A feasibility study of acupuncture vs standard medical treatment for men with erectile dysfunction (ED), measuring biomarkers of inflammation

By Merete Linden Dahle - Online MSc - Advanced Oriental Medicine

Abstract

Background

ED is perceived as a taboo topic, despite being a prevalent sexual dysfunction as well as a predisposition for cardiovascular disease. There are some groups considered to be more difficult to recruit to both research and health care, such as young men as they are often hesitant to recognise that they need help and health care. Therefore, it remains unclear whether it is possible to recruit the sufficient number of participants for a trial on acupuncture and ED.

The number of studies on acupuncture and ED is few and of poor methodological quality, opening an opportunity for pioneering work. The use of biomarkers appears to be novel in an acupuncture research context.

 

Aims

  • To investigate the feasibility of recruitment to a study on acupuncture and ED.
  • To pilot and investigate the feasibility of the use of biomarkers in a study for patients with ED.
  • To build knowledge regarding the procedures on the use of biomarkers.
  • To gather quantitative data on acupuncture and ED using patient-reported outcome questionnaires IIEF-5 and EDITS.

 

Objectives

  • To pilot the feasibility of recruitment.
  • To pilot the eligibility and feasibility of biomarker testing in acupuncture research.
  • To collect quantitative data that can be used for a sample size estimation for a later effect study on the topic.

 

Method

A feasibility study, enrolling 16 men under 40 years of age with ED for more than six months assigned to either ten weeks of TCM acupuncture (twice per week) or standard medical treatment for ED (PDE5 inhibitors). The inflammatory biomarkers high sensitive-CRP, testosterone and heart rate variability (HRV) will be assessed. Quantitative data will be obtained by using the IIEF-5 questionnaire in the two patient groups at baseline, and after the ten-week period and the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire after the ten-week treatment period.

 

Outcome measures

Outcome measures include a feasibility assessment of the available patient population and willingness of patients to participate in the study, and willingness of general practitioners to refer participants to the study, the measurement of hs-CRP, testosterone and HRV, as well as an assessment of the procedures used in the clinical trial. No effect analysis will be performed, but the data may be used for an effect size calculation for a possible later effect study.

 

Results

The aspired recruitment numbers were not reached, and recruitment was too low. Quantitative and self-reported assessments could not be performed.

 

Conclusion

Slow recruitment and impaired recruitment rates appear to be a major problem in medical research. Special considerations may be required for recruiting patients with ED.

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