From pharmaceutical standardizing to clinical research: 20 years of experience with fifty-millesimal potencies

Background: 20 years ago we began to standardize the procedures of preparation and use of fifty-millesimal dilutions (LM or Q) according to indications in the 6th edition of HahnemannÃƒÂ¢Ã¢â€šÂ¬Ã¢â€žÂ¢s Organon. Aim: to describe the main stages in standardization as well as our teaching and research experience on Organon 6th edition. Results: with the use of standardized LM dilutions we observed a lower incidence of homeopathic aggravation than with our earlier experience with non standardized preparations. Organon.modus, a clinical-pharmaceutical protocol derived from the standardization was adequate for the teaching of homeopathy at Faculty of Medicine of Jundiai (SÃƒÆ’Ã‚Â£o Paulo), the first Brazilian medical school with a graduate course on homeopathy. A randomized double-blind trial comparing individualized homeopathic medicines prescribed in LM dilutions and fluoxetine showed the former not be inferior to the latter in the treatment of moderate-to-severe depression. Conclusion: protocol Organon.modus showed to be adequate to graduate-level teaching of homeopathy and efficient in a controlled clinical trials, favoring its use as common denominator between the art of healing and medical science.

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Cardiovascular and cerebrovascular events among patients receiving omalizumab: Pooled analysis of patient-level data from 25 randomized, double-blind, placebo-controlled clinical trials

Journal of Allergy and Clinical Immunology ◽

10.1016/j.jaci.2016.12.953 ◽

2017 ◽

Vol 139 (5) ◽

pp. 1678-1680 ◽

Cited By ~ 11

Author(s):

Carlos Iribarren ◽

Kenneth J. Rothman ◽

Mary S. Bradley ◽

Gillis Carrigan ◽

Mark D. Eisner ◽

...

Keyword(s):

Clinical Trials ◽

Pooled Analysis ◽

Controlled Clinical Trials ◽

Double Blind ◽

Double Blind Placebo ◽

Patient Level Data ◽

Patient Level ◽

Cerebrovascular Events ◽

Level Data

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Modafinil Augmentation for Residual Symptoms of Fatigue in Patients with a Partial Response to Antidepressants

Annals of Pharmacotherapy ◽

10.1345/aph.1h526 ◽

2007 ◽

Vol 41 (6) ◽

pp. 1005-1012 ◽

Cited By ~ 18

Author(s):

Jenny Y Lam ◽

Maisha Kelly Freeman ◽

Marshall E Cates

Keyword(s):

Clinical Trials ◽

Data Extraction ◽

Controlled Clinical Trials ◽

Open Label ◽

Double Blind ◽

Residual Symptoms ◽

Randomized Controlled ◽

Manual Search ◽

Number Of Patients ◽

Residual Fatigue

OBJECTIVE: To evaluate the literature discussing the use of modafinil in the treatment of residual symptoms of fatigue in patients with depression. DATA SOURCES: PubMed (1966–March 2007) and International Pharmaceutical Abstracts(1970–March 2007) were searched using the key words modafinil and depression. A manual search of the reference section of the articles retrieved was conducted to identify articles not indexed in either of these sources. STUDY SELECTION AND DATA EXTRACTION: All articles published in English were evaluated. Studies were included if modafinil was used to treat patients with residual fatigue from depression and the effects were measured with validated fatigue subscales. DATA SYNTHESIS: One retrospective study, 5 open-label trials, and 2 randomized controlled clinical trials met the inclusion criteria for assessment of residual symptoms of fatigue as assessed by commonly used fatigue subscales after modafinil administration. Although improvement with fatigue has occurred with modafinil therapy, literature regarding the topic is limited by the lack of well-controlled clinical trials. Modafinil does appear to improve residual fatigue with depression as evidenced by open-label trials; however, the efficacy of this agent has not been duplicated in randomized controlled trials. The open-label trials that have been conducted often had no comparator and a small number of patients. In addition, outcome measures used in the studies were not consistent between trials. Modafinil appears to be well tolerated, with the main adverse effects being headache and nausea. CONCLUSIONS: Open-label trials indicate that modafinil may be effective in ameliorating fatigue associated with depression; however, this effect has not been reproduced in randomized, double-blind, placebo-controlled clinical trials. Therefore, the use of modafinil for the treatment of residual fatigue is not recommended due to the lack of reproducible data of its efficacy. Long-term, adequately powered clinical trials should be conducted to determine its place in therapy.

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Homeopathic aggravations: a systematic review of randomised, placebo-controlled clinical trials

Homeopathy ◽

10.1016/s1475-4916-03-00007-9 ◽

2003 ◽

Vol 92 (02) ◽

pp. 92-98

Author(s):

S Grabia ◽

E Ernst

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Adverse Effects ◽

Randomised Clinical Trials ◽

Controlled Clinical Trials ◽

Double Blind ◽

Literature Searches

AbstractHomeopathic aggravations have often been described anecdotally. However, few attempts have been made to scientifically verify their existence. This systematic review aimed at comparing the frequency of homeopathic aggravations in the placebo and verum groups of double-blind, randomised clinical trials. Eight independent literature searches were carried out to identify all such trials mentioning either adverse effects or aggravations. All studies thus found were validated and data were extracted by both authors. Twenty-four trials could be included. The average number of aggravations was low. In total, 50 aggravations were attributed to patients treated with placebo and 63 to patients treated with homoeopathically diluted remedies. We conclude that this systematic review does not provide clear evidence that the phenomenon of homeopathic aggravations exists.

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