Thyroid nodule reduction with spirulina, curcumin and boswellia? Perhaps.

Relation

Stancioiu F, Mihai D, Papadakis GZ, Spandidos DA, Badiu C. Treatment of benign thyroid nodules with a combination of natural extracts.Mol Med Rep.2019;20(3):2332-2338.

Study objective

To determine whether a combination of spirulina, curcumin andBoswelliareduces the size of benign thyroid nodules

Draft

Prospective, double-blind, placebo-controlled, cross-over clinical study lasting 12 weeks

intervention

Placebo or a combination of spirulina (400 mg)/curcumin (50 mg)/Boswellia(50 mg) per capsule. No further information on extract form/strength is provided in the study. The dose was 2 capsules twice daily about 30 minutes before breakfast and lunch.

Participant

There were 34 participants; half (17) of the participants received active agents (AI) and half (17) placebo (P).

Inclusion criteria

Adult patients over 18 years of age; euthyroid state (within normal limits: thyrotropin [TSH] and free thyroxine 4 [FT₄]); no active dysfunctional thyroid disease; single benign thyroid nodule (between 2-5 cm) confirmed by fine needle aspiration biopsy (FNAB); no previous thyroid surgery, thyroid ablation treatment, or thyroid hormone replacement treatment; no treatment with steroids or beta-blockers; Presence of 1 or more thyroid nodules documented by ultrasound.

Exclusion criteria

Age under 18 years, diagnosis of suspected malignancy, Wilson's disease, hypo/hyperthyroidism, contraception with an intrauterine device (IUD), acute infection or known allergy to spirulina, curcumin orBoswellia.

Study parameters assessed

The following parameters were assessed at 3 time points:

• Baseline (V1): Schilddrüsen-Ultraschall (U/S) und TSH, FT₄und Serumkupferspiegel aus der Blutabnahme.
• Woche 6 (V2): 17 Patienten, die zuvor mit P behandelt wurden, erhielten AI; 12 der 17 Patienten, die zuvor AI erhielten, erhielten P; und 5 zufällig ausgewählte AI-Patienten blieben bei AI. U/S und Labors wiederholt.
• Woche 12 (V3), das war der letzte Besuch mit abschließender U/S und Blutabnahme: 17 Patienten hatten P-AI erhalten, 12 Patienten hatten AI-P erhalten und 5 Patienten hatten AI-AI erhalten. U/S und Labors wiederholt.

Primary outcome measures

Primary outcome: Change in the size of the participant's thyroid nodule, measuring both the largest and smallest diameters at the same angle of incidence each time and multiplying these to arrive at an estimate of the area (size = D x d).

Secondary outcome: serum levels of TSH, FT₄and serum copper to see if a change occurred.

Key insights

Primary outcome: Comparison of nodal area at each time point revealed an overall decrease; V1 was 4.38 ± 3.14 cm2; V2 3.87 ± 2.79 cm2; and V3 3.53±2.84 cm2 (P<0.04).

Of the total 34 subjects enrolled, 29 (85.29%) had a decrease in thyroid nodule size of 5% or more at the end of the study; Twenty-two patients experienced decreases of 10% or more after 3 months. One patient had an insignificant decrease in nodule size and 4 patients had an increase in their nodule size.

In some scenarios, it is important to reduce benign thyroid nodules to avoid surgery, but there are several parameters that dictate this.

Statistical analysis showed that the patients with AI had a reduction of 0.611 cm2 ± 0.933 (SD), but the authors report N = 39, although only 34 people completed the study. Placebo administration (n = 29) had a mean decrease of 0.178 cm2 ± 0.515 (SD). The reason for the 5 randomly selected subjects not switching from AI to P was not explained and may have biased the statistics and comparison between groups.

Practice implications

In some scenarios, it is important to reduce benign thyroid nodules to avoid surgery, but there are several parameters that dictate this. Most clinicians know that a lump is generally monitored until it meets certain criteria for surgery. The American Association of Clinical Endocrinology (AACE) guidelines.¹Divide thyroid nodules into 3 classes:

• Klasse 1 – Schilddrüsenläsion mit geringem Risiko. Meist zystische, isoechoische/spongiforme Knoten, regelmäßiger Halo.
• Klasse 2 – Schilddrüsenläsion mit mittlerem Risiko. Leicht echoarme Knötchen oder isoechoische Knötchen mit Rändern, die eiförmig, rund und glatt oder schlecht definiert sind; Vaskularisierung; Randverkalkungen; und echoreiche Flecken.
• Klasse 3 – Hochrisiko-Schilddrüsenläsionen. Ausgeprägte Hypoechogenität, Mikroverkalkungen, größer als breit, ungleichmäßige Ränder und Hinweise auf extrathyreoidales Wachstum/Adenopathie.

FNAB is recommended for high-risk U/S thyroid lesions >10 mm; mean US risk >20 mm; low risk US > 20 mm and increasing size.

This study suggests that using a Spirulina/Curcumin/BoswelliaExtract for 3 months can reduce the size of benign thyroid nodules. Unfortunately, the study was funded by a company that will be releasing this in a combination product in the future. Although no researchers appeared to be associated with the company, the study was funded by that company; Therefore, some bias for positive results may exist.

The exact formulation of the natural active ingredients in the capsule was not clear in this study. Although spirulina is believed to be a dried powder of the whole algae, there are many different types of curcumin andBoswelliaExcerpts. The low dose used in this particular formula may or may not be explained by the extraction process, the amount of active ingredients (e.g. boswellic acids). This study is difficult to replicate and validate without the specifics of the extractions used.

If thyroid nodule reduction is a helpful, beneficial outcome, this study seems to suggest that the study supplement was effective.