Evaluation of the effect of Date Palm Pollen (D.P.P) on sexual desire and potency of male patients after coronary artery bypassgraft surgery

The effect of date palm pollen product on sexual desire and ability of male patients after coronary artery bypass graft surgery

A randomized controlled clinical trial with parallel groups, double blinded

The research center is Tehran Heart Center. The drug used is 3 grams of date palm pollen and placebo 3 grams of Avicel powder, both administered every 12 hours for 2 months. Both are similar in appearance and packaging, only distinguishable by proprietary codes inserted on the drug label by the pharmacist. The patient and the prescriber are not aware of the meaning of the codes.

Inclusion criteria: patients undergoing coronary artery bypass surgery; sexual dysfunction; IIEF score less than 50; ejection fraction greater than 30%; male Gender; age: 40 to 70 years old. Exclusion criteria: creatinine over 1.5; AST and ALT are more than twice the normal; history or prostate cancer; CABG again; active inflammatory diseases; myocardial infarction in the past 6 months; CABG with valve replacement; EF less than 30%; uncontrolled thyroid disorders; anemia; pre-surgery sexual dysfunction; major depression; consumption of high dose beta blockers; coldness of marital relations that leads to inability to have sex; history of allergies to pollen of flowers and plants.

Intervention group: 3 grams of ِ Shahani Date palm pollen from Jahrom sachet one morning 9 and one night 9, for 8 weeks. Control group: 3 grams of ِAvisel sachet one morning 9 and one night 9, for 8 weeks.

Index of erectile function; index of sexual desire

From the beginning, the study was double-blind, which was mistakenly recorded triple-blind, so this mistake corrected. Due to the fact that symptomatic patients usually have an IIEF below 50, this criterion was modified in consultation with specialists and according to other similar studies. Due to the fact that bypass patients are mainly suffering from metabolic syndrome, including diabetes, it was excluded from the exclusion criteria with the advice of diabetes experts. The sample size was modified for two reasons: first, due to observations of studies that allowed us to complete the work with a smaller sample size, and second, due to COVID19 pandemic non-emergency surgery and follow-up of patients was disrupted. Therefore, in consultation with the statistics consultant and finding supportive studies, the sample size was corrected and the study was terminated and the data were analyzed.

Assignment of patients to study groups is done using Block Randomization method. Samples are divided into intervention and placebo groups based on the random sequence generated by the statistic consultant. A random sequence is generated by random four-way blocks; each block represents four participants. Distribution of placebo and interventions in each block is random but under a condition that there must be two placebos and two interventions in each block. Using this method, the number of samples assigned to each of the groups are equal, so in cases that mid-term analysis is required, the equal number of samples for both groups are available.

Medication and placebo are identical in terms of appearance an packaging, only differentiated through the proprietary codes set by the pharmacist on the box of medicine. The patient and the prescribing researcher are not aware of the code. The outcomes of the study are prepared by the researcher who is unaware of the grouping and is blind to the groups and type of medications.