A preliminary assessment of a combination of rhodiola and saffron in the management of mild–moderate depression

Figures & data

Figure 1 Flow diagram.

Abbreviations: GP, general practitioner; mITT, modified intention-to-treat; D42, day 42; PP, per protocol.

Table 1 Patient characteristics

	Safety population (n= 45)	PP population (n=37)
Women	37 (82.2%)	30 (81.1%)
Men	8 (17.8%)	7 (18.9%)
Age (years)	47.6±14.6	47.0±14.2
Patient history of depression	20 (44.4%)	16 (43.2%)
Family history of depression	7 (15.6%)	7 (18.9%)
Duration of ongoing depressive episode (months)	4.4±4.5	4.0±3.6
Surgery or medical historya	18 (40.0%)	15 (40.5%)

Note:

a Patients who declared having suffered or suffering from at least one disease other than depression.

Abbreviation: PP, per protocol.

Figure 2 Patients’ distribution into HRSD classes at day 0 (D0) and D42 (% [n], modified intention-to-treat population).

Abbreviation: HRSD, Hamilton Rating Scale for Depression.

Figure 3 Evolution of HADS anxiety (A) and HADS depression (B) scores between day 0 (D0; n=40, mITT population) and D42 (n=39).

Notes: Data shown as mean ± SEM. *P<0.05, ***P<0.0001 versus D0.
Abbreviations: HADS, Hospital Anxiety and Depression Scale; mITT, modified intention-to-treat.

Figure 4 Evolution of patients’ distribution into HADS classes between day 0 (D0) and D42 (% [n]; modified intention-to-treat population).

Abbreviation: HADS, Hospital Anxiety and Depression Scale.

Table 2 CGI and PGIC scores in the mITT population

CGI-S	D0	D42	CGI-I	D42
Normal, not at all ill	2.4% (1/41)	51.2% (21/41)	Very much improved	56.1% (23/41)
Borderline	4.9% (2/41)	21.9% (9/41)	Much improved	21.9% (9/41)
Mildly ill	17.1% (7/41)	12.2% (5/41)	Slightly improved	12.2% (5/41)
Moderately ill	39.0% (16/41)	12.2% (5/41)	No change	7.3% (3/41)
Markedly ill	36.6% (15/41)	2.4% (1/41)	Minimally worse	2.4% (1/41)
PGIC		D14	D28	D42
Worsening		2.6% (1/39)	0	0
No change		2.6% (1/39)	12.5% (5/40)	7.7% (3/39)
Almost the same, hardly any change		12.8% (5/39)	7.5% (3/40)	10.3% (4/39)
A little bit better, but no noticeable change		20.5% (8/39)	10% (4/40)	5.1% (2/39)
Somewhat better, but change does not make any real difference		5.1% (2/39)	7.5% (3/40)	2.6% (1/39)
Better, moderate change, but noticeable		41% (16/39)	12.5% (5/40)	20.5% (8/39)
Better, with a definite improvement that makes the difference		12.8% (5/39)	35% (14/40)	15.4% (6/39)
A great deal better, and a considerable improvement that makes all the difference		2.6% (1/39)	12.5% (5/40)	33.3% (13/39)
Complete recovery		0	2.5% (1/40)	5.1% (2/39)

Abbreviations: CGI-S, Clinical Global Impression – severity; PGIC, Patient Global Impression of Change; mITT, modified intention to treat.