The possible "calming effect" of subchronic supplementation of a standardised phospholipid carrier-based Melissa officinalis L. extract in healthy adults with emotional distress and poor sleep conditions: results from a prospective, randomised, double-blinded, placebo-controlled clinical trial.
Aasiya Bano,
Piril Hepsomali,
Fazle Rabbani,
Umer Farooq,
Ayesha Kanwal
et al.
Other
Frontiers in pharmacology
2023
11 sitasi
PubMed
DOI
CC-BY
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Study Design
- Jenis Studi
- randomized controlled trial
- Ukuran Sampel
- 100
- Durasi
- 3 weeks
- Intervensi
- The possible "calming effect" of subchronic supplementation of a standardised phospholipid carrier-based Melissa officinalis L. extract in healthy adults with emotional distress and poor sleep conditi 200 mg twice daily (400 mg/day) for 3 weeks
- Pembanding
- Placebo
- Arah Efek
- Positive
- Risiko Bias
- Low
Abstract
Background: Emotional distress conditions such as depression, anxiety, stress, and poor sleep are widespread health problems that have a significant impact on people's lives. Conventional drugs are commonly prescribed to treat emotional distress and poor sleep conditions; however, these medications have several limitations and have shown multiple side effects. Over recent years botanicals-based pharmacological agents have gained increasing research and clinical interest in the management of emotional distress and sleep disorder. Of note, Melissa officinalis L. (MO) leaf extract has demonstrated considerable neuropharmacological properties both in animal and human studies and has emerged as a promising natural "calming agent." However, research in this area is limited, and more studies are needed to validate its efficacy in amelioration of emotional distress and poor sleep conditions. Objectives: We aimed to assess the pharmacological effects of subchronic supplementation of an innovative standardised phospholipid carrier-based MO aqueous extract on emotional distress and poor sleep conditions. Design: A 3-week prospective, randomised, placebo-controlled, parallel-group, double-blinded clinical trial was conducted in 100 healthy adults complaining of a moderate degree of depression, anxiety, or stress, with scores of ≥14, ≥10, and ≥19, respectively, in the self-report Depression, Anxiety, and Stress Scale (DASS-42) or poor sleep, as indicated by the score of >5 in the Pittsburgh Sleep Quality Index (PSQI) scale. In addition, the impact of emotional distress and/or poor sleep on participants' mental wellbeing, emotional feelings, and quality of life was also assessed using the self-reported Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), Positive and Negative Affect Schedule (PANAS) scale, and quality of life (WHO-QoL-BREF) scale, respectively. Results: Oral supplementation of 200 mg of phospholipid-based MO aqueous extract (Relissa™) tablets twice a day (i.e., 400 mg/day) for 3 weeks led to significant improvements in the depressive mood, anxiety, stress, positive and negative affect (emotional feelings), overall mental wellbeing, and quality-of-life scores (all p values <0.001). Supplementation of MO extract was well tolerated, and no treatment-emergent effects or serious adverse events were reported. Conclusion: According to the results of this study, the phospholipid carrier-based MO aqueous extract possesses considerable neuropharmacological properties, and its supplementation may provide a promising therapeutic option for the management of moderate emotional distress and/or poor sleep conditions. Clinical Trial Registration: clinicaltrials.gov, identifier NCT05602688.
Full Text
Figures
FIGURE 1
CONSORT flow diagram for the randomized, double-blinded, placebo-controlled trial of standardised phospholipid carrier-based Melissa officinalis extract in adults with emotional distress and poor sleep conditions.
flowchart
FIGURE 2
Changes in anxiety, depression, and stress scores over the supplementation period, comparing the Melissa officinalis extract group to placebo. The results suggest a calming effect associated with the botanical intervention.
chart
FIGURE 3
Sleep quality assessment using validated instruments (such as PSQI or ISI) in participants receiving Melissa officinalis versus placebo, indicating improvements in subjective sleep parameters.
chartTables
TABLE 1
| Emotional distress status | Depression score | Anxiety score | Stress score |
|---|---|---|---|
| Normal | 0–9 | 0–7 | 0–14 |
| Mild | 10–13 | 8–9 | 15–19 |
| Moderate | 14–20 | 10–14 | 19–25 |
| Severe | 21–27 | 15–19 | 26–33 |
| Extremely severe | 28+ | 20+ | 34+ |
TABLE 2
| Supplement ( | Placebo ( | t/U/χ2 |
| |
|---|---|---|---|---|
| Sex (men/women), | 24/28 | 12/36 | 4.85 |
|
| Age (M ± SD) years | 30.96 ± 8.62 | 31.04 ± 9.84 | 1221.50 | 0.855 |
| BMI (M ± SD) kg/m2 | 23.80 ± 4.42 | 23.89 ± 4.20 | −0.104 | 0.918 |
| Marital status (married/single) | 33/19 | 30/18 | 0.01 | 0.921 |
| Residence (urban/rural) | 34/18 | 37/11 | 1.66 | 0.198 |
TABLE 3
| Measure | Group |
| Baseline score (M ± SD) |
| Follow-up score (M ± SD) |
| (Group × Time) |
|---|---|---|---|---|---|---|---|
| Mental Health DASS-42 | |||||||
|
| Supplement | 52 | 23.3 ± 7.9 | 0.676 | 6.9 ± 4.5 |
|
|
| Placebo | 48 | 22.7 ± 8.1 | — | 17.1 ± 8.7 | — | — | |
| Anxiety | Supplement | 52 | 22.2 ± 7.2 | 0.498 | 6.7 ± 3.8 |
|
|
| Placebo | 48 | 21.1 ± 8.0 | — | 15.9 ± 7.3 | — | — | |
| Stress | Supplement | 52 | 26.3 ± 7.7 | 0.860 | 8.2 ± 4.8 |
|
|
| Placebo | 48 | 26.1 ± 6.9 | — | 20.0 ± 9.4 | — | — | |
| WEMWBS | Supplement | 52 | 34.5 ± 9.5 | 0.070 | 50.0 ± 9.0 |
|
|
| Placebo | 48 | 37.8 ± 8.3 | — | 41.1 ± 9.8 | — | — | |
| PANAS | |||||||
|
| Supplement | 52 | 12.9 ± 3.2 | 0.172 | 18.0 ± 3.0 |
|
|
| Placebo | 48 | 13.8 ± 3.0 | — | 14.8 ± 3.4 | — | — | |
| Negative affect | Supplement | 52 | 18.2 ± 3.1 |
| 11.0 ± 3.2 |
|
|
| Placebo | 48 | 16.5 ± 4.6 | — | 15.0 ± 4.6 | — | — | |
| Sleep quality | |||||||
|
| Supplement | 52 | 10.9 ± 4.3 |
| 3.5 ± 2.6 |
|
|
| Placebo | 48 | 8.6 ± 3.8 | — | 6.6 ± 3.3 | — | — | |
| Quality of life | |||||||
|
| Supplement | 52 | 5.0 ± 1.3 |
| 7.3 ± 1.3 |
|
|
| Placebo | 48 | 6.0 ± 1.4 | — | 6.4 ± 1.5 | — | — | |
| Physical | Supplement | 52 | 17.9 ± 3.2 | 0.106 | 23.5 ± 3.0 |
|
|
| Placebo | 48 | 19.0 ± 3.3 | — | 20.0 ± 3.5 | — | — | |
| Psychological | Supplement | 52 | 15.5 ± 4.0 |
| 19.3 ± 3.6 |
|
|
| Placebo | 48 | 17.1 ± 2.7 | — | 17.4 ± 2.7 | — | — | |
| Social | Supplement | 52 | 8.1 ± 2.3 | 0.082 | 10.8 ± 2.3 |
|
|
| Placebo | 48 | 8.9 ± 2.0 | — | 9.5 ± 2.2 | — | — | |
| Environmental | Supplement | 52 | 17.2 ± 5.6 |
| 22.5 ± 8.3 | 0.710 |
|
| Placebo | 48 | 21.9 ± 6.2 | — | 22.0 ± 6.2 | — | — | |
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