Subj: PBC Survey Results Questions A - F

Date: 97-05-22 18:44:08 EDT

From: PBCers

To: PBCers

Some in the group were confused about the survey, so I've listed the

questions then the answer results. I've combined all the survey parts 1 - 5.

Hope this helps.

Meg.....Thank you so much for taking the time to compile the survey

results. Linie

PBCers Survey Results Question and answer results

A total of 40 surveys were received. I have given the results in detail where

appropriate as you might like to add your own comments for the final report

and you might notice some significant points that I have overloooked. I

hope the tables look OK on your screens. You might need to reduce the

font size if it is too spread around. Let me know if there any problems so i

can take this into account for the rest of the results. Meg

QUESTIONS/ANSWERS A THRU F

Question A. HISTORY

1 Mo/Yr of PBC diagnosis

2 Age at diagnosis

3 Current Age

4 Male/Female

5 Hair/Skin Color

6 Ethnic Background

7 Diagnosed by GI, Internist, Hepatologist

Most respondents (82.5%) have been diagnosed in the last 5 years

YEAR of

diagnosis| Freq Percent

---------+-----------------------

1983 | 1 2.5%

1985 | 1 2.5%

1986 | 1 2.5%

1988 | 2 5.0%

1989 | 2 5.0%

1992 | 3 7.5%

1993 | 7 17.5%

1994 | 5 12.5%

1995 | 4 10.0%

1996 | 12 30.0%

1997 | 2 5.0%

---------+-----------------------

Total | 40 100.0%

Total Sum Mean Variance Std Dev Std Err

40 3731 93.275 11.692 3.419 0.541

Minimum 25%ile Median 75%ile Maximum Mode

83.000 92.500 94.000 96.000 97.000 96.000

DATE of

diagnosis| Freq Percent

---------+-----------------------

83/3 | 1 2.5%

85/5 | 1 2.5%

86/ | 1 2.5%

88/ | 1 2.5%

88/11 | 1 2.5%

89/ | 1 2.5%

89/12 | 1 2.5%

92/11 | 1 2.5%

92/7 | 1 2.5%

92/9 | 1 2.5%

93/1 | 2 5.0%

93/10 | 1 2.5%

93/11 | 1 2.5%

93/3 | 1 2.5%

93/4 | 1 2.5%

93/8 | 1 2.5%

94/10 | 2 5.0%

94/11 | 2 5.0%

94/4 | 1 2.5%

95/12 | 1 2.5%

95/5 | 1 2.5%

95/8 | 2 5.0%

96/10 | 5 12.5%

96/11 | 1 2.5%

96/2 | 1 2.5%

96/3 | 2 5.0%

96/4 | 1 2.5%

96/5 | 1 2.5%

96/7 | 1 2.5%

96/9 | 1 2.5%

97/1 | 1 2.5%

---------+----------------

Total | 40 100.0%

month | Freq Percent

------+-----------------------

1 | 3 8.1%

2 | 1 2.7%

3 | 4 10.8%

4 | 3 8.1%

5 | 3 8.1%

7 | 2 5.4%

8 | 3 8.1%

9 | 2 5.4%

10 | 8 21.6% October is the most common month of diagnosis

11 | 6 16.2%

12 | 2 5.4%

------+-----------------------

Total | 37 100.0%

The mean and median age at diagnosis was 45 years and

the mean current age is 48 years.

age at

diagnosis| Freq Percent

---------+-----------------------

30 | 1 2.5%

35 | 3 7.5%

36 | 1 2.5%

37 | 3 7.5%

38 | 2 5.0%

39 | 1 2.5%

40 | 1 2.5%

41 | 2 5.0%

43 | 2 5.0%

44 | 1 2.5%

45 | 5 12.5%

46 | 2 5.0%

47 | 1 2.5%

48 | 3 7.5%

49 | 2 5.0%

50 | 2 5.0%

51 | 2 5.0%

52 | 2 5.0%

53 | 1 2.5%

54 | 1 2.5%

58 | 2 5.0%

---------+----------------------

Total | 40 100.0%

Total Sum Mean Variance Std Dev Std Err

40 1784 44.600 45.118 6.717 1.062

Minimum 25%ile Median 75%ile Maximum Mode

30.000 38.500 45.000 49.500 58.000 45.000

current

age | Freq Percent

-------+-----------------------

31 | 1 2.5%

38 | 3 7.5%

39 | 3 7.5%

40 | 1 2.5%

42 | 1 2.5%

44 | 1 2.5%

45 | 3 7.5%

46 | 1 2.5%

47 | 5 12.5%

48 | 1 2.5%

49 | 2 5.0%

50 | 4 10.0%

51 | 3 7.5%

52 | 1 2.5%

53 | 3 7.5%

54 | 1 2.5%

55 | 2 5.0%

57 | 1 2.5%

58 | 1 2.5%

60 | 1 2.5%

62 | 1 2.5%

-------+-----------------------

Total | 40 100.0%

Total Sum Mean Variance Std Dev Std Err

40 1915 47.875 45.497 6.745 1.066

Minimum 25%ile Median 75%ile Maximum Mode

31.000 44.500 48.500 52.500 62.000 47.000

95% of the respondents were female.

sex | Freq Percent Cum.

-------+-----------------------

F | 38 95.0% 95.0%

M | 2 5.0% 100.0%

-------+-----------------------

Total | 40 100.0%

Skin and hair colour were difficult to analyse as so many different terms

were

used. I have made a classification into the following groups to give some

idea

of the answers.

hair colour | Freq Percent

-----------------------+-------------------

auburn | 2 5.1%

black | 2 5.1%

blond | 9 23.1%

brown | 12 30.8%

dark brown | 6 15.4%

light brown | 4 10.3%

red | 4 10.3%

-----------------------+-----------------

Total | 39 100.0%

skin colour | Freq Percent

------------------------+----------------

brown | 1 2.8%

dark | 1 2.8%

fair | 17 47.2%

medium | 4 11.1%

olive | 2 5.6%

sallow | 1 2.8%

white | 9 25.0%

yellow | 1 2.8%

------------------------+-----------------------

Total | 36 100.0%

Ethnic type was even more difficult to analyse. Again I have made some

different classifications to give some idea.

The following table is the predominant ethnic type given.

ethnic type | Freq Percent

---------------------+----------------

caucasian | 10 27.8%

east europe | 2 5.6%

middle europe | 1 2.8%

north europe | 22 61.1%

south europe | 1 2.8%

---------------------+----------------

Total | 36 100.0%

In addition 8 people identified themselves as Jewish. North European is

quoted in the literature as the most commmon population predisposed to

PBC and this is supported in this survey. It was interesting that Scottish (9),

English (9) and Irish (8) were also frequently given. 4 people mentioned

American Indian in their ethnic origin.

As to who made the diagnosis, 13 respondents identified a hepatologist, 20

said a GI and 4 a gastroenterologist (I'm not used to American terminology

so I don't know if these are different or the same) and 6 said an internist

made the diagnosis. 3 people identified other specialists involved. The

numbers add up to more than 40 as some identified more than one type of

doctor in their answers.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Question B: SYMPTOMS (Y/N) At Diagnosis Current

1 Itching

2 Jaundice

3 Fatigue

4 Joint pain

5 Sleep disturbance

6 Sharp pain lower rib area

7 Pressure at top area of liver

8 Edema (Ascities)

9 Small fat deposits under eyes

10 Bleeding gums

11 Mouth ulcers

12 Other

13 How long before diagnosis did 1-4 begin?

The answers given about symptoms were especially difficult to assess as

everyone replied in a different way. Some people gave 3 answers,

presumably Y/N to whether there were symptoms at all and then answering

for "at diagnosis" and "current". Others obviously gave their current

symptoms first and then the at diagnosis answer. Most didn't give headings

to the answers so I have to assume that they were answered in the same way

that they were asked. These variations give some doubt as to the validity of

the answers. However, these are the results to the best of my ability.

SYMPTOMS: AT DIAGNOSIS CURRENT

itching 18 (45%) 22 (55%)

jaundice 4 (10%) 3 (8%)

fatigue 27 (68%) 26 (65%)

joint pain 11 (28%) 17 (43%)

sleep disturbances 13 (33%) 19 (48%)

sharp pain (lower ribs) 5 (13%) 10 (25%)

pressure on liver 7 (17%) 12 (30%)

ascites 3 (8%) 6 (15%)

fat deposits under eyes 5 (13%) 7 (18%)

bleeding gums 7 (18%) 9 (23%)

mouth ulcers 5 (13%) 5 (13%)

In general more people are showing some kind of symptom at present than

at the time of diagnosis. The exceptions are jaundice and fatigue.

Some people had symptoms for long periods before their diagnosis. For

others the diagnosis was made more quickly. Others didn't comment.

time before diagnosis | Freq Percent

---------------------------------+---------

2-3WEEKS | 1 4.0%

3 MONTHS | 2 8.0%

6 MONTHS | 1 4.0%

8 MONTHS | 1 4.0%

1 YEAR | 4 16.0%

1-2 YEARS | 2 8.0%

2 YEARS | 5 20.0%

2-3 YEARS | 1 4.0%

2-4 YEARS | 1 4.0%

3 YEARS | 1 4.0%

4 YEARS | 1 4.0%

5 YEARS | 1 4.0%

10-15 YEARS | 1 4.0%

20 YEARS | 2 8.0%

YEARS | 1 4.0%

-------------------------+-----------------

Total | 25 100.0%

Other symptoms that were mentioned included:

ACHING FLU LIKE ARMS

COLESTEROL DEPOSIT

CONFUSION

DRY EYES

DRY EYES/MOUTH

ECZEMA

ENLARGED SPLEEN

FUZZY BRAIN SOMETIMES

GALLSTONES REMOVED

GAS

HEARTBURN

HYPOTHYROID

INDIGESTION

LEG & FOOT CRAMPS

LOW LIBIDO

MUSCLE SPASMS.PAINS

MUSCLE WASTING

NIGHT SWEATS

NOSE BLEEDS

RED PUFFY FINGERS

SHARP ABDOMINAL PAIN

SORE TASTE BUDS

TEETH PROBLEMS

BONE LOSS IN JAW

CONFUSION

FATTY DEPS ARM/HAND

HAEMANGIOMA/LIVER

HEADACHES

SKIN PROBLEMS ON LEGS

SUDDEN WEAK FEELINGS

Symptom summery

I have done a bit more work looking at the symptoms people report and

trying to find some common themes. The most common symptoms

reported are itching, fatigue, joint pains and sleep disturbances.

Those who do not report either itching or fatigue (9 respondents in total) are

unlikely to mention any other symptoms other than small fat deposits under

the eyes (2) or bleeding gums (2). 3 of these respondents reported

symptoms at diagnosis but not currently. The other 6 have never had

symptoms.

Once symptoms appear it seems that there is a greater chance that multiple

symptoms will be present.

Those who report itching are also likely to report

fatigue 77%

joint pain 50%

broken sleep 55%

Those who report fatigue are also likely to report

itching 65%

joint pain 62%

broken sleep 69%

31 respondents reported itching and/or fatigue as symptoms and 87% of

these also reported other symptoms.

no other symptoms 4

1 other symptom 7

2 other symptoms 5

3 other symptoms 3

4 other symptoms 8

5 or more 4

Those who report joint pain are also likely to report

itching 65%

fatigue 94%

broken sleep 77%

sharp pain 53%

pressure 59%

Those who report sleep disturbances are also likely to report

itching 63%

fatigue 95%

joint pains 68%

Those who report both itching and fatigue are also likely to report

joint pains 59%

broken sleep 65%

However it does not appear that the presence of symptoms is related to the

stage of the illness in any clear way other than that the absence of

symptoms is not likely to be linked with late stage PBC.

Those not reporting itching or fatigue as a symptom currently (9) show a

spread of stages.

stage 1 4 (45%)

1-2 2 (22%)

2 0

2-3 3 (33%)

Even those who have never had symptoms (6) show a spread of stages.

stage 1 3

stage 1-2 1

stage 2-3 2

Those reporting itching or fatigue

stage 1 8 (26%)

1-2 5 (16%)

2 5 (16%)

2-3 1 (3%)

3 2 (7%)

3-4 1 (3%)

4 2 (7%)

Those reporting both itching and fatigue and most likely to have many other

symptoms.

stage 1 4 (24%)

1-2 3 (18%)

2 2 (12%)

2-3

3 2 (12%)

3-4 1 (6%)

4 1 (6%)

I have also looked at whether symptoms are associated or not with other

auto-immune diseases and it does seem that the presence of symptoms is

linked with the presence of other auto-immune diseases, in particular

Sjogrens, psoriasis and Reynaud's disease.

Those not reporting itching or fatigue

rheumatoid arthritis 1

fibromyalgia 1

Hashimotos thyroiditis 1

Those reporting both itching and fatigue

Lupus 1

Rheumatoid arthritis 2

Sjorgrens 4

Costochondritis 1

Psoriasis 5

Reynauds disease 4

Thyroid problems 2

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Question C. STAGING

1 Biopsy (Y/N)

2 How many? (Mo/Yr)

3 Current stage (1 2 3 4 Unknown)

4 Are you currently on a transplant list? (Y/N)

5 Transplant status (1 2 3 4 Unknown)

6 At what (center/state) are you listed?

38 (95%) of the respondents have had their diagnosis confirmed by biopsy.

Most have had only 1 biopsy (27 or 68%).

No. of biopsies | Freq Percent

----------------+----------------

0 | 2 5.0%

1 | 27 67.5%

2 | 8 20.0%

3 | 1 2.5%

4 | 1 2.5%

8 | 1 2.5%

----------------+----------------

Total | 40 100.0%

Most respondents had their first biopsy close to the time of their first

diagnosis (22 or 55% within 1 month). However some had a biopsy long

before the diagnosis was actually made (4 years in 1 case) and for some the

diagnosis was made on blood tests and a biopsy was taken several months

later.

time difference between

biopsy and diagnosis | Freq Percent

------------------------+----------------

not given | 7 17.5%

+ 4 years | 1 2.5%

+ 1 year | 1 2.5%

+ 10 months | 1 2.5%

+ 4 months | 1 2.5%

+ 1 month | 4 10.0%

at time | 15 37.5%

- 1 month | 3 7.5%

- 2 months | 2 5.0%

- 3 months | 1 2.5%

- 5 months | 1 2.5%

- 6 months | 2 5.0%

- 1 year | 1 2.5%

------------------------+----------------

Total | 40 100.0%

The largest group of people are in the earliest stages (12 or 30%).

Current Stage | Freq Percent

-----------------+----------------

1 | 12 30.0%

1-2 | 7 17.5%

2 | 5 12.5%

2-3 | 4 10.0%

3 | 2 5.0%

3-4 | 1 2.5%

4 | 2 5.0%

UNKNOWN | 7 17.5%

-----------------+----------------

Total | 40 100.0%

Only 1 respondent is currently on a transplant list with transplant status 3.

3 people gave the following centres as centres where they are listed for

transplant.

PITTSBURGH/CLEVELAND

UNI MICHIGAN/ANN ARBOR

VANDERBILT UNI VA MED

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Question D. TESTS (Levels) At Diagnois Current

1 ALT

2 AST

3 Alk/Phos

4 Bilirubin

5 GGT

6 Anti-Mitochondrial

7 Anti-Nuclear

8 Anti-Phospholid

9 Other

The normal values of the following tests vary depending on the source of

information and possibly on the way the test is carried out. However I have

taken a close approximation and assumed all the test results are consistent.

Alanine aminotransferase ALT normal values 5-40 U/L

at diagnosis current

normal 5 (13%) 13 (33%)

41-80 U/L 10 (25%) 7 (18%)

81-120 U/L 6 (15%) 4 (10%)

121-160 U/L 2 (5%) 4 (10%)

161-200 U/L 4 (10%) 1 (3%)

200+ U/L 2 (5%) 0

not known 11 11

Aspartate aminotransferase AST normal values 5-40 U/L

at diagnosis current

normal 5 (13%) 17 (43%)

41-80 U/L 15 (38%) 8 (20%)

81-120 U/L 8 (20%) 3 (8%)

121-160 U/L 1 (3%) 2 (5%)

161-200 U/L 1 (3%) 1 (3%)

200+ U/L 0 0

not known 10 9

Alkaline phosphatase normal values 25-100 U/L

at diagnosis current

normal 1 (3%) 5 (13%)

41-80 U/L 7 (18%) 15 (38%)

81-120 U/L 7 (18%) 5 (13%)

121-160 U/L 6 (15%) 1 (3%)

161-200 U/L 3 (8%) 3 (8%)

200+ U/L 6 (15%) 2 (5%)

not known 10 9

There is a general reduction in serum ALT, AST and alkaline phosphatase

levels currently compared to the levels at diagnosis. This is to be expected

as most poeple are receiving Actigall or another form of ursodeoxycholic

acid and this is a known result of these drugs. Of the 5 people not receiving

Urso., only 1 of these shows a drop in these enzyme levels and this could

be due to treatment with colchicine.

Bilirubin normal values <0.5 mg/dL. There was considerable ambiguity

in the reporting of these results so the significance is dubious. I am not

sure in many cases whether the result was for the direct or total bilirubin.

However, taking these figures at face value there is no general change in

the bilirubin levels with treatment with Actigall, and if anything they are

going up.

at diagnosis current

normal 16 (40%) 13 (33%)

0.6-1.0 10 (25%) 8 (20%)

1.1-1.5 1 (3%) 4 (10%)

1.6-2.0 0 0

2.0+ 0 2 (7%)

not known 13 13

Anti-mitochondrial antibodies. 22 people reported that they were positive

and only 1 negative. The reported titres varied considerably.

9 people reported that they were positive for anti-nuclear antibodies.

It was difficult to recognise any correlation of the test levels with symptoms

such as itching or fatigue. A more detailed analysis was carried out for the

alkaline phosphatase test results but itching and fatigue seemed to occur in

40% and 75% of the respondents respectively, irrespective of the test

results. A similar result was obtained for the bilirubin levels.

An examination of possible correlations between the test results and stage

of the illness was also carried out. The alkaline phosphatase results showed

no correlation with stage in any way. The bilirubin results were varied at

the earlier stages of PBC but were consistently high at stages 3 to 4.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Question E. OTHER AUTO-IMMUNE DISEASES (Y/N) Date of

Diagnosis PrePBC (Y/N)

1 Lupus

2 Rheumatoid Arthritis

3 Fibromyalgia

4 Sjorgrens

5 Costochondritis

6 Psoriasis

7 Reynauds

8 (Hypo/hyper) thyroidism

9 Other

Thyroid problems were the most frequent of other auto-immune diseases

reported, 25% of all respondents, followed by Reynaud's disease (18%) and

psoriasis (15%)

Yes No Not answered

Lupus 1 35 4

Rheumatoid Arthritis 3 30 7

Fibromyalgia 3 32 5

Sjorgrens 4 30 6

Costochondritis 2 33 5

Psoriasis 6 28 6

Reynauds 7 29 4

Thyroid problems 10 27 3

hypothyroid 7

hyperthyroid 2

not given 1

Other problens that were mentioned include: ASTHMA, AUTOIMMUNE

HEPATITIS, BURSITIS, DEPRESSION, DIABETES ITP,

MYAESTHENIA GR, SARCOID, UTI, ALLERGIES

Frequency of occurence of other auto-immune diseases.

17 respondents have no auto-immune disease diagnosed other than PBC.

15 respondents have one other disease and 8 have 2 or more other diseases.

No other disease 17 (42%)

1 other disease 15 (38%

2 other diseases 5 (13%)

3 other diseases 2 (5%)

4 other diseases 0

5 other diseases 1

Further analysis of those 17 people with no other auto-immune disease

shows that the majority (65%) are at an early stage (1 or 2). This compares

with 57% of those with other auto-immune diseases. Given the small

numbers the significance of these figures is dubious.

Stage of PBC: no other auto-immune disease other auto-immune diseases

Stage

1 6 (35%) 6 (26%)

1-2 2 (12%) 5 (22%)

2 3 (18%) 2 (9%)

2-3 2 (12%) 2 (9%)

3 2 (9%)

3-4 1 (4%)

4 2 (9%)

NK 4 3

-------------------------------------

17 23

Those with no other auto-immune disease show itching and fatigue as the

most common presenting symptoms. Fatigue, joint pain, disturbed sleep and

pressure at the top area of the liver are more frequently reported when other

auto-immune diseases are also present.

no other auto-immune disease other auto-immune diseases

Itching 10 (59%) 12 (52%)

Jaundice 2 (12%) 1 (4%)

Fatigue 8 (47%) 18 (78%)

Joint pain 5 (29%) 12 (52%)

Sleep broken 3 (18%) 16 (70%)

Sharp pain 3 (18%) 7 (30%)

Pressure 2 (12%) 10 (44%)

Ascites 2 (12%) 4 (17%)

Fat deposits 3 (18%) 4 (17%)

Bleeding gums 3 (18%) 6 (26%)

Mouth ulcers 2 (12%) 3 (13%)

---------------------------------------------------

No. of people 17 23

Age at diagnosis:

no other auto-immune disease other auto-immune diseases

30-39 3 (18%) 8 (35%)

40-49 9 (52%) 10 (43%)

50-59 5 (30%) 5 (22%)

Those with other auto-immune diseases may be diagnosed earlier but these

results could be due to the fact that people with other diseases are more

likely to be in regular contact with their doctors and therefore they are more

likely to undergo tests that could identify their PBC earlier rather than

having a true earlier onset.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Question F. ALLERGIES (List)

1 Food

2 Sun (Y/N)

3 Chemicals

4 Medications

5 Other

Yes No

Food 6 31 dairy, fish, nuts,fruit

Sun 8 29

Chemicals 2 33 formalin, cleaners, cosmetics,

Medications 18 18

Medications to which people were allergic included penicillin (7), codeine

(5), sulfa drugs (5), other antibiotics (4), aspirin (2), anti-inflammatories

(2), anti-histamines and caffeine.

Other allergies that were mentioned include: ADHESIVE TAPE, CATS

(2), DOGS, MITES (2), FEATHERS, POLLENS (2), DUST (4), ANIMAL

DANDERS, GRASS, TREES, MOLD (3),INSULATION

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Subj: PBC Survey Results Questions G-J & Summary

Date: 97-05-22 18:44:30 EDT

From: PBCers

To: PBCers

QUESTIONS G THRU J

Question G. MEDICAL HISTORY (Y/N)

1 Gallbladder removed

2 Smoker a.Previous

3 Osteoporosis

Female

4 (Pre/Post) Menopausal

5 Hysterectomy

6 Estorogen treatment (Patch/Oral)

7 Birth Control Pills (Current/Prior)

8 Other significan surgeries/illnesses

A high proportion of respondents have smoked at some time in their lives (53%) but probably this figure is not different to the general female community. 50% of the respondents have used birth control pills at some time in their lives but only 10% are still using them.

Yes No Not answered

Gallbladder removed 8 29 3

Smoker - current 6 31 3

Smoker - previous 21 10 9

Osteoporosis 7 29 4

Menopausal 20 17 3

Pre-menopausal 17

Peri-menopausal 3

Post-menopausal 17

Hysterectomy 10 25 5

Oestrogen - HRT 11 24 5

(now or prior)

Contraception-current 4 32 4

Contraception-prior 20 2 18

A further analysis showed that a total of 27 (71%) of the female respondents have used oestrogen (birth control and/or HRT) at some time in their lives.

Other serious illnesses or surgery that were mentioned include:

CAESARIAN SECTIONS (), MISCARRIAGES (2), ASTHMA(2), UTI (3),

APPENDIX, TUBAL LIGATION, ARTHRITIC KNEES, EATING

DISORDER, HERNIATED DISC, BREAST CANCER (2), BREAST

FIBROIDS, CATARACTS, PROLAPSED UTERUS, ENDOMETRIOSIS,

MASS ON VOCAL CHORD, LUNG BIOPSY,ESOPHAGITIS,

ANGIODYSPLASIA, HYPERTENSION (2), THROMBOSIS, MIGRAINE,

SPLENECTOMY, KIDNEY STONES, MITRAL VALVE PROLAPSE

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

H. MEDICATIONS Dosage x's Daily

1 Actigall

2 Metotrexate

3 Prednisone

4 Milk Thistle

5 Other

6 Do you use acupuncture? (Y/N)

35 people (88%) are on some form of ursodeoxycholic acid.

The daily dose varies from 300mg (1 person)

600mg (14 people)

900mg (10 people)

1200mg (5 people).

However, as the dose is calculated on a per weight basis it is not possible to

give a true indication of the relative dose being received.

1 person is receiving methotrexate treatment. Other medications reported

also include colchicine (5 people) which is a drug also used to treat auto-

immune diseases.

2 people receive prednisone

13 people (33%) are taking milk thistle. The dose of milk thistle taken

varies considerably from 200mg per day up to 1500mg per day. Those

taking milk thistle tend to be in the earlier stages of PBC (8 people - 62%

are stage 1 or 2). The incidence of symptoms is no different to the general

sympton rate at:

itching 46%

fatigue 62%

joint pain 31%

sleep broken 46%

Only 4 people appear to be receiving treatment for itching (eg questran) but

other manufacturers' names may have been used making it difficult to

identify the relevant drugs.

A variety of other medications were reported including calcium, vitamins

(various) and other herbal preparations. The variations in reporting make

any useful analysis difficult.

Only 3 people reported using acupuncture at any time.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Question I. PERSONAL (Y/N)

1 Do you currently work outside the home?

2 Have you decreased your work hours?

3 Do you have health insurance?

4 If not, are you enrolled in a state/federal program?

5 Are you eligible for SSI or SSD?

6 Have you applied?

7 Have you, or are you currently apppealing refusal of SSI or SSD?

25 people (63%) currently work outside the home. 11 people (28%) have

had to reduce their work hours; 3 of these 11 still work outside the home

though. Reducing working hours seems to be related to a higher stage of the

illness:

stage 1 3 people

2 1 person

3 or higher 5 people

unknown 2 people

It is also related, not surprisingly, to a high level of reported fatigue as a symptom. 91% of those who have reduced their working hours reported fatigue.

36 people (90%) have health insurance. 2 people answered that they are

enrolled in a state or federal program; 1 of these also has health insurance.

6 people (15%) said they are eligible for SSI or SSD. 5 of these people said

that they have applied. 4 people have appealed against refusal of SSI or

SSD, including 3 of those who answered yes to being eligible. As I do not

understand the workings of the US health and benefits system I cannot

make much comment on these results - maybe this will meam something to

you.

1 person mentioned that their PBC had been accepted as service related and

that they had VA entitlement. It would be interesting to find out on what

grounds this decision had been made.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Question J. FAMILY HISTORY Disease Family Member Status

1 Auto-Immune Diseases

2 Asthma

3 Liver Disease

4 Allergies

5 Other (Cancer, Heart Disease, Diabetes)

14 people (35%) reported other auto-immune illnesses in their families

including arthritis (4), ITP (1), thyroid problems (2), multiple sclerosis (1)

and lupus (1).

There was no obvious relationship between a reported family history of

auto-immune disease and other auto-immune problems in the respondent.

13 people (33%) reported a family history of asthma in close family

members.

11 people (28%) reported other liver diseases in their family. This included

hepatitis (4), alcoholic cirrhosis (2), cancer (1), Budd-Chiari (1), fatty liver

(1),gallbladder disease (4) and unknown disease leading to transplant (1).

One respondent had a sister with high alkaline phosphatase.

16 people (40%) reported a family history of allergies to a variety of

chemicals.

Other illnesses reported in family members included cancer (36 reports) and

heart/vascular problems (33 reports). As these are common problems these

results are not unexpected. The only other illness to rate a common mention

is diabetes (19 reports). The nature of the survey did not allow for good

reporting and in particular there is no indication in most cases as to the type

of diabetes. Diabetes is becoming increasingly common, in particular

mature age onset diabetes, and there may be no significance in the results.

Juvenile onset diabetes is less common and may involve an auto-immune

component. Further study in this area may be worth while.

Subj: Summary of survey results

Date: 97-03-25 07:21:22 EST

Summary of the PBCers Survey Results

Method:

A questionnaire was developed by Mari, a member of the PBC support group.

All members with a definite diagnosis of PBC were asked to respond.

Responses were stripped of identifying factors and sent to another member,

Meg, for analysis.

Results:

A total of 40 surveys were received out of a total membership of 107.

General Information.

Most respondents (82.5%) have been diagnosed in the last 5 years. The mean

and median age at diagnosis was 45 years and the mean current age is 48

years. 95% of the respondents were female. There was no apparent

correlation of the diagnosis of PBC with characteristics such as skin or

hair colour. North European is quoted in the literature as the most commmon

population predisposed to PBC and this is supported in this survey. In

addition 8 people identified themselves as Jewish, a surprisingly high

number as PBC has been thought to be uncommon in this group. The diagnosis

of PBC is most likely to be made by a GI or a hepatologist.

Symptoms.

The most common symptoms at diagnosis were itching (45%) and fatigue (68%).

Sleep disturbances occurred in 33% and joint pain in 28% of the respondents.

Despite treatment, usually with ursodeoxycholic acid, the occurrence of

these symptoms has not decreased and a higher incidence of sleep

disturbances (48%) and joint pains (43%) is in fact reported. A significant

number of people also report pain (25%) or pressure on their liver (30%).

Bleeding gums (23%) and mouth ulcers (13%) were also reported but these are

relatively common problems in the community and may not be significant.

Of the 25 respondents who had symptoms at diagnosis, 80% had had the

symptoms for more than 1 year before the diagnosis was made.

Once symptoms such as itching and fatigue are reported, it seems that there

is a greater chance that other symptoms such as sleep disturbances and joint

pain will also be present. However it does not appear that the presence of

symptoms is related to the stage of the illness in any clear way other than

that the absence of symptoms is not likely to be linked with late stage PBC.

Stageing of the illness.

38 (95%) of the respondents have had their diagnosis confirmed by biopsy but

most have had only 1 biopsy (27 or 68%). Most respondents had their first

biopsy close to the time of their first diagnosis (22 or 55% within 1

month). However some had a biopsy long before the diagnosis was actually

made (4 years in 1 case) and for some the diagnosis was first made on blood

tests and a biopsy was only taken several months later.

30% of the respondents are in stage 1 of PBC, 30% in stage 1-2 or 2 and 23%

at later stages. Only 9 respondents do not have any symptoms at present but

staging of the illness ranges from Stage 1 to stage 2-3. Even those

reporting multiple symptoms vary from stage 1 to stage 4. 17% did not know

the stage of their illness. Only 1 respondent is currently on a transplant

list with transplant status 3.

Medications.

35 people (88%) are on some form of ursodeoxycholic acid, most commonly

Actigall. The daily dose varies from 300mg to 1200mg. However, as the dose

is calculated on a per weight basis it is not possible to give a true

indication of the relative dose being received.

1 person is receiving methotrexate treatment. Other medications reported

also include colchicine (5 people) which is a drug also used to treat auto-

immune diseases. 2 people receive prednisone. Many other drugs were

mentioned but the data given did not easily identify those specifically

prescribed for treatment of the liver disease

13 people (33%) are taking milk thistle, a herbal remedy. The dose of milk

thistle taken varies considerably from 200mg per day up to 1500mg per day. Those

taking milk thistle tend to be in the earlier stages of PBC (8 people - 62%

are stage 1 or 2).

Only 4 people appear to be receiving treatment for itching (eg questran) but

other manufacturers' names may have been used making it difficult to

identify the relevant drugs.

A variety of other medications were reported including calcium, vitamins

(various) and other herbal preparations. The variations in reporting make

any useful analysis difficult.

Only 3 people reported using acupuncture at any time.

Test results.

The normal values of the following tests vary depending on the source of

information and possibly on the way the test is carried out. However I have

taken a close approximation and assumed that all the test results are

consistent.

As expected, alanine aminotransferase (ALT), aspartate aminotransferase

(AST), and alkaline phosphatase were raised at the time of diagnosis but are

generally lower at the current time. However, they are generally still

higher than ormal. This is to be expected as most people are receiving

Actigall or another form of ursodeoxycholic acid and this is a known result

of these drugs. Of the 5 people not receiving Ursodeoxycholic acid, only 1

of these shows a drop in these enzyme levels and this could be due to

treatment with colchicine.

There is no general change in the bilirubin levels with treatment and if

anything they are more likely to be higher now than at diagnosis. Bilirubin

levels were normal at the time of diagnosis in 40% of the respondents and

are still within normal limits for 33%.

22 out of 23 people reported that they were positive for Anti-mitochondrial

antibodies. 9 people reported that they were positive for anti-nuclear

antibodies.

It was difficult to recognise any correlation of the test levels with

symptoms such as itching or fatigue. A more detailed analysis was carried

out for the alkaline phosphatase test results but itching and fatigue seemed

to occur in 40% and 75% of the respondents respectively, irrespective of the

whether levels were normal or raised. A similar result was obtained for the

bilirubin levels.

An examination of possible correlations between the test results and stage

of the illness was also carried out. The alkaline phosphatase results showed

no correlation with stage in any way. The bilirubin results were varied at

the earlier stages of PBC but were consistently higher at stages 3 to 4.

Other auto-immune diseases.

Thyroid problems (25%) were the most frequent of other auto-immune diseases

reported, followed by Reynaud's disease (18%), psoriasis (15%) and

Sjorgren's (10%)

17 respondents have no auto-immune disease diagnosed other than PBC. 15

respondents have one other disease and 8 have 2 or more other diseases.

Further analysis of those 17 people with no other auto-immune disease shows

that the majority (65%) are at an early stage (1 or 2) of PBC. This compares

with 57% of those with other auto-immune diseases. Given the small numbers

the significance of these figures is dubious.

Those with no other auto-immune disease show itching and fatigue as the

most common presenting symptoms. Fatigue, joint pain, disturbed sleep and

pressure at the top area of the liver are more frequently reported when other

auto-immune diseases are also present. The presence of symptoms such as

itching and fatigue is more likely to be linked with the presence of other

auto-immune diseases, in particular Sjogrens, psoriasis and Reynaud's disease.

Those with other auto-immune diseases may be diagnosed earlier but these

results could be due to the fact that people with other diseases are more

likely to be in regular contact with their doctors and therefore they are

more likely to undergo tests that could identify their PBC earlier rather than

having a true earlier onset.

Allergies.

Medications were the most common group to which people reported allergies.

Medications to which people were allergic included penicillin (7), codeine

(5), sulfa drugs (5) and other antibiotics (4).

Medical History.

8 respondents had their gall bladder removed and 10 had had a hysterectomy.

A high proportion of respondents have smoked at some time in their lives

(53%) but probably this figure is not different to the general female

community.

50% of the respondents have used birth control pills at some time

in their lives but only 10% are still using them. 11 respondents are using

or have used hormone replacement therapy for menopause. A further analysis

showed that a total of 27 (71%) of the female respondents have used

oestrogen (birth control and/or HRT) at some time in their lives.

Family History.

14 people (35%) reported other auto-immune illnesses in their families

including arthritis (4), ITP (1), thyroid problems (2), multiple sclerosis

(1) and lupus (1). There was no obvious relationship between a reported

family history of auto-immune disease and other auto-immune problems in the

respondent.

13 people (33%) reported a family history of asthma in close family

members and 11 people (28%) reported other liver diseases in their family.

Other illnesses reported in family members included cancer (36 reports) and

heart/vascular problems (33 reports). As these are common problems these

results are not unexpected. The only other illness to rate a common mention

is diabetes (19 reports). The nature of the survey did not allow for good

reporting and in particular there is no indication in most cases as to the

type of diabetes. Diabetes is becoming increasingly common, in particular

mature age onset diabetes, and there may be no significance in the results.

Juvenile onset diabetes is less common and may involve an auto-immune

component.

Personal Information.

25 people (63%) currently work outside the home. 11 people (28%) have

had to reduce their work hours; 3 of these 11 still work outside the home

though. Reduction of working hours seems to be related to a higher stage of the

illness. It is also related, not surprisingly, to a high level of reported

fatigue as a symptom. 91% of those who have reduced their working hours reported

fatigue.

36 people (90%) have health insurance. 6 people (15%) said they are eligible

for SSI or SSD and 5 have applied. 4 people have appealed against refusal of

SSI or

SSD in the past.

Conclusions.

There were many similarities with the survey carried out by the liver

support group although this represents a more varied group of people

(although a similar age range) with a range of liver diseases. Allergies to

penicillin and other medications were high in both groups.