In a prospective study, we investigated the potentially curative effect of acupuncture in patients with psychogenic erectile dysfunction (pED). A total of 22 patients with pED were randomized into two groups. They were either treated with acupunture specific against ED (treatment group) or acupuncture specific against headache (placebo group). Nonresponders of the placebo group were crossed over to the treatment group. Prior to acupuncture, serum sexual hormone levels, IIEF score, nocturnal penile tumescence testing for three nights (Rigiscan) and the erectile response to 50 mg sildenafil were evaluated. Out of 21 patients, 20 completed the study, including 10 patients after crossover. A satisfactory response was achieved in 68.4% of the treatment group and in 9% of the placebo group (P=0.0017). Another 21.05% of the pateints had improved errections, that is, sufficient rigidity under simultaneous treatment with 50 gm sildenafil. The results of our pilot study indicate that acupuncture can be an effective treatment option in more than two-thirds of patients with psychogenic erectile dysfunction.
At the NIH consensus conference in 1993 erectile dysfunction was defined as the inability to obtain a penile erection sufficient for satisfactory sexual relation. Considering the results presented in the Massachusetts Male Aging Study erectile dysfunction is a major health problem that affects 10–20 million men in the United States.1,2 Penile erection requires a physiological network of nervous, endocrinological and vascular pathways.3 Since the introduction of drugs such as sildenafil or apomorphine, therapy of organic erectile dysfunction on the one hand has seen considerable improvement. On the other, progress in the therapy of psychogenic erectile dysfunction has been less impressive, mainly because its pathology still remains to be clarified. Its diagnosis is still one of exclusion. Hyperactivity of the sympathetic tone along with an inhibition of neurotransmitters responsible for erection have been postulated.
Treatment strategies and guidelines such as those offered by the American Urological Association are clearly defined in patients with organic erectile dysfunction. In contrast, therapy guidelines are less precise in patients thought to have psychogenic erectile dysfunction. Most often, long-term and cost-intensive psychotherapy and behaviour modification therapy is recommended, and may be performed in conjunction with oral and/or injection therapy. Acupuncture as one method of therapy of traditional Chinese medicine (TCM) has recently gained increased attention both in the lay press media as well as in Western medical research. It is an accepted option in the treatment of acute and chronic pain. In urology, acupuncture is being used in the treatment of bladder instability, in the so-called female urge syndrome, in nocturnal enuresis, as well as in male infertility.4,5,6,7;22,23,24,25,26 Furthermore, some studies have demonstrated a beneficial effect of acupuncture in patients with psychogenic erectile dysfunction, which prompted us to initiate a prospective, placebo-controlled trial.8,9,10
Material and methods
In all, 21 consecutive patients with psychogenic erectile dysfunction and without any prior therapy were recruited between January 1999 and December 2001. Informed consent was obtained from all patients, and the study itself was started with the approval of the local ethics commission. The mean age was 38.9 y (range 20–61 y), and the mean duration of erectile dysfunction was reported to be 23.8 months (range 2–72 months). Evaluation included the medical, sexual and psychologic history, an urological exam and the serum sexual hormone status (total testosterone, free testosterone, sexual hormone binding globulin, follicle-stimulating hormone, luteinizing hormone, oestrogen, prolactin). Exclusion criteria were comorbidities such as hypogonadism, diabetes mellitus, hypertension, cigarette smoking and any type of neurological disorder. During three consecutive nights, nocturnal penile tumescence testing using a Rigiscan™ was done in every patient, resulting in recurrent erections above the level of 70% in all cases. Patients with normal nocturnal erection during Rigiscan™, with normal sexual hormonal levels and no organic comorbidites were defined as psychogenic erectile dysfunction. In addition, every patient reported to obtain a sufficient erection following oral administration of 50 mg of sildenafil. Evaluation of the IIEF 15 score was done prior to and after acupuncture therapy.11
According to protocol, patients were randomized into two groups. In group 1 (treatment group), n=10, acupuncture was done at the standardized spots used in the treatment of erectile dysfunction (N6, N27, KG4, KG6, LG4, MP6, B23).8,9,10,12 In group 2 (placebo group), n=11, acupuncture was done at points used in the treatment of headache (G39, M41, M25). Acupuncture at these spots has no known effects in the treatment of sexual disorders. Non-responder in group 2 were crossed over to group 1.
The duration of each acupuncture was 20 min once or twice weekly with disposable hypodermic needles (0.3 × 30 mm, Seirin Company, Germany). The number of treatments given ranged from 5 to 20 (mean 11) and were exclusively done by two certified coauthors (TZ, LKD). In all, 20 treatment sessions was considerd to be a maximum of treatment—in case of ineffectiveness or effectiveness of therapy acupuncture was finished earlier. After 5, 10 and 15 sessions, the sexual status was re-evaluated. Acupuncture treatment was considered to be effective when erections became sufficient for penetration and sexual intercourse. In case erections became better, but intercourse was only possible in conjunction with an additional therapy, effectiveness of acupuncture was considered as partly effective. Statistical analysis was done using Fisher's exact test power analysis (P<0.05).
Out of 21 patients, one patient was lost to treatment because of personal reasons not related to our study. At the start of the protocol, both therapy arms were comparable regarding the duration of erectile dysfunction as well as patient age (Tables 1 and 2).
Under placebeo therapy it soon became apparent that the majority of patients (10/11, 91%) in the placebo arm did not show any improvement of their erection status, on average after 6.2 acupuncture sessions (range 4–10). In only one patient, an improvement was seen. According to protocol, these 10 patients were crossed over to the treatment group.
Overall, in 13 out of 19 patients (68.4%, P=0.0017) acupuncture was effective, in that no further therapy became necessary to obtain full erections. In another four patients (21.05%), acupuncture was partly effective. A sufficient erection for sexual intercourse was obtained only after an additional treatment with 50 mg sildenafil. In two patients (10.5%), acupuncture remained ineffective (Table 1).
The 15 questions of the IIEF questionnaire were categorized into five domains relating to different aspects of sexual function. The mean scores at baseline and after treatment are shown in Table 2. Improvement in all categories was shown after verum acupuncture therapy, however the categories ‘Orgasmic function’ and ‘Sexual desire’ showed no statistical significance.
In median, the number of treatment sessions was 6.2 (range 4–10) and 11 (range 5–20) in the placebo group and in the treatment group, respectively. We could not observe any side effects according to acupuncture therapy.
Acupuncture as part of TCM has its origin in ancient China. First anectodal reports of the use of acupuncture date back as far as 2000 y and were presented by historians of the Han dynasty such as Si Ma Jian in 206 BC. The basic concepts of TCM are linked to the philosophy of Yin and Yang, two powers that complement one another. Both drive the ‘Qi’, the body's very energy. Yin stands for coldness, consolidation, stability and a balanced nature, whereas Yang is associated with heat, activity and expansion. The vital energies of the human body and its organs is represented by Qi. Each organ has its own Qi, which in turn governs organ function. According to the theories and doctrines of TCM, the energy of the human body is flowing and can be found along the so-called meridians. The meridians, like strings of pearls, each carry several organ and organ function-specific acupuncture points. Activation of meridians and acupuncture points can redirect and reactivate Qi as well as organ function.12,13
From the point of view of Western oriented medicine, the possible pathways involved are still poorly understood. However, there is increasing evidence, that a variety of physiological effects are triggered with acupuncture. Recent reports have emphasized activation of nervous, endocrine, vasoactive and immune-modulating factors.14,15,16
Outside the countries where it has a long-standing history, acupuncture is mainly used in the treatment of chronic pain and as a analgetic procedure.17,18 In urologic disorders, acupuncture has been successful both as primary or adjuvant therapy in enuresis, bladder instability and male infertility.4,5,6,19,20,21,22,23
To our knowledge, only three papers on the use of acupuncture in erectile dysfunction have been presented in the international, peer-reviewed literature.8,9,10 In addition, our study represents the first attempt to conduct a randomized, prospective trial, where acupuncture is tested against a valid placebo treatment. To enable better comparison of both treatment arms, we refrained from the use of oral placebos or placebo-needles, where the tip is not placed intradermally. The acupuncture procedure in both patient groups was identical, with the exception of the choosen acupuncture points. In our placebo group, acupuncture points were not the ones specifically recommended for the use in the treatment of erectile dysfunction, but those choosen in the therapy of chronic pain. Stimulation of acupuncture points not related to erectile dysfunction may furthermore indicate whether unspecific stimulation harbours beneficial effects.
In a study in 13 patients, among them nine patients with psychogenic erectile dysfunction, Kho et al9 demonstrated an overall improvement of the patients condition in 46%, however, sufficient erections in only 15%. One may speculate that the rate could have been higher when only patients with psychogenic erectile dysfunction were been treated. In contrast, Yaman et al8 reported a success rate of acupuncture of 69% in 29 patients, all patients being diagnosed with psychogenic erectile dysfunction. However, both reports did not mention a placebo group. Aydin et al10 have recently compared acupuncture alone vs hypnosis vs oral placebo vs placebo needle therapy in 29 patients. Acupuncture and hypnosis were successful in 60 and 70%, respectively, while patients in both placebo groups reported significantly better erections in 43–47%. Selection of patients and pretreatment evaluation may explain the differences to our results.
The evaluation of the erectile dysfunction domains showed a highly statistically significant improvement in all categories, except sexual desire and orgasmic function. Acupuncture therapy was most effective in the domains of erectile dysfunction, intercourse satisfaction and overall satisfaction. Owing to the genesis of psychogenic erectile dysfunction with normal sexual hormone levels and no orgasmic disorders, acupuncture therapy showed no statistically significant effect in these domains.
Most often, long-term and cost-intensive psychotherapy and behaviour modification therapy is recommended for the treatment of psychogenic erectile dysfunction. One may argue that acupuncture may also be a time consuming and costly therapy. In our study sample patients were treated in 4–20 sessions, in an average of 7 weeks. The costs of our treatment were sponsored by a hospital study fund — so we were not able to analyse the real treatment costs. However, if we compared treatment costs of our national health system of one session psychotherapy vs one session acupuncture therapy we found a difference of about €60 per session in favour of acupuncture therapy.
We are fully aware of the fact that our sample size is limited and that data analysis in our study will soon reach its limits. However, erectile dysfunction on a psychogenic basis only is not a common diagnosis, so that a multicenter trial seems to be recommended. Nonetheless, even a small population may indicate trends. In our study, acupuncture had a curative effect in 68.4%. Another 21.05% of the patients reported at least improved erections, and only in 10.5% no effect at all was seen. In contrast, placebo therapy yielded a success rate of only 9%. These results suggest that acupuncture is a valid option in the treatment of psychogenic erectile dysfunction.
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Der Urologe (2014)