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Clinical evaluation of alkaline ionized water for abdominal complaints:
Placebo controlled double blind tests
by Hirokazu Tashiro, Tetsuji
Hokudo, Hiromi Ono, Yoshihide Fujiyama, Tadao Baba (National Ohkura Hospital,
Dept. of Gastroenterology; Institute of Clinical Research, Shiga University of
Medical Science, Second Dept. of Internal Medicine)
Effect of alkaline ionized water on abdominal complaints was evaluated by
placebo controlled double blind tests. Overall scores of improvement using
alkaline ionized water marked higher than those of placebo controlled group, and
its effect proved to be significantly higher especially in slight symptoms of
chronic diarrhoea and abdominal complaints in cases of general malaise. Alkaline
ionized water group did not get interrupted in the course of the test, nor did
it show serious side effects nor abnormal test data. It was confirmed that
alkaline ionized water is safer and more effective than placebos.
Summary
Effect of alkaline ionized water on abdominal complaints
was clinically examined by double blind tests using clean water as placebo.
Overall improvement rate was higher for alkaline ionized water group than
placebo group and the former proved to be significantly more effective than the
other especially in cases of slight symptoms. Examining improvement rate for
each case of chronic diarrhoea, constipation and abdominal complaints, alkaline
ionized water group turned out to be more effective than placebo group for
chronic diarrhea, and abdominal complaints. The test was stopped in one case of
chronic diarrhoea, among placebo group due to exacerbation, whereas alkaline
ionized water group did not stop testing without serious side effects or
abnormal test data in all cases. It was confirmed that alkaline ionized water is
more effective than clean water against chronic diarrhoea, abdominal complaints
and overall improvement rate (relief of abdominal complaints) and safer than
clean water.
Introduction
Since the approval of alkaline ionized water
electrolyzers by Pharmaceutical Affairs Law in 1966 for its antacid effect and
efficacy against gastrointestinal disorders including hyperchylia, indigestion,
abnormal gastrointestinal fermentation and chronic diarrhea, they have been
extensively used among patients. However, medical and scientific evaluation of
their validity is not established. In our study, we examined clinical effect of
alkaline ionized water on gastrointestinal disorders across many symptoms in
various facilities. Particularly, we studied safety and usefulness of alkaline
ionized water by doubleblind tests using clean water as a control group.
Test subjects and methods
163 patients (34 men, 129 women, age 21
to 72, average 38.6 years old) of indigestion, abnormal gastrointestinal
fermentation (with abnormal gas emission and rugitus) and abdominal complaints
caused by irregular dejection (chronic diarrhea, or constipation) were tested as
subjects with good informed consent. Placebo controlled double blind tests were
conducted using alkaline ionized water and clean water at multiple facilities.
An alkaline ionized water electrolyzer sold commercially was installed with a
pump driven calcium dispenser in each of the subject homes. Tested alkaline
ionized water had pH at 9.5 and calcium concentration at 30ppm. Each subject in
placebo group used a water purifier that has the same appearance as the
electrolyzer and produces clean water.
The tested equipment was randomly
assigned by a controller who scaled off the key code which was stored safely
until the tests were completed and the seal was opened again.
Water
samples were given to each patient in the amount of 200ml in the morning with
the total of 50OmI or more per day for a month. Before and after the tests,
blood, urine and stool were tested and a log was kept on the subjective
symptoms, bowel movements and accessory symptoms. After the tests, the results
were analyzed based on the log and the test data.
Test Results
1. Symptom
Among 163 tested subjects, alkaline
ionized water group included 84 and placebo group 79. Background factors such as
gender, age and basal disorders did not contribute to significant difference in
the results.
2. Overall improvement rate
As to overall improvement rate of
abdominal complaints, alkaline ionized water group had 2 cases of outstanding
improvement (2.5%), 26 cases of fair improvement (32.1%), 36 cases of slight
improvement (44.4%), 13 cases of no change (16%) and 4 cases of exacerbation
(4.9%), whereas placebo group exhibited 4 (5.2%), 19 (24.7%), 27 (35.1%), 25
(32.5%) and 2 cases (2.6%) for the same category. Comparison between alkaline
ionized water and placebo groups did not reveal any significant difference at
the level of 5% significance according to the Wilcoxon test, although alkaline
ionized water group turned out to be significantly more effective than placebo
group at the level of p value of 0.22.
Examining overall improvement
rates by a 7, 2 test (with no adjustment for continuity) between the effective
and noneffective groups, alkaline ionized water group had 64 (79%) of effective
cases and 17 cases (21%) of non effective cases, whereas placebo group had 50
(64.9%) and 27 (35.1%) cases respectively. The result indicated that alkaline
ionized water group was significantly more effective than placebo group at the
level of p value of 0.0.48.
Looking only at 83 slight cases of abdominal
complaints, overall improvement rate for alkaline ionized water group
(45
cases) was composed of 11 cases (242%) of fair improvement, 22 cases (48.9%) of
slight improvement, 17 cases (44.7%) of no change and 3 cases (6.7%) of
exacerbation, whereas placebo group (38 cases) had 3 (7.8%), 17 (44.7%), 17
(44.7%) and 1 (2.6%) cases for the same category. Alkaline ionized water group
was significantly more effective than placebo group according to the comparison
between the groups (p value = 0.033).
3. Improvement rate by basal symptom
Basal symptoms were divided
into chronic diarrhea, constipation and abdominal complaints (dyspepsia) and
overall improvement rate was evaluated for each of them to study effect of
alkaline ionized water. In case of chronic diarrhea, alkaline ionized water
group resulted in 94.1% of effective cases and 5.9% of non effective cases.
Placebo group came up with 64,7% effective and 35.3% non effective. These
results indicate alkaline ionized water group proved to be significantly more
effective than placebo group. In case of slighter chronic diarrhoea, comparison
between groups revealed that alkaline ionized water group is significantly more
effective than placebo group (p=0.015). In case of constipation, alkaline
ionized water group consisted of 80.5% of effective and 19.5% of non effective
cases, whereas placebo group resulted in 73.3% effective and 26.3 non effective.
As to abdominal complaints (dyspepsia), alkaline ionized water group had 85.7%
of effective and 14.3% non effective cases while placebo group showed 47.1% and
62.9% respectively. Alkaline ionized water group proved to be significantly more
effective than placebo group (p=0.025).
4. Safety
Since one case of chronic diarrhoea, in placebo group saw
exacerbation, the test was stopped. There was no such cases in alkaline ionized
water group. Fourteen cases of accessory symptoms, 8 in alkaline ionized water
group and 6 in placebo group, were observed, none of which were serious. 31 out
of 163 cases (16 in alkaline ionized water group, 15 in placebo group) exhibited
fluctuation in test data, although alkaline ionized water group did not have any
problematic fluctuations compared to placebo group. Two cases in placebo group
and one case in alkaline ionized water group have seen K value of serum climb up
and resume to normal value after re testing which indicates the value changes
were temporary.
Conclusion
As a result of double blind clinical tests of alkaline
ionized water and clean water, alkaline ionized water was proved to be more
effective than clean water against chronic diarrhea, abdominal complaints
(dyspepsia) and overall improvement rate (relief from abdominal complaints).
Also, safety of alkaline ionized water was confirmed which clinically verifies
its usefulness.
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