P0755 - Saffron: A Promising Adjuvant Therapy in Ulcerative Colitis - A Trial Evaluating Clinical and Laboratory Outcomes

Sunday, October 22, 2023

3:30 PM – 7:00 PM PT

Location: Exhibit Hall

Has Audio

Presenting Author(s)

Roham Salman Roghani, MD

Eisenhower Health
Rancho Mirage, CA

Roham Salman Roghani, MD¹, Farzad Jalili, MD², Majid Emtiazi, MD², Mohammad kazem Amirbeigy, MD², Hassan Salmanroghani, MD³, Hassan Brim, PhD⁴, Hassan Ashktorab, PhD⁴
¹Eisenhower Health, Rancho Mirage, CA; ²Shahid Sadoughi University of Medical Sciences, Yazd, Yazd, Iran; ³Shahid Sadoughi University of Medical Sciences, Blacksburg, VA; ⁴College of Medicine, Howard University, Washington, DC

Introduction: Ulcerative Colitis (UC) is a chronic inflammatory bowel disease (IBD) characterized by recurrent inflammation of the colonic mucosa. The existing immunosuppressive treatments for UC have adverse side effects, leading to the exploration of alternative therapeutic options. In recent years, there has been growing interest in the potential role of dietary and nutritional interventions as adjuvant treatments for UC. Saffron, a spice derived from the Crocus sativus flower, has shown promising anti-inflammatory and anti-oxidant properties in preclinical models of IBD. This study aims to evaluate the clinical and laboratory response of patients with mild to moderate UC to the addition of saffron to conventional treatment.

Methods: This clinical trial took place at Sadoughi Hospital, a university-based facility. Twenty-seven patients >18 years with UC in remission and fecal calprotectin levels >50 μg/mg were randomly assigned to one of three arms: placebo, low-dose (25 mg), or high-dose saffron (50mg), two times a day for 8 weeks in addition to their standard treatment. Laboratory markers including hemoglobin, platelet levels, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and fecal calprotectin along with clinical data such as simple clinical colitis activity index (SCCAI), partial Mayo score, and Hamilton anxiety score (HAM-A) were recorded at baseline and completion of treatment. The study was approved by Ethical committee, including obtaining informed consent. Univariant analysis was used to compare the post treatment outcomes to their baseline.

Results: All 27 patients successfully completed the study. The basic characteristics of the participants in the different treatment groups are summarized in Table 1. While the HAM-A score and fecal calprotectin significantly improved in both the high (p=0.001 and 0.009, respectively) and low dose groups (p= 0.01 and 0.039, respectively), the SCCAI (p=0.04), Partial Mayo score (p=0.01), and CRP (p =0.001) showed significant improvement only in the high dose group compared to their baseline (Table 1). No adverse drug events were reported during the study.

Discussion: Saffron demonstrates promising results in UC, improving both clinical and laboratory outcomes. As an adjuvant treatment, it has the potential to enhance therapeutic efficacy and minimize the reliance on immunosuppressant drugs that associate with side effects.

Figure: Figure 1. Pre and post-treatment clinical and laboratory variables among the treatment groups.
*p <0.05.

Basic characteristics			Placebo N=8		Low dose N=9		High dose N=10
Age (mean ± SD)			36.25 ± 7.13		32.22 ± 5.71		39.8±9.76
Female Sex, n (%)			4(50%)		5(55%)		7(70%)
Smoking, n (%)			2(25%)		1(11%)		0(0%)
Body mass index (mean ± SD)			24.88 ± 2.41		23.50 ± 2.32		24.77±3.63
Disease duration (mean ± SD)			5.13 ± 1.81		3.67 ± 1.58		4.2±1.54
Clinical variable
SCCAI (mean ± SD)	Base line	P value	2.25±1.175	0.999	2.44±2.00	0.312	2.50±1.29	0.046
	Post treatment		2.25±1.175		2.00±1.32		1.6±0.51
Partial Mayo score (mean ± SD)	Base line	P value	1.87±1.55	0.687	2.00±1.58	0.750	2.00±1.15	0.015
	Post treatment		1.62±1.40		1.77±1.09		1.00±0.81
HAM-A (mean ± SD)	Base line	P value	18.37±8.22	0.140	15.55±5.38	0.011	17.80±4.82	0.001
	Post treatment		15.87±8.14		11.77±3.34		10.80±3.67
Laboratory variable
CRP (mean ± SD)	Base line	P value	4.94±3.30	0.218	3.92±2.02	0.437	4.22±1.74	0.001
	Post treatment		4.48±3.59		3.1±2.09		2.71±0.82
ESR (mean ± SD)	Base line	P value	22.12±13.57	0.875	23.88±19.45	0.738	25.40±20.78	0.154
	Post treatment		23.87±12.81		20.88±10.88		19.40±9.74
Fecal calprotectin (mean ± SD)	Base line	P value	285.93±172.47	0.843	396.68±333.88	0.039	288.79±139.32	0.009
	Post treatment		290.62±180.10		329.53±265.59		192.93±75.99
Hemoglobin (mean ± SD)	Base line	P value	11.76±1.83	0.015	12.65±1.5	0.984	12.12±1.95	0.054
	Post treatment		12.02±1.83		12.61±1.2		12.34±1.66

Table: Table 1. Basic characteristics, clinical variables, and laboratory variables among the study participants in different groups.

Disclosures:

Roham Salman Roghani indicated no relevant financial relationships.

Farzad Jalili indicated no relevant financial relationships.

Majid Emtiazi indicated no relevant financial relationships.

Mohammad kazem Amirbeigy indicated no relevant financial relationships.

Hassan Salmanroghani indicated no relevant financial relationships.

Hassan Brim indicated no relevant financial relationships.

Hassan Ashktorab indicated no relevant financial relationships.

Roham Salman Roghani, MD¹, Farzad Jalili, MD², Majid Emtiazi, MD², Mohammad kazem Amirbeigy, MD², Hassan Salmanroghani, MD³, Hassan Brim, PhD⁴, Hassan Ashktorab, PhD⁴. P0755 - Saffron: A Promising Adjuvant Therapy in Ulcerative Colitis - A Trial Evaluating Clinical and Laboratory Outcomes, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.