Association of Pre- and Post-Treatment Expectations with Improvements after Acupuncture in Patients with Migraine

Objective To study whether a higher expectation of acupuncture measured at baseline and after acupuncture is associated with better outcome improvements in patients with migraine. Methods We performed a secondary analysis of a previous published trial in which 476 patients with migraine were randomly allocated to three real acupuncture groups and one sham acupuncture control group. All the participants received 20 sessions of acupuncture over a 4-week period. The primary outcome was the number of days with a migraine attack (NDMA) assessed at 5–8 weeks after randomisation. The secondary outcomes were visual analogue scale, headache intensity and quality of life assessed at 4, 8 and 16 weeks after randomisation. Expectations of the acupuncture effect were assessed at baseline and at the end of treatment and categorised into five levels, with 0% the lowest and 100% the highest. Outcome improvement was first compared among the participants with different expectation levels using an analysis of variance model. The association between expectations of treatment and outcome improvement was then calculated using a logistic regression model. Results Patients with 100% baseline expectations did not report significantly fewer NDMA than those with 0% baseline expectations after adjusting for the covariates (at 5–8 weeks, 1.7 vs 3.9 days, p=0.987). High baseline expectations had no significant impact on improvement of the primary outcome (100% vs 0%: OR 8.50, 95% CI 0.89 to 191.65, p=0.682). However, patients with 100% post-treatment expectations reported fewer NDMA than those with 0% expectations (primary outcome: 1.3 vs 5.0 days, p<0.001) and were more likely to have a favourable response (100% vs 0%: OR 68.87, 95% CI 6.26 to 1449.73, p=0.002). Similar results were found when analysing the impact of expectation on the secondary outcomes. Conclusions A high level of expectation after acupuncture treatment rather than at baseline was associated with better long-term outcome improvements in patients with migraine. Clinical Trial Number NCT00599586.

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747 Long-term effects of pharmacological treatment in patients with takotsubo syndrome with or without hypertension: a report from the takotsubo Italian network

European Heart Journal Supplements ◽

10.1093/eurheartj/suab142.008 ◽

2021 ◽

Vol 23 (Supplement_G) ◽

Author(s):

Angelo Silverio ◽

Serena Migliarino ◽

Giuseppe Iuliano ◽

Eduardo Bossone ◽

Michele Bellino ◽

...

Keyword(s):

Pharmacological Treatment ◽

Lower Risk ◽

Primary Outcome ◽

Takotsubo Syndrome ◽

Term Outcome ◽

Long Term Outcome ◽

Study Population ◽

Secondary Outcomes

Abstract Aims Hypertension (HT) is one of the most frequent comorbidities reported in patients with Takotsubo syndrome (TTS). However, the clinical outcome as well as the effect of pharmacological treatment on long-term follow-up have never been investigated in this cohort. To investigate the impact of the pharmacological treatment with beta-blocker (BB) and/or renin–angiotensin–aldosterone system inhibitor (RAASi) on long-term outcome of TTS patients with and without HT. Methods and results This study included TTS patients prospectively included in the Takotsubo Italian Network register from January 2007 to December 2018. The study population was divided in two groups according to the presence or not of HT. The effect of BB and RAASi at discharge was evaluated in these groups. The primary outcome was the composite of all-cause death and TTS recurrence; secondary outcomes were the single components of the primary outcome. The propensity score weighting technique was employed to account for potential selection bias in treatment assignment at discharge. The study population included 825 patients [median age 72 (63–78) years; 8.1% were males]; 525 (63.6%) patients had history of HT and 300 (36.4%) patients did not. At median follow-up of 24.0 months (11.0–38.0), the primary outcome occurred in 102 patients (12.4%); all-cause death and TTS recurrence were reported in 76 (9.2%) and 33 (4.0%), respectively. There were no differences in terms of the primary outcome (adjusted HR: 1.082; 95% CI: 0.689–1.700; P = 0.733), all-cause death (adjusted HR: 1.214; 95% CI: 0.706–2.089; P = 0.483) and TTS recurrence (adjusted HR: 0.795; 95% CI: 0.373–1.694; P = 0.552) between patients with vs. without HT. Among patients with HT, those receiving BB at discharge showed a significantly lower risk of the primary outcome (adjusted HR: 0.375; 95% CI: 0.228–0.617; P < 0.001) compared with patients not receiving BB. There was also a significantly lower risk of all-cause death (adjusted HR: 0.381; 95% CI: 0.217–0.666; P < 0.001) and TTS recurrence (adjusted HR: 0.393; 95% CI: 0.155–0.998; P = 0.049) in patients treated with BB. Among patients without HT, there was no significant association of BB treatment with any of the study outcomes. RAASi treatment showed no significant effect on the primary and secondary outcomes. These results were consistent between patients with and without HT. Conclusions TTS patients with HT patients experienced a survival benefit from BB treatment in terms of both all-cause death and TTS recurrence; this effect was not confirmed in patients without HT. Conversely, RAASi did not affect long-term outcome, independently from the coexistence of HT. Albeit hypothesis-generating, a such evidence supports a tailored pharmacological therapy after discharge in TTS patients taking into account the coexistence of HT.

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Re-use of trial data in the first 10 years of the data-sharing policy of the Annals of Internal Medicine: a survey of published studies

10.1101/2020.06.16.20132894 ◽

2020 ◽

Author(s):

Claude Pellen ◽

Laura Caquelin ◽

Alexia Jouvance-Le Bail ◽

Jeanne Gaba ◽

Mathilde Vérin ◽

...

Keyword(s):

Internal Medicine ◽

Data Sharing ◽

Primary Outcome ◽

Meta Analysis ◽

Secondary Analysis ◽

Primary Analysis ◽

Share Data ◽

Recherche Médicale ◽

Secondary Outcomes ◽

The Impact

ABSTRACTBackgroundThe Annals of Internal Medicine (AIM) has adopted a policy encouraging data-sharing since 2007.ObjectiveTo explore the impact of the AIM data-sharing policy for randomized controlled trials (RCTs) in terms of output from data-sharing (i.e. publications re-using the data).DesignRetrospective study.SettingAIM.ParticipantsRCTs published in the AIM between 2007 and 2017 were retrieved on PubMed. Publications where the data had been re-used were identified on Web of Science. Searches were performed by two independent reviewers.InterventionsIntention to share data (or not) expressed in a data-sharing statement.MeasurementsThe primary outcome was any published re-use of the data (i.e. re-analysis, secondary analysis, or meta-analysis of individual participant data [MIPD]), where the first, last and corresponding authors were not among the authors of the RCT. Components of the primary outcome and analyses without any author restriction were secondary outcomes. Analyses used Cox (primary analysis) models adjusting for RCT characteristics.Results185 RCTs were identified. 106 (57%) mentioned willingness to share data and 79 (43%) did not. 208 secondary analyses, 67 MIPD and no re-analyses were identified. No significant association was found between intent to share and re-use where the first, last and corresponding authors were not among the authors of the primary RCT (adjusted hazard ratio = 1.04 [0.47-2.30]). Secondary outcomes also showed no association between intent to share and re-use.LimitationsPossibility of residual confounding and limited power.ConclusionOver ten years, RCTs published in AIM expressing an intention to share data were not associated with more extensive re-use of the data.Registrationhttps://osf.io/8pj5e/Funding SourceGrants from the Fondation pour la Recherche Médicale, Région Bretagne, and French National Research Agency.

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The management of Hemorrhoidal Disease by Dearterialization and Mucopexy.

Reviews on Recent Clinical Trials ◽

10.2174/1574887115666200506091306 ◽

2020 ◽

Vol 15 ◽

Author(s):

Veronica De Simone ◽

Francesco Litta ◽

Angelo Parello ◽

Paola Campennì ◽

Raffaele Orefice ◽

...

Keyword(s):

Postoperative Management ◽

Term Outcome ◽

Long Term Outcome ◽

Doppler Probe ◽

Minimally Invasive Surgical ◽

Bowel Movements ◽

Excessive Strain ◽

Life Threatening ◽

Hemorrhoidal Prolapse ◽

The Impact

: Several minimally invasive surgical procedures have been recently developed to treat hemorrhoids without any excision. About 25 years ago, a non-excisional procedure providing doppler-guided ligation of the hemorrhoidal arteries has been proposed - named “hemorrhoidal dearterialization”. The original technique has been modified over the years, and indications were expanded. In particular, a plication of the redundant and prolapsing mucosa/submucosa of the rectum (named “mucopexy”) has been introduced to treat hemorrhoidal prolapse, without excision of the hemorrhoidal piles. At present, the THD® Doppler procedure is one of the most used techniques to treat hemorrhoids. Aim of this technique is to realize a target dearterialization, using a Doppler probe with the final purpose to reduce the arterial overflow to the hemorrhoidal piles. In case of associated hemorrhoidal prolapse, a mucopexy is performed together with Doppler-guided dearterialization. The entity and circumferential extension of the hemorrhoidal prolapse guides the mucopexy, which can be considered tailored to a single patient; the dearterialization should be considered mandatory. Advantages of this surgical technique are the absence of serious and life-threatening postoperative events, chronic complications, and limited recurrence risks. The impact of the procedure on the anorectal physiology is negligible. However, a careful postoperative management is mandatory to avoid complications and to guarantee an improved long-term outcome. Therefore, regular physiologic bowel movements, excessive strain at the defecation and strong physical activity are advisable.

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Healthy eating and lifestyle in pregnancy (HELP): a cluster randomised trial to evaluate the effectiveness of a weight management intervention for pregnant women with obesity on weight at 12 months postpartum

International Journal of Obesity ◽

10.1038/s41366-021-00835-0 ◽

2021 ◽

Author(s):

Sharon A. Simpson ◽

Elinor Coulman ◽

Dunla Gallagher ◽

Karen Jewell ◽

David Cohen ◽

...

Keyword(s):

Weight Management ◽

Healthy Eating ◽

Primary Outcome ◽

Intervention Group ◽

Control Group ◽

Risky Drinking ◽

Management Intervention ◽

Cluster Randomised ◽

Secondary Outcomes ◽

Weight Management Intervention

Abstract Objective To assess whether a weight management intervention for pregnant women with obesity was effective in reducing body mass index (BMI) 12 months after giving birth. Methods Pragmatic, cluster randomised controlled trial (RCT) with embedded cost-effectiveness analysis. 598 women with a BMI of ≥30 kg/m2 (between 12 and 20 weeks gestation) were recruited from 20 secondary care maternity units in England and Wales. BMI at 12 months postpartum was the primary outcome. A range of clinical and behavioural secondary outcomes were examined. Interventions Women attending maternity units randomised to intervention were invited to a weekly weight management group, which combined expertise from a commercial weight loss programme with clinical advice from midwives. Both intervention and control participants received usual care and leaflets on diet and physical activity in pregnancy. Results Mean (SD) BMI at 12 months postpartum was 36.0 kg/m2 (5.2) in the control group, and 37.5 kg/m2 (6.7) in the intervention group. After adjustment for baseline BMI, the intervention effect was −0.02 (95% CI −0.04 to 0.01). The intervention group had an improved healthy eating score (3.08, 95% CI 0.16 to 6.00, p < 0.04), improved fibre score (3.22, 1.07 to 5.37, p < 0.01) and lower levels of risky drinking at 12 months postpartum compared to the control group (OR 0.45, 0.27 to 0.74, p < 0.002). The net incremental monetary benefit was not statistically significantly different between arms, although the probability of the intervention being cost-effective was above 60%, at policy-relevant thresholds. Conclusions There was no significant difference between groups on the primary outcome of BMI at 12 months. Analyses of secondary outcomes indicated improved healthy eating and lower levels of risky drinking. Trial registration: Current Controlled Trials ISRCTN25260464.

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Laparoscopic Revisional Surgery After Failed Heller Myotomy for Esophageal Achalasia: Long-Term Outcome at a Single Tertiary Center

Journal of Gastrointestinal Surgery ◽

10.1007/s11605-021-05041-x ◽

2021 ◽

Author(s):

Giovanni Capovilla ◽

Renato Salvador ◽

Luca Provenzano ◽

Michele Valmasoni ◽

Lucia Moletta ◽

...

Keyword(s):

Heller Myotomy ◽

Revisional Surgery ◽

Stage Iv ◽

Postoperative Outcomes ◽

Control Group ◽

Term Outcome ◽

Long Term Outcome ◽

Eckardt Score ◽

Stage Iv Disease

Abstract Background Laparoscopic Heller myotomy (HM) has gained acceptance as the gold standard of treatment for achalasia. However, 10–20% of the patients will experience symptom recurrence, thus requiring further treatment including pneumodilations (PD) or revisional surgery. The aim of our study was to assess the long-term outcome of laparoscopic redo HM. Methods Patients who underwent redo HM at our center between 2000 and 2019 were enrolled. Postoperative outcomes of redo HM patients (redo group) were compared with that of patients who underwent primary laparoscopic HM in the same time span (control group). For the control group, we randomly selected patients matched for age, sex, FU time, Eckardt score (ES), previous PD, and radiological stage. Failure was defined as an Eckardt score > 3 or the need for re-treatment. Results Forty-nine patients underwent laparoscopic redo HM after failed primary HM. A new myotomy on the right lateral wall of the EGJ was the procedure of choice in the majority of patients (83.7%). In 36 patients (73.5%) an anti-reflux procedure was deemed necessary. Postoperative outcomes were somewhat less satisfactory, albeit comparable to the control group; the incidence of postoperative GERD was higher in the redo group (p < 0.01). At a median 5-year FU time, a good outcome was obtained in 71.4% of patients in the redo group; further 5 patients (10.2%) obtained a long-term symptom control after complementary PD, thus bringing the overall success rate to 81.6%. Stage IV disease at presentation was independently associated with a poor outcome of revisional LHD (p = 0.003). Conclusions This study reports the largest case series of laparoscopic redo HM to date. The procedure, albeit difficult, is safe and effective in relieving symptoms in this group of patients with a highly refractory disease. The failure rate, albeit not significantly, and the post-operative reflux are higher than after primary HM. Patients with stage IV disease are at high risk of esophagectomy.

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AB0423 NEUROPSYCHIATRIC OUTCOME OF CHILDREN BORN TO WOMEN WITH SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) WOMEN AND EXPOSED IN UTERO TO AZATHIOPRINE: A CASE-CONTROL STUDY.

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.4912 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1511.2-1511

Author(s):

M. G. Lazzaroni ◽

F. Crisafulli ◽

I. Debeni ◽

C. Nalli ◽

L. Andreoli ◽

...

Keyword(s):

Lupus Erythematosus ◽

Renal Involvement ◽

In Utero ◽

Learning Disorders ◽

Control Group ◽

In Utero Exposure ◽

Term Outcome ◽

Similar Frequency ◽

Long Term Outcome

Background:A possible increase in neurodevelopmental (ND) and learning disorders (LD) in the offspring of mothers affected by SLE have been suggested in some studies, along with the identification of different possible risk factors. Azathioprine (AZA) is commonly used during pregnancy, based on its non-teratogenicity and extended experience in women with different diseases. However, a few small studies suggested an association between in utero exposure to AZA and possible increased frequency of ND/LD in children, indirectly derived from increased request of supportive educational services.Objectives:To evaluate the medium-long term outcome in terms of ND/LD in children of school age (≥6 years) born to SLE women treated with AZA during pregnancy, as compared to that of children born to SLE mothers not treated with AZA during pregnancy.Methods:Data from our Pregnancy Clinic registry were collected for prospectively followed pregnancies of SLE women treated with AZA (cases) and compared to pregnancies of SLE women not treated with AZA (controls), that were matched for age at pregnancy, presence of renal involvement and aPL positivity. SLE patients (cases and controls) were interviewed by phone to collect data about their children, focusing on the presence of ND/LD certified by Neuropsychiatrists.Results:Data were collected for 14 SLE mothers in the AZA group and 31 in the control group, with similar age at pregnancy (30.3±5.21 vs 31.4±4.70 years, p:0.45) and frequency of renal involvement (50.0% vs 44.1%, p:0.77), aPL positivity (33.3% vs 29.4%, p:0.76) and anti-Ro/SSA positivity (27.8% vs. 26.5%, p:0.55). A SLE flare during pregnancy was more frequently recorded in the AZA group (27.8% vs. 2.94%, p:0.02). Other medications included HCQ (55.6% vs. 70.6%, p:0.36) and corticosteroids (100% vs 79.4%, p:0.08).We collected data for 18 children in the AZA group and 34 children in the control group, that had a similar mean age at the time of the interview (12.7±4.80 vs. 12.9±5.61 years, p:0.91). The two groups had also similar gestational age (37.4±2.20 weeks vs. 38.0±1.29 weeks, p:0.23), birth weight (3003±433 g vs 3011±453 g, p:0.95) and rate of male sex (61.1% vs 44.1%, p:0.38).We recorded similar frequency of ND/LD in the two groups. In particular, a ND was present in 2/18 (11.1%) of children exposed to AZA vs. 2/34 (5.88%) in the control group (p:0.60). A LD was present in 1/18 cases (5.56%) and 6/34 controls (17.6%) (p:0.40).Conclusion:The medium-long term outcome of children born to SLE mothers in the whole cohort was characterized by the presence of ND in 4/54 (7.69%) and LD in 7/52 (13.5%). ND/LD do not seem to be related to in utero exposure to AZA.Disclosure of Interests:None declared

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Affective Temperaments and Illness Severity in Patients with Bipolar Disorder

Medicina ◽

10.3390/medicina57010054 ◽

2021 ◽

Vol 57 (1) ◽

pp. 54

Author(s):

Mario Luciano ◽

Luca Steardo ◽

Gaia Sampogna ◽

Vito Caivano ◽

Carmen Ciampi ◽

...

Keyword(s):

Quality Of Life ◽

Bipolar Disorder ◽

Protective Factor ◽

Psychiatric Symptoms ◽

Control Group ◽

Term Outcome ◽

Long Term Outcome ◽

Affective Temperaments

Background and objectives: Bipolar disorder (BD) is one of the most burdensome psychiatric illnesses, being associated with a negative long-term outcome and the highest suicide rate. Although affective temperaments can impact on BD long-term outcome, their role remains poorly investigated. The aims of the present study are to describe the clinical characteristics of patients with BD more frequently associated with the different affective temperaments and to assess the relation between affective temperaments and severity of clinical picture in a sample of patients with BD. Materials and Methods: A total of 199 patients have been recruited in the outpatients units of two university sites. Patients’ psychiatric symptoms, affective temperaments, and quality of life were investigated through validated assessment instruments. Results: Predominant cyclothymic and irritable temperaments are associated to higher number of relapses, poorer quality of life, higher rates of aggressive behaviors, and suicide attempts. Conversely, the predominant hyperthymic disposition was a protective factor for several outcome measures, including relapse rate, severity of anxiety, depressive and manic symptoms, suicidality, and earlier age at onset. One limitationo of the present study is that the recruitment took place in two university sites; therefore, our findings cannot be fully generalized to the whole community of BD patients. Other limitations are the lack of a control group and the cross-sectional design of the study. Conclusions: The early identification of affective temperaments can help clinicians to identify those BD patients who are more likely to show a poor long-term outcome. An early screening of affective temperaments can be useful to develop targeted integrated pharmacological and psychosocial interventions.

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Effectiveness and cost-effectiveness of the PLAN-A intervention, a peer led physical activity program for adolescent girls: results of a cluster randomised controlled trial

International Journal of Behavioral Nutrition and Physical Activity ◽

10.1186/s12966-021-01133-8 ◽

2021 ◽

Vol 18 (1) ◽

Author(s):

Russell Jago ◽

Byron Tibbitts ◽

Kathryn Willis ◽

Emily Sanderson ◽

Rebecca Kandiyali ◽

...

Keyword(s):

Physical Activity ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Control Group ◽

Cluster Randomised ◽

Secondary Outcomes ◽

Randomised Controlled

Abstract Background Physical activity is associated with improved health. Girls are less active than boys. Pilot work showed that a peer-led physical activity intervention called PLAN-A was a promising method of increasing physical activity in secondary school age girls. This study examined the effectiveness and cost-effectiveness of the PLAN-A intervention. Methods We conducted a cluster randomised controlled trial with Year 9 (13–14 year old) girls recruited from 20 secondary schools. Schools were randomly assigned to the PLAN-A intervention or a non-intervention control group after baseline data collection. Girls nominated students to be peer leaders. The top 18 % of girls nominated by their peers in intervention schools received three days of training designed to prepare them to support physical activity. Data were collected at two time points, baseline (T0) and 5–6 months post-intervention (T1). Participants wore an accelerometer for seven days to assess the primary outcome of mean weekday minutes of moderate-to-vigorous physical activity (MVPA). Multivariable mixed effects linear regression was used to estimate differences in the primary outcome between the two arms on an Intention-to-Treat (ITT) basis. Resource use and quality of life were measured and a within trial economic evaluation from a public sector perspective was conducted. Results A total of 1558 girls were recruited to the study. At T0, girls in both arms engaged in an average of 51 min of MVPA per weekday. The adjusted mean difference in weekday MVPA at T1 was − 2.84 min per day (95 % CI = -5.94 to 0.25) indicating a slightly larger decline in weekday MVPA in the intervention group. Results were broadly consistent when repeated using a multiple imputation approach and for pre-specified secondary outcomes and sub-groups. The mean cost of the PLAN-A intervention was £2817 per school, equivalent to £31 per girl. Economic analyses indicated that PLAN-A did not lead to demonstrable cost-effectiveness in terms of cost per unit change in QALY. Conclusions This study has shown that the PLAN-A intervention did not result in higher levels of weekday MVPA or associated secondary outcomes among Year 9 girls. The PLAN-A intervention should not be disseminated as a public health strategy. Trial registration ISRCTN14539759–31 May, 2018.

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Two-component surface replacement implants compared with perichondrium transplantation for restoration of Metacarpophalangeal and proximal Interphalangeal joints: a retrospective cohort study with a mean follow-up time of 6 respectively 26 years

BMC Musculoskeletal Disorders ◽

10.1186/s12891-020-03687-3 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Daniel Muder ◽

Nils P. Hailer ◽

Torbjörn Vedung

Keyword(s):

Primary Outcome ◽

Statistical Significance ◽

Surface Replacement ◽

Level Of Evidence ◽

Term Outcome ◽

Long Term Outcome ◽

Two Component ◽

Pip Joint

Abstract Background The aim of our study was to compare the long-term outcome after perichondrium transplantation and two-component surface replacement (SR) implants to the metacarpophalangeal (MCP) and the proximal interphalangeal (PIP) joints. Methods We evaluated 163 joints in 124 patients, divided into 138 SR implants in 102 patients and 25 perichondrium transplantations in 22 patients. Our primary outcome was any revision surgery of the index joint. Results The median follow-up time was 6 years (0–21) for the SR implants and 26 years (1–37) for the perichondrium transplants. Median age at index surgery was 64 years (24–82) for SR implants and 45 years (18–61) for perichondium transplants. MCP joint survival was slightly better in the perichondrium group (86.7%; 95% confidence interval [CI]: 69.4–100.0) than in the SR implant group (75%; CI 53.8–96.1), but not statistically significantly so (p = 0.4). PIP joint survival was also slightly better in the perichondrium group (80%; CI 55–100) than in the SR implant group (74.7%; CI 66.6–82.7), but below the threshold of statistical significance (p = 0.8). Conclusion In conclusion, resurfacing of finger joints using transplanted perichondrium is a technique worth considering since the method has low revision rates in the medium term and compares favorable to SR implants. Level of evidence III (Therapeutic).

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