Cerebral mechanism of puncturing at He-Mu point combination for functional dyspepsia: study protocol for a randomized controlled parallel trial
CONTEXT Functional dyspepsia represents a frequent gastrointestinal disorder in clinical practice. According to the Roma III criteria, functional dyspepsia can be classified into two types as the predominant symptom: epigastric pain and postprandial discomfort. Even though the pathophysiology is still uncertain, the functional dyspepsia seems to be related to multiple mechanisms, among them visceral hypersensitivity, changes in the gastroduodenal motility and gastric accommodation and psychological factors. OBJECTIVE Evaluate the effectiveness of acupuncture as a complementary to conventional treatment in functional dyspepsia patients. METHODS Randomized clinical trial in which were enrolled patients with functional dyspepsia patients in according with Rome III criteria. One group was submitted to drug therapy and specific acupuncture (GI) and the other to drug therapy and non-specific acupuncture (GII). The gastrointestinal symptoms, presence of psychiatric disorders and quality of life were evaluated, at the end and three months after treatment. RESULTS After 4 weeks of treatment there was improvement of gastrointestinal symptoms in Group I (55 ± 12 vs 29 ± 8.8; P = 0.001) and Group II (50.5 ± 10.2 vs 46 ± 10.5; P = 0.001). Quality of life was significantly better in Group I than group II (93.4 ± 7.3 vs 102.4 ± 5.1; P = 0.001). Anxiety (93.3% vs 0%; P = 0.001) and depression (46.7% vs 0%; P = 0.004) were significantly lower in Group I than group II. When comparing the two groups after 4 weeks of treatment, gastrointestinal symptoms (29 ± 8.8 vs 46 ± 10.5; P<0.001) and quality of life (102.4 ± 5.1 vs 96 ± 6.1; P = 0.021) were significantly better in Group I than group II. Three months after the treatment, gastrointestinal symptoms remained better only in Group I, when compared to the pre-treatment values (38 ± 11.3 vs 55 ± 12; P = 0.001). CONCLUSION In patients with functional dyspepsia the complementary acupuncture treatment is superior to conventional treatment. Further studies with more patients are needed to confirm these findings.