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?