Libimax Barij Soft Capsule

Improving sexual function in patients taking Serotonin Specific reuptake Inhibitors (SSRI) due to Major Depressive Disorder

In comparison with healthy individuals, patients suffering depression report sexual dysfunction more often. There are various therapeutic options for management of depression, including: psychotherapy, physical exercise, Electro Shock Therapy (EST) and psychopharmacotherapy (use of anti-depressants). Several studies have shown that the efficacy of antidepressants is limited and therapeutic effects is seen in 70% of patients; 4 weeks after the onset of treatment, only 50% are committed to the continuation of the regimen, which is probably due to the two-week delay in the onset of action or various adverse effects like weight gain, dryness of mouth and sexual dysfunction. Sexual dysfunction following treatment with SSRI drugs (like citalopram, fluoxetine, fluvoxamine and sertraline), with a prevalence of 25.8 to 80.3 percent, is one of the most distressing and damaging adverse effects of this group of antidepressants. In fact, these drugs have a negative effect on either one or the entire phases of the sexual cycle; they can decrease libido, affect arousal and cause erectile dysfunction, mostly in the form of delayed erection and delay in or lack of orgasm. The role of the drugs in the SSRI group in causing sexual dysfunction is their significant weakness in treatment of Major Depressive Disorder. Suggested treatment for the sexual dysfunction caused by SSRIs is the use of drugs like sildenafil, tadalafil, mianserin and bupropion, none of which have been approved by the FDA. To assess the effect of rose essential oil in male patients suffering MDD under SSRI treatment, in a double-blind clinical trial, 68 patients were randomly assigned to either rose essential oil group or placebo, so that, alongside their SSRI medication, they would take for 8 weeks daily either 2 ml of a rose product developed by Barij Essence company containing 17 mg citronellol (standardized based on presence of at least 5.8 mg citronellol per ml of the product) or 2 ml of an oil-aqueous solution with an aroma resembling that of rose. The patients reported their depressive symptoms and sexual function at the beginning of the study, after 4 weeks and 8 weeks (end of the study). At the end of the study, data analysis was carried out on 60 patients (30 in each group). Based on the results of this study, compared to the placebo group, the rose essential oil group showed better improvement in sexual function. The improvement in sexual function was witnessed in the rose essential oil group from week 4 to week 8. The depressive symptoms improved in both groups, more improvement seen in the rose essential oil group. This study showed that administration of rose essential oil alleviates sexual dysfunction in male patients suffering Major Depressive Disorder and sexual dysfunction due to SSRI usage. Also, in addition to improvement in sexual function, symptoms of depression improve as well.

Furthermore, to assess the effect of rose essential oil in female patients suffering MDD under SSRI treatment, in a double-blind clinical trial, 61 patients were randomly assigned to either rose essential oil group or placebo, so that, alongside their SSRI medication, they would take for 8 weeks daily either 2 ml a rose product developed by Barij Essence company containing 17 mg citronellol (standardized based on presence of at least 5.8 mg citronellol per ml of the product) or 2 ml of an oil-aqueous solution with an aroma resembling that of rose. The patients filled out questionnaires about depression and sexual function at the beginning of the study, after 4 weeks, and at the end of the study. At the end of the study, data analysis was carried out on 50 individuals (25 in each group). Based on the results of this study, improvement in libido, orgasm and sexual satisfaction was evident over time. The patients in the rose group reported reduced pain during intercourse, and in comparison with the control group, the overall score of sexual function increased in the rose group. The researchers came to the conclusion that, although in male patients suffering MDD under SSRI treatment, adjuvant therapy with rose essential oil results in better sexual function, the outcome regarding the use of rose essential oil in female patients suffering MDD under SSRI treatment indicates lower efficacy of this product in improving sexual function.

Twice per day, 1 soft capsule each time with some fluids.

Dosage form

Soft Capsule

 

Packaging

15 mg soft capsules in plastic container in cardboard box

Patient information leaflet inside

Ingredients

  • Rose (Rosa damascene)
  • Rose geranium (Pelargonium roseum)

Active Ingredients

  • citronellol

Contraindications and Cautions

There is not enough data on the use of the product during pregnancy, lactation and for children.

Adverse Effects

During the clinical trial carried out on the product, no adverse effect has been reported.

 

Drug Interaction

Concurrent use with sedative and antidepressant drugs might increase their effect.

 

Administration during Pregnancy and Lactation

 

Further Notes

  • Keep Libimax Barij Soft Capsules, like all other medication, away from sight and reach of children.
  • Close the cap tightly right after taking the medication.
  • Keep the medicine away from light and in 15-30°C.
  • Keep this leaflet; you may need to read it again.

Based on presence of 5.7 mg citronellol per each soft capsule.