1.PT1-7 Balneotherapy for common metabolic conditions - the French experience
Christian François ROQUES ; Hanh T ; Blin P ; Gin H ; Moore N
The Journal of The Japanese Society of Balneology, Climatology and Physical Medicine 2014;77(5):391-391
Overweight, obesity and the metabolic syndrome are usual conditions treated in french balneotherapy care facilities. 42,507 patients were treated last year in France for metabolic conditions, most of them benefiting a social security reimbursed treatment. The therapeutic intervention core is made of hydro-thermal cares: drinking mineral water (alkaline sodium bicarbonated water), individual mineral water bathing, showers, massages under mineral water, mineral water pool collective exercise; education on nutritional concepts, adapted physical activity are also essential informations delivered in group or customized sessions. AFRETH promoted two clinical studies investigating the topic. The randomised controlled trial Maathermes (1) assessed the benefit of the intervention on 257 overweight or obese patients randomized between balneotherapy (delivered in Brides, Capvern, Vals, Vichy, Vittel) and a control group (usual care and booklet on nutrition from the french health autorithy). At month 14th, the patients treated in the balneotherapy group showed a significant weight reduction (5.17 kg vs .54 kg ; p<.001) and they had more perspective to reach a stable weight loss of 5% (57.1% vs 18.6 % ; p<.001). Prisme (2), a feasability cohort study, investigated the results of the intervention in 93 patients with a metabolic syndrome treated in Eugenie les Bains. At month 12th, 67 patients could be assessed. Metabolic syndrome had disappeared in 76% of the patients (glycemia normalised in 15%, waist circumference returned to acceptable in 15%, lipidic disorders disappeared in 33% ; blood pressure had acceptable values, without increased drug intake, in 67%.). 75 % of the patients were continuing the adapted physical activity, 65 % had a correct lipid intake. Balneotherapy is useful for patients with overweight or obesity. Education during the stay is helpful for the weight and metabolic syndrome control. The medico-economic benefit of such an intervention remains to be established on scientific basis.
2.Does Post-traumatic Stress Disorder Impact Treatment Outcomes within a Randomised Controlled Trial of Mitochondrial Agents for Bipolar Depression?
Samantha E. RUSSELL ; Anna L. WROBEL ; Melanie M. ASHTON ; Alyna TURNER ; Mohammadreza MOHEBBI ; Michael BERK ; Sue COTTON ; Seetal DODD ; Chee H. NG ; Gin S. MALHI ; Olivia M. DEAN
Clinical Psychopharmacology and Neuroscience 2023;21(3):457-465
Objective:
Bipolar disorder often co-occurs with post-traumatic stress disorder, yet few studies have investigated the impact of post-traumatic stress disorder in bipolar disorder on treatment outcomes. The aim of this sub-analysis was to explore symptoms and functioning outcomes between those with bipolar disorder alone and those with comorbid bipolar disorder and post-traumatic stress disorder.
Methods:
Participants (n = 148) with bipolar depression were randomised to: (i) N-acetylcysteine alone; (ii) a combination of nutraceuticals; (iii) or placebo (in addition to treatment as usual) for 16 weeks (+4 weeks discontinuation).Differences between bipolar disorder and comorbid bipolar disorder and post-traumatic stress disorder on symptoms and functioning at five timepoints, as well as on the rate of change from baseline to week 16 and baseline to week 20, were examined.
Results:
There were no baseline differences between bipolar disorder alone and comorbid bipolar disorder and post-traumatic stress disorder apart from the bipolar disorder alone group being significantly more likely to be married (p = 0.01). There were also no significant differences between bipolar disorder alone and comorbid bipolar disorder and post-traumatic stress disorder on symptoms and functioning.
Conclusion
There were no differences in clinical outcomes over time within the context of an adjunctive randomised controlled trial between those with bipolar disorder alone compared to those with comorbid bipolar disorder and post-traumatic stress disorder. However, differences in psychosocial factors may provide targets for areas of specific support for people with comorbid bipolar disorder and post-traumatic stress disorder.
3.Mixed Methods Thematic Analysis of a Randomised Controlled Trial of Adjunctive Mitochondrial Agents for Bipolar Depression
Samantha E. RUSSELL ; Anna L. WROBEL ; Olivia M. DEAN ; Michael BERK ; Seetal DODD ; Chee H. NG ; Gin S. MALHI ; Susan M. COTTON ; Jerome SARRIS ; Alyna TURNER
Clinical Psychopharmacology and Neuroscience 2022;20(2):300-310
Objective:
There is often a shortfall in recovery following treatment for an episode of bipolar disorder (BD). Exploration of participant’s experience provides vital information to enhance statistical outcomes for novel therapy trials. This study used mixed-methods to explore participants’ experience of a trial testing N -acetyl cysteine (NAC) and mitochondrially active nutraceuticals for BD depression.
Methods:
Case report forms from a randomised controlled trial (RCT) of BD depression (n = 148) were analysed using a pragmatic adaption of grounded theory and thematic analysis.
Results:
Thematic analysis of 148 study participants indicated numerous changes in participant experience over time. For example, perceived environmental stressors reported by participants decreased over the trial in both treatment groups. Quantitative analysis of the themes revealed more positive theme reports in the combination treatment arm compared to the placebo arm and there were more negative themes identified in the placebo arm, compared to the NAC arm.
Conclusion
This approach revealed additional results not elucidated in the primary quantitative analysis. This emphasises the value of mixed-methods research in capturing participants’ experiences in RCTs and detecting possible latent benefits and risks. Such methods can detect latent target signals in novel therapy trials conducted in BD and generate novel hypotheses.
4.Exploring Clinical Subgroups of Participants with Major Depressive Disorder that may Benefit from Adjunctive Minocycline Treatment
Gerard ANMELLA ; Alcy MEEHAN ; Melanie ASHTON ; Mohammadreza MOHEBBI ; Giovanna FICO ; Chee H. NG ; Michael MAES ; Lesley BERK ; Michele De PRISCO ; Ajeet B. SINGH ; Gin S. MALHI ; Michael BERK ; Seetal DODD ; Diego HIDALGO-MAZZEI ; Iria GRANDE ; Isabella PACCHIAROTTI ; Andrea MURRU ; Eduard VIETA ; Olivia M. DEAN
Clinical Psychopharmacology and Neuroscience 2024;22(1):33-44
Objective:
To explore illness-related factors in patients with major depressive disorder (MDD) recipients of adjunctive minocycline (200 mg/day) treatment. The analysis included participants experiencing MDD from a 12-week, double blind, placebo-controlled, randomized clinical trial (RCT).
Methods:
This is a sub-analysis of a RCT of all 71 participants who took part in the trial. The impact of illness chronicity (illness duration and number of depressive episodes), systemic illness (endocrine, cardiovascular and obesity), adverse effects and minocycline were evaluated as change from baseline to endpoint (12-week) using ANCOVA.
Results:
There was a consistent but statistically non-significant trend on all outcomes in favour of the use of adjunctive minocycline for participants without systemic illness, less illness chronicity, and fewer adverse effects.
Conclusion
Understanding the relationship between MDD and illness chronicity, comorbid systemic illness, and adverse effects, can potentially better characterise those individuals who are more likely to respond to adjunctive anti-inflammatory medications.