Conflict of interest
My child is an employee of Nippon Zoki Pharmaceutical Co., Ltd..
Ethics approval statement N/A
Patient consent statement N/A
KEYWORDS
hormone therapy, menopause, fibromyalgia, ineffectiveness
Abstract
As a general rule in pharmacotherapy, ineffective pharmacological treatment should be discontinued. Ineffective pharmacotherapy should not be administered for a long time. The first problem is the appropriate duration to determine that the pharmacological treatment is ineffective. The second problem is the criterion for determining the efficacy (or ineffectiveness) of the pharmacological treatment. As far as I know, there is no evidence regarding the duration. Nevertheless, it is necessary to determine the duration. Standards by academic organizations are necessary, even provisional standards are acceptable. Long-term administration of ineffective medicine causes the problem of adverse effects. It loses the opportunity to receive effective treatment. In case that HT is ineffective for menopause, the treatment of fibromyalgia may relieve symptoms of menopause. Patients do not get medical attention for the improvement of abnormal hormone levels but do for the improvement of subjective symptoms such as widespread pain, numbness, insomnia, and fatigue. Some people are almost asymptomatic even if their hormone levels are abnormal. I believe that the efficacy (or ineffectiveness) should be determined with the improvement of the above-mentioned subjective symptoms rather than the improvement of the abnormal hormone levels. As a general rule in pharmacotherapy, ineffective pharmacological treatment should be discontinued. Ineffective pharmacotherapy should not be administered for a long time. In case that ineffective pharmacological treatment is discontinued, there are two problems. The first problem is the appropriate duration to determine that the pharmacological treatment is ineffective. The second problem is the criterion for determining the efficacy (or ineffectiveness) of the pharmacological treatment.
The same patient has been diagnosed with fibromyalgia or its incomplete form by pain specialists and menopause by gynecologists. This is because each medical department independently created its diagnosis and definition of medically unexplained pain and/or symptoms. In Japan, fibromyalgia is usually treated as a fake and is rarely diagnosed. This article does not mention the issue any further.
As far as I know, the duration to determine that the HT is ineffective in menopause is unclear. It is a problem. The North American Menopause Society published The 2022 hormone therapy position statement.1 The statement includes “Discontinuation of hormone therapy” However, it only describes how to discontinue hormone therapy when it is effective. It does not describe how to discontinue hormone therapy when it is ineffective. In Japan, HT has been often administered for more than 6 months, even if it is ineffective. How long is the appropriate duration to determine that HT is ineffective in menopause? As far as I know, there is no evidence regarding the duration. Nevertheless, it is necessary to determine the duration. If individual physicians decide the duration, we would have a situation like Japan. Standards by academic organizations are necessary, even provisional standards are acceptable. Long-term administration of ineffective medicine causes the problem of adverse effects. It loses the opportunity to receive effective treatment. HT is effective for both menopause and fibromyalgia.2 In my experience, the treatment of fibromyalgia is effective in patients with a diagnosis of menopausal. Naturally, it is ineffective in some patients with fibromyalgia. In case that HT is ineffective for menopause, the treatment of fibromyalgia may relieve symptoms of menopause. Patients do not get medical attention for the improvement of abnormal hormone levels but do for the improvement of subjective symptoms such as widespread pain, numbness, insomnia, and fatigue. Some people are almost asymptomatic even if their hormone levels are abnormal. I believe that the efficacy (or ineffectiveness) should be determined with the improvement of the above-mentioned subjective symptoms rather than the improvement of the abnormal hormone levels. What is the criterion to determine the efficacy (or ineffectiveness) of HT?