A pilot double-blind, randomized, placebo-controlled trial of the efficacy of trace elements in the treatment of endometriosis-related pain: study design and methodology

Didier Oberweis, Patrick Madélénat, Michelle Nisolle, Etienne Demanet
In: Nutrition and Dietary Supplements · 2016 · pp. 1 · doi:10.2147/nds.s92503 · W2268065487
article OA: gold CC0 ⤵ 3 in-corpus citations
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⚙ AI-generated summary by claude@2026-06, 2026-06-08 ⓘ

This pilot study design describes a randomized, placebo-controlled trial investigating if trace elements can reduce pain and improve quality of life in endometriosis patients.

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⚙ AI-generated deep summary by claude@2026-06, 2026-06-10 ⓘ

This paper describes the design and methodology of a prospective, interventional, randomized, double-blind, placebo-controlled pilot trial testing an eight-trace-element oral supplement versus placebo for reducing endometriosis-related pain and improving quality of life over 4 months in women with revised AFSr stage II–IV endometriosis, with or without adenomyosis, across 12 centers in France and Belgium. Participants either remain on stable background therapies (≥2 months) or take the study intervention without additional treatment, and a placebo run-in period is included to exclude high placebo responders. Pain is measured using a 100 mm visual analog scale and quality of life using the EHP-30 at multiple visits, alongside diaries tracking rescue NSAID use and adverse events. The paper explicitly notes that prior evidence on trace elements largely comes from in vitro, animal, ex vivo, or case-control studies and that randomized placebo-controlled trials are needed to establish clinically and statistically significant benefit. This paper is centrally about endometriosis — it lays out the methodology for a trial of trace elements aimed at endometriosis-related pain, including participants with endometriosis combined or not with adenomyosis.

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Abstract

Abstract: Endometriosis is one of the most common benign gynecological disorders, affecting almost 10%–15% of all women of reproductive age and >30% of infertile women. The pathology is associated with various distressing symptoms, particularly pelvic pain, which adversely affect patients' quality of life. It is an estrogen-dependent disease. There is evidence both in animals and in humans that metal ions can activate the estrogen receptors. They are defined as a variety of xenoestrogens, called metalloestrogens, which could act as endocrine disruptors. Therefore, it could be considered to act on this gynecological disorder using food supplements containing trace elements (ie, nutripuncture). The assumption is that they could modulate estrogen receptors and thus influence the tropism and the survival of cells involved in endometriosis. By a modulation of the antioxidant system, they might also interact with various parameters influencing tissue biochemistry. The objective of this article is to describe and discuss the design and methodology of an ongoing double-blind, randomized, placebo-controlled study aiming to evaluate the efficacy of metal trace elements on the reduction of pain and improvement of quality of life, in patients with a revised American Fertility Society Score Stages II–IV endometriosis, combined or not with adenomyosis, during a treatment period of 4 months. Trace elements or placebo is proposed in the absence of any other treatment or as an add-on to current therapies, such as sexual hormones, nonsteroidal anti-inflammatory drugs, and surgery. A placebo run-in period of one menstrual cycle or 30 days for women in amenorrhea has been scheduled to eliminate the patients who are responding too much to the placebo. After a 1:1 ratio randomization on Day 0, the treatment with trace elements or placebo will last for 4 months (120 days). Keywords: endometriosis, trace elements, randomized, placebo-controlled study, pain, quality of life

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endometriosisadenomyosis

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