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How Can Follow-Up of Patients with Raynaud Phenomenon be Optimized?

How Can Follow-Up of Patients with Raynaud Phenomenon be Optimized? HUMAN STUDY eISSN 2325-4416 © Med Sci Monit Basic Res, 2015; 21: 47-52 DOI: 10.12659/MSMBR.893998 Received: 2015.03.03 How Can Follow-Up of Patients with Raynaud Accepted: 2015.03.10 Published: 2015.04.02 Phenomenon be Optimized? Authors’ Contrib ution: AE 1 Murat Kadan 1 Department of Cardiovascular Surgery, Gulhane Military Medical Academy, Study Design A Ankara, Turkey FG 2 Gökhan Erol Data Collection B 2 Department of Cardiovascular Surgery, Maresal Cakmak Military Hospital, F 1 Kubilay Karabacak Statistical Analysis C Erzurum, Turkey Data Interpr etation D B 1 Erkan Kaya Manuscript Preparation E C 1 Gökhan Arslan Literature Search F AD 1 Suat Doğancı Funds Collection G A 1 Ufuk Demirkılıç Corresponding Author: Murat Kadan, e-mail: muratkadan@yahoo.com Source of support: Departmental sources Background: Raynaud phenomenon (RP) is common worldwide and presents diagnostic and therapeutic difficulties. We aimed to share our experience with optimizing of patient follow-up by using the cold-stimulation test (CST). Material/Methods: Data of 81 patients admitted with RP symptomatology were collected. Demographic data and symptoms were recorded. A scale was used for determining the severity of disease at pre-treatment and post-treatment. CST was performed to all patients at pre-treatment and post-treatment for assessment of treatment efficiency in follow-up. Results were analyzed with the SPSS for Mac 20.0 program. Results: All the patients were male. Mean age was 22.3±2.14 (19–29). Mean duration of symptoms from onset to pres- ent was 4.59±2.85 years. There were statistically signic fi ant die ff rences between pre-treatment and post-treat - ment hand temperatures measured by CST (p<0.001). However, there were no statistically significant differ - ences between pre-treatment and post-treatment severity scores of patients (p=0.135). Conclusions: To quantitatively determine the treatment efficacy, CST may be used instead of asking simple questions of patients. MeSH Keywords: Cold Temperature • Diagnosis • Peripheral Vascular Diseases Full-text PDF: http://www.basic.medscimonit.com/abstract/index/idArt/893998 1934 5 1 9 This work is licensed under a Creative Commons Indexed in: [Index Medicus/MEDLINE] [EMBASE/Excerpta Medica] [Chemical Abstracts/CAS] [Index Copernicus] Attribution-NonCommercial-NoDerivs 3.0 Unported License Kadan M. et al.: HUMAN STUDY © Med Sci Monit Basic Res, 2015; 21: 47-52 Background first and second distal phalanges. 2. The most affected ex - tremity is immersed into the +4°C iced-water for 20 seconds. Raynaud phenomenon is a common health problem charac- 3. After drying the hands, the fingertip temperature is mea - th th th th terized by episodic cyanosis, swelling, and pallor on both up- sured again at 5 , 10 , 15 and 20 minutes, with the same per and lower extremities with cold exposure. Its prevalence technique as detailed before. 4. The rewarming time to initial variously estimated at 3.3% to 22% [1]. This group of disor- temperature is also recorded. ders predominantly affects females [2]. We recently defined an assessment scale of CST in our previ - In the history of this disorder, researches have described many ous paper [3]. The assessment scale for CST is given in Table 1. etiologic factors, but, to date, neither an objective, quantita- tive diagnostic tool, nor an objective follow-up method has In order to evaluate the effectiveness of the medical treatment, been defined [3]. we routinely use a verbal complaint severity scale (VCSS) de- scribed in our previous study [4]. In this study, we aimed to find an optimized method for the follow-up of patients with Raynaud phenomenon. Medical treatment According to our clinical protocol, we routinely use the combi- Material and Methods nation of pentoxifylline 1200 mg/d bid (2×600 mg) as a vaso- dilator molecule, nifedipine 60 mg/d bid (2×30 mg) as a calci- In this retrospective study, we aimed to describe an optimized um-channel blocker, and acetylsalicylic acid 300 mg/d (1×300 method for the follow-up of patients with Raynaud phenom- mg) as an antiplatelet agent. Beside these medications, all of enon, and to compare its’ efficacy with a verbal complaint se - the patients are advised to protect themselves from cold as verity scale. Our local ethics committee approved the study much as possible. (Ethics approval number 1291). Patients were informed about the possible adverse effects of Patient’s selection these medications. Between August 2012 and July 2013, data of 81 patients Statistical analysis with Raynaud phenomenon symptomatology were collected. Systemic evaluation including blood examinations, capillaros- SPSS for Mac 20.0 package program (SPSS Inc, Chicago, IL) copy, and Doppler ultrasonography are routinely performed in was used for statistical evaluation. Descriptive results were our clinic to exclude secondary etiologic factors. Therefore, in expressed as mean ± standard deviation for normally dis- this study we included only patients with primary Raynaud phe- tributed continuous variables and median values for abnor- nomenon. Demographic data, concomitant disorders (such as mally distributed continuous variables. Categorical variables hypertension, diabetes mellitus, renal insufficiency, and tho - were reported as numbers and percentages. Before analyses, racic outlet syndromes), and type and duration of symptoms Kolmogorov-Smirnov test was used for analyzing the distri- were recorded. bution pattern of data. Comparisons of the parametric values were performed with the t-test for normally distributed groups Cold stimulation test and with Mann-Whitney U test and Wilcoxon signed ranks test with abnormally distributed groups. Pearson’s chi-square test, In our center, testing of patients’ response to cold stimula- Fisher’s exact test, and McNemar-Bowker test were used for tion is mandatory due to our national regulations. Therefore, the comparisons of categorical variables. we routinely apply the cold stimulation test (CST) to all of our patients presenting with the Raynaud phenomenon symp- A p value of <0.05 was considered as statistically significant tomatology. CST is performed at room temperature (26°C). All with a 95% confidence interval. patients are only allowed to wear their shirts, without addi- tional jackets or coats throughout the test. All measurements of CST are performed with the patient’s hand at the level of Results the heart. A Sonatemp™ 400/700 Monitor (Sheridan Catheter Corp. Argyle, NY, USA) device was used for temperature mea- Patients’ characteristics surements. According to our protocol, application of the CST is as follows: 1. Hand temperatures of the patients are mea- Military service is an obligatory duty in Turkey for every young sured with a probe, which is inserted between the pulp of the male. Since this study was performed in a military hospital, all This work is licensed under a Creative Commons Indexed in: [Index Medicus/MEDLINE] [EMBASE/Excerpta Medica] Attribution-NonCommercial-NoDerivs 3.0 Unported License [Chemical Abstracts/CAS] [Index Copernicus] Kadan M. et al.: HUMAN STUDY © Med Sci Monit Basic Res, 2015; 21: 47-52 Table 1. Assessment scale for cold stimulation test. Stage Rewarming time (minute) Assessment Potential diagnosis 0 0–10 Normal Healthy person I 11–15 Mild disturbed Otherwise healthy person II 16–20 Moderate disturbed Mild vasospastic disorder III 21–30 Serious disturbed Moderate vasospastic disorder IV ³31 Serious disturbed Serious vasospastic disorder Table 2. Patients’ demographic data. numbness (47 patients, 58%) were the most frequent symp- toms. The other complaints were as following: hyperhidrosis Age (year) 22.3±2.14 (19–29) (45 patients, 55.5%), cold aggravated swelling (32 patients, 39.5%), burning sensation (19 patients, 23.4%) and pain (9 Gender (male/female) 81/0 patients, 11.1%); 57 of patients (70.1%) had 3 or more com- Smoking (n) 56 plaints mentioned before, while only 1 patient had all com- Co-morbidity (n) plaints above. Mean duration of symptoms from onset to pres- ent was 4.59±2.85 years. None of the included patients were Hypertension 2 observed to have adverse effects associated with medications. Diabetes mellitus 0 Demographic data of patients are given in Table 2. Renal insufficiency 0 Verbal complaint severity scale Vasculitis 0 COLD 0 According to VCSS, patients were categorized into 3 groups. Before the treatment, 11 patients were in VCSS I, 32 patients Other 0 were in VCSS II, and 38 patients were in VCSS III. After the treat- Symptoms ment, when those patients were questioned again, there were Cyanosis (n,%) 66 (81.4%) no statistically significant differences between before and af - ter treatment VCSS. However, 4 patients changed their scores Coldness (n,%) 50 (61.7%) after the treatment. One patient in VCSS I declared as VCSS II Numbness (n,%) 47 (58%) and 3 patients in VCSS III declared as VCSS II. VCSS distribu- Hyperhidrosis (n,%) 45 (55.5%) tion of patients is given in Table 3. Hand swelling (n,%) 32 (39.5%) Temperature changes Burning sensation (n,%) 19 (23.4%) There was a significant decrease in hand temperatures after Pain (n,%) 9 (11.1%) cold exposure in both pre-treatment and post-treatment peri- Duration of symptoms (year) 4.59±2.85 ods. Then, hand temperatures were increasing slowly with dif- ferent parabolas. Pre-treatment parabola appeared to have a of the patients were young males; 56 out of 81 patients (69.1%) concave curve, which means that the temperature increased are heavy smokers (17 patients >10 years). Cold-aggravated cy- gradually. Post-treatment parabola appeared like a convex anosis (66 patients, 81.4%), coldness (50 patients, 61.7%), and curve, which means that temperature increased quickly, and Table 3. Verbal complaint severity scale distribution of patients. Before treatment After treatment Verbal Complaint p value Severity Scale n % n % I 11 13.6 10 12.3 II 32 39.5 36 44.4 0.135 III 38 46.9 35 43.2 This work is licensed under a Creative Commons Indexed in: [Index Medicus/MEDLINE] [EMBASE/Excerpta Medica] [Chemical Abstracts/CAS] [Index Copernicus] Attribution-NonCommercial-NoDerivs 3.0 Unported License Kadan M. et al.: HUMAN STUDY © Med Sci Monit Basic Res, 2015; 21: 47-52 Figure 1. Changes of the hand temperatures during cold stimulation test. 29.93±1.89 28.35±2.59 29.28±2.41 29.91±2.26 24.08±2.96 29.56±1.95 26.68±4.19 23.4±4.34 21.46±3.85 20.05±3.47 Post-treatment Pre-treatment Before cold After 5 After 10 After 15 After 20 exposure minutes minutes minutes minutes (p=0.071) (p<0.001) (p<0.001) (p<0.001) (p<0.001) Table 4. Comparing of rewarming time at pre-treatment and post-treatment periods. Definition n Mean (minute) Standard deviation p value Pre-treatment 81 26.67 9.68 Rewarming time <0.001 Post-treatment 81 19.48 8.27 Table 5. Distribution of patients according to assessment scale. Before treatment After treatment Stage p value Mean time (minute) n Mean time (minute) n 0 0 0 8.5±0.9 8 I 13.6±1.08 10 12.5±1.3 19 II 18±1.51 15 17.5±1.16 23 <0.001 III 25.1±2.3 30 24.3±3.05 21 IV 38.5±5.4 26 35.7±3.6 10 continued almost at this level. The changes in hand tempera- In addition, there was a 7.2±4.4 minutes decrease in rewarm- tures during the CST are given in Figure 1. ing time to initial temperature at post-treatment period com- pared with pre-treatment values, which was also statistical- There were statistically significant differences between pre- ly significant (p<0.001). treatment and post-treatment hand temperatures at each mea- surement (p<0.001) except initial values (p>0.05). A comparison of rewarming times at pre-treatment and post- treatment periods is given in Table 4. According to assessment When the results of CST for every measurement time point scale of CST results, the distribution of included patients in were separately analyzed, the following results were found: the present study is given in Table 5. th 1. At 5 minute measurements, there was 4.0±2.9°C increase when compared to pre-treatment values (p<0.001). th 2. At 10 minute measurements, there was 6.9±3.1°C increase Discussion when compared to pre-treatment values (p<0.001). th 3. At 15 minute measurements, there was 5.9±3.4°C increase Since the first description of Raynaud phenomenon, sever - when compared to pre-treatment values (p<0.001). al diagnostic tools and treatment methods have been used. th 4. At 20 minute measurements, there was 3.2±3.3°C increase However, neither a definitive diagnostic tool nor an obvious when compared to pre-treatment values (p<0.001). curative treatment method has been defined [5], primarily This work is licensed under a Creative Commons Indexed in: [Index Medicus/MEDLINE] [EMBASE/Excerpta Medica] Attribution-NonCommercial-NoDerivs 3.0 Unported License [Chemical Abstracts/CAS] [Index Copernicus] Hand temperature °C Kadan M. et al.: HUMAN STUDY © Med Sci Monit Basic Res, 2015; 21: 47-52 due to the complex etiopathogenesis, which is still not un- significant differences in rewarming patterns between the 2 derstood completely. groups (Figure 1). The concave curve of pre-treatment figures in the rewarming period shows that the temperature increas- The second cause of this diagnostic problem may be the subjec- es slowly at the beginning, then there was a gradually increase tivity of patients’ symptoms. Most RP patients complain about in rewarming rate, which suggests that vasospasm lasts lon- cyanosis and numbness, which is often aggravated with cold ger. In contrast, the convex curve of post-treatment figures in exposure [6]. These symptoms are quite inadequate for defin - the rewarming period shows that the temperature increased itive diagnosis, but secondary forms of this disorder, mostly quickly at the beginning, and then reached initial temperature based on an underlying disease, can be diagnosed with more slowly, which suggests that vasospasm duration was shorter objective tests [6,7]. In this respect, objective diagnosis for pri- than in the former period. mary forms of RP is often not possible. When our results were analyzed and compared objectively, Several diagnostic tools for definitive diagnosis have been there were 2 parameters that can be used for follow-up of pa- defined: observation of triphasic color changes of hands and tients. One of them is patients’ verbal complaint severity scale fingers, measurement of finger systolic blood pressure or fin - and the other is the result of CST. We analyzed data from the ger-brachial index, plethysmography, capillaroscopy, Doppler 4 patients who had changed their verbal complaint severity ultrasonography, and, rarely, more invasive techniques such as scale after treatment as a subgroup, and we compared their arteriography [2,3,8]. Most of these tools require special con- CST results independent from the study group. In paired cor- ditions, such as special technicians, devices, and sometimes relations, we found that there were no statistically significant laboratory conditions. However, even though they could be differences between measured temperatures or rewarming performed once for diagnosis, none of them could be used times before and after treatment (p>0.05). We also found that for follow-up, because of the above-mentioned features [9]. there were no statistically significant differences in the other remaining patients who considered that no improvement was In addition to these problems, assessment of treatment effi - observed within the treatment protocol (p>0.05). These results cacy in the follow-up period is the other important problem, mean that if the follow-up period assessment depends only which also mainly depends on subjectivity of patients and their on “patients’ expression”, researchers would have to reach a symptoms. Most patients consider that all treatment modali- conclusion about treatment (positive or negative); however, ties, independent of their types, are ineffective. However, if we these results would be far from real conclusions. could find a user-friendly, objective test to follow up these pa - tients, we can evaluate their progress and document it; then we can convince the patients about the progress of their status. Conclusions In our study we used verbal complaint severity scale (VCSS) We form 2 main conclusions from this study. First, the cold for patient self-expressed feelings, such as their ideas about stimulation test can be used as an objective and quantitative the treatment efficacy and the progress of the disease; 11 test, especially for follow-up of patients under treatment when patients were categorized in VCSS I at pre-treatment and 10 it is performed with certain criteria like in our study. Second, patients were categorized in VCSS I after treatment. Thus, it although the patients have expressed that there is no change seems that 1 of these 11 patients probably thought that their after treatment, the study results revealed that the treatment complaint became worse in the follow-up period. However, 3 were objectively effective. Although more extensive studies are patients in VCSS III before treatment were categorized in VCSS necessary, based on our results, we conclude that CST with II after treatment, which probably means that their symptoms certain criteria seems to be a much more objective, quantita- improved with treatment, but none of these changes were tive, easy to use, and scientific method than “patients’ self- statistically significant and none were quantitative, obvious, expression” for follow-up of patients with RP, regardless of and re-measurable. In this regard, CST seems to be helpful treatment methods. for quantitative and objective follow-up of patients with RP. Study limitations In our study the quantitative data of CST such as temperature changes and decreases in rewarming time were statistically This study was performed in a military hospital; therefore, significant. When we analyzed these parameters of CST, be - all of the patients were male. For this reason, it may be dif- sides the accuracy of our test, we also observed variable pat- ficult to make a generalized conclusion for both sexes from terns of rewarming and rewarming time. Following a decrease these results. There is a need for further research in broad- in hand temperature after the cold stimulation, we observed er populations. This work is licensed under a Creative Commons Indexed in: [Index Medicus/MEDLINE] [EMBASE/Excerpta Medica] [Chemical Abstracts/CAS] [Index Copernicus] Attribution-NonCommercial-NoDerivs 3.0 Unported License Kadan M. et al.: HUMAN STUDY © Med Sci Monit Basic Res, 2015; 21: 47-52 References: 1. Moneta GL, Landry GJ: Vasospastic disease of the upper extremity: prima- 6. Silman A, Holligan S, Brennan P, Maddison P: Prevelance of symptoms of ry Raynaud’ s syndrome. In: Ascher E (ed.), Haimovici’ s Vascular Surgery. Raynauds phenomenon in general practice. BMJ, 1990; 301(6752): 590–92 th 6 ed. Oxford: Wiley-Blackwell; 2012; 949–61 7. Hirschl M, Hirschl K, Lenz M et al: Transition from primary Raynaud’ s phe- 2. Bakst R, Merola JF, Franks AG Jr, Sanchez M: Raynaud’s phenomenon: patho- nomenon to secondary Raynaud’ s phenomenon identified by diagnosis genesis and management. J Am Acad Dermatol, 2008; 59(4): 633–53 of an associated disease: results of ten years of prospective surveillance. Arthritis Rheum, 2006; 54(6): 1974–81 3. Kadan M, Karabacak K, Kaya E: Vasospastic disorders: pathogenesis and management: review. Turk J Vasc Surg, 2013; 22(2): 225–37 8. Meli M, Gitzelmann G, Koppensteiner R, Amann-Vesti BR: Predictive val- ue of nailfold capillaroscopy in patients with Raynaud’s phenomenon. Clin 4. Karabacak K, Kadan M, Kaya E et al: Adding Doppler ultrasonography to Rheumatol, 2006; 25(2): 153–58 the follow up of patients with vasospastic disorders Improves objectivity. Med Sci Monit Basic Res, 2015; 21: 4–8 9. Karabacak K, Genç G, Kaya E et al: [Retrospective Evaluation of Clinical Experiences with Raynaud’ s Phenomenon in Young Age Group]. Turk J 5. Carpentier PH, Satger B, Poensin D, Maricq HR: Incidence and natural histo- Vasc Surg, 2012; 21(2): 110–14 ry of Raynaud phenomenon: a long term follow-up (14 years) of a random sample from the general population. J Vasc Surg, 2006; 44(5): 1023–28 This work is licensed under a Creative Commons Indexed in: [Index Medicus/MEDLINE] [EMBASE/Excerpta Medica] Attribution-NonCommercial-NoDerivs 3.0 Unported License [Chemical Abstracts/CAS] [Index Copernicus] http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Medical Science Monitor Basic Research Pubmed Central

How Can Follow-Up of Patients with Raynaud Phenomenon be Optimized?

Medical Science Monitor Basic Research , Volume 21 – Apr 2, 2015

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2325-4394
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10.12659/MSMBR.893998
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Abstract

HUMAN STUDY eISSN 2325-4416 © Med Sci Monit Basic Res, 2015; 21: 47-52 DOI: 10.12659/MSMBR.893998 Received: 2015.03.03 How Can Follow-Up of Patients with Raynaud Accepted: 2015.03.10 Published: 2015.04.02 Phenomenon be Optimized? Authors’ Contrib ution: AE 1 Murat Kadan 1 Department of Cardiovascular Surgery, Gulhane Military Medical Academy, Study Design A Ankara, Turkey FG 2 Gökhan Erol Data Collection B 2 Department of Cardiovascular Surgery, Maresal Cakmak Military Hospital, F 1 Kubilay Karabacak Statistical Analysis C Erzurum, Turkey Data Interpr etation D B 1 Erkan Kaya Manuscript Preparation E C 1 Gökhan Arslan Literature Search F AD 1 Suat Doğancı Funds Collection G A 1 Ufuk Demirkılıç Corresponding Author: Murat Kadan, e-mail: muratkadan@yahoo.com Source of support: Departmental sources Background: Raynaud phenomenon (RP) is common worldwide and presents diagnostic and therapeutic difficulties. We aimed to share our experience with optimizing of patient follow-up by using the cold-stimulation test (CST). Material/Methods: Data of 81 patients admitted with RP symptomatology were collected. Demographic data and symptoms were recorded. A scale was used for determining the severity of disease at pre-treatment and post-treatment. CST was performed to all patients at pre-treatment and post-treatment for assessment of treatment efficiency in follow-up. Results were analyzed with the SPSS for Mac 20.0 program. Results: All the patients were male. Mean age was 22.3±2.14 (19–29). Mean duration of symptoms from onset to pres- ent was 4.59±2.85 years. There were statistically signic fi ant die ff rences between pre-treatment and post-treat - ment hand temperatures measured by CST (p<0.001). However, there were no statistically significant differ - ences between pre-treatment and post-treatment severity scores of patients (p=0.135). Conclusions: To quantitatively determine the treatment efficacy, CST may be used instead of asking simple questions of patients. MeSH Keywords: Cold Temperature • Diagnosis • Peripheral Vascular Diseases Full-text PDF: http://www.basic.medscimonit.com/abstract/index/idArt/893998 1934 5 1 9 This work is licensed under a Creative Commons Indexed in: [Index Medicus/MEDLINE] [EMBASE/Excerpta Medica] [Chemical Abstracts/CAS] [Index Copernicus] Attribution-NonCommercial-NoDerivs 3.0 Unported License Kadan M. et al.: HUMAN STUDY © Med Sci Monit Basic Res, 2015; 21: 47-52 Background first and second distal phalanges. 2. The most affected ex - tremity is immersed into the +4°C iced-water for 20 seconds. Raynaud phenomenon is a common health problem charac- 3. After drying the hands, the fingertip temperature is mea - th th th th terized by episodic cyanosis, swelling, and pallor on both up- sured again at 5 , 10 , 15 and 20 minutes, with the same per and lower extremities with cold exposure. Its prevalence technique as detailed before. 4. The rewarming time to initial variously estimated at 3.3% to 22% [1]. This group of disor- temperature is also recorded. ders predominantly affects females [2]. We recently defined an assessment scale of CST in our previ - In the history of this disorder, researches have described many ous paper [3]. The assessment scale for CST is given in Table 1. etiologic factors, but, to date, neither an objective, quantita- tive diagnostic tool, nor an objective follow-up method has In order to evaluate the effectiveness of the medical treatment, been defined [3]. we routinely use a verbal complaint severity scale (VCSS) de- scribed in our previous study [4]. In this study, we aimed to find an optimized method for the follow-up of patients with Raynaud phenomenon. Medical treatment According to our clinical protocol, we routinely use the combi- Material and Methods nation of pentoxifylline 1200 mg/d bid (2×600 mg) as a vaso- dilator molecule, nifedipine 60 mg/d bid (2×30 mg) as a calci- In this retrospective study, we aimed to describe an optimized um-channel blocker, and acetylsalicylic acid 300 mg/d (1×300 method for the follow-up of patients with Raynaud phenom- mg) as an antiplatelet agent. Beside these medications, all of enon, and to compare its’ efficacy with a verbal complaint se - the patients are advised to protect themselves from cold as verity scale. Our local ethics committee approved the study much as possible. (Ethics approval number 1291). Patients were informed about the possible adverse effects of Patient’s selection these medications. Between August 2012 and July 2013, data of 81 patients Statistical analysis with Raynaud phenomenon symptomatology were collected. Systemic evaluation including blood examinations, capillaros- SPSS for Mac 20.0 package program (SPSS Inc, Chicago, IL) copy, and Doppler ultrasonography are routinely performed in was used for statistical evaluation. Descriptive results were our clinic to exclude secondary etiologic factors. Therefore, in expressed as mean ± standard deviation for normally dis- this study we included only patients with primary Raynaud phe- tributed continuous variables and median values for abnor- nomenon. Demographic data, concomitant disorders (such as mally distributed continuous variables. Categorical variables hypertension, diabetes mellitus, renal insufficiency, and tho - were reported as numbers and percentages. Before analyses, racic outlet syndromes), and type and duration of symptoms Kolmogorov-Smirnov test was used for analyzing the distri- were recorded. bution pattern of data. Comparisons of the parametric values were performed with the t-test for normally distributed groups Cold stimulation test and with Mann-Whitney U test and Wilcoxon signed ranks test with abnormally distributed groups. Pearson’s chi-square test, In our center, testing of patients’ response to cold stimula- Fisher’s exact test, and McNemar-Bowker test were used for tion is mandatory due to our national regulations. Therefore, the comparisons of categorical variables. we routinely apply the cold stimulation test (CST) to all of our patients presenting with the Raynaud phenomenon symp- A p value of <0.05 was considered as statistically significant tomatology. CST is performed at room temperature (26°C). All with a 95% confidence interval. patients are only allowed to wear their shirts, without addi- tional jackets or coats throughout the test. All measurements of CST are performed with the patient’s hand at the level of Results the heart. A Sonatemp™ 400/700 Monitor (Sheridan Catheter Corp. Argyle, NY, USA) device was used for temperature mea- Patients’ characteristics surements. According to our protocol, application of the CST is as follows: 1. Hand temperatures of the patients are mea- Military service is an obligatory duty in Turkey for every young sured with a probe, which is inserted between the pulp of the male. Since this study was performed in a military hospital, all This work is licensed under a Creative Commons Indexed in: [Index Medicus/MEDLINE] [EMBASE/Excerpta Medica] Attribution-NonCommercial-NoDerivs 3.0 Unported License [Chemical Abstracts/CAS] [Index Copernicus] Kadan M. et al.: HUMAN STUDY © Med Sci Monit Basic Res, 2015; 21: 47-52 Table 1. Assessment scale for cold stimulation test. Stage Rewarming time (minute) Assessment Potential diagnosis 0 0–10 Normal Healthy person I 11–15 Mild disturbed Otherwise healthy person II 16–20 Moderate disturbed Mild vasospastic disorder III 21–30 Serious disturbed Moderate vasospastic disorder IV ³31 Serious disturbed Serious vasospastic disorder Table 2. Patients’ demographic data. numbness (47 patients, 58%) were the most frequent symp- toms. The other complaints were as following: hyperhidrosis Age (year) 22.3±2.14 (19–29) (45 patients, 55.5%), cold aggravated swelling (32 patients, 39.5%), burning sensation (19 patients, 23.4%) and pain (9 Gender (male/female) 81/0 patients, 11.1%); 57 of patients (70.1%) had 3 or more com- Smoking (n) 56 plaints mentioned before, while only 1 patient had all com- Co-morbidity (n) plaints above. Mean duration of symptoms from onset to pres- ent was 4.59±2.85 years. None of the included patients were Hypertension 2 observed to have adverse effects associated with medications. Diabetes mellitus 0 Demographic data of patients are given in Table 2. Renal insufficiency 0 Verbal complaint severity scale Vasculitis 0 COLD 0 According to VCSS, patients were categorized into 3 groups. Before the treatment, 11 patients were in VCSS I, 32 patients Other 0 were in VCSS II, and 38 patients were in VCSS III. After the treat- Symptoms ment, when those patients were questioned again, there were Cyanosis (n,%) 66 (81.4%) no statistically significant differences between before and af - ter treatment VCSS. However, 4 patients changed their scores Coldness (n,%) 50 (61.7%) after the treatment. One patient in VCSS I declared as VCSS II Numbness (n,%) 47 (58%) and 3 patients in VCSS III declared as VCSS II. VCSS distribu- Hyperhidrosis (n,%) 45 (55.5%) tion of patients is given in Table 3. Hand swelling (n,%) 32 (39.5%) Temperature changes Burning sensation (n,%) 19 (23.4%) There was a significant decrease in hand temperatures after Pain (n,%) 9 (11.1%) cold exposure in both pre-treatment and post-treatment peri- Duration of symptoms (year) 4.59±2.85 ods. Then, hand temperatures were increasing slowly with dif- ferent parabolas. Pre-treatment parabola appeared to have a of the patients were young males; 56 out of 81 patients (69.1%) concave curve, which means that the temperature increased are heavy smokers (17 patients >10 years). Cold-aggravated cy- gradually. Post-treatment parabola appeared like a convex anosis (66 patients, 81.4%), coldness (50 patients, 61.7%), and curve, which means that temperature increased quickly, and Table 3. Verbal complaint severity scale distribution of patients. Before treatment After treatment Verbal Complaint p value Severity Scale n % n % I 11 13.6 10 12.3 II 32 39.5 36 44.4 0.135 III 38 46.9 35 43.2 This work is licensed under a Creative Commons Indexed in: [Index Medicus/MEDLINE] [EMBASE/Excerpta Medica] [Chemical Abstracts/CAS] [Index Copernicus] Attribution-NonCommercial-NoDerivs 3.0 Unported License Kadan M. et al.: HUMAN STUDY © Med Sci Monit Basic Res, 2015; 21: 47-52 Figure 1. Changes of the hand temperatures during cold stimulation test. 29.93±1.89 28.35±2.59 29.28±2.41 29.91±2.26 24.08±2.96 29.56±1.95 26.68±4.19 23.4±4.34 21.46±3.85 20.05±3.47 Post-treatment Pre-treatment Before cold After 5 After 10 After 15 After 20 exposure minutes minutes minutes minutes (p=0.071) (p<0.001) (p<0.001) (p<0.001) (p<0.001) Table 4. Comparing of rewarming time at pre-treatment and post-treatment periods. Definition n Mean (minute) Standard deviation p value Pre-treatment 81 26.67 9.68 Rewarming time <0.001 Post-treatment 81 19.48 8.27 Table 5. Distribution of patients according to assessment scale. Before treatment After treatment Stage p value Mean time (minute) n Mean time (minute) n 0 0 0 8.5±0.9 8 I 13.6±1.08 10 12.5±1.3 19 II 18±1.51 15 17.5±1.16 23 <0.001 III 25.1±2.3 30 24.3±3.05 21 IV 38.5±5.4 26 35.7±3.6 10 continued almost at this level. The changes in hand tempera- In addition, there was a 7.2±4.4 minutes decrease in rewarm- tures during the CST are given in Figure 1. ing time to initial temperature at post-treatment period com- pared with pre-treatment values, which was also statistical- There were statistically significant differences between pre- ly significant (p<0.001). treatment and post-treatment hand temperatures at each mea- surement (p<0.001) except initial values (p>0.05). A comparison of rewarming times at pre-treatment and post- treatment periods is given in Table 4. According to assessment When the results of CST for every measurement time point scale of CST results, the distribution of included patients in were separately analyzed, the following results were found: the present study is given in Table 5. th 1. At 5 minute measurements, there was 4.0±2.9°C increase when compared to pre-treatment values (p<0.001). th 2. At 10 minute measurements, there was 6.9±3.1°C increase Discussion when compared to pre-treatment values (p<0.001). th 3. At 15 minute measurements, there was 5.9±3.4°C increase Since the first description of Raynaud phenomenon, sever - when compared to pre-treatment values (p<0.001). al diagnostic tools and treatment methods have been used. th 4. At 20 minute measurements, there was 3.2±3.3°C increase However, neither a definitive diagnostic tool nor an obvious when compared to pre-treatment values (p<0.001). curative treatment method has been defined [5], primarily This work is licensed under a Creative Commons Indexed in: [Index Medicus/MEDLINE] [EMBASE/Excerpta Medica] Attribution-NonCommercial-NoDerivs 3.0 Unported License [Chemical Abstracts/CAS] [Index Copernicus] Hand temperature °C Kadan M. et al.: HUMAN STUDY © Med Sci Monit Basic Res, 2015; 21: 47-52 due to the complex etiopathogenesis, which is still not un- significant differences in rewarming patterns between the 2 derstood completely. groups (Figure 1). The concave curve of pre-treatment figures in the rewarming period shows that the temperature increas- The second cause of this diagnostic problem may be the subjec- es slowly at the beginning, then there was a gradually increase tivity of patients’ symptoms. Most RP patients complain about in rewarming rate, which suggests that vasospasm lasts lon- cyanosis and numbness, which is often aggravated with cold ger. In contrast, the convex curve of post-treatment figures in exposure [6]. These symptoms are quite inadequate for defin - the rewarming period shows that the temperature increased itive diagnosis, but secondary forms of this disorder, mostly quickly at the beginning, and then reached initial temperature based on an underlying disease, can be diagnosed with more slowly, which suggests that vasospasm duration was shorter objective tests [6,7]. In this respect, objective diagnosis for pri- than in the former period. mary forms of RP is often not possible. When our results were analyzed and compared objectively, Several diagnostic tools for definitive diagnosis have been there were 2 parameters that can be used for follow-up of pa- defined: observation of triphasic color changes of hands and tients. One of them is patients’ verbal complaint severity scale fingers, measurement of finger systolic blood pressure or fin - and the other is the result of CST. We analyzed data from the ger-brachial index, plethysmography, capillaroscopy, Doppler 4 patients who had changed their verbal complaint severity ultrasonography, and, rarely, more invasive techniques such as scale after treatment as a subgroup, and we compared their arteriography [2,3,8]. Most of these tools require special con- CST results independent from the study group. In paired cor- ditions, such as special technicians, devices, and sometimes relations, we found that there were no statistically significant laboratory conditions. However, even though they could be differences between measured temperatures or rewarming performed once for diagnosis, none of them could be used times before and after treatment (p>0.05). We also found that for follow-up, because of the above-mentioned features [9]. there were no statistically significant differences in the other remaining patients who considered that no improvement was In addition to these problems, assessment of treatment effi - observed within the treatment protocol (p>0.05). These results cacy in the follow-up period is the other important problem, mean that if the follow-up period assessment depends only which also mainly depends on subjectivity of patients and their on “patients’ expression”, researchers would have to reach a symptoms. Most patients consider that all treatment modali- conclusion about treatment (positive or negative); however, ties, independent of their types, are ineffective. However, if we these results would be far from real conclusions. could find a user-friendly, objective test to follow up these pa - tients, we can evaluate their progress and document it; then we can convince the patients about the progress of their status. Conclusions In our study we used verbal complaint severity scale (VCSS) We form 2 main conclusions from this study. First, the cold for patient self-expressed feelings, such as their ideas about stimulation test can be used as an objective and quantitative the treatment efficacy and the progress of the disease; 11 test, especially for follow-up of patients under treatment when patients were categorized in VCSS I at pre-treatment and 10 it is performed with certain criteria like in our study. Second, patients were categorized in VCSS I after treatment. Thus, it although the patients have expressed that there is no change seems that 1 of these 11 patients probably thought that their after treatment, the study results revealed that the treatment complaint became worse in the follow-up period. However, 3 were objectively effective. Although more extensive studies are patients in VCSS III before treatment were categorized in VCSS necessary, based on our results, we conclude that CST with II after treatment, which probably means that their symptoms certain criteria seems to be a much more objective, quantita- improved with treatment, but none of these changes were tive, easy to use, and scientific method than “patients’ self- statistically significant and none were quantitative, obvious, expression” for follow-up of patients with RP, regardless of and re-measurable. In this regard, CST seems to be helpful treatment methods. for quantitative and objective follow-up of patients with RP. Study limitations In our study the quantitative data of CST such as temperature changes and decreases in rewarming time were statistically This study was performed in a military hospital; therefore, significant. When we analyzed these parameters of CST, be - all of the patients were male. For this reason, it may be dif- sides the accuracy of our test, we also observed variable pat- ficult to make a generalized conclusion for both sexes from terns of rewarming and rewarming time. Following a decrease these results. There is a need for further research in broad- in hand temperature after the cold stimulation, we observed er populations. This work is licensed under a Creative Commons Indexed in: [Index Medicus/MEDLINE] [EMBASE/Excerpta Medica] [Chemical Abstracts/CAS] [Index Copernicus] Attribution-NonCommercial-NoDerivs 3.0 Unported License Kadan M. et al.: HUMAN STUDY © Med Sci Monit Basic Res, 2015; 21: 47-52 References: 1. Moneta GL, Landry GJ: Vasospastic disease of the upper extremity: prima- 6. Silman A, Holligan S, Brennan P, Maddison P: Prevelance of symptoms of ry Raynaud’ s syndrome. In: Ascher E (ed.), Haimovici’ s Vascular Surgery. Raynauds phenomenon in general practice. BMJ, 1990; 301(6752): 590–92 th 6 ed. Oxford: Wiley-Blackwell; 2012; 949–61 7. Hirschl M, Hirschl K, Lenz M et al: Transition from primary Raynaud’ s phe- 2. Bakst R, Merola JF, Franks AG Jr, Sanchez M: Raynaud’s phenomenon: patho- nomenon to secondary Raynaud’ s phenomenon identified by diagnosis genesis and management. J Am Acad Dermatol, 2008; 59(4): 633–53 of an associated disease: results of ten years of prospective surveillance. Arthritis Rheum, 2006; 54(6): 1974–81 3. Kadan M, Karabacak K, Kaya E: Vasospastic disorders: pathogenesis and management: review. Turk J Vasc Surg, 2013; 22(2): 225–37 8. Meli M, Gitzelmann G, Koppensteiner R, Amann-Vesti BR: Predictive val- ue of nailfold capillaroscopy in patients with Raynaud’s phenomenon. Clin 4. Karabacak K, Kadan M, Kaya E et al: Adding Doppler ultrasonography to Rheumatol, 2006; 25(2): 153–58 the follow up of patients with vasospastic disorders Improves objectivity. Med Sci Monit Basic Res, 2015; 21: 4–8 9. Karabacak K, Genç G, Kaya E et al: [Retrospective Evaluation of Clinical Experiences with Raynaud’ s Phenomenon in Young Age Group]. Turk J 5. Carpentier PH, Satger B, Poensin D, Maricq HR: Incidence and natural histo- Vasc Surg, 2012; 21(2): 110–14 ry of Raynaud phenomenon: a long term follow-up (14 years) of a random sample from the general population. J Vasc Surg, 2006; 44(5): 1023–28 This work is licensed under a Creative Commons Indexed in: [Index Medicus/MEDLINE] [EMBASE/Excerpta Medica] Attribution-NonCommercial-NoDerivs 3.0 Unported License [Chemical Abstracts/CAS] [Index Copernicus]

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Published: Apr 2, 2015

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