| Background:Premature ovarian insufficiency is the loss of function of the ovaries before age 40,characterized by menstrual abnormalities(menopause,oligomenorrhea or polymenorrhea),elevated gonadotropin levels and decreased estrogen levels.With complex etiology and various clinical manifestations,premature ovarian insufficiency is an important cause of infertility.Premature ovarian insufficiency conflicts patient physically and psychologically,it is hot and difficult topic in the field of reproductive health.Effective modern medicine interventions for improving ovarian function and pregnancy outcomes are yet insufficient.Studies showed acupuncture could be effective,with little or no side effects,for treating premature ovarian insufficiency.Acupuncture may regulate hormone levels,restore menstraation,and increase the pregnancy outcomes which could bring hope for those who have fertility needs,yet the efficacy of acupuncture treatment varied greatly.Controversies existed in acupuncture therapeutic strategies such as syndrome differentiation,acupuncture point selection,intervention timing,etc.Optimal management strategies were still unclear.Acupuncture intervention package for improving pregnancy outcomes was lacking.Acupuncture interventions for premature ovarian insufficiency were mostly based on personal experience and preference.From the perspective of evidence-based medicine,patients'appeals and experience are important sources of clinical decision-making.However,the relevant data on acupuncture treatment for this disease was of dearth.Neither qualitative research nor quantitative research alone can solve the above-mentioned clinical and scientific dilemma,so it is necessary to combine qualitative research and quantitative research to explore acupuncture therapeutic strategy for premature ovarian insufficiency.Aim:To generate practical acupuncture therapeutic strategies for premature ovarian insufficiency and to provide methodological exploration for the formation of effective acupuncture treatment for complex diseasesIdea:Targeting on generation of therapeutic strategies for complex clinical conditions based on effectiveness of acupuncture.Strategies were formulated in the framework of TCM classics combined with modern medical science.Mixed methods were used for integrating doctors' experience and patients' appeal.Content:Through literature review,a preliminary framework for acupuncture treatment for POI was established to provide targeted data for expert interviews.Based on results of expert interviews and patient interviews,the framework for diagnosis and treatment was refined to form a diagnosis and treatment strategies.Lastly,one of the recommendations was applied in an observational study to verify the effectiveness and feasibility of the strategies.Result:1.Literature reviewSystematic review and meta-analysis showed that acupuncture significantly lowered serum follicle-stimulating hormone and luteinizing hormone levels,significantly increased estradiol levels.Mechanism of POI in acupuncture was disharmony and damage of liver,spleen,kidney and bladder meridian,conception vessel and thoroughfare vessel.Most frequently mentioned syndrome differentiations were kidney deficiency,disharmony of the thoroughfare and conception vessels,kidney deficiency and liver qi stagnation,liver and kidney yin deficiency,spleen and kidney deficiency.The core acupuncture point prescriptions of POI were Shen shu,Pi shu,Qi hai,Gui lai,Guan yuan,Tai chong,Tai xi,San yinjiao,Zi gong,and Zhong ji;2.Qualitative researchTwenty-two senior experts were interviewed including acupuncture clinical professions,TCM gynecologists,assisted reproductive authorities,and acupuncture theorists,forming 300 thousand words interview transcripts.The frame analysis method was used,summarizing expert interviews into six themes:syndrome differentiation,integrated traditional Chinese and western medicine,and acupuncture manipulation,prescription of Chinese medicine,communication between doctors and patients,scientific evidence;20 premature ovarian insufficiency patients who received acupuncture treatment were analyzed through framework analysis and four themes were summarized:disease cognition,treatment choice,lifestyle changes,medical communication.3.Quantitative research(1)The scores of health changes and general health scores on the SF-36 scale were the lowest,indicating that the self-feeling health status of POI patients had a significant decrease compared with a year ago;(2)Kupperman score showed that hot flashes,night sweats,fatigue,and mood changes were most evident among the perimenopausal symptoms of POI;(3)The results of the Self Anxiety Scale showed that 25%of patients had a low degree of anxiety.(4)The TCM constitution scores indicated that patient had constitution intendency of calm,yang deficiency,qi deficiency,yin deficiency,and blood stasis.(5)Clinical trail showed that the recommended point prescriptions can significantly lowered serum follicle-stimulating hormone and increased estradiol levels of POI patients.4.Mixed methods study:1)Mechanism of POI in acupuncture therapyMost experts agreed that disharmony and damage of liver,spleen,kidney and bladder meridian,conception vessel and thoroughfare vessel counted for the mechanism of POI.There was interplay between emotional factors and the onset and development of POI.2)Acupuncture treatment principles(1)Acupuncture treatment should focus on reinforcing kidney,regulating conception vessel and thoroughfare vessel,tranquilizing shen,providing sufficient disease explanation,protecting patient privacy,establishing reasonable expectations and attaching importance to humanism(2)Expert interviews,patient interviews,demographic information showed thatPOI patients suffered high pregnancy failure,recommending consecutive treatment after pregnancy to improve the outcome;3)Acupuncture point prescription recommendationPoint selection principle:Kidney,liver,bladder,spleen,stomach meridian and conception vessel and thoroughfare vessel points were recommended and detailed as follows:(1)Kidney and bladder meridian:Shen shu,Pi shu,Tai xi,Ci liao,Zhong liao,Da he,Huang shu.(2)Spleen and stomach:Zu sanli,San yinjiao,Tian shu,Gui lai,Xue hai.(3)Conception vessel and thoroughfare vessel:Guan yuan,Zhong ji,Qi hai.(4)Local points:Luan chao,Zi gong,Yin lian.(5)Qi regulation and shen tranquilization:Bai hui,Si shencong,Ben shen,Shen ting,Tai chong,Gan shu,Yin tang.Acupuncture point prescription:(1)Ben shen,Shen ting.Bai hui,Huang shu,Guan yuan,Da he,Luan chao,Zu sanli,San yinjiao,Tai xi,Tai chong.Shen shu,Ci liao.(2)Bai hui,Yin tang,Gan shu,Pi shu,Shen shu,Zi gong,Gui lai,Guan yuan,Zhong ji,Qi hai,San yinjiao,Zu sanli,Tai chong.(3)Tianshu,Zigong,Guan yuan,Zhongliao,Ci liao,Tai xi,Shen shu,San yinjiao.Deqi was recommended,three times a week for 3 months treatment.Conclusion:1)Mechanism of POI in acupuncture was kidney deficiency,disharmony and damage of conception vessel and thoroughfare vessel.There was interplay between emotional factors and onset of POI.The therapeutic strategy should focus on reinforcing kidney,unblocking meridian,regulating qi and blood,tranquilizing shen.2)Mixed methods study design could be used for developing therapeutic strategy. |
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