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Author Topic: Does a homeopathic medicine reduce hot flushes induced by adjuvant endocrine the  (Read 298 times)

YanTing

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  • Posts: 205

Supportive Care in Cancer
May 2019, Volume 27, Issue 5, pp 1879–1889

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

Pierre-Etienne Heudel et al. (+13 additional authors, located at 11 French institutions)

Abstract

Purpose: Endocrine therapy (ET) used to reduce the risk of recurrence in hormone receptor-expressing disease (75% of breast cancers) is associated with worsening of climacteric symptoms with a negative impact on quality of life (QoL). Homeopathy might allow a better management of hot flushes (HF).

Methods: In this multicenter randomized double-blind placebo-controlled phase III study (ClinicalTrials.gov NCT01246427), we enrolled >=18 years old women with histologically proven non metastatic localized breast cancer, with Eastern Cooperative Oncology Group-Performance Status (ECOG-PS) <=1, treated for at least 1 month with adjuvant ET, and complaining about moderate to severe HF. Patients should not be scheduled for chemotherapy or radiotherapy, and had no associated pathology known to induce HF. After a 2- to 4-week placebo administration, we randomly assigned (1:1) patients with HFS >=10 using an interactive web-based centralized platform to BRN-01 homeopathic medicine complex (Actheane®) in arm A or Placebo (Arm P). Randomization was stratified by adjuvant ET (taxoxifen/aromatase inhibitor) and recruiting site. HF scores (HFS) were calculated as the mean of HF frequencies before randomization, at 4, and at 8 weeks post-randomization (pre-, 4w,- and 8w-) weighted by a 4-level intensity scale. Primary endpoint was assessed at 4-week post-randomization, as the variation between pre- and 4w-HFS. Secondary endpoints included HFS variation between pre- and 8w-HFS, compliance and tolerance assessed 8 weeks after randomization, and QoL and satisfaction assessed at 4- and 8-week post-randomization.

Results: Two hundred ninety-nine patients were included, and 138 (46.2%) randomized (A, 65; P, 73). Median 4w-HFS absolute variation (A, -2.9; P, -2.5 points, p=0.756) and relative decrease (A, -17%; P, -15%, p=0.629) were not statistically different. However, 4w-HFS decreased for 46 (75%) in A vs 48 (68%) patients in P arm. 4w-QoL was stable or improved for respectively 43 (72%) vs 51 (74%) patients (p=0.470).

Conclusions: 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 good tolerance profile.

https://link.springer.com/article/10.1007/s00520-018-4449-x


Excerpts:

"Homeopathy is currently in use to alleviate menopausal symptoms and HF and could reduce this frequent ET’s side effect. BRN-01 (Actheane®) is registered in France for the treatment of menopausal HF and functional disorders. BRN-01 is composed of five homeopathic medications in one tablet (Actaea racemosa 4CH, Arnica Montana 4CH, Glonoinum 4CH, Lachesis mutus 5CH, and Sanguinaria Canadensis 4CH. Mechanism of action hypothesized, in particular, the involvement of the hypotensive activity of Actaea racemosa, the cardiovascular activity of Arnica Montana, Glonoinum, Lachesis mutus and Sanguinaria Canadensis, and neuroendocrine activity of Lachesis mutus. The constitutive components are homeopathic drugs indicated for the management of menopausal HF [11, 12]. A placebo-controlled trial reported the efficacy of BRN-01 on the frequency and intensity of menopausal HF experienced over a 12-week period. No statistically significant difference in the number of patients experiencing adverse events or serious adverse events had been reported, and any adverse event was considered to be related to treatment. [13]."

"The placebo tablets were identical to BRN-01 but inert. Treatments were provided by Laboratoires Boiron, in identical primary and secondary packaging .

"We performed a baseline assessment within a 2- to 4-week run-in period before randomization. All patients received, a single-blinded HF evaluation kit for a 4-week treatment period exclusively including placebo (two boxes including tablets for twice daily oral intake -morning and evening, between meals-) and a diary for HF self-reporting. After this run-in period, only patients displaying a hot flushes score (HFS) >=10 were randomized to receive experimental treatment, five boxes of either BRN-01 or placebo for the ten following weeks. Masked study drug administration was continued until ET discontinuation, sponsor or investigator-reasoned decision, death, or consent withdrawal."

"This randomized double-blinded placebo-controlled phase III study failed to demonstrate BRN01 efficacy. Indeed, the efficacy endpoint was not reached, and no significant difference in hot flushes score (HFS) variation was observed between arms in patients with breast cancer. This trial demonstrated that the efficacy of BRN-01 to alleviate hot flushes (HF) was not better than placebo."

"The results in our series contrast with the greater effect of BRN-01 on the HF severity in terms of frequency and intensity reported in a randomized double-blind placebo-controlled trial [13] in menopausal women experiencing > 12-month duration amenorrhea and spontaneously complaining of HF with significant repercussion on their social and professional life."

"The question whether homeopathic intervention differs from placebo awaits decisive answers and despite important growth activity in homeopathic research in the last decades, concerns about study quality limit the interpretation of available randomized controlled trials data [20, 21]. Homeopathy, as other complementary and alternative medicine like phytotherapy and acupuncture might represent an active coping strategy for the management of cancer-related symptoms and distress, through greater understanding of biopsychosocial approaches to cancer treatment regimens [22], and might facilitate the growth of benefit finding."

"Although efficacy endpoint was not reached, the management of HF globally decreased HFS, with a positive impact on QoL in patients with breast cancer. Without any validated treatment to alleviate disabling symptoms such as HF, Actheane® could be a well-tolerated therapeutic option contributing to overcome the related endocrine therapy side effects, enhance adherence to endocrine therapy, and thereby improve treatment efficacy and survival. Further studies will be required to evaluate more accurately the impact of care management."

"Laboratoires Boiron provided the study drug Actheane® and its matching placebo, and funds to the sponsor to conduct this study. Laboratoires Boiron had no role in study design, data collection, data analysis, data interpretation, nor writing of the report."


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Comments: as usual, there is no mention of the fact that homeopathy is scientifically implausible, or even that it is controversial.

Even though the results of the study were negative, the authors somehow conclude that the homeopathic drug "could be a promising option."
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