Efeito da spirulina platensis nos sintomas dispépticos após suspensão do uso crônico de inibidores da bomba protônica : resultados de um ensaio clínico fase II

Abstract

Proton pump inhibitors (PPIs) are drugs that strongly inhibit the secretion of hydrochloric acid by the stomach, and are commonly used for treatment of dyspeptic symptoms. Approximately 5% of the world population makes regular use of PPIs, and half of them do so without formal indication. This can be explained by hypersecretion of acid rebound that occurs after temporarily stopping PPI and may be accompanied by the reappearance of dyspeptic symptoms in 30-60 days after the interruption. This phenomenon hinders or prevents the PPIs withdrawal from individuals who do not require this treatment. Besides the harmful effect of medicine (PPIs) addiction, the chronic use of these drugs may increase the risk of bone fractures, especially in elderly people. In this contenxt, the use of agents with analgesic and antiinflammatory properties such as Spirulina platensis (Sp) could be useful to minimize the symptoms of rebound after the withdrawal of PPIs. We conducted a clinical trial to test this hypothesis. Methods: We studied 45 patients (91% women, 29% elderly, age 51 ± 14 years, BMI 25.7 ± 4.1 kg/m2) in regular use of PPIs without previous history of peptic ulcer or reflux esophagitis. The patients were prospectively treated with pantoprazole 40 mg / day for 28 days and underwent clinical and endoscopic (E1) evaluation. In the absence of contraindications (hiatal hernia medium to large size, peptic ulcer, oesophagitis grade ≥ B), patients were randomized to treatment with Sp 2 months (1.6 g / day) or placebo, they were allowed to use antacids on demand. At the end of 2 months, clinical and endoscopic evaluation were repeted. The outcomes were appearance or persistence of dyspeptic symptoms with score > 50% of the baseline and appearance or persistence of the GERD bothersome symptoms heartburn or regurgitation. Intention to treat analysis was used. Results: Two patients were excluded in E1 due to hiatal hernia. Among 43 patients, 25 (58%) were randomized to placebo and 18 to Sp. After 2 months, 18 patients treated with placebo (72%) and 12 treated with Sp (67%) completed the study (P = 0.968). The outcome dyspepsia occurred in 10 among 18 patients who were treated with Sp and 22 among 25 patients treated with placebo [56% vs. 88%; relative risk 0,63 (IC95% 0,41 0,98)].The outcome GERD occurred in 13 among 18 patients Who received Sp and in 19 among 25 patients treated with placebo [72% vs.76%; relative risk 0,95 (IC95% 0,66 1,36)]. The score of GERD [median (IQR25-75%)] did not change after administration of placebo [before 8.5 (3.5-16.5) vs. 8.5 (4.3-18) vs., P = 0830] and Sp [before 5.5 (4 - 11) vs. 4.5 (1.2-9.5) P = 0567]. The dyspepsia score decreased significantly after Sp [before 16.5 (4.2-23) vs. 6 (2-13.2), P = 0.027], but not after placebo [before 13 (7.7-19) vs. 15.5 (5.7-19), P = 0353]. There were no significant side effects with Sp or placebo. Conclusions: The results of our study indicate that the majority (two thirds) of patients in chronic use of PPIs was able to discontinue medication for 2 months, regardless of Sp or placebo therapy. However, dyspeptic symptoms were significantly less severe in patients treated with Sp, whereas no benefit was seen in relation to reflux symptoms after Sp or placebo. Considering the good safety profile Sp treatment could be used.