Layout 1 Placebo-controlled effect of topical Qust (Costus) oil on postmenopausal women’s sexual desire disorder Eur J Transl Myol 34 (4) 12660, 2024 doi: 10.4081/ejtm.2024.12660 Most women spend more than a third of their life with menopause, and the population of postmenopausal women in the world will increase to 1,000,300,000 by 20301. Hot flashes, circadian rhythm disorders, mood disorders such as decreased concentration, depression and anxiety, tachycardia, headache, musculoskeletal pain, and sexual disorders are common problems during menopause2. The onset of menopause is associated with changes in sex hormones, including a decrease in estrogen, increase in FSH (Follicle-Stimulating Hormone), decrease in LH (Luteinizing Hormone) and consequently a decline in progesterone and cessation of menstruation3. Despite the numerous advances in the prevention and treatment of menopause complications, decreased libido and anorgasmia are still among the most common problems experienced by postmenopausal women that can decrease their quality of life4. Sexual functioning is an important component of quality of life5. The high prevalence of sexual dysfunction, its undeniable impact on marital disputes and the ensuing social problems, and the patients’ refusal to discuss their sexual problems out of shame highlight the need to delve deeper into this subject6. The prevalence of sexual dysfunction is reported to be about 72% in postmenopausal women in Iran, with 75% affecting the women’s arousal and 62% their desire7. Sex- ual dysfunction leading to divorce has been reported to be about 40% in Iran. Meanwhile, lack of sexual satisfaction can lead to problems such as depression and deterioration of the family’s mental health8. Sexual responses and de- sires are multifactorial, influenced by psychological, so- cial, environmental, and learned factors. Sexual dysfunction is often accompanied by other psychological disorders such as anxiety, depression, personality disorder, Abstract Decreased libido and anorgasmia are common problems for women after menopause that reduce the quality of life of couples. This study examined the effect of topical Qust oil on sexual desire disorder in postmenopausal women. In this double-blind, randomized, clinical trial, 110 postmenopausal women with decreased sexual desire visiting a Traditional Medicine Center and Hazrat Rasool Akram Hospital (affiliated to Iran University of Medical Sciences) were selected by convenience consecutive sampling and randomly assigned to experimental and control groups. The experimental group received qust oil, while the control group was given a placebo (liquid paraffin); they were instructed to massage the product topically on their pubic area and perineum daily. The sexual function of both groups was assessed and compared before the intervention and four weeks after the intervention using the Female Sexual Function Index. The mean and standard deviation of the improvement of sexual function post-intervention were 37.66±32.52% and 11.96±11.18% in the experimental and control groups, respectively (p<0.001). In terms of the improvement of components of sexual function, a significant difference was observed between the two groups in the sub-scales of sexual desire [57.05±42.99% vs. 21.25±27.85%, p<0.001], arousal, orgasm, and satisfaction (p<0.001 for all); however, no significant difference was observed in terms of lubrication (p=0.25) and pain during intercourse (p=0.776). In postmenopausal women with sexual dysfunction, massaging the pubic area and perineum with qust oil for at least four weeks significantly improves desire, arousal, orgasm, and sexual satisfaction. Key Words: sexual desire, menopause, costus oil, Persian medicine. Eur J Transl Myol 34 (4) 12660, 2024 doi: 10.4081/ejtm.2024.12660 Placebo-controlled effect of topical Qust (Costus) oil on postmenopausal women’s sexual desire disorder: a double-blind, randomized clinical trial Akram Fallah, Fattaneh Hashem Dabbaghian, Amirhossein Jamshidi, Elham Akhtari Institute for Studies in Medical History, Persian and Complementary Medicine, Iran University of Medical Sciences, Tehran, Iran. This article is distributed under the terms of the Creative Commons Attribution Noncommercial License (CC BY-NC 4.0) which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited. - 8 - Non -co mmerc ial us e o nly Placebo-controlled effect of topical Qust (Costus) oil on postmenopausal women’s sexual desire disorder Eur J Transl Myol 34 (4) 12660, 2024 doi: 10.4081/ejtm.2024.12660 and schizophrenia4. Currently, two modalities, namely sex therapy and drug therapies, are used to treat female sexual dysfunction9. Drug therapies include estrogen and testos- terone compounds and anti-anxiety and anti-depressant medications, which have side effects and may interact with other drugs taken by the patient during menopause10. The American Endocrine Society has recommended against excessive prescription of androgens for treating female sexual problems, citing side effects such as in- creased risk of breast cancer and cardiovascular diseases11. In traditional medicine references, the reasons for poor sexual desire include weaknesses of the main body organs (heart, brain, and liver)12. The corroboration of the comor- bidity in the increased prevalence of sexual dysfunction and psychological problems based on new statistical studies is somewhat aligned with this view held by tradi- tional medicine13. The treatments mentioned in accessible sources of traditional medicine include a wide range of commonly-used substances, from libido-enhancing single ingredients to compounds containing numerous elements. Despite the increasing availability of effective conventional medical treatments, herbal remedies continue to be a pop- ular alternative for men and women looking to improve their sexual functioning. Nevertheless, the efficacy of most herbal agents in treating sexual problems remains unclear14. Out of the proposed treatments, this study examines a sim- ple and accessible drug that can be used topically to avoid interfering with the drugs used by postmenopausal women, who are often middle-aged and might be taking multiple drugs to manage other chronic diseases. Oil massage has been mentioned in many references of traditional medicine as a mechanism for stimulating sexual desire15. Qust (Cos- tus) oil is derived from Iranian books of traditional medi- cine. It contains bitter qust root, Chinese cinnamon, marjoram, valerian root, cloves, nutmeg fruit, Acorus cal- mus root, Ferula gummosa gum resin, olive oil, grape vine- gar, and water15According to traditional medicine, this product is muhalal and musakhan and a tonic for the nerves, organs, and sexual desire15When topically used, simple qust oil, which is the main part of this product, is a tonic for the nerves, organs, and sexual desire, a strong muhalal and re- liever of melancholic and phlegmatic fever and chills15Al- though it is mostly used to strengthen the nerves and organs, it was chosen in this study due to the effects of its constit- uent plants on sexual desire. Materials and Methods This was a double-blind, randomized, clinical trial on post- menopausal women aged 40-65 years with sexual dysfunc- tion visiting a traditional medicine center and Hazrat Rasool Akram Hospital, affiliated to Iran University of Medical Sciences. Sample size was calculated based on type-I error of 0.05 and study power of 80%. Since there was no information about the effect of this drug, and assuming the equality of the standard deviation (SD) of changes in sexual desire in the two groups, the effect size index and Cohen’s formula were used to determine the sample size, and the effect size was taken as 0.6. The sample size was thus estimated as 44 per group. After adding 20% attrition, the required sample size was in- creased to 55. Inclusion criteria Menopause (at least 1 year since the last menstruation), age 40 to 65 years, complaining of decreased sexual desire, hav- ing an emotionally satisfying relationship with a stable and sexually active husband within at least the last 6 months, normal pelvic examination, and providing informed consent for participation in the study. Exclusion criteria Vaginal infection, vaginal bleeding, a serious physical med- ical condition or chronic illness requiring constant care, consuming any chemical or herbal medicines known to af- fect sexual desire, smoking, or any substance abuse. Attrition criteria Breakdown of the satisfactory emotional relationship with the husband during the study, unwillingness to continue par- ticipating in the study, using other treatments for sexual dys- function or other problems during the study, low compliance or adherence to instructions, and developing skin allergy or other intolerable complications. The participants were selected from eligible women using convenience consecutive sampling. After explaining the ob- jectives of the study, the women who were willing to par- ticipate first reported their age, age of marriage, education level, and sexual functioning. Then, by block randomiza- tion, they were randomly assigned to the experimental or control groups. In the experimental group, qust oil (Tooba Company) was delivered to the patients, who were instructed to massage 20 drops on the pubic area, twice a day for 4 weeks, in a back and forth motion for 5 minutes (superficial and with- out pressure) and 3 drops on the perineum for 1 minute in a circular motion. In the control group, liquid paraffin (man- ufactured by Merck) was delivered to the patients, who were instructed to massage 20 drops on the pubic area, twice a day for 4 weeks, in a back and forth motion for 5 minutes (superficial and without pressure) and 3 drops on the perineum area for 1 minute in a circular motion. Both groups were followed up by phone every week to monitor their regular use of the drugs and to check any side effects. At the end of the fourth week, the two groups were again examined in terms of sexual functioning and severity of menopausal symptoms. The primary outcome was change in sexual desire, and the secondary outcome was arousal, lubrication, orgasm, satisfaction, pain during intercourse, and overall sexual function, as evaluated by the FSFI four weeks after the start of the intervention14. Data analysis SPSS v. 27 was used for the data analysis. Chi-square test and Fisher’s exact test were used in order to compare the - 9 - Non -co mmerc ial us e o nly Placebo-controlled effect of topical Qust (Costus) oil on postmenopausal women’s sexual desire disorder Eur J Transl Myol 34 (4) 12660, 2024 doi: 10.4081/ejtm.2024.12660 two groups in terms of qualitative variables (education level, occupation, and complications). In order to compare the group in terms of sexual functioning, the normality of the data distribution was first checked using the Kolmogo- rov-Smirnov test. Based on the test result and rejection of the null hypothesis of normal data distribution, Mann-Whit- ney U test was used to compare the two groups. The sig- nificance level was set at 95% (P<0.05). Results Among 120 postmenopausal women with sexual dysfunc- tion, ten were excluded due to not meeting the inclusion criteria, and 110 women were included in the study in two groups of 55. Three women from the experimental group and six from the control group dropped out during the study. Finally, 52 women in the experimental group and 49 in the control group remained until the final analysis (Figure 1). The mean and SD of the age of the participants was 54.35±5.06 years (range: 43-65 years) and the duration of marriage was 31.66±8.21 years (range: 1.47 years). In terms of education level, in both experimental and control groups, most of the participants had a high school di- ploma, followed by higher education. In terms of occupa- tion, in both groups, most women were homemakers. No significant difference was observed between the experi- mental and control groups in terms of occupation and edu- cation level (Table 1). There was no significant difference between the two groups in terms of sexual function before the treatment, except for satisfaction. The level of sexual satisfaction of the women was significantly lower in the experimental compared to the control group (p=0.039). After the intervention, significant differences were observed between the experimental and control groups in sexual functioning in the domains of sex- ual desire (p<0.001), arousal (p<0.001), orgasm (p<0.001), - 10 - Figure 1. CONSORT diagram of sample selection. Non -co mmerc ial us e o nly Placebo-controlled effect of topical Qust (Costus) oil on postmenopausal women’s sexual desire disorder Eur J Transl Myol 34 (4) 12660, 2024 doi: 10.4081/ejtm.2024.12660 satisfaction, and overall score (p<0.001). Meanwhile, no significant difference was observed in lubrication and pain during intercourse (Table 2, Figure 2). One woman (2.0%) from the experimental group had com- plications (hives), which improved with oral treatment. No complications were observed in the control group. No sig- nificant difference was observed between the two groups in the frequency of complications (p=0.485). Discussion In the present study, the topical use of qust oil by postmeno- pausal women with sexual dysfunction for four weeks sig- nificantly increased sexual desire, arousal, orgasm, satisfaction, and overall sexual functioning; however, no significant difference was observed in lubrication and pain during intercourse. The researchers’ search of electronic da- tabases yielded no relevant or similar papers that had used - 11 - Table 1. Frequency of the participants’ education level and occupation divided by group. Variable Group P-value Experimental number (%) Control number (%) Education level Below high school diploma 5 (9.6) 9 (18.4) 0.302 High school diploma 28 (53.8) 20 (40.8) Associate or bachelor’s degree 9 (17.3) 13 (26.5) Master’s degree or higher 10 (19.3) 7 (14.3) Total 52 (100) 49 (100) Occupation Homemaker 33 (63.5) 35 (71.4) 0.120 Self-employed 7 (13.5) 1 (2.0) Governmental employment 12 (23.1) 13 (26.5) Total 52 (100) 49 (100) Table 2. The mean and standard deviation of the pre-intervention sexual functioning score by group. Variable Group P-value Experimental Control Mean±sd Mean±sd Pre-intervention Desire 1.47±4.23 1.45±3.76 0.103 Arousal 3.08±7.40 2.74±8.73 0.283 Lubrication 2.73±9.47 2.95±9.68 0.667 Orgasm 2.28±7.07 2.72±6.65 0.293 Satisfaction 2.48±7.44 2.57±6.44 0.039 Pain during intercourse 2.71±8.03 2.54±7.67 0.380 Overall 11.59±44.67 13.51±41.94 0.277 Post-intervention Desire 1.31±6.13 1.53±4.41 0.001> Arousal 2.42±12.37 2.80±7.80 0.001> Lubrication 2.19±11.85 3.20±11.14 0.250 Orgasm 1.64±9.21 2.52±6.37 0.001> Satisfaction 1.66±10.08 2.24±7.32 0.001> Pain during intercourse 2.71±8.92 2.21±8.80 0.776 Overall 8.44±58.83 11.84±45.84 0.001> *Mann-Whitney U test. Non -co mmerc ial us e o nly Placebo-controlled effect of topical Qust (Costus) oil on postmenopausal women’s sexual desire disorder Eur J Transl Myol 34 (4) 12660, 2024 doi: 10.4081/ejtm.2024.12660 qust oil topically to treat women’s sexual dysfunction. Two human studies, i.e., carried out by Sadeghi et al. (2020) on the oral effect of carrot seed and by Akhtari et al. (2014) on the effect of Tribulus terrestris extract on reduced sexual desire in women of reproductive age, reported favorable re- sults in terms of increasing libido14, 16. Similarly, two human studies were conducted by Preedy et al. (2021) and Akbar et al. (2020) on the effect of olive oil and valerian (a com- ponent of qust oil), respectively. Preedy et al. (2021), who examined the effect of olive oil on physical health, observed that short-term massaging with olive oil can increase sexual desire17. Akbar et al. (2020) examined the effects of Valeri- ana jatamansi and found that the root of this plant increases libido while reducing anxiety, depression, seizures, head- aches, and menstrual cramps18 In-vitro animal studies have investigated the medicinal effects of qust oil or each of its components separately, yielding promising results19- 22.Muchtaromah (2020) examined the combined protective and therapeutic effects of three herbs, including garlic, tur- meric, and A. calmus (a component of qust oil), on mice. This combination increased the animal subjects’ endome- trial thickness, secretion of sex hormones, and fertility19 . Mehanna et al. (2020) examined the oil extract of marjoram (a component of qust oil) and observed that with its strong antioxidant effects, this substance increases spermatogen- esis and testosterone levels in male rats suffering tissue damage and necrosis of the testicular cells20. Mishra et al. (2016) examined clove extract (a component of qust oil) and showed that its administration at low doses (15 mg) has androgenic effects, increases testosterone levels, and rejuve- nates sex genes21. As can be observed, each component of qust oil has been examined in human and animal studies, showing androgenic effects and influencing the sex hor- mones, testosterone levels, fertility, and sexual function. Our study was conducted on a human sample, and instead of examining the individual effects of the mentioned me- dicinal plants, we studied their combined effect (valerian, marjoram, cloves, F. gummosa, olive, nutmeg, A. calmus, bitter qust, and Chinese cinnamon) through a product known as qust oil, which significantly improved the sexual functioning of postmenopausal women; it can be argued that these substances have had a synergistic effect. Another difference between the present study and most of the cited studies was the different method of qust oil administration (topical use via massage versus oral use). Regarding the positive effect of massage therapy on sex- ual desire, Chia et al. (2011) examined the therapeutic ef- fect of massage on sexual desire and reported that massaging the pubic area increases libido and sexual de- sire.22 Therefore, the therapeutic effects of qust oil alone in sexual dysfunction and its massaging on the pubic area may increase the effectiveness of this compound. Mean- while, this route of administration will have no side ef- fects potentially arising through oral consumption. As for other uses of qust oil, the results of studies have shown that rubbing qust oil on the pubic area is effective in treat- ing bed wetting in children23and urinary incontinence in women24. In two review studies and meta-analyses, Kar- imi et al. and Zalchour et al. investigated the effect of medicinal plants on sexual functioning. The review study by Karimi et al. (2023) in Iran carried out a systematic review of clinical trials to investigate the effect of medic- inal plants on sexual functioning in Iranian postmeno- pausal women. The studied plants included Ginkgo biloba, fennel, Hypericum perforatum, date palm pollen, Aphrodite, fenugreek, common hop, black cohosh, lav- ender, ginseng, saffron, red clover, T. terrestris, Nigella sativa, and Vitex agnus-castus, and combined aromather- apy (fennel, Heracleum persicum, common sage, bitter orange, lavender, and geranium). The results showed that most plants were effective in improving sexual function- ing25. In a review and meta-analysis by Zalchour et al. (2023), the effect of medicinal plants on the sexual func- tioning and satisfaction of postmenopausal women in Iran and other countries was investigated. The meta-analysis showed that herbal medicines significantly increase the overall sexual functioning score and the sexual satisfac- tion score of postmenopausal women26. To investigate the pharmacological and phytochemical properties of qust oil, Kumari et al. (2024) carried out a phytochemical analysis of the product in India and showed that Saussu- rea costus (Falc) Lipsch contains a large number of bio- active compounds, including sesquiterpenes, flavonoids, and essential oils, which are responsible for its numerous medicinal properties. Pharmacological studies have shown anti-inflammatory, antioxidant, anti-cancer, hep- atoprotective, and immune-modulating effects for this product. As a result, it is widely used in the treatment of diseases such as asthma, digestive disorders, and skin dis- eases. S. costus has significant therapeutic potential, mainly owing to its rich phytochemical composition. The convergence of its traditional uses and modern pharma- cological findings offers promising avenues for future re- search, especially in drug development and understanding its mechanism of action in various diseases27.According to the study by Bahrami et al. (2018) on the characteris- tics of thick vessels, energy channels, meridians, and - 12 - Figure 2. The mean and standard deviation of the post- intervention overall score of sexual functioning by group. Non -co mmerc ial us e o nly Placebo-controlled effect of topical Qust (Costus) oil on postmenopausal women’s sexual desire disorder Eur J Transl Myol 34 (4) 12660, 2024 doi: 10.4081/ejtm.2024.12660 chakras, it can be concluded that massaging and stimu- lating the second pair of the thick vessels lead to connec- tion and balance of the cephalo uterin axis and favorable results in the treatment of decreased sexual desire28. In the present study, no complications (itching, rash, burn- ing, or hives) were observed as a result of qust oil mas- saging on the pubic and perineal area, which suggests the safety of the topical use of qust oil to treat sexual dys- function in postmenopausal women. Conclusions In postmenopausal women with sexual dysfunction, mas- saging the pubic area and perineum with qust oil for at least four weeks has no side effects and significantly improves the components of desire, arousal, orgasm, and sexual sat- isfaction. List of abbreviations FSFI, Female sexual function index FSH, Follicle-Stimulating Hormone LH, Luteinizing Hormone Conflict of interest The authors declare no potential conflict of interest, and all authors confirm accuracy. Ethics approval The Ethics Committee of Iran University of Medical Sciences under the code of ethics IR.IUMS.REC.1402.378 . The Iranian Registers of Clinical Trial (lRCT) code IRCT 2023730058969NI. The study is conformed with the Hel- sinki Declaration of 1964, as revised in 2013, concerning human and animal rights. Informed consent All patients participating in this study signed a written in- formed consent form for participating in this study. Patient consent for publication Written informed consent was obtained from a legally au- thorized representative(s) for anonymized patient infor- mation to be published in this article. Availability of data and materials all data generated or analyzed during this study are included in this published article. Acknowledgements The authors express their gratitude to the Research and Technology Deputy of the university, the Faculty of Tradi- tional Medicine, the Traditional Medicine Center, and the participants, for their financial and non-financial support. The authors declare that they have no conflicts of interest. Corresponding author Elham Akhtari, Associate professor, Institute for Studies in Medical History, Persian and Complementary Medi- cine, Iran University of Medical Sciences, Tehran, Iran. ORCID ID: 0000-0003-4491-6443 E-mail: eli.akhtari@gmail.com Akram Fallah ORCID ID: 0009-0006-0356-4890 E-mail: Akram.fallah@gmail.com Fattaneh Hashem Dabbaghian ORCID ID: 0000-0003-0005-5792 E-mail: dabaghian.f@iums.ac.ir Amirhossein Jamshidi ORCID ID: 0000-0003-1310-1516 E-mail: jamshidi.ah@iums.ac.ir References 1. Nappi RE, Lachowsky M. Menopause and sexuality: prevalence of symptoms and impact on quality of life. Maturitas 2009;63:138-41. 2. Berek J. Berek & Novak Gynecology. Translated by Ghazijahani B, Zonuzi A, Bahrami N. Tehran, Iran: Golban publication; 2007: pp. 471-501. 3. Bagheriani N, Bahrami M, Kamalinejad M, et al. The effect of rheum ribes root (rhubarb) on menopausal hot flashes: a randomized double-blind, placebo-controlled trial. Res J Pharmacogn 2023;10:41-50. 4. 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