今日の臨床サポート

更年期の不定愁訴

著者: 望月 善子 もちづき女性クリニック

監修: 小林裕明 鹿児島大学大学院医歯学総合研究科生殖病態生理学

著者校正/監修レビュー済:2019/07/19
患者向け説明資料

概要・推奨   

症状のポイント:
  1. 更年期にはさまざまな症状(いわゆる不定愁訴)が出現する。このうち日常生活を障害するものが更年期障害であり、治療の対象となる。更年期女性の約50~80%が更年期に愁訴を訴えるといわれている。そこで以下は更年期障害に対する対応を中心に記載する。
  1. なお、更年期とは閉経の前後5年間、計10年間をいう。更年期女性において、1年間無月経が続いた時点で閉経と判断する。日本人女性の閉経年齢は約50歳であるが、個人差が大きく、更年期障害は40歳過ぎから60歳頃の女性にみられると考えてよい。
  1. 更年期指数を用いると愁訴を拾い上げやすい。よく用いられている更年期指数としては簡略更年期指数(SMI)や更年期症状評価表などがある。
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薬剤監修について:
オーダー内の薬剤用量は日本医科大学付属病院 薬剤部 部長 伊勢雄也 以下、林太祐、渡邉裕次、井ノ口岳洋、梅田将光による疑義照会のプロセスを実施、疑義照会の対象については著者の方による再確認を実施しております。
※薬剤中分類、用法、同効薬、診療報酬は、エルゼビアが独自に作成した薬剤情報であり、
著者により作成された情報ではありません。
尚、用法は添付文書より、同効薬は、薬剤師監修のもとで作成しております。
※薬剤情報の(適外/適内/⽤量内/⽤量外/㊜)等の表記は、エルゼビアジャパン編集部によって記載日時にレセプトチェックソフトなどで確認し作成しております。ただし、これらの記載は、実際の保険適用の査定において保険適用及び保険適用外と判断されることを保証するものではありません。また、検査薬、輸液、血液製剤、全身麻酔薬、抗癌剤等の薬剤は保険適用の記載の一部を割愛させていただいています。
(詳細はこちらを参照)
著者のCOI(Conflicts of Interest)開示:
望月 善子 : 特に申告事項無し[2021年]
監修:小林裕明 : 講演料(中外製薬株式会社,アストラゼネカ株式会社),奨学(奨励)寄付など(中外製薬株式会社)[2021年]

病態・疫学・診察

疫学情報・病態・注意事項  
  1. 更年期障害とは「更年期に現れる多種多様な症状のなかで、器質的変化に起因しない症状を更年期症状と呼び、これらの症状のなかで日常生活に支障を来す病態を更年期障害と定義する」とされている。
  1. 更年期女性の約50~80%が更年期に愁訴を訴えるといわれている。これらのうち、少なく見積もって30%が何らかの治療が必要であるとしても、更年期障害は400万人、総女性人口の6%もが治療対象となると推計される。産婦人科のみならず内科や整形外科を初診で受診する症例も少なくない。
  1. 更年期に現れる原因不明の種々の不定愁訴のうち、日常生活に差し障りのあるものが更年期障害であり、以下の点を満たすことが必要である。診断基準はない。
  1. 更年期に現れること
  1. 器質的疾患に起因しないこと
  1. 日常生活に支障を来すこと
  1. 症状は多彩である。のぼせ・ほてりといったホットフラッシュが有名であるが、これがあれば更年期障害といえる特徴的な症状はない。
  1. 閉経に伴うエストロゲンの消退が最も大きな要因であるが、対人関係や家族の問題などの社会的環境的要因や生来の性格や生育歴などの心理的・性格的要因も無視できない。
  1. 除外診断によって診断される疾患であるため、鑑別診断が重要であり、特に、うつ病などの精神疾患、不安障害、甲状腺機能異常(亢進症・低下症)などは常に念頭に置く。
問診・診察のポイント  
  1. 更年期とは閉経の前後10年間をいう。最終月経より1年間月経がない時点で閉経と診断される。日本人女性の閉経年齢は約50歳であるが、個人差が大きく、更年期障害は40歳から60歳ごろの女性にみられると考えてよい。したがって、70歳以降の女性や20歳代、30歳代の女性に生じる更年期障害類似の症状は更年期障害とはいえない。子宮摘出後の場合にはホルモン値(エストロゲン値は月経周期中でも変化の幅が大きいため、卵胞刺激ホルモン[FSH]値)を参考にする。特徴的な症状はないとされてはいるが、のぼせ・ほてり・発汗は頻度が高く、これらがまったくない症例は少ない。

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文献 

著者: A H Maclennan, J L Broadbent, S Lester, V Moore
雑誌名: Cochrane Database Syst Rev. 2004 Oct 18;(4):CD002978. doi: 10.1002/14651858.CD002978.pub2. Epub 2004 Oct 18.
Abstract/Text BACKGROUND: Hot flushes and night sweats are common symptoms experienced by menopausal women. Hormone therapy (HT), containing oestrogens alone or oestrogens together with progestogens in a cyclic or continuous regimen, is often recommended for their alleviation.
OBJECTIVES: To examine the effect of oral HT compared to placebo on these vasomotor symptoms and the risk of early onset side-effects.
SEARCH STRATEGY: We searched the Cochrane Menstrual Disorders Group and Subfertility Group trials register (searched May 2002). This register is based on regular searches of MEDLINE, EMBASE, CINAHL, the Cochrane Central Register of Controlled Trials (CENTRAL), PsycINFO, the handsearching of 20 relevant journals and conference proceedings, and searches of several key grey literature sources. We also contacted all relevant pharmaceutical companies, The Journal of the International Menopause Society and Climacteric.
SELECTION CRITERIA: Double-blind, randomised, placebo-controlled trials of oral HT for at least three months duration.
DATA COLLECTION AND ANALYSIS: Study quality and outcome data were assessed independently. Random effects models were considered appropriate due to the variety of trial methodologies. The meta-analyses were explored for sensitivity to trial quality and therapy duration. Symptom frequency and severity were assessed separately, together with withdrawals and side-effects. Frequency data were analysed using the Weighted Mean Difference (WMD) between treatment and placebo outcomes. For severity data, odds ratios were estimated from the proportional odds model. From 115 references originally identified, 24 trials meeting the selection criteria were included in the review. Study participants totaled 3,329. Trial duration ranged from three months to three years.
MAIN RESULTS: There was a significant reduction in the weekly hot flush frequency for HT compared to placebo (WMD -17.92, 95% CI -22.86 to -12.99). This was equivalent to a 75% reduction in frequency (95% CI 64.3 to 82.3) for HT relative to placebo. Symptom severity was also significantly reduced compared to placebo (OR 0.13, 95% CI 0.07 to 0.23). Withdrawal for lack of efficacy occurred significantly more often on placebo therapy (OR 10.51, 95% CI 5.00 to 22.09). Withdrawal for adverse events, commonly breast tenderness, oedema, joint pain and psychological symptoms, was not significantly increased (OR 1.25, 95% CI 0.83 to 1.90), although the occurrence of any adverse events was significantly increased for HT (OR 1.41, 95% CI 1.00 to 1.99). In women who were randomised to placebo treatment, a 57.7% (95% CI 45.1 to 67.7) reduction in hot flushes was observed between baseline and end of study.
REVIEWERS' CONCLUSIONS: Oral HT is highly effective in alleviating hot flushes and night sweats. Therapies purported to reduce such symptoms must be assessed in blinded trials against a placebo or a validated therapy because of the large placebo effect seen in well conducted randomised controlled trials, and also because during menopause symptoms may fluctuate and after menopause symptoms often decline. Withdrawals due to side-effects were only marginally increased in the HT groups despite the inability to tailor HT in these fixed dose trials. Comparisons of hormonal doses, product types or regimens require analysis of trials with these specific "within study" comparisons.

PMID 15495039  Cochrane Database Syst Rev. 2004 Oct 18;(4):CD002978. d・・・
著者: Ellen W Freeman, Katherine A Guthrie, Bette Caan, Barbara Sternfeld, Lee S Cohen, Hadine Joffe, Janet S Carpenter, Garnet L Anderson, Joseph C Larson, Kristine E Ensrud, Susan D Reed, Katherine M Newton, Sheryl Sherman, Mary D Sammel, Andrea Z LaCroix
雑誌名: JAMA. 2011 Jan 19;305(3):267-74. doi: 10.1001/jama.2010.2016.
Abstract/Text CONTEXT: Concerns regarding the risks associated with estrogen and progesterone to manage menopausal symptoms have resulted in its declining use and increased interest in nonhormonal treatments with demonstrated efficacy for hot flashes.
OBJECTIVE: To determine the efficacy and tolerability of 10 to 20 mg/d escitalopram, a selective serotonin reuptake inhibitor, in alleviating the frequency, severity, and bother of menopausal hot flashes.
DESIGN, SETTING, AND PATIENTS: A multicenter, 8-week, randomized, double-blind, placebo-controlled, parallel group trial that enrolled 205 women (95 African American; 102 white; 8 other) between July 2009 and June 2010.
INTERVENTION: Women received 10 to 20 mg/d of escitalopram or a matching placebo for 8 weeks.
MAIN OUTCOME MEASURES: Primary outcomes were the frequency and severity of hot flashes assessed by prospective daily diaries at weeks 4 and 8. Secondary outcomes were hot flash bother, recorded on daily diaries, and clinical improvement (defined as hot flash frequency ≥50% decrease from baseline).
RESULTS: Mean (SD) daily hot flash frequency was 9.78 (5.60) at baseline. In a modified intent-to-treat analysis that included all randomized participants who provided hot flash diary data, the mean difference in hot flash frequency reduction was 1.41 (95% CI, 0.13-2.69) fewer hot flashes per day at week 8 among women taking escitalopram (P < .001), with mean reductions of 4.60 (95% CI, 3.74-5.47) and 3.20 (95% CI, 2.24-4.15) hot flashes per day in the escitalopram and placebo groups, respectively. Fifty-five percent of women in the escitalopram group vs 36% in the placebo group reported a decrease of at least 50% in hot flash frequency (P = .009) at the 8-week follow-up. Reductions in hot flash severity scores were significantly greater in the escitalopram group (-0.52; 95% CI, -0.64 to -0.40 vs -0.30; 95% CI, -0.42 to -0.17 for placebo; P < .001). Race did not significantly modify the treatment effect (P = .62). Overall discontinuation due to adverse events was 4% (7 in the active group, 2 in the placebo group). Three weeks after treatment ended, women in the escitalopram group reported a mean 1.59 (95% CI, 0.55-2.63; P = .02) more hot flashes per day than women in the placebo group.
CONCLUSION: Among healthy women, the use of escitalopram (10-20 mg/d) compared with placebo resulted in fewer and less severe menopausal hot flashes at 8 weeks of follow-up.
TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00894543.

PMID 21245182  JAMA. 2011 Jan 19;305(3):267-74. doi: 10.1001/jama.2010・・・
著者: Akira Oishi, Yoshiko Mochizuki, Reiko Otsu, Noriyuki Inaba
雑誌名: Biopsychosoc Med. 2007 Jun 5;1:12. doi: 10.1186/1751-0759-1-12. Epub 2007 Jun 5.
Abstract/Text BACKGROUND: Selective serotonin-reuptake inhibitors (SSRIs) are commonly prescribed for the treatment of depression and can be used as nonhormonal alternatives to manage hot flashes for women with a history of breast cancer and unable to take hormone replacement therapy. There are, however, few reports on the efficacy of SSRIs for the treatment of natural postmenopausal climacteric symptoms. In this pilot study, we evaluate the SSRI, fluvoxamine, for controlling climacteric symptoms and vasomotor symptoms, in particular.
METHODS: Twenty-two patients were enrolled from our hospital. All were orally administered fluvoxamine (50 mg daily). Climacteric and depressive symptoms were assessed using simple menopausal index (SMI) and self-rating questionnaire for depression (SRQ-D), respectively, at baseline, and at 2 and 6 weeks post-treatment.
RESULTS: Six weeks following drug administration, neither the SRQ-D nor SMI scores significantly decreased compared to baseline. The mean levels of vasomotor symptoms and mental symptoms decreased significantly following fluvoxamine administration, while skeletal muscle symptom scores did not.
CONCLUSION: We were able to demonstrate that fluvoxamine was effective in treating not only depressive moods in climacteric symptoms but also the associated vasomotor symptoms. There are several limitations to this preliminary study. Future controlled studies are needed to further evaluate the efficacy of fluvoxamine for climacteric disturbances.

PMID 17547780  Biopsychosoc Med. 2007 Jun 5;1:12. doi: 10.1186/1751-07・・・
著者: Kyoko Taku, Melissa K Melby, Fredi Kronenberg, Mindy S Kurzer, Mark Messina
雑誌名: Menopause. 2012 Jul;19(7):776-90. doi: 10.1097/gme.0b013e3182410159.
Abstract/Text OBJECTIVE: This analysis was conducted to determine the efficacy of extracted or synthesized soybean isoflavones in the alleviation of hot flashes in perimenopausal and postmenopausal women.
METHODS: PubMed and The Cochrane Controlled Clinical Trials Register Database were searched for relevant articles reporting double-blinded randomized controlled trials through December 14, 2010. References within identified articles, as well as peer-reviewed articles that had come to the attention of the authors through other means, were also examined for suitability. This systematic review and meta-analysis, which evaluated the effects of isoflavones on the frequency, severity, or composite score (frequency × severity) of hot flashes compared with placebo was conducted according to Cochrane Handbook guidelines.
RESULTS: From 277 potentially relevant publications, 19 trials (reported in 20 articles) were included in the systematic review (13 included hot flash frequency; 10, severity; and 3, composite scores), and 17 trials were selected for meta-analyses to clarify the effect of soybean isoflavones on hot flash frequency (13 trials) and severity (9 trials). Meta-analysis revealed that ingestion of soy isoflavones (median, 54 mg; aglycone equivalents) for 6 weeks to 12 months significantly reduced the frequency (combined fixed-effect and random effects model) of hot flashes by 20.6% (95% CI, -28.38 to -12.86; P < 0.00001) compared with placebo (heterogeneity P = 0.0003, I = 67%; random effects model). Meta-analysis also revealed that isoflavones significantly reduced hot flash severity by 26.2% (95% CI: -42.23 to -10.15, P = 0.001) compared with placebo (heterogeneity, P < 0.00001, I = 86%; random effects model). Isoflavone supplements providing more than 18.8 mg of genistein (the median for all studies) were more than twice as potent at reducing hot flash frequency than lower genistein supplements.
CONCLUSIONS: Soy isoflavone supplements, derived by extraction or chemical synthesis, are significantly more effective than placebo in reducing the frequency and severity of hot flashes. Additional studies are needed to further address the complex array of factors that may affect efficacy, such as dose, isoflavone form, baseline hot flash frequency, and treatment duration.

PMID 22433977  Menopause. 2012 Jul;19(7):776-90. doi: 10.1097/gme.0b01・・・
著者: Takeshi Aso, Shigeto Uchiyama, Yasuhiro Matsumura, Makoto Taguchi, Masahiro Nozaki, Kiyoshi Takamatsu, Bunpei Ishizuka, Toshiro Kubota, Hideki Mizunuma, Hiroaki Ohta
雑誌名: J Womens Health (Larchmt). 2012 Jan;21(1):92-100. doi: 10.1089/jwh.2011.2753. Epub 2011 Oct 12.
Abstract/Text OBJECTIVE: The objective of this clinical trial was to examine the efficacy of a supplement containing natural S-(-)equol, a daidzein metabolite, in reducing menopausal symptoms.
METHODS: In this multicenter, double-blind placebo-controlled trial, 160 equol nonproducing, postmenopausal Japanese women who experienced at least 1 hot flush/day were randomly assigned to consume 10 mg/day S-(-)equol (n=77 women) or placebo (n=83 women) for 12 weeks. Participants completed a standardized menopausal symptom checklist and rated five common menopause symptoms by a visual analog scale at baseline, week 12, and week 18 (6-week postintervention). Physical, blood, and urine examinations were conducted. One hundred twenty-six women completed the study.
RESULTS: At baseline, daily hot flush frequency was 2.9±2.1 for the S-(-)equol group and 3.2±2.4 for the placebo group. After the 12-week intervention, the S-(-)equol group had a greater decrease from baseline in hot flush frequency compared with the placebo group (-1.9±1.8/day, -58.7%, vs. -1.0±2.0/day, -34.5%, p=0.009). The severity of hot flushes and neck or shoulder muscle stiffness significantly decreased in the S-(-)equol group compared with the placebo group. No changes in clinical parameters or serious adverse effects were reported.
CONCLUSIONS: This is the first trial to show beneficial effects of a 10-mg natural S-(-)equol supplement consumed daily for 12 weeks on major menopausal symptoms, specifically, hot flushes and neck or shoulder muscle stiffness, in postmenopausal Japanese women. This supplement offers a promising alternative for management of menopausal symptoms.

PMID 21992596  J Womens Health (Larchmt). 2012 Jan;21(1):92-100. doi: ・・・
著者: K Takamatsu, H Ohta, K Makita, F Horiguchi, S Nozawa
雑誌名: J Obstet Gynaecol Res. 2001 Jun;27(3):133-40.
Abstract/Text OBJECTIVES: We objectively assessed the effects of counseling on climacteric symptoms in Japanese postmenopausal women.
METHODS: Symptoms in 44 women (age, 51.4 +/- 3.4 years; period after menopause, 3.6 +/- 3.4 years) treated with counseling were evaluated according to the Keio modified menopause index. The response to counseling was compared with that to hormone replacement therapy (HRT).
RESULTS: Forty cases (90.9%) showed an improvement in index score. There were no significant relationships between improvement and age, the period after menopause, or the severity or type of symptoms before counseling. The most improved symptom was headache, followed by palpitation and insomnia. Physical symptoms accounted for most of the common symptoms. The pattern of improvement with counseling was markedly different from that with HRT.
CONCLUSIONS: We suggest that counseling is effective for treating climacteric symptoms, since it improves not only psychological symptoms, but also physical ones. Counseling may deserve evaluation as a complementary treatment to HRT.

PMID 11561829  J Obstet Gynaecol Res. 2001 Jun;27(3):133-40.

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