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Der Einfluß von Akupunktur auf eine Ultra-Low-Dose Hormontherapie zur Behandlung des Klimakterischen Syndroms

English title The Impact of Acupuncture on Ultralow Dose Hormone Therapy for the Climacteric Syndrome
Applicant Stute Petra
Number 162717
Funding scheme Project funding (special)
Research institution Departement für Klinische Forschung Klinik und Poliklinik für Frauenheilkunde Inselspital
Institution of higher education University of Berne - BE
Main discipline Clinical Endocrinology
Start/End 01.07.2016 - 30.11.2019
Approved amount 267'000.00
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All Disciplines (2)

Discipline
Clinical Endocrinology
Gynaecology

Keywords (7)

menopause; acupuncture; laser acupuncture; hot flush; climacteric syndrome; partially double blinded study design; menopause hormone therapy

Lay Summary (German)

Lead
Akupunktur ist eine Therapieform deren Wurzeln sowohl in die Chinesischen Medizin aber auch in andere asiatische Medizinsysteme reichen. Zahlreiche westliche Erweiterungen haben dazu beigetragen, dass Akupunktur heute eine weltweite angewandte ärztliche Methode darstellt. Insbesondere in Kombination mit schulmedizinischen Verfahren können die Symptome von Patientinnen und Patienten besser behandelt, und die Zahl möglicher Nebenwirkungen reduziert werden. Diese Studie untersucht diesen Zusammenhang bei Beschwerden der Wechseljahre.
Lay summary

Inhalt und Ziele des Forschungsprojekts

Eine Hormontherapie ist in den Wechseljahren die Therapie der Wahl, um z.B. Symptome wie Hitzewallungen zu lindern. Jedoch versucht man, diese Hormondosis so gering wie möglich zu halten, denn eine Hormontherapie hat ernste Nebenwirkungen. Eine niedrigere Hormondosis ist mit einem geringeren Risiko für Thrombosen und Schlaganfällen verbunden. Akupunktur kann lindernd auf die Symptome der Wechseljahre einwirken und somit dazu verhelfen, die benötigte Hormondosis noch niedriger zu halten. Im Rahmen dieser Studie möchten wir dies untersuchen.

Wissenschaftlicher und gesellschaftlicher Kontext des Forschungsprojekts
Das Projekt befasst sich mit klinischer Forschung. Das heisst dass die zu erwartenden Forschungsergebnisse unmittelbaren Einfluss auf die klinische Versorgung zukünftiger Patientinnen in der Menopause haben können.

Eine reeuzierte Anzahl hormon-bedingter Nebenwirkungen trägt zudem zu einer Entlastung des öffentlichen Gesundheitssystems bei.

Direct link to Lay Summary Last update: 02.06.2016

Responsible applicant and co-applicants

Employees

Collaboration

Group / person Country
Types of collaboration
Prof. Dr. Niko Kohls, Fakultät Soziale Arbeit und Gesundheit, Hochschule Coburg Germany (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
Clinical Trial Unit, Universität Bern Switzerland (Europe)
- Research Infrastructure
Interdiszipilinäre Schmerzambulanz, Klinik für Anaesthesiologie, Universität München Germany (Europe)
- in-depth/constructive exchanges on approaches, methods or results

Associated projects

Number Title Start Funding scheme
133918 CTU Bern 01.09.2010 Clinical Trial Units

Abstract

Background:Conventional estrogen-progestin hormone therapy is the standard therapy for climacteric symptoms. According to international guidelines the dosage should be as low as possible to decrease cardiovascular and thromboembolic risks. In a previous pilot study we were able to demonstrate efficacy of acupunture in the reduction of menopausal symptoms. This means that the current hormone dosage may be reduced or at least does not have to be increased.Methods:Based on the previous study we developed a two+two armed randomized-controlled partially blinded trial with a 12 week intervention period and 36 week follow-up period. All women newly assigned to ultralow-dose hormone therapy will be randomized to one of three treatment arms:• Treatment groupACU (additional needle acupuncture): 65 women• Treatment group CON (control group without further intervention): 65 women• Comparator group S-ACU(additional sham needle acupuncture): 65 women• Comparator group LAS (additional laser acupuncture): 65 womenThe special aspect of this study design is the rigorous control of the acupuncture treatement. On the one hand by introducing sham needle acupuncture, on the other hand by introducing a sham laser. In contrast to other studies, it will be possible to blind the practitioner in the laser group, too. Only the primary investigators and regulatory agencies will know that within the treatment group laser acupuncture a sham laser will be used. These control procedures will allow that besides efficacy also specific and unspecific effects can be assessed.Hypothesis: A serie of acupuncture treatments in women that are treated with an ultralow-dose hormone therapy (ULD-HT) for menopausal symptom relief helps to maintain or even reduce the hormone dosage in comparison to women in the control group. Primary endpoint: Changes in hot flushes frequency per week after 12 weeks in comparison to group ACU and group CON. Secundary endpoints: Comparison between the three treatment arms:•According to FDA: mean changes in frequency and severity of moderate to severe hot flushes after 4 and 12 weeks between treatment groups ACU and CON.•Rate of women after 12 weeks that do not need an increase in hormone dosage comparing treatment groups ACU and CON. •Rate of women after 24, 36 and 48 weeks, that do not need an increase in hormone dosage. •Rate of women that receive a change in the dosage of HT at any timepoint•Weekly changes in the Menopause II Rating Scale (MRS-II) across 48 weeks.•Differentes within the Menopause II Rating Scale (MRS-II) after 12, 24, 36 and 48 weeks.•Daily diary to assess flush symptoms during first 12 weeks•Frequency and severity of hot flushes across 48 weeks as well as after 12, 24, 36 and 48 weeks•Differences in quality of life (SF-12) after 12 and 48 weeks•Differences in Medical Outcomes Study Sleep measure after 12 and 48 weeks•Differences in Trier Inventory for Chronic Stress (TICS) after 12 and 48 weeks•Serum concentration of Estradiol, Progesterone, LH and FSH after 12, 24, 36 and 48 weeks•Credibility-Assessment before and after treatment.Work programPatients that are assigned to ULD-HT by an independet gynecologist will be informed about the study nature by a study physician (subinvestigator) and if interested will be randomised to one of three treatment groups(randomisation). In both acupuncture treatment groups (needle acupuncture, sham laser acupuncture) a 12 week treatment period will follow. The primary endpoint is the reduction of frequency and severity of hot flushes after 12 weeks between the verum acupuncture and control group. After 12 weeks all three groups will be re-evaluated by the treating gynecologist based on which a decision will be made to maintain, increase or decrease the hormone dosage (secondary endpoint). A re-evaluation will be performed every 12 weeks up to 48 weeks. Follw-up ends after 48 weeks for each patient.Statistics: We plan to conduct an intention-to-treat-analysis. In a first step, missing data will not be replaced and the primary outcome criterion (Sum Scores of the MRS-II) will be computed for every data point when the scoring prerequisites of the MRS-II are met. In order to adjust treatment effects for potential intersample differences, an ANCOVA will be utilized. Secondary analyses utilizing apt imputation techniques (e.g. maximum likelihood) will be employed in case missing data patterns turn out to be non-randomly distributed.The power calculation is based on our previous pilot study (Nedeljkovic, 2013). Given a power of 95%, an expected mean difference of 15.6 hot flushes per week pro Woche and an alpha error of 0.050 a sample size of 70 per group was calculated. Considering three groups and a dropout-rate of approx. 15% 320 women will be included into the study.Risks/ side effects/ tolerability: According to the current literature acupuncture is treatment with on little side effects. We expect at best that patients will have a benefit by the additional treatment.
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