Correspondence (reply): In Reply

Following its publication, the guideline met with broad approval from patients and members of the medical profession alike. Precisely for this reason we are happy to respond to critical voices.

Cordula Mühr draws attention to the lack of patient involvement. There are no relevant patient or self-help organizations that deal with this issue, and the Association of Scientific Medical Societies in Germany (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften e.V., AWMF) does not make patient involvement mandatory. The guideline was submitted for comment to Mrs. Mühr and a colleague in the patient counseling department (recorded in the guideline documents). Although the guideline authors respect the critical appraisal of possible over-treatment, they also know many women who suffer considerably and who would not adopt an approach that involves waiting until after the menopause for their symptoms to abate. It is true that the available studies compare interventions and do not have a „wait-and-see“ arm, meaning that statements on satisfaction are lacking. It would be interesting to discover whether such a study could be successfully conducted. Nevertheless, we still point the reader to the drug-based or organ-preserving alternatives to hysterectomy that have been described in detail.

We would like once again to draw attention to the adopted guideline recommendation on the treatment of uterine fibroids (1): „If uterine fibroids are the cause of symptoms, the decision on which approach to adopt should be taken together with the patient and in consideration of her life situation.“ The task now is to implement the guideline. Not all women wish to take part in shared decision-making (2). Nevertheless, we agree with Mrs. Mühr that each consultation should enable a shared decision-making process and we deem communication skills (medical virtues such as listening, taking the patient seriously, advising, considering options together), as well as an appropriate framework, essential. In our opinion, evidence that consultations are per se more successful in the second-opinion context is still lacking.

We would like to thank our colleague Prof. Dr. Stang for his corrective statement on statistical concepts and the required risk communication and invite him to collaborate on the guideline update. The facts, in our opinion, remain unaltered from a clinical perspective: women operated using a minimally invasive approach generally experience less pain postoperatively compared with women undergoing abdominal hysterectomy.

Our colleague Dr. Eisele calls for a discussion on radiofrequency ablation as a method to treat uterine fibroids and draws attention to the mention of acupuncture in the guideline. Both methods are only briefly addressed in the full version of the guideline, since reliable study data are lacking compared with established alternatives. A systematic review of randomized controlled studies (RCT) on acupuncture for uterine fibroids was included (3); however, the authors ultimately dismissed all RCTs due to the high risk of bias. To our knowledge, the randomized single-center study (n = 50) referred to (4) is the only data available on radiofrequency ablation as a method of organ-preserving laparoscopic uterine fibroid treatment; the study yielded 2-year interim results (5) (published after guideline research was concluded) demonstrating safety and quality of life comparable to fibroid enucleation. Long-term results, while still awaited, will be considered in the guideline update.

Our colleague Prof. Dr. Wenderlein makes the case for drug therapy in abnormal uterine bleeding due to fibroids using ulipristal acetate (UPA) and points to the negative long-term effects of oophorectomy/hysterectomy. The full version of the guideline addresses UPA as a treatment option, including the possibility of multiple dosing (investigated: up to 4 doses every 3 months over a total study period of 18 months)—with, however, a view to subsequent hysterectomy. Approval for multiple dosing, based on a non-blinded study (an extension trial of an RCT), was new at the time of drawing up the guideline. The amenorrhea rate increased by 9% (from 79.5% to 88.2 %) among participating women (non-randomized) after the second administration and remained consistent at cycles 2–4. In view of the study’s open design, positive selection can be assumed. Attention should be paid to the endometrial changes specifically associated with progesterone receptor modulators, which have been described in 25%–60% of cases (6, 7) and which may result in endometrial biopsy—with no indication as yet of an increased cancer risk. Studies with longer observation periods are lacking. We fully concur with Prof. Dr. Wenderlein that salpingo-oophorectomy should be avoided in the setting of hysterectomy (see recommendation No. 12.S11 on page 84 of the guideline) and consider the provision of adequate information, counseling, and shared decision-making important in all treatment options.