Efficacy and Safety of Two Polyherbal Combinations: E-MA-H and E-MA-HP in Male Sexual Dysfunction

Abstract

Efficacy and safety of 2 herbal products--E-MA-H at 2 dose levels, low (HLD) and high (HHD), and E-MA-HP (HP) capsules--versus placebo (PL) was evaluated in subjects with male sexual dysfunction. Males aged 21-60 with erectile dysfunction, premature ejaculation, or other form of sexual dysfunction were studied in this triple-blind, randomized, placebo-controlled, parallel-groups trial. Subjects received any one of the following 4 interventions: E-MA-H 2 capsules at night (HLD) for 60 days; E-MA-H 2 capsules twice daily for 30 days, followed by 2 capsules at night for 30 days (HHD); E-MA-HP (HP) 2 capsules twice daily for 60 days; or placebo (PL) 2 capsules twice daily for 60 days. All dosage regimens were standardized to 2 capsules twice daily by using 2 matching placebo capsules as the morning dose for HLD and on days 31-60 for HHD. Efficacy outcome measures were the international index of erectile function; index for premature ejaculation; erectile dysfunction inventory of treatment satisfaction; subjects' and investigators' global assessment. Safety was assessed through adverse events; hematology; blood chemistry. Of 148 subjects enrolled, 1 was excluded from analysis; data on the intention-to-treat population of 147 (PL = 36, HLD = 38, HHD = 37, HP = 36) were analyzed. There was a significant (P < 0.01) increase in the total international index of erectile function score (mean ± SEM) in subjects receiving HLD (16.28 ± 1.39), HHD (15.40 ± 1.22), and HP (18.55 ± 1.36) compared with PL (6.83 ± 1.52). The same pattern was seen with increase in index for premature ejaculation scores: HLD (9.68 ± 1.17), HHD (10.27 ± 1.05), HP (11.36 ± 1.20) versus PL (3.77 ± 1.04). There was no significant difference in effect among the active treatment groups. The incidence of adverse events was similar in all the groups. Laboratory evaluations did not show any clinically significant abnormality in any of the groups. Treatment with HLD, HHD, and HP is well tolerated, and more effective than placebo (P < 0.01), in subjects with erectile dysfunction, premature ejaculation, and other forms of sexual dysfunction.

Traditional, Complementary and Alternative Medicines in the Treatment of Ejaculatory Disorders: A Systematic Review

“…Forty-five full texts were assessed for eligibility, with 23 articles excluded, resulting in 22 articles included for qualitative analysis. Reasons for articles excluded at eligibility included no full-length clinical trial (n = 7) [ 35 , 36 , 37 , 38 , 39 , 40 , 41 ], no TCAM intervention (n = 5) [ 42 , 43 , 44 , 45 , 46 ], no comparison group (n = 6) [ 47 , 48 , 49 , 50 , 51 , 52 ], no ejaculatory disorder cohort under investigation (n = 3) [ 53 , 54 , 55 ], and combined treatment with conventional medicine (n = 2) [ 56 , 57 ].…”

Massive Levemir (Long-Acting) Insulin Overdose: Case Report

“…On a PubMed search, we noted multiple case reports of large insulin overdoses the largest of which was 10 000 units of Humulin R [2]. Other overdoses were 800 units of lispro and 3800 units of glargine in a patient [3], 2500 units of NPH insulin in a patient [4] and 750 units regular insulin and 750 units NPH insulin in a patient [5]. A case of 1500 units of overdose of insulin glargine was also reported.…”