scholarly journals Intramedullary nail fixation versus locking plate fixation for adults with a fracture of the distal tibia: the UK FixDT RCT

2018 ◽  
Vol 22 (25) ◽  
pp. 1-148 ◽  
Author(s):  
Matthew L Costa ◽  
Juul Achten ◽  
Susie Hennings ◽  
Nafisa Boota ◽  
James Griffin ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Locking Plate ◽  
Plate Fixation ◽  
Distal Tibia ◽  
Locking Plate Fixation ◽  
Fixation Group ◽  
Plate Group ◽  
Significant Difference

BackgroundThe best treatment for fractures of the distal tibia remains controversial. Most of these fractures require surgical fixation, but the outcomes are unpredictable and complications are common.ObjectivesTo assess disability, quality of life, complications and resource use in patients treated with intramedullary (IM) nail fixation versus locking plate fixation in the 12 months following a fracture of the distal tibia.DesignThis was a multicentre randomised trial.SettingThe trial was conducted in 28 UK acute trauma centres from April 2013 to final follow-up in February 2017.ParticipantsIn total, 321 adult patients were recruited. Participants were excluded if they had open fractures, fractures involving the ankle joint, contraindication to nailing or inability to complete questionnaires.InterventionsIM nail fixation (n = 161), in which a metal rod is inserted into the hollow centre of the tibia, versus locking plate fixation (n = 160), in which a plate is attached to the surface of the tibia with fixed-angle screws.Main outcome measuresThe primary outcome measure was the Disability Rating Index (DRI) score, which ranges from 0 points (no disability) to 100 points (complete disability), at 6 months with a minimum clinically important difference of 8 points. The DRI score was also collected at 3 and 12 months. The secondary outcomes were the Olerud–Molander Ankle Score (OMAS), quality of life as measured using EuroQol-5 Dimensions (EQ-5D), complications such as infection, and further surgery. Resource use was collected to inform the health economic evaluation.ResultsParticipants had a mean age of 45 years (standard deviation 16.2 years), were predominantly male (61%, 197/321) and had experienced traumatic injury after a fall (69%, 223/321). There was no statistically significant difference in DRI score at 6 months [IM nail fixation group, mean 29.8 points, 95% confidence interval (CI) 26.1 to 33.7 points; locking plate group, mean 33.8 points, 95% CI 29.7 to 37.9 points; adjusted difference, 4.0 points, 95% CI –1.0 to 9.0 points;p = 0.11]. There was a statistically significant difference in DRI score at 3 months in favour of IM nail fixation (IM nail fixation group, mean 44.2 points, 95% CI 40.8 to 47.6 points; locking plate group, mean 52.6 points, 95% CI 49.3 to 55.9 points; adjusted difference 8.8 points, 95% CI 4.3 to 13.2 points;p < 0.001), but not at 12 months (IM nail fixation group, mean 23.1 points, 95% CI 18.9 to 27.2 points; locking plate group, 24.0 points, 95% CI 19.7 to 28.3 points; adjusted difference 1.9 points, 95% CI –3.2 to 6.9 points;p = 0.47). Secondary outcomes showed the same pattern, including a statistically significant difference in mean OMAS and EQ-5D scores at 3 and 6 months in favour of IM nail fixation. There were no statistically significant differences in complications, including the number of postoperative infections (13% in the locking plate group and 9% in the IM nail fixation group). Further surgery was more common in the locking plate group (12% in locking plate group and 8% in IM nail fixation group at 12 months). The economic evaluation showed that IM nail fixation provided a slightly higher quality of life in the 12 months after injury and at lower cost and, therefore, it was cost-effective compared with locking plate fixation. The probability of cost-effectiveness for IM nail fixation exceeded 90%, regardless of the value of the cost-effectiveness threshold.LimitationsAs wound dressings after surgery are clearly visible, it was not possible to blind the patients to their treatment allocation. This evidence does not apply to intra-articular (pilon) fractures of the distal tibia.ConclusionsAmong adults with an acute fracture of the distal tibia who were randomised to IM nail fixation or locking plate fixation, there were similar disability ratings at 6 months. However, recovery across all outcomes was faster in the IM nail fixation group and costs were lower.Future workThe potential benefit of IM nail fixation in several other fractures requires investigation. Research is also required into the role of adjuvant treatment and different rehabilitation strategies to accelerate recovery following a fracture of the tibia and other long-bone fractures in the lower limb. The patients in this trial will remain in longer-term follow-up.Trial registrationCurrent Controlled Trials ISRCTN99771224 and UKCRN 13761.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 22, No. 25. See the NIHR Journals Library website for further project information.

scholarly journals Percutaneous fixation with Kirschner wires versus volar locking-plate fixation in adults with dorsally displaced fracture of distal radius: five-year follow-up of a randomized controlled trial

2019 ◽  
Vol 101-B (8) ◽  
pp. 978-983 ◽  
Author(s):  
M. L. Costa ◽  
J. Achten ◽  
A. Rangan ◽  
S. E. Lamb ◽  
N. R. Parsons
Keyword(s):  
Quality Of Life ◽  
Distal Radius ◽  
Locking Plate ◽  
Controlled Trial ◽  
Plate Fixation ◽  
Locking Plate Fixation ◽  
Plate Group ◽  
Displaced Fracture

Aims The aim of this study was to compare the clinical effectiveness of Kirschner wire (K-wire) fixation with locking-plate fixation for patients with a dorsally displaced fracture of the distal radius in the five years after injury. Patients and Methods We report the five-year follow-up of a multicentre, two-arm, parallel-group randomized controlled trial. A total of 461 adults with a dorsally displaced fracture of the distal radius within 3 cm of the radiocarpal joint that required surgical fixation were recruited from 18 trauma centres in the United Kingdom. Patients were excluded if the surface of the wrist joint was so badly displaced it required open reduction. In all, 448 patients were randomized to receive either K-wire fixation or locking-plate fixation. In the K-wire group, there were 179 female and 38 male patients with a mean age of 59.1 years (19 to 89). In the locking-plate group, there were 194 female and 37 male patients with a mean age of 58.3 years (20 to 89). The primary outcome measure was the patient-rated wrist evaluation (PRWE). Secondary outcomes were health-related quality of life using the EuroQol five-dimension three-level (EQ-5D-3L) assessment, and further surgery related to the index fracture. Results At 12 months, 402/448 participants (90%) recruited into the main study provided PRWE scores. At year two, 294 participants (66%) provided scores; at year five, 198 participants (44%) provided scores. There was no clinically relevant difference in the PRWE at any point during the five-year follow-up; at five years, the PRWE score was 8.3 (12.5) in the wire group and 11.3 (15.6) in the plate group (95% confidence interval -6.99 to 0.99; p = 0.139). Nor was there a clinically relevant difference in health-related quality of life. Only three participants had further surgery in the five years after their injury (one in the wire group and two in the plate group). Conclusion This follow-up study continues to show no evidence of a difference in wrist pain, wrist function, or quality of life for patients treated with wires versus locking plates in the five years following a dorsally displaced fracture of the distal radius. Cite this article: Bone Joint J 2019;101-B:978–983.

scholarly journals Breast reconstruction after breast cancer surgery – persistent pain and quality of life 1–8 years after breast reconstruction

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Nina Honkanen ◽  
Laura Mustonen ◽  
Eija Kalso ◽  
Tuomo Meretoja ◽  
Hanna Harno
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Breast Reconstruction ◽  
Perforator Flap ◽  
Persistent Pain ◽  
Rectus Abdominis ◽  
Preoperative Pain ◽  
Significant Difference

Abstract Objectives To assess the long-term outcome of breast reconstructions with special focus on chronic postsurgical pain (CPSP) in a larger cohort of breast cancer survivors. Methods A cross-sectional study on 121 women with mastectomy and breast reconstruction after mean 2 years 4 months follow up. The mean time from breast reconstruction to the follow-up visit was 4 years 2 months. We studied surveys on pain (Brief Pain Inventory, BPI and Douleur Neuropathique 4, DN4), quality of life (RAND-36 health survey), sleep (insomnia severity questionnaire, ISI), mood (Beck’s Depression Index, BDI; Hospital Anxiety and Depression Scale, HADS), and a detailed clinical sensory status. Patients were divided into three groups: abdominal flap (Deep inferior epigastric perforator flap, DIEP; Free transverse rectus abdominis flap, fTRAM, and Pedicled transverse rectus abdominis flap, pTRAM), dorsal flap (Latissimus dorsi flap, LD and Thoracodorsal artery perforator flap, TDAP), and other (Transverse myocutaneous gracilis flap, TMG; implant). Clinically meaningful pain was defined ≥ 4/10 on a numeric rating scale (NRS). We used patients’ pain drawings to localize the pain. We assessed preoperative pain NRS from previous data. Results 106 (87.6%) of the patients did not have clinically meaningful persistent pain. We found no statistically significant difference between different reconstruction types with regards to persistent pain (p=0.40), mood (BDI-II, p=0.41 and HADS A, p=0.54) or sleep (p=0.14), respectively. Preoperative pain prior to breast reconstruction surgery correlated strongly with moderate or severe CPSP. Conclusions Moderate to severe CPSP intensity was present in 14% of patients. We found no significant difference in the prevalence of pain across different reconstruction types. Preoperative pain associated significantly with postoperative persistent pain.

Comparative Analysis of Patients with Robotic Hiatal Hernia Repairs with and without Collis Gastroplasty

2021 ◽  
pp. 000313482198905
Author(s):  
John A. Perrone ◽  
Stephanie Yee ◽  
Manrique Guerrero ◽  
Antai Wang ◽  
Brian Hanley ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Statistical Analysis ◽  
Hospital Stay ◽  
Hiatal Hernia ◽  
Collis Gastroplasty ◽  
Significant Difference ◽  
Related Quality

Introduction After extensive mediastinal dissection fails to achieve adequate intra-abdominal esophageal length, a Collis gastroplasty(CG) is recommended to decrease axial tension and reduce hiatal hernia recurrence. However, concerns exist about staple line leak, and long-term symptoms of heartburn and dysphagia due to the acid-producing neoesophagus which lacks peristaltic activity. This study aimed to assess long-term satisfaction and GERD-related quality of life after robotic fundoplication with CG (wedge fundectomy technique) and to compare outcomes to patients who underwent fundoplication without CG. Outcomes studied included patient satisfaction, resumption of proton pump inhibitors (PPI), length of surgery (LOS), hospital stay, and reintervention. Methods This was a single-center retrospective analysis of patients from January 2017 through December 2018 undergoing elective robotic hiatal hernia repair and fundoplication. 61 patients were contacted for follow-up, of which 20 responded. Of those 20 patients, 7 had a CG performed during surgery while 13 did not. There was no significant difference in size and type of hiatal hernias in the 2 groups. These patients agreed to give their feedback via a GERD health-related quality of life (GERD HRQL) questionnaire. Their medical records were reviewed for LOS, length of hospital stay (LOH), and reintervention needed. Statistical analysis was performed using SPSS v 25. Satisfaction and need for PPIs were compared between the treatment and control groups using the chi-square test of independence. Results Statistical analysis showed that satisfaction with outcome and PPI resumption was not significantly different between both groups ( P > .05). There was a significant difference in the average ranks between the 2 groups for the question on postoperative dysphagia on the follow-up GERD HRQL questionnaire, with the group with CG reporting no dysphagia. There were no significant differences in the average ranks between the 2 groups for the remaining 15 questions ( P > .05). The median LOS was longer in patients who had a CG compared to patients who did not (250 vs. 148 min) ( P = .01). The LOH stay was not significantly different ( P > .05) with a median length of stay of 2 days observed in both groups. There were no leaks in the Collis group and no reoperations, conversions, or blood transfusions needed in either group. Conclusion Collis gastroplasty is a safe option to utilize for short esophagus noted despite extensive mediastinal mobilization and does not adversely affect the LOH stay, need for reoperation, or patient long-term satisfaction.

scholarly journals Quality of Life Following Urgent LVAD Implantation for ECMO Therapy in Cardiogenic Shock: A Long-Term Follow-Up

Medicina ◽  
2021 ◽  
Vol 57 (8) ◽  
pp. 747
Author(s):  
Rafal Berger ◽  
Hasan Hamdoun ◽  
Rodrigo Sandoval Boburg ◽  
Medhat Radwan ◽  
Metesh Acharya ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cardiogenic Shock ◽  
Left Ventricular ◽  
Ecmo Support ◽  
Circulatory Support ◽  
Significant Difference ◽  
Va Ecmo ◽  
Ecmo Therapy

Background and Objectives: Over the past decade, veno-arterial extracorporeal membrane oxygenation (VA-ECMO) has developed into a mainstream treatment for refractory cardiogenic shock (CS) to maximal conservative management. Successful weaning of VA-ECMO may not be possible, and bridging with further mechanical circulatory support (MCS), such as urgent implantation of a left ventricular assist device (LVAD), may represent the only means to sustain the patient haemodynamically. In the recovery phase, many survivors are not suitably prepared physically or psychologically for the novel issues encountered during daily life with an LVAD. Materials and Methods: A retrospective analysis of our institutional database between 2012 and 2019 was performed to identify patients treated with VA-ECMO for CS who underwent urgent LVAD implantation whilst on MCS. Post-cardiotomy cases were excluded. QoL was assessed prospectively during a routine follow-up visit using the EuroQol-5 dimensions-5 level (EQ-5D-5L) and the Patient Health Questionnaire (PHQ-9) surveys. Results: Among 126 in-hospital survivors of VA-ECMO therapy due to cardiogenic shock without prior cardiac surgery, 31 (24.6%) urgent LVAD recipients were identified. In 11 (36.7%) cases, cardiopulmonary resuscitation (CPR) was performed (median 10, range 1–60 min) before initiation of VA-ECMO, and in 5 (16.7%) cases, MCS was established under CPR. Mean age at LVAD implantation was 51.7 (+/−14) years and surgery was performed after a mean 12.1 (+/−8) days of VA-ECMO support. During follow-up of 46.9 (+/−25.5) months, there were 10 deaths after 20.4 (+/−12.1) months of LVAD support. Analysis of QoL questionnaires returned a mean EQ-5D-5L score of 66% (+/−21) of societal valuation for Germany and a mean PHQ-9 score of 5.7 (+/−5) corresponding to mild depression severity. When compared with 49 elective LVAD recipients without prior VA-ECMO therapy, there was no significant difference in QoL results. Conclusions: Patients requiring urgent LVAD implantation under VA-ECMO support due to CS are associated with comparable quality of life without a significant difference from elective LVAD recipients. Close follow-up is required to oversee patient rehabilitation after successful initial treatment.

scholarly journals Slowly resorbable biosynthetic mesh: 2-year results in VHWG grade 3 hernia repair

Hernia ◽  
2021 ◽  
Author(s):  
M. M. J. Van Rooijen ◽  
T. Tollens ◽  
L. N. Jørgensen ◽  
T. S. de Vries Reilingh ◽  
G. Piessen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Hernia Repair ◽  
Hernia Recurrence ◽  
Recurrence Rates ◽  
Elective Repair ◽  
Significant Difference ◽  
Grade 3

Abstract Introduction Information on the long-term performance of biosynthetic meshes is scarce. This study analyses the performance of biosynthetic mesh (Phasix™) over 24 months. Methods A prospective, international European multi-center trial is described. Adult patients with a Ventral Hernia Working Group (VHWG) grade 3 incisional hernia larger than 10 cm2, scheduled for elective repair, were included. Biosynthetic mesh was placed in sublay position. Short-term outcomes included 3-month surgical site occurrences (SSO), and long-term outcomes comprised hernia recurrence, reoperation, and quality of life assessments until 24 months. Results Eighty-four patients were treated with biosynthetic mesh. Twenty-two patients (26.2%) developed 34 SSOs, of which 32 occurred within 3 months (primary endpoint). Eight patients (11.0%) developed a hernia recurrence. In 13 patients (15.5%), 14 reoperations took place, of which 6 were performed for hernia recurrence (42.9%), 3 for mesh infection (21.4%), and in 7 of which the mesh was explanted (50%). Compared to baseline, quality of life outcomes showed no significant difference after 24 months. Despite theoretical resorption, 10.7% of patients reported presence of mesh sensation in daily life 24 months after surgery. Conclusion After 2 years of follow-up, hernia repair with biosynthetic mesh shows manageable SSO rates and favorable recurrence rates in VHWG grade 3 patients. No statistically significant improvement in quality of life or reduction of pain was observed. Few patients report lasting presence of mesh sensation. Results of biosynthetic mesh after longer periods of follow-up on recurrences and remodeling will provide further valuable information to make clear recommendations. Trial registration Registered on clinicaltrials.gov (NCT02720042), March 25, 2016.

Abstract TP295: Stroke Prevention Surgery > Quality of Life and Cognitive Ability to Drive Are Maintained After Surgical Repair of Unruptured Intracranial Aneurysm

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Joan M ODonnell ◽  
Maurizio Manuguerra ◽  
Jemma L Hodge ◽  
Greg Savage ◽  
Michael K Morgan
Keyword(s):  
Quality Of Life ◽  
Intracranial Aneurysm ◽  
Surgical Management ◽  
Cognitive Abilities ◽  
Short Form ◽  
Unruptured Intracranial Aneurysm ◽  
Significant Difference ◽  
Ability To Drive

Background: Studies have questioned the effectiveness of surgery for the management of unruptured intracranial aneurysm (uIA). Few studies have examined the ability to drive and quality of life (QOL) after surgery for uIA. Objective: This study examined the effectiveness of surgical management of uIA by measuring patients’ perceived quality of life and their cognitive abilities related to driving. Methods: Between January 2011 and January 2016 patients with a uIA were assessed using the Quality Metric Short Form 36 (SF36) and the off-road driver screening instrument DriveSafeDriveAware. Reassessments were conducted at the 6-week post-operative follow-up for surgical patients and at 12-month follow-up for surgical and conservatively managed patients. Results: 175 patients enrolled in the study, of which 112(66%) had surgical management of their aneurysm. For the surgical cases who completed all assessments (N=74), there was a trend for the DriveSafe pre-operative mean score of 108 (SD 10.7) to be lower than the 6-week and 12-month post-operative mean scores (111 SD 9.7 and 112 SD 10.2 respectively)(p=0.05). There were no significant changes in DriveAware scores at any epoch or between patient groups nor in the MCS in the surgical group.. There was a significant decline in PCS scores at 6 weeks post-operatively which recovered at 12 months (52 SD 8.1, 46 SD 6.8 and 52 SD 7.1 respectively)( p <0.01). There was no significant difference in 12-month mRS scores between the surgical cases who completed with cases who did not complete all assessments. Conclusion: Surgery for uIA did not affect cognitive abilities for driving at 6 weeks or 12 months after surgery. There was a decline in the QOL in the first months after surgery, however QOL returned to pre-surgical status 12 months after surgery. If the risk of seizures is low and there are no post-operative complications, returning to driving can be recommended.

scholarly journals Health-Related Quality of Life following Cytoreductive Radical Prostatectomy in Patients with de-novo Oligometastatic Prostate Cancer

Cancers ◽  
2021 ◽  
Vol 13 (22) ◽  
pp. 5636
Author(s):  
Michael Chaloupka ◽  
Lina Stoermer ◽  
Maria Apfelbeck ◽  
Alexander Buchner ◽  
Vera Wenter ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Radical Prostatectomy ◽  
De Novo ◽  
Health Related Quality ◽  
Significant Difference ◽  
Related Quality ◽  
Health Related

(1) Background: local treatment of the primary tumor has become a valid therapeutic option in de-novo oligo-metastatic prostate cancer (PC). However, evidence regarding radical prostatectomy (RP) in this setting is still subpar, and the effect of cytoreductive RP on postoperative health-related quality of life (HRQOL) is still unclear. (2) Methods: for the current study, patients with de-novo oligo-metastatic PC (cM1-oligo), defined as ≤5 bone lesions in the preoperative staging, were included, and matched cohorts using the variables age, body-mass index (BMI), and pT-stage were generated. Patient-reported outcome measures (PROMS) were assessed pre- and postoperatively using the validated EORTC-QLQ-C30, IIEF-5, and ICIQ-SF questionnaires. The primary endpoint for univariate and multivariable analysis was good general HRQOL defined by previously validated cut-off values. (3) Results: in total, 1268 patients (n = 84 (7%) cM1-oligo) underwent RP between 2012 and 2020 at one tertiary care center. A matched cohort of 411 patients (n = 79 with oligo-metastatic bone disease (cM1-oligo) and n = 332 patients without clinical indication of metastatic disease (cM0)) was created. The median follow-up was 25mo. There was no significant difference in good general HRQOL rates between cM1-oligo-patients and cM0-patients before RP (45.6% vs. 55.2%, p = 0.186), and at time of follow-up (44% vs. 56%, p = 0.811). Global health status (GHS) worsened significantly in cM0-patients compared to baseline (−5, p = 0.001), whereas GHS did not change significantly in cM1-oligo-patients (+3.2, p = 0.381). In multivariate analysis stratified for good erectile function (IIEF5 > 18; OR 5.722, 95% CI 1.89–17.36, p = 0.002) and continence recovery (OR 1.671, 95% CI 1.03–2.70, p = 0.036), cM1-oligo was not an independent predictive feature for general HRQOL (OR 0.821, 95% CI 0.44–1.53, p = 0.536). (4) Conclusions: in this large contemporary retrospective analysis, we observed no significant difference in HRQOL in patients with the oligometastatic bone disease after cytoreductive radical prostatectomy, when compared to patients with localized disease at time of surgery.

scholarly journals Is quality of life after mastectomy comparable to that after breast conservation surgery? A 5-year follow up study from Mumbai, India

2019 ◽  
Vol 29 (3) ◽  
pp. 683-692
Author(s):  
K. V. Deepa ◽  
A. Gadgil ◽  
Jenny Löfgren ◽  
S. Mehare ◽  
Prashant Bhandarkar ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Breast Conservation ◽  
Radical Mastectomy ◽  
Breast Conservation Surgery ◽  
Breast Cancer Surgery ◽  
Significant Difference ◽  
Domain Scores

Abstract Purpose Breast cancer is the commonest cancer in women worldwide. Surgery is a central part of the treatment. Modified radical mastectomy (MRM) is often replaced by breast conserving therapy (BCT) in high-income countries. MRM is still the standard choice, in low- and middle-income countries (LMICs) as radiotherapy, a mandatory component of BCT is not widely available. It is important to understand whether quality of life (QOL) after MRM is comparable to that after BCT. This has not been studied well in LMICs. We present, 5-year follow-up of QOL scores in breast cancer patients from India. Methods We interviewed women undergoing breast cancer surgery preoperatively, at 6 months after surgery, and at 1 year and 5 years, postoperatively. QOL scores were evaluated using FACT B questionnaire. Average QOL scores of women undergoing BCT were compared with those undergoing MRM. Total scores, domain scores and trends of scores over time were analyzed. Results We interviewed 54 women with a mean age of 53 years (SD 9 ± years). QOL scores in all the women, dipped during the treatment period, in all subscales but improved thereafter and even surpassed the baseline in physical, emotional and breast-specific domains (p < 0.05) at 5 years. At the end of 5 years, there was no statistically significant difference between the MRM and BCT groups in any of the total or domain scores. Conclusion QOL scores in Indian women did not differ significantly between MRM and BCT in the long term. Both options are acceptable in the study setting.

scholarly journals Hyeonggaeyeongyo-Tang for Treatment of Allergic and Nonallergic Rhinitis: A Prospective, Nonrandomized, Pre-Post Study

2016 ◽  
Vol 2016 ◽  
pp. 1-7 ◽  
Author(s):  
Min-Hee Kim ◽  
Jaewoong Son ◽  
Hae Jeong Nam ◽  
Seong-Gyu Ko ◽  
Inhwa Choi
Keyword(s):  
Quality Of Life ◽  
Allergic Rhinitis ◽  
Life Questionnaire ◽  
Nonallergic Rhinitis ◽  
Prick Test ◽  
Chronic Rhinitis ◽  
Nasal Symptoms ◽  
Significant Difference

Hyeonggaeyeongyo-tang (HYT) is an ancient formula of oriental medicine traditionally used to treat rhinitis; however, clinical evidence has not yet been established. The aim of this study was to investigate the short-term and long-term efficacy and safety of HYT for chronic rhinitis. Adult subjects with chronic rhinitis symptoms were recruited. The subjects received HYT for 4 weeks and had follow-up period of 8 weeks. Any medicines used to treat nasal symptoms were not permitted during the study. The skin prick test was performed to distinguish the subjects with allergic rhinitis from those with nonallergic rhinitis. After treatment, the total nasal symptoms score and the Rhinoconjunctivitis Quality of Life Questionnaire score significantly improved in the whole subject group, in the allergic rhinitis group, and in the nonallergic rhinitis group, with no adverse events. This improvement lasted during a follow-up period of 8 weeks. Total IgE and eosinophil levels showed no significant difference after treatment in the allergic rhinitis group. HYT improved nasal symptoms and quality of life in patients with allergic rhinitis and nonallergic rhinitis. This is the first clinical study to evaluate the use of HYT to treat patients with rhinitis. This trial has been registered with the ClinicalTrials.gov IdentifierNCT02477293.

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