The Effects of Spirulina (Arthrospira Platensis) Dietary Supplement As An Adjunct Therapy For Children Aged 7–14 Years Old With Asthma: A Randomized – Double Blind Placebo Controlled Clinical Trial
Lou Ver Leigh A. Manzon-Reyes, Agnes M. Gonzalez-Andaya
Sep 2017 DOI 10.35460/2546-1621.2017-0051
INTRODUCTION
Asthma is the most prevalent chronic disease in children. It is estimated to affect more than 20% of the population in industrialized countries. (1) Establishing asthma control is a cornerstone of therapy. Standard treatment for asthma includes inhaled β2 agonists and inhaled corticosteroids. (2) Newer classes of medications have been developed that target mediator release and modify biologic response. Although current therapies are effective in controlling daily asthma symptoms, continuous and long term treatment with corticosteroids may pose significant adverse effects, especially in children.
The use of complementary and alternative medicine (CAM) for asthma has been gaining popularity since the 1990s. Multiple herbal medicines and dietary supplements have made positive claims in controlling asthma symptoms. Common CAM medications studied include linden, thyme, stinging nettle, mixed herbal teas, rosehip, and garden sage. (3-5)
The dietary supplement Spirulina (Arthrospira platensis) is a filamentous blue-green alga that flourishes in various aquatic environments at extremely high pH. (6) This cyanobacterium has C-phycocyanin as its main active ingredient which has been shown to possess numerous potential health benefits. (7,8) Due to its high nutritional content and easy digestability, it has been commercialized as a dietary supplement and has been used for nutritional build-up of undernourished children. It contains 70% protein, various minerals, vitamins, amino acids, essential fatty acids, carbohydrates, sterols, and blue pigments (phytocyanins) which help to increase body protein and iron availability and helps lower cholesterol and lipid contents. (9) Spirulina has also demonstrated anti-carcinogenic and anti-inflammatory effects. (10-12)
The anti-inflammatory effect of Spirulina has been demonstrated by its capacity to inhibit histamine release from mast cell–mediated allergic reactions. The mechanism of action of Spirulina is likely related to the prevention of calcium release from mast cell stores after elevation of intracellular cAMP level brought about by cAMP phosphodiesterase inhibition. (13) Previous studies in allergic rhinitis have demonstrated that Spirulina can suppress interleukin 4 (IL-4), thereby inhibiting the T helper 2 (TH2) synthesis of immunoglobulin E (IgE). (14,15) C-phycocyanin can selectively inhibit the activity of cyclooxygenase, which is a critical enzyme in the biosynthesis of prostaglandins and, it displays antioxidative and free radical scavenging properties that may contribute to its anti-inflammatory effects. (16) In addition, Spirulina has also been shown to have protective effects on orally induced food allergy by increasing immunoglobulin A (IgA) antibody and preventing increase in IgE. (17)
The effects of Spirulina in patients with allergic disease have been documented. In a study by Evets et al., 270 children given five grams per day of Spirulina tablets for six weeks resulted in the normalization of IgE levels and reduced allergic symptoms. (18) In a study by Cingi et al., two grams of Spirulina daily for six months significantly improved the symptoms of allergic rhinitis compared with the placebo group (P< 0.001). (19) Mao et al., reported that allergic patients consuming two grams of Spirulina daily for 12 weeks had reduced production of IL-4 thereby suppressing the differentiation of TH2 cells. (20) In a study by Labhe et al., one gram of Spirulina administered daily for two months significantly optimized improvement of bronchial asthma when taken together with asthma medications. (21)
To date, local data on the effects of Spirulina among the pediatric age group suffering from allergic disorders are limited. The demonstrable potential benefits and safety profile of Spirulina among the older population with allergic disorders may extend to younger allergic patients and may thus provide an additional option of treatment for them.
The aim of this study was to determine the effects of Spirulina supplementation on asthma control among children aged 7-14 years old as to symptom scoreusing the Asthma Control Test (ACT) and the Composite Asthma Severity Index (CASI) and to determine lung function test among asthmatic patients.
METHODOLOGY
The study was a randomized, double-blind, placebo-controlled trial that was conducted at the University of Santo Tomas Hospital (USTH) Outpatient Department. This study was conducted in compliance with the ethical principles of the Declaration of Helsinski and with Good Clinical Practice guidelines. Written informed consent was obtained from all subjects. The protocol was approved by the Institutional Review Board (IRB) of the USTH.
Thirty nine subjects aged 7 to 14 years old with mild to moderate persistent asthma were included. The diagnosis and classification of asthma were based on the Global Initiative for Asthma guidelines and National Asthma Education and Prevention Program’s Expert Panel Report 3 (EPR-3), respectively. (22)
Subjects presenting with any of the following were excluded from participating in the study: severe persistent or uncontrolled asthma, unremitting chronic illness other than asthma, use of oral or inhaled corticosteroid for more than six months, concurrent chemotherapy or immunosuppressive therapy, on immunotherapy, spirulina or similar herbal supplement intake within six months prior to the time of consult, unlikely compliance with study procedures.
Data on family history of atopy, allergy or asthma, living conditions, environmental and tobacco/cigarette smoke exposure were obtained. Medications taken by the patient and duration of intake were thoroughly investigated. Only short acting β2 agonist (SABA), oral steroids, inhaled corticosteroids or combination of inhaled corticosteroid with long acting β2 agonist (LABA) and systemic steroids were allowed as medications for mild to moderate persistent asthma among patients enrolled in this study.
Asthma Control Test(ACT) and Composite Asthma Severity Index (CASI) were utilized to assess severity of asthma symptoms in participants.
The ACT score is a reliable and validated tool that measures asthma control. The five-item questionnaire consists of four symptoms (wheezing, coughing, shortness of breath, chest tightness), need for rescue inhaler or nebulizer medication and a patient self-assessed level of control in the past four weeks. Total score ranges from five to 25. A score below the cut-off point of 19 indicates poor asthma control. (23)
The CASI is another validated tool that measures asthma control and provides quantification of asthma severity. The CASI score incorporates the five domains of day symptoms and salbutamol use, night symptoms and salbutamol use, controller treatment, lung function measures, and exacerbations. The maximum possible score is 20 indicating poor asthma control and disease severity. (24)
Clinical evaluations using the different scoring systems were performed solely by the primary investigator throughout the study period.
All study participants may withdraw from the study any time at their own request or at the responsible discretion of the investigator. Patients who were not able to commit to follow-up visits or signified inability to comply with taking the daily Spirulina supplement or placebo were automatically not included, but follow-up care was still provided for them. Those who have completed treatment for one to two months and consequently withdrew their participation from the study were included in the intention-to-treat group. Subjects who withdrew from the study were immediately replaced by new participants only up to the fifth month of the study period, i.e., patients who withdrew from the study after this date was not anymore replaced.
Spirometry using the KoKo Spirometer with a Fleisch-type pneumotach was performed on all patients. The following parameters were measured: forced expiratory volume at 1 second (FEV1), forced vital capacity (FVC), the ratio of FEV1 to FVC (FEV1/FVC) and peak expiratory flow rate (PEFR).
Each subject enrolled into the study was assigned a subject identification number. Patients were randomized on a 1:1 basis (computer-generated randomization list) to receive the proprietary Spirulina-based dietary supplement, CELLIFE (Pharmaceia Jimenez) or placebo.(25) Based on the manufacturer’s recommended dose, children aged 7 to 10 years old received two tablets of Spirulina 250 mg twice a day, which was equivalent to 1,000 mg per day, while those aged 11 to 14 years old received four tablets twice a day, which was equivalent to 2,000 mg per day. The placebo group took tablets that were color-matched and of the same weight as Cellife, but was made of inert material and without nutritional content. Medicines were placed in color-matched bottles labelled with coded numbers unknown to the patient or the investigator. Pharmaceia Jimenez Corp. CELLIFE was duly authorized to keep the codes confidential, but codes were broken in cases of emergency or a serious adverse event.
Each patient was instructed to take the study medication daily for three months, without discontinuing any of their regular medications for asthma. Study medications were dispensed upon inclusion in the study (baseline or week 0) and during subsequent visits, scheduled at weeks 2, 4, 8 and 12 after enrollment. Any unused study drug previously dispensed was asked to be returned on their next visit. Any participant found to be taking 20% more or less than the prescribed study medication were counseled on the importance of following their recommended dosing schedule. With each follow-up visit, review of symptoms, ACT and CASI scoring, physical examination and spirometry were carried out. Furthermore, post-supplementation follow-up of symptoms and physical examination were done for each subject at four, five and six months from beginning of treatment. (Figures 1) summarizes the methodology.
Data was encoded and analyzed using SPSS v10. Descriptive statistics was generated for all variables. For nominal data, frequencies and percentages were computed. For numerical data, mean and standard deviations (SD) were generated. Paired T-test was applied to asthma symptom scores, and Wilcoxon signed rank test to measures of pulmonary function, to compare before and after treatment values. In detecting overall differences over time, repeated measures ANOVA was used on pulmonary function tests, and Friedman test (nonparametric counterpart) on asthma scores.
During data collection, the participants were monitored for any adverse events, regardless of the treatment group they belonged to. Possible adverse effects associated with intake of Spirulina include diarrhea, constipation, and allergic reactions (e.g. rashes). Occurrence of any adverse event was reported immediately to the primary investigator and IRB. Sufficient information were obtained by the investigator to assess causality and these were followed-up until the event or its sequelae have resolved or stabilized to an acceptable level. Emergency medical treatment was provided free for subjects when needed.
RESULTS
Thirty-nine patients with bronchial asthma, ranging between 7 to 14 years, were enrolled in the clinical trial from October 2013 to June 2014. The subjects were randomly divided into two groups wherein 20 subjects received the proprietary Spirula-based dietary supplement and 19 subjects received the placebo supplement. The sociodemographic characteristics of gender, age, weight, height, body mass index and medical history were not significantly different between the two groups Table 1.
Effect of Spirulina and placebo on ACT and CASI scores
After three months of supplementation, improvement in the median ACT scores was observed in both the Spirulina (score of 14.5 to 22,P< 0.0001) and placebo groups (score of 18 to 20, P = 0.019). However, CASI scores decreased after three months of supplementation for both groups, but these changes were not statistically significant Table 2.
Post-supplementation, the Spirulina group remained to have significantly higher ACT scores than placebo group (from score of 15 to 25 versus 18 to 20, P < 0.0001; Figure 2).
At two months from baseline, median CASI scores fell from seven to three in both groups. CASI scores in the Spirulina group significantly decreased further to two at one month post-supplementation before it finally levelled off (P < 0.0001; Figure 3).
Effect of Spirulina and placebo on pulmonary function tests
After three months of suplementation, pulmonary function test results improved from baseline in both groups. However, significant changes were only found in the FEV1 (P = 0.014), FVC (P = 0.008), and PEFR (P = 0.0001) of the Spirulina group compared to placebo (Table 3). At the beginning of supplementation, FEV1 performance of the Spirulina group was slightly lower than that of placebo, but a trend reversal was reached by the second month. From then on, the Spirulina group showed siginificant improvement in FEV1 over the next four months (P = 0.0002; Figure 4).There was no significant change in the FVCs of both groups during the six-month observation period (P = 0.4182; Figure 5). In both groups, FVCs increased by second month of supplementation and changed relatively little thereafter.
The FEV1 to FVC ratios of the two groups did not differ significantly from one another throughout the observation period (P = 0.1403; Figure 6).
The PEFR averages significantly increased steadily over time in the Spirulina group compared to the placebo where values remained close to baseline levels (P<0.0001; Figure 7).
Safety and tolerability were assessed by adverse events reported by subjects at each postrandomization clinic visit. There were no adverse events reported such as diarrhea, constipation, or allergic reactions directly attributed to the supplements given between the groups during the study period.
DISCUSSION
This double blind, randomized, placebo-controlled study has demonstrated that Spirulina supplementation for three months was effective in improving asthma symptoms and lung function in asthmatic children. During the supplementation phase, Spirulina was as effective as placebo in improving asthma symptom scores. However, post-supplementation asthma symptom scores significantly improved over time in the Spirulina group compared to placebo. Daily intake of Spirulina significantly improved pulmonary function tests as demonstrated by increased FEV1 and PEFR in the Spirulina group compared to placebo. The tolerability profile of Spirulina was comparable to placebo and no serious adverse effects were encountered.
The anti-inflammatory effects of Spirulina is related to its ability to inhibit calcium release from mast cell stores after elevation of intracellular cAMP within ten seconds. (13) In acute asthma exacerbation, Spirulina can inhibit release of pro-inflammatory mediators such as histamine, tumor necrosis factor-alpha (TNF α), and vascular permeability factor or vascular endothelial cell growth factor from mast cells. (26,27) Newly synthesized lipid mediators such as prostaglandin D2, leukotrienes (LTC4, LTD4, LTE4, LTB4) and platelet-activating factor (PAF), as well as reactive oxygen species (ROS) are also released from mast cells during IgE-dependent allergic reactions. Previous animal studies have shown that in arachidonic acid-induced inflammation, Spirulina can significantly reduce LTB4 and prostaglandin E2 levels. (28,29)
In this study, both the spirulina and placebo groups showed improvement in asthma symptom score during the supplementation phase. During this time, both study groups were still receiving standard maintenance medications for asthma i.e. short acting or long acting beta agonist plus inhaled corticosteroids. This may have contributed in part with the control of asthma symptoms in both groups during the supplementation phase.
Taking together the results presented, extended supplementation with Spirulina appeared to have targeted both preformed and newly synthesized mediator release from mast cells as reflected by more significant and sustained improvement in both patient-reported symptoms and objective measures of asthma control compared to placebo.
The long-termimmunomodulatory effect of Spirulina was demonstrated in previous studies. Mao et al. has shown that after 12 weeks of supplementation with Spirulina, there was significant decrease in interleukin-4 (IL-4) by 32% (20). IL-4 is a critical cytokine involved in type I hypersensitivity reactions and it effectively promotes IgE production. Decreased production of IL-4 therefore aids in shifting the humoral-mediated immunity towards TH1 differentiation leading to less allergic responses.
In addition, spirulina has also been shown to potentiate the function of the immune system. Hirashi et al. reported that both interferon gamma (IFN-γ) and cytolysis are upregulated in more than 50% of the patients taking 1,000 to 8,000 mg of Spirulina extract orally for a total of eight weeks. (12) The direct immunomodulatory effects of Spirulina on myeloid lineages and natural killer (NK) cells has been ascribed through its signalling responses in Toll-like receptors. This imply that Spirulina may also provide additional benefit as an anti-bacterial or anti-viral agent. (30)
Overall, Spirulina has been classified as a GenerallyRecognizedasSafe (GRAS) substance by the United States Food and Drug Administration (FDA). (31-33) Human clinical trials and animal studies have supported the safety and nutritional benefits of Spirulina. The pigment, C-phycocyanin in Spirulina, has been classified into the “practically nontoxic” category. Moreover, daily consumption of 4,132 mg/kg body weight of Spirulina among humansdid not result in any adverse effects even in infants and young children. (34,35)
The present study is the first local study to measure asthma symptom scores using combined ACT and CASI with lung function assessment using spirometry. Both the ACT and CASI scores are reliable and validated tools to measure asthma control. Wildfire et al. reported that using CASI detected 32% larger improvement in asthma control than by reported symptoms alone. (24) One strength of this study is the use of CASI, in addition to ACT score, which provided a more comprehensive assessment of asthma control and severity of symptoms in response to the investigational drug, Spirulina.
In the present study, it was shown that, Spirulina was as effective as placebo in improving asthma symptom scores after three months of supplementation. However, improved asthma symptom scores were significantly sustained in the Spirulina group even after discontinuing the supplement compared to placebo. These results indicate that patient-reported improvement in asthma symptoms were achieved as early as three months of supplementation with Spirulina and this effect was sustained for a longer time compared to placebo.
In the diagnosis of asthma, reversibility in PEFR and rise in FEV1 after inhaled β2-agonist are the most frequently used index for assessing airway obstruction. (23,24) The present study has demonstrated that FEV1 and PEFR significantly improved in the Spirulina group compared to placebo. In this study, improvement in lung function tests was achieved as early as two months and three months in FEV1 and PEFR, respectively. Similar results were observed in the study by Labhe et al. which showed that extended supplementation with Spirulina plus medication over a period of two months resulted in increased lung function efficacy. This indicates a long-term sustainable effect of Spirulina in relieving bronchial obstruction. (21)
CONCLUSION
This study has shown that in children with mild to moderate persistent asthma, supplementation with Spirulina at a dose of 1,000 to 2,000 mg per day for three months was safe and associated with improvement of asthma symptoms as measured by increased Asthma Control Test Scores, reduced Composite Asthma Severity Index scores, and improvement of FEV1 and PEFR. Moreover, even after cessation of supplementation with Spirulina, the reported subjective benefits and objective outcome measures were significantly sustained until the end of the six-month observation period.
ACKNOWLEDGEMENTS
This work was supported in part by CELLIFE Spirulina (Pharmaceia Jimenez). It was agreed upon with the manufacturer and distributor of Cellife Spirulina (Pharmaceia Jimenez) that any information collected or generated by the investigator will be published, whether the results were favorable to the investigational drug or not. CELLIFE was provided opportunity to review any proposed publication or other type of disclosure at least 30 days before the final manuscript was submitted to a publishing company.
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Conflict(s) of Interest:There are no conflicts of interest in the authorship or publication of this manuscript.
Financial support: No financial support was provided in this manuscript. Material support for this research and work are clearly identified in the acknowledgments section of this manuscript.
FIGURE 1. Consort diagram of the Spirulina clinical trial. SABA, short-acting β2 agonist. LABA, long-acting β2 agonist. ICS, inhaled corticosteroids. ACT, Asthma Control TestTM. CASI, Composite Asthma SeverityIndex.
Figure 2. Median ACT scores of the Spirulina and placebo groups over six months
Figure 3. Median CASIs of the Spirulina and placebo groups over six months
Figure 4. Effect of Spirulina on FEV1 of the Spirulina and placebo groups over six months
Figure 5. Effect of Spirulina on FVC of the Spirulina and placebo groups over six months
Figure 6. Effect of Spirulina on FEV1/FVC of the Spirulina and placebo groups over six months
Figure 7. Effect of Spirulina on PEFR of the Spirulina and placebo groups over six months
TABLES
TABLE 1. Demographics and characteristics of the 39 subjects in the Spirulina Trial
Spirulina (n = 20) Placebo (n = 19) n (%) or Mean ± SD |
P value |
||
Female |
6 (30) |
9 (47) |
0.267 |
Age (years) |
9.95 ± 1.99 |
9.53 ± 1.90 |
0.500 |
Body weight (kilograms) |
32.33 ± 9.52 |
30.29 ± 7.32 |
0.459 |
Height (centimeters) |
139.07 ± 14.75 |
134.65 ± 12.78 |
0.322 |
Body Mass Index |
16.54 ± 3.51 |
17.05 ± 3.28 |
0.641 |
Past illnesses |
|
|
|
Atopic dermatitis |
1 (5) |
2 (10) |
0.516 |
Allergic rhinitis |
10 (50) |
13 (68) |
0.242 |
Bronchial asthma |
20 (100) |
19 (100) |
|
Admission in past 12 months |
|
|
|
Emergency room |
5 (25) |
4 (21) |
0.772 |
Hospital |
4 (20) |
1 (5) |
0.168 |
Environmental exposures |
|
|
|
Industrial or automotive smoke |
6 (30) |
7 (37) |
0.653 |
Cigarette or tobacco smoke |
11 (55) |
10 (53) |
0.881 |
Animal fur or dander |
5 (25) |
6 (32) |
0.645 |
TABLE 2. Asthma symptom scores at baseline and 3 months (end of treatment) in the Spirulina and placebo groupsa
|
Spirulina |
Placebo |
||||||
Baseline |
3 months |
P value |
Baseline |
3 months |
P value |
|||
ACT* |
14.5 |
22.0 |
<0.0001 |
18.0 |
20.0 |
0.019 |
||
CASI† |
6.5 |
3.0 |
1.000 |
7.0 |
3.0 |
0.999 |
||
aScores are given as medians. Significant P values < 0.05 are in boldface. *Higher value indicates better asthma control. †Lower value is indicative of better asthma control. ACT, Asthma Control Test. CASI, Composite Asthma Severity Index. |
TABLE 3. Pulmonary function tests at baseline and 3 months (end of treatment) in the Spirulina and placebo groupsa
|
Spirulina |
Placebo |
|||||||
Baseline |
3 months |
P value |
Baseline |
3 months |
P value |
||||
FEV1 |
56.55 ± 31.06 |
72.75 ± 24.15 |
0.014 |
65.79 ± 28.58 |
68.89 ± 25.02 |
0.296 |
|||
FVC |
62.95 ± 30.33 |
79.5 ± 16.88 |
0.008 |
66.95 ± 26.26 |
75.32 ± 21.48 |
0.071 |
|||
FEV1/FVC |
80.80 ± 32.69 |
92.05 ± 22.38 |
0.088 |
94.42 ± 27.04 |
91.05 ± 15.46 |
0.692 |
|||
PEFR |
36.85 ± 23.88 |
56 ± 23.51 |
0.0001 |
46.05 ± 25.62 |
50.16 ± 24.37 |
0.252 |
|||
a Before and after values are given as mean ± SD. Significant P values < 0.05 are in bold face. FEV1, forced expiratory volume at 1 second. FVC, forced vital capacity. PEFR, peak expiratory flow rate. |
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