8 ")^ International Journal of Leprosy^ 1993

Priorities for the Future and Prospects forLeprosy Control

PRIORITIES FOR THE FUTUREThe major priorities for leprosy control

services in the near future are: a) to increasemultidrug therapy (MDT) coverage; b) tointegrate the leprosy control services withthe general health services; and c) to preventdisabilities.

Increase of MDT CoverageThe first priority for many leprosy control

programs should be to increase MDT cov-erage. Based on at least one leprosy patienton treatment per 10,000 population, at thebeginning of 1992 leprosy was a publichealth problem in 88 countries. The MDTcoverage in these countries at that time, ex-pressed as the percentage of registered pa-tients on MDT, is given in Table 1)

Thus, by the beginning of 1992 the MDTcoverage was still below 25% in 15 countries(17%); 11 (73%) of them belonged to theAfrican Region. Of the 57 countries (65%)with MDT coverage of over 50%, only 18(32%) were situated in the African Region.

The registered number of leprosy cases,the registered number of cases per 10,000population, the proportion of patients onMDT, and the cumulative MDT coverage(defined as the proportion of patients eli-gible for MDT brought under MDT sinceits introduction) at the beginning of 1992,for the different WHO regions, are given inTable 2.

The changes in registered leprosy pa-tients, in registered number of patients per10,000 population, and in MDT coveragebetween the end of 1990 and the beginningof 1992 are given in Table 3. Although theMDT coverage in the African Region is stilllow, the 50% increase is promising. A mainreason for the low MDT coverage in theAfrican Region was that Nigeria, with 44.3%of all registered leprosy patients, had at-tained MDT coverage and a cumulativeMDT coverage of only 8.9% and 10.2%,respectively. The situation in the Americas,with the lowest MDT coverage of all the

' World Health Organization. Weekly Epidemiolog-ical Record 67 (1992) 153-160.

WHO regions, and a 13% decrease in MDTcoverage, is particularly worrisome. Brazil,where 77.5% of all leprosy patients of theAmerican Region were registered, had onlyreached 12.4% MDT coverage, with a cu-mulative MDT coverage of 14.6%. Al-though the MDT coverage in the South-EastAsia Region, where 71% of all leprosy pa-tients were registered, is one of the highest,the 30% decrease should be a matter of con-cern. Apparently one or more countries inthis region were not able to maintain highMDT coverage. The poor results in the Eu-ropean Region were especially caused by lowMDT coverage in the Russian Federationand Turkey, where 86.3% of the patientswere registered. In the Russian Federation,both MDT coverage and cumulative MDTcoverage were 54.9%, and in Turkey bothrates were 16.5%. The most satisfactory re-sults were obtained in the West Pacific Re-gion, which had the highest MDT coveragerate and where MDT coverage continued toincrease.

The background for the recommendationof MDT was the increasing problem of dap-sone resistance, which was considered aworld-wide problem.' Although recent dataabout dapsone resistance are not available,it should be expected that in the areas wherethe majority of the patients are still treatedwith dapsone monotherapy, the dapsone-resistance problem has further increased.The 1.8 million registered leprosy patientswho were still on dapsone monotherapy bythe beginning of 1992 most probably in-cluded several hundreds of thousands of pa-tients with dapsone-resistant leprosy. If thesepatients are not treated effectively, they willcontinue to increase the dapsone-resistanceproblem, while their condition may seri-ously deteriorate.

The present situation, 10 years after therecommendation of MDT, requires imme-diate and vigorous attention, particularly inthose countries which have not been able

= WHO Study Group. Chemotherapy of leprosy forcontrol programmes. Geneva: World Health Organi-zation, 1982, Tech. Rep. Scr. 675.

EUR^SEAR^WPR

No.^No.AFR^AMR^EMR

No. ̂ No. ̂ No. No.

MDTcoverage

Countries in WHO regions'Total

No. %

61, 1^ Editorials^ 83

TABLE 1. MDT coverage in the 88 leprosy-endemic countries at the beginning of992.'

76 11 (32) 11 (55) 3 (43) 0 4 (44) 11 (61) 40 4551-75 7 (21) 1 (5) 1 (14) 0 3 (33) 5 (28) 17 1926-50 5 (15) 6 (30) 0 0 (22) 2 (11) 15 1711-25 5 (15) 2 (10) 2 (29) 0 0 0 9 111-10 6 (17) 0 0 0 0 0 6 7

No information 0 0 1 (14) 0 0 0 1

Total 34 20 7 0 9 18 88

AFR = African Region, AMR = American Region, EMR = East-Mediterranean Region, EUR = EuropeanRegion, SEAR = South-East Asian Region, WPR = West Pacific Region.

to attain at least 50% MDT coverage. Sev-eral of these countries face major problems,including a poor infrastructure for leprosycontrol. Others have more pressing publichealth problems, difficulties in the mobili-zation of resources, and the preparation ofa realistic plan of action for MDT. Theyshould be assisted with the preparation ofa plan of action, including the developmentof strategies for MDT which can be appliedunder the prevailing circumstances, whilemaking optimal use of the available re-sources. Furthermore, these countries mayneed substantial financial assistance, notonly for drugs and training but also for op-erational costs, particularly during the firstyears of MDT implementation.

Recently the World Health Assemblyadopted a resolution on the elimination ofleprosy as a public health problem by theyear 2000. 3 Its plea to member states toincrease their commitment for leprosy may

' Noordeen, S. K. Elimination of leprosy as a publichealth problem. Lepr. Rev. 63 (1992) 1-4.

hopefully lead to increased efforts towardMDT implementation.

As a result of MDT implementation thenumber of patients registered for treatmentwill rapidly decrease. In several programs adecline in the number of patients on anti-leprosy treatment of 75% or more was ob-served some years after the introduction ofMDT. 4-1 5 In the All Africa Leprosy and Re-

4 Becx-Bleumink, M. New developments in theALERT leprosy control programme and the issues ofintegration. Ethiopia J. Health Dcv. 1 (1984) 49-55.

Becx-Bleumink, M. Implementation of multidrugtherapy in the ALERT leprosy control programme inthe Shoa region of Ethiopia. First results with pauci-bacillary patients. Lepr. Rev. 57 (1986) 111-119.

Becx-Bleumink, M. Operational aspects of multi-drug therapy. Int. J. Lepr. 57 (1989) 540-551.

7 Chum, H. J. The impact of MDT implementationin the Tanzanian National TB-Leprosy Programme.Lepr. Rev. 57 Suppl. 3 (1986) 63-66.

Ekambaram, V. and Rao, M. K. Changing pictureof leprosy in North Arcot district, Tamil Nadu, afterMDT. Indian J. Lepr. 61 (1989) 31-43.

Gilbody, J. S. Impact of multidrug therapy on thetreatment and control of leprosy. Int. J. Lepr. 59 (1991)458-478.

TABLE 2. Registered leprosy cases, registered cases per 10,000 population, MDT coverageand cumulative MDT coverage at the beginning of 1992 for the different WHO regions)

WHO region Registeredleprosy cases

Registeredleprosy casesper 10,000

MDTcoverage

% CumulativeMDT coverage

Africa 352,222 6.6 27.6 45.2Americas 335,490 4.6 20.6 25.7South-E. Asia 2,190,324 16.3 46.2 75.6Europe 7,021 0.1 33.2 34.9East Mediterranean 92,606 2.3 41.3 51.6West Pacific 110,125 0.7 69.9 82.0

Total 3,087,788 5.7 42.0 69.9

84^ International Journal of Leprosy^ 1993

TABLE 3. Changes in registered leprosypatients, registered number of patients per10,000 population and MDT coverage, be-tween the end of l990 and the beginning of1992 for the dilkrent 11710 regions.

WHO region

Regis-teredno.

leprosycases'

Regis-tered % MDTleprosy coverage.'cases per

10,000'

Africa /7 -28 +50Americas +II +1 0 —13South-E. Asia —19 — 20 —30Europe —3 0 —33East Mediterranean —7 —1/ +7West Pacific —28 —30 +10

Total —17 - 21 - 25

Percentage change.

habilitation Training Center (ALERT) lep-rosy control program the number of patientson antileprosy treatment declined from21,338 in July 1982 to 3725 in July 1989.This is a reduction of 82.5% within a periodof 7 years. As a consequence of the markeddecrease in case- and workload, the orga-nization of leprosy control services shouldbe reconsidered and priorities of these ser-vices should be redefined. In this respect thetwo major priority areas are: a) the integra-tion of the leprosy control services with thegeneral health services, and b) the preven-tion of disabilities.

Jesudasan, K., Vijayakumaran, P., Pannikar, V.K. and Christian, M. Impact of MDT on leprosy asmeasured by selective indicators. Lepr. Rev. 59 (1988)215-223.

" Noordeen, S. K. A look at world leprosy. Lepr.Rev. 62 (1991) 72-86.

' 2 Revankar, C. R., Pawar, P. L., Belurkar, L. S.,Rashmi, R. P. and Ganapati, R. Reduction in caseloadafter multidrug therapy in an urban leprosy controlprogramme—a retrospective study in Bombay. Lepr.Rev. 62 (1991) 44-48.

'' Rose, P. Changes in epidemiological indices fol-lowing the introduction of WHO MDT into the Guy-ana leprosy control programme. Lepr. Rev. 60 (1989)151-156.

Sundar Rao, P. S. S., Jesudasan, K., Pannikar, V.K. and Christian, M. Epidemiological impact of mul-tidrug therapy in Gudiyatham control area, Karigiri.(Abstract) Int. J. Lepr. 57 (1989) 331.

Wheate, H. W. and Harris, G. F. Operationalproblems in leprosy programmes when the endemicitydeclines. Lepr. Rev. 58 (1987) 1-5.

Integration of Leprosy Control withGeneral Health Services

So far most of the progress with MDTimplementation has been made in nonin-tegrated programs. A logical option for theseprograms will be the integration of leprosycontrol activities within the general healthservices.'• 6 ' 16-2(1 Integration has political,professional, operational, technical and fi-nancial implications. Although it is the pol-icy of many governments that control ofcommunicable diseases should be integrat-ed within the general health services, its im-plications have not always been worked out.

There is much confusion about the mean-ing of integration. It implies that the leprosycontrol activities will become the respon-sibility of the permanent multipurpose ser-vices.`' ' 6 ' 18 ' 2() This does not mean that allspecialized staff and services should disap-pear. Specialized staff at each country'sMinistry of Health and at defined admin-istrative levels will often remain essentialfor planning, organization, supervision, dis-tribution of supplies, training, monitoringand evaluation.

The transformation of a nonintegratedinto an integrated program is a complexprocess. It requires careful planning includ-ing the identification of areas where prob-lems can be expected and finding the solu-tions for preventing or solving theseproblems. The lack of motivation of a gen-eral health staff for leprosy control is one ofthese problems. Others are the absorptionof specialized leprosy staff by the generalhealth services and the reluctance of spe-cialized leprosy staff to delegate responsi-bilities to the general health staff.

While integration may be the most ap-propriate, efficient, and effective solution inseveral countries, this may not be the case

16 Feenstra, P. and Tedla, T. A broader scope forleprosy control. World Health Forum 9 (1988) 53-58.

17 Loretti, A. Leprosy control: the rationale of inte-gration. Lepr. Rev. 60 (1989) 306-316.

' 8 McDougall, A. C. and Georgiev, G. D. Priority inleprosy control. Lepr. Rev. 60 (1989) 1-7.

World Health Organization. A Guide to LeprosyControl. 2nd ed. Geneva: World Health Organization,1988.

2" World Health Organization. Report of a consul-tation on implementation of leprosy control throughprimary health care. Geneva: World Health Organi-zation, 1986. WHO/CDS/LEP/86.3.

61, 1^ Editorials^ 85

everywhere. An adequately functioninggeneral health service is considered a pre-requisite for integration. 16 ' 20 This impliesthat the general health services are adequatein quantity and quality. Thus, the vast ma-jority of the population should have accessto the general health services, meaning thatthey live within 5 km from such a service,and staff should be available who can takeresponsibility for the leprosy control activ-ities. Where such services do not exist, itwill be more effective and efficient to usethe leprosy control infrastructure forstrengthening the control of other diseases,in particular tuberculosis. It is sometimesrecommended that dermatological servicesshould take up the responsibility for leprosycontrol. These services should certainly beinvolved in diagnosing patients. However,because they often only exist in towns andconcentrate on curative treatment, they arenot the most appropriate units for takingresponsibility for the control of leprosy.

Another option is combined leprosy andtuberculosis control which is integrated intothe general health services, with specializedstaff at various administrative levels. In anincreasing number of countries such com-bined, integrated programs are inuse. 7 - '5' 21. 22

Which strategy would be most appropri-ate under the prevailing circumstances alsodepends on, besides the infrastructure of thegeneral health services, factors such as: a)the extent of the leprosy problem; b) the costof specialized services; c) the existence ofprograms for control of other diseases, andpossibilities for combined services; and e)the available resources. To illustrate whatmay be the most appropriate approach, un-der the prevailing circumstances, theALERT leprosy control program is given asan example.

ALERT Leprosy Control ProgramLeprosy control services

In 1971, at the request of the EthiopianGovernment, ALERT took the responsi-

2 ' Alvarenga, A. E. Report of the Joint Leprosy—Tuberculosis Project in Paraguay. Lepr. Rev. 57 Suppl.3 (1986) 53-59.

" de Rijk, A. J. Combining tuberculosis and leprosyservices in one programme. Ethiopian J. Health Dev.1 (1984) 37-43.

bility for leprosy control in the Shoa Ad-ministrative Region, excluding the southernpart of the region and Addis Ababa. In 1972Addis Ababa was added and in 1978, thesouthern part of Shoa. The area covers about85,000 sq. km with an estimated populationof about 11 million (1989).

The ALERT leprosy control program isa nonintegrated program. In 1989 the lep-rosy control activities in the field were car-ried out by about 60 field workers and 16supervisors. The field workers were healthassistants who had followed a formal gen-eral medical training of 1 1/2 years, whichshould equip them with the knowledge andskills to take care of common medical prob-lems in the rural areas. The supervisors wereeither sanitarians, who had been trained inenvironmental health, or experienced healthassistants. They had over 10 years of ex-perience as intermediate-level leprosy con-trol managers.

Of the 329 general health facilities whichexisted in the rural areas of the Shoa Region,151 operated leprosy clinics run by a leprosyfield worker. The main reasons that serviceswere not provided in all facilities were theunequal distribution of these facilities, aswell as the disease: a relatively high numberof facilities were located in areas with thelowest leprosy problem. The leprosy controlfield staff also provided services in 114 so-called "leprosy clinics," which had been es-tablished in remote areas where a generalhealth service did not exist. These clinicswere conducted in a school, farmers' asso-ciations' buildings or in the open field.

About 50% of the clinics where leprosyservices were provided were accessible bycar during the whole year; 32% were acces-sible by car during the dry season only and18% were not accessible by car and had tobe reached on foot or by mule. Public trans-port was hardly available, and due to themountainous terrain and the existence ofonly a few tarmac roads, the possibilities forthe use of motorcycles and bicycles werevery limited. The majority of the leprosypatients lived more than 1 hour's travel froma clinic. Of 1641 leprosy patients who werediagnosed during the period July 1987 toJuly 1989, 38% lived within 1 hour's travelfrom a leprosy clinic, 27% within 1-2 hours,24% within 2-4 hours, and 11% more than4 hours.

86^ International Journal of Leprosy^ 1993

Leprosy control activitiesCase detection. Case detection was al-

most exclusively passive, that is, throughvoluntary reporting by patients. 018224 pa-tients who were diagnosed during the periodJuly 1979 to July 1989, 94.6% were self-reporting, 2.3% were detected through con-tact examination, 1.5% through examina-tion of school children, and 1.6% throughexamination of special groups.

Figure 1 shows the annual self-reportedleprosy incidence per 10,000 populationduring the period 1975 to 1989. A declinein the self-reported incidence can be ob-served starting in 1981. The decline formsa plateau since 1985, with a stabilization ata self-reported incidence rate of about 1 per10,000 population. Similar trends were ob-served in other regions of Ethiopia. 23 Be-cause the proportion of new patients with adisability grade of 2 at the time of diagnosisof leprosy decreased from an estimated per-centage of over 30 in 1977," to 20.6% in1984, 25 the decline most probably reflects adecline in incidence of the disease ratherthan delay in case finding. Data on classi-fication and age of new patients were onlycollected since 1984. Therefore, a possibleincrease in the proportion of new patientswith lepromatous leprosy and shifts in therelative age distribution of new patients to-ward higher age groups, which are indica-tors of a decline in leprosy incidencerates,"' 26-29 could not be studied.

" Berhe, D., Haimanot, R. T., Tedla, T. and Tad-esse, T. Epidemiological patterns of leprosy in Ethio-pia: a review of the control programmes. Lepr. Rev.61 (1990) 258-266.

" 13ecx-13Ieumink, M. Assessment of the disabilityproblem in the ALERT Leprosy Control Programme,unpublished data, 1988.

ALERT, Annual Reports 1984-1989. Addis Aba-ba: All Africa Leprosy and Rehabilitation TrainingCenter.

Boerrigter, G. and Ponnighaus, J. M. Ten years'leprosy control work in Malawi (Central Africa)—II.Patterns of endemicity since 1973. Lepr. Rev. 57 (1986)11 1—?36.

" Irgens, L. M. Leprosy in Norway. Lepr. Rev. 51Suppl. 1 (1980) 1-130. •

Irgens, L. M. Secular trends in leprosy: increasein age at onset associated with declining rates and longincubation periods. Int. J. Lepr. 53 (1985) 610-617.

Irgens, L. M., Melo Caciro, F. and Lechat, M. F.Leprosy in Portugal 1946-80. Epidemiologic patternsobserved during declining incidence rates. Lepr. Rev.61 (1990) 32-49.

The possible reasons for the decline inincidence of the disease could be a decreasein transmission of leprosy infection due todiagnosis and treatment of patients, protec-tion of healthy individuals by BCG vacci-nation, or improvement of the socioeco-nomic conditions of the population. Avariable degree of protection by BCG, rang-ing from 20% to 80%, has been demonstrat-ed in several studies. 30-37 Because in Ethi-opia the BCG coverage of newborns was lessthan 25% in the 1980s 38 and probably nothigher in the 1970s and earlier, protectionby BCG will not have been a major reasonfor the decline. If there was any improve-ment at all in the socioeconomic conditionsof the rural population during the last de-cades, it will have been very marginal.Therefore, the effects of the leprosy controlactivities appear the most probable reasonfor the decline in incidence. Because MDTwas introduced in 1983, this must have beenthe effect of treatment with dapsone mono-therapy. Others are, however, ofthe opinionthat there is no strong evidence that che-motherapy-based control attributes to a de-cline in incidence rates. 26 • 39

'" Bagshawc, A., Scott, G. C., Russel, D. A., Wigley,S. C., Merianos, A. and Berry, G. BCG vaccination inleprosy; final results of the trial in Karimui, Papua NewGuinea. Bull. WHO 67 (1989) 389-399.

Fine, P. E. M. The Kellersberger Memorial Lec-ture 1985: the role of BCG in the control of leprosy.Ethiopian Med. J. 23 (1985) 179-191.

" Fine, P. E. M. BCG vaccination against tubercu-losis and leprosy. Br. Med. J. 55 (1988) 691-703.

Fine, P. E. M. Vaccination against leprosy: ne-glecting the obvious? In: Health Cooperation Papers,Proceedings of the VI Leprosy Symposium on "LeprosyResearch," Santa Margherita Ligure-Genoa, Italy, Oc-tober 3-7 1990. Associazione Italiana "Amici di RaoulFollereau," 1992, pp. 211-215.

Gupte, M. D. Report of a pre-Congress workshopon "Vaccine trials." XIllth International Leprosy Con-gress, The Hague, The Netherlands, 11-17 September1988. Lepr. Rev. 59 (1988) 296-300.

" Lwin, K., Sundaresan, T., Gyi, M. M., Bechelli,L. M., Tamondong, C., Garbajosa, P. G., Sansarricq,H. and Noordeen, S. K. BCG vaccination of childrenagainst leprosy: fourteen-year findings of the trial inBurma. Bull. WHO 63 (1985) 1069-1078.

" Stanley, B. J., Howland, C., Stone, M. M. andSutherland, I. BCG vaccination of children against lep-rosy in Uganda. Final results. J. Hyg. (Cambridge) 87(1981) 233-248.

Tripathy, S. P. The case for BCG. Ann. Natl. Acad.Med. Sci. (India) 19 (1983) 11-21.

" Abite, M., Head, National Tuberculosis Control

61, 1^ Editorials^ 87

TABLE 4. Annual self-reported incidence rates per 10,000 population for the differentdistricts of Shoa Region.

DistrictYear

1981 1982 1983 1984 1985 1986 1987 1988 1989

Chebo & G 2.0 1.0 0.7 0.8 0.7 0.5 0.5' 0.8 0.6Haykoch & B 2.6 2.0 2.0 1.8 1.3' 1.7 1.2 1.1 0.9Jibat & M 4.3 3.1 1.6 1.6 1.2 1.3 1.0' 1.1 0.9Kembata & 1-1 2.2 1.4 0.9 1.0 0.6' 0.7 0.4 0.4 0.4Menagesha 1.1 0.9 0.8 0.9' 0.7 0.5 0.5 0.4 0.3Menz & G 7.0 3.8 3.2 2.3 2.1 1.8' 2.6 1.9 2.0Merhabete 5.3 4.6 2.5 2.0 2.6 2.3 2.0 1.4' 1.3Selale 1.0 0.9 0.8 0.8 0.8 0.8' 1.0 0.7 0.8Tegulet & B 3.0 2.1 2.9" 2.5 2.0 0.8 1.3 1.6 1.0Yerer & K 0.9 1.7 1.1 0.7' 1.1 0.5 0.3 0.5 0.3Yifat & T 8.0 6.1 6.8' 5.7 2.1b 3.6 3.5 3.8 3.0Addis Ababa 1.4 1.3 0.8 0.6" 0.3 0.3 0.4 0.3 0.6

Total 2.4 1.7 1.4 1.3 0.9 1.0 1.0 1.0 0.8

Year of implementation of MDT.'' Decline in the rate was due to the severe drought and famine.

Table 4 presents the annual self-reportedincidence rates per 10,000 population from1982 to 1989 for the 11 rural districts andAddis Ababa separately. Besides a substan-tial difference in case-detection rates be-tween the districts, a decline in self-reportedincidence rates can be observed in most dis-tricts, particularly until the end of 1985. Asubstantial increase in case detection fol-lowing the implementation of MDT was notobserved. If there was some increase, forexample, in the Haykoch & B. and Menz &G. districts, it seems to have been very tem-porary.

The period between the patients' obser-vation of the first signs of the disease andthe time of diagnosis of leprosy is still long.The average period for 1641 patients whowere diagnosed during the period July 1987-July 1989 is presented in Table 5.

The delay in diagnosis of the patients in-dicates that there are many undiagnosed pa-tients in the community. Thus, although theprogram has been effective with respect totreatment results, it has not been effectivewith regard to case detection. The accessi-bility of the services is certainly one of thefactors contributing to the delay in diagnosisof patients. The data in Table 5 show thatthe more the average period between the

Programme, Ethiopia, personal communications, 1987-1989.

Meade, T. W. How effective is the treatment ofleprosy? Lepr. Rev. 48 (1977) 3-8.

first signs of leprosy and the diagnosis in-creases, the more the classification is towardthe LL pole.

Registered patients. The evolution ofthe rate of registered leprosy patients per10,000 population from 1972 until 1989 ispresented in Figure 2. The rate graduallyincreased until 1982, after which, due toimplementation of MDT and the release ofpatients on dapsone monotherapy, it steadi-ly decreased.

General health serviceIn July 1987 the general health service in

the rural areas of Shoa consisted of 10 hos-pitals, 18 health centers, and 301 health sta-tions-one health care facility for, on theaverage, 32,000 population, with a range of12,000 to 49,000 for the different districts. 40

With respect to integration of the leprosycontrol services within the general healthservices, the health stations would be themost important units. During the year 1986/1987 the total budget for the hospitals, healthcenters and health stations in the Shoa Re-gion was approximately US$6,500,000, ofwhich US$962,000 (14.8%) was allocatedto the health stations. 4° Of this amountUS$417,000 (43.4%) was for drugs, aver-aging US$1400 for each health station.

4" People's Democratic Republic of Ethiopia, Min-istry of Health. Comprehensive Health Service Direc-tory 1979 E.0 (1986/1987 G.C.). Planning and Pro-gramming Bureau, Addis Ababa, August 1988.

Classi-fica-tion'

No.patients

1988 19891975 1976 1977 1978 1979 1980 1981 1992 1983 1984 1985 1986 1987

39

25

t 2.0

7., 1.5

1.0

05

88^ International Journal of Leprosy^ 1993

TABLE 5. Average period between pa-t lent 's first observation qfsigns of leprosy andthe time of diagnosis of leprosy.

Avg. periodbetween

^95°h Confi-

first signs^

denceof leprosy

^interval

and diagnosis^

(yr)(yr)

TT^

107^

1.4^

0-4.0BT^

689^

2.1^

0-6.5BL^

602^

2.4^

0-7.0LL^

243^

2.9^

0-7.9

1641^

2.3^0-6.8

TT = Tuberculoid leprosy; BT = borderline tuber-culoid leprosy; BL = borderline lepromatous leprosy;LL = lepromatous leprosy.

In most of the health stations a healthassistant was the officer in charge and mighthave been assisted by other health assistantsor one or more nurses. In the year 1986/1987 a total of 588 health assistants wereassigned to the 301 health stations in theShoa Region. The number of health assis-tants per health station varied from none(6.3%) to one (35.2%), two (37.2%), three(12.0%) and more than three (8.3%). 4" Thus,a health station, with an average of twohealth assistants and an average annualbudget for drugs of US$1400, was respon-sible for the health care in an area with anaverage population of 32,000.

Because of nonavailability of transpor-tation and funds, a referral system fromhealth stations to health centers and hos-pitals did not exist. The chronic shortage ofdrugs was certainly an important reason forthe fact that health stations were often openonly a few hours per day or closed duringpart of the month (own observation). Fur-

ther, a system of supervision did not existin practice. Patients who could afford to payfor transportation often went directly to ahospital. About 60% of the population inthe rural areas lived more than 1 hour'stravel from a health care facility. There isno evidence that this situation has changedduring the last few years.

Tuberculosis problemTuberculosis is a major public health

problem. In the year 1986/1987 it was thethird leading cause for hospitalization andthe first leading cause of hospital death.'"The estimated annual risk of tuberculousinfection is 2%. 38 This corresponds with anannual incidence of about 100 sputum-smear-positive tuberculosis patients per100,000 population. For the Shoa Regionand Addis Ababa this means that 11,000persons will develop infectious pulmonarytuberculosis each year. In addition, 11,000persons will develop noninfectious pulmo-nary tuberculosis or extra-pulmonary tu-berculosis. During the last decades system-atic, large-scale tuberculosis controlmeasures have not been undertaken. Dueto shortages of drugs in the hospitals, thenonavailability of drugs in the rural areas,and the absence of a system of follow up,the vast majority of patients who were di-agnosed with tuberculosis and started ontreatment discontinued it within a fewweeks. 38 The tuberculosis problem is defi-nitely increasing due to the increasing prob-lem of infection with the human immuno-deficiency virus (HIV). By early 1992, 1818AIDS patients had been diagnosed, -" com-pared to 348 two years earlier. 42 Because inmost people the cause of death is not es-

30

fa. 25

20

86215

010721. 5

z 0

Fla. 1. Annual self-reported leprosy incidence per

1972^1974^1976^1978^1980^1982^1984^1986^19881973^1975^1977^1979^1981^1983^1985^1987^1989

FIG. 2. Evolution in the rate of registered leprosy10,000 population during the period 1975-1989.^patients.

61, 1^ Editorials^ 89

tablished, these patients represent only thetip of the iceberg.

Combined leprosy and tuberculosis controlFor the Shoa Region, and probably for

Ethiopia as a whole, the most appropriateapproach would be to establish combinedtuberculosis and leprosy control. Tubercu-losis control would greatly benefit from theleprosy control infrastructure, and a justi-fiable infrastructure could be maintained forleprosy control. Although the number ofleprosy patients on treatment has been re-duced greatly due to the implementation ofMDT, specialized staff at regional and dis-trict levels is certainly still required, es-pecially for supervision, training and mon-itoring.

At the time a combined leprosy and tu-berculosis program will have been intro-duced in the whole of the Shoa Region, theestimated caseload of patients on treatmentwill be as follows: a) the number of leprosypatients on MDT will, at any time, be about2250. This is based on 1000 patients whowill be put on MDT each year; about 850of them new patients and 150 others (re-lapses, returned defaulters); 50% of thempaucibacillary (PB) patients and 50% mul-tibacillary (MB) patients. The period oftreatment is 6 months for PB patients and4 years, on average, for MB patients if MDTis continued until skin-smear negativity. Ifthe period of treatment of MB patients islimited to 2 years, to be completed withinan average period of 2'/2 years, the numberof patients on MDT will be about 1500. b)The number of tuberculosis patients ontreatment will, at any time, be about 7300,half of them smear-positive pulmonary tu-berculosis patients and half of them smear-negative pulmonary- and extra-pulmonarycases. This is based on the assumption that50% of the estimated new smear-positivepatients and 50% of the smear-negative pul-monary- and extra-pulmonary patients willbe diagnosed and put on treatment. The pe-riod of treatment with short-course che-motherapy is 8 months. Because the com-

World Health Organization. Weekly Epidemio-logical Record 67 (1992) 97.

" World Health Organization. Weekly Epidemio-logical Record 65 (1990) 133.

bined program should be implementedgradually, and diagnosis of 50% of the es-timated tuberculosis patients will, mostprobably, not be attained immediately fromthe start of the program, the above numberof patients will be reached after some time.After the program has been well established,gradually a higher proportion of the esti-mated tuberculosis patients may be diag-nosed.

For a combined leprosy and tuberculosisprogram some supervisors, in addition tothe available leprosy control supervisors,will be required. These should be recruitedfrom among staff who are already workingin tuberculosis. Combined control of the twodiseases should, as much as possible, be in-tegrated within the general health services.However, the leprosy control services whichhave been established in remote areas shouldcontinue to be operational for leprosy andtuberculosis until adequate general healthservices have been established or alterna-tive solutions, particularly for the treatmentof patients, have been found.

In order to monitor the operational as-pects, combined tuberculosis and leprosycontrol initially should be implemented ina limited area. If the results are satisfactory,the combined program should be expandedto other areas. Important indicators for as-sessing whether results are satisfactoryshould be the proportion of new sputum-smear-positive tuberculosis patients whohave been cured and the proportion of lep-rosy patients who completed the prescribedcourse of MDT.

Prerequisites for combined leprosy andtuberculosis control are: a) a detailed planof operations for the combined program isprepared; b) the infrastructure which hasbeen established for leprosy control will re-main operational; c) the government ofEthiopia will continue its support for lep-rosy control, and will intensify its commit-ments to tuberculosis control; d) interna-tional leprosy sponsors continue theirsupport for leprosy control; e) additionalfunding will be secured for the training ofstaff, antituberculosis drugs, and establish-ing and up-grading laboratory facilities fortuberculosis. In addition, because hospitalinpatient facilities are very limited (in theShoa Region there is one hospital bed for12,000 population on average), alternatives

90^ International Journal of Leprosy^ 1993

for ensuring supervised treatment during theinitial intensive phase of treatment of smear-positive tuberculosis patients have to befound. This could be the establishment of"tukuls," traditional houses. At severalplaces, mainly attached to nongovernmen-tal hospitals, "tukuls" arc already used aslow-care units.

Disability PreventionA major problem of leprosy control pro-

grams, which will continue to be a problemfor several years, arc the disabled patients.The seriousness of leprosy comes from thefact that it is mainly a disease of peripheralnerves. Although effective treatment canensure bacterial cure, it does not reversenerve function loss.

It is estimated that there are 2-3 millionindividuals in the world who are physicallydisabled as a result of past or present lep-rosy." 2.13 There is wide variation in thepublished data on disabilities in registeredleprosy patients. The data range from lessthan 10% to over 75%. 44- " The data are

" World Health Organization. Report of a consul-tation on disability prevention and rehabilitation inleprosy. Geneva: World Health Organization, 1987.WHO/CDS/LEP/87.3.

Bechelli, L. M. and Martinez Dominguez, V. Theleprosy problem in the world. Bull. WHO 34 (1966)811-826.

4' Bechelli, L. M. and Martinez Dominguez, V. Fur-ther information on the leprosy problem in the world.Bull. WHO 46 (1972) 523-536.

• I3ecx-131eumink, M. Operational aspects of the im-plementation of multidrug therapy at ALERT, Ethio-pia. Lepr. Rev. 57 Suppl. 3 (1986) 115-123.

• Boerrigter, G. and Ponnighaus, J. M. Preliminaryevaluation of the effect of WHO-MDT on disabilitiesin leprosy patients in Malawi (Central Africa). Lepr.Rev. 57 Suppl. 3 (1986) 101-105.

4' Bravo, L. L. and Ratard, R. C. Leprosy disabilitiesin the New Hebrides. Lepr. Rev. 48 (1977) 247-260.

:" Chum, H. J. and Otsyula, Y. Leprosy disability inYimbo and its economic effects. East Afr. Med. J. 47(1970) 389-394.

`“ Hasan, S. A survey of leprosy deformities amongthe patients of Hyderabad city. Lepr. India 49 (1977)393-398.

" Kaur, P. and Sing Gurmehan. Deformities in lep-rosy patients attending urban leprosy clinics at Vara-nasi. Indian J. Lepr. 57 (1985) 178-182.

" Keeler, R. and Ryan, M. A. The incidence of dis-abilities in Hansen's disease after the commencementof chemotherapy. Lepr. Rev. 51 (1980) 149-154.

" Kushmah, S. S., Gorila, A. K. and Kushwah, J.Disabilities among leprosy patients attending leprosy

difficult to interpret because it is not alwaysspecified to which leprosy cases they refer,or they relate to special groups of patients,such as those institutionalized or attendingurban clinics. Further, the disability gradingrecommended by the WHO has been re-vised a few times, 62-" and modifications tothis grading have been used in several coun-tries. 56 . 65-67 Also, very little is known aboutthe extent and pattern of leprosy-attribut-able disability in populations, and hardlyany information has been published on when

clinics in Gralior, an epidemiological study. Lepr. India53 (1981) 240-247.

" Martinez-Dominguez, V., Bechelli, L. M. and Pat-wary, K. NI. WHO surveys of disabilities in leprosy inNorthern Nigeria (Katsina), Cameroon and Thailand(Khon Kaen). Int. J. Lepr. 34 (1966) 244-254.

Noordeen, S. K. and Srinivasan, H. Deformity inleprosy: an epidemiological study. Indian J. Med. Res.57 (1969) 175-181.

Ponnighaus, I. NI., Boerrigter, G., Fine, P. E. M.,Ponnighaus, ,I. M. and Russel, J. Disabilities in leprosypatients ascertained in the total population survey inKaronga District, Northern Malawi. Lepr. Rev. 61(1990) 366-374.

Prasad, S. Deformities in leprosy, a survey in aclosed community. Lepr. India 53 (1981) 626-633.

`" Rao, P. S. S., Karat, S., Karat, A. B. A. and Fur-ness, M. A. Prevalence of deformities and disabilitiesamong leprosy patients in an endemic area. Part 1.General findings. Int. J. Lepr. 38 (1970) 1-11.

" Rao, P. S. S., Karat, S., Karat, A. B. A. and Fur-ness, M. A. Prevalence of disabilities in children af-fected with leprosy. Int. J. Lepr. 41 (1973) 577-583.

Reddy, B. N. and Bansal, R. D. N. An epidemi-ological study of leprosy disability in a leprosy endemicrural population. Indian J. Lepr. 56 (1984) 191-199.

" Sehgal, V. N. and Sharwa, P. K. Patterns of de-formities/disabilities in urban leprosy. Indian J. Lepr.57 (1988) 183-192.

62 WHO Expert Committee on Leprosy. Second re-port. Geneva: World Health Organization, 1960. Tech.Rep. Ser. 189.

6 ' WHO Expert Committee on Leprosy. Fourth re-port. Geneva: World Health Organization, 1970. Tech.Rep. Ser. 459

'' WHO Expert Committee on Leprosy. Sixth report.Geneva: World Health Organization, 1988. Tech. Rep.Ser. 768.

65 Brandsma, J. W., de Jong, N. and Tjepkema, T.Disability grading in leprosy; suggested modificationsto the WHO disability grading forms. Lepr. Rev. 57(1986) 361-369.

Hasan, S. An appraisal of use of the classificationof disabilities resulting from leprosy in field work andsuggestions for improvement. Lepr. India 54 (1982)135-142.

' Kulkarni, U. P., Kulkarni, V. N. and Jogaikar, D.G. Classification of disabilities as followed by Poonadistrict leprosy committee. Lepr. India 56 (1984) 269-279.

61, I^ Editorials^ 91

patients are most at risk of developing dis-abilities.

A main part of the disability problem isconsidered the result of failure to incorpo-rate in leprosy control programs activitieswhich are directed toward prevention ofdisabilities.' ' Prevention of disabilities hasdefinitely not been given due attention inmost leprosy programs.

International organizations have givenbasic recommendations for the preventionof disabilities. There are a number of ex-cellent manuals on the control of disabilitiesin patients with irreversible nerve functionloss. 68-71 However, manuals which cover allmajor components of disability prevention,which can be applied under routine fieldconditions, have not yet been published.

Most beds in leprosy hospitals are occu-pied by patients with severe complicationsdue to nerve function loss. Substantiallymore resources are spent on the treatmentof such patients than on the prevention ofdisabilities or on the prevention of compli-cations of nerve function loss. Furthermore,the number of patients who require hospitaladmission often by far exceed the availableinpatient facilities. The long-term results oftreatment of complications are often poor;ulcers frequently recur, which ultimatelylead to loss of bones and soft tissue. Re-constructive surgery, if available at all, canonly be of help to a very limited number ofpatients and requires surgeons trained inspecialized techniques, as well as physio-therapists.'' Because surgery can only cor-rect deformities due to motor paralysis, thepossible consequences of loss of sensationremain.

It is obvious that the first priority in theprevention of disabilities should be the pre-

Kelly, E. D. Physical therapy in leprosy for para-medicals. Levels I & II and levels I & II & III. 3rd ed.Elmwood Park, New Jersey, U.S.A.: American Lep-rosy Missions, 1981.

Nevile, P. J. A footwear manual for leprosy controlprogrammes. Part I and Part 2. Addis Ababa: All Af-rica Leprosy and Rehabilitation Training Centre.

7" Watson, J. M. Preventing disability in leprosy pa-tients. London: The Leprosy Mission International,1986.

Watson, J. M. Essential action to minimise dis-ability in leprosy patients. London: The Leprosy Mis-sion International, 1986.

" Bourret, P. Surgical rehabilitation. Lepr. Rev. 62(1991) 241-254.

vention of irreversible nerve function loss.The early detection and effective treatmentof patients is usually considered the mosteffective way to prevent disabilities. Theearly detection and appropriate treatmentof leprosy reactions is another importantmeasure.

The next priority is the prevention ofcomplications of irreversible nerve functionloss. Once nerve function loss is established,disability has a natural tendency to deteri-orate. This tendency is unaffected by che-motherapy and specific measures have to betaken to prevent this. 73

Early diagnosis and effectivetreatment of patients

In leprosy control programs early diag-nosis means diagnosis before disabilitieshave occurred. Early detection and effectivetreatment alone, however, will not preventdisabilities. A major problem after startingchemotherapy is the development of lep-rosy reactions, notably reversal reactions.There is no evidence that the risk of devel-oping a reaction is less in patients who arediagnosed at an early stage of the diseasethan in those who already have nerve func-tion loss at the time of diagnosis of leprosy.It has been reported that the incidence ofreactions is significantly lower among ac-tively detected patients than among self-re-porting patients.' Because in a proportionof actively detected patients the lesionswould have been self-healing if they had notbeen diagnosed," this group is not com-parable with self-reporting patients.

Only if early diagnosis and effective treat-ment of patients goes hand in hand withappropriate management of leprosy reac-tions will disabilities be prevented. Healtheducation, training of medical and para-medical staff, and improvement of the de-livery of the service at the peripheral levelare usually recommended as measures to

" Watson, J. M. Disability control in a leprosy con-trol programme. Lepr. Rev. 60 (1989) 169-177.

" Boerrigter, G., Ponnighaus, J. M. and Fine, P. E.M. Preliminary appraisal of a WHO-recommendedmultiple drug regimen in paucibacillary leprosy pa-tients in Malawi. Int. J. Lepr. 56 (1988) 408-417.

" Ekambaram, V. and Sithambaram, M. Self-heal-ing in non-lepromatous leprosy in an area of the ELEPLeprosy Control Project Dharmapuri (Tamil Nadu).Lepr. India 49 (1977) 387-392.

92^ International Journal of Leprosy^ 1993

TABLE 6. Percentages ofdisabled patientsamong newly diagnosed cases.

Year No ' newpatients^Disability Disabilitygrade 1"^grade 2

'YoTotal

disability

1984 804 20.4 20.6 41.01985 652 18.6 18.4 37.01986 845 18.9 18.6 37.51987 885 21.8 16.0 37.81988 951 21.6 15.1 36.71989 784 27.6 13.9 41.5

Patients are graded according to the highest dis-ability grade of hands, feet and eyes.

promote the early diagnosis of leprosy pa-tients.'

Management of leprosy reactionsThis aspect of the prevention of disabil-

ities has been discussed extensively in an-other paper.'' Provided that preconditionsare fulfilled and precautions are taken, themanagement of reactions under field con-ditions should be a major component in theprevention of disabilities. The preventionof irreversible nerve function loss throughadequate treatment of reactions is certainlya very efficient and effective measure in theprevention of disabilities.

It is very unfortunate that there has beenhardly any progress in the development ofmethods for the prevention and treatmentof leprosy reaction during the last decades.The importance of research on identifica-tion of risk factors for the development ofleprosy reactions cannot be over-empha-sized. Furthermore, there is an urgent needfor studies on the treatment of reactions,including identification of drugs other thanprednisolone.

Prevention of complications ofirreversible nerve function loss

Ideally, no patient should have irrevers-ible nerve function loss at the time of di-agnosis of the disease. Although a gradualdownward trend in the proportion of pa-

Becx-Bleumink, M. and Berhe, D. Occurrence ofreactions, their diagnosis and management in leprosypatients treated with multidrug therapy; experience inthe leprosy control program of the All Africa Leprosyand Rehabilitation Training Center (ALERT) in Ethi-opia. Int. J. Lepr. 60 (1992) 173-184.

tients who are already disabled at the timeof diagnosis of leprosy has been observedin sonic programs,"• 56 ' 77 many patients arestill diagnosed only at the time they are al-ready disabled.

Table 6 gives the percentages of patientswith a disability grade of 1 and 2 amongthose diagnosed in the ALERT leprosy con-trol program during the years 1984 to 1989.The disability grading is according to therecommendation of a WHO Expert Com-mittee on Leprosy of 1988. 64 Grade 1 ofhands and feet means loss of sensation, butno visible deformity or damage; grade 2 isvisible deformity or damage. Grade 1 ofeyes means eye problems due to leprosy, butvision not severely affected; grade 2 is se-vere visual impairment. The data in Table6 show a gradual downward trend in thepercentage of patients with a disability gradeof 2. This indicates earlier diagnosis of cases.However, the total percentage of patientswith a disability remained the same.

Disabilities of the eyes occur least fre-quently. However, a substantial proportionof patients with an eye disability also havedisabilities of the hands and feet. Of 1643patients who were diagnosed with leprosyin the ALERT leprosy control program dur-ing the period July 1987 to July 1989, 68patients (4.1%) had an eye disability; 47 ofthese patients (69.1%) also had a disabilityof the hands and/or feet, in 27 patients(39.7% of those with an eye disability) botheyes, both hands, and both feet were affect-ed.

The pattern of hand and foot disabilityof these 1643 patients at the time of diag-nosis of leprosy, and that of 1349 patientswho were started on MDT during the sameperiod but had been treated with dapsonebefore MDT, is presented in Table 7.

In both groups of patients, particularlythose who had been treated with dapsonebefore MDT, both the hands and feet weremost commonly affected, followed by thefeet only. Of the new patients, 24.7% haddisability grade 1 and 15.1% had disabilitygrade 2, compared with 14.9% and 34.4%,respectively, of the patients who had been

7 ' Cruz, M. D. The future of leprosy in the Domin-ican Republic: experience with multidrug therapy. Lepr.Rev. 57 Suppl. 3 (1986) 127-133.

61. 1^ Editorials^ 93

TABLE 7. Pattern of hand and foot disability in new patients and in patients who hadbeen treated with dapsone before MDT.

Pattern of disabilityNew patients Patients treated before MDT

No. No. °/o

No disability 989 60.2 684 50.7

Hand onlyGrade 1

One hand 49 3.0 23 1.7Two hands 14 0.8 6 0.4

Grade 2One hand 43 2.6 54 4.0Two hands 11 0.7 32 2.4

Subtotal hands 117 7.1 115 8.5

Feet onlyGrade 1

One foot 88 5.4 43 3.2Two feet 104 6.3 39 2.9

Grade 2One foot 42 2.6 62 4.6Two feet 16 1.0 29 2.1

Subtotal feet 250 15.3 173 12.8

Hands and feetGrade 1 152 9.2 90 6.7Grade 2 135 8.2 287 21.3

Subtotal hands and feet 287 17.4 377 28.0Total 1643 1349

treated with dapsone. Whether the lattergroup already had a higher disability at thetime of diagnosis of leprosy, with respect tothe grade and the number of limbs affected,or the disability increased during treatmentis not known. Because the management ofleprosy reactions was grossly inadequate be-fore 1987 and measures toward preventionof the increase of disability were hardly orpoorly applied, it is most probable that inpart of the patients the disability either de-veloped or increased during treatment.

The data in Table 7 show that the dis-ability problem is an immense problem. Itis also a very complicated problem. The so-cial stigma attached to the disease is an im-portant cause for late self-reporting by pa-tients. Complications due to peripheralnerve damage in turn contribute to main-taining the stigma.

There is wide variation in recommendedapproaches regarding care for patients withdisabilities. 11• 19, 20, 73, 78-82 These range from

78 Becx-Bleumink, M., Berhe, D. and 't Mannetje,W. The management of nerve damage in the leprosycontrol services. Lepr. Rev. 61 (1990) 1-11.

medical, social and economic rehabilitationduring and after treatment, provided or ini-tiated by the leprosy control services, to thepromotion of community-based rehabili-tation. Medical, social and economic re-habilitation schemes are usually small-scaleinitiatives.

In several programs patients are providedwith appliances, especially footwear, to pro-tect insensitive limbs. Such provision is of-ten limited to patients who attend a leprosyinstitution. Rather than supplying appli-ances, the importance of promotion of self-

Brand, M. Report of a pre-Congress workshop on"Rehabilitation." XIIIth International Leprosy Con-gress, The Hague, The Netherlands, 11-17 September1988. Lepr. Rev. 59 (1988) 304-305.

"" Duerksen, F. Report of a pre-Congress workshopon "Prevention and management of impairment inleprosy." XIIIth International Leprosy Congress, TheHague, The Netherlands, 11-17 September 1988. Lepr.Rev. 59 (1988) 295-296.

Gershon, W. and Srinivasan, G. R. Community-based rehabilitation: an evaluation study. Lepr. Rev.63 (1992) 51-59.

$2 Neville, J. After multidrug therapy (MDT) who isresponsible for continuing care? Lepr. Rev. 59 (1988)1-3.

94^ International Journal of Leprosy^ 1993

care by patients is more and more recog-nized. Even if funds would be available,which is mostly not the case, the organi-zation of a service which provides footwearwithout interruption and for life to patientswith insensitive soles is extremely difficult,if at all possible.' 8

Community-based rehabilitation is an-other recommended way to deal with thedisability problem."• Si This approach aimsat promoting awareness, self-reliance, andresponsibility for rehabilitation in the com-munity. Compared to institution-based ser-vices, which take care of the physical con-dition of usually a very limited number ofpatients only, community-based rehabili-tation, which is expected to take into ac-count the social and economic condition ofthe patient as well, is a much more appro-priate approach. However, whether this isa feasible approach in rural communitieswhich face many other problems besidesleprosy is questionable, particularly if onealso takes into consideration the stigmawhich is attached to the disease. Althoughwith increased MDT coverage the numberof patients on antileprosy treatment steadilydecreases, the disability problem in past,present and future patients will remain atremendous one for many years. We do notknow how to deal with it effectively andefficiently.

As long as the social and economic con-ditions of leprosy patients and their com-munities do not improve, it is unlikely thatmedical interventions will decrease theproblem of leprosy-related disabilities andcomplications due to this disease. They mayhelp some individual patients, but at a costwhich is not affordable for most countries.

The following experiences in the ALERTleprosy control program illustrate the manydifficulties in dealing with the disabilityproblem.

Early detection of patients was promotedthrough health education in the communi-ties and the provision of diagnosis and treat-ment through a network of clinics. How-ever, as shown in Table 6, a substantialproportion of the patients was already dis-abled at the time of diagnosis of the disease.The introduction of management of leprosyreactions in the field during 1987 was animportant step toward the prevention ofdisabilities.

In order to prevent complications of nervefunction loss, the leprosy field workers hadto teach patients how to take care of insen-sitive and/or paralyzed limbs. They had topromote self-care by patients with compli-cations, notably wounds on soles and palmsand eye problems. The results of these mea-sures were not evaluated systematically.However, during field visits it was observedthat in most patients with established nervefunction loss the disability deteriorated.Only rarely were wounds healed, or stiffnessof joints improved, or impairment of visionprevented. Part of this could certainly beattributed to the attitude and teachingmethods of the staff, which often did notappear to encourage patients to practice self-care. However, a major problem was thatmany patients, because of their social andeconomic situation, had hardly any oppor-tunities to practice self-care. The loss of solesensation and sole wounds were majorproblems. Most patients either could notafford to buy footwear or they used inap-propriate footwear. Because of the scarcityof water, proper care of wounds was oftennot possible, and patients were often not inthe position to rest their limbs in case ofwounds. It was estimated in 1988 that about8500 patients in the field were in need ofprotective footwear-7000 of them neededfootwear with soft innersoles and 1500 pa-tients, with advanced foot disability, neededmore specialized footwear.

The ALERT hospital had to provide spe-cialized services to patients who could notbe managed in the field. These services in-cluded the treatment of patients with septicwounds, provision of protective footwear,and reconstructive surgery for patients withmotor paralysis. The hospital could, how-ever, not meet the requirements and limitedits services almost exclusively to patientswho had easy access to them. Most of thesepatients lived in the "leprosy village" in thevicinity of the ALERT compound. Over75% of the leprosy patients lived in the ruralareas, and their access to the hospital ser-vices was very limited. Of patients with sep-tic wounds not more than 5% could be ad-mitted. Of those in need of reconstructivesurgery, less than 15% received surgery. Theorthopedic workshop covered only about10%-15% of the requirements for protec-tive footwear.

61, 1^ Editorials^ 95

In order to provide protective footwearto patients in the rural areas, a Sandal Pro-duction Unit under the responsibility of theleprosy control program was established in1988. This unit had to prepare standardsandals for patients in the field. The initialexperience with the production and distri-bution of sandals was that footwear whichwas suitable on medical grounds but whichcould be identified as "leprosy footwear"was not acceptable to many patients. Fur-ther, it appeared very difficult to make stan-dard footwear which is suitable for differentterrains and climatological conditions. Thedurability of the standard footwear was poor;many of the distributed sandals needed sim-ple repairs within the first few months. Be-cause there were no provisions for repair inthe field, the sandals had to be brought toALERT, leaving the patients without foot-wear for 1 month or more. The cost of pro-duction of one pair of sandals was aboutUS$8; most patients could not afford or werenot prepared to share US$1 per pair in thecost.

PROSPECTS FOR LEPROSYCONTROL

The forty-fourth World Health Assemblyadopted in May 1991 a resolution on theelimination of leprosy as a public healthproblem by the year 2000. 1 Elimination wasdefined as "attaining a level of prevalencebelow one case per 10,000 population." Theresolution referred to elimination on a glob-al scale. It was adopted after the Assemblynoted the significant progress which wasmade with MDT and the subsequent re-duction in prevalence of the disease. 3 Theresolution also urged member states to in-crease their political commitment for lep-rosy, and requested the Director-General ofthe World Health Organization to strength-en the technical support to member statesand to continue to mobilize and coordinateresources from nongovernmental organi-zations to achieve the goal.

What Does This Resolution Imply inPractical Terms?

Firstly, it does not mean eradication ofleprosy. By definition, a residual leprosyproblem should be accepted. Less than oneleprosy case per 10,000 population refers topatients registered for treatment and not to

new and undetected cases which occur inthe communities. It is hoped that, as a con-sequence of MDT, early self-reporting ofpatients will increase and, therefore, the gapbetween the registered and estimated caseswill steadily decrease, and that the residualunregistered cases will consist of mainly ear-ly minimal and mostly self-healing PBcases. 3 Gradually, the registered cases willthen consist mainly of incident cases. Al-though the introduction of MDT may haveled to an increase in early self-reporting bypatients in some programs, there are hardlyany published data which substantiate this,certainly not in the long term. The defini-tion of elimination in relation to registeredcases may be appropriate in some programs,especially those which rely on vigorous ac-tive case-finding. However, as was shownin Table 5, the patients who were diagnosedin the ALERT leprosy control program rep-resent only a proportion of the existing cases,and this is likely to be the case in mostleprosy control programs.

Certainly, in programs which depend onself-reporting by patients, an indicator ofdelay in case detection should be included.The proportion of patients with a leprosy-related disability at the time of diagnosis ofthe disease would be an appropriate indi-cator. For example, only if at the time therate of patients registered for treatment isless than 1 per 10,000 population, and lessthan 5% of the patients have a leprosy-re-lated disability at the time of diagnosis ofthe disease, will elimination have been at-tained.

Secondly, because the resolution refers toglobal elimination, the strategies for achiev-ing this (implementation of MDT and ef-fective case detection) should be imple-mented rather evenly in leprosy endemiccountries. The wide variation in coveragewith MDT shows that much work still needsto be done. Even if efforts to implementMDT would be intensified during the nextfew years, it is very unlikely that globalelimination will be reached by the year 2000.

Annually about 600,000 new leprosy pa-tients are diagnosed in the world. There isno evidence that this number will substan-tially decrease in the near future. On thecontrary, it is expected that, because of in-creased self-reporting, the number of diag-nosed patients will increase. Let us assume

96^ International Journal of Leprosy^ 1993

that the number of diagnosed patients willremain 600,000 annually, of whom 60% willbe classified as PB and 40% as MB. With atreatment period of 6 months for PB pa-tients and 2 years for MB patients (whichwill be completed during an average periodof 21/2 years), at any time there will be about800,000 patients on treatment in the world.With a world population of 5.4 billion, thiswould mean about 1.5 patient per 10,000population, being the contribution of newlydiagnosed patients only. An increase in theworld population to 6 billion by the year2000 will still not bring the number of pa-tients registered for treatment under 1 per10,000. In addition, there were 1.8 millionregistered leprosy patients at the beginningof 1992 who had not been put on MDT.

Further, it is only realistic that the globalgoal will be translated into national goals.At the time the goal has been reached, gov-ernments may decide to reallocate the re-sources for leprosy, irrespective of the qual-ity and effectiveness of case finding andtreatment.

Thirdly, the elimination strategy impliesthat MDT will continue to be effective. Al-though the relapse rates so far have beenvery low, the duration of follow up is mostprobably too short to draw final conclu-sions. Because the results were mainly ob-tained in well-established, nonintegratedprograms, the findings may well be quitedifferent in areas with a less favorable in-frastructure, depending on poorly super-vised staff.

Fourthly, the question arises whether theelimination of leprosy can be achieved withthe presently available MDT alone. An in-creasing proportion of the patients who re-side in areas where MDT has not yet beenimplemented will have developed or beeninfected with dapsone-resistant bacilli. Asa result of improper application of MDT orinadequate treatment, there is potentially arisk of development of multiple drug resis-tance. In particular, resistance to rifampincould become a major problem.

Fifthly, it is questionable whether theelimination of leprosy through detection ofcases at an early stage of the disease, andtreating these patients with MDT, is feasi-ble. The uncertainties about the route oftransmission of infection, the insidious on-set of the disease, the unknown period of

infectivity, and the need for long-term treat-ment (although the period of treatment hassubstantially been decreased with MDT) areimportant limiting factors. Furthermore, atthe time the rate of registered patients isclose to 1 per 10,000 population, the effortsrequired to further reduce this rate are likelyto increase.

Developments in the following fieldscould have a considerable bearing on theprospects of possible elimination of leprosy:a) primary prevention through vaccinationagainst leprosy; b) better treatment regi-mens, especially from the point of view ofoperational applicability; c) tests for theidentification of individuals infected with

leprae, and the prediction of develop-ment of the disease; and d) effects of theHIV pandemic on the leprosy problem.

Vaccination Against LeprosyPrimary prevention, through vaccina-

tion, has been a main issue for several years.Considerable efforts have been made to de-velop a vaccine which is highly efficacious,cost-effective and acceptable. Trials on theprotective value of BCG vaccination againstleprosy have been carried out in Uganda,Myanmar (Burma), India, and Papua NewGuinea. 30-36 The efficacy of BCG vaccinesagainst leprosy varied from 20% in Myan-mar to 80% in Uganda. In particular, thePapua New Guinean trial showed evidenceof protection against the muitibacillaryforms of leprosy. 3" It is considered unlikelythat the variations are due to methodolog-ical artefacts." Possible reasons for the vari-ability in protection by BCG vaccines couldbe the differences in exposure of the pop-ulation to M. leprae and other mycobacte-ria, differences in immunogenetic charac-teristics of the population, different strainsofM. leprae, and the variance in BCG strainswith respect to their protective effect. 32 ' 34

From a public health point of view, anideal vaccine should be able to prevent par-ticularly the multibacillary forms which areresponsible for transmission of the infec-tion. In view of the low incidence of mul-tibacillary leprosy and its long incubationperiod, field trials which include large pop-

Smith, P. G. Epidemiological methods to evaluatevaccine efficacy. Br. Med. J. 44 (1988) 679-690.

61, 1^ Editorials^ 97

ulations over long time periods have to becarried out to measure the protective effectof a possible vaccine against multibacillaryleprosy. In attempts to find a vaccine thatgives greater and more consistent protectionagainst leprosy than BCG vaccine alone,BCG with and without killed Al. leprac wascompared in trials in Venezuela and in Ma-lawi."'" During the first 5 years of followup of the Venezuelan trial there was no ev-idence that BCG plus killed Al. leprae offerssubstantially better protection than BCGalone." Continued follow up of the trialpopulation over an additional 10 years isconsidered important.

Research is also being done on the de-velopment of BCG into a multivaccine ve-hicle. Hope has been expressed about thepossibility of testing the feasibility of im-munizing with different protective antigenswhich are expressed in recombinant BCGin experimental systems within the next fewyears." However, such hope may only berealistic if protective leprosy antigens willbe identified.

Even if a very effective vaccine would bedeveloped, its application will, most prob-ably, be limited. Problems in the applica-tion of even the most effective tools in con-trol activities often appear more difficult tosurmount than the problems in the devel-opment of such tools." The comment ofAntia and Birdie should be well taken:"Meanwhile, the enthusiasm of the scientistand the associated wide publicity given tothe vaccine as the final solution for leprosyshould be tempered with caution since, un-fortunately, it has tended to divert and di-lute the attention from other priority areassuch as early detection, drug research andensuring regularity of treatment. It shouldalso be remembered that even if a vaccinewas available, its delivery, especially if itrequires repeated injections, may prove an

Convit, J., Sampson, C., Zuniga, M., Smith, P. G.,Plata, J., Silva, J., Molina, J., Pinandi, M. E., Bloom,B. R. and Salgado, A. Immunoprophylactic trial withcombined AL Ieprae/BCG vaccine against leprosy: pre-liminary results. Lancet 339 (1992) 446-450.

" Bloom, B. R. An ordinary mortal's guide to themolecular biology of mycobacteria. Int. J. Lepr. 58(1990) 365-375.

86 Noordeen, S. K. Vaccination against leprosy; re-cent advances and practical implications. Lepr. Rev.56 (1985) 1-3.

insurmountable problem with the existingmachinery for delivery of health services.This has been well demonstrated in the caseof tetanus, where an effective vaccine hasbeen available for over half a century yettetanus continues to be the second largestkiller in India today."s 7

If it would be possible to identify clusterswith high transmission of infection, andprovided that an effective vaccine againstleprosy would become available, selectivevaccination could aid the elimination ofleprosy. Although the observed protectiveeffect of BCG vaccination against leprosyvaries considerably, because of its wide usein many leprosy-endemic countries it islikely to have protected thousands of indi-viduals from getting leprosy. At present theactive support by the leprosy control ser-vices of a wider application of BCG vacci-nation appears an appropriate approach inthe prevention of leprosy.

New Treatment RegimensAt present the most effective tool for in-

dividual patients as well as the control ofleprosy in the community is chemotherapy.From experience with tuberculosis, bacte-ricidal drugs should be used as much as pos-sible. Such drugs allow a shorter durationof treatment and, when used in combina-tion, there is less chance of the developmentof resistant mutants. In the present MDTregimens only one strong bactericidal drug,rifampin, is included. A combination ofdrugs must consist of at least two effectivedrugs, each of which must work by a dif-ferent mechanism. New regimens shouldprevent the causes of failure of dapsonemonotherapy, notably poor compliance, theemergence of resistance and the phenome-non of bacterial persisters.

So far the results of MDT are very en-couraging. Significant improvements in thecompliance have been reported from manyparts of the world. The relapse rates duringthe first years after stopping MDT are verylow. The problem of bacterial persisters hasnot yet been solved. Although it has beenreported that persisters may survive for 20years, very little is known about their sig-nificance in the development of relapses.

Antia, N. H. and Birdi, T. J. Leprosy vaccine—areappraisal. Int. J. Lepr. 56 (1988) 310-313.

98^ International Journal of Leprosy^ 1993

With the apparent successes of well im-plemented MDT the question arises wheth-er new drugs and other drug regimens arcstill needed. The answer should certainly beyes, for the following reasons: a) Only fourantileprosy drugs [dapsone, rifampin, clo-fazimine and thioamide (prothionamide/ethionamide)] with activities that act by dif-ferent mechanisms are available. Becausethioamide may cause hepatotoxicity, es-pecially when combined with rifampin, thisshould not be used under routine field con-ditions. Therefore there is no alternative tothe present MDT regimen for MB patients.b) Resistance to each of the antileprosy drugshas been documented." Therefore, there iscertainly a threat of multiple-resistant strainsin the near future. Strains which are resis-tant to both dapsone and rifampin have al-ready been identified in areas where rif-ampin monotherapy was given to patientswith dapsone-resistant leprosy." The treat-ment of these double-resistant patients isextremely difficult." c) Although we do notknow if the development of rifampin resis-tance in patients treated with MDT will besignificant, this should certainly be consid-ered. d) Alternative regimens are needed forpatients who do not tolerate the present reg-imens or object to clofazimine (because ofskin discoloration) and for those who can-not comply with the monthly supervisedtreatment, for example, because they live inunaccessible areas. e) The present MDT reg-imens are certainly not ideal. The recom-mended duration of the treatment, partic-ularly for MB patients, is still rather long.

Ideally, the treatment should have the following characteristics: tablet formulation,preferably in a combined preparation; longperiodicity or self-administration if fre-quent doses are required; short duration, afew weeks to at most a few months; effec-

" Baker, R. J. The need for new drugs in the treat-ment and control of leprosy. Int. J. Lepr. 58 (1990)78-97.

" Grosset, J.-H., Guelpa-Lauras, C.-C., Bobin, P.,Brucker, G., Cartel, J.-L., Constani-Desportes, NI., Fla-guel, B., Frederic, M., Guillaume, J.-C. and Millan, J.Study of 39 documented relapses of multibacillary lep-rosy after treatment with rifampin. Int. J. Lepr. 57(1989) 607-614.

"" Ji, B. and Grosset, J.-H. Recent advances in thechemotherapy of leprosy. Lepr. Rev. 61 (1990) 313-329.

tive; low toxicity; and low cost. Further-more, the regimen should destroy "persis-tent" organisms and be the same for allpatients.

The prospects for new drugs are prom-ising. Especially the fluoroquinolones, pe-floxacin and ofloxacin, and minocycline (atetracycline), show strong bactericidal ef-fects against Al. leprae. 88, 9"-96 It has beendemonstrated in a clinical trial that 22 dailydoses of either pefloxacin or ofloxacin kills4 logs of viable Al. leprae." 4 This is aboutthe number of rifampin-resistant mutantswhich are expected to be present in a lep-romatous patient before the start of treat-ment. It is, therefore, very well possible thatthe combination of ofloxacin or pefloxacinand rifampin will considerably shorten therequired duration of MDT.

A 1-month regimen of daily rifampin andofloxacin will be compared with the stan-dard WHO/MDT regimens in a multicenterdouble-blind trial." Both PB and MB pa-tients will be treated with the 1-month reg-imen. In order to be able to demonstratethat the regimen is at least as good as orbetter than the current regimens, the trialrequires quite a large number of patientsand a long period of follow up (the periodof follow up after completion of treatmentwill be 5 years for PB patients and 7 yearsfor MB patients). Therefore, the results ofthis trial will not be available before the endof the century. Besides the relapse rate, thetolerance, side effects and feasibility of theregimen will also be evaluated. Clinical tri-

" Gelber, R. H. Activity of minocycline in M. lep-rae-infected mice. J. Infect. Dis. 186 (1987) 236-239.

Grosset, J.-H. Recent developments in the field ofmultidrug therapy and future research in chemother-apy of leprosy. Lcpr. Rev. 57 Suppl. 3 (1986) 223-234.

Grosset, J.-H., Guelpa-Lauras, C.-C., Perani, E.G. and Beoletto, C. Activity of ofloxacin against Al.leprae in the mouse. Int. J. Lepr. 56 (1988) 259-264.

"' Grosset, J.-H., Ji, B., Guelpa-Lauras, C.-C., Pera-ni, E. G. and N'Deli, L. Clinical trial of pefloxacin andofloxacin in the treatment of lepromatous leprosy. Int.J. Lepr. 58 (1990) 281-295.

" Guelpa-Lauras, C.-C., Perani, E. G., Giroir, A. M.and Grosset, J.-H. Activities of pefloxacin and cipro-floxacin against Al. leprae in the mouse. Int. J. Lcpr.55 (1987) 70-77.

N'Deli, L., Guelpa-Lauras, C.-C., Perani, E. G.and Grosset, J.-H. Effectiveness of pefloxacin in thetreatment of lepromatous leprosy. Int. J. Lepr. 58 (1990)12-18.

61, 1^ Editorials^ 99

als in which the bactericidal activity ofminocycline is evaluated are presently beingcarried out.""

Because the new drugs are very expen-sive, their use in leprosy-endemic countrieswill probably remain limited unless the costis reduced drastically. It is likely that thecurrent MDT regimens will have to be usedfor many more years. The major constraintat present is not the effectiveness of theavailable regimens, but their applicationunder routine field conditions.

A main problem with regimens of veryshort duration will be the development ofleprosy reactions and nerve damage afterstopping treatment. This is already a prob-lem with the current regimens, especially inPB patients.' In evaluating new treatmentregimens, the incidence rate of reactionsduring and after chemotherapy is certainlyas important as the relapse rate.

Tests for Identification of LeprosyInfection and Prediction of

Disease DevelopmentOne of the present challenges of leprosy

research is the identification of past or pres-ent infection with M. leprae as distinct fromclinical disease."' This could provide the an-swers to important questions, such as thesources of infection in the communities, theduration of the incubation period, and theidentification of risk factors for infection andfor disease." All of these questions are high-ly relevant for the elimination goal.

Several studies have been carried out onthe seroprevalence of M. leprae-specific an-tibodies, especially phenolic glycolipid-I(PGL-I)-IgM antibodies, in leprosy endem-ic-communities and in household contactsof leprosy patients.99- '°" In studies among

' 7 Fine, P. E. M. Problems in the collection and anal-ysis of data in leprosy studies. Lepr. Rev. 52 Suppl. 1(1981) 197-206.

Fine, P. E. M. Leprosy: the epidemiology of a slowbacterium. Epidemiol. Rev. 4 (1982) 161-188.

Bagshawe, A. F., Garsia, R. J., Baumgart, K. andAstbury, L. IgM serum antibodies to phenolicglycolipid-1 and clinical leprosy; two years' observa-tion in a community with hyperendemic leprosy. Int.J. Lepr. 58 (1990) 25-30.

m" Cartel, J.-L., Chanteau, S., Boutin, J.-P., Plichart,R., Richez, P., Roux, J.-F. and Grosset, J.-H. Assess-ment of anti-phenolic glycolipid-I IgM levels using anELISA for detection of M. leprae infection in popu-

household contacts, a statistical associationbetween serological positivity and leprosyrisk was observed, showing that a seropos-itive individual had a 21-40 times higherchance of developing leprosy than a sero-negative person. RH, 103. 106, 109 However, themajority of seropositives (85% or more) didnot develop the disease within the time-frame of these studies, which was 2-3 years.Even if there is a strong association betweenantibody level and the subsequent risk ofdeveloping leprosy, it is very unlikely thatserological screening would be a usefulmethod of detecting persons at risk. In one

lations of the South Pacific islands. Int. J. Lepr. 58(1990) 512-517.

10 ' Chanteau, S., Cartel, J.-L., Guidi, C., Plichart, R.and Bach, M.-A. Seroepidemiological study on 724household contacts of leprosy patients in French Pol-ynesia using disaccharide-octyl-BSA as antigen. Int. J.Lepr. 55 (1987) 626-632.

101 Chujor, C. S. N., Bernheimer, H., Levis, W. R.and Schwerer, B. Serum IgA 1 and IgM antibodiesagainst Al. leprae-derived phenolic glycolipid-I: a com-parative study in leprosy patients and their contacts.Int. J. Lepr. 59 (1991) 441-449.

'"' Douglas, J. T., Cellona, R. V., Abalos, R. M.,Madarang, M. G. and Fajardo, T. Serological reactivityand early detection of leprosy among contacts of lep-romatous patients in Cebu, The Philippines. Int. J.Lepr. 55 (1987) 718-721.

"" Fine, P. E. M., Ponnighaus, J. M., Burgess, P.,Clarkson, J. A. and Draper, C. C. Seroepidemiologicalstudies of leprosy in northern Malawi based on anenzyme-linked immunosorbcnt assay using syntheticglycoconjugatc antigen. Int. J. Lepr. 56 (1988) 243-254.

103 Groenen, G., Pattyn, S. R., Ghys, P., Tshilumba,K., Kuykens, L., Colston, M. J. and the YalisomboStudy Group. A longitudinal study of the incidence ofleprosy in a hyperendemic area in Zaire with specialreference to PGL-antibody results. Int. J. Lcpr. 58 (1990)641-650.

Klatser, P. R., de Wit, M. Y. L. and Kolk, A. H.J. An ELISA-inhibition test using monoclonal anti-body for the serology of leprosy. Clin. Exp. Immunol.62 (1985) 468-473.

107 Krishnamurthy, P., Rao, P. S., Reddy, B. N., Sub-ramanian, M., Dhandayudapani, S., Bhatia, V., Nec-lan, P. N. and Dutta, A. Seroepidemiological study ofleprosy in a highly endemic population of South Indiabased on an ELISA using synthetic PGL-I. Int. J. Lcpr.59 (1991) 426-431.

10" Soebono, H. and Klatscr, P. R. A seroepide-miological study of leprosy in high- and low-endemicIndonesian villages. Int. J. Lepr. 59 (1991) 416-425.

")" Ulrich, M., Smith, P. G., Sampson, C., Zuniga,M., Centeno, M., Garcia, V., Manrique, X., Salgado,A. and Convit, J. IgM antibodies to native phenolicglycolip-1 in contacts of leprosy patients in Venezuela:epidemiological observations and a prospective studyof the risk of leprosy. Int. J. Lepr. 59 (1991) 405-415.

100^ International Journal of Leprosy^ 1993

study in which two cases of MB leprosy weredetected among ten contacts with the high-est levels of PGL-I antibodies, 9500 serawere screened to identify these ten per-sons.' 09 Fine commented on the test spec-ificity in relation to the rarity of leprosy. Hecalculated that, even if a test is 99% specific,and the true risk of leprosy is 1 per 1000,10 out of 11 (90.9%) of the positive testswill be false, that is, not resulting in dis-ease.' ' 0 The studies showed that the assayof antibodies to PGL-I is not a sensitive orspecific test for infection with Al. leprae.Further, its value, if there is any, in the iden-tification of those at risk of developing lep-rosy is very limited.

In terms of sensitivity, serological testshave been surpassed by the development inmolecular biology of the polymerase chainreaction (PCR) which was discovered in1987. 1 " Because of the inability to cultivateM. leprae in vitro, this technique may es-pecially be valuable for the detection of smallnumbers of Al. leprae. Results from studiesindicate that the PCR technique can spe-cifically detect as few as 10-100 organ-isms." -2- 115

A potential use of the PCR technique is

"° Fine, P. E. M. Immunological tools in leprosycontrol. Int. J. Lepr. 57 (1989) 671-686.

"' Mullis, K. B. and Fallona, F. A. Specific synthesisof DNA in vitro via a polymerase-catalyzed chain re-action. Meth. Enzymol. 155 (1987) 335-350.

" 2 Fiallo, P., Williams, D. L. and Gillis, T. P. Thedetection of Al. leprae from formalin-fixed and paraf-fin-embedded tissues using PCR amplification. In:Health Cooperation Papers, Proceedings of thel'l Lep-rosy Symposium on "Leprosy Research," SantaMargherita Ligure-Genoa, Italy, October 3-7 1990.Associazione Italiana "Amici di Raoul Follereau,"1992, pp. 171-172.

"3 Gillis, T. P. and Williams, D. L. Polymerase chainreaction and leprosy. Int. J. Lepr. 59 (1991) 311-316.

14 Hartskeerl, R. A., de Wit, M. Y. L. and Klatser,P. R. Polymerase chain reaction for the detection ofM. leprae. J. Gen. Microbiol. 135 (1989) 2357-2365.

" 5 Klatser, P. R., de Wit, M. Y. L, Faber, W. R.,Krieg, S. R., Douglas, J. T., Lucas, S. B., Montrewa-sewat, N., Pattyn, S. R. and Hartskeerl, R. A. Appli-cation of a polymerase chain reaction for the detectionof M. leprae in infected tissues. In: Health CooperationPapers, Proceedings of the VI Leprosy Symposium on"Leprosy Research," Santa Margherita Ligure-Genoa,Italy, October 3-7 1990. Associazione Italiana "Amicidi Raoul Follereau," 1992, p. 173.

for the study of the transmission of leprosyand the development of the disease in in-fected persons.'"' ' ' 6 Other possible uses arethe diagnosis of patients thought to haveleprosy but with negative skin smears, andthe differentiation between a reversal reac-tion and a relapse in PB patients, providedthat PCR positivity is shown to be relatedto viable bacilli."'' '' Studies in untreatedpatients gave positive PCR results in 92%t>-100% of skin-smear-positive patients and56%-61% in skin-smear-negative pa-tients: 15 The test still has a number of pit-falls which limit its possibilities for routineuse. These include contamination of sam-ples or reagents producing false-positive re-sults, and its cost (US$3—$3.50 per test)." 3

PCR at present is mainly a research toolwhich may give answers to specific prob-lems. Its practical value in the control ofleprosy has yet to be determined.

Leprosy and HIVThe control of leprosy might be jeopar-

dized by the increasing problem of HIV in-fection, particularly on the African conti-nent. HIV infection constitutes a major riskfactor for the development of clinical tu-berculosis in persons infected with M. tu-berculosis."' So far there is no evidence foran association between HIV infection andleprosy incidence." 8 ' I" Studies have shownthat the prevalence of HIV antibodies isidentical in leprosy patients and controlsand no difference in the prevalence of HIV

' 6 Klatser, P. R., Ellard, G. A., Fiallo, P., Williams,D. L. and Gillis, T. P. Working Group on PCR. In:Health Cooperation Papers, Proceedings of the VI Lep-rosy Symposium on "Leprosy Research," SantaMargherita Ligure-Genoa, Italy, October 3-7 1990.Associazione Italiana "Amici di Raoul Follereau,"1992, p. 291.

Styblo, K. The global aspects of tuberculosis andHIV infection. Bull. IUATLD. 65 (1990) 28-32.

1 " Miller, R. A. Leprosy and AIDS: a review of theliterature and speculations on the impact of CDA+lymphocyte depletion on immunity to Al. leprae. Int.J. Lepr. 59 (1991) 639-644.

Ponnighaus, J. M., Mwanjasi, L. J., Fine, P. E.M., Shaw, M.-A., Turner, A. C., Oxborrow, S. M.,Lucas, S. B., Jenkins, P. A., Sterne, A. C. and Bliss, L.Is HIV infection a risk factor for leprosy? Int. J. Lepr.59 (1991) 221-228.

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infection in lepromatous and tuberculoidpatients was found.' 2°• ' 2 ' It has been sug-gested that infection with HIV may increasethe incidence of leprosy among individualswith subclinical infection with H. leprae,either through shortening the incubation pe-riod or by increasing disease penetrance." 7

Similarly, clinical leprosy may accelerate thecourse of HIV disease. Possible effects ofHIV infection may be an increase in thedetection of tuberculoid patients, or a de-cline in case detection rates if patients withlepromatous leprosy are unrecognized be-cause they die before the onset of clinicalsymptoms. 1 22 Further, the relapse rates afterMDT may be high in HIV-positive indi-viduals.

Whether, how, and to what extent leprosywill be affected by HIV infection has to bedetermined in studies on the epidemiology,clinical manifestations, response to antilep-rosy treatment, and immunological re-sponses of patients dually infected with Al.leprae and HIV. Particularly in Africa therewill be many such individuals.

'"" Leonard, G., Sangare, A., Verdier, M., Sassou-Gusseau, E., Petit, G., Milan, J., M'Boup, S., Rey, J.-L., Dumas, J.-L., Hugen, J., N'Gaporo, I. and Denis,F. Prevalence of HIV infection among patients withleprosy in African countries and Yemen. Immune De-fic. Syndr. 3 (1990) 1109-1113.

Tekle-Haimanot, R., Frommel, D., Tadcsse, T.,Verdier, M., Abebe, M. and Denis F. A survey ofHTLV-1 and HIVs in Ethiopian leprosy patients. AIDS5 (1991) 108-110.

'' Turk, J. L. and Rees, R. J. W. AIDS and leprosy.Lepr. Rev. 59 (1988) 193-194.

CONCLUSIONSIn conclusion, it is most probable that, at

least during the next decade, our tools inthe control and ultimately the eliminationof leprosy will continue to be the early de-tection of patients and their treatment withthe presently available MDT regimens. Al-though it is not known whether the elimi-nation of leprosy can be achieved with thesetools only, major emphasis should be puton using them as widely, as effectively, andas efficiently as possible. The availability ofnew drug regimens of shorter duration mayfacilitate implementation of MDT. Re-search in the field of immunology and mo-lecular biology may ultimately provide toolswhich could aid in the elimination of lep-rosy. If there will be a practical use of suchtools in field programs, their application will,most probably, be limited to selected areas.They are unlikely to provide answers to mostof the present pressing problems in leprosycontrol which, in particular, concern ensur-ing early detection of patients and theircompletion of MDT, and the prevention ofdisabilities. Field research on the effectiveapplication of available methods for thecontrol of leprosy, under different field con-ditions, should be given high priority. Inaddition, there is an urgent need for researchon the prevention of disabilities and on therisk factors for the development of leprosyreactions.

— Marijke Becx-Bleumink,M.D., D.T.P.H., Ph.D.

Plasweg 153768 AK SoestThe Netherlands