Objective: To observe the clinical effect and safety of Shanhaidan Granules (SHDG) combined with tadalafil tablets (TT) in the treatment of ED. METHODS: In this open multi-center case-control clinical trial, we enrolled 247 ED patients according to the designed criteria, and treated them orally with SHDG at 10 g per time tid (n = 74), TT at 5 mg per time bid (n = 52), or SHDG + TT at the above doses (n = 121), all for 8 weeks. Before and after medication, we recorded the IIEF-6, erection hardness scores (EHS), traditional Chinese medicine syndromes (TCMS) scores, penile cavernous blood flow parameters and adverse reactions, and compared them between the 3 groups of patients. RESULTS: After 8 weeks of treatment, all the patients showed significantly increased IIEF-6, EHS and TCMS scores in comparison with the baseline (P < 0.05). The total effectiveness rates in the SHDG, TT and SHDG + TT groups were 60.8%, 67.3% and 69.4% respectively based on the IIEF-6 scores, remarkably higher in the TT and SHDG + TT groups than in the SHDG group (P < 0.05), and 40.5%, 32.7% and 63.6% respectively according to the TCMS scores, markedly higher in the SHDG and SHDG + TT groups than in the TT group (P < 0.05). Single-center data manifested significantly increased peak systolic velocity (PSV) of the penile artery in the SHDG + TT and TT groups (P < 0.05). The improvement values of relevant parameters were remarkably higher in the SHDG + TT group than in the TT and SHDG groups, so were IIEF-6 scores in the TT than in the SHDG group, and TCM syndromes in the SHDG than in the TT group. No medication-related adverse events were found in any of patients after treatment, except for some mild side effects including muscle soreness and gastrointestinal reactions in a few cases, all soon relieved, none with abnormalities in blood and urine routine tests or hepatic and renal function indicators. CONCLUSIONS Shanhaidan Granules combined with tadalafil can significantly improve the erectile function and reduce TCM syndromes in ED patients, and therefore can be applied effectively and safely in clinical practice./.
Erectile Dysfunction/drug therapy* ; Humans ; Male ; Medicine, Chinese Traditional ; Penile Erection ; Syndrome ; Tadalafil/therapeutic use*

This study aimed to evaluate whether adding a vacuum erection device (VED) to regular use of Tadalafil could achieve better penile rehabilitation following posterior urethroplasty for pelvic fracture-related urethral injury (PFUI). Altogether, 78 PFUI patients with erectile dysfunction (ED) after primary posterior urethroplasty were enrolled and divided into two treatment groups: VED combined with Tadalafil (Group 1, n = 36) and Tadalafil only (Group 2, n = 42). Changes in penile length, testosterone level, International Index of Erectile Function-5 (IIEF-5) questionnaire, Quality of Erection Questionnaire (QEQ), and nocturnal penile tumescence (NPT) testing were used to assess erectile function before and after 6 months of ED treatment. Results showed that the addition of VED to regular use of Tadalafil preserved more penile length statistically (0.4 ± 0.9 vs -0.8 ± 0.7 cm, P < 0.01). IIEF-5 score and QEQ score in Group 1 were higher than Group 2 (both P < 0.05). After treatment, 21/36 (58.3%) Group 1 patients and 19/42 (45.2%) Group 2 patients could complete vaginal penetration. Group 1 patients also had markedly improved testosterone levels (P = 0.01). Unexpectedly, there was no significant difference in NPT testing between two therapies. For PFUI patients with ED after posterior urethroplasty, the addition of VED to regular use of Tadalafil could significantly improve their conditions - improving erection and increasing penile length - thus increasing patient satisfaction and confidence in penile rehabilitation.
Adult ; Combined Modality Therapy/methods* ; Erectile Dysfunction/rehabilitation* ; Humans ; Male ; Middle Aged ; Penile Erection ; Penis/surgery* ; Phosphodiesterase 5 Inhibitors/therapeutic use* ; Tadalafil/therapeutic use* ; Treatment Outcome ; Urethra/surgery* ; Vacuum ; Young Adult

Once-daily tadalafil administration has been well established; however, studies about tadalafil once-daily treatment in the Chinese population are lacking. In this phase 4, postmarketing study, we ascertained the long-term safety and effectiveness of tadalafil 2.5 mg and 5.0 mg once daily in Chinese men with erectile dysfunction (n = 635). The primary endpoint of the study was safety at 12 months as assessed by the proportion of patients experiencing at least one treatment-emergent adverse event (serious or nonserious). The secondary endpoints included safety and effectiveness, measured by the International Index of Erectile Function-Erectile Function (IIEF-EF) domain scores. Similar adverse events to the known safety profile of tadalafil, such as nasopharyngitis, upper respiratory tract infection, headache, and dizziness, were detected. No new cardiovascular safety concerns were observed. After 3 months of treatment, significant increases in IIEF-EF domain scores were detected for both 2.5-mg (least squares [LS] mean change: 6.3; 95% confidence interval [CI]: 5.4-7.1; P < 0.001) and 5.0-mg (LS mean change: 7.4; 95% CI: 6.8-7.9; P < 0.001) tadalafil doses, and significance was maintained up to 12 months. In addition, approximately 40% of patients regained normal erectile function (IIEF-EF ≥26) following 1 year of tadalafil once-daily treatment. The findings in this study provide evidence for the extended effectiveness and tolerability of tadalafil, demonstrating no new safety concerns, in a Chinese population and make once-daily tadalafil administration a viable option for improving sexual performance and satisfaction in Chinese men with erectile dysfunction.
Adult ; Aged ; Asian People ; Double-Blind Method ; Erectile Dysfunction/drug therapy* ; Female ; Humans ; Male ; Middle Aged ; Patient Safety ; Phosphodiesterase 5 Inhibitors/therapeutic use* ; Product Surveillance, Postmarketing ; Prospective Studies ; Tadalafil/therapeutic use* ; Treatment Outcome ; Young Adult

ObjectiveTo evaluate the effect of the oral-appliance combined with tadalafil in the treatment of erectile dysfunction (ED) induced by severe obstructive sleep apnea-hypopnea syndrome (OSAHS).

METHODSWe equally randomized 90 patients with severe OSAHS-induced ED to groups A, B, and C to be treated with the oral-appliance, tadalafil (10 mg daily qd), and oral-appliance plus tadalafil, respectively, all for 3 months. Then we compared the therapeutic effects among the three groups of patients using the IIEF-5 questionnaire, Sexual Encounter Profile (SEP) diaries, and the intercourse satisfaction rate of the patients' partners.

RESULTSTotally 87 of the patients accomplished the treatment, 29 in group A, 30 in B, and 28 in C. After treatment, group C, as compared with A and B, showed significant increases in the IIEF-5 score (4.18±1.19 vs 2.66±1.63 and 2.77±1.74, P=0.009 and P=0.026), the success rate of penile intromission (SEP2) (85.7% vs 58.6% and 53.3%, P=0.023 and P=0.008), and the success rate of intercourse (SEP3) (64.3%% vs 37.9% and 33.3%, P=0.047 and P=0.018). The overall satisfaction of the female partners was remarkably higher in groups A and C than in B (P=0.027 and P=0.007).

CONCLUSIONSOral-appliance combined with tadalafil can improve erectile function in patients with severe OSAHS-induced ED, with a better efficacy than either of them used alone.

Adult ; Coitus ; psychology ; Combined Modality Therapy ; methods ; Erectile Dysfunction ; etiology ; therapy ; Female ; Humans ; Male ; Orthodontic Appliances ; Penile Erection ; Personal Satisfaction ; Sexual Partners ; psychology ; Sleep Apnea, Obstructive ; complications ; therapy ; Surveys and Questionnaires ; Tadalafil ; therapeutic use ; Treatment Outcome ; Vasodilator Agents ; therapeutic use

ObjectiveTo observe the clinical efficacy of Kangle Decoction in the treatment of erectile dysfunction (ED) with liver-qi stagnation and kidney deficiency.

METHODSA total of 79 ED patients with liver-qi stagnation and kidney deficiency were randomly assigned to an experimental group (aged ［36.62±8.05］ yr and with a disease course of ［18.15±6.41］ mo) and a control group (aged ［37.44±8.10］ yr and with a disease course of ［17.51±6.79］ mo), the former treated orally with Kangle Decoction at 0.5 dose bid while the latter with Cialis at 10 mg qd alt, both for 8 weeks. Before treatment, after 4 and 8 weeks of medication, and at 4 weeks after drug withdrawal, we obtained the scores of the patients in the International Index of Erectile Function-5 (IIEF-5), Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS), and Short-Form Psychological and Interpersonal Relationship Scales (SF-PAIRS), and compared the indexes between the two groups of patients.

RESULTSThe IIEF-5 score was dramatically increased in both the treatment and control groups after 4 weeks (13.40±2.42 and 16.00±2.68) and 8 weeks of medication (18.60±3.50 and 18.59±3.80) and at 4 weeks after drug withdrawal (17.00±3.05 and 13.95±2.61) as compared with the baseline (10.78±2.28 and 10.77±2.33) (P<0.05 ), even higher in the treatment than in the control group after drug withdrawal (P<0.05 ). The EDITS scores in the treatment and control groups were (28.88±3.31 and 28.90±3.31) after 4 weeks of intervention, (29.68±3.30 and 29.13±3.32) after 8 weeks of intervention, and (29.20±2.92 and 26.82±3.23) at 4 weeks after drug withdrawal, all significantly higher in the former than in the latter group after drug withdrawal (P<0.05 ). The sexual self-confidence score (SSCS), sexual spontaneity score (SSS), and sexual time-concern score (STCS) were all improved in the treatment and control groups after medication as compared with the baseline (P<0.05 ), even higher in the former than in the latter group after drug withdrawal (P<0.05 ).

CONCLUSIONSKangle Decoction has a definite efficacy in the treatment of ED with liver-qi stagnation and kidney deficiency, with few adverse reactions and long-term post-withdrawal effect, and therefore deserves a wide clinical application.

Adult ; Drugs, Chinese Herbal ; therapeutic use ; Erectile Dysfunction ; drug therapy ; Humans ; Male ; Middle Aged ; Patient Satisfaction ; Qi ; Self Concept ; Sexual Behavior ; Tadalafil ; therapeutic use ; Treatment Outcome

OBJECTIVETo evaluate the safety and efficacy of tadalafil on demand and on time in men with erectile dysfunction.

METHODSWe conducted a multi-centered randomized controlled study on 120 ED males, who were assigned to take tadalafil at 10 mg/ 20 mg on demand before sexual activity and at the same dose on time twice a week for 8 weeks. Before and at 4 and 8 weeks after treatment, and 1 month after withdrawal, we obtained the scores on IIEF-5, ED Inventory of Treatment Satisfaction (EDITS) and the short form of Psychological and Interpersonal Relationship Scales (SF-PAIRS) , and compared the safety and efficacy of medication between the two groups of patients.

RESULTSTotally, 110 patients accomplished the trial, 56 in the on-time and 54 in the on-demand group. At 4 and 8 weeks of medication and 1 month after withdrawal, the IIEF-5 scores were improved in both the on-time and on-demand groups, even more significantly in the former than in the latter at 8 weeks of treatment (21.6 +/- 2.9 vs 18.5 +/- 1.7) and 1 month after withdrawal (20.9 +/- 2.1 vs 17.9 +/- 2.3) (P < 0.05). The EDITS scores were significantly higher in the on-time than in the on-demand group at 8 weeks of treatment (31.7 +/- 6.9 vs 28.6 +/- 5.8) and 1 month after withdrawal (30.6 +/- 4.7 vs 27.9 +/- 6.5) (P < 0.05). The scores on the sexual self-confidence, spontaneity and time-concern domains of SF-PAIRS were remarkably improved after medication as compared with the baseline (P < 0.05), even more significantly in the on-time than in the on-demand group at 1 month after withdrawal. Both dosing schedules were well tolerated and no significant differences were observed in safety between the two groups.

CONCLUSIONOn-time dosing of tadalafil is efficacious and well tolerated in the treatment of ED, and has an even better effect than on-demand dosing at 8 weeks of medication and 1 month after withdrawal.

Adult ; Carbolines ; administration & dosage ; therapeutic use ; Drug Administration Schedule ; Erectile Dysfunction ; drug therapy ; Humans ; Male ; Middle Aged ; Phosphodiesterase Inhibitors ; administration & dosage ; therapeutic use ; Prospective Studies ; Tadalafil ; Treatment Outcome

OBJECTIVETo evaluate the safety and effect of L-carnitine combined with tadalafil in the treatment of late-onset hypogonadism (LOH) with erectile dysfunction (ED).

METHODSWe randomly divided 140 cases of LOH with ED aged 40 -70 years into a treatment and a control group to receive L-carnitine + tadalafil and testosterone undecanoate + tadalafil, respectively. After 8 weeks of treatment, we obtained the scores on IIEF-5 and Aging Male Symptoms (AMS), observed changes in the levels of sex hormones, analyzed the results of the routine blood test and PSA level, and evaluated the safety of medication.

RESULTSFinally, 110 cases were included, 60 in the treatment group and 50 in the control. After 8 weeks of medication, the IIEF-5 and AMS scores were significantly improved as compared with the baseline both in the treatment group (17.7 +/- 3.5 vs 10.2 +/- 2.7 and 36.2 +/- 6.5 vs 48.8 +/- 5.8) and in the control group (16.7 +/- 2.6 vs 9.3 +/- 2.4 and 35.8 +/- 6.6 vs 50.7 +/- 5.0) (both P < 0.05), with no significant differences between the two groups (P > 0.05). As for the safety of medication, there were no significant differences between the two groups before and after treatment (P > 0.05). Two patients in the control group showed a PSA level > 4 microg/L, which was confirmed to be caused by prostatitis during follow-up.

CONCLUSIONL-carnitine combined with tadalafil is safe and effective for the treatment of LOH with ED.

Adult ; Aged ; Carbolines ; therapeutic use ; Carnitine ; therapeutic use ; Erectile Dysfunction ; drug therapy ; Humans ; Hypogonadism ; drug therapy ; Male ; Middle Aged ; Tadalafil ; Treatment Outcome

Administration, Inhalation ; Adult ; Carbolines ; administration & dosage ; therapeutic use ; Female ; Heart Defects, Congenital ; drug therapy ; Humans ; Hypertension, Pulmonary ; drug therapy ; Iloprost ; administration & dosage ; therapeutic use ; Male ; Tadalafil ; Young Adult

OBJECTIVETo observe the clinical effect of low-dose once-daily tadalafil combined with Shuganyiyang Capsules in the treatment of mild-to-moderate erectile dysfunction (ED).

METHODSNinety patients with mild-to-moderate ED were equally randomized to groups A, B and C to receive Shuganyiyang Capsules, tadalafil, and tadalafil + Shuganyiyang Capsules, respectively. The scores of the patients on IIEF-5 and SF-PAIRS (15-Item Short Form of Psychological Interpersonal Relationship Scales) were recorded before and at 1 and 3 months after treatment.

RESULTSThe IIEF-5 scores of groups A, B and C were 10.13 +/- 1.55, 11.00 + 1.60 and 10.73 +/- 1.91 before treatment, and 13.77 +/- 2.11, 17.77 +/- 2.13 and 17.17 +/- 3.84 at 1 month after treatment, significantly higher in B and C than in A (P <0. 001) , but with no remarkable difference between B and C (P =0. 411). At 3 months after treatment, the IIEF-5 scores were 15.77 +/- 2.05, 18.07 +/- 2.24 and 19.37 +/- 3.76 in the three groups, dramatically higher in B and C than in A (P <0.001) as well as in C than in B (P<0.05). The scores on sexual self-confidence, sexual spontaneity and time concerns in SF-PAIRS were 3.90 +/-0.80, 8.67 +/- 1.94 and 14.43 +/- 1.92 before medication, 5.83 +/- 1.02, 9.90 +/- 1.75 and 11.17 +/- 1.68 at 1 month and 6.73 +/- 0.98, 11.07 +/- 2.08 and 10.67 +/-1.60 at 3 months after medication in group A; 4.17 +/- 0.87, 9.37 +/-1.43 and 14.47 +/-1.57 before medication, 6.47 +/-0.78, 10.83 +/- 2.18 and 10.20 +/-1.56 at 1 month and 6.83 +/-0.91, 11.30 +/- 1.88 and 9.47 +/- 1.57 at 3 months in group B; and 4.23 +/-0. 94, 9.50 +/- 1.89 and 14.67 +/- 2.91 before medication, 8.03 +/- 1.67, 13.43 +/-1.10 and 9.70 +/-1.21 at 1 month and 8.93 +/- 1.78, 14.70 +/- 1.26 and 8. 87 +/- 0. 97 at 3 months in group C. Compared with the baseline, the SF-PAIRS scores of the three groups were all significantly improved after treatment (P <0. 05) , and markedly higher in C than in the other two groups (P <0.05).

CONCLUSIONLow-dose once-daily tadalafil combined with Shuganyiyang Capsules is obviously effective in the treatment of mild-to-moderate ED, which not only improves the patients'erectile function, sexual self-confidence and sexual spontaneity, but also reduces their time concerns.

Adult ; Carbolines ; administration & dosage ; therapeutic use ; Drugs, Chinese Herbal ; therapeutic use ; Erectile Dysfunction ; drug therapy ; Humans ; Male ; Tadalafil ; Treatment Outcome

OBJECTIVETo sum up the experience in administering oral tadalafil on alternate days for the treatment of erectile dysfunction (ED) that fails to respond to on-demand medication.

METHODSWe retrospectively analyzed the clinical data of 15 cases of ED treated with oral tadalafil on alternate days from September 2010 to March 2012. All the patients had failed to respond to on-demand medication of sildenafil previously.

RESULTSAfter 4 weeks of tadalafil treatment, 11 (73.3%) of the cases were remarkably improved, with significant difference in IIEF-5 scores before and after treatment (P < 0.05). Transient adverse reactions were observed in the other 4 cases, including mild headache in 2, slight backache in 1, and facial flush in 1.

CONCLUSIONOral tadalafil on alternate days is safe and effective in the treatment of ED that fails to respond to on-demand medication of sildenafil.

Administration, Oral ; Adult ; Carbolines ; administration & dosage ; therapeutic use ; Erectile Dysfunction ; drug therapy ; Humans ; Male ; Phosphodiesterase Inhibitors ; administration & dosage ; therapeutic use ; Piperazines ; therapeutic use ; Purines ; therapeutic use ; Retrospective Studies ; Sildenafil Citrate ; Sulfones ; therapeutic use ; Tadalafil ; Treatment Failure ; Treatment Outcome