Outcomes and safety of concomitant topiramate or metformin for antipsychotics-induced obesity: a randomized-controlled trial

Abstract Background Although there are some existing data describing the usage of topiramate in patients with antipsychotic-induced obesity, study on its comparison with metformin is limited. This study aimed to explore the effectiveness and safety of concomitant topiramate on antipsychotic-induced obesity as well as its comparison with metformin. Methods 62 stabilized outpatients with antipsychotic-induced obesity were randomized into the topiramate group and the metformin group with 16-week treatment. The patients’ weight, body mass index (BMI), waist–hip ratio, and their side effects were assessed and compared. Intention-to-treat and completer analyses were performed. Meanwhile, covariance analysis was conducted to control the impact of the significant difference in BMI between the two groups. Results The two groups had comparable characteristics, though their difference in baseline BMI was significant. (1) Intention-to-treat analyses: the random missing values were replaced using the last observation carried forward method when intention-to-treat analyses were conducted. Compared with the baseline, the weight, BMI, and waist–hip ratio in the topiramate group markedly decreased at each follow-up, whereas, in the metformin group, only waist–hip ratio significantly decreased at 4 weeks after treatment. Compared with the metformin, only weight and BMI in the topiramate group were significantly decreased at week 4 after treatment, and at week 8–16, weight, BMI and waist–hip ratio were remarkably declined. (2) Completer analyses: compared with the baseline, the weight, BMI, and waist–hip ratio in the topiramate group at week 4–16 were markedly decreased, whereas only waist–hip ratio with metformin was significantly decreased at week 4. Compared with the metformin, all BMI with topiramate were markedly decreased at week 4–16. Moreover, its weight and waist–hip ratio also were notably lowered at week 8. No significant differences in adverse events were found between the two groups. Conclusions Topiramate, similar to metformin in reducing obesity as previously reported, also significantly reduced body weight, BMI, and waist–hip ratio in patients with antipsychotic-induced obesity and demonstrated well tolerance in psychiatric patients. Trialregistration The trial was registered at http://www.chictr.org.cn, and the number was ChiCTR-IPR-17013122.

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Outcomes and safety of concomitant topiramate or metformin for antipsychotics-induced obesity: A randomized controlled trial

10.21203/rs.3.rs-47407/v1 ◽

2020 ◽

Author(s):

Congjie Wang ◽

Wenjie Shi ◽

Jianyang Xu ◽

Chengbing Huang ◽

Jiannan Zhu

Keyword(s):

Missing Values ◽

Controlled Trial ◽

Intention To Treat ◽

Waist Hip Ratio ◽

Reduced Body ◽

Significant Difference ◽

The Difference ◽

The Impact ◽

Baseline Bmi

Abstract BackgroundAlthough some data exist describing the use of topiramate in patients with antipsychotic-induced obesity, direct comparision with metformin is limited. The purpose of this study was to explore the effectiveness and safety of concomitant topiramate on antipsychotic-induced obesity and compare with metformin.Methods62 stabilized outpatients with antipsychotic-induced obesity were randomized to 16-week treatment group of topiramate or metformin. The patients’ weight, body mass index (BMI), waist-hip ratio and side effects were assessed and compared. Intention-to-treat and completer analyses were performed. Meanwhile, Covariance analysis was conducted to control the impact of the significant difference in BMI when comparison between the two groups.ResultsTwo groups had comparable characteristics though the difference in baseline BMI was significant. Intention-to-treat analyses: The random missing values were replaced using the last observation carried forward method when intention-to-treat analyses. Compared with the baseline, the weight, BMI and waist-hip ratio with topiramate markedly decreased at each follow-up, whereas, only waist-hip ratio with metformin significantly decreased at 4-week. Compared with metformin,only weight and BMI with topiramate significantly decreased at 4-week, and all weight, BMI and waist-hip ratio at week 8–16 also remarkably declined. Completer analyses: Compared with the baseline, the weight, BMI and waist-hip ratio with topiramate at week 4–16 markedly decreased, whereas, only waist-hip ratio with metformin significantly decreased at 4-week. Compared with metformin, all BMI with topiramate markedly decreased at week 4–16, moreover weigh and waist-hip ratio also notably lowered at 8-week. No significant differences in adverse events were found between the two groups.ConclusionsTopiramate, similar to metformin in reducing obesity as previously reported, also significantly reduced body weight, BMI and waist-hip ratio in patients with antipsychotic-induced obesity and demonstrated well tolerance in psychiatric patients.The trial was registered at http://www.chictr.org.cn, and the number was ChiCTR-IPR-17013122.

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Reducing the Social Stigma Associated with Obsessive Compulsive Disorder: A Controlled Trial of an Intervention Program in a Turkish Community Sample

Journal of Evidence-Based Psychotherapies ◽

10.24193/jebp.2020.2.14 ◽

2020 ◽

Vol 20 (2) ◽

pp. 101-120

Author(s):

Ayça Aktaç Gürbüz ◽

Orçun YORULMAZ ◽

Gülşah DURNA

Keyword(s):

Obsessive Compulsive Disorder ◽

Intervention Program ◽

Controlled Trial ◽

Community Sample ◽

Case Vignette ◽

Control Group ◽

Obsessive Compulsive ◽

Compulsive Disorder ◽

Significant Difference ◽

The Impact

Scientific research into the reduction of stigmatization, particularly related to specific problems such as Obsessive-Compulsive Disorder (OCD), is scarce. In the present study, we examine the impact of a video-based antistigma intervention program for OCD in a pretest-posttest control group research. After being randomly assigned to either an intervention (n= 101) or control group (n= 96), the participants reported their attitudes on a hypothetical case vignette before and after OCD vs. Multiple Sclerosis (MS) videos, and again six months later as a follow up assessment. The mixed design analyses for the group comparisons indicated that although there was no significant difference in the measures of the control group, the participants watching the anti-stigma OCD video, in which the focus was psychoeducation and interaction strategies, reported significantly lower scores on social distances and negative beliefs for the case vignettes they read, and this difference was maintained six months later. Then, the present results indicate the effectiveness of our anti-stigma intervention program for OCD. Interventions to reduce stigmatization can also be viewed as effective tools for changing the attitudes of people toward OCD, although further research and applications are needed related to specific disorders if a longlasting impact is to be achieved.

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Interest of a standardized hypnotic message for the reduction of pain and anxiety in cancer patients treated by capsaicin patch for neuropathic pain: a randomized controlled trial

BMC Complementary Medicine and Therapies ◽

10.1186/s12906-021-03329-8 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Rémi Etienne ◽

Myriam Laurent ◽

Aline Henry ◽

Antoine Bioy ◽

Julia Salleron ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Neuropathic Pain ◽

Rating Scales ◽

Controlled Trial ◽

Standard Group ◽

Randomized Controlled ◽

Significant Difference ◽

Numerical Rating ◽

Reduction Of Pain ◽

The Impact

Abstract Background Neuropathic pain is characterized by spontaneous painful symptoms. Medical therapies include the use of a capsaicin 8% patch (Qutenza®, Grünenthal Gmbh, Germany), and patients may experience a sharp burning sensation at application and removal of the patch. This study aimed to evaluate the impact of playing a standardized hypnosis recording during application, on the pain and anxiety induced by capsaicin treatment. Methods In a randomized, controlled trial, we assessed the benefits of the intervention firstly on pain and secondly on anxiety, as measured using numerical rating scales. All patients had application of the capsaicin patch, including the possibility for the patient to apply a cold patch. Participants were randomly assigned to one of 3 groups, namely the “Standard group” (no intervention), “Hypnosis group”, in which a standardized hypnotic message was played during application, or the “Music group” in which relaxing music was played during application of the patch. Results Sixty-nine patients were included. Overall, there was no significant difference in pain scores between groups (p = 0.355). Compared to standard application, anxiety was significantly lower in the hypnosis group after application (p = 0.007), with no significant difference between the standard and music arms (p = 0.271), or between the hypnosis and music arms (p = 0.423). Conclusions Listening to a standardized hypnotic message during application of a capsaicin patch was found to significantly lower anxiety. These findings indicate that the use of a hypnotic message can reduce discomfort and warrant its evaluation in other indications of pain or anxiety during treatment procedures. Trial registration NCT02822625.

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Neonatal outcomes in case of euglycemic control in gestational diabetes using insulin versus metformin. Randomized controlled trial

Women Health Care and Issues ◽

10.31579/2642-9756/045 ◽

2021 ◽

Vol 04 (01) ◽

pp. 01-08

Author(s):

Ahmed Mansour

Keyword(s):

Randomized Controlled Trial ◽

Birth Weight ◽

Gestational Diabetes ◽

Controlled Trial ◽

Insulin Injection ◽

Neonatal Outcomes ◽

Insulin Group ◽

Randomized Controlled ◽

Metformin Group ◽

Significant Difference

Background: Gestational diabetes mellitus (GDM) is a major global public health issue, with prevalence increasing in recent years due to the epidemic of obesity and type 2 diabetes. Aim of the Work: to compare different neonatal outcomes according to the different treatment modalities used in the management of GDM. Our hypothesis was that Metformin is as effective and safe as insulin in patients with gestational diabetes. Patients and Methods: The current non inferiority-Randomized controlled trial was conducted at Ain Shams Maternity hospital between June 2020 to February 2021. The study included 140 outpatient cases or admitted patients for antenatal care: Group A: women were given Metformin (Total 70) and Group B: Women were given insulin. (Total 70). Results: there was no significant difference between Metformin and Insulin groups regarding age, enrollment BMI, parity and family history of DM. There was no significant difference between Metformin and Insulin groups regarding gestational age at enrollment and delivery as well as pregnancy duration after intervention. BMI at delivery, BMI increase as well as BMI increase rate were significantly lower in Metformin group. There were no significant differences between Metformin and Insulin groups regarding fasting, two-hour postprandial and HbA1c blood glucose at enrollment and throughout treatment as well as their reduction after intervention. Maternal complications as hypoglycemia, hyperglycemia and preeclampsia were non-significantly less frequent among Metformin group than among Insulin group. Compliance to treatment was significantly more frequent among Metformin group than among Insulin group. Cesarean delivery was nonsignificantly less frequent among Metformin group than among Insulin group. There was no significant difference between Metformin and Insulin regarding birth weight APGAR-1, but APGAR-5 was significantly higher in Metformin group. Neonatal complications as IUFD, IUGR, macrosomia, congenital anomalies, neonatal hypoglycemia, respiratory distress and NICU admission were non-significantly less frequent among Metformin group. Conclusions: From the results of current study we can conclude that: Oral metformin was effective as insulin injection in control and management of GDM. BMI was controlled with oral metformin better than insulin injection. Maternal and neonatal complications specially birth weight were the same with both types of treatment. Women had better compliance to metformin treatment. Type of delivery wasn’t affected by type of treatment.

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The Effect of Glycomacropeptide versus Amino Acids on Phenylalanine and Tyrosine Variability over 24 Hours in Children with PKU: A Randomized Controlled Trial

Nutrients ◽

10.3390/nu11030520 ◽

2019 ◽

Vol 11 (3) ◽

pp. 520 ◽

Cited By ~ 2

Author(s):

Anne Daly ◽

Sharon Evans ◽

Satnam Chahal ◽

Saikat Santra ◽

Alex Pinto ◽

...

Keyword(s):

Amino Acids ◽

Controlled Trial ◽

Target Range ◽

Blood Spots ◽

Meal Plan ◽

Significant Difference ◽

Randomised Controlled ◽

Limiting Amino Acids ◽

The Impact ◽

Rate Limiting

Introduction: In phenylketonuria (PKU), evidence suggests that casein glycomacropeptide supplemented with rate-limiting amino acids (CGMP-AA) is associated with better protein utilisation and less blood phenylalanine (Phe) variability. Aim: To study the impact of CGMP-AA on blood Phe variability using 3 different dietary regimens in children with PKU. Methods: This was a 6-week randomised controlled cross-over study comparing CGMP-AA vs. Phe-free l-amino acids (l-AA) assessing blood Phe and tyrosine (Tyr) variability over 24 h in 19 children (7 boys) with PKU, with a median age of 10 years (6–16). Subjects were randomised to 3 dietary regimens: (1) R1, CGMP-AA and usual dietary Phe (CGMP + Phe); (2) R2, CGMP-AA − Phe content of CGMP-AA from usual diet (CGMP − Phe); and (3) R3, l-AA and usual dietary Phe. Each regimen was administered for 14 days. Over the last 48 h on days 13 and 14, blood spots were collected every 4 h at 08 h, 12 h, 16 h, 20 h, 24 h, and 04 h. Isocaloric intake and the same meal plan and protein substitute dosage at standardised times were maintained when blood spots were collected. Results: Eighteen children completed the study. Median Phe concentrations over 24 h for each group were (range) R1, 290 (30–580), R2, 220 (10–670), R3, 165 (10–640) μmol/L. R1 vs. R2 and R1 vs. R3 p < 0.0001; R2 vs. R3 p = 0.0009. There was a significant difference in median Phe at each time point between R1 vs. R2, p = 0.0027 and R1 vs. R3, p < 0.0001, but not between any time points for R2 vs. R3. Tyr was significantly higher in both R1 and R2 [70 (20–240 μmol/L] compared to R3 [60 (10–200) μmol/L]. In children < 12 years, blood Phe remained in the target range (120–360 μmol/L), over 24 h, for 75% of the time in R1, 72% in R2 and 64% in R3; for children aged ≥ 12 years, blood Phe was in target range (120–600 μmol/L) in R1 and R2 for 100% of the time, but 64% in R3. Conclusions: The residual Phe in CGMP-AA increased blood Phe concentration in children. CGMP-AA appears to give less blood Phe variability compared to l-AA, but this effect may be masked by the increased blood Phe concentrations associated with its Phe contribution. Reducing dietary Phe intake to compensate for CGMP-AA Phe content may help.

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Interest of a standardized hypnotic message for the reduction of pain and anxiety in cancer patients treated by capsaicin patch for neuropathic pain: A randomized-controlled trial

10.21203/rs.3.rs-147663/v1 ◽

2021 ◽

Author(s):

Rémi Etienne ◽

Myriam Laurent ◽

Aline Henry ◽

Antoine Bioy ◽

Julia Salleron ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Neuropathic Pain ◽

Rating Scales ◽

Controlled Trial ◽

Standard Group ◽

Randomized Controlled ◽

Significant Difference ◽

Numerical Rating ◽

Reduction Of Pain ◽

The Impact

Abstract BackgroundNeuropathic pain is characterised by spontaneous painful symptoms. Medical therapies include the use of a capsaicin 8% patch (Qutenza ®, Grünenthal Gmbh, Germany), and patients may experience a sharp burning sensation at application and removal of the patch. This study aimed to evaluate the impact of playing a standardized hypnosis recording during application, on the pain and anxiety induced by capsaicin treatment.MethodsIn a randomized-controlled trial, we assessed the benefits of the intervention firstly on pain and secondly on anxiety, as measured using numerical rating scales. All patients had application of the capsaicin patch, including the possibility for the patient to apply a cold patch. Participants were randomly assigned to one of 3 groups, namely the “Standard group” (no intervention), “Hypnosis group”, in which a standardized hypnotic message was played during application, or the “Music group” in which relaxing music was played during application of the patch.ResultsSixty-nine patients were included. Overall, there was no significant difference in pain scores between groups (p = 0.355). Compared to standard application, anxiety was significantly lower in the hypnosis group after application (p = 0.007), with no significant difference between the standard and music arms (p = 0.271), or between the hypnosis and music arms (p = 0.423).ConclusionsListening to a standardized hypnotic message during application of a capsaicin patch was found to significantly lower anxiety. These findings indicate that the use of a hypnotic message can reduce discomfort and warrant its evaluation in other indications of pain or anxiety during treatment procedures.Trial Registration : NCT02822625

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Abstract 17169: The Impact of Renal Function on Outcomes With Edoxaban in the ENGAGE AF-TIMI 48 Trial

Circulation ◽

10.1161/circ.132.suppl_3.17169 ◽

2015 ◽

Vol 132 (suppl_3) ◽

Author(s):

Erin A Bohula ◽

Robert P Giugliano ◽

Christian T Ruff ◽

Julia F Kuder ◽

Sabina A Murphy ◽

...

Keyword(s):

Renal Function ◽

Clinical Outcome ◽

Factor Xa ◽

Intention To Treat ◽

Significant Difference ◽

Prevention Of Thromboembolic Events ◽

Treatment Analysis ◽

Net Clinical Benefit ◽

The Impact ◽

Treat Analysis

Background: Edoxaban (edox), an oral factor Xa inhibitor with 50% renal clearance, was non-inferior to warfarin for prevention of thromboembolic events and significantly reduced bleeding in pts with AF. However, a detailed analysis of the impact of creatinine clearance (CrCl) on clinical outcomes with edox has not been described. Purpose: We evaluated the safety, efficacy and net clinical outcome of edox vs warfarin (warf) across the range of baseline CrCl in the ENGAGE AF-TIMI 48 trial. Methods: 14,071 AF pts at moderate-to-high risk of stroke were randomized to edox 60mg QD or warf. Severe renal dysfunction (CrCl<30ml/min) was exclusionary and a CrCl 30-50 resulted in a 50% dose reduction of edox (30mg QD). Endpoints of stroke or systemic embolism (SSE), ISTH major bleeding (MB) and the primary net clinical outcome of SSE/MB and all-cause mortality (ACM) were evaluated by intention-to-treat analysis by the pre-specified singular CrCl cutpoint of 50ml/min and additional exploratory cutpoints. Results: The relative risk of SSE with edox vs warf in the pre-specified analysis in those with CrCl≤50 (HR 0.87, 0.65-1.18) was similar to those with CrCl>50 (HR 0.87, 0.72-1.04; p-int=0.94). Evaluation by more granular, exploratory cutpoints demonstrated higher rates of SSE (Fig 1a; p-int<0.001) and ischemic stroke (p-int=0.05) with edox vs warf in the upper range of CrCl, but lower rates of bleeding were observed at all levels of CrCl with edox (Fig 1a; p-int=0.39). For the net clinical outcome (SSE/MB/ACM), there was no significant difference between edox and warf at higher levels of renal function due to the preserved effect on bleeding and mortality (Fig 1b; p-int 0.17). An on-treatment analysis with plasma drug levels will be shown. Conclusion: While there is a trend towards decreasing efficacy with increasing CrCl for edox compared to well-managed warfarin, the overall safety and net clinical benefit of edox compared to warfarin is consistent across renal function groups.

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A143 IMPACT OF A SIMULATION-BASED AUGMENTED REALITY CURRICULUM ON POLYPECTOMY SKILLS AMONG NOVICE ENDOSCOPISTS: A RANDOMIZED CONTROLLED TRIAL

Journal of the Canadian Association of Gastroenterology ◽

10.1093/jcag/gwz047.142 ◽

2020 ◽

Vol 3 (Supplement_1) ◽

pp. 5-7

Author(s):

R Khan ◽

M A Scaffidi ◽

N Gimpaya ◽

D Tham ◽

M Atalla ◽

...

Keyword(s):

Augmented Reality ◽

Ad Hoc ◽

Controlled Trial ◽

Skill Training ◽

Control Group ◽

Small Group Teaching ◽

Significant Difference ◽

Simulation Based ◽

Free Environment ◽

The Impact

Abstract Background Polypectomy is an essential endoscopic skill. Training in polypectomy has been identified as a major deficiency for endoscopists worldwide as polypectomy occurs ad hoc during a colonoscopy when a polyp is detected, and a lack of standardized curricula. Augmented reality (AR), which superimposes computer-generated images on a user’s view of the world, can address these gaps by standardizing encounters with polyps while completing simulated procedures and enabling polypectomy-specific teaching. Aims Evaluate the impact of a simulation-based augmented reality curriculum on polypectomy performance among novice endoscopists. Methods This study includes two cohorts of participants from 2019 to 2020. In 2019, participants were randomized into either: (1) a control curriculum, involving 6 hours of simulation-based training (SBT) supplemented by expert feedback, interlaced with 4 hours of small group teaching on the theory of colonoscopy; or (2) the augmented reality curriculum (ARC), in involving the same curriculum with integrated AR, wherein participants engaged with an AR-enhanced video demonstrating relevant therapeutic and pathologic details during polypectomy. The SBT for all participants involved a progressive curriculum starting on a bench-top model and then moving to the EndoVR® virtual reality simulator. The primary outcome was polypectomy-specific performance using the Direct Observation of Polypectomy Skills (DOPyS) tool during a simulated polypectomy after training, with a maximum score of 100. Results Demographic characteristics are summarized in Table. In 2019, 21 novice endoscopists were enrolled. Immediately after training, the mean DOPyS score among ARC group participants was 76.2 (SD=17.9) compared to 71.8 (SD=13.2) among control group participants (Figure). In this interim analysis, there was no significant difference between groups. Data analysis will be completed after 2020 participants complete the study. Conclusions Interim results show a trend towards improved polypectomy performance with no significant difference. The results of this study have the potential to impact polypectomy education among novices. Simulation-based AR interventions may allow learners to progress towards achieving competency in polypectomy in a risk-free environment prior to first patient contact. Funding Agencies None

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Impact of collateralisation to a concomitant chronic total occlusion in patients with ST-elevation myocardial infarction: a subanalysis of the EXPLORE randomised controlled trial

Open Heart ◽

10.1136/openhrt-2018-000810 ◽

2018 ◽

Vol 5 (2) ◽

pp. e000810 ◽

Cited By ~ 2

Author(s):

Ivo M van Dongen ◽

Joëlle Elias ◽

K Gert van Houwelingen ◽

Pierfrancesco Agostoni ◽

Bimmer E P M Claessen ◽

...

Keyword(s):

Myocardial Infarction ◽

Clinical Decision Making ◽

Controlled Trial ◽

Left Ventricular ◽

St Elevation Myocardial Infarction ◽

Left Ventricular Ejection ◽

Ventricular Ejection Fraction ◽

Significant Difference ◽

St Elevation ◽

The Impact

ObjectiveThe impact on cardiac function of collaterals towards a concomitant chronic total coronary occlusion (CTO) in patients with ST-elevation myocardial infarction (STEMI) has not been investigated yet. Therefore, we have evaluated the impact of well-developed collaterals compared with poorly developed collaterals to a concomitant CTO in STEMI.Methods and resultsIn the EXPLORE trial, patients with STEMI and a concomitant CTO were randomised to either CTO percutaneous coronary intervention (PCI) or no-CTO PCI. Collateral grades were scored angiographically using the Rentrop grade classification. Left ventricular ejection fraction (LVEF) and left ventricular end-diastolic volume (LVEDV) at 4 months were measured using cardiac magnetic resonance imaging. Well-developed collaterals (Rentrop grades 2–3) to the CTO were present in 162 (54%) patients; these patients had a significantly higher LVEF at 4 months (46.2±11.4% vs 42.1±12.7%, p=0.004) as well as a trend for a lower LVEDV (208.2±55.7 mL vs 222.6±68.5 mL, p=0.054) when compared with patients with poorly developed collaterals to the CTO. There was no significant difference in the total amount of scar in the two groups. Event rates were statistically comparable between patients with well-developed collaterals and poorly developed collaterals to the CTO at long-term follow-up.ConclusionsIn patients with STEMI and a concomitant CTO, the presence of well-developed collaterals to a concomitant CTO is associated with a better LVEF at 4 months. However, this effect on LVEF did not translate into improvement in clinical outcome. Therefore, the presence of well-developed collaterals is important, but should not solely guide in the clinical decision-making process regarding any additional revascularisation of a concomitant CTO in patients with STEMI.Clinical trial registrationNTR1108.

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Exercise as migraine prophylaxis: A randomized study using relaxation and topiramate as controls

Cephalalgia ◽

10.1177/0333102411419681 ◽

2011 ◽

Vol 31 (14) ◽

pp. 1428-1438 ◽

Cited By ~ 125

Author(s):

Emma Varkey ◽

Åsa Cider ◽

Jane Carlsson ◽

Mattias Linde

Keyword(s):

Controlled Trial ◽

Scientific Evidence ◽

Randomized Study ◽

Exercise Group ◽

Migraine Prophylaxis ◽

Primary Efficacy Variable ◽

Primary Efficacy ◽

Intention To Treat ◽

Significant Difference

Aim: Scientific evidence regarding exercise in migraine prophylaxis is required. Therefore this study aimed to evaluate the effects of exercise in migraine prevention. Methods: In a randomized, controlled trial of adults with migraine, exercising for 40 minutes three times a week was compared to relaxation according to a recorded programme or daily topiramate use, which was slowly increased to the individual’s highest tolerable dose (maximum 200 mg/day). The treatment period lasted for 3 months, and migraine status, quality of life, level of physical activity, and oxygen uptake were evaluated. The primary efficacy variable was the mean reduction of the frequency of migraine attacks during the final month of treatment compared with the baseline. Results: Ninety-one patients were randomized and included in the intention-to-treat analysis. The primary efficacy variable showed a mean reduction of 0.93 (95% confidence interval (CI) 0.31–1.54) attacks in the exercise group, 0.83 (95% CI 0.22–1.45) attacks in the relaxation group, and 0.97 (95% CI 0.36–1.58) attacks in the topiramate group. No significant difference was observed between the groups ( p = 0.95). Conclusion: Exercise may be an option for the prophylactic treatment of migraine in patients who do not benefit from or do not want to take daily medication.

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