A.A.TH繊維のアンダーウエア着用による月経随伴症状の軽減効果—ランダム化二重盲検法による検討

Effects of underwear woven with A.A.TH fibers in reduction of menstrual discomfort: Double-blinded randomized control study

抄録

【目的】血流を改善する繊維（Active Anti Thrombotic：以下、A.A.TH）製の下着を着用した若い女性の月経随伴症状軽減効果を評価する。

【対象と方法】19歳〜25歳の女性で、月経痛があり低用量ピル内服等のない女子大学生を対象とした。これらの適格基準に合う対象者をA.A.TH群とプラセボ群に2重盲検で無作為に割り付けた。分析終了まで研究者と参加者ともに、群分けは知らされなかった。適格者は月経開始予定の1週間前から月経終了まで1日8時間以上、A.A.THの下着またはプラセボの下着を着用した。アンケートは下着装着前および下着装着後に発来した月経終了後に記載した。痛みについてのVisual Analogue Scale（VAS）、Menstrual Distress Questionnaire（MDQ）と鎮痛薬の使用等について、介入群とプラセボ群の比較及び介入前後の比較を行った。

【結果】無作為に割り付けた131名中、116名からアンケート回答があった。月経困難症2名等を除き、有効回答103名について分析した（A.A.TH群N＝53、プラセボ群N＝50）。両群の下着着用時間等のベースラインに有意差はなかった。介入後、両群のVASとMDQは有意に低下し、A.A.TH群のVAS減少率（27.2％）がプラセボ群（16.0％）より有意に高かった（t検定、p＝0.031）。MDQ減少率はA.A.TH群の方が、有意差はないが「痛み」と「負の感情」で高かった。鎮痛薬使用は、介入後に両群共に低下したが、A.A.TH群では服用者39人（73.6％）が23人（43.4％）に有意に減少した（McNemar test、P＜0.001）。

【結論】A.A.TH繊維で作られた下着着用により、機能的月経随伴症状の軽減、特に月経痛の軽減に効果があることが示唆された。

【Objective】To evaluate the reduction of symptoms associated with menstruation in young women by wearing underwear made of Active Anti Thrombotic (A.A.TH.) fibers, which have a blood circulation-promoting effect.

【Subjects and methods】Female university students aged 19-25 years who experienced menstrual pain, were not taking low-dose pills, and/or had no metal allergy were included. Subjects who met these eligibility criteria were randomly allocated in a double-blind fashion to the A.A.TH group or the placebo group. Neither the researchers nor the participants were informed of their group assignment until the end of the analysis. Eligible participants wore A.A.TH or placebo underwear for at least eight hours a day from one week before the expected start of menstruation until the end of menstruation. Questionnaires were completed regarding their menstruation before wearing the underwear and at the end of menstruation occurring while wearing the underwear. The main outcomes were the Visual Analogue Scale (VAS) for pain, Menstrual Distress Questionnaire (MDQ) and analgesic use, compared between the intervention and placebo groups and before and after the intervention.

【Results】Questionnaire responses were received from 116 of 131 randomly allocated participants. Excluding 2 dysmenorrhea patients, 103 valid responses were analyzed (A.A.TH group N=53, placebo group N=50). There were no significant differences in baseline data such as underwear wearing time etc. between groups. After the intervention, VAS and MDQ in both groups decreased significantly, with a significantly higher rate of VAS reduction in the A.A.TH group (27.2%) than in the placebo group (16.0%)(t-test, p=0.031). MDQ reduction was higher in the A.A.TH group for 'pain' and 'negative emotions'，although the difference was not significant. Analgesic use decreased in both groups after the intervention, but significantly decreased in the A.A.TH group from 39(73.6%) to 23(43.4%) users (McNemar test, P＜0.001).

【Conclusion】The results suggest that wearing underwear made of A.A.TH fiber is effective in reducing functional menstrual complications, particularly menstrual pain.