Systematic Review of Pharmacologic and Compression Therapies for Treatment of Post-Thrombotic Syndrome

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 4207-4207
Author(s):  
Jacqueline M. Cohen ◽  
Elie A. Akl ◽  
Susan R. Kahn

Abstract Abstract 4207 Background: Post-thrombotic syndrome (PTS) is a chronic complication of deep venous thrombosis (DVT) characterized by chronic pain, swelling and other signs in the affected limb that can severely impact individuals' quality of life. There are no widely accepted treatments for PTS, although varied treatment strategies have been proposed. Objective: To systematically review evidence for the effectiveness and safety of pharmacologic and compression therapies for treatment of PTS. Methods: Randomized controlled trials (RCTs) of PTS treatments were sought in a search of PubMed and by reverse citation searches. Results: A total of 121 titles were reviewed and 12 full-text publications were assessed for inclusion. Seven trials were selected for inclusion in the review. Four trials (3 parallel RCTs, 1 crossover RCT) including 521 patients assessed the effectiveness of various drugs for treatment of PTS. These pharmacotherapies included rutosides, hidrosmin, and defibrotide and treatment durations ranged from 2–12 months. Three trials (1 parallel RCT, 2 crossover RCTs) including 82 patients assessed compression therapies. Two used intermittent pneumatic compression (IPC) devices worn for 4–8 weeks, while one used continuous compression in the form of graduated compression stockings (GCS) worn for at least 1 year. Follow-up in these studies ranged from 8 weeks to over 1 year. All studies identified PTS as occurring after DVT in the same leg, often requiring objective diagnosis of DVT. One study used CEAP criteria for venous insufficiency, including patients classified as C2, C3 or C4. Another required participants to have had deep venous insufficiency (not further defined) for at least 12 months. Two studies used the Villalta scale to classify patients as having PTS, while one study only included patients with a score >14, corresponding to severe PTS. Another study defined PTS as the presence of chronic and typical pain and swelling 1 year post-DVT, and another defined it as intractable symptoms causing significant limitations of lifestyle and/or morbidity. In one study, PTS was not defined. Indicators used to assess the success of the interventions varied. Clinical signs and symptoms were often assessed with a quantitative scoring system. Validated scales used included Kakkar & Lawrence, Villalta, and VEINES-Sym. Calf and ankle circumference were often measured, where significant differences in these measures were used to attest to the success of an intervention; however, the clinical significance of these changes may be questionable. The IPC studies defined treatment success based on factors such as perceived benefit, patient preference for the active treatment, and willingness to continue to use the intervention. The GCS study defined treatment failure based on symptom deterioration, work absences, and development of venous ulcer. Only 1 study assessed the effect on quality of life, using the VEINES-QOL questionnaire. Studies of pharmacotherapies demonstrated minimal benefit on symptom scores, reduced calf and ankle circumference, and ulcer healing. In one study that continued to follow-up subjects for 6 months after treatment was terminated, the effect of drug treatment was not sustained (50% of ulcers returned). Studies of compression therapy did not convincingly demonstrate benefits of GCS; but for the IPC devices, treatment success was more likely than on the placebo devices. None of these treatments were associated with any important side effects and hence, compliance was acceptable in all studies that reported it. Studies of pharmacologic and compression therapies for treatment of PTS suffer from study design limitations including lack of blinding and wash-out periods that have the potential to introduce bias. Short duration of treatment in some studies may limit the extent to which the interventions were found to be effective. Sustained effectiveness was not assessed except for one study. Conclusions: There is limited and low quality evidence for the effectiveness of rutosides, hidrosmin, and defibrotide to treat PTS. There is also limited and low quality evidence for the effectiveness of GCS, but IPC devices seem to provide at least short term relief from PTS. More rigorous studies are needed to assess the effectiveness and sustainability of pharmacologic and compression treatments for PTS, and study endpoints should focus on clinically important improvements in patient condition. Disclosures: No relevant conflicts of interest to declare.

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 10-11
Author(s):  
Mauricette Michallet ◽  
Romain Buono ◽  
Mohamad Sobh ◽  
Solene Poirey ◽  
Emmanuelle Nicolas-Virelizier ◽  
...  

Introduction In France, cancer incidence is increasing, reaching approximately 400,000 new cases in 2017. Thanks to diagnostic and therapeutic advances, net survival at 5 years is improving, with a corollary increase in the number of survivors. Among survivors, 44% have a poor quality of life due to the more or less late onset of treatment-related complications. Despite the objectives of the 2014-2019 national cancer plan considering the latest therapeutic advances, very few initiatives integrating systematic, early detection and management of complications exist in France. Methods and analysis PASCA (Care pathways through cancer) is a single-arm, interdisciplinary, prospective, interventional, cohort study. During a period of 24 months, it is intended to include 858 adults aged 18 to 65 years with non-Hodgkin and Hodgkin lymphoma, acute myeloid leukemia, testicular germ cell tumor, non-metastatic invasive breast cancer, soft tissue sarcoma, osteosarcoma or Ewing's sarcoma at Centre Leon Berard (Lyon, France). The program consists on exhaustive identification of 22 complications at 1 month, 6 months, 24 months and 60 months after the end of first line treatment: social precariousness, return-to-work issues, cognitive problems, anxiety and depression disorders, chronic fatigue, physical deconditioning, overweight/obesity, chronic pain, dermatological disorders, gastrointestinal disorders, sexual disorders, hypogonadism, premature ovarian failure, osteoporosis, chronic kidney failure, heart failure, coronary heart disease, respiratory failure, hypothyroidism, lymphedema, modifiable risk factors associated with the occurrence of secondary cancers. Each identification will give rise to management, which consists of referring the patient to a healthcare professional belonging to the network of dedicated healthcare professionals at the regional level. The course of action to be followed will be defined using decision trees based on international, national or learned society recommendations. Referral outside Centre Leon Berard will be made to a specialist doctor, a health professional from the paramedical field or the patient's general practitioner who will confirm the diagnosis and initiate patient management and follow-up. These patients will also benefit from their usual follow-up in the context of their initial malignancy. Each study visit will include a search for clinical signs using questionnaires, an assay of 12 biological parameters, a urine test strip, 5 tests evaluating physical deconditioning and an electrocardiogram. The weight, height, waist circumference, blood pressure will also be measured. Primary outcome will be the incidence of the 22 complications, measured at 1 month, 6 months, 24 months and 60 months after the end of intensive chemotherapy treatment. Ethics and dissemination The study protocol was approved by the French ethics committee (Comité de protection des personnes Ile de France IV), the study database is currently being declared and registered to the Commission Nationale de l'Informatique et des Libertés (CNIL) and the study on ClinicalTrials.gov. The results will be disseminated to patients and in peer-reviewed journals and academic conferences. Strengths and limitations of this study This study is based on a previous feasibility study with 52 patients recruited in onco-hematology, which demonstrated the feasibility of the intervention and the existence of patient management needs.(1) The study design does not include a comparator arm, as the objective of the study is to provide a comprehensive picture of treatment-related complications, especially those that appear over the long term. Due to the lack of recent data concerning some complications, sample size was calculated empirically on the basis of the active queue of patients at the Centre Leon Berard. References Michallet M, Sobh M, Buono R, Poirey S, Pascu I, Nicolas-Virelizier E, et al. Personalised Follow-up Program after Acute Phase of Treatment in Oncology/Hematology Patients Towards Early Intervention, Better Care and Quality of Life Improvement: Results from Pasca Pilot Study. Blood. 13 nov 2019;134(Supplement_1):5817-5817. Disclosures Nicolini: Sun Pharma Ltd: Consultancy; Incyte: Research Funding, Speakers Bureau; Novartis: Research Funding, Speakers Bureau.


2018 ◽  
Vol 31 (Supplement_1) ◽  
pp. 30-30
Author(s):  
Oleksandr Khoma ◽  
Miho Mugino ◽  
Gregory Falk

Abstract Background Patients with giant hiatal herniae are often symptomatic and have significantly reduced quality of life (QoL). Laparoscopic fundoplication is an established treatment of giant hiatal hernia. Advanced age has been previously shown to be the most significant predictor of mortality and morbidity in hiatal hernia repair. Reported outcomes of laparoscopic fundoplication in patients over the age of 80 are limited to case reports and small case series. Methods Data was extracted from a prospectively populated single surgeon database of laparoscopic fundoplication procedures between 1995 and 2014. Patients who were operated for giant HH (> 30% of stomach in the chest) that were aged 80 or older at the time of surgery were included. Quality of life (QOL) data was collected pre-operatively, in early post-operative period (within 12 months) and late post-operative period (24 months or later). QOL data included gastro-intestinal quality of life index (GIQLI), Visick score, dysphagia score and overall satisfaction with surgery. Search of Ryerson index (was conducted to establish month and year of death and calculate post-operative life expectancy. Results Inclusion criteria were met by 89 patients. Average age was 84 (80–93). The proportion of herniated stomach was 70.9% on average (range 30–100%; SD 27.25), the hiatal defect was large in all patients. There was 1 perioperative death from myocardial infarction at 30 days after surgery. There were no other major complications (Clavien-Dindo Grade III-IV). Post-operative survival was an average of 74.5 months (SD 47.8; range 1–233). GIQLI was reduced pre-operatively (mean 91.8; SD 19.4). There was improvement in GIQLI scores on early (mean 101.45; SD 21.2) and late (mean 106.7; SD 19.2; P = 0.005) post-operative follow up. Pre-operative Visick scores (mean 2.92; SD 0.98) have improved significantly in early (mean 1.94; SD 0.97; P = 0.000) and late (mean 2.03; SD 0.99; P = 0.001) post-operative periods. During early post-operative follow up 97% of the patients were satisfied with overall outcome of their operation, whilst 3% were dissatisfied. Overall satisfaction scores remained high on late follow up (93.3% satisfied, 6.7% dissatisfied). Conclusion Findings of this study demonstrate that in carefully selected patients with giant HH surgery is safe and results in improved quality of life post operatively. Disclosure All authors have declared no conflicts of interest.


2019 ◽  
Vol 8 (9) ◽  
pp. 1407
Author(s):  
Victoria Manning ◽  
Joshua B. B. Garfield ◽  
Tina Lam ◽  
Steve Allsop ◽  
Lynda Berends ◽  
...  

People seeking treatment for substance use disorders (SUD) ultimately aspire to improve their quality of life (QOL) through reducing or ceasing their substance use, however the association between these treatment outcomes has received scant research attention. In a prospective, multi-site treatment outcome study (‘Patient Pathways’), we recruited 796 clients within one month of intake from 21 publicly funded addiction treatment services in two Australian states, 555 (70%) of whom were followed-up 12 months later. We measured QOL at baseline and follow-up using the WHOQOL-BREF (physical, psychological, social and environmental domains) and determined rates of “SUD treatment success” (past-month abstinence or a statistically reliable reduction in substance use) at follow-up. Mixed effects linear regression analyses indicated that people who achieved SUD treatment success also achieved significantly greater improvements in QOL, relative to treatment non-responders (all four domains p < 0.001). Paired t-tests indicated that non-responders significantly improved their social (p = 0.007) and environmental (p = 0.033) QOL; however, their psychological (p = 0.088) and physical (p = 0.841) QOL did not significantly improve. The findings indicate that following treatment, QOL improved in at least some domains, but that reduced substance use was associated with both stronger and broader improvements in QOL. Addressing physical and psychological co-morbidities during treatment may facilitate reductions in substance use.


Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 3369-3369 ◽  
Author(s):  
Maayan Seitelbach ◽  
Ian H. Chin-Yee ◽  
Jeff Kinney ◽  
Justin Chia ◽  
Katrina Ormond ◽  
...  

Abstract Abstract 3369 Introduction Red blood cell concentrates (RBCs) are stored for up to 42 days. Prolonged storage of RBCs results in “the storage lesion” which has been associated with adverse outcomes in patients with critical illness, sepsis, and post-cardiac surgery. No studies have assessed the impact of the storage lesion on the quality of life (QoL) of patients who require chronic transfusion support. This study assessed the effects of fresh versus standard issue blood on QoL and follow-up hemoglobin (Hb) in transfusion-dependent patients. Methods Transfusion-dependent patients age 18 years or older, were invited to participate in an N-of-1 trial. Transfusion dependence required at least one unit of RBCs every four weeks. Each participant was randomly assigned four fresh (less than seven days of storage) and four standard issue (seven to 42 days of storage) blood transfusions. Investigators, study participants, treating physicians, and nurses were blinded to product allocation. A questionnaire containing a visual analog scale (VAS) and the Functional Assessment of Cancer Therapy-Anemia questionnaire (FACT-An) was completed prior to and 24 hours after each transfusion. Changes were calculated as post-transfusion scores minus pre-transfusion scores. Hemoglobin levels were measured at each subsequent transfusion. Within-subject (each participant) between-treatment comparisons of QoL scores and hemoglobin levels were assessed by unpaired t-tests among participants who completed at least six transfusions. Between-group changes in QoL scores for all participants were assessed by paired t-tests and a mixed model approach. Results Twenty patients were enrolled (mean age 66.8 years, 12 females). Underlying diagnoses included myelodysplastic syndromes (12), β-thalassemia (3), myeloproliferative neoplasms (3), Diamond-Blackfan anemia (1), and chronic anemia of undetermined etiology (1). Mean ages of fresh and standard blood were 4.0 days and 23.2 days, respectively. Nine participants completed at least six transfusions. Among remaining participants, nine were non-compliant, and two died. All data were analysed in the between-group comparisons. There were no statistically significant differences in the effect of standard blood and fresh blood on the eight QoL parameters assessed in all analyses. This was seen in the within subject between-group analysis as well as the between-group analysis. Similarly, there were no statistically significant differences in the effect of standard blood and fresh blood on follow-up Hb levels. Conclusions No significant differences in QoL parameters or follow-up Hb levels were observed in patients receiving fresh versus standard issue blood. These results suggest that local blood transfusion laboratory practices do not need to be altered for transfusion-dependent patient populations. To our knowledge, this is the first study to assess the QoL effects of age of blood on transfusion-dependent patients using N-of-1 trials. While larger studies are needed to confirm these findings, our results demonstrate that N-of-1 studies are feasible and informative in the management of individual patients. The randomized controlled multiple crossover design of N-of-1 studies may be also useful in addressing questions in transfusion medicine regarding differences in the quality of blood products. Disclosures: No relevant conflicts of interest to declare.


2016 ◽  
Vol 30 (12) ◽  
pp. 1141-1155 ◽  
Author(s):  
Kesava Kovanur Sampath ◽  
Ramakrishnan Mani ◽  
Takayuki Miyamori ◽  
Steve Tumilty

Objective: To determine whether manual therapy or exercise therapy or both is beneficial for people with hip osteoarthritis in terms of reduced pain, improved physical function and improved quality of life. Methods: Databases such as Medline, AMED, EMBASE, CINAHL, SPORTSDiscus, PubMed, Cochrane Library, Web of Science, Physiotherapy Evidence Database, and SCOPUS were searched from their inception till September 2015. Two authors independently extracted and assessed the risk of bias in included studies. Standardised mean differences for outcome measures (pain, physical function and quality of life) were used to calculate effect sizes. The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach was used for assessing the quality of the body of evidence for each outcome of interest. Results: Seven trials (886 participants) that met the inclusion criteria were included in the meta-analysis. There was high quality evidence that exercise therapy was beneficial at post-treatment (pain-SMD-0.27,95%CI-0.5to-0.04;physical function-SMD-0.29,95%CI-0.47to-0.11) and follow-up (pain-SMD-0.24,95%CI- 0.41to-0.06; physical function-SMD-0.33,95%CI-0.5to-0.15). There was low quality evidence that manual therapy was beneficial at post-treatment (pain-SMD-0.71,95%CI-1.08to-0.33; physical function-SMD-0.71,95%CI-1.08to-0.33) and follow-up (pain-SMD-0.43,95%CI-0.8to-0.06; physical function-SMD-0.47,95%CI-0.84to-0.1). Low quality evidence indicated that combined treatment was beneficial at post-treatment (pain-SMD-0.43,95%CI-0.78to-0.08; physical function-SMD-0.38,95%CI-0.73to-0.04) but not at follow-up (pain-SMD0.25,95%CI-0.35to0.84; physical function-SMD0.09,95%CI-0.5to0.68). There was no effect of any interventions on quality of life. Conclusion: An Exercise therapy intervention provides short-term as well as long-term benefits in terms of reduction in pain, and improvement in physical function among people with hip osteoarthritis. The observed magnitude of the treatment effect would be considered small to moderate.


Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 2309-2309 ◽  
Author(s):  
Maria Ljungqvist ◽  
Margareta Holmstrom ◽  
Helle Kieler ◽  
Gerd Larfars

Abstract Introduction: Post-thrombotic syndrome (PTS) is the most common complication after a venous thromboembolism (VTE). PTS is a chronic condition affecting health-related quality-of-life (QoL). In this study we aimed to determine the risk of PTS and how it affects QoL after a first episode of VTE in young and middle-aged women. Methods: We conducted a cohort study, including 1438 women with a first episode of VTE. Patients were recruited from 'Thrombo Embolism Hormonal Study' (TEHS), a Swedish nation-wide case-control study on risk factors for VTE in women 18-65 years of age. Consecutive patients with a first episode of deep vein thrombosis (DVT) in the lower leg or pulmonary embolism (PE) were included between 2002 and 2009. In 2011 all women still living in Sweden were followed up through a questionnaire. PTS was measured using self-reported Villalta score and Veins-QoL was used to measure QoL. Results: After a median follow-up time of 6 years 1049 patients accepted participation in the follow-up study. The reported prevalence of PTS was 20 % for all patients, 28 % among women with a previous episode of a proximal DVT, 19 % among women with a previous distal DVT and 12 % among women with PE. Women with a history of leg symptoms before the first VTE-event had a higher risk of PTS (OR 3.5 (95% CI 2.5 - 4.8), with a prevalence of 32% compared to 12% in women with no history of leg symptoms. Obese women were at increased risk of PTS (OR 1.9, 95% CI 1.4 - 2.7) compared to non-obese. Similar women with proximal DVT (OR 1.6, 95% CI 1.1 - 2.3) and ipsilateral recurrence (OR 3.8, 95% CI 1.9 - 7.7) had increased risk of PTS. Patients with PTS scored lower on Veins-QoL (44 vs. 52, p < 0.01). Conclusions: PTS is a common complication of VTE. Women with a history of leg-symptoms before time of VTE-diagnosis have more than 3-fold increased risk of PTS. Occurrence of PTS significantly reduces QoL. Disclosures No relevant conflicts of interest to declare.


2008 ◽  
Vol 55 (4) ◽  
pp. 53-59 ◽  
Author(s):  
Z.V. Maksimovic ◽  
M. Maksimovic ◽  
D. Jadranin ◽  
I. Kuzmanovic ◽  
O. Andonovic

Introduction: Chronic venous insufficiency (HVI) is manifested by the progressive signs of venous stasis. This disorder is treated by: compressive bandaging, medicaments, sclerotherapy, surgery, etc. Aim: Prospective study of the effects of semisynthetic diosmin (clinical signs, quality of life, local biochemical parameters) on patients with HVI to whom no other method of treatment has previously been administered. Method applied: This prospective study analyzed the presence of risk factors and personal history of 80 patients with HVI. Diagnosis of HVI was based on the clinical appearance and the color duplex scan. Each patient's clinical signs (pain, edema, feeling of heaviness and tightness in the lower leg), quality of life (physical, social, and psychological), and CEAP stage were assessed prior to and 30 days after the treatment with Phlebodia 600?. For 15 patients with unilateral varicose veins, local values of lactates and gas analysis were taken under the conditions before and following the static load, and venous control samples were taken from the healthy leg. The acquired data were processed by means of descriptive statistics, while the significance of nonparametric features was measured by Wilcoxon test. Results: HVI is somewhat more frequent among females than among mails, on the left than on the right leg, and at the average age of 52.3+ 10.5. The patients with HVI are basicly engaged in professions with static load and have positive family history. The patients mainly started medical treatment 12.5+8.6 years after the first symptoms of the disease. Clinical improvement was recorded on the state of 65/80 patients. After the treatment numerical values of some of the clinical signs were statistically lower compared to the values before the administration of semisynthetic diosmin: oedema (0.94:1.50), pain (1.10:1.84), feeling of heaviness (1.20:1.96), and tightness (1.14:1.78). After the administration of the tested medication, parameters of physical, social, and psychological quality of life were significantly improved (p<0,0001), accompanied with significantly improved (p<0,0001) CEAP stage of HVI (3.00:3.40). Local biochemical parameters had not been significantly changed. Conclusion: Administration of semisynthetic diosmin during 30 days results in significant improvement of clinical signs, quality of life and CEAP stage of HVI.


2014 ◽  
Vol 29 (1_suppl) ◽  
pp. 104-111 ◽  
Author(s):  
FS Catarinella ◽  
FHM Nieman ◽  
MAF de Wolf ◽  
CHA Wittens

Introduction Treatment of deep venous occlusive disease is gaining popularity, although the results and outcomes of various techniques are yet to be fully studied. Quality-of-Life (QoL) improvement is a valid and important outcome in medicine, but no specific QoL instruments for deep venous pathology exist up until now. We assessed the short term QoL effects of treated patients with post thrombotic syndrome after deep venous occlusion. Materials and methods Patients with proven venous occlusive disease referred to the outpatient clinic of our department of Venous Surgery in the Maastricht University Medical Centre were included. After inclusion, patients were treated by PTA and stenting and when indicated an endophlebectomy was performed and an AV fistula was made. QoL was assessed with the disease specific VEINES-QOL/Sym and the generic SF-36 questionnaires preoperatively at baseline and postoperatively at 3 and 12 months. Results 61 patients completed the 3 month follow-up period and 28 patients the 12 month follow-up period. VEINES-QOL and Sym scores improved after 3 months: 17.5 points for QOL (p = < 0.001) and 21.4 points for Sym (p = < 0.001)) and after 12 months 18.8 points for QOL (p = 0.004) and 21.3 points for Sym (p = 0.003)). The SF-36 scores improved significantly in the domains “physical functioning”, “role physical” and “bodily pain”. Conclusions Treating deep venous occlusive disease leads to short-term improvement of both disease specific QoL as well as generic QoL scores. Larger long-term follow-up studies are needed to corroborate these results.


2021 ◽  
pp. 1-8
Author(s):  
Aditya K. Gupta ◽  
Maanasa Venkataraman ◽  
Emma M. Quinlan ◽  
Madhulika A. Gupta ◽  
Naveen Anbalagan ◽  
...  

<b><i>Introduction:</i></b> Onychomycosis is a common, difficult-to-treat fungal nail infection. Clinical signs include nail discoloration and thickening, which patients often find embarrassing, causing a negative impact on their quality of life (QOL). <b><i>Methods:</i></b> In this post hoc study, we analyze the effect of efinaconazole 10% solution on a patient’s QOL using patient-reported scores from the OnyCOE-t™ questionnaire (appearance, stigma, physical problems, symptom frequency, symptom bothersomeness, treatment satisfaction, and overall problem). Higher scores corresponded to better functioning, thus higher QOL. <b><i>Results:</i></b> Efinaconazole 10% treatment and clinical efficacy were positively correlated with improved QOL in all domains for all groups, except with symptom bothersomeness (how much the onychomycosis symptoms worried or concerned the patient) for female patients &#x3c;40 years. While still showing improvement in most domains during efficacious treatment, female and younger patients reported lower QOL scores than their male and older counterparts, despite having better clinical outcomes at follow-ups. <b><i>Discussion:</i></b> Female and younger patients appear to be more emotionally bothered by their symptoms, regardless of treatment success or improvement of their nail’s appearance, suggesting that onychomycosis is more than nail deep and has a greater psychological effect on these patients. Therefore, younger female patients may require more assurance and mental support.


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