint registry of German outpatient AM practitioners and AM hospitals. In this paper we present the project and a first data overview and compare it to epidemiological registers and current literature. RESULTS: NO has collected 10,405 cancer patients' records in 6 years. Compared to epidemiological registers our data show minor differences in disease entity distribution, age, and gender. There is an overproportional amount of young breast cancer patients in NO institutions indicating a demand for integrative therapies in this group. There is no difference between the UICC (Union for International Cancer Control) stages at first diagnosis and at admission to a NO facility. According to our data conventional therapies were less frequently administered after admission to a NO facility. Nevertheless, one third of the patients received their first conventional therapy in a NO facility. 80% of the patients received mistletoe preparations and 63% had nonpharmacotherapeutic, complementary interventions. CONCLUSION: Integrative oncological approaches attract a great number of patients visiting AM institutions. The NO provides an infrastructure to evaluate integrative interventions in AM, allows comparison to other clinical registers, and thus can contribute to health service research in this field.
Subject(s)
Health Services Research/methods , Integrative Medicine/statistics & numerical data , Medical Oncology , Registries , Adolescent , Adult , Aged , Aged, 80 and over , Anthroposophy , Child , Child, Preschool , Female , Humans , Infant , Male , Middle Aged , Mistletoe/chemistry , Neoplasms/diagnosis , Neoplasms/epidemiology , Neoplasms/therapy , Plant Extracts/therapeutic use , Young AdultABSTRACT
UNLABELLED: Background. Chronic fatigue is one of the most restricting symptoms following primary breast cancer treatment, but clinical studies on symptom management are rare. The objective was to evaluate the impact of a multimodal mind-body program (MMMT), including moderate physical activity as compared with a walking intervention alone, on chronic fatigue symptoms of women with stage I to IIIA breast cancer. PATIENTS AND METHODS: Sixty-four women (mean age = 56.7 years) suffering from chronic fatigue after active tumor treatment were randomly assigned to either an experimental or a control (n = 32 each) intervention (10 weeks). Fatigue, quality of life (QoL), functional well-being, anxiety, and depression were measured with standard questionnaires at baseline, after 10 weeks, and after 3 months. RESULTS: Compared with baseline, both groups had reduced fatigue scores after treatment without any significant difference between groups (posttreatment, Δ = -0.3, confidence interval = -1.6 to 1.0, P = .678; follow-up, Δ = -0.4, confidence interval = -1.8 to 0.9, P = .510). All patients also improved regarding QoL and general functional well-being. CONCLUSION: Since both interventions reduced fatigue symptoms and enhanced QoL to a similar extent, we observed no verifiable add-on effect of the MMMT regarding fatigue symptoms. Considering the higher costs with additional expenditure related to MMMT, home-based walking intervention is recommended.
Subject(s)
Breast Neoplasms/therapy , Fatigue/etiology , Fatigue/therapy , Mind-Body Therapies , Motor Activity , Adult , Aged , Chronic Disease , Combined Modality Therapy , Female , Humans , Middle Aged , Quality of Life , Survivors , Treatment OutcomeABSTRACT
Acupuncture is the most popular component of traditional Chinese medicine in Western countries. However, the mechanisms of its effects remain unclear. The therapeutic effect of acupuncture appears when a sensation of DeQi is achieved. We previously reported that repeated, but not single acupuncture treatment affected leukocyte circulation and blood pressure in healthy young humans. The objective of this study was to quantify DeQi sensation by using visual analog scales (VASs) and, to test whether DeQi induction is an important factor for the therapeutic effects of acupuncture in the same cohort. After either acupuncture or sham-acupuncture (placebo) treatment, a questionnaire containing five individual VASs was given to subjects to evaluate their DeQi sensation, including numbness, pressure, heaviness, warmth, and radiating paraesthesia, respectively. A separate VAS to measure their levels of anxiety during the treatment was also included. Our results showed that acupuncture significantly induced higher VAS values for numbness, pressure, warmth, and radiating paraesthesia, but not for heaviness than the placebo across three treatment sessions. Additionally, acupuncture did not induce higher anxiety levels than the placebo. These data confirm that VAS is an objective and reliable way to quantify DeQi sensation and, indicate that DeQi is unique to verum acupuncture treatment. Furthermore, either acupuncture-induced therapeutic effects or DeQi sensation should not be attributed to the stress-mediated effects. In summary, the induction of DeQi in each treatment session is an important factor for the physiological outcomes of repeated acupuncture treatment, and VASs offer objective, an easy and reliable way to assess it.
Subject(s)
Acupuncture , Immune System/physiology , Pain Measurement , Adolescent , Adult , Cross-Over Studies , Double-Blind Method , Female , Humans , Male , Reference Values , Treatment OutcomeABSTRACT
BACKGROUND: The aim of this study was to investigate the effects of mind-body therapy on neuroendocrine and cellular immune measures, health-related quality of life and disease activity in patients with ulcerative colitis (UC) in remission. METHODS: Thirty UC patients in remission or with low disease activity were randomly assigned to an intervention group (n = 15) or a usual-care waiting control group (n = 15). Intervention consisted of a structured 60-hour training program over 10 weeks which included stress management training, moderate exercise, Mediterranean diet, behavioral techniques and self-care strategies. Quality of life, perceived stress and disease activity were assessed with standardized questionnaires (IBDQ, SF-36, PSS, CAI). In addition, the distribution of circulating lymphocytes and lymphocyte subsets as well as the beta-adrenergic modulation of TNF-alpha production in vitro were analyzed. Urine catecholamines and plasma cortisol, prolactin and growth hormone were measured pre- and postinterventionally, and were compared with a healthy control group (n = 10). RESULTS: In response to therapy, patients in the intervention group showed significantly greater improvement in the SF-36 scale Mental Health and the Psychological Health Sum score compared with changes observed in the usual-care waiting control group. Patients in the intervention group showed significantly greater improvement on the IBDQ scale Bowel Symptoms compared with the control group. However, no significant group differences in circulating lymphocyte subsets or endocrine parameters were observed in response to therapy. In addition, no significant effects of intervention on either the basal levels of TNF-alpha or the suppressive action of the beta-adrenergic agonist isoproterenol on TNF-alpha production were observed. CONCLUSION: Mind-body therapy may improve quality of life in patients with UC in remission, while no effects of therapy on clinical or physiological parameters were found, which may at least in part be related to selective patient recruitment.
Subject(s)
Antigens, CD/immunology , Colitis, Ulcerative , Killer Cells, Natural/immunology , Mind-Body Therapies , Quality of Life/psychology , Receptors, Adrenergic, beta/immunology , Tumor Necrosis Factor-alpha/immunology , Adult , Antigens, CD/blood , Colitis, Ulcerative/diagnosis , Colitis, Ulcerative/immunology , Colitis, Ulcerative/therapy , Female , Humans , In Vitro Techniques , Male , Severity of Illness Index , Surveys and Questionnaires , Treatment OutcomeABSTRACT
Acupuncture is the most popular component of traditional Chinese medicine in western countries, which has been widely used in the treatment of numerous medical conditions, e.g., pain, emesis or asthma. However, the effects of acupuncture on neuroendocrine and immune functions in humans remain unclear. Therefore, the present study was performed to analyse whether acupuncture treatment affects leukocyte circulation as well as plasma levels of cortisol and norepinephrine in humans. Ten healthy young male subjects were enrolled in a randomized single-blind two-period crossover study. Each period contained three sessions of either acupuncture or sham acupuncture (placebo) treatment. After randomisation, the group 1 (n=5) received acupuncture treatment at acu-points ST36, LI11, SP10, and GV14, while sham acupuncture was performed for group 2 (n=5). Two weeks later, each group received the alternative treatment. Blood samples were taken before needling, 10 min after, and 30 min after removing the needles in the first and the third session. In addition, blood pressure and heart rate were determined simultaneously. Although acupuncture treatment did not affect leukocyte circulation in peripheral blood after the first session, we observed a significant decrease in leukocyte and lymphocyte values after the third session. In contrast, cortisol and norepinephrine plasma levels remained unchanged by acupuncture. These data indicate that repeated acupuncture treatment can affect leukocyte circulation in healthy humans by still unknown mechanisms.
Subject(s)
Acupuncture Therapy , Blood Pressure/physiology , Hydrocortisone/blood , Leukocytes/immunology , Norepinephrine/blood , Adult , Cross-Over Studies , Humans , Leukocyte Count , Leukocytes/cytology , Male , Reference Values , Retreatment , Single-Blind MethodABSTRACT
BACKGROUND: Leech therapy was commonly used in traditional medicine for treating localized pain. Clinically significant pain relief after leech therapy for osteoarthritis of the knee has been demonstrated by preliminary data. OBJECTIVE: To evaluate the effectiveness of leech therapy for symptomatic relief of osteoarthritis of the knee. DESIGN: Randomized, controlled trial. SETTING: Outpatient department for integrative medicine of an academic teaching hospital. PATIENTS: 51 patients with osteoarthritis of the knee (leech therapy: 24 patients, mean age [+/-SD], 62.5 +/- 10.2 years; topical diclofenac therapy: 27 patients, mean age [+/-SD], 65.5 +/- 6.7 years). INTERVENTION: A single treatment with 4 to 6 locally applied leeches (leech therapy group) or a 28-day topical diclofenac regimen (control group). MEASUREMENTS: Mean of the pain, function, and stiffness subscores of the Western Ontario and McMaster Universities Osteoarthritis Index and physical sum score of the Medical Outcomes Study 36-Item Short-Form Health Survey with group comparisons at days 3, 7, 28, and 91. RESULTS: The primary end point, pain at day 7, was reduced from a mean (+/-SD) of 53.5 +/- 13.7 to 19.3 +/- 12.2 after leech therapy compared with 51.5 +/- 16.8 to 42.4 +/- 19.7 with topical diclofenac (estimated group difference, -23.9 [95% CI, -32.8 to -15.1]; P < 0.001). Although the difference between group pain scores was no longer significant after day 7, differences for function, stiffness, and total symptoms remained significant in favor of leech therapy until the end of study and for quality of life until day 28. Results were not affected by outcome expectation. CONCLUSIONS: Leech therapy helps relieve symptoms in patients with osteoarthritis of the knee. The potential of leech therapy for treating osteoarthritis and the pharmacologic properties of leech saliva remain to be clarified.
Subject(s)
Leeches , Osteoarthritis, Knee/therapy , Pain/prevention & control , Administration, Topical , Animals , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Diclofenac/therapeutic use , Humans , Knee Joint/physiopathology , Osteoarthritis, Knee/drug therapy , Osteoarthritis, Knee/physiopathology , Quality of Life , Treatment OutcomeABSTRACT
BACKGROUND: Chronic heart failure is characterized by increased peripheral vascular resistance and reduced peripheral perfusion due to adrenergic and renin angiotensin activation and impaired endothelial function. Recent studies have shown that nonpharmacological peripheral vasodilation with thermal therapy by means of warm-water baths and sauna has beneficial effects in chronic heart failure. European hydrotherapy (according to Kneipp) additionally uses short cold water stimuli, which lead to prolonged vasodilation and adaptive responses. Studies on the efficacy of hydrotherapy in chronic heart failure are lacking. METHODS: We studied 15 patients (5 men, 10 women, mean (+/- SD) age 64.3 +/- 1.8 years) with mild chronic heart failure (NYHA functional class II to III, ejection fraction 30%-40%). Patients were randomly assigned to 6 weeks of intensive home-based hydrotherapy or 6 weeks restriction in a crossover intervention trial. Quality of life and heart-failure--related symptoms were assessed by means of a validated questionnaire (PLC). Graded bicycle exercise test with incremental workloads (0, 50, 75, 100 watts) was performed at the end of each treatment period. The hydrotherapeutic program consisted of a structured combination of daily home-based external warm- and cold-water applications. RESULTS: Baseline characteristics were balanced between the groups. With hydrotherapy, a significant (P < or =.05) improvement in 3 of 6 dimensions of quality of life (mood, physical capacity, enjoyment) and a significant reduction in heart-failure-related symptoms was found. Heart rates at rest and at 50-Watt workload were significantly reduced by hydrotherapy; blood pressure decreased nonsignificantly at rest and during exercise. The hydrotherapeutic treatment was well accepted and no relevant adverse effects were observed. CONCLUSIONS: A home-based hydrotherapeutic thermal treatment program improves quality of life, heart-failure-related symptoms and heart rate response to exercise in patients with mild chronic heart failure. The results of this investigation suggest a beneficial adaptive response to repeated brief cold stimuli in addition to enhanced peripheral perfusion due to thermal hydrotherapy in patients with chronic heart failure.
Subject(s)
Cryotherapy/methods , Heart Failure/therapy , Hot Temperature/therapeutic use , Hydrotherapy/methods , Quality of Life , Aged , Analysis of Variance , Baths/methods , Chronic Disease , Cross-Over Studies , Exercise Test , Female , Heart Failure/physiopathology , Heart Rate/physiology , Hemodynamics/physiology , Humans , Male , Middle Aged , Stroke Volume/physiology , Vascular Resistance/physiologyABSTRACT
CONTEXT: Leech therapy was a mainstay in conventional treatment for pain from antiquity until the mid-19th century. Its use is still widespread in traditional healing procedures in Asia, Africa, and Arabic countries. There is renewed interest in leech therapy in the field of complementary medicine and empirical evidence for specific benefit in knee osteoarthritis. OBJECTIVES: To determine the effect of leech therapy as an adjunctive treatment in painful knee osteoarthritis, to investigate the onset of action, to evaluate patients' acceptance of this treatment, and to investigate the side effects of the procedure. DESIGN: Observational, controlled, nonrandomized pilot-study. SETTING: Subjects were inpatients of an academic teaching hospital of the University of Essen, Department of Internal and Integrative Medicine, Essen, Germany. PATIENTS: 16 inpatients (mean age 69 +/- 9 years) with a confirmed diagnosis of osteoarthritis of the knee joint; 10 patients were treated with leeches and 6 served as controls. INTERVENTION: A single trial of 4 leeches (Hirudo medicinalis) applied topically at painful periarticular sites of the knee joint in the experimental group (n = 10). Both groups received conventional treatment for pain with the exclusion of nonsteroidal anti-inflammatory drugs. MAIN OUTCOME MEASURES: Self-reported general knee pain, assessed by visual analog scale for 10 days daily and in a follow-up after 28 days. Frequency of adverse effects also was recorded. RESULTS: Periarticular application of 4 leeches led to rapid relief of pain with sustained improvement after 4 weeks in the absence of major complications. CONCLUSION: Leech therapy may be an effective treatment for rapid reduction of pain associated with osteoarthritis of the knee. Its efficacy should be tested in larger randomized controlled trials with assessment of expectation bias.