2018
DOI: 10.1007/s00520-018-4449-x
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Does a homeopathic medicine reduce hot flushes induced by adjuvant endocrine therapy in localized breast cancer patients? A multicenter randomized placebo-controlled phase III trial

Abstract: The efficacy endpoint was not reached, and BRN-01 administration was not demonstrated as an efficient treatment to alleviate HF symptoms due to adjuvant ET in breast cancer patients. However, the study drug administration led to decreased HFS with a positive impact on QoL. Without any recommended treatment to treat or alleviate the HF-related disabling symptoms, Actheane® could be a promising option, providing an interesting support for better adherence to ET, thereby reducing the risk of recurrence with a goo… Show more

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Cited by 18 publications
(25 citation statements)
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“…While earlier studies showed that pharmacological interventions using clonidine could lead to significant reduction in hot flashes score, frequency and intensity [28,29], other studies reported non-significant differences (p ≥ 0.54) in the changes of these parameters between the intervention and control group at pre-and post-intervention [25][26][27]. Notably, both the intervention and control participants reported a decrease in these parameters from baseline to post-intervention [25,26], which demonstrates why non-significant differences were observed. Interestingly, in a cross-over study on a pharmacological intervention using the anti-depressant sertraline, significant between-group differences were observed in hot flashes frequency and hot flashes score after cross-over at Week 12 of the intervention, despite the lack of such difference before the cross-over at Week 6 [27].…”
Section: Hot Flashesmentioning
confidence: 96%
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“…While earlier studies showed that pharmacological interventions using clonidine could lead to significant reduction in hot flashes score, frequency and intensity [28,29], other studies reported non-significant differences (p ≥ 0.54) in the changes of these parameters between the intervention and control group at pre-and post-intervention [25][26][27]. Notably, both the intervention and control participants reported a decrease in these parameters from baseline to post-intervention [25,26], which demonstrates why non-significant differences were observed. Interestingly, in a cross-over study on a pharmacological intervention using the anti-depressant sertraline, significant between-group differences were observed in hot flashes frequency and hot flashes score after cross-over at Week 12 of the intervention, despite the lack of such difference before the cross-over at Week 6 [27].…”
Section: Hot Flashesmentioning
confidence: 96%
“…Five studies reported the effect of pharmacological interventions on addressing hot flashes among the participants [25][26][27][28][29]. While earlier studies showed that pharmacological interventions using clonidine could lead to significant reduction in hot flashes score, frequency and intensity [28,29], other studies reported non-significant differences (p ≥ 0.54) in the changes of these parameters between the intervention and control group at pre-and post-intervention [25][26][27]. Notably, both the intervention and control participants reported a decrease in these parameters from baseline to post-intervention [25,26], which demonstrates why non-significant differences were observed.…”
Section: Hot Flashesmentioning
confidence: 99%
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“…For example, homeopathy was tested to reduce hot flushes induced by endocrine therapy in 299 breast cancer patients. It had no impact on hot flushes or the quality of life [19]. A randomized controlled trial testing the efficacy of X-ray 15CH versus placebo in order to limit the radio-induced dermatitis reaction was also negative [25].…”
Section: Discussionmentioning
confidence: 99%
“…The highest satisfaction rates were reported with healing touch (median satisfaction: 81%), Chinese medicines (median satisfaction: 79.5%), hypnosis (median satisfaction: 79%), and osteopathy (median satisfaction: 79%). However, so far, few prospective randomized controlled trials have tested the efficacy of CAMs [19]. …”
Section: Discussionmentioning
confidence: 99%