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Keywords:

  • clinical global impression of change;
  • intravaginal ejaculatory latency time;
  • premature ejaculation;
  • premature ejaculation diagnostic tool;
  • sertraline

Summary

  1. Top of page
  2. Summary
  3. What is Known, Background and Objective
  4. Methods
  5. Results
  6. Discussion
  7. What is New and Conclusion
  8. References

What is known and objective

This study aimed at evaluating the safety and efficacy of an improved dosage regimen of sertraline in patients with premature ejaculation (PE) and to examine whether the premature ejaculation diagnostic tool (PEDT) can be used as a measure of treatment response in these patients.

Methods

A total of 218 PE patients were randomized into control (= 61) and treatment (= 157) groups to receive mycelium of cordyceps sinensis C4 and sertraline 50 mg daily for 8 weeks, respectively. Following this blinded stage, sixty-three patients chose to take sertraline 100 mg daily for an additional 4-week period, and 80 other patients continued treatment with sertraline 50 mg. Main outcome measures include intravaginal ejaculatory latency time (IELT), PEDT score and Clinical Global Impression of Change (CGIC) score.

Results

At weeks 4 and 8, mean IELT of patients who subsequently chose to take 100 mg of sertraline was significantly lower than that of patients who continued taking 50 mg of sertraline, although the IELT value was comparable between the two groups of patients at baseline. However, with an additional 4-week treatment, the mean IELT increased significantly more in the 100-mg group than in the 50-mg continuation group. Similar results were also obtained in the analyses of the PEDT and CGIC scores. Both regimens were well tolerated, and relapse rate did not differ significantly between the two groups.

What is new and conclusion

These findings suggest that PE patients not responding to an 8-week treatment with sertraline 50 mg can benefit from an additional 4-week treatment with sertraline 100 mg and that the PEDT may be a valid measure of treatment response in PE patients.


What is Known, Background and Objective

  1. Top of page
  2. Summary
  3. What is Known, Background and Objective
  4. Methods
  5. Results
  6. Discussion
  7. What is New and Conclusion
  8. References

Premature ejaculation (PE) is a male sexual dysfunction characterized by early ejaculation occurring at nearly every intercourse, the inability to delay ejaculation during vaginal penetration and negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy.[1] As the most common male sexual disorder, PE affects 30–40% of sexually active men, and up to 75% of men will experience at least one episode of PE at some point in their lifetime.[2, 3] PE imparts tremendous psychological, emotional and physical burdens to men by reducing their self-esteem, affecting relationships and causing anxiety, embarrassment and depression.[4] Moreover, PE places a great burden on the man's partner, and it is associated with a higher prevalence of female sexual dysfunction.[4] Therefore, PE represents a serious public health issue.

Despite the high prevalence of PE, its aetiology is unclear in most cases although it is increasingly accepted that PE may result from organic or psychogenic causes.[4] Currently, there are no licensed medications for PE, and the treatment options include sexual therapy, medications and psychotherapy.[5, 6] In recent years, researchers have accumulated evidence suggesting that PE has neurobiological causes. The discovery that a common side effect of selective serotonin reuptake inhibitors (SSRIs) is delayed ejaculation has led to interest in treating PE with SSRIs.[6, 7] Numerous studies have demonstrated positive results of treating PE with SSRIs in terms of prolonging the intravaginal ejaculatory latency time (IELT).[8]

Sertraline is an SSRI that has been reported to be effective in PE.[9-15] Many PE patients treated with sertraline for several weeks had a significant increase in IELT.[12] However, the manufacturer's recommended dose of sertraline (50 mg) may be inadequate for the resolution of PE in a significant number of patients.[3] Patients treated with the usual dose (50 mg) or below had a lower IELT than those treated with higher doses.[13] However, doses higher than 100 mg did not appear to confer any additional benefit with regard to efficacy and are associated with a greater probability of treatment intolerance when compared to patients taking twice the usual starting dose.[16] Thus, new regimens should be developed to treat PE to maximize the efficacy of treatment while minimizing side effects.

Previous studies showed that patients treated with sertraline for depression required an upward dose titration from the initial 50-mg dose.[17] Patients who fail to respond to 50 mg/day of sertraline may benefit from dose increases.[16, 18] Hence, a regimen beginning with the usual starting dose (50 mg/day) and then increasing to twice the usual starting dose may improve the efficacy of treatment in PE patients who do not respond to 50 mg/day of sertraline. To examine the efficacy and safety of this regimen, we performed a 12-week, single-blind, controlled trial in the present study. In addition, we evaluated the validity of the premature ejaculation diagnostic tool (PEDT), whose utility is usually confined to use as a diagnostic instrument, as a measure of treatment response in PE patients.

Methods

  1. Top of page
  2. Summary
  3. What is Known, Background and Objective
  4. Methods
  5. Results
  6. Discussion
  7. What is New and Conclusion
  8. References

Study participants

This study was approved by the Ethics Committee of Huashan Hospital Affiliated to Fudan University. Written informed consent was obtained from each participant. A total of 218 men were recruited between January 2009 and February 2011. Primary inclusion criteria included the following: age >18 years, a history of PE (men experiencing ejaculation within 2 min of penetration in 75% or more of their sexual intercourse attempts were considered to have PE) for more than 6 months, being in a stable, monogamous, heterosexual relationship for at least 6 months prior to study entry, sexual intercourse at least three times in the past month and monthly during therapy, and a score of 9 or more on the PEDT. Exclusion criteria were a history of erectile dysfunction (ED), other diseases affecting erectile function, mental illness, use of any PE-related medications and surgical treatments, and undergoing PE treatment (either behavioural or pharmacological therapy).

Study design

This was a 12-week, single-blind, controlled study. At the beginning of the study, the 218 PE patients were randomly assigned to two groups using a random number table: control group (= 61) and treatment group (= 157). The control group was treated with mycelium of cordyceps sinensis C4, a Chinese herb that is traditionally considered to be effective in PE and other sexual dysfunctions, whereas the treatment group took 50 mg of sertraline (Zoloft, Pfizer, Inc., New York, NY, USA) daily. Both drugs were administered as tablets with the same appearance. At this stage, the patient was not told which drug was being given. After 8 weeks of treatment, the patients in the treatment group who were not satisfied with the overall results and who were willing to take a higher dose of sertraline were treated with 100 mg of sertraline daily for an additional 4-week period. The other patients in the treatment group continued treatment with 50 mg of sertraline for the same duration.

Efficacy and safety assessments

The treatment response was evaluated by measuring the IELT and computing the PEDT score and the Clinical Global Impression of Change (CGIC) score at baseline and at weeks 4, 8 and 12. The IELT was recorded with a stopwatch by the patient's partner who had undergone training in measurement techniques. All participants were asked to complete the previously developed and validated PEDT questionnaire,[19, 20] which included five items capturing the essence of the Diagnostic and Statistical Manual of Mental Disorders–Fourth Edition (DSM-IV) definition of PE (control, frequency, minimal stimulation, distress and interpersonal difficulty). A PEDT score was calculated at each assessment. Patient-reported CGIC measures were used to evaluate the treatment response.[21] The CGIC asked the following question: ‘Compared to the start of the study, would you describe your premature ejaculation problem as: much worse, worse, slightly worse, no change, slightly better, better, or much better?’ The response was scored using a 7-point scale ranging from ‘much worse’ (−3) to ‘much better’.[3] In addition, adverse events during therapy were recorded at each visit, and relapse was evaluated 6 months after treatment.

Statistical analysis

Statistical analyses were performed using spss 16·0 software (SPSS, Inc., Chicago, IL, USA). The t-test was used to compare differences in age and differences in the IELT and PEDT scores at baseline between the control and treatment groups. The Wilcoxon's rank sum test was used to compare the PE history at baseline between the control and treatment groups and the differences in IELT and CGIC scores during the follow-ups between the control and treatment groups and between the 50- and 100-mg groups. Repeated measures analysis of variance (anova) was used to compare the differences in the changes in IELT and PEDT during the follow-ups between the control and treatment groups and between the 50-mg and 100-mg groups. Spearman's correlation analyses were performed to evaluate the correlations between the CGIC scores and the changes in the IELT and PEDT scores. A P value < 0·05 was considered to be statistically significant.

Results

  1. Top of page
  2. Summary
  3. What is Known, Background and Objective
  4. Methods
  5. Results
  6. Discussion
  7. What is New and Conclusion
  8. References

Follow-up information and demographic characteristics

A total of 218 PE patients, including 157 in the treatment group and 61 in the control group, were originally enrolled in the study. Three patients in the treatment group discontinued therapy at week 1 because of adverse reactions. Three patients in the control group and two patients in the treatment group were lost to follow-up after 4 weeks of treatment. As a result, data analysis was performed on 215 subjects for week 4 and on 210 subjects for week 8. Patients in the treatment group had comparable age (31·6 ± 7·4 year vs. 31·0 ± 6·9 year, > 0·05) and PE history (18·0 months vs. 24·0 months, > 0·05) to those in the control group. Of the 152 patients who completed 8 weeks of treatment with 50 mg of sertraline, 80 underwent treatment with 100 mg of sertraline for an additional 4 weeks, 63 continued treatment with 50 mg of sertraline for the same duration and nine patients rejected further treatment. One patient who continued treatment with 50 mg of sertraline was lost to follow-up and considered as an invalid subject.

Efficacy – control versus sertraline 50 mg at 8 weeks

The number and percentage of patients with different IELTs during the study period for each group are shown in Table 1. At baseline, the percentage of patients having an IELT of 1 min or less was 39·3% (24/61) in the control group and 46·1% (71/154) in the treatment group. At week 8, only 27·6% (16/58) of patients in the control group and 13·2% (20/142) of patients in the treatment group had an IELT of 1 min or less. The percentage of patients with positive results was significantly higher in the treatment group than in the control group. Figure 1 shows the mean IELTs for each group over time. At baseline, the mean IELT was comparable between the control and treatment groups. At weeks 4 and 8, the mean IELT showed a significant increase in the treatment group compared to the control group. Repeated measures anova showed that after 8 weeks of treatment, the increase in the mean IELT was more significant in the treatment group than in the control group (= 34·91, < 0·01).

Table 1. Numbers and percentages of patients with different IELTs during the study period for each group
GroupIELT (min)BaselineWeek 4Week 8Week 12P valuea
  1. Data shown are the mean ± SD or number (%).

  2. a

    Comparisons between different time points.

  3. b

    Comparisons between control and treatment.

  4. c

    Comparisons between groups treated with 50 mg and 100 mg of sertraline.

Control (= 58)03 (4·9)2 (3·3)2 (3·5)2 (3·5)0·0230
(0,1)21 (34·4)18 (29·5)14 (24·1)13 (22·4)
(1,2)37 (60·7)31 (50·8)32 (55·2)29 (50·0)
>20 (0)10 (16·4)10 (17·2)14 (24·1)
Treatment (= 142)08 (5·2)2 (1·3)0 (0)0 (0)<0·0001
(0,1)63 (40·9)34 (22·1)20 (13·2)9 (6·3)
(1,2)83 (53·9)47 (30·5)36 (23·7)19 (13·4)
>20 (0)71 (46·1)96 (63·1)114 (80·3)
P valueb 0·48260·0010<0·0001<0·0001 
50 mg (= 79)05 (6·3)1 (1·3)0 (0)0 (0)<0·0001
(0,1)29 (36·7)9 (11·4)1 (1·3)2 (2·5)
(1,2)45 (57·0)15 (19·0)13 (16·4)11 (13·9)
>20 (0)54 (68·3)65 (82·3)66 (83·5)
100 mg (= 63)03 (4·8)1 (1·6)0 (0)0 (0)<0·0001
(0,1)32 (50·8)23 (36·5)18 (28·6)7 (11·1)
(1,2)28 (44·4)24 (38·1)17 (27·0)8 (12·7)
>20 (0)15 (23·8)28 (44·4)48 (76·2)
P valuec 0·2805<0·0001<0·00010·0951 
image

Figure 1. Mean intravaginal ejaculatory latency time (IELT)s for each group over time. Differences in the mean IELTs were compared between patients treated with either the control or 50 mg of sertraline (treatment) for 8 weeks and between patients treated with either 50 mg or 100 mg of sertraline for an additional 4 weeks. * < 0·01 vs. control; ** < 0·01 vs. 50 mg; # < 0·01 vs. week 4.

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Table 2 and Figure 2 show the mean PEDT score for each group over time. At baseline, there was a significant difference in the mean PEDT score between the control and treatment groups (= 0·0334). At weeks 4 and 8, the mean PEDT scores showed a significant decrease in the treatment group compared to the control group (both Ps < 0·001). Repeated measures anova showed that after 8 weeks of treatment, the decrease in the mean PEDT scores was more significant in the treatment group than in the control group (= 50·56, < 0·01).

Table 2. PEDT scores for each group over time
GroupBaselineWeek 4Week 8Week 12P valuea
  1. Data shown are mean ± SD.

  2. a

    Comparisons between different time points.

  3. b

    Comparisons between control and treatment.

  4. c

    Comparisons between groups treated with 50 mg and 100 mg of sertraline.

Control (= 58)16·1 ± 3·014·9 ± 3·514·8 ± 3·514·5 ± 3·6<0·0001
Treatment (= 142)17·0 ± 2·213·1 ± 4·911·0 ± 4·97·6 ± 4·9<0·0001
P valueb0·03340·0023<0·0001<0·0001 
50 mg (= 79)16·9 ± 2·210·6 ± 5·17·9 ± 3·96·7 ± 4·0<0·0001
100 mg (n = 63)17·3 ± 2·015·7 ± 2·914·2 ± 3·68·7 ± 5·7<0·0001
P valuec0·3996<0·0001<0·00010·0261 
image

Figure 2. Mean premature ejaculation diagnostic tool (PEDT) scores for each group over time. Differences in mean PEDT scores were compared between patients treated with either the control or 50 mg of sertraline (treatment) for 8 weeks and between patients treated with either 50 mg or 100 mg of sertraline for an additional 4 weeks. * < 0·01 vs. control; **< 0·01 vs. 50 mg; #< 0·05 vs. 50 mg; ##< 0·05 vs. week 4.

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The CGIC scores for each group over time are shown in Table 3. Significant differences were noted in CGIC scores at weeks 4 and 8 between the control and treatment groups (all Ps < 0·01). According to the Wilcoxon's rank sum test, after 8 weeks of treatment, the difference in the CGIC scores was significant in the treatment group (< 0·01), but not in the control group (= 0·68).

Table 3. CGIC scores for each group over time
GroupCGICWeek 4Week 8Week 12P valuea
  1. Data shown are the number (%).

  2. a

    Comparisons between different time points.

  3. b

    Comparisons between control and treatment.

  4. c

    Comparisons between groups treated with 50 mg and 100 mg of sertraline.

Control (= 58)047 (77·1)42 (72·4)41 (70·7)0·68
111 (18·0)12 (20·7)12 (20·7)
23 (4·9)3 (5·2)4 (6·9)
30 (0)1 (1·7)1 (1·7)
Treatment (= 142)070 (45·5)45 (29·6)18 (12·7)<0·0001
135 (22·7)37 (24·3)24 (16·9)
227 (17·5)45 (29·6)50 (35·2)
322 (14·3)25 (16·5)50 (35·2)
P valueb <0·0001<0·0001<0·0001 
50 mg (= 79)016 (20·2)1 (1·2)3 (3·8)0·0054
119 (24·1)19 (24·0)14 (17·7)
224 (30·4)35 (44·3)35 (44·3)
320 (25·3)24 (30·4)27 (34·2)
100 mg (= 63)042 (66·7)34 (54·0)15 (23·8)<0·0001
116 (25·4)18 (28·6)10 (15·9)
23 (4·8)10 (15·9)15 (23·8)
32 (3·2)1 (1·6)23 (36·5)
P valuec <0·0001<0·00010·04 

Efficacy – control versus sertraline at 12 weeks

At week 12, 25·9% (15/58) of patients in the control group and 6·3% (9/142) of patients in the treatment group had an IELT of 1 min or less. The percentage of patients with positive results was significantly higher in the treatment group than in the control group. The mean IELT showed a significant increase and the mean PEDT scores showed a significant decrease in the treatment group compared to the control group (both Ps < 0·001) (Figs. 1 and 2, Table 2). A significant difference was also noted in the CGIC scores at week 12 between the control and treatment groups (< 0·01) (Table 3).

Efficacy – sertraline 50 mg versus sertraline 100 mg at 12 weeks

Patients who were not satisfied with the overall results after 8 weeks of treatment with 50 mg of sertraline and were willing to accept a higher dose of sertraline had their medication dose doubled at week 8. Interestingly, the mean IELT of these patients was significantly lower than that of patients who continued taking 50 mg of sertraline at weeks 4 and 8, although the IELT value was comparable between the two groups of patients at baseline (Fig. 1). Accordingly, the percentage of patients with a positive treatment result at weeks 4 and 8 was significantly lower in the group that then continued to 100 mg than in the 50-mg group that chose to continue on this dose (Table 1). However, after an additional 4-week treatment, the mean IELT increased significantly in patients taking 100 mg of sertraline when compared to those who continued taking 50 mg of sertraline. As a result, the mean IELT at week 12 was comparable between the 50- and 100-mg groups (Fig. 1). Repeated measures anova showed that, after an additional 4-week treatment, there was a significant increase in the mean IELT in patients taking 100 mg of sertraline when compared to those taking 50 mg of sertraline (= 51·61, < 0·01). In addition, the mean IELT was significantly higher in both the 50- and 100-mg groups at week 8 than at week 4 (both Ps < 0·01).

The mean PEDT score was significantly higher in patients who chose to increase their dose to 100 mg of sertraline than in those who continued taking 50 mg of sertraline at weeks 4 and 8 (both Ps < 0·01), although the values were comparable between the two groups of patients at baseline (> 0·05). Repeated measures anova showed that after 8 weeks of treatment with 50 mg of sertraline, the mean PEDT score was significantly lower in patients who continued taking 50 mg of sertraline than in those taking 100 mg of sertraline (= 50·66, < 0·01). However, after an additional 4-week treatment, the mean PEDT score decreased significantly in patients taking 100 mg of sertraline compared to those who continued taking 50 mg of sertraline (< 0·01). The repeated measures anova showed that after an additional 4-week treatment, there was a significantly larger decrease in the mean PEDT score in patients taking 100 mg of sertraline than in those taking 50 mg of sertraline (= 13·04, < 0·01). In addition, the PEDT scores were significantly lower in both the 50- and 100-mg groups at week 8 than at week 4 (both Ps < 0·01).

At weeks 4 and 8, the CGIC scores were significantly higher in the 50-mg group than in the 100-mg group (both Ps < 0·01). At week 12, although the CGIC score was still higher in the 50-mg group than in the 100-mg group, the difference was not as large as the differences at weeks 4 and 8. The Wilcoxon's rank sum test showed that after 8 weeks of treatment, the differences in the CGIC scores were significant in both the 50- and 100-mg groups (both Ps < 0·01).

Correlations between CGIC scores and changes in IELT and PEDT scores

As shown in Table 4, significant correlations were observed between the CGIC scores and the changes in the IELT and PEDT scores at weeks 4, 8 and 12 relative to the baseline.

Table 4. Correlations between the CGIC scores and changes in the IELT and PEDT scores from the baseline
 Change in IELT from baselineChange in PEDT score from baseline
Week 4Week 8Week 12Week 4Week 8Week 12
  1. Data shown are mean ± SD. CC, correlation coefficient.

CGIC00·05 ± 0·210·08 ± 0·250·17 ± 0·300·11 ± 0·600·22 ± 0·930·15 ± 0·48
11·09 ± 0·681·16 ± 0·751·20 ± 0·723·98 ± 2·154·57 ± 2·414·97 ± 2·66
22·15 ± 0·752·73 ± 1·033·34 ± 1·337·17 ± 3·058·52 ± 2·8410·06 ± 3·16
35·04 ± 3·265·17 ± 2·962·97 ± 2·0811·77 ± 3·2913·00 ± 3·2413·87 ± 3·11
CC0·890·920·910·930·920·91
P value<0·0001<0·0001<0·0001<0·0001<0·0001<0·0001

Adverse reactions

Approximately 11·5% (7/61) of patients in the control group experienced adverse effects, including mild dizziness in two patients, reduced libido in one patient and gastrointestinal discomfort in four patients. All of these adverse events resolved spontaneously and did not cause early termination of the treatment. In the treatment group, 33·1% (52/157) of patients developed adverse effects. The majority of these adverse effects, including dizziness in 30 patients and reduced libido in 12 patients, were mild and predictable and did not contribute to premature discontinuation of the treatment. However, three patients discontinued the treatment because they developed severe dizziness within 1 week after taking 50 mg of sertraline. Aside from five patients who developed mild dizziness that could be tolerated, no other exceptional adverse effects were observed in patients after increasing the sertraline dose from 50 mg to 100 mg when compared to those taking 50 mg of sertraline throughout the study. These results suggest that the sertraline doses of 50 mg and 100 mg were both generally well tolerated.

Relapse

Ninety patients with improved ejaculation status (44·2%, 17 in the control group and 78 in the treatment group) were available for relapse evaluation 6 months after treatment. As shown in Table 5, no significant differences were observed in the relapse rate between the control and treatment groups or between the 50- and 100-mg treatment groups.

Table 5. Relapse by group
GroupRelapseP value
NoYes
  1. Data shown are number (%).

Control (= 17)7 (41·2)10 (58·8)0·57
Treatment (= 78)38 (48·7)40 (51·3)
50 mg (= 47)23 (48·9)24 (51·1)0·96
100 mg* (= 31)15 (48·4)16 (51·6)

Discussion

  1. Top of page
  2. Summary
  3. What is Known, Background and Objective
  4. Methods
  5. Results
  6. Discussion
  7. What is New and Conclusion
  8. References

Previous studies have demonstrated that up to 81% of men with PE could experience significant improvement after treatment with 50 mg of sertraline.[3] However, there were still a significant number of patients who failed to respond to 50 mg/day of sertraline. A study by McMahon [13] suggested that sertraline could prolong the ejaculatory interval in a dose-dependent manner. In the current study, we doubled the dose of sertraline in PE patients who were not satisfied with the overall results after 8 weeks of treatment with 50 mg of sertraline. Our results demonstrate that the mean IELT and CGIC score increased and the PEDT score decreased more significantly in patients taking 100 mg of sertraline than in those continuing on 50 mg of sertraline. These results suggest that increasing the sertraline dose to 100 mg could improve the response rate in PE patients who do not respond to 50 mg of sertraline. This result is consistent with those of previous studies.[16-18]

The DSM-IV-TR criteria highlight the multifaceted nature of PE. Many factors were incorporated into the new definition of PE, such as timing of the ejaculatory response, control over ejaculation and satisfaction with sexual intercourse.[22] Although IELT has been widely used as an objective measure of response to treatment, it only captures one element of the PE condition.[21] Clinically, some patients with relatively short IELTs reported little or no trouble, whereas others with longer IELTs might report difficulty with PE.[23] We therefore included PEDT and CGIC measures, both of which encompass the multifaceted nature of PE, to evaluate the treatment response. Considering that the degree of satisfaction with sexual intercourse is associated not only with the length of IELT but also with many other factors, we asked the patients to choose whether or not they wished to increase their dose of sertraline after 8 weeks of treatment with 50 mg of sertraline. Intriguingly, we found that treatment with 50 mg of sertraline for 8 weeks had less impact, in terms of changing the mean IELT, PEDT and CGIC scores, on patients who chose to increase their dosage than on patients who continued treatment with 50 mg of sertraline. These results suggest that personalized selection of dosage increase may represent a promising approach to identify PE patients requiring further treatment with higher doses of sertraline. In addition, the presence of significant correlations between the mean IELT, PEDT and CGIC scores corroborates the reliability of our results.

When using sertraline to treat depression, some researchers [24] proposed that the dosage should be increased after 4 weeks of treatment in patients whose depression has not improved. Meanwhile, others [17] found that premature increase of the dose of sertraline might not allow for an adequate length of time for a treatment response, as some patients who had not responded to 50 mg/day of sertraline after 4 weeks of treatment demonstrated a positive response at 8 weeks. In this study, we noted that the mean IELT was significantly higher and the mean PEDT score was significantly lower in both the 50- and 100-mg groups at week 8 than at week 4, and a small portion of patients developed a positive response in the second month. Thus, an increase in the dose of sertraline to 100 mg at week 8 might be a better choice in treating PE patients.

Treatment with sertraline is associated with a range of side effects, such as nausea, dizziness, anxiety, insomnia, reduced libido and ED. Higher doses are often associated with a greater probability of adverse events.[18] In the present study, except for three patients who developed severe dizziness and discontinued the treatment, most of the adverse effects were mild and predictable, disappeared spontaneously and did not contribute to premature discontinuation of the treatment. An increase in sertraline dose from 50 to 100 mg did not cause more severe adverse effects compared to treatment with 50 mg of sertraline. The occurrence of anejaculation and ED was not observed. In addition, there was no significant difference in the relapse rate between the 50- and 100-mg groups. These findings suggest that both regimens were well tolerated.

This study has some limitations. First, the results of this study are limited by the non-random assignment of subjects between the 50- and 100-mg groups in the continuation stage, which may yield non-robust findings. However, non-random assignment would have eliminated personalized choice of dosage. Second, although stopwatch-measured IELT is an objective measure of treatment response, the evaluation of satisfaction by the patients themselves may be affected by many factors, such as education levels, socioeconomic conditions, personality, sexual partner's personality, and the individual's physical and psychological conditions. These factors may increase the difficulty in evaluating the results.

What is New and Conclusion

  1. Top of page
  2. Summary
  3. What is Known, Background and Objective
  4. Methods
  5. Results
  6. Discussion
  7. What is New and Conclusion
  8. References

We present evidence that a large portion of PE patients had a positive response to an 8-week treatment with 50 mg of sertraline. In patients who were not satisfied with the overall results after 8 weeks of treatment and were willing to accept a higher dose of sertraline, an additional 4-week treatment with 100 mg of sertraline improved the response rate. Both regimens were well tolerated, and the relapse rate did not differ significantly between patients taking 100 mg of sertraline and those taking 50 mg of sertraline. In addition, we found significant correlations between CGIC scores and changes in IELT and PEDT scores in PE patients treated with sertraline. Taken together, our findings suggest that increasing the dose of sertraline following treatment with the usual starting dose may represent a promising regimen to improve the efficacy of treating PE patients who do not respond to the usual dose of sertraline and that the PEDT may be a valid measure of treatment response in PE patients.

References

  1. Top of page
  2. Summary
  3. What is Known, Background and Objective
  4. Methods
  5. Results
  6. Discussion
  7. What is New and Conclusion
  8. References
  • 1
    McMahon CG, Althof SE, Waldinger MD et al. An evidence-based definition of lifelong premature ejaculation: report of the International Society for Sexual Medicine (ISSM) ad hoc committee for the definition of premature ejaculation. J Sex Med, 2008;5:15901606.
  • 2
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