Comparison of Two Different Treatment Protocols Using Systemic and Intratympanic Steroids with and without Hyperbaric Oxygen Therapy in Patients with Severe to Profound Idiopathic Sudden Sensorineural Hearing Loss: A Randomized Controlled Trial

2018 ◽  
Vol 23 (4) ◽  
pp. 199-207 ◽  
Author(s):  
Ilyoung Cho ◽  
Hyun-Min Lee ◽  
Sung-Won Choi ◽  
Soo-Keun Kong ◽  
Il-Woo Lee ◽  
...  
Keyword(s):  
Oxygen Therapy ◽  
Protocol Analysis ◽  
Controlled Trial ◽  
Sudden Sensorineural Hearing Loss ◽  
Oral Steroid ◽  
Control Group ◽  
Study Group ◽  
Intention To Treat ◽  
Hearing Recovery

Objectives: This study aimed to investigate the efficacy of simultaneous steroid and hyperbaric oxygen therapy (HBOT) in patients with severe to profound idiopathic sudden sensorineural hearing loss (ISSNHL), which has a poor prognosis. Methods: Sixty patients diagnosed with severe to profound ISSNHL (≥70 dB HL) were randomly divided into two groups in a prospective controlled trial: an oral steroid + intratympanic steroid injection (ITSI) group (control group) and an oral steroid + ITSI + HBOT group (study group). Pure-tone audiometry (PTA) results and word discrimination scores (WDS) were compared between the two groups before treatment and 10 days and 1, 2, and 3 months after treatment. Hearing improvement was assessed using the modified American Academy of Otolaryngology-Head and Neck Surgery criteria. Analyses were by both intention to treat and per protocol. Results: A total of 58 patients completed the 3-month follow-up, and 2 patients in the study group were excluded due to follow-up loss in the per-protocol analysis. In the intention-to-treat and per-protocol analyses, the study group showed significantly better hearing levels than did the control group at 500 Hz (p < 0.05) 1 month after treatment and at 1 kHz (p < 0.05) 3 months after treatment. However, the average PTA values and PTA at 2, 4, and 8 kHz showed no significant difference. WDS improvement was significantly higher in the study group compared to the control group 3 months after treatment by both per-protocol (66.4 ± 13.3 and 56.7 ± 19.1%, respectively; p = 0.029) and intention-to-treat analyses (65.9 ± 14.1 and 56.7 ± 19.1%, respectively; p = 0.035). The sum of complete and partial hearing recovery for the study group was significantly higher than that for the control group by per-protocol analysis (60.7 vs. 33.3%; p = 0.037) and intention-to-treat analysis (60.0 vs. 33.3%; p = 0.038). Conclusion: These results demonstrate that the addition of HBOT to steroid combination therapy does not improve the average PTA values in severe to profound ISSNHL; however, it was associated with a better outcome at 500 Hz 1 month after treatment and, at 1 kHz, WDS 3 months after treatment. The sum of complete and partial hearing recovery was significantly higher for the study group than for the control group.

scholarly journals Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lena Violetta Krämer ◽  
Nadine Eschrig ◽  
Lena Keinhorst ◽  
Luisa Schöchlin ◽  
Lisa Stephan ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Mixed Model ◽  
Controlled Trial ◽  
Control Group ◽  
Web Based ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Link Type

Abstract Background Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. Methods A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare (www.studicare.com). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. Discussion This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. Trial registration The German clinical trials register (DRKS) DRKS00016889. Registered on 28 February 2019

scholarly journals A novel brief treatment for methamphetamine use disorders in South Africa: a randomised feasibility trial

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
K. Sorsdahl ◽  
D. J. Stein ◽  
S. Pasche ◽  
Y. Jacobs ◽  
R. Kader ◽  
...  
Keyword(s):  
South Africa ◽  
Controlled Trial ◽  
Adverse Outcomes ◽  
Feasibility Trial ◽  
Control Group ◽  
Brief Treatment ◽  
Middle Income ◽  
Methamphetamine Use ◽  
Intention To Treat

Abstract Background Effective brief treatments for methamphetamine use disorders (MAUD) are urgently needed to complement longer more intensive treatments in low and middle income countries, including South Africa. To address this gap, the purpose of this randomised feasibility trial was to determine the feasibility of delivering a six-session blended imaginal desensitisation, plus motivational interviewing (IDMI) intervention for adults with a MAUD. Methods We enrolled 60 adults with a MAUD and randomly assigned them 1:1 to the IDMI intervention delivered by clinical psychologists and a control group who we referred to usual care. Feasibility measures, such as rates of recruitment, consent to participate in the trial and retention, were calculated. Follow-up interviews were conducted at 6 weeks and 3 months post-enrollment. Results Over 9 months, 278 potential particiants initiated contact. Following initial screening 78 (28%) met inclusion criteria, and 60 (77%) were randomised. Thirteen of the 30 participants assigned to the treatment group completed the intervention. Both psychologists were highly adherent to the intervention, obtaining a fidelity rating of 91%. In total, 39 (65%) participants completed the 6-week follow-up and 40 (67%) completed the 3-month follow-up. The intervention shows potential effectiveness in the intention-to-treat analysis where frequency of methamphetamine use was significantly lower in the treatment than in the control group at both the 6 week and 3-month endpoints. No adverse outcomes were reported. Conclusions This feasibility trial suggests that the locally adapted IDMI intervention is an acceptable and safe intervention as a brief treatment for MAUD in South Africa. Modifications to the study design should be considered in a fully powered, definitive controlled trial to assess this potentially effective intervention. Trial registration The trial is registered with the Pan African Clinical Trials Registry (Trial ID: PACTR201310000589295)

scholarly journals Effect of manual therapy in patients with hemophilia and ankle arthropathy: a randomized clinical trial

2019 ◽  
Vol 34 (1) ◽  
pp. 111-119 ◽  
Author(s):  
Elena Donoso-Úbeda ◽  
Javier Meroño-Gallut ◽  
José Antonio López-Pina ◽  
Rubén Cuesta-Barriuso
Keyword(s):  
Manual Therapy ◽  
Joint Pain ◽  
Controlled Trial ◽  
Control Group ◽  
Load Bearing ◽  
Intention To Treat ◽  
Joint Health ◽  
Experimental Group ◽  
Treat Analysis

Objective: The aim of this study was to evaluate the effects of a manual therapy using fascial therapy on joint bleeding, joint pain and joint function in patients with hemophilic ankle arthropathy. Setting: Hemophilia patient associations. Design: Randomized, controlled trial, multicenter and intention-to-treat analysis. Participants: A total of 65 patients with hemophilic ankle arthropathy. Intervention: The experimental group ( n = 33) received one fascial therapy session per week for three weeks. The control group ( n = 32) received no treatment. Outcome measure: The primary outcome was frequency of joint bleeding measured using self-reporting. Secondary outcomes were joint pain (under load-bearing and non-load-bearing conditions) measured using the visual analog scale; joint condition was measured using the Hemophilia Joint Health Score. Outcomes were measured at baseline, posttreatment and after five months of follow-up. Results: Improvements in the frequency joint bleeding at T0, T1 and T2 were significantly higher in the experimental group (T0: mean (SD) = 1.56 (1.30); T1: mean (SD) = 0.00 (0.00); T2: mean (SD) = 0.27 (0.57)) compared to the control group (T0: mean (SD) = 1.70 (1.78); T1: mean (SD) = 0.05 (0.21); T2: mean (SD) = 0.58 (0.85)). Mean improvement of joint state after the study period was 1.74 points (±1.66) for patients in the experimental group, while the control group exhibited a joint deterioration with 0.43 points (±0.85). Ankle joint pain under load-bearing and non-load-bearing conditions improved in the experimental group with −1.72 (±1.86) and −0.50 (±1.39) points, respectively. Conclusion: The study showed that fascial therapy is favorable for patients with hemophilic ankle arthropathy.

scholarly journals Metacognitive reflection and insight therapy (MERIT) for patients with schizophrenia

2018 ◽  
Vol 49 (2) ◽  
pp. 303-313 ◽  
Author(s):  
S. de Jong ◽  
R. J. M. van Donkersgoed ◽  
M. E. Timmerman ◽  
M. aan het Rot ◽  
L. Wunderink ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Drop Out ◽  
Future Research ◽  
Control Group ◽  
Treatment As Usual ◽  
Self Reflection ◽  
Intention To Treat ◽  
Metacognitive Reflection ◽  
Secondary Outcomes

AbstractBackgroundImpaired metacognition is associated with difficulties in the daily functioning of people with psychosis. Metacognition can be divided into four domains: Self-Reflection, Understanding the Other's Mind, Decentration, and Mastery. This study investigated whether Metacognitive Reflection and Insight Therapy (MERIT) can be used to improve metacognition.MethodsThis study is a randomized controlled trial. Patients in the active condition (n = 35) received forty MERIT sessions, the control group (n = 35) received treatment as usual. Multilevel intention-to-treat and completers analyses were performed for metacognition and secondary outcomes (psychotic symptomatology, cognitive insight, Theory of Mind, empathy, depression, self-stigma, quality of life, social functioning, and work readiness).ResultsEighteen out of 35 participants finished treatment, half the drop-out stemmed from therapist attrition (N = 5) or before the first session (N = 4). Intention-to-treat analysis demonstrated that in both groups metacognition improved between pre- and post-measurements, with no significant differences between the groups. Patients who received MERIT continued to improve, while the control group returned to baseline, leading to significant differences at follow-up. Completers analysis (18/35) showed improvements on the Metacognition Assessment Scale (MAS-A) scales Self Reflectivity and metacognitive Mastery at follow-up. No effects were found on secondary outcomes.ConclusionsOn average, participants in the MERIT group were, based on MAS-A scores, at follow-up more likely to recognize their thoughts as changeable rather than as facts. MERIT might be useful for patients whose self-reflection is too limited to benefit from other therapies. Given how no changes were found in secondary measures, further research is needed. Limitations and suggestions for future research are discussed.

Capsular bag performance of a novel hydrophobic acrylic single-piece intraocular lens: Two-year results of a randomised controlled trial

2020 ◽  
pp. 112067212096059
Author(s):  
Andreea D Fișuș ◽  
Nino D Hirnschall ◽  
Sophie Maedel ◽  
Maria Fichtenbaum ◽  
Petra Draschl ◽  
...  
Keyword(s):  
Intraocular Lens ◽  
Controlled Trial ◽  
Visual Outcome ◽  
Automated Image Analysis ◽  
Control Group ◽  
Study Group ◽  
Ocular Surgery ◽  
Randomised Study ◽  
Hydrophobic Acrylic

Purpose: To determine the visual outcome, intraocular lens (IOL) stability and posterior capsule opacification (PCO) rate of a hydrophobic acrylic intraocular lens. Setting: Vienna Institute for Research in Ocular Surgery, Hanusch Hospital, Vienna, Austria Design: This double-masked randomised study included patients who underwent standard cataract surgery. Method: Patients received either the hydrophobic acrylic IOL (iPure, PhysIOL) or the hydrophobic acrylic control IOL (Tecnis ZCB00, Johnson&Johnson). Subjective refraction, uncorrected and corrected distance visual acuity (UDVA, CDVA), IOL tilt and decentration (Purkinje meter) and PCO intensity using retroillumination images with automated image analysis (automated quantification of after-cataract, AQUA), were evaluated for both groups 2 years after surgery. Results: A total number of 31 patients completed the 2-year follow-up, 16 in the study group and 15 in the control group. The CDVA was 0.0 logMAR (standard deviation – SD: 0.1) for the study IOL and 0.1 logMAR (SD: 0.2) for the control IOL, p = 0.001. The AQUA PCO score for the study group was 2.1 and 1.4 for the control group, p = 0.44. Mean IOL tilt was 2.9° (SD: 1.8) in the study group and 5.0° (SD: 4.5) in the control group, whilst the mean decentration was 0.37 mm (SD: 0.18) and 0.45 mm (SD: 0.3), p = 0.610. Conclusion: The studied parameters revealed a good performance for both IOLs. Both IOLs had good CDVA, a small amount of tilt and decentration and none of the patients required laser capsulotomies during the follow-up time of 2 years after surgery. Presented at the 37th ESCRS Congress Paris, France, September 2019

scholarly journals Do Relaxation Exercises Decrease Postoperative Pain after Rotator Cuff Repair? A Randomized Controlled Trial

2019 ◽  
Vol 7 (7_suppl5) ◽  
pp. 2325967119S0038
Author(s):  
Danielle G. Weekes ◽  
Eric D. Wicks ◽  
Richard E. Campbell ◽  
Christopher Hadley ◽  
Aaron Carter ◽  
...  
Keyword(s):  
Treatment Group ◽  
Controlled Trial ◽  
Control Group ◽  
Study Group ◽  
Relaxation Techniques ◽  
Randomized Controlled ◽  
Breathing Techniques ◽  
Relaxation Exercises ◽  
Cuff Repair

Objectives: During the last decade, concern about opioid dependence and abuse has spurred an increasing interest within orthopedic surgery to decrease reliance on narcotics for pain management. Non-pharmacologic interventions, such as patient opioid education, can decrease narcotic consumption after arthroscopic rotator cuff repair (ARCR). Another non-pharmacologic intervention, the use of relaxation exercises, has been promoted for pain management following surgical procedures; however, its’ effect has not been investigated following ARCR. The purpose of this investigation was to evaluate the effects of relaxation exercises on post-operative pain and narcotics use after ARCR. Methods: This was a prospective, randomized, controlled trial evaluating 151 consecutive patients undergoing ARCR. The treatment group (n: 75) received and reviewed relaxation education materials including a 5 minute video explaining relaxation breathing techniques, while the control group (n: 75) received no relaxation education materials. Both groups received a standardized pre-operative interscalene nerve block as well as the same standardized post-op care, including oxycodone 5mg/acetaminophen 325 mg, and cryotherapy. Patients recorded a 5-day journal of their pain level and opioid consumption. Patients were then queried with the American Shoulder and Elbow Surgeons (ASES) Shoulder Score, Single Assessment Numerical Evaluation (SANE) score, and Visual Analog Score (VAS) for pain pre-operatively, and at 2, 6, 12, 18, and 24 weeks post-operatively. Additionally, patients were given a follow-up survey at 2 weeks post-operative to assess subjective pain relief efficacy of the relaxation techniques. T-test analyses were utilized to compare differences between the treatment group and the control group. Results: Ninety-five percent of patients completed the follow-up survey. Sixty-three percent (43/68) of study group patients reported that the relaxation techniques decreased their pain levels, while 37% said that it had no effect on their pain. There were no significant differences between the study and control groups in mean post-op VAS pain scores on post-op day 1 (treatment: 55.40, control: 59.5; p= 0.94), post-op day 2 (treatment: 56.15, control: 56.93; p= 0.88), post-op day 3 (treatment: 48.38, control: 47.07; p= 0.52), post-op day 4 (treatment: 40.03, control: 45.54; p= 0.79) and post-op day 5 (treatment: 38.57, control: 40.57; p= 0.71). At two weeks post-op the study group consumed significantly less narcotics than the control group (mean: 21.7 doses vs. 29.7; p= 0.016, Cohen’s d: 0.42), and 51% were still performing the relaxation techniques. There were no significant differences in ASES and SANE scores at each time point throughout the study period. Conclusion: Although nearly two-thirds of patients in the treatment group believed that the use of relaxation breathing techniques decreased their pain, there was no difference in pain measures between the treatment group and the control group. However, the treatment group did utilize less opioid medication than the control group. While the effect on post-op pain is uncertain, the use of relaxation techniques can provide an easy to implement, non-pharmacologic strategy to significantly decrease narcotics consumption after ARCR.

Acupuncture Vs Streitberger Needle in Knee Osteoarthritis – An Rct

2006 ◽  
Vol 24 (1_suppl) ◽  
pp. 15-24 ◽  
Author(s):  
Jorge Vas ◽  
Camila Méndez ◽  
Emilio Perea-Milla
Keyword(s):  
Protocol Analysis ◽  
Controlled Trial ◽  
Multiple Linear Regression Model ◽  
Chronically Ill ◽  
Visual Analogue Scale Pain ◽  
Control Group ◽  
Osteoarthritis Of The Knee ◽  
Clinical Variables ◽  
Intention To Treat ◽  
Treat Analysis

Aims To determine the effectiveness of acupuncture as a therapy complementary to the pharmacological treatment of osteoarthritis of the knee. Methods Randomised, single blind, placebo controlled trial. Patients with osteoarthritis of the knee were randomly assigned to either 12 sessions of true acupuncture or 12 sessions of placebo acupuncture (Streitberger needle), these sessions taking place once a week. A baseline measurement was carried out, followed by further observations at 4, 8, 12 and 16 weeks. The clinical variables were the WOMAC (Western Ontario and McMaster Universities Osteoarthritis) index, knee pain measured by a visual analogue scale (pain VAS), the weekly consumption of diclofenac and the Profile of the Quality of Life of the Chronically Ill (PQLC). The two groups were compared for each of the clinical variables per protocol and by intention to treat. A multiple linear regression model for the dependent variables was constructed. Results Ninety seven outpatients were selected, with 88 remaining for the per protocol analysis; the analysis of homogeneity concluded that the lost subjects were not significantly different from those that completed the study. The multivariate per protocol model for the relative pain VAS variable showed a difference in improvement of 43.7% (95% CI 29.4% to 58.0%) for acupuncture, compared with the control group. In an intention to treat analysis, the relative improvement was 32.4% (20.3% to 44.4%). In a per protocol analysis, the total WOMAC showed a relative decrease of 52.0% (34.3% to 69.6%) in favour of the acupuncture group, or 37.6% (22.4% to 52.8%) in an intention to treat analysis. Conclusions The group treated with acupuncture showed significantly better effects, both clinically and statistically, in the reduction of pain intensity as measured by pain VAS, on the WOMAC index and in decreased consumption of diclofenac.

Effects of kinesiotaping and exercise program on patients with obesity-induced coccydynia: a randomized, double-blinded, sham-controlled clinical trial

2020 ◽  
Vol 34 (4) ◽  
pp. 471-479
Author(s):  
Nabil Mahmoud Abdel-Aal ◽  
Hany Mohamed Elgohary ◽  
Elsadat Saad Soliman ◽  
Intsar Salem Waked
Keyword(s):  
Range Of Motion ◽  
Pain Score ◽  
Controlled Trial ◽  
Exercise Program ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Study Group ◽  
Obese Patients ◽  
Double Blinded

Objective: To investigate the effect of kinesiotaping and a designed exercise program versus sham kinesiotaping and the same exercise program on pain, range of motion, and activities of daily living in obese patients suffering from coccydynia. Design: A double-blinded, randomized, sham-controlled trial. Setting: Outpatient, Cairo University hospitals. Participants: Sixty patients with coccydynia randomized equally into kinesiotape plus exercise and sham kinesiotape plus exercise groups. Intervention: The kinesiotape was worn for three days and replaced for three weeks. Each patient practiced exercises for three weeks. Outcome measures: All patients were examined by visual analogue scale (VAS) for rating pain, Modified Modified Schober Test (MMST), and Oswestry Disability Index (ODI). All outcomes were measured at baseline, three weeks postintervention, and four weeks follow-up. Results: There were no statistically significant differences between groups at baseline ( P < 0.05), but there were statistically significant differences between groups for pain score, MMST, and ODI at post and follow-up data in favor of the kinesiotape group ( P < 0.001). For the three weeks postintervention, mean (SD) for pain score, MMST, and ODI was 33.07 ± 3.8, 6.6 ± 0.7, and 8.7 ± 2.1 in the study group and 39.9 ± 4.7, 5.8 ± 1.4, and 14.4 ± 2.7 in the control group, respectively. For the four weeks follow-up, mean (SD) for pain score, MMST, and ODI was 32.2 ± 3.4, 7.13 ± 0.6, and 7.2 ± 1.8 in the study group and 40.9 ± 4.4, 6.6 ± 0.75, and 13 ± 2 in the control group, respectively. Conclusion: Experimental kinesiotape intervention and exercise program provided significant improvements in pain, range of motion, and disability. It is suggested as an adjunctive therapy in treating obese patients with coccydynia.

scholarly journals Efficacy of acupuncture versus sham acupuncture or waitlist control for patients with chronic plantar fasciitis: study protocol for a two-centre randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e036773
Author(s):  
Weiming Wang ◽  
Sixing Liu ◽  
Yan Liu ◽  
Zhiwei Zang ◽  
Weina Zhang ◽  
...  
Keyword(s):  
Plantar Fasciitis ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Sham Acupuncture ◽  
Primary Objective ◽  
Control Group ◽  
P Value ◽  
Waitlist Control ◽  
Intention To Treat

IntroductionPlantar fasciitis (PF) is reported to be the most common cause of plantar heel pain. Acupuncture has been used for patients experiencing PF, but evidence of the efficacy of acupuncture on PF is limited. The primary objective of this trial is to compare combined acupuncture and sham acupuncture (SA) versus waitlist control for improving the level of pain experienced by patients suffering from chronic PF.Methods and analysisThis will be a two-centre, parallel-group, sham and no-treatment controlled, assessor-blinded randomised trial. We will randomly allocate 120 participants with chronic PF to acupuncture, SA and waitlist control groups at a ratio of 2:1:1. Participants in the acupuncture and SA groups will receive a 30 min acupuncture or SA treatment for a total of 12 sessions over 4 weeks, with a 12-week follow-up. Participants in the waitlist control group will not undergo treatment for a period of 16 weeks but instead will have the option of 4 weeks (12 sessions) of acupuncture free of charge at the end of the follow-up period. The primary outcome will be the treatment response rate 4 weeks after randomisation, assessed as a minimum of 50% improvement in the worst pain intensity during the first steps in the morning compared with the baseline. All analyses will be performed with a two-sided p value of <0.05 considered significant following the intention-to-treat principle.Ethics and disseminationThe study has been approved by the Ethical Committee of the Guang’anmen Hospital, China Academy of Chinese Medical Sciences (approval no. 2019-210-KY). The results will be disseminated through presentation at a peer-reviewed medical journal, the relevant conferences and scientific meetings.Trial registrationNCT04185259.

scholarly journals Bariatric surgery and the incidence of rheumatoid arthritis – a Swedish Obese Subjects study

Rheumatology ◽  
2019 ◽  
Vol 59 (2) ◽  
pp. 303-309 ◽  
Author(s):  
Cristina Maglio ◽  
Yuan Zhang ◽  
Markku Peltonen ◽  
Johanna Andersson-Assarsson ◽  
Per-Arne Svensson ◽  
...  
Keyword(s):  
Bariatric Surgery ◽  
Protocol Analysis ◽  
International Classification Of Diseases ◽  
Control Group ◽  
Intention To Treat ◽  
Classification Of Diseases ◽  
National Patient ◽  
Obese Subjects ◽  
Serum Crp

Abstract Objective The aim of this study was to determine the effect of bariatric surgery on the incidence of RA in participants of the Swedish Obese Subjects (SOS) study. Methods The SOS is a longitudinal study aiming to assess the effect of bariatric surgery on mortality and obesity-related diseases. This report includes 2002 subjects with obesity who underwent bariatric surgery and 2034 matched controls; none of them had RA at baseline. Cases of incident RA were identified through the Swedish National Patient Register by searching for International Classification of Diseases codes. Both intention-to-treat analyses and per-protocol analyses are reported. In the per-protocol analysis, participants from the control group who underwent bariatric surgery later on during follow-up were censored at the time of surgery. Results During follow-up, 92 study participants developed RA. The median follow-up was 21 years (range 0–29). Bariatric surgery was neither associated with the incidence of RA in the intention-to-treat analysis [hazard ratio (HR) 0.92 (95% CI 0.59, 1.46), P = 0.74], nor in the per-protocol analysis [HR 0.86 (95% CI 0.54, 1.38), P = 0.53]. Weight change at the 2 year follow-up, expressed as the change in BMI compared with baseline, did not associate with the development of RA. Higher serum CRP levels and smoking associated with the future development of RA independent of other factors. Conclusions We did not detect any association between bariatric surgery and the incidence of RA in subjects affected by obesity followed up for up to 29 years. ClinicalTrials.gov (http://clinicaltrials.gov): NCT01479452.

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