©Quarterly Homœopathic Digest, Vol.XXIX, 1 & 2/2012. Private circulation only. 44
heterogeneous, including carriers of Human
Immunodeficience Virus (HIV) and sufferers from
Acquired Immunodeficience Syndrome (AIDS).
On the other hand, the etiologic agent of the disease
under study was not duly defined in 2 papersc,k. In 2
trialsm,n, the criteria defining the diagnosis were
exclusively clinic; one of themm included children in a
wide age range suffering from upper and lower airway
infections. 4a,f,g,i (22.2%) studies assessed the
homeopathic treatment in cases of middle ear infection,
also exclusively diagnosed through clinical criteria,
without microbiological investigation; 2 f,g also
included children in a wide age range, including
teenagers.
Among the 8a,c,f,g,I,k,m,n papers with distortion in the
diagnostic criteria or the features of the sample, 4c,i,m,n
were previously considered as high methodological
quality; their exclusion would decrease the frequence of
this category from 55.5% (10/18) to 33.3% (6/18).
Discussion and conclusions
In the present study, the criteria of inclusion
previously established were essential to attain the
highest homogeneity among the 18 clinical trials
selected and they also warranted the possibility of
comparing them.
14 preselected papers, written in German or
Russian, should have been considered, but due to the
impossibility of a reliable translation, they had to be
excluded. It is possible that the inclusion of these papers
would have modified the results obtained.
Some interesting features were not included in the
evaluation of the papers, such as: separate analysis of
the masking criteria by the observer and the research
subjects; calculus of the size of the sample; if there was
a pilot study or not; adequate statistical analysis; criteria
for the comparison of groups; bias due to drop-
outs/excluded cases were included in the statistical
analysis (principle of the intention to treat); correct
description of the clinical outcome; approval by ethics
committee; reference to the term of consent; description
of the place and time of the study, among other indexes
of high quality in clinical trials.
Such items were not included in the modified
Jadad’s scale. It is probable that if included, all papers
assessed in the present study would have received very
low, even null scores. Moreover, in the present study
there was no limits in the time of publication, thus, if
the items above would have been included, most of the
oldest papers would have received the lowest scores, as
such items began to receive more attention in recent
years. It is advisable to take these items into account in
future systematic review studies aimed at the evaluation
of the quality of clinical trials.
It is also advisable to include the alternative of the
negative score (-1) for all items, whenever an article
inadequately incorrectly describes a topic under the
analysis of the observer, instead of exclusively, as Jadad
et al.24 suggested, in the questions on the criteria for
randomization and masking. This new analysis strategy
would avoid the high frequence of null score (=0), thus,
some studies would not receive a proportionately higher
final score. Therefore, in future revisions of the
modified Jadad scale, the Form of Evaluation of the
Quality of Papers ought to include the alternatives and
items mentioned above, as well as the suggested in the
present study.
No matter its limitations, the Jadad scale, together
with the added modifications, might be considered
valid, due to the good concordance between the 2
external reviewers, as well as between the latter and the
gold-standard evaluation.
The present study did not aim to evaluate the
adequacy of the clinical outcome, especially, as it be
noted that the 18 studies approached different diseases.
Most of them described positive of favorable outcomes,
however, the assessment of the effectiveness of the
homeopathic therapy requires its correct application,
individualizing cases and excluding co-interventions.
Among the 18 studies, only 3 g,k,p showed a stricter
compliance to the homeopathic principles, and only 1p
of them rated as high methodological quality. Yet, as
mentioned above, the sample was heterogeneous,
composed of non comparable groups. Taking all criteria
into account, none of the 18 selected papers showed
methodological rigor and observance of the
homeopathic principles.
Nonetheless, when considering exclusively the
adopted scale, more than half (55.6%) of the studies was
classified as high quality. This frequence is smaller
(33.3%) if the criteria of etiologic diagnosis and stricter
inclusion criteria are taken into account.
On the other hand, most of the systematic reviews
of the use of homeopathic remedies were not limited to
the clinical situation, and some even included other
therapies (acupuncture and phytotherapy) besides
homeopathy,16,18,20 while others did not assess the
quality of the studies.1,10,11,20 Among those which did,
none considered as inclusion criteria neither high
methodologic quality nor individualized homeopathy.
Only 117 review included individualized homeopathy as
a criterion. Other authors2,3,17,23 were so explicit in their
opinion adverse to homeopathy, that the impartiality of
their results is doubtful. Some review studies17,23
included simultaneously therapeutic and prophylactic
trials, compromising the homogeneity of the sample.
Thus, such systematic reviews are more confusing than
enlightening, making the study of clinical trials with
homeopathic remedies significantly more complex or
inducing the reviewer to suppose that homeopathy is an
actual panacea,29 which was objected by Atallah &
Castro26 and Verhagen et al.27 These authores stressed
that in systematic reviews, only well designed and well