Dovepress Rosa damascena oil for male SSRl-induced sexual dysfunction reproduction,that it is seriously impaired during MDD.and it to destinations all around the world.3354 The extract has that the most disturbing side effect of SSRI treatment is also been found to have medicinal properties.It has shown SSRI-I SD. antimicrobial activity.It also has been reported to protect Recommended treatments ofSSRI-I SD involve commer- neurons against amyloid B toxicity,a major pathological cially available medications such as sildenafil (Viagra),467 component of Alzheimer's disease,and to protect rats against tadalafil (Cialis"),47 mianserin,48 and bupropion.4 Further, seizures.s-ss The active components of R.damascena are not several case reports have been published that focus on the known.R.damascena oil is composed of a large number of use of antidotes such as cyproheptadine and on augment- volatile organic compounds including various terpenes such ing agents including gingko biloba,sildenafil,tadalafil,as citronellol,heneicosane,and disiloxane.The marc,mate- amantadine,bethanechol,bromocriptine,bupropion,dex- rial left after rose oil is extracted,has significant polyphenol troamphetamine,granisetron,loratadine,methylphenidate, content,including quercetin,myricetin,kaempferol,and mianserin,mirtazapine,nefazodone,neostigmine,pemo- gallic acid,though the predominant molecules have been sug- line,pramipexole,ropinirole,trazodone,vardenafil,and gested to be glycosides of quercetin and kaempferol.40 With yohimbine.(Extensive reviews are provided by Segraves regard to the effects of R.damescena on sexual dysfunction, and Balon3o and by Balon alone).35 However,Nurnberg40 we currently lack evidence based on double-blind,random- concludes that: ized,and placebo-controlled clinical trials.Accordingly,the aim of this study was to test the hypothesis that the adjuvant ....despite several thousand published reports on treat- administration of R.damascena oil has a favorable effect ment modalities based on heuristic post hoc hypotheses of on sexual dysfunction among male patients suffering from central serotonin inhibition and those involving agonist, MDD and SSRI-I SD. antagonist,partial agonist,switching,augmentation,and The following three hypotheses were formulated.First, waiting management approaches,no evidence-based data following Boskabady et alsI we anticipated the adjuvant are available to support those treatment modalities,leaving administration of R.damascena oil would improve sexual patients exposed to random pharmacology dysfunction among male patients suffering from MDD Moreover,to the best of our knowledge,there is no US and SSRI-I SD.Second,we expected that the adminis- Food and Drug Administration(FDA)-approved pharmaco- tration of R.damascena would alleviate symptoms of logical treatment for SSRI-I SD,and there is a shortage of depression.Third,we expected that the improvements in randomized,placebo-controlled,and double-blind clinical symptoms of depression and of sexual dysfunction would trials of potential treatments.To address the latter issue, be associated. the aim of the present study was to conduct a double-blind, randomized,and placebo-controlled clinical trial examining Method the effect of R.damascena oil,a herbal agent,on SSRI-I SD Study design among male patients suffering from MDD. The study entailed an 8-week,randomized,double-blind, In the context of more traditional treatments based on placebo-controlled clinical trial.The entire study was phytopharmaca,the oil of R.damascena is particularly wor- approved by the local ethics committee and conducted thy of attention because within the long history of Persian in accordance with the ethical standards laid down in medicine,R.damascena has been well known for its positive the Declaration of Helsinki(trial registration number: effects on mood,on a broad range of illnesses and diseases, IRCT2013100814333N10;http://www.irct.ir.). and,most importantly,on sexual dysfunction.5!R.dama- scena is a hybrid rose species predominantly grown in Iran, Procedure and sample Turkey,and Bulgaria to produce rose oil and rose water to Figure 1 shows the Consolidated Standards of Reporting be used in perfume and in the cosmetic and food industries.Trials flowchart for patient sampling.Male patients who The cultivation and consumption of R.damascena in Iran has were diagnosed with MDD,treated with SSRIs,and com- a long history,and Iran is one of its origins.32 It is believed plained about sexual dysfunction after commencement of that the crude distillation of roses for the oil originated in the SSRI regimen were recruited between October 2013 Persia in the late 7th century AD and spread to the provinces and June 2014 at the Outpatients Clinic of Farabi Hospital, of the Ottoman Empire in the 14th century.Iran was the Kermanshah University of Medical Sciences in Kermanshah, main producer ofrose oil until the 16th century and exported Iran.So that only patients suffering from MDD and Neuropsychiatric Disease and Treatment 2015:II submit your 627 DovepressNeuropsychiatric Disease and Treatment 2015:11 submit your manuscript | www.dovepress.com Dovepress Dovepress 627 Rosa damascena oil for male SSRI-induced sexual dysfunction reproduction, that it is seriously impaired during MDD, and that the most disturbing side effect of SSRI treatment is SSRI-I SD. Recommended treatments of SSRI-I SD involve commer￾cially available medications such as sildenafil (Viagra®),46,47 tadalafil (Cialis®),47 mianserin,48 and bupropion.49 Further, several case reports have been published that focus on the use of antidotes such as cyproheptadine and on augment￾ing agents including gingko biloba, sildenafil, tadalafil, amantadine, bethanechol, bromocriptine, bupropion, dex￾troamphetamine, granisetron, loratadine, methylphenidate, mianserin, mirtazapine, nefazodone, neostigmine, pemo￾line, pramipexole, ropinirole, trazodone, vardenafil, and yohimbine. (Extensive reviews are provided by Segraves and Balon50 and by Balon alone).35 However, Nurnberg40 concludes that: ….despite several thousand published reports on treat￾ment modalities based on heuristic post hoc hypotheses of central serotonin inhibition and those involving agonist, antagonist, partial agonist, switching, augmentation, and waiting management approaches, no evidence-based data are available to support those treatment modalities, leaving patients exposed to random pharmacology. Moreover, to the best of our knowledge, there is no US Food and Drug Administration (FDA)-approved pharmaco￾logical treatment for SSRI-I SD, and there is a shortage of randomized, placebo-controlled, and double-blind clinical trials of potential treatments. To address the latter issue, the aim of the present study was to conduct a double-blind, randomized, and placebo-controlled clinical trial examining the effect of R. damascena oil, a herbal agent, on SSRI-I SD among male patients suffering from MDD. In the context of more traditional treatments based on phytopharmaca, the oil of R. damascena is particularly wor￾thy of attention because within the long history of Persian medicine, R. damascena has been well known for its positive effects on mood, on a broad range of illnesses and diseases, and, most importantly, on sexual dysfunction.51 R. dama￾scena is a hybrid rose species predominantly grown in Iran, Turkey, and Bulgaria to produce rose oil and rose water to be used in perfume and in the cosmetic and food industries. The cultivation and consumption of R. damascena in Iran has a long history, and Iran is one of its origins.52 It is believed that the crude distillation of roses for the oil originated in Persia in the late 7th century AD and spread to the provinces of the Ottoman Empire in the 14th century. Iran was the main producer of rose oil until the 16th century and exported it to destinations all around the world.53,54 The extract has also been found to have medicinal properties. It has shown antimicrobial activity. It also has been reported to protect neurons against amyloid β toxicity, a major pathological component of Alzheimer’s disease, and to protect rats against seizures.55–58 The active components of R. damascena are not known. R. damascena oil is composed of a large number of volatile organic compounds including various terpenes such as citronellol, heneicosane, and disiloxane.59 The marc, mate￾rial left after rose oil is extracted, has significant polyphenol content, including quercetin, myricetin, kaempferol, and gallic acid, though the predominant molecules have been sug￾gested to be glycosides of quercetin and kaempferol.60 With regard to the effects of R. damescena on sexual dysfunction, we currently lack evidence based on double-blind, random￾ized, and placebo-controlled clinical trials. Accordingly, the aim of this study was to test the hypothesis that the adjuvant administration of R. damascena oil has a favorable effect on sexual dysfunction among male patients suffering from MDD and SSRI-I SD. The following three hypotheses were formulated. First, following Boskabady et al51 we anticipated the adjuvant administration of R. damascena oil would improve sexual dysfunction among male patients suffering from MDD and SSRI-I SD. Second, we expected that the adminis￾tration of R. damascena would alleviate symptoms of depression. Third, we expected that the improvements in symptoms of depression and of sexual dysfunction would be associated. Method Study design The study entailed an 8-week, randomized, double-blind, placebo-controlled clinical trial. The entire study was approved by the local ethics committee and conducted in accordance with the ethical standards laid down in the Declaration of Helsinki (trial registration number: IRCT2013100814333N10; http://www.irct.ir.). Procedure and sample Figure 1 shows the Consolidated Standards of Reporting Trials flowchart for patient sampling. Male patients who were diagnosed with MDD, treated with SSRIs, and com￾plained about sexual dysfunction after commencement of the SSRI regimen were recruited between October 2013 and June 2014 at the Outpatients Clinic of Farabi Hospital, Kermanshah University of Medical Sciences in Kermanshah, Iran. So that only patients suffering from MDD and