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Visitors’ Opine
TB News from India, Nov-Dec 2003
Some points to ponder
It was nice to read your lead article ( TB News from India:
November-December 2003).There are indeed some points to ponder.
I was wondering , why doctors are adopting different ways of
treating TB when we have a proven strategy in DOTS. Are the things
going the malaria way ? I think the (Chest and TB) Specialists
should be encouraged to follow what is best in the interest of
country. Their personal attitudes confuse the specialists of other
branches and medical students, who have a substantial role to play
in stopping TB in its tracks.
And why not involve PPs like me ( who are seeing lots of HIV
positive persons) and allow them to provide DOTS services to their
patients. Most of these patients do not want go to other specialists
and I think there is no need as well, as an HIV specialist can treat
TB also. If NACO is serious about controlling HIV which is a big co
infection of TB in India why not DOTS HAART too???
Rakesh Bharti
rakeshbharti1@rediffmail.com
Upgrading the NTP
Upgrading the NTP needs reflection. The young team of creative
people within the Stop TB Department of WHO may need to reflect on
three business objectives: how to improve efficiency (done the
things right?), increase effectiveness (done the right things?) and
how to innovate NTP strategy done something new?).
1. Towards a more Rational Approach in TB Case Finding : It
has been a general consensus that case finding be done by three
consecutive microscopic sputum smear examinations. The problem
arises when chest X-ray (CXR) comes into the picture, i.e. to also
becoming involved in case finding.
When appropriate sputum examinations were negative, a patient could
be prescribed anti-TB drugs (according to the very powerful Category
I regimen) whenever there were CXR abnormalities, presumably caused
by TB . And here is the biggest tragedy of what has been disrupting
the NTPs for nearly half a century! Especially those NTPs in high
prevalence countries, where a large majority of CXR readers are not
competent enough to correctly assess these abnormalities.
Patients may have “old” tuberculous lesions on CXR. There may be
many “old” cases ranging from tiny CXR lesions to far advanced
fibrotic lesions, with extensive parenchymal involvement, or massive
pleural adhesions, due to previously maltreated tuberculosis, but
all having negative sputum results.
Very often, CXR readers would state that the “abnormalities are old
lesions, but still active” or “activity can not yet be excluded”,
etc., frustrating physicians to treat or not to treat the patient.
In honor of the principle: safety first, patients get full TB
chemotherapy (Category I regimen) despite negative sputum
examinations.
As a rule, “old or quiescent” lesions should be determined through
comparison with previous CXR’s, but alas, for various reasons this
is too often neglected by unscrupulous, ignorant or incompetent
readers. Treatment for minor, old and quiescent TB have been given
notwith-standing consecutive negative sputum results.
The physician in charge would start questioning about the value of
sputum examination and finally, looses interest in microscopic
sputum examination. More and more tuberculosis cases based on CXR
findings alone, are treated. At the same time, microscopic
examinations become scarce, the number of sputum positive cases
found will be lesser and lesser. And the target of finding at least
70 percent of the sputum positive cases becomes more and more
remote!
The above situation leads toward overdiagnosis and overtreatment of
tuberculosis patients as a consquence of allowing CXR screening as a
tool of case finding in the NTP. It is lamentable, that the so
called “sputum negative Rontgen positive” cases (i.e. cases with
negative sputum but with CXR lesions presumably, caused by TB) will
by far exceed the number of sputum positive cases. Consequently,
lots and lots of effort, labor, costs and time will be spent for
serving this category of sputum negative Rontgen positive cases, who
nota bene are epidemiologically less important than those who are
sputum positive, who are the very sources of infection. Eventually,
the infectious cases would not get optimal services they deserve to
receive.
Would it be acceptable, if the Global Fund be spent on the
treatment of these numerous sputum negative Rontgen positive cases?
The answer is:”NO WAY!”
In the developing countries the ability to recognize TB on CXR is
limited. So far, too many non-TB cases are given unnecessary TB
treatment. It is as if any lesion on chest X ray is considered TB,
to be given TB treatment, as long as the diagnosis is insecure, like
in chronic bronchitis, bronchiectasis, pneumonia, or other lung
diseases. It is not uncommon, that even lung cancer patients are put
on anti-TB treatment. Such ill-fated patients could evade TB
treatment, if only sputum positive cases were eligible for receiving
anti-TB treatment.
The Tragedy of TB among Children : The NTP has a program for
childhood tuberculosis. The situation is sickening, since during my
last 25 years in TB control, 99 (ninety nine) percent of the
children with (lung) TB, I encountered, are false diagnoses
(personal communication: Dr G. Hitze and Dr Tripathy, resp. WHO
director TB Control and WHO TB consultant in the early 198ies).
There is also striking overdosage in the chemotherapy of
tuberculosis. Even several ‘popular’ professors of paediatry make
false diagnoses of childhood TB
(Ref: Clinical Tuberculosis by Sir John Crofton and Childhood
Tuberculosis by Prof Pierre Chaulet). To date, they would still
prescribe ethambutol (which may cause damage of the optic berve) for
small children and even babies, if they “fail to thrive” and have a
positive tuberculin test after BCG vaccination. The duration of TB
chemotherapy may last up to two years, if “no improvement” was seen
on their (basically, normal) CXRs!
The Role of Radiography in the NTP: Radiographic examination
should not be used as a tool for case finding. It should be done
carefully and cautiously by a well-trained physician with ample
experience in succesfully diagnosing tuberculosis, backed by proper
sputum examination. The use of radiography should better not receive
endorsement in the NTPs, unless and until proper case finding and
adequate results are obtained in treating all sputum positive cases
found (target: cure rate of 85 percent).
On the Limitation of the Category II regimen: Sputum positive
patients who had been treated with the WHO Category I regimen either
HRZE or HRZS in the initial intensive phase, and still excreting
acid fast bacilli at the end of treatment period (i.e. treatment
failures after the Category I regimen) do not benefit from treatment
with the Category II regimen (HRZSE). The reason is, that the
addition of one single drug to a failing regimen will not cure the
patient, instead will create a new source of incurable MDR-TB
(multi-drug resistant tuberkel bacilli).
The Introduction of Fixed-Dose Combination (FDC) tablets:
Thanks to the WHO for introducing these FDC tablets and replacing
the combipacks for patients of 33 - 50kg. Applying the combipacks,
each patient with a body weight of 37 kg and below receive excessive
doses of anti-TB drugs (300 mg of isoniazid, 450 mg of rifampicin,
1500 mg of Pyrazinamide, all of these drugs are potentially,
hepatotoxic) and 750 mg ethambutol per day during the intensive
phase. Another constraint is the refusal or reluctance of patients
to swallow eight relatively large tablets altogether every morning
on an empty stomach.
The standard WHO recommended dosages of the first-line anti-TB drugs
in mg/kg body weight are isoniazid 5 +/- 1 mg, rifampicin 10 +/- 2
mg, ethambutol 15-20 mg and pyrazinamide 25 +/- 5 mg and
streptomycin 15 +/- 3 mg (daily doses).
In our practice, the exact dosage of each anti-TB drug per kg body
weight according to the WHO recommendation can correctly be
calculated by the field workers (nurses) of the TB Program.
Fortunately, the present FDC tablets contain meticulously precise
dosages according to the recommended dosages. One 4FDC tab contains
H: 75, R: 150, Z: 400, E: 275 mg to be used during the initial
intensive phase. Whereas one 2FDC tablet contains H: 150 and R: 150
mg to be used for the intermittent phase (3 times weekly). The
Category I regimen in our NTP is 2 HRZE/ 4 H3R3.
For the intensive and intermittent phases the numbers of each FDC
tablet needed are consistently the same: if three 4FDC tablets are
required in the intensive phase, the same number, also three 2FDC
tablets are required in the intermittent phase (provided patient’s
body weight remained in the same body weight band). The dosages for
patients as introduced in the NTP are:
30 - 37 kg: 2 tablets
38 - 54 kg: 3 tabs
55 - 70 kg: 4 tabs
71+ kg : 5 tabs.
By applying the cut off points of 37 kg and 50 kg (WHO Bulletin
2001, 79(I):61-68) the various body weight bands above, perhaps
difficult to be memorized by the fieldworkers, can be simplified as
follows:
37 kg or below: 2 tablets
50 kg or below: 3 tabs
over 50 kg: 4 tabs.
Remarks:
In high prevalence countries, there are only exceptionally few
sputum positive patients with a body weight
1. of 71 kg and over. They may receive 5 tablets;
2. of 30 to 27 kg (their dosages, 2 tablets, are still within the
therapeutic range).
3. Patients below 27 kg may receive 1 ½ tablet.
Specially, the doctors and nurses in the NTP could successfully be
trained to memorize the standard WHO recommended dosages for each
essential anti-TB drug per kg body weight. This will be needed when
FDC tablets cause uncontrolled side effects (3-6%), or in case there
is an interrupted supply of FDC tablets (which of course, should
never happen in the NTP).
Directly Observed Treatment by Patient’s Relatives: This is a
controversial topic of debate. Directly observed treatment (DOT)
literally, means that a supervisor watches the patient swallowing
the tablets. It is suggested that the treatment observer in
outpatient settings may be a health worker, nurse, midwife, health
volunteer, sanitarian, immunization assistant, village head, teacher
or other trained and supervised member of the community). In the
writer’s experience, DOT should best be done by the closest kin or
family member, who is often also the very person who accompanied the
sick patient to the healthcenter. But WHO and other prominent
figures in TB Control from the USA (e.g. Drs John Sbarbaro and Tom
Frieden) resolutely, rejected the idea of having patient’s relative
as treatment supervisor. The principle of treatment observer, other
than the closest family member, may not be applicable in the
industrialized or in the developing countries. Even among simple,
impoverished people, no outsider is welcome to watch a family member
(the TB patient) swallowing the tablets every day for 2 months and
then 3 times weekly for another 4 months.
This would be an intrusion of patient’s family privacy. More
importantly, this could also be a proof, that the provider does not
fully trust patient’s desire to take the medicines regularly and
uninterruptedly. Practically, it is very doubtful, if any outsider
could be found to do such job. In fact, the ultimate responsibility
to have patients take their drugs regularly and uninterruptedly is
with the health provider (doctor, nurse).
Completion of treatment :
It is obligatory, that health providers (doctors and nurses) should
give much time and spend more efforts in motivating the TB patient
with its nearest relative, before treatment was started. The better
the quality of motivation, the less likely patient will abscond from
treatment and the less frequent home visits to absconding patients
have to be made, who may live in far remote areas!
Completion of treatment encompasses regular and uninterrupted
treatment or drug intake. Treatment should not be reported complete,
if treatment was interrupted for one episode of say, eight
consecutive weeks (cf NTP) or even more!. Treatment completion can
be quantified (expressed in percentages of drugs taken during the
treatment period). One month
corresponds to 30 doses of treatment in a daily regimen. Whereas in
an intermittent regimen (3 times per week) one month corresponds to
12 doses.
In such a way, patient’s performance (doses taken) can be calculated
every month and finally, again at the end of treatment. An intake of
less than 90 percent of the drugs within the prescribed treatment
period, is reported as defaulter (i.e. due to defaultive treatment).
Treatment completion is reported, if the patient achieved at least a
90 percent intake of drugs within the prescribed treatment period
(source: WHO of the 197ties!) and final sputum examination was not
done for whatever reason. Drop out is recorded if a patient
absconded before the termination of treatment.
‘Genuine’ Cure: A patient is declared cured, if at the end of
regular and uninterrupted treatment , sputum has become
bacteriologically (if possible, culturally) TB negative. A patient
who is genuinely cured, may not experience relapse during life. But
if for whatever reason, such relapse would occur, the mycobacteria
would still remain sensitive to the drugs
previously prescribed, so that the disease can successfully be cured
with the Category II regimen. It is now considered imperative, that
chemotherapy against tuberculosis, be administered regularly and
uninterruptedly. Because regular and uninterrupted treatment will
not only result in a 100 percent cure for new cases, but also makes
future relapses unlikely. In this regard, the theme of Robert Koch’s
centenary of 1982 becomes more relevant: “Defeat TB, now and
forever!”
In Conclusion: By applying very strict definitions and
regulations, the world may have a different, but realistic picture
of the achievements of NTPs. It is said, that patients’ and
healthworkers’ compliance is a key factor to success of the NTP.
Such compliance can only be achieved if the relationship between
health provider and patient is based on mutual respect
and mutual trust in a caring facility. It is perhaps time now for
WHO to innovate nurturing and developing such relationships towards
an efficient, effective and innovative upgrading of NTPs throughout
the world.
Dr Muherman Harun, STB Partner
Pneumo-phthisiologist
Email: mhjkt@attglobal.net
Jakarta, 1 November 2003
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