Pedometer Recorded Activity and Self-Report as Measures of Treatment Outcome in Primary Dysmenorrhea: Relationship to Premenstrual Syndrome

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1 Western Michigan University ScholarWorks at WMU Master's Theses Graduate College Pedometer Recorded Activity and Self-Report as Measures of Treatment Outcome in Primary Dysmenorrhea: Relationship to Premenstrual Syndrome Vicki Link Trejbal Western Michigan University Follow this and additional works at: Part of the Psychoanalysis and Psychotherapy Commons Recommended Citation Trejbal, Vicki Link, "Pedometer Recorded Activity and Self-Report as Measures of Treatment Outcome in Primary Dysmenorrhea: Relationship to Premenstrual Syndrome" (1985). Master's Theses This Masters Thesis-Open Access is brought to you for free and open access by the Graduate College at ScholarWorks at WMU. It has been accepted for inclusion in Master's Theses by an authorized administrator of ScholarWorks at WMU. For more information, please contact

2 PEDOMETER RECORDED ACTIVITY AND SELF-REPORT AS MEASURES OF TREATMENT OUTCOME IN PRIMARY DYSMENORRHEA: RELATIONSHIP TO PREMENSTRUAL SYNDROME by V ic k i L ink T re jb a l A T h esis Subm itted to th e F a c u lty o f The G raduate C ollege in p a r t i a l f u lf illm e n t of th e req u irem en ts f o r th e Degree of M aster o f A rts D epartm ent o f Psychology W estern M ichigan U n iv e rsity Kalamazoo, M ichigan A p ril 1985 R ep rod uced with perm ission of the copyright ow ner. Further reproduction prohibited without perm ission.

3 PEDOMETER RECORDED ACTIVITY AND SELF-REPORT AS MEASURES OF TREATMENT OUTCOME IN PRIMARY DYSMENORRHEA: RELATIONSHIP TO PREMENSTRUAL SYNDROME V ic k i L in k T r e jb a l, M.A. W estern M ichigan U n iv e rs ity, 1985 The purpose of t h i s stu d y was th re e fo ld : f i r s t, to determ ine i f a pedom eter measure o f m otor a c t i v i t y co u ld be used a s one in d i c a to r o f th e degree o f dysm enorrhea p re s e n t in an in d iv id u a l; second, to determ ine th e d e g re e, i f an y, of th e r e la tio n s h ip p re s e n t between t h i s m easure and s e lf - r e p o r t m easures of symptomatology used in a m odified D aily Symptom R a tin g S c a le ; and t h i r d, to a s s e s s the e f f e c ts o f naproxen sodium and a p lacebo on th e s e lf - r e p o r t m easures and the b e h a v io ra l m easure of sym ptom atology. Three s u b je c ts wore pedom eters and com pleted m odified D aily Symptom R atin g S cale form s th roughout th e stu d y. Each s u b je c t showed tre a tm e n t a n d /o r p lacebo e f f e c ts on one o r more m easures o f sym ptom atology. The r e s u l t s must be i n t e r p re te d w ith c a u tio n s in c e th e s ig n if ic a n t d iffe re n c e s d em o n stratin g th e s e e f f e c ts could have o ccu rred by chance. R eproduced with perm ission of the copyright owner. Further reproduction prohibited without perm ission.

4 ACKNOWLEDGEMENTS I would f i r s t l i k e to th an k Dr. I. R. Weiss whose g e n e ro s ity was a p p a re n t in h is g iv in g o f both tim e and knowledge w ith no thought to p e rs o n a l o r p r o fe s s io n a l g a in. Of eq u al im portance was th e lo n g -te rm su p p o rt and c o n s tr u c tiv e c r i t i c i s m of ray a d v is o r, Dr. R. W. Fuqua; th e su p p o rt o f th e o th e r members o f my com m ittee, Dr. M. R obertson and Dr. C. Koronakos; and, th e in p u t of D r. F. G a u lt. I would a ls o l ik e to th an k my good f r ie n d, D r. L. R. Gannon, s p e c i f ic a lly f o r help w ith s t a t i s t i c a l a n a ly s e s, an d, in g e n e ra l, f o r more than can be s ta te d h e re ; my "w onderful husband", John L in k, th e com puter w hiz, f o r a id and p a tie n c e ; a n d, F rie n d, Oboe, Linda Rae, S ta rb u c k, and F o u r-n in e f o r t o l e r a t i n g tem porary c a t n e g le c t. F in a lly, I would lik e to thank my f a t h e r, M r. 0. J. T r e jb a l, f o r a l l of our heated b u t lo v in g d e b a te s, which ta u g h t me th a t every one has som ething to le a r n, and i f b o th s id e s do l e a r n, they each come o u t w inning. V ick i L in k T re jb a l i i with p erm ission of the copyright ow ner. Further reproduction prohibited without perm ission

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7 T re jb a l, Vicki Link PEDOMETER RECORDED ACTIVITY AND SELF-REPORT AS MEASURES OF TREATMENT OUTCOME IN PRIMARY DYSMENORRHEA: RELATIONSHIP TO PREMENSTRUAL SYNDROME Western Michigan University M.A University Microfilms International 300 N. Zeeb Road, Ann Arbor, Ml R eproduced with perm ission of the copyright ow ner. Further reproduction prohibited without perm ission.

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10 TABLE OF CONTENTS ACKNOWLEDGEMENTS i i LIST OF TABLES iv CHAPTER I. INTRODUCTION I I. METHOD... 7 S u b je c ts A pparatus Dependent V a ria b le s P rocedure D ata A n a ly sis C o m p lia n c e I I I. RESULTS A djacent Phase A n a ly sis Comparison of B a se lin e F o llic u la r to P rem en stru al Phases A n a ly sis o f M enstrual Phase IV. DISCUSSION APPENDICES A. SUBJECT FORMS B. MODIFIED DAILY SYMPTOM RATING SCALE BIBLIOGRAPHY ill R eproduced with perm ission of the copyright owner. Further reproduction prohibited without perm ission.

11 LIST OF TABLES 1. A djacent Phase A n a ly s is, C onsecutive P hases: M enstrual Symptoms Comparison o f B a se lin e F o llic u la r P hases to P re m e n stru a l P hases: P rem enstrual S y m p to m s A n aly sis of M en stru al P hases: C y c le -to -C y cle V a r ia b ility ; T reatm ent and Placebo E ffe c ts iv R eproduced with perm ission of the copyright ow ner. Further reproduction prohibited without perm ission.

12 CHAPTER I INTRODUCTION Women a r e e n te rin g th e work fo rc e in in c re a s in g num bers, making a p p aren t th e problem s a s s o c ia te d w ith dysm enorrhea. Dysmenorrhea i s e stim a te d to cau se 140 m illio n l o s t work hours p er y e a r, an av e r age of two o r more days l o s t p e r fem ale p e r y e a r. s tu d e n ts m iss c la s s two to th re e days p e r month. Fem ale c o lle g e And, 20% of high school women m iss one day o f sch o o l per y e a r due to problem s r e la te d to dysm enorrhea (Sobczyk, 1980). The re p o rte d in c id e n c e of dysm enorrhea v a r ie s w id e ly. Moos (1968) and Coppen and K essel (1963) found th a t 45% of women s u ffe r from t h is problem. E a r lie r d a ta su p p o rt th is f ig u r e ( D r illie n, 1946; Haman, 1945). More r e c e n tly, in a survey of 113 p a tie n ts, Sobczyk, B ra u n ste in, and S olberg (1978) showed a p rev a len c e ra n g in g from 29% to 44% in any two month p e rio d. T his in cid e n ce may v a ry w ith age, p a r ie ty, w e ig h t, and e x e rc is e (Gannon, 1981; Sobczyk, 1980). A v a r ie ty of tre a tm e n ts f o r dysm enorrhea have in c lu d e psychoth e ra p y, o v u la tio n s u p p re ssio n, and hysterecto m y. P harm acological tre a tm e n ts have been e x te n s iv e ly in v e s tig a te d. T reatm ents w ith v a rio u s p ro s ta g la n d in sy n th e ta se i n h ib i to r s ap p ear to be e f f e c tiv e, tim e -lim ite d, and r e l a t i v e l y f re e from s id e e f f e c ts (Lannane, 1980). A lthough th e re a re no c o n tro lle d s tu d ie s of th e com parative e ffic a c y of a l l the v a rio u s p ro s ta g la n d in s y n th e ta s e in h ib ito r s to d a te, newer a g en ts such a s ib u p ro fen and naproxen appear to have few er sid e 1 R eproduced with perm ission of the copyright owner. Further reproduction prohibited without perm ission.

13 e f f e c ts than th e o ld e r a g e n ts such as indom ethacin (G onzalez, 1980). The fo llo w in g s tu d ie s dem onstrate th a t tre a tm e n t w ith naproxen sodium appears e f f e c tiv e in r e lie v in g dysm enorrhea. In a double b lin d p a r a l l e l t r i a l, 11 dysm enorrheic women w ere given a s in g le dose (1,100 mg) of Anaprox; 13 dysm enorrheic women were given a placebo (H enzl, O rteg a -H e rre ra, R odriguez, & Iz u, 1979) At th e end of a tw o-hour p e rio d, th e 11 p a tie n ts given Anaprox, and 3 p a tie n ts given th e p la c e b o, experienced com plete pain r e l i e f. The in te n s ity of p a in, b o th p r e - and p o s t-m e d ic a tio n, was s e lf - r a te d on a s c a le of 1 to 5: 1, no p a in ; 2, m ild p a in ; 3, m oderate p a in ; 4, se v ere p a in ; 5, very se v e re p ain. In a l a t e r stu d y, 212 women tr e a te d w ith naproxen sodium d u rin g 496 dysm enorrheic e p iso d e s ex p erienced com plete o r s u b s ta n tia l p a in r e l i e f in 63% of p a in f u l m e n s tru a tio n s, a m ild to s u b s ta n tia l r e l i e f in 11%, and a m ild r e l i e f in 9% (H enzl, M assey, Hanson, B uttram, Rosenwaks, & P a u ls, 1980). The 219 women re c e iv in g placebo e x p e rienced com plete or s u b s ta n tia l r e l i e f in 18% of p a in f u l m en stru a tio n s and m ild to s u b s ta n tia l r e l i e f in 7%. A p a in s c a le a s s e s s in g th e s e v e r ity of m e n stru a l cram ping, s im ila r to th a t used by Henzl e t a l. (1979) was used in t h i s stu d y. The r e l i e f s c a le was c o n stru c te d in a lik e manner. In an a tte m p t to reduce the s u b je c tiv ity of t h i s d a ta, the in v e s tig a to rs a ls o a s se s s e d fu n c tio n in g by a sk in g s u b je c ts q u e s tio n s concerning a c t i v i t i e s. Normal to s li g h t l y impeded fu n c tio n in g was re p o rte d d u rin g 64% o f tre a tm e n ts w ith naproxen sodium. Some in te r fe re n c e was re p o rte d in 31% of th e tre a tm e n ts, and in 5% of th e R eproduced with perm ission of the copyright owner. Further reproduction prohibited without perm ission.

14 tre a tm e n ts s ta y in g a t home, a n d /o r in bed ( in c a p a c ita tio n ), fo r a t l e a s t one day was re p o r te d. In c a p a c ita tio n d u rin g m en stru atio n f o r th e placebo groups was re p o rte d a t 34%. S u b je c ts a lso re p o rte d ta k in g a d d itio n a l pain m e d ic atio n, w ith the naproxen sodium group ta k in g a d d itio n a l m ed icatio n in 16% o f the tre a tm e n t c o u rs e s, and th e p lacebo group ta k in g a d d itio n a l m ed icatio n in 56% of th e c o u rse s. A s im ila r study was conducted comparing naproxen sodium, a s p ir in and a placebo (Rosenwaks, S e e ja r-j o n e s, H enzl, D ubln, Ghodgonkar, & Hoffman, 1981). Pain r e l i e f, in te rfe re n c e w ith a c t i v i t i e s, need f o r a d d itio n a l p a in m ed ic atio n, and le v e l of a p ro s ta g la n d in F metabol i t e, were used a s c r i t e r i a f o r e f f e c tiv e n e s s. In a ffo r d in g r e l i e f, naproxen sodium was s u p e rio r to a s p ir in and p la c e b o, though a s p ir in d id n o t prove su p e rio r to p la c e b o. A c t iv i tie s were l e s s im paired w ith naproxen sodium th a n w ith a s p ir in or p laceb o. R e l ia b i lity and v a l i d i t y d a ta f o r the s e l f - r e p o r t m easures u se d were n o t p re se n te d in th e se th re e s tu d ie s. S e lf - r e p o r t m easures have a ls o been used in d e te rm in in g t r e a t ment e ffic a c y in d e s e n s itiz a tio n based p ro cedures. Chesney and T a stro (1975), u sin g m uscle r e la x a tio n combined w ith m en stru a l im agery sc e n e s, reduced symptoms a s so c ia te d w ith prim ary dysm enorrhea b u t n o t th o se a s s o c ia te d w ith p rem en stru al syndrom e. The M enstrual Symptom Q u e stio n n a ire, used in th is stu d y to a s s e s s sym ptom atology, was l a t e r found to be in v a lid and u n r e lia b le (W ebster, M a rtin, U c h a lik, & Gannon, 1978). Cox and Meyer (1978), u s in g deep muscle r e la x a tio n in a sy ste m a tic d e s e n s itiz a tio n paradigm, reduced symptoms a s s o c ia te d w ith both dysm enorrhea and p rem en stru al syndrom e. The R eproduced with perm ission of the copyright owner. Further reproduction prohibited without perm ission.

15 M enstrual D is tre s s Q u e stio n n a ire used in t h is study has s in c e been shown to be in v a lid (A bplanap, D onnelly, & Rose, 1979). Both the M enstrual Syndrome Q u e stio n n a ire and M enstrual D is tr e s s Q uestionn a ir e were r e tr o s p e c tiv e. The s e l f - r e p o r t m easures used to a s se s s tre a tm e n t e ffic a c y in b o th pharm acological and b e h a v io ra l s tu d ie s a r e not n e c e s s a rily v a lid o r r e l i a b i l e. In a d d itio n th o se m easures used in th e b e h a v io ra l s tu d ie s were r e tr o s p e c tiv e. The manner in which the e ffic a c y o f th e drug has been e v a lu a te d may n o t be the m ost p ro d u c tiv e in term s of tr e a tin g th e in d iv id u a l p a tie n t. The m easures used re v e a le d l i t t l e about th e a c tu a l tim e o f d i s t r e s s, th e d egree o r type of p re tre a tm e n t d isc o m fo rt, th e amount of r e l i e f a ffo rd e d, o r changes in in d iv id u a l fu n c tio n in g. The c r i t e r i a f o r tre a tm e n t su ccess have been in a d e q u a te. Although p a s t m easures have provided some in d ic a tio n o f o v e r a ll e f f i c a cy, they a re not n e c e s s a r ily v a lid, r e l i a b l e m easures of an in d i v i d u a l 's degree of d i s t r e s s d u rin g th e m en stru al p e rio d or p o s t tre a tm e n t. A lso, symptoms re p o rte d th roughout th e c y c le a re not m easured, le a v in g open th e p o s s i b i l i t y th a t tre a tm e n t i s n o t a c tu a lly d ire c te d a t symptomatology o c c u rrin g d u rin g th e m en stru al phase. T aylor (1979) has s in c e developed a D aily Symptom R atin g S c a le, and re p o rte d d a ta w hich d id in d ic a te ad eq u ate r e l i a b i l i t y and v a lid i t y, fo r most item s. C e rta in ite m s, h o p e le ssn e ss, w ith d ra w a l, c h e e r f u ln e s s, e n erg y, b r e a s t sw e llin g o r te n d e rn e s s, and s w e llin g of f a c e, h an d s, a n k le s, did n o t c o r r e la te w ith th e s e le c te d v a lid ity c r i t e r i a f o r p rem en stru al symptoms, which w ere: 1) th e numbers of ta b l e ts consumed in th e p rem en stru al week, 2) a h is to r y of having c o n su lte d R ep rod uced with perm ission of the copyright owner. Further reproduction prohibited without perm ission.

16 w ith a d o c to r about p rem en stru al symptoms, 3) th e s u b je c t 's s e l f - r a tin g of th e usu al s e v e r ity of p rem e n stru al symptoms, and 4) th e s u b je c t 's e stim a te o f the s e v e r ity of h er p rem en stru al symptoms r e l a t i v e to th o se o f most women. The item s which did n o t c o r r e la te w ith th e se c r i t e r i a, e x c lu d in g b r e a s t sw e llin g and te n d e rn e s s, p lu s the ite m, la c k of i n i t i a t i v e, a ls o did n o t dem onstrate c le a r c y c lic p a tte r n s. A lthough th is s c a le seems p re fe ra b le to th e p re v io u s ly m entioned s e lf - r e p o r t m easures in t h a t i t i s v a lid and r e l i a b l e f o r most ite m s, and a v o id s th e problem s in h e re n t in r e tr o s p e c tiv e r e p o r ts, i t rem ains a s u b je c tiv e m easure. Henzl e t a l. (1980) s ta te d t h a t sin c e pain i s a s u b je c tiv e phenomenon, changes in p a in i n te n s ity cannot be o b je c tiv e ly m easured. T h e re fo re, we cannot o b je c tiv e ly m easure th e a n a lg e s ic e f f e c ts o f a drug. Lennane (1980) a p p e ars to a g re e, su g g e stin g th a t th e only argum ent p o s s ib le ab o u t w hether o r n o t p a in i s p re s e n t in the s u b je c t is w hether o r not th e s u b je c t i s ly in g. Fordyce and S te g e r (1979) made a d is t i n c t io n which su g g e sts th a t the problem may be d e f i n i t i o n a l. They d is tin g u is h e d "p ain " as a form of s e n s a tio n, " s u ffe rin g " a s a f e e lin g s t a t e, and "p ain b e h a v io r" as the v i s i b l e o r a u d ib le m a n ife s ta tio n s of th e problem. A f u r th e r su g g estio n was made. Since s e lf - r e p o r t d a ta a re s u b je c t to d i s t o r tio n and lin k e d to n o n -tre a tm e n t v a r ia b le s, th e c r i t e r i o n fo r su ccess should be o b serv ab le and m easurable b eh a v io r. Uptim e, th e number of m iles walked in an h o u r, and the number o f pounds l i f t e d, a re exam ples given which avoid th e co m p lic a tio n s of s e l f - r e p o r t d a ta. R eproduced with perm ission of the copyright ow ner. Further reproduction prohibited without perm ission.

17 There i s l i t t l e ev id en ce in su p p o rt of o b se rv a b le and m easura b le changes in b e h a v io r ta k in g p lace throughout th e m en stru a l c y c le in women n o t n e c e s s a rily re p o rtin g p a in o r p re m e n stru a l symptomato lo g y (Sommer, 1973). M orris and Udry (1970) d id f in d in c re a s e s in a c t i v i t y in 25 women w earing pedom eters f o r th re e m en stru a l c y c le s. These in c re a s e s o ccurred on Days 2, 15, 16, and 27. Howe v e r, th e d a ta were a g g re g a te. D iffe re n c e s betw een women, w ith in c y c le s and betw een c y c le s, were n o t re p o rte d. A lthough th e im p lic a tio n s o f th e s e fin d in g s a re n o t c le a r, obj e c t iv e m easurem ent of p a in b eh av io r may avoid problem s in h e re n t in th e use o f r e tr o s p e c tiv e s e lf - r e p o r t d a ta w hich a re th en s t a t i s t i c a l l y a g g re g a te d. O b je c tiv e m easures may be u s e fu l in e v a lu a tin g b o th b e h a v io ra l and pharm aco lo g ical tre a tm e n ts of dysm enorrhea, p ro v id in g a v a lid and r e l i a b l e outcome c r i t e r i a. A d d itio n a lly, an o b je c tiv e m easure of b e h a v io r could prove u s e fu l in a s s e s s in g symptoma to lo g y th ro u g h o u t o th e r phases of th e cy c le. T his study used p edom eter-recorded a c t i v i t y as an index of g e n e ra l m otor a c t i v i t y in an a tte m p t to a s se s s p a in a s s o c ia te d w ith dysm enorrhea, th e e f f e c ts of tre a tm e n t w ith naproxen sodium, and th e e f f e c ts o f a p laceb o. A m odified D aily Symptom R a tin g S cale was used as an a d d itio n a l m easure o f symptomatology in o rd e r to determ ine th e r e la tio n s h ip between th e b e h a v io ra l data and th e d a ily s e l f - r e p o r t m easures. R eproduced with perm ission of the copyright owner. Further reproduction prohibited without perm ission.

18 CHAPTER I I METHOD S u b je cts The s u b je c ts w ere th re e v o lu n te e rs, r e c r u ite d v ia p o s te r s and word of m outh, ages 20, 30, and 33, re p o rtin g r e g u la r (between 24 and 30 day) m en stru al c y c le s, and p a in d u rin g m en stru a tio n. Each s u b je c t was screened fo r e x c lu sio n a ry c o n d itio n s c o n tr a in d ic a tin g the use of naproxen sodium p r io r to o b ta in in g a p h y s ic a l exam ination and w ritte n perm ission from a p h y s ic ia n, and had sig n ed a sta te m e n t of inform ed consent (se e Appendix A). P rio r to in c lu s io n, th e s u b je c ts were q u estio n ed re g a rd in g the p o s s i b i l i t y of pregnancy and c u rre n t b i r t h c o n tro l m ethods. Those who were p lan n in g a c h ild were ex clu d ed. A pparatus P re c is e K & R, Model #301 pedom eters were used to m easure a c t i v i t y le v e l. P r io r to b e g in n in g the stu d y, each pedom eter was checked fo r accu racy and r e l i a b i l i t y by b ein g worn d u rin g a one- m ile walk f o r th re e w alks. In o rd e r to ensure t h a t any changes in the m easure were n o t due to in stru m en t m a lfu n c tio n, th e pedom eters were checked a f t e r th e s u b je c ts had com pleted d a ta re c o rd in g. An a d d itio n a l check was made on S u b je ct A 's pedom eter appro x im ately lh months a f t e r b egin n in g re c o rd in g. A m odified D aily Symptom R atin g S cale form was used as an ' 7 R eproduced with perm ission of the copyright owner. Further reproduction prohibited without perm ission.

19 8 a d d itio n a l m easure (se e Appendix B ). A ll ite m s, exclu d in g e n erg y, which had n o t shown c le a r p e rim e n s tru a l ( a t about th e tim e m enstrua tio n b e g in s) peaks were e lim in a te d : h o p e le ssn e ss; la c k o f i n i t i a tiv e ; w ithdraw al; c h e e rfu ln e s s ; and sw e llin g o f f a c e, hands, and a n k le s. A lthough th e item, energy, a ls o had n o t shown any c le a r c y c lic p a tte r n, t h i s item was re ta in e d due to th e p o s s ib le r e l a tio n s h ip between i t and th e b e h a v io ra l m easure u sed. O ther changes in form at were made. D esignated sp aces f o r re c o rd in g drug in ta k e, a lc o h o l consum ption, pedom eter re a d in g s, and day of m en stru al p e rio d were added. The o r ig in a l form was d esig n ed in a manner by which s u b je c ts ra te d item s d a ily f o r e n tir e c y c le s on th e same form. In o rd er to avoid d a ta a lre a d y recorded from in flu e n c in g th e fo llo w in g r a t i n g s, se p a ra te form s w ere used each day. Each form was stamped and addressed to th e in v e s tig a to r. was Anaprox m anufactured by Syntex. The tre a tm e n t m edication used The p lacebo used was Cebocaps 3 m anufactured by O 'N eal, Jones & Feldman. Dependent V a ria b le s The dependent v a r ia b le s were th e number o f m ile s p e r day recorded on th e pedom eter and re p o rte d on th e form, the r a tin g s (0-5) of th e item s on the D aily Symptom R ating S cale form, and th e number of d rin k s recorded on th e form. Each s u b je c t wore a pedom eter from the tim e o f g e ttin g out o f bed in the m orning u n t i l j u s t p r io r to r e t i r ing a t n ig h t, e x c lu d in g b a th in g and t o i l e t r e la te d a c t i v i t i e s. They record ed the number o f m ile s r e g is te r e d im m ediately a f t e r rem oving th e pedom eter, and com pleted the m odified D aily Symptom R atin g S cale R eproduced with perm ission of the copyright ow ner. Further reproduction prohibited without perm ission.

20 9 form a t th e end of each day. Each form was m ailed to the in v e s tig a to rs on th e fo llo w in g day. Weekend re p o rts were m ailed th e fo llo w in g Monday. P rocedure The independent v a r ia b le s were in g e s tio n of naproxen sodium and in g e s tio n of p laceb o. The s u b je c ts were in s tr u c te d to tak e the m ed icatio n d a ily, in fo u r s e p a ra te doses per day, w ith food o r m ilk. The i n i t i a l d o se, taken a t th e o n se t o f the m e n stru a l p e rio d, was 550 mg (two t a b l e t s o r c a p s u le s ). The fo llo w in g doses c o n s is te d of 275 mg (one t a b l e t or c a p su le ) taken every 6 h o u rs, f o r th e d u ra tio n of tim e th a t th e s u b je c t re p o rte d p a in d u rin g m e n stru a tio n. The in s tr u c tio n s f o r ta k in g th e placebo were given in th e same manner: 2 i n i t i a l t a b l e ts o r c a p su le s follow ed by 1 every 6 h o u rs. The s u b je c ts were a p p rise d of p o s s ib le r e a c tio n s to the d ru g, m ainly g a s t r o i n t e s t i n a l d istu rb a n c e ; in s tr u c te d n o t to in g e s t a lc o h o l o r a n a lg e s ic s w h ile ta k in g the m ed icatio n ; a n d, to r e p o rt any o ccu rren ce of s id e - e f f e c ts to th e in v e s tig a to r. In th e event th a t a n a lg e s ic s were consid ered n e c e ssa ry by the s u b je c t when n o t ta k in g the t e s t m e d ic a tio n, the s u b je c t was re q u ire d to re c o rd th e ty p e, the am ount, th e d a ta, and th e tim e of a d m in is tra tio n. T his was done in o rd e r to p a r t i a l l y cont r o l and a s s e s s th e e f f e c ts of th e se confounding v a r ia b le s, f u l l c o n tr o l b e in g im p ra c tic a l and p o s s ib ly u n e th ic a l. The s u b je c ts re c e iv e d b o th in s tr u c tio n s and m ed icatio n from an a s s i s t a n t who had no knowledge of th e drug b ein g a d m in is te re d. The t a b l e t s o r c a p su le s were c o n ta in ed in i d e n tic a l unmarked envelopes. R ep rod uced with perm ission of the copyright ow ner. Further reproduction prohibited without perm ission.

21 10 In o rd e r to h e lp e n su re t h a t the t e s t m ed icatio n s were tak en as d ir e c te d, th e s u b je c ts were re q u ire d to re c o rd th e d a te and tim e of s e lf -a d m in is tr a tio n d i r e c t l y on th e p a c k e ts, and to r e tu r n th e packe ts to the i n v e s tig a to r. The o n se t of each in te rv e n tio n phase was determ ined by th e onset of each s u b je c t's m e n stru a l p e rio d. The d u ra tio n of in te r v e n tio n was determ ined by th e d u ra tio n of re p o rte d pain in b a s e lin e. The maximum number of days each s u b je c t re p o rte d p ain d u rin g m en stru atio n in the two b a s e lin e c y c le s was fo u r. Each s u b je c t re c e iv e d m edication f o r fo u r days, a t o ta l of seventeen t a b l e t s, fo r the f i r s t tre a tm e n t c y c le. D ata A n aly sis No sta n d a rd procedure e x is ts f o r phase d e f in itio n (Gannon, 1981). Number of phases and phase le n g th v a ry from study to study (Sommer, 1973). However, fo llo w in g o v u la tio n, the corpus luteum has a p re determ ined l i f e span o f appro x im ately 14 d a y s. V a ria tio n in c y c le le n g th may o ccu r u n t i l the tim e of o v u la tio n (M oghissi, 1980). Cons e q u e n tly, m ost procedures f o r phase d e f in itio n use an in d ir e c t m ethod, assum ing o v u la tio n, to d e sig n a te p h ases o f i n t e r e s t. Four phases of th e m en stru al c y c le w ere d e fin e d in th e fo llo w in g manner: m en stru a l, from th e f i r s t day of m e n stru a tio n through th e f i f t h day of th e c y c le ; f o l l i c u l a r, th e n in e te e n th day p r io r to th e o n set o f m en stru atio n through the f i f t e e n t h day p r io r to o n s e t; l u t e a l, the te n th day p r io r to o n set through the s i x t h day p r io r to o n s e t; and, p re m e n stru a l, th e f iv e days p reced in g th e o n se t of m e n stru a tio n. R eproduced with perm ission of the copyright owner. Further reproduction prohibited without perm ission.

22 Data p o in ts f o r each dependent v a ria b le f o r each s u b je c t were summed a c ro s s each phase f o r each cy cle and th e n averaged. The fo llo w in g a n a ly se s of v a ria n c e w ere perform ed: (a) com parisons betw een a d ja c e n t phases o f the m e n stru a l cycle from th e prem en stru al phase in B a se lin e 1 th ro u g h th e p rem en stru al p h ase in B a se lin e 2 f o r each s u b je c t, to determ ine s ig n i f ic a n t d iffe re n c e s re v e a lin g m en stru a l symptom atology; (b) betw een th e f o l l i c u l a r phase and p re m en stru al phase o f both B a s e lin e 1 and B a se lin e 2 c y c le s fo r each s u b je c t to determ ine p re m e n stru a l sym ptom atology; and (c) com parisons among a l l m en stru a l phases f o r each s u b je c t to determ in e c y c le - to -c y c le v a r i a b i l i t y and tre a tm e n t a n d /o r p lacebo e f f e c ts. Com pliance No s u b je c t to o k th e m ed icatio n as in s tr u c te d. D uring th e f i r s t tre a tm e n t c y c le, S u b ject A took a t o t a l of fo u r t a b l e ts a t i r r e g u la r i n te r v a ls f o r one day. S u b je c t B took a t o ta l o f s ix t a b l e t s, in te r v a ls u n re p o rte d, fo r two d ay s. S u b je ct C to o k a t o t a l of seven t a b l e ts a t i r r e g u la r i n te r v a ls f o r th re e days. Each s u b je c t was s t i l l r e p o rtin g some p a in when she d is c o n tin u e d m edication. In o rd e r to make v a lid com parisons between c y c le s, the number of t a b l e ts o r c a p su le s given to each s u b je c t a f t e r th e f i r s t tre a tm e n t c y c le rem ained th e same a s she had tak en d u ring th e f i r s t tre a tm e n t c y c le. R eproduced with perm ission of the copyright ow ner. Further reproduction prohibited without perm ission.

23 CHAPTER I I I RESULTS The r e s u l t s su g g e st tre a tm e n t e f f e c ts fo r S u b je c ts A and B, and b o th tre a tm e n t and p laceb o e f f e c ts f o r S u b je ct C, on one o r more m easures of symptom atology o c c u rrin g d u rin g the m en stru a l phase. Placebo e f f e c ts fo r S u b je ct B, and tre a tm e n t e f f e c ts fo r S u b ject C, appear on m easures w hich o th erw ise had rem ained r e l a t i v e l y c o n sta n t throughout a l l fo u r p h ases o f the m en stru a l c y c le, showing no s i g n i f ic a n t d iffe re n c e s among p h ases in b a s e lin e c y c le s. A d jacent Phase A n aly sis The a d ja c e n t p h ase a n a ly s is (se e Table 1) compares f iv e consec u tiv e p h ases, from p re m e n stru a l in B a se lin e 1 through p rem e n stru al in B aselin e 2, in o rd e r to d eterm in e any s i g n i f ic a n t d iffe re n c e s between co n secu tiv e p h ases w hich would re v e a l m en stru al symptomato lo g y. The d a ta show a s t a t i s t i c a l l y s ig n i f ic a n t in c re a s e in abdom inal sw e llin g and p elv ic /a b d o m in a l p a in d u rin g the m e n stru a l phase f o r S u b je ct A, a s ig n if ic a n t in c re a s e in b r e a s t sw e llin g o r ten d e rn ess fo r S u b ject B, and a s ig n if ic a n t in c re a s e in a lc o h o l consumpion and p e lv ic /a b d o m in a l p a in d u rin g th e m en stru al phase fo r S u b ject C. Comparison of B a se lin e F o l lic u la r to P re m en stru al Phases The comparison o f B a se lin e p rem e n stru al to f o l l i c u l a r phases 12 R eproduced with perm ission of the copyright owner. Further reproduction prohibited without perm ission.

24 T a b le 1 ADJACENT PHASE ANALYSIS, CONSECUTIVE PHASES: MENSTRUAL SYMPTOMS Subject A S ubject B Subject C FBI 102 FB2 U12 FB2 FBI MB2 FB2 LB2 FB2 FBI HB2 FB2 LB2 PB2 X X X X X X X X X X X I X X X H-5 K-4 H-5 M-5 H-5 H-5 K H Alcohol Pedometer Oapreealon Tension I r r ita b ility ArguMncaclvanasa Outgo in gness Energy E roast Swelling or Tenderness [... ] 8 Abdominal Sw elling t ] 9 Pelvic/Abdominal Fain [ - ^ 10 Backache Headache T iredness ] - S ig n ifican t D ifference P <.0 5 B - Baseline P - Premenstrual M - Menstrual F - F o llic u la r L - Luteal R eproduced with perm ission of the copyright owner. Further reproduction prohibited without perm ission.

25 14 T able 2 COMPARISON OF BASELINE FOLLICULAR PHASES TO PREMENSTRUAL PHASES: PREMENSTRUAL SYMPTOMS Subject A FBI FBI FB2 FB2 Z Z Z Z H-5 H-3 Alcohol Padoaacer Z.15 z.o s Dapraaalon Z Tanaion I r r i t a b i l ity Argtaancaclva naaa S Oucgoingneaa Energy 3.Z Braaac S ta llin g or Tndarnaea 8 Abdominal Swalling 9 Palvlc/Abdominal Pain 10 Backache Baadacha Z Tlradaaaa 1.Z0 z.zo Subject B Subject C FBI FBI TB2 FB2 FBI FBI FB2 FB2 Z Z Z Z Z Z Z Z 3-5 H-5 H-S 3-5 H-S H-5 H-5 H Z.Z ( ] t Z Z0 Z t ] 3.00 ' Z [ ) - Significant: D iffaranca P <.0 5 B - Baaaiina r - F o llic u la r P - Praaasacrual R eproduced with perm ission of the copyright ow ner. Further reproduction prohibited without perm ission.

26 (see T able 2) determ ined p re m e n stru a l symptomatology w hich may n o t have been dem onstrated in th e a d ja c e n t phase a n a ly s is, s in c e p re m en stru al and m en stru a l symptom atology may be s im ila r due to th e s im ila r ity in hormonal le v e ls. P ro g e ste ro n e and e s tro g e n a re dec re a s in g d u rin g the p rem e n stru al phase and a re lo w e st a t th e o n se t of m e n stru a tio n. B oth hormones a r e in c re a s in g d u rin g th e f o l l i c u l a r phase, e stro g e n peaking a t o v u la tio n, and p ro g e ste ro n e peaking about two to th re e days a f t e r o v u la tio n. Since th e hormonal le v e ls d i f f e r more betw een th e f o l l i c u l a r and p re m e n stru a l phases than betw een the p rem en stru al and m en stru al phases d iffe re n c e s in symptomatology may be g r e a te r. M easures which show a s ig n if ic a n t d iffe r e n c e betw een phases in only one o u t of th e two b a s e lin e c y c le s dem onstrate c y c le - to -c y c le v a r i a b i l i t y on th e s e m easures. A s ig n if ic a n t in c re a s e in th e pedom eter m easure and in b r e a s t sw e llin g or te n d e rn e s s o ccu rred d u rin g th e p rem en stru al p h ase, when compared to th e f o l l i c u l a r p h ase, i n both c y cles f o r S u b ject B. The in c re a s e in arg u m e n ta tiv e n e ss o ccu rred in B a se lin e 2 o n ly. In Baselin e 1 o n ly, outgoingness was s ig n i f ic a n tly in c re a se d and headache was s ig n i f ic a n tly d ecreased f o r S u b je ct C. A n a ly sis of M enstrual Phase Com parisons of th e m en stru al phase o n ly, among a l l c y c le s f o r each s u b je c t (se e T able 3 ), were made in o rd e r to : (a) determ in e f u r th e r c y c le -to - c y c le v a r i a b i l i t y, and (b) to d em o n strate tre a tm e n t an d /o r p laceb o e f f e c t s. In comparing th e m en stru al p h ases between B a s e lin e s 1 and 2, R eproduced with perm ission of the copyright owner. Further reproduction prohibited without perm ission.

27 Table 3 ANALYSIS OF MENSTRUAL PHASES: CYCLE-TO-CYCLE VARIABILITY; TREATMENT AND PLACEBO EFFECTS S ubject A SubJ u c t U Sul) 0(!t C B1 B2 T1 P T2 B1 B2 T P B1 B2 T1 P X X X X X X X X X X X X X N-5 N-4 N-5 N-5 N-5 N-5 N-5 N-4 N-5 N-5 N-4 N-5 N-5 Alcohol , t ) ( * ««] Pedometer D epr.s.lon 2 Tan*Ion Q I r r i t a b i l i t y [ [ 1 ( J A rgw encatlveness S Outgolngness Energy [ " ' ( I ' [ - 1 i ] j (------] [ t 1 -] B reast Sw elling o r Tenderness Abdoslnal Sw elling [*** 9 Pelvlc/A bdoelnal Pain 10 Backaeh* 11 Haadach* t ] J M ra M 'm a n ] {>...] Tlrednas* l J - S ig n ific a n t D ifference P B - B aseline T - Treatment P - Placebo R eproduced with perm ission of the copyright ow ner. Further reproduction prohibited without perm ission.

28 the in c re a s e in a lc o h o l and headache v a rie d from c y c le -to - c y c le fo r S u b je c t C. E lim in a tin g th o se changes which may be due to c y c le -to -c y c le v a r i a b i l i t y, and, ex clu d in g th o se m easures w hich rem ain c o n s is te n t throughout th e c y c le, showing no s ig n if ic a n t d iffe re n c e s among p h a ses, the fo llo w in g m easures rem ain a s r e l i a b l e symptoms o c c u rrin g during the m e n stru a l phase w hich may show changes due to e i t h e r tre a tm e n t or p laceb o e f f e c ts : S u b je c t A, abdom inal sw e llin g and p e lv ic / abdom inal p a in ; S u b je ct B, pedom eter and b r e a s t sw e llin g o r ten d e r n e s s; and S u b je c t C, p e lv ic /a b d o m in a l p a in. Of th e s e ta rg e te d m easures a s ig n if ic a n t d e c re a se in abdom inal sw e llin g o ccu rre d betw een B a se lin e 2 and T reatm ent 1 f o r S u b je ct A (see Table 3 ). The d e c re a se from B aselin e 2 to P lacebo was n o t s ig n i f ic a n t, and a lth o u g h th e d e c re a se from B a se lin e 2 to T reatm ent 2 was g re a te r th an th a t from B a se lin e 2 to P laceb o, i t was a ls o not s t a t i s t i c a l l y s ig n i f ic a n t. For S u b ject B, a s ig n i f ic a n t in c re a s e o ccurred betw een B a se lin e 1 and T reatm ent on th e pedom eter m easure. S u b je ct C 's d a ta show s ig n i f ic a n t d e c reases i n p e lv ic /a b d o m in a l p a in from B a se lin e 2 to b o th T reatm ent 1 and P laceb o, th e d iffe re n c e s being g r e a te r between B a se lin e 2 and T reatm ent 1. Changes occurred a ls o on n o n -ta rg e te d m easures, m easures which had shown no s ig n if ic a n t d iffe re n c e s among p h ases in th e two a n a ly se s of b a s e lin e. The d a ta f o r S u b je c t A show: (a ) a d ecre a se in te n sio n between Treatm ent 1 and P laceb o ; (b) a d e c re a se in i r r i t a b i l i t y between B aselin e 1 and P laceb o, B a se lin e 2 and T re atm e n t, and an inc re a s e from P lacebo to T reatm ent 2; and (c) in c re a s e s in both energy R eproduced with perm ission of the copyright owner. Further reproduction prohibited without perm ission.

29 and b r e a s t sw e llin g o r ten d e rn ess from P lacebo to Treatm ent 2. Upon v is u a l in s p e c tio n o f th e d a ta, th e s e changes ap p ear to be due to c y c le -to - c y c le v a r i a b i l i t y not dem onstrated in p r io r a n a ly s e s. The d e c re a se fo r S u b ject A from Treatm ent 1 to Placebo on the pedom eter m easure appears to be a r e s u l t o f a g rad u al d e c re a se on t h a t m easure from th e beg in n in g to th e end of d a ily re c o rd in g. F o r S u b ject B th e d ep re ssio n m easure showed s ig n if ic a n t dec re a s e s from B a se lin e 1 to b o th Treatm ent and P lacebo, d e m o n stra t ing a p ro b ab le placebo e f f e c t. There was a s ig n if ic a n t d e c re a se in te n sio n from B a se lin e 1 to P laceb o. I t i s n o t c le a r w hether t h i s was a placebo e f f e c t s in c e th e d ecre a se from B ase lin e 1 to Treatm ent was n o t s ig n if ic a n t. T here w ere s ig n if ic a n t d e c re a ses on th e pedom eter m easure f o r S u b ject C from both B a se lin e 1 and B a se lin e 2 to P lacebo. This was n o t a placebo e f f e c t s in c e th e d ecrease from B a se lin e 2 to Treatm ent was m inim al. D e p re ssio n, te n s io n, and i r r i t a b i l i t y decreased s i g n i f ic a n tly from B a se lin e 2 to T reatm ent 1 and in c re a se d s ig n i f ic a n tly from T reatm ent 1 to P la ceb o. A rgum entativeness d e c reased from b o th B a se lin e 1 and B a se lin e 2 to T reatm ent. Abdominal sw e llin g decreased from B a se lin e 1 to T reatm en t. These changes appear to b e e f f e c ts a s s o c ia te d w ith T reatm ent. They w ere m easures w hich had o th erw ise shown l i t t l e phase v a r i a b i l i t y. R eproduced with perm ission of the copyright ow ner. Further reproduction prohibited without perm ission.

30 CHAPTER IV DISCUSSION E f fe c ts of tre a tm e n t a n d /o r placebo on two ty p e s of symptomato lo g y have been dem onstrated: on symptoms a s s o c ia te d w ith the m e n stru a l phase only, and on m easures of symptom atology w hich had rem ained r e l a tiv e ly s ta b le th roughout a l l phases o f the m en stru al c y c le d u rin g B a se lin e. The tre a tm e n t a n d /o r p lacebo e f f e c ts on m e n stru a l phase symptoms w ere few. s w e llin g. S u b je ct A 's d a ta re v e a le d a tre a tm e n t e f f e c t on abdom inal S u b je ct B 's d a ta re v e a le d a tre a tm e n t e f f e c t on th e pedom eter m easure. S u b ject C 's d a ta rev e a le d a tre a tm e n t and p o s s ib le placebo e f f e c t on p elv ic /a b d o m in a l p a in. A lthough th e s e e f f e c ts w ere few, the o n ly m en stru al symptoms c o n s is te n tly re p o rte d d u rin g th e two B a se lin e c y c le s th a t w ere n o t a f f e c te d by e ith e r tre a tm e n t o r p laceb o, a c co rd in g to c r i t e r i a of s ig n i f ic a n t d if f e r e n c e s, were b r e a s t s w e llin g or te n d e rn e ss fo r S u b je ct B, a symptom t h a t i s u s u a lly c o n sid e red p re m e n s tru a l, but had o ccurred in b o th th e p rem en stru al and m e n stru a l phases f o r Subj e c t B; an d, p e lv ic /a b d o m in a l p a in f o r S u b ject A, w hich d id show n o n - s ig n if ic a n t d e c re a ses d u rin g both Treatm ent p h a ses. A lthough e f f e c ts have been dem onstrated, any c o n c lu sio n s a re s u s p e c t. Since th e re was a la r g e number of s ig n i f ic a n t d if f e r e n c e s, some of th e s ig n if ic a n t d iffe re n c e s w hich show tre a tm e n t a n d /o r 19 R eproduced with perm ission of the copyright ow ner. Further reproduction prohibited without perm ission.

31 placebo e f f e c ts may have o ccurred by chance. Other problem s a ls o c o n trib u te d to th e d i f f i c u l t i e s in d e m o n stra tin g e f f e c ts. More e f f e c t s, and more s a lie n t e f f e c t s, may have been observed i f two c o n d itio n s had been m et: (a) i f the method o f s u b je c t s e le c tio n had in clu d e d a c r i t e r i o n o f i n i t i a l r e p o r ts of fo u rs (la rg e amount) o r f iv e s (very la rg e ) on th e s e l f - r e p o r t m easures u s u a lly a s s o c ia te d w ith dysm enorrhea, p e lv ic /a b d o m in a l p a in, backache, and abdom inal s w e llin g ; and (b) i f com pliance w ith in s tr u c tio n s f o r ta k in g th e m edication had o ccu rre d. The method of s t a t i s t i c a l a n a ly s is may have obscured b o th e x i s t in g symptomatology and tre a tm e n t a n d /o r p lacebo e f f e c ts. A lthough S u b ject B 's d a ta did n o t dem onstrate p e lv ic /a b d o m in a l p ain d u rin g m e n stru a tio n, a c co rd in g to th e c r i t e r i a of s ig n i f ic a n t d if f e r e n c e s, th e re was an in c re a s e in th is m easure d u rin g th e m en stru a l phase over o th e r phases in th e c y c le. A lso, a d e c re a se in t h is m easure o ccurred d u rin g T reatm ent. V a r ia b ility d u rin g th e phase may have c o n trib u te d to o b scu rin g t h i s e f f e c t. I t was n e c e ssa ry f o r an e q u a l number of d a ta p o in ts to b e used in comparing p h a ses. However, m en stru a l symptom atology is u s u a lly g r e a te s t durin g th e f i r s t two days o f th e c y c le, c o n tr ib u tin g to w ith in -p h a se v a r i a b i l i t y. An a d d itio n a l problem c o n tr ib u tin g to th e d i f f i c u l t y in demons t r a t i n g tre a tm e n t outcome was th e low pedom eter re c o rd in g s fo r S u b ject A, v i r t u a l l y e lim in a tin g th a t m easure as a b e h a v io ra l index o f p ain f o r th a t p a r t i c u l a r s u b je c t. The pedom eters in t h i s stu d y were s e t f o r accuracy and r e l i a b i l i t y. The m easures re p o rte d were a c tu a l record ed m ile s ; th e R eproduced with perm ission of the copyright ow ner. Further reproduction prohibited without perm ission.

32 low est re p o rt was 1.05 f o r S u b ject A, th e h ig h e s t re p o rt was 4.03 f o r S u b je ct B. In th e stu d y d eterm in in g v a r ia tio n s in pedom eter a c t i v i t y d u rin g m en stru a tio n (M orris & Udry, 1970), th e pedom eters were s e t fo r maximum d e f le c tio n. The m easures re p o rte d were pedom eter u n its : th e lo w est v a lu e was ; th e h ig h e s t value was S e ttin g th e pedom eter f o r maximum d e f le c tio n may in c re a s e th e d a ily m easures but t h i s in c re a s e io i t s e l f would n o t n e c e s s a rily r e s u l t in s ig n if ic a n t d iffe re n c e s betw een phases f o r a s>*v e c t w ith v e ry low a c t i v i t y le v e ls. A gain, a p a r t i a l s o lu tio n may be in th e ^/elopm ent of c r i t e r i a f o r s u b je c t s e le c tio n, perhaps re q u irin g pe,m eter re c o rd in g s to meet a p a r t i c u l a r le v e l p r io r to b eg in n in g a c tu a l stu d y. T his would n o t e lim in a te th e p o te n tia l f o r a d e c re a se due to o th e r v a r i a b le s, b u t would a t l e a s t e n su re t h a t th e s u b je c t was c u rre n tly engaging in a le v e l of a c t i v i t y com parable to o th e r s u b je c ts. However, i t must be consid ered th a t o th e r f a c to r s b e s id e s dysm enorrhea c o n tro l pedom eter re c o rd in g s. S u b ject C 's d a ta dem onstrated e f f e c ts a s s o c ia te d w ith tre a tm e n t on symptoms th a t had p re v io u s ly shown no p h a se-to -p h a se v a r i a b i l i t y : abdom inal s w e llin g, d e p re s s io n, te n s io n, i r r i t a b i l i t y, and argum entativ e n e s s. The c a u sa l r e la tio n s h ip s betw een th e se e f f e c ts and t r e a t ment a r e n o t c le a r. I t i s p o s s ib le t h a t th e d ecrease in th e s e m easures was a consequence o f a d e c re a se in p a in. This seems most p ro b ab le fo r th e d e c re a se on th e s e lf - r e p o r t measure o f abdom inal s w e llin g, a symptom f re q u e n tly a s s o c ia te d w ith dysm enorrhea. R eproduced with perm ission of the copyright ow ner. Further reproduction prohibited without perm ission.