Home » Articles » Article: Propecia. Is it effective?
Article: Propecia. Is it effective?
As usual the result are very good, men can renew hair growth not only on the cinciput (top of the head), but in the forehead's high temple area as well. The effectiveness of Propecia is proved by the fact that about 33% of those who took Propecia, didn't see any difference or hair grew a little, the other 66% verified considerable hair growth instead of those fallen out. It wasn't kind of lanugo, that you only feel hair's growing, it was a natural hair.
And what is most important: clinical findings show that not a single patient taking Propecia lost hair eversince.
The clinical effect was studied in the amount of 1 mg daily per os during 2 years with 1553 men suffering from circumscribed alopecia. 48% of probationers had a positive effect after 1 year of treatment.
Another research was carried out during 1 year with 1800 men (18-41 years old) having some hair loss problems. The research testified hair growth in 66% of men. These patients reported better hair appearance and reduction of hair loss.
Side effects of Propecia are rarely found. Only 0,5% had sexual problems: erectile dysfunction, reduction of sperm amount. These problems disappeared after they stopped taking Propecia. Propecia is not to be taken by women because of the risk of child-bearing disturbance and getting congenital malformation of fetus development.
Other studies assessed the efficacy of Propecia by 4 criteria: hair counts in a one-inch diameter circle of the scalp; assessments of "before" and "after" photographs by a panel of dermatologists; patient questionnaires and investigator assessments of changes in scalp hair growth. The effectiveness of Propecia vs. placebo was demonstrated as follows:
Hair count: in the beginning, baseline hair counts averaged 876 hairs in a one-inch diameter area of scalp. By the end of the first year, men taking Propecia had an average of 126 more hairs than men taking placebo. But hair was still growing, and, by the end of the fifth year, the net difference between the groups increased to 277 hairs in favor of the men taking Propecia. At the end of the fifth year, 65 percent of men taking Propecia (n=219) maintained or improved their hair count compared to their hair count at the start of the studies, while all of the men on placebo (n=15) lost hair count.
Before and after photos:The panel of dermatologists who reviewed standardized clinical photographs of men treated with Propecia (n=279) and men on placebo (n=16) at the end of the five-year study rated 90 percent of men treated with Propecia as having had no further visible hair loss compared to baseline vs. 25 percent of men on placebo.
Patient questionnaires: Questionnaires completed at five years by men on Propecia (n=284) and by men on placebo (n=15) showed that men treated with Propecia indicated a higher level of satisfaction with the appearance of: their hair overall (63 percent vs. 20 percent), the hair on top of their heads (59 percent vs. 13 percent) and their frontal hairline (48 percent vs. 7 percent). Men treated with Propecia were more likely to say that: their bald spot was getting smaller (61 percent vs. 20 percent); the appearance of their hair had improved (77 percent vs. 40 percent); they had experienced increased hair growth (75 percent vs. 40 percent) and their hair loss had slowed (90 percent vs. 67 percent).
Investigator assessments:Physician investigators who evaluated the men treated with Propecia (n=279) and men on placebo (n=13) at the end of five years determined that 77 percent of the men treated with Propecia had increases in scalp hair, compared with 15 percent of men on placebo.
The five-year study confirmed the excellent safety profile of Propecia. In the initial 12-month clinical studies, the following side effects were the most common and reported by a very small number of men: less desire for sex (1.8 percent vs. 1.3 percent on placebo), difficulty in achieving an erection (1.3 percent vs. 0.7 percent on placebo) and a decrease in the amount of semen (0.8 percent vs. 0.4 percent on placebo). These sexual side effects went away in all men who discontinued therapy because of them and also disappeared in most (56 percent men who chose to continue taking Propecia through the fifth year of the study. By the end of the fifth year, the incidence of those side effects was less than or equal to 0.3 percent in men who continued treatment with Propecia vs. men on placebo (GlaxoSmithKline's describing information).
Another study was a dose-response trial conducted at 3 clinical centers. Patients in this study were treated for 7 weeks with 1 of 3 doses of ZYBAN (100,150, or 300 mg/day) or placebo; quitting was defined as total abstinence during the last 4 weeks of treatment (weeks 4 through 7). Abstinence was determined by patient daily diaries and verified by carbon monoxide levels in expired air.
Results of this dose-response trial with ZYBAN demonstrated a dose-dependent increase in the percentage of patients able to achieve 4-week abstinence (weeks 4 through 7). Treatment with ZYBAN at both 150 and 300 mg/day was significantly more effective than placebo in this study.
Table 1 presents quit rates over time in the multicenter trial by treatment group. The quit rates are the proportions of all persons initially enrolled (i.e., intent to treat analysis) who abstained from week 4 of the study through the specified week. Treatment with ZYBAN (150 or 300 mg/day) was more effective than placebo in helping patients achieve 4-week abstinence. In addition, treatment with ZYBAN (7 weeks at 300 mg/day) was more effective than placebo in helping patients maintain continuous abstinence through week 26 (6 months) of the study.
| Table 1. Dose-Response Trial: Quit Rates by Treatment Group |
 | Treatment Groups |
 |  | Zyban | Zyban | Zyban |
| Placebo
| 100 mg/day | 150 mg/day | 300 mg/day |
| Abstinence From | (n=151) | (n=153) | (n=153) | (n=156) |
| Week 4 Through | % | % | % | % |
| Specified Week | (95% CI) | (95% CI) | (95% CI) | (95% CI) |
| Week 7 (4-week quit) | 17% | 22% | 27%* | 36%* |
 | (11-23) | (15-28) | (20-35) | (28-43) |
| Week 12 | 14% | 20% | 20% | 25%* |
 | (8-19) | (13-26) | (14-27) | (18-32) |
| Week 26 | 11% | 16% | 18% | 19%* |
 | (6-16) | (11-22) | (12-24) | (13-25) |
Significantly different from placebo (p <= 0.05).
The second study was a comparative trial conducted at 4 clinical centers. Four treatments were evaluated: ZYBAN 300 mg/day, nicotine transdermal system (NTS) 21 mg/day, combination of ZYBAN 300 mg/day plus NTS 21 mg/day, and placebo. Patients were treated for 9 weeks. Treatment with ZYBAN was initiated at 150 mg/day while the patient was still smoking and was increased after 3 days to 300 mg/day given as 150 mg twice daily. NTS 21 mg/day was added to treatment with ZYBAN after approximately 1 week when the patient reached the target quit date. During weeks 8 and 9 of the study, NTS was tapered to 14 and 7 mg/day, respectively. Quitting, defined as total abstinence during weeks 4 through 7, was determined by patient daily diaries and verified by expired air carbon monoxide levels. In this study, patients treated with any of the 3 treatments achieved greater 4-week abstinence rates than patients treated with placebo.
Table 2 presents quit rates over time by treatment group for the comparative trial.
| Table 2. Comparative Trial: Quit Rates by Treatment Group |
 | Treatment Groups |
 |  | Nicotine |  |  |
 |  | Transdermal |  | ZYBAN |
 |  | System (NTS) | ZYBAN | 300 mg/day and |
 | Placebo
| 21 mg/day | 300 mg/day | NTS 21 mg/day |
| Abstinence From | (n=160) | (n=244) | (n=244) | (n=245) |
| Week 4 Through | % | % | % | % |
| Specified Week | (95% CI) | (95% CI) | (95% CI) | (95% CI) |
| Week 7 (4-week quit) | 23% | 36% | 49% | 58% |
 | (17-30) | (30-42) | (43-56) | (51-64) |
| Week 10 | 20% | 32% | 46% | 51% |
 | (14-26) | (26-37) | (39-52) | (45-58) |
When patients in this study were followed out to one year, the superiority of ZYBAN and the combination of ZYBAN and NTS over placebo in helping patients to achieve abstinence from smoking was maintained. The continuous abstinence rate was 30% (95% CI 24-35) in the ZYBAN treated patients, and 33% (95% CI 27-39) for patients treated with the combination at 26 weeks compared with 13% (95% CI 7-18) in the placebo group. At 52 weeks, the continuous abstinence rate was 23% (95% CI 18-28) in the ZYBAN treated patients, and 28% (95% CI 23-34) for patients treated with the combination, compared with 8% (95% CI 3-12) in the placebo group. Although the treatment combination of ZYBAN and NTS displayed the highest rates of continuous abstinence throughout the study, the quit rates for the combination were not significantly higher (p>0.05) than for ZYBAN alone.
The comparisons between ZYBAN, NTS, and combination treatment in this study have not been replicated, and, therefore should not be interpreted as demonstrating the superiority of any of the active treatment arms over any other.
|