Daikenchuto Treatment For Chronic Constipation
Traditional Japanese herbal medicine called daikenchuto (DKT) has been confirmed by a number of studies to have an effect on the serotonergic and cholinergic mechanisms with a satisfactory safety margin. Daikenchuto has an effect on improving gastrointestinal symptoms such as bloating and abdominal pain. DKT has previously been shown to provide benefit for postoperative ileus.
This study was performed to assess the safety and efficacy of DKT in treating chronic constipation.
This was a multicenter, randomized, double-blinded, placebo-controlled clinical trial involving 67 participants who have chronic constipation was carried out in accordance with Rome III criteria.
Following a 2 week period of observation, 63 participants with persistent symptoms were randomized to a DKT or placebo treatment course of four weeks.
The principal endpoint included an assessment of the overall treatment effect (OTE), meanwhile, the secondary endpoints include improvements in spontaneous bowel movements, lower gastrointestinal symptoms like constipation and stool consistency.
Overall treatment effect (OTE) was higher for daikenchuto treatment than the placebo after 4 weeks of treatment.
No side effects were recorded or observed. There was a significant improvement in lower gastrointestinal symptoms and stool consistency with daikenchuto treatment compared to the placebo.
Daikenchuto was seen to be safe and effective in the treatment of chronic constipation, more so in patients who have symptoms related to constipation without an altered mental component score.
Constipation is a gastrointestinal condition characterized by difficulty in defecation.
In constipation, feces are usually hard in consistency and are not easily passed out during defecation. In some cases, excessive straining to defecate may lead to injuries to the anus and subsequent bleeding.
Chronic constipation is noted to be one of the most common gastrointestinal conditions seen in clinical practice. It is associated with adverse impact on the quality of life and economic status of the patient.
Chronic constipation can be managed by improving abnormal bowel movements and gastrointestinal symptoms associated with constipation such as abdominal pain and bloating.
Although laxatives have been known to improve bowel movements, its effectiveness in improving constipation related GI symptoms however, has not been well understood.
Symptoms associated with constipation such as bloating is frequently seen in patients of Asian descent who have lower gastrointestinal motility dysfunction.
Bloating may be caused by several factors including gut hypersensitivity to intestinal distention and excess production of gas in the colon precipitated by constipation.
Daikenchuto (DKT) is a traditional Japanese herbal medication which comprises Japanese pharmacopoeia koi ( maltose powder) and mixed daikenchuto extract powder, balanced in a ratio of 10:1.25 (wt/wt).
Daikenchuto extract powder is a mix of dried extracts of Japanese pharmacopoeia pepper (Zanthoxyli fructu), Japanese pharmacopoeia processed ginger (Zingiberis rhizoma) and Japanese pharmacopoeia ginseng radix (Panax ginseng) in a ratio of 2:5:3.
Daikenchuto has been utilized clinically, majorly for the prevention and treatment of postoperative bowel obstruction due to adhesions.
In previous studies, daikenchuto is noted to enhance the release of acetylcholine from cholinergic nerve endings through 5-HT4 and 5-HT3 receptors. Daikenchuto causes intestinal contractions by blocking or inhibiting the KCNK9 channels (potassium channel subfamily K member 9) and releasing calcitonin related peptides.
A clinical study carried out among healthy individuals reported a reduction in the intestinal transit time following 5 days of ingesting daikenchuto. These results have also been replicated in a series of animal experiments involving pigs and dogs.
Results from these studies suggest that daikenchuto may effectively treat abdominal pain and bloating associated with chronic constipation. Although the efficacy of daikenchuto in treating chronic constipation has been noted in a study, the evidence is not sufficient enough as the study had a small sample size and was carried out in a single institution.
Due to this, a multicenter, randomised, double blind, placebo controlled clinical trial was carried out to evaluate the safety and efficiency of daikenchuto in the treatment of constipation associated with abdominal bloating.
This trial was approved by the ethics committee of the hospital, in accordance with the tenets of the declaration of Helsinki. It was registered under the University Hospital Medical Information Network (UMIN).
Following an observatory period of two weeks, patients were placed in the four weeks randomized, double blinded, placebo controlled clinical trial.
Numbered enveloped with computer-generated allocations were utilized to conceal the given groups.
The physicians were blinded to the symptoms experienced by the patient that are associated with the medication given.
Every participant that had chronic constipation was subjected to several tests such as blood test, ultrasound and colonoscopy to rule out the presence of other organic conditions.
Participants were randomized to take either a placebo or 15mg of daikenchuto (DKT) after meals three times daily for the four week period of treatment. Patients were also told to record stools using the Bristol stool form scale, spontaneous bowel movements and symptoms related to constipation in a diary.
The health status of the patient is assessed on the second visit using the acute version of the Short Form-8 health-related quality of life survey (SF-8). SF-8 comprises the mental component summary and physical component summary.
After four weeks, patients were to visit the clinic and fill a questionnaire on the overall treatment efficacy (OTE). The questionnaire was on gastrointestinal symptoms associated with constipation such as bloating, strain, abdominal pain and feeling of incomplete evacuation. The assessment of the overall treatment efficacy (OTE) was estimated using a questionnaire which scored the OTE with a scoring system of 3 points meaning symptoms have extremely improved and 0 points meaning symptoms have not changed. Also, 3 points if the symptom has been extremely aggravated.
Symptoms were graded using scores on a Likert scale. A score of 0 indicates no symptoms, while a score of 6 indicates symptoms are always present.
Follow-up after treatment was carried out for 7 – 10 days via a phone call.
Patients with functional constipation or constipation-predominant irritable bowel syndrome (IBS) in accordance with the Rome III criteria were included in the study. Participants were aged 18 to 75 years, and were required to have chronic constipation with which they were still able to halt laxative use during the 6 week study period. Patients should also be able to report bloating.
Participants were instructed to avoid medications for abnormal bowel movements for at least one week prior to the study. They were to carry on with their daily activities during the study period and simply just inform the researchers on changes in their bowel habits.
Patients with other organic diseases that could precipitate gastrointestinal symptoms, those with systemic or metabolic diseases affecting the digestive system (e.g diabetes) and those who have received treatment for functional constipation or irritable bowel syndrome within one week before or during the study were excluded from the trial.
63 out of 67 patients who had chronic constipation were recruited and randomized for the clinical trial.
34 patients comprising 22 women and 12 men with a mean age of 64.3 ± 12.0 years were allocated to the placebo group, while 29 patients comprising 14 women and 15 men with a mean age of 66.1 ± 11.7 years were allocated to the daikenchuto (DKT) group.
Constipation symptoms for all eligible participants had a median duration of 2 years.
The mean number of spontaneous bowel movements (SBM) was 0.7 ± 0.3, abdominal pain score was 4.5 ±0.6, straining score was 4.6 ±0.9, Bristol stool form scale was 2.9 ± 1.0, abdominal bloating score if 3.5 ± 1.1 and feeling of incomplete evacuation score was 4.0 ± 0.2.
The principal efficacy endpoint is to assess the overall treatment efficacy (OTE). No significant adverse effects associated with treatment were observed during the period of observation and treatment. The overall treatment efficacy (OTE) of daikenchuto (DKT) (1.7 ± 1.2) during the four week administration was significantly greater than that of the placebo group (1.0 ± 1.2).
The secondary efficacy endpoints include number of spontaneous bowel movements (SBM), improvements in stool consistency using the Bristol stool form scale, and lower gastrointestinal symptoms associated with constipation.
Lower gastrointestinal symptoms like abdominal bloating, abdominal pain and stool consistency were noted to improve in the daikenchuto (DKT) group, while these symptoms did not improve in the placebo group. Symptoms like strain, feeling of incomplete evacuation and spontaneous bowel movements were not significantly improved during the course of treatment.
This randomized, multicenter, double blinded, placebo controlled clinical trial reports two outcomes.
Firstly, four week administration of DKT treatment resulted in notably higher overall treatment efficacy (OTE) compared to the placebo treatment.
Secondly, DKT effectiveness was more notable in patients with improvements in lower gastrointestinal symptoms score who had no impairment in the SF-8 mental component summary prior to treatment.
Daikenchuto treatment has proven to be effective option in managing symptoms related to constipation in patients with certain conditions like pregnancy, Parkinson’s disease and stroke.
Additionally, studies have shown that daikenchuto effectively treats constipation and abdominal pain or bloating. These studies however, do not have enough evidence to back them.
This present study is considered the first from the Asian region to demonstrate the usefulness or efficiency of daikenchuto in improving the overall treatment efficacy and symptoms related to constipation.
Animal studies suggested that daikenchuto improves gastrointestinal motility via four major mechanisms. These mechanisms include : activation of TRPA1 channels, promotion of motilin secretion and activation of TRPV1.
Hydroxy-α sanshool which is a component of daikenchuto is assimilated or absorbed and gets to the colon through the blood. It exerts a motility enhancing effect on the colon by blocking the KCNK9 channels.
Daikenchuto, a Japanese herbal medicine, has shown to be a safe and effective treatment modality for chronic constipation and its associated symptoms which include abdominal bloating and pain.
In addition to chronic constipation, daikenchuto can also be used to treat abdominal bloating and pain caused by other conditions such as irritable bowel syndrome and Crohns disease.
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