Ubiratan Cardinalli Adler , Maristela Schiabel Adler , Renan dos Santos Nogueira , Márcio Normando Borges Coelho Filho , Eugênio de Moura Campos , Patrícia Andréa da Fonseca Magalhães , Antonio Brazil Viana Júnior , Suellen Monike do Vale Sabino , Annyta Fernandes Frota , Michelle Verde Ramo Soares , Anderson Carneiro Costa , Raelle Ferreira Gomes , Regina Celia Monteiro de Paula , Rosemayre Souza Freire , Eduardo Mello Barroso Filho , Carla Soraya Costa Maia , Felipe Domingos de Sousa , Allysson Allan de Farias , Francisco Luan Fonsêca da Silva , Caren Nádia Soares de Sousa , Lia Lira Olivier Sanders
{"title":"治疗重度抑郁症的个性化综合方法：血浆蛋白质组和顺势疗法制剂理化分析的N-of-1研究","authors":"Ubiratan Cardinalli Adler , Maristela Schiabel Adler , Renan dos Santos Nogueira , Márcio Normando Borges Coelho Filho , Eugênio de Moura Campos , Patrícia Andréa da Fonseca Magalhães , Antonio Brazil Viana Júnior , Suellen Monike do Vale Sabino , Annyta Fernandes Frota , Michelle Verde Ramo Soares , Anderson Carneiro Costa , Raelle Ferreira Gomes , Regina Celia Monteiro de Paula , Rosemayre Souza Freire , Eduardo Mello Barroso Filho , Carla Soraya Costa Maia , Felipe Domingos de Sousa , Allysson Allan de Farias , Francisco Luan Fonsêca da Silva , Caren Nádia Soares de Sousa , Lia Lira Olivier Sanders","doi":"10.1016/j.bbii.2025.100133","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Major Depressive Disorder (MDD) treatment remains challenging. This N-of-1 study evaluated a personalized integrative homeopathic protocol for MDD. Methods: A 28-week, double-blind, randomized, placebo-controlled crossover trial assessed <em>Sulphur</em> fifty-millesimal potencies (LM4–7) effectiveness and safety in a 45-year-old female with MDD. The primary outcomes were Beck Depression Inventory-II (BDI-II) scores, and secondary outcomes included SF-12 and Clinical Global Impression Scale scores. We conducted Plasma proteomics and physicochemical analyses (SEM, DLS, ICP-MS) of <em>Sulphur</em> LM2–7.</div></div><div><h3>Results</h3><div>BDI-II scores increased significantly in the placebo group (P = 0.017), whereas no significant change was observed in the <em>Sulphur</em>-treated group (P = 0.243). Overall symptom improvement with homeopathy compared to placebo, controlling for baseline, was 78 % (p < 0.05). MCS-12 significantly decreased during placebo (P = 0.008) but remained stable during homeopathic treatment (P = 0.542). No significant PCS-12 changes were observed (P > 0.2). CGI-I scores improved during the run-in treatment but showed no further change during the N-of-1 trial. Sulfur-loaded LM formulations presented nanoparticles, as confirmed by SEM analysis, demonstrated distinct particle size characteristics via DLS, and exhibited quantifiable sulfur concentrations detected through ICP-MS. Proteomic analysis suggested that <em>Sulphur</em> treatment modulates immune response pathways, highlighting a potential mechanism underlying its antidepressant-like effects.</div></div><div><h3>Conclusions</h3><div>This personalized integrative homeopathic protocol demonstrated superior effectiveness to placebo in the studied individual. The physicochemical characteristics and proteomic findings indicate potential immunomodulatory effects mediated by nanomedicine mechanisms. However, further research involving larger cohorts is warranted to confirm these preliminary observations.</div></div>","PeriodicalId":100197,"journal":{"name":"Brain Behavior and Immunity Integrative","volume":"11 ","pages":"Article 100133"},"PeriodicalIF":0.0000,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A personalized, integrative approach in treating major depressive disorder: N-of-1 study with plasma proteome and physicochemical analysis of homeopathic preparations\",\"authors\":\"Ubiratan Cardinalli Adler , Maristela Schiabel Adler , Renan dos Santos Nogueira , Márcio Normando Borges Coelho Filho , Eugênio de Moura Campos , Patrícia Andréa da Fonseca Magalhães , Antonio Brazil Viana Júnior , Suellen Monike do Vale Sabino , Annyta Fernandes Frota , Michelle Verde Ramo Soares , Anderson Carneiro Costa , Raelle Ferreira Gomes , Regina Celia Monteiro de Paula , Rosemayre Souza Freire , Eduardo Mello Barroso Filho , Carla Soraya Costa Maia , Felipe Domingos de Sousa , Allysson Allan de Farias , Francisco Luan Fonsêca da Silva , Caren Nádia Soares de Sousa , Lia Lira Olivier Sanders\",\"doi\":\"10.1016/j.bbii.2025.100133\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>Major Depressive Disorder (MDD) treatment remains challenging. This N-of-1 study evaluated a personalized integrative homeopathic protocol for MDD. Methods: A 28-week, double-blind, randomized, placebo-controlled crossover trial assessed <em>Sulphur</em> fifty-millesimal potencies (LM4–7) effectiveness and safety in a 45-year-old female with MDD. The primary outcomes were Beck Depression Inventory-II (BDI-II) scores, and secondary outcomes included SF-12 and Clinical Global Impression Scale scores. We conducted Plasma proteomics and physicochemical analyses (SEM, DLS, ICP-MS) of <em>Sulphur</em> LM2–7.</div></div><div><h3>Results</h3><div>BDI-II scores increased significantly in the placebo group (P = 0.017), whereas no significant change was observed in the <em>Sulphur</em>-treated group (P = 0.243). Overall symptom improvement with homeopathy compared to placebo, controlling for baseline, was 78 % (p < 0.05). MCS-12 significantly decreased during placebo (P = 0.008) but remained stable during homeopathic treatment (P = 0.542). No significant PCS-12 changes were observed (P > 0.2). CGI-I scores improved during the run-in treatment but showed no further change during the N-of-1 trial. Sulfur-loaded LM formulations presented nanoparticles, as confirmed by SEM analysis, demonstrated distinct particle size characteristics via DLS, and exhibited quantifiable sulfur concentrations detected through ICP-MS. Proteomic analysis suggested that <em>Sulphur</em> treatment modulates immune response pathways, highlighting a potential mechanism underlying its antidepressant-like effects.</div></div><div><h3>Conclusions</h3><div>This personalized integrative homeopathic protocol demonstrated superior effectiveness to placebo in the studied individual. The physicochemical characteristics and proteomic findings indicate potential immunomodulatory effects mediated by nanomedicine mechanisms. 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A personalized, integrative approach in treating major depressive disorder: N-of-1 study with plasma proteome and physicochemical analysis of homeopathic preparations
Background
Major Depressive Disorder (MDD) treatment remains challenging. This N-of-1 study evaluated a personalized integrative homeopathic protocol for MDD. Methods: A 28-week, double-blind, randomized, placebo-controlled crossover trial assessed Sulphur fifty-millesimal potencies (LM4–7) effectiveness and safety in a 45-year-old female with MDD. The primary outcomes were Beck Depression Inventory-II (BDI-II) scores, and secondary outcomes included SF-12 and Clinical Global Impression Scale scores. We conducted Plasma proteomics and physicochemical analyses (SEM, DLS, ICP-MS) of Sulphur LM2–7.
Results
BDI-II scores increased significantly in the placebo group (P = 0.017), whereas no significant change was observed in the Sulphur-treated group (P = 0.243). Overall symptom improvement with homeopathy compared to placebo, controlling for baseline, was 78 % (p < 0.05). MCS-12 significantly decreased during placebo (P = 0.008) but remained stable during homeopathic treatment (P = 0.542). No significant PCS-12 changes were observed (P > 0.2). CGI-I scores improved during the run-in treatment but showed no further change during the N-of-1 trial. Sulfur-loaded LM formulations presented nanoparticles, as confirmed by SEM analysis, demonstrated distinct particle size characteristics via DLS, and exhibited quantifiable sulfur concentrations detected through ICP-MS. Proteomic analysis suggested that Sulphur treatment modulates immune response pathways, highlighting a potential mechanism underlying its antidepressant-like effects.
Conclusions
This personalized integrative homeopathic protocol demonstrated superior effectiveness to placebo in the studied individual. The physicochemical characteristics and proteomic findings indicate potential immunomodulatory effects mediated by nanomedicine mechanisms. However, further research involving larger cohorts is warranted to confirm these preliminary observations.
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