Table 2. Summary of included studies for the effects of topical application and oral intake of R damascena on adults’ acute pain.
| Authors | Study design | Participants | Sample size/ age (mean ± SD) | Intervention | Outcome/ study tool (measurement times) | Adverse events/ findings* | ||
|---|---|---|---|---|---|---|---|---|
| Study arms | Administration route | Administration dosage and duration; total dosage and duration† | ||||||
| Shirazi et al,35 | Triple-blind, placebo-controlled, 3-arm, parallel-group | Pregnant women with low back pain | I: 37/27.7 ± 0.8 C: 38/27.9 ± 0.7 |
I: R.D drop (essential oil in carrier of almond oil) + standard care C: Placebo drop (almond oil) + standard care |
Topical application* | 7 drops of each product (estimated as 0.7 mL), 2 times daily for 4 consecutive weeks; total dosage: 39 mL; total duration: 28 days | Pregnancy-related low back pain/VAS (baseline, 2nd week of intervention, 2 weeks after the end of intervention) | Mild allergic rhinitis/Sig. |
| Khatibi et al,32 | Double-blind, placebo-controlled, 2-arm, parallel-group | Females and males with minor aphthous ulcers | I: 50/30 ± 13.81 C: 50/24.5 ± 8.34 |
I: R.D drop + standard care C: Placebo drop (Diphenhydramine syrup) + standard care |
Topical application** | 10 drops of each product (estimated as 1 mL), 4 times daily for 1 week; total dosage: 28 mL; total duration: 7 days | Aphthous ulcer pain/VAS (baseline, 2nd, 4th, and 7th days of intervention) | Nrep./NS |
| Sadeghi Aval Shahr et al,36 | Single-blind, placebo-controlled, 3-arm, parallel-group | Female college students with PD | I: 25/26 ± 3.6 C: 25/24.6 ± 3.1 |
I: R.D drop (essential oil in carrier of almond oil) C: Placebo drop (almond oil) |
Topical application*** | 5 drops of each product (estimated as 0.5 mL) at the 1st day of menstruation for 2 subsequent MC; total dosage: 1 mL; total duration: 2 days | Menstrual-related abdominal pain/VAS (before and after intervention in 1st and 2nd MC) | Nrep./Sig. only at the 2nd MC |
| Hoseinpour et al,31 | Double-blind, placebo-controlled, 2-arm, parallel-group | Females and males with minor aphthous ulcers | I: 25/34.4 ± 9.6 C: 25/33.6 ± 14.4 |
I: R.D mouthwash C: Placebo mouthwash |
Topical application**** | 5 mL of each product, 4 times daily for 2 weeks; total dosage: 280 mL; total duration: 14 days | Aphthous ulcer pain/ perceived pain rating scale (baseline and 4th, 7th, 11th, and 14th days of intervention) | Nrep./Sig. only at 4th and 7th days |
| Farnia et al,28 | Double-blind, placebo-controlled, 2-arm, parallel-group | Opioid-dependent females with methadone-related sexual dysfunction | I: 25/38.92 ± 8.31 C: 25/38.72 ± 7.24 |
I: R.D soft gelatin capsule (filled with 2 mL essential oil) + standard care C: Placebo soft gelatin capsule (filled with 2 mL oil-water solution) + standard care |
Oral intake | One capsule of each product (estimated as 2 mL), daily for 8 consecutive weeks; total dosage: 112 mL; total duration: 56 days | Sexual-related pain/FSFI (baseline, 4th, and 8th weeks of intervention) | Nrep./NS |
| Davaneghi et al,26 | Double-blind, placebo-controlled, 4-arm, parallel-group | Females with PD | I: 27/22.63 ± 0.47 C: 25/22.08 ± 0.39 |
I: R.D hard gelatin capsule (filled with 800 mg R.D extract) + fish oil soft gelatin capsule (placebo) C: R.D hard gelatin capsule (filled with placebo) + fish oil soft gelatin capsule (placebo) |
Oral intake | One capsule of each product (estimated as 0.8 mL), daily from the first day of menstruation until 60 consecutive days; total dosage: 48 mL; total duration: 60 days | Menstrual-related headache and abdominal pain/VAS (baseline, 30th, and 60th days of intervention) | Nrec./NS |
| Ataollahi et al,24 | Double-blind, placebo-controlled, 2-arm, parallel-group | Female college students with PD | I: 55/21.41 ± 1.49 C: 55/21.38 ± 1.72 |
I: R.D oral drop C: Placebo drop (water and sugar) |
Oral intake | 10 drops of each product (estimated as 1 mL), 2 times daily during first 3 days of menstruation for 2 subsequent MC; total dosage: 12 mL; total duration: 6 days | Menstrual-related abdominal pain/McGill (baseline, end of 2nd MC) | Nrec./Sig. |
| Farnia et al,27 | Double-blind, placebo-controlled, 2-arm, parallel-group | Females with SSRI-induced sexual dysfunction | I: 25/32.45 ± 5.68 C: 25/34.02 ± 6.45 |
I: R.D soft gelatin capsule (filled with 2 mL essential oil) + standard care C: Placebo soft gelatin capsule (filled with 2 mL oil-water solution) + standard care |
Oral intake | One capsule of each product (estimated as 2 mL), daily for 8 consecutive weeks; total dosage: 112 mL; total duration: 56 days | Sexual-related pain/FSFI (baseline, 4th, and 8th weeks of intervention) | Nrep./NS |
| Bani et al,25 | Double-blind, placebo-controlled, 2-arm, cross-over groups | Female college students with PD | I: 46/22.20 ± 2.11 C: 46/22.13 ± 2.06 |
I: R.D hard gelatin capsule (filled with 200 mg R.D extract) C: Mefenamic acid capsule (250 mg) |
Oral intake | One capsule of each product (estimated as 0.2 mL), 4 times daily during first 3 days of menstruation for 2 subsequent MC; total dosage: 4.8 mL; total duration: 6 days | Menstrual-related abdominal pain/VAS (baseline and 1, 2, 3, 6, 12, 24, 48, and 72 hours after taking the first drug during 1st and the 2nd MC) | Nrep./NS |
| Jamilian et al,29 | Double-blind, placebo-controlled, 3-arm, parallel-group | Females with PMS | I: 40/25.93 ± 4.68 C: 40/26.56 ± 3.53 |
I: R.D oral drop C: Placebo drop (distilled water) |
Oral intake | 15 drops of each product (estimated as 1.5 mL), 2 times daily from 14 days before menstruation until end of menstruation for 3 subsequent MC; total dosage: 180 mL; total duration: 60 days | Menstrual-related headache/ DSRS (baseline, end of 3rd MC) | Nrec./NS |
| Mostafa-Gharabaghi et al,30 | Double-blind, placebo-controlled, 2-arm, parallel-group | Females undergoing C/S | I: 46/27.78 ± 4.04 C: 46/22.28 ± 5.04 |
I: R.D hard gelatin capsule (filled with 400 mg R.D extract) + standard care C: Placebo hard gelatin capsule (filled with 400 mg starch) + standard care |
Oral intake | 2 capsules of each product (each estimated as 0.4 mL); during 15 min before anesthesia; total dosage: 0.8 mL | Post-operative pain/VAS (baseline and 3, 6, 12, and 24 hours after surgery) | Nrep./Sig. |
| Frequency and dosage of administrated analgesics (baseline, end of intervention) | ||||||||
C: control; I: intervention; C/S: cesarean section; DSRS: daily symptom rating scale; DW: distilled water; FSFI: female sexual function index; MC: menstrual cycle; McGill: McGill pain questionnaire; min: minutes; nrep.: not reported; nrec.: not recorded; NS: not significant; PD: primary dysmenorrhea; PMS: premenstrual syndrome; R.D: rosa damascena; Sig.: significantly; SSRI: selective serotonin-reuptake inhibitors; VAS: visual analog scale.
† Ten drops and 1 mg of Rosa damascena was estimated as 1 mL and 0.001 mL, respectively.
*Products were self-administered topically for 100 cm2 of the painful part of the skin (without massage).
**Products were self-administered topically on the lesions using a sterile swab (without massage and after meals, and before sleep).
***Products were self-administered topically on the abdomen and then the abdomen was massaged by clockwise circular movements for 15 min.
****Products were swished around the mouth for 30 seconds and then were expelled (preferably after oral-hygiene procedures).
*Significantly lower in the intervention group compared to the comparison group after the intervention.