A randomized clinical study on the effect of Bukhoor with Panchangusht leaves (medicated steam), in the management of prolapsed intervertebral disc

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1 Indian Journal of Traditional Knowledge Vol. 17(2), April 2018, pp A randomized clinical study on the effect of Bukhoor with Panchangusht leaves (medicated steam), in the management of prolapsed intervertebral disc Uzma Bano 1, Mohd Akhtar Siddiqui 2, Javed jameel 3, Beenish Aslam 4, Shazia Jilani 5, Asrar Ahmad, 6 Inaamul Haq 7 & Azhar Jabeen* 1 Department of Amraz Atfal (Paediatrics); 2,5,* Department of Moalijat (Medicine); 3 Department of orthopedics, HIMSR; 4 Department of rehabilitation, Alied Health sciences, Jamia Hamdard University, New Delhi , India; 6 Medical Of ficer, In charge, Govt. Unani Dispensary, Salwan, District Karnal, Haryana , India; 7 Department of PSM, Govt. Medical College, Srinagar , Kashmir, India; * Department of Moalijat (Medicine); Faculty of Unani Medicine, Jamia Hamdard University, New Delhi , India s: ajabin@jamiahamdard.ac.in, uzmabano64@gmail.com, masiddiqui@jamiahamdard.ac.in, drjavedjameel@gmail.com, benishaslam@hotmail.com, shaziajilani@jamiahamdard.ac.in, drasrarhashmi@gmail.com, haqinaam@yahoo.co.in Received 8 August 2017, revised 14 December 2017 PIVD (Prolapsed intervertebral disc) commonly known as slipped disc, is a postural and life style disorder caused due to excess of sitting, driving, bending or traumatic factors like a sudden fall, push, pull or jerk. It is common in athletes and other sports persons. An open labeled, randomized, controlled clinical trial was carried out at Majeedia Unani hospital, New Delhi, where the patients were randomized into two groups: control group (given physiotherapy) and test group. Intervention used was Bukhoor (medicated steam) with Panchangusht leaves (Vitex negundo L.). The assessment of clinical efficacy, i.e., improvement in pain and lifestyle of patients suffering from PIVD was done by the Oswestry low back pain disability scale and SF-12 (Quality of life questionnaire). A highly significant effect on Oswestry low back pain disability scale was observed on 7 th, 13 th visit of the treatment when compared with the base line along with significant relief in perceived pain in the test group. The X-Rays showed that all the muscle spasm and the straightening of the vertebrae completely improved at the end of the therapy in all the patients in the test group. A significantly high score was observed for the Physical Component Summary (PCS) and the Mental Component Summary (MCS) using the SF 12 score in both the groups with a trend towards the better SF 12 Score in the test group in comparison to control group. Thus, Bukhoor can be a better alternative treatment and relief for PIVD. Keywords: PIVD, Medicated steam, Bukhoor, Unani medicine, Physiotherapy, Vitex negundo, Panchangusht. IPC Int. Cl. 8 : A61K 36/00, A01D 9/00, A63C 7/00, A63C 7/12, G16H 20/30, G16H 50/50 A prolapsed intervertebral disc is commonly referred to as a slipped disc. This description is a misnomer as what has actually occurred is rarely a "slipping" of the disc but a bulging out (herniation) of the inner part of the disc. In PIVD, the intervertebral disc gets dislocated or prolapsed causing severe pain in the back and surrounding areas. Mostly lumbosacral regions of the spine get involved. Lumbar disc disease accounts for a large amount of lost productivity in the workforce 1-3. Prolapse of Intervertebral Disc (PIVD) is a postural and life style disorder caused due to excess of sitting, driving, bending, table computer work, standing and travelling. Sometimes, traumatic factors like a sudden fall, push, pull or jerk can be the cause of PIVD. About 80 % of population suffers *Corresponding author from low back pain at some time in life and 40 % of patients with LBA have pain radiating to lower limb. Patients with higher body weight are more prone to develop LBA 4. Prolapsed lumbar disc most often affects individuals in the age range yrs; prolapse occurs infrequently in persons below 20 yrs or over 65 yrs. In conventional medicine, the mainstay of treatment is non-steroidal anti inflammatory drugs. However, NSAIDs can cause adverse effects like gastric ulceration and perforation. Unani physicians have been treating various types of joint disorders by using different drugs and classical regimens since antiquity. While going through the classical Unani literature for the management of joint and backache (Wajaul Mafasil and Waja-u-Zahar), a number of drugs and various classical therapies are reported to

2 264 INDIAN J TRADIT KNOWLE, VOL. 17, NO. 2, APRIL 2018 be effective in its management. Panchangusht (Vitex negundo L.) is one of the drugs that have been extensively used in the treatment of arthritis, gout and other various musculoskeletal disorders 5 because of its analgesic, anti-inflammatory and muscle relaxant properties. In order to scientifically validate the efficacy of Panchangusht (Vitex negundo L.) in the management of PIVD, the present clinical study was carried out as per Good Clinical Practice (GCP) guidelines. Materials and methods The protocol was approved by the Institutional Ethics Committee of Jamia Hamdard University, Board of studies of the department and Board of Research studies of Jamia Hamdard University. The protocol was implemented in accordance with provisions of the Declaration of Helsinki and Good Clinical Practice guidelines. All the participants provided their written informed consents to participate in this study. The present open labeled, randomized, controlled clinical study was designed to evaluate the therapeutic effect of Bukhoor (Medicated steam) of Unani drug (Vitex negundo L.) in Lumbosacral Prolapse of Intervertebral disc (PIVD). It was conducted at Majeedia Hospital, Jamia Hamdard. All the patients were enrolled in OPD clinic. GCP guidelines were followed as close as possible during the study. The duration of the study was 2 yrs and the duration of the protocol therapy was 8 weeks. The study was done as per the protocol designed. The patients of more than 18 yrs of age already diagnosed with PIVD and LBA with more than 6 weeks duration and who were willing to discontinue all NSAIDs or other analgesic medication taken for any condition, were included in the study. The patients willing to sign the informed consent, follow the protocol and participate in clinical trial voluntarily were enrolled. Patients were selected on the basis of history, physical examination and investigations and confirmed by MRI Lumbosacral spine (in order to exclude other non specific low back pain). The exclusion criteria were pregnancy, lactation, renal dysfunction, liver diseases, CAD and other cardiac problems, Potts spine, history of spinal surgery, other types of arthritis and patients in which MRI is contraindicated. Patients were allocated into two groups (the test and control group) by simple randomization. The test group received Bukhoor (medicated steam of Unani drug) whereas the control group was given physiotherapy. Both the groups were treated for 8 weeks. A total of 97 patients were included in the study, 61 completed the protocol therapy and the rest were lost to follow up. Because of the randomized nature of the study, out of 61 patients 30 patients were allocated to the test group and 31 to the control group. Intervention Test therapy: Bukhoor (medicated steam) of Panchangusht (Vitex Negundo L.) Procedure of test therapy (Bukhoor) Ten gram of Panchangusht (Vitex Negundo L.) leaves soaked in 1.5 L of water and put in Bukhoor apparatus. Bukhoor apparatus is a heavy body steam generator which is fitted with an electric heater, pressure gauge, safety pressure valve and steam flow control valve. Steam flows from a hand-held nozzle to give proper steam-bath at a point. The steam generator is fitted with digital temperature controller and a timer to prefix the treatment time. The apparatus is mounted on four wheels for easy mobility. The medicated steam was applied on the particular area for 20 min at particular temperature. Control therapy Rehabilitation treatment protocol for lumbar PIVD The physiotherapy treatment protocol for lumbar prolapsed intervertebral disc (PIVD) patients was based on physiotherapy and occupational therapy treatment methods which included - Intermittent lumbar traction with the parameters described in Table 1. The weight applied in the traction unit was taken as 1/3 rd of the body weight of patient. Along with lumbar traction, an extension on proper body mechanics, positioning work simplification and energy conservation techniques with an extinction exercise regime was given as described in Table 1. Follow Up During 1 st week (after inclusion in the study) the therapy was given once daily. After 1 st week, the therapy was given twice a week for seven weeks. Assessment of efficacy Assessment of efficacy was done using the following parameters: Clinical parameters and outcome measures 1. Oswestry low back pain disability scale. 2. Quality of Life Scales SF-12 Questionnaires.

3 BANO et al.: EFFECT OF BUKHOOR WITH PANCHANGUSHT LEAVES IN THE MANAGEMENT OF PIVD 265 Table 1 Rehabilitation treatment protocol for lumbar PIVD Extension exercises Extension-oriented exercises Goal Options for progress. Front Lying 5 minutes May use pillow to allow Lumber flexion initially if needed. Progress to full lumber extension without pillows or lateral shift of pelvis. Progress time up to 5 minutes. Prone lying on Elbows 5 minutes May use partial range of Extension motion initially if needed. Progress to full lumber extension with-out lateral shift of pelvis. Progress time up to 5 minutes. Prone Press-ups 30 repetitions May use partial range of Extension motion initially if needed. Progress to full lumber extension with-out lateral shift of pelvis. Progress to exhalation during the last repetition to promote increased extension. Progress to therapist over-pressure during repetition to promote increased extension. Progress up to 30 repetitions. Extension in Standing 30 repetitions May use partial range of Extension motion initially if needed. Progress to full lumber extension with-out lateral shift of pelvis. Progress up to 30 repetitions. Traction parameters Traction Parameter Recommended Guidelines (Harte et al., 2005) Traction bed Split table motorized traction unit Traction position Fowler position (hips and knees flexed to 90 supported on stool) Traction weight 5-60 Kg Traction duration minutes each session Traction Frequency 2-3 times per week Radiological parameters 1. X-ray of the affected joints was taken before and after therapy to compare radiological changes (if any). 2. MRI before and after therapy to compare changes (if any). Assessment of safety Assessment of safety of the procedure was made on the following parameters: The clinical assessment. Hematological assessment: TLC, DLC, ESR, Hb %. Any adverse effect reported by the patient. Any adverse effect observed by the physician (investigator). Withdrawal criteria Failure to follow the protocol. Noncompliance. Any adverse reaction or untoward effects. Statistical analysis Assessment of results was performed as per the protocol using computer based Bonferroni test. Test results were ranked as: ns non-significant, *p < 0.05 significant, **p < 0.01 very significant, ***p < extremely significant Observations and results Though Demographic data was recorded in a maximum possible accurate way and maintained well, it does not reflect any epidemiological purpose as the sample size was very small. Demographic data was recorded and analyzed. The test and control groups were closely matched for age, sex, weight, height, BMI, religion, occupation, family history of PIVD whether present or not, dietary habits and Mizaj. Analysis of demographical data showed no statistically significant difference between the two groups at the start of treatment, thus justifying the randomization in both groups.

4 266 INDIAN J TRADIT KNOWLE, VOL. 17, NO. 2, APRIL 2018 The investigation reports and clinical data were collected and recorded on each visit. All the data were either parametric or nonparametric type were collected before treatment and at an interval of every 2 weeks up to 8 weeks. Statistical analysis was done according to the type of data. Assessment of efficacy For the evaluation of clinical efficacy, the assessment was done by the Oswestry low back pain disability scale and SF-12 (Quality of life questionnaire). Assessment was also done by radiological parameters, i.e., X-ray and MRI Lumbosacral spine to compare the radiological changes if any, before and after treatment. Out of the total patients in the both groups (61 patients) it was found that most of the patients belonged to the age group of yrs old. This is supported by epidemiological data that prolapsed lumber disc most affects individuals in age range yrs 1,3,6,7. However, it was found that the majority of patients were females (37 out of 61) which supports the data with the previous studies that PIVD is more common in females depending on the work situation, e.g. housewives. The maximum number of patients being females may be attributed to the reason that most of the patients were housewives 3,8,9,10. This supports the data that women in physically heavy job had low back pain (PIVD) compared to males 10. It was seen that the BMI of the patients in both groups were showing the tendencies towards the BMI for overweight. This again supports that overweight is a risk factor for development of PIVD (Table 2). Effect on Oswestry low back pain disability scale The assessment of effect of the therapy in relieving low back pain was done by Oswestry low back pain disability scale. The assessment was done at day one, 7 th visit (day 7), 13 th visit (day 31) and after treatment (21 st visit or day 56). The effect on Oswestry low back pain disability scale was highly significant on 7 th visit, 13 th visit and end of the treatment when compared with the base line in the test group (Table 3, Fig. 1). The effect in relieving the pain in the test group can be attributed to the effect of the test drug Punchangusht (Vitex negundo L.). The effect may be because of the anti inflammatory activity, analgesic activity besides being muscle relaxant This shows that the drug Punchangusht (Vitex negundo L.) is effective in the treatment of low back pain due to its anti-inflammatory and muscle relaxant actions, hence proving efficacy of the test drug in the treatment of low back pain. SF-12 health survey - PCS and MCS scores SF-12 was designed to measure general health status from the patient's point of view. There was statistically significant difference in SF-12 score before and after the treatment in both the groups. It was again observed that the effect on the SF-12 score between the test and control group was statistically not significant. However, it was observed that there was a trend towards the better SF-12 score Table 2 BMI of patients in two groups Groups No. of patients (f) No. of patients (% ) Sex of patients (%) Mean age Mean wt. BMI Male Female Test group Control group Total Group Table 3 Effect on Oswestry low back pain scale before & after treatment in both groups Time Baseline Day 7 Day 14 Day 21 p-value* Baseline versus Day 7 p-value # Day 7 versus Day 14 Test (N=30) 45.1± ± ± ±7.79 Mean±SD (40.4 to 49.7) (33.8 to 41.8) (27.1 to 33.4) (19.6 to 25.5) <0.001 <0.001 <0.001 <0.001 Control (N=31) 43.7± ± ± ±8.44 Mean±SD (39.2 to 48.3) (31.0 to 38.8) (26.3 to 32.4) (23.3 to 29.1) <0.001 < p-value $ (Test versus Control) * Repeated Measures ANOVA; # Bonferroni post-hoc test; $ Independent samples t-test Figures in parantheses are 95% Confidence Interval of mean Day 14 versus 21

5 BANO et al.: EFFECT OF BUKHOOR WITH PANCHANGUSHT LEAVES IN THE MANAGEMENT OF PIVD 267 in the test group in comparison to control group (Table 4, Fig. 2). X-ray and MRI are essential investigations to confirm the diagnosis of PIVD and to differentiate its diagnosis with non specific low back pain. It was repeated after treatment only to assess the prognosis if any. Effect of X-ray LS spine X-ray of all the patients in the study showed straightening of lumbosacral spine suggestive of muscular spasm. X-ray was repeated after the completion of the treatment in both the groups. In the test group, all the muscle spasm and the straightening of vertebrae completely improved in all the patients whereas in the control group, out of 31 patients, 16 patients showed improvement in muscular spasm and straightening of vertebrae. Fifteen patients out of 31 showed no change in their X-ray in the control group (Table 5). The improvement in the muscular spasm in all the patients in test group again proves the anti inflammatory and muscle relaxant activity of Punchangusht (Vitex negundo L.). Effect on MRI Lumbosacral spine To assess any change in the MRI, it was done before and after the treatment. The MRI revealed diffused disc bulge of different grades in different patients, thus confirming the diagnosis of PIVD before the treatment. The MRI was repeated and compared with the MRI done before the treatment. It was found that there was no change in MRI in two months of the treatment in both the test and control group. However, it may be appreciated that there was no further advancement in the pathology of lumbosacral spine (Table 6). Fig.1 Effect on Oswestry low back pain Scale before & after Treatment in both groups Fig. 2 Effect on SF 12 Questionnaire for Quality of life before & after treatment in both groups Table 4 Effect on SF 12 questionnaire for quality of life Group Test (N=30) Control (N=31) p-value* Before test (Mean±SD) 40.5±3.59 (0.655) 42.5±4.82 (0.865) PCS After test (Mean±SD) 38.6±3.61 (0.658) 39.1±4.80 (0.862) p-value $ Before test (Mean±SD) 42.4±4.62 (0.843) 40.6±6.65 (1.194) MCS After test (Mean±SD) 50.0±5.00 (0.913) 46.8±5.37 (0.965) p-value $ < * Independent samples t-test; $ Paired samples t-test Figures in parentheses are standard error of mean; PCS=Physical Component Summary; MCS=Mental Component Summary Table 5 Effect on X-ray Lumbosacral Spine before & after treatment in both groups Groups Parameter Total patients Patients showing positive change Patients showing no changes Control X-ray Test group X-ray

6 268 INDIAN J TRADIT KNOWLE, VOL. 17, NO. 2, APRIL 2018 Table 6 Effect on MRI Lumbosacral Spine before & after treatment in both groups Groups Parameter Total patients Patients showing Patients showing no changes positive change Control MRI Test group MRI Safety parameters Haematological and biochemical parameters were done before and after therapy to assess the safety and tolerance of Bukhoor with Punchangusht (Vitex negundo L.). During the whole therapy period no significant change was seen in haematological (Haemoglobin, TLC, RBC, platelet count) parameters. It can be concluded that Bukhoor therapy of Punchangusht (Vitex negundo L.) was found safe and better tolerated in test group. No significant change was observed in any safety parameters and all differences were statistically insignificant, thus showing that the test drug was well tolerated. Summary and Conclusion Prolapse of Intervertebral Disc (PIVD) is a postural and life style disorder caused due to excess of sitting, driving, bending, table computer work, standing and travelling. Low back pain is common throughout the adult years in both men and women; treatment is controversial. As a consequence, this disease can generate distrust of physicians on the part of patients and vice versa. Lumbar disc disease is a rather encompassing term. For example, some physicians include back pain alone as a symptom of disc disease; others make the diagnosis without evidence of disc disease on MRI. In conventional medicine, the mainstay of treatment is Non Steroidal Anti Inflammatory Drugs. Despite the recent introduction of cyclo-oxygenase-2 (COX-2) inhibitors with a reduced toxicity profile, alternative treatments for symptoms in LBA are still needed. Now, when even modern therapy has provided only limited success in preventing joint destruction, the Unani drugs and classical local regimens have, extensively and successfully, been used in the treatment of joint disorders. Unani physicians have been treating various types of joint disorders using different drugs and classical regimens since antiquity. A number of drugs and various classical therapies are reported to be effective in its management. Panchangusht (Vitex negundo L.) is one of the drugs that has been extensively used in the treatment of arthritis, gout and other various musculoskeletal disorders because of its analgesic, anti-inflammatory and muscle relaxant properties. Oswestry low back pain disability scale was highly significant when compared with the base line in the test group. It was observed that there was significant improvement in relieving pain in the test group when compared with the control group at the end of therapy. The effect in relieving the pain in the test group can be attributed to the effect of the test drug Panchangusht (Vitex negundo L.). The effect may be because of the anti-inflammatory activity, analgesic activity besides being muscle relaxant. This shows that the drug Panchangusht (Vitex negundo L.) is effective in the treatment of low back pain due to its antiinflammatory and muscle relaxant action. Hence, proving efficacy of the test drug in the treatment of Low back pain. X-ray showed that all the muscle spasm and straightening of the vertebrae completely improved at the end of the therapy in all the patients in test group. The improvement in the muscular spasm in all the patients in the test group again proves the anti inflammatory and muscle relaxant activity of Panchangusht (Vitex negundo L.). The MRI revealed that there was no further pathological change in the MRI after the treatment which indicates that the therapy Bukhoor as well as physiotherapy did not affect the pathological changes in the lumbosacral spine. However, it may be appreciated that there was no further advancement in the pathology of lumbosacral spine. The Physical Component Summary (PCS) and the Mental Component Summary (MCS) in the test group was statistically significant after the treatment in both the groups. The Bukhoor seems to be an effective treatment for reducing symptoms of Lumbosacral Prolapse of Intervertebral disc (PIVD) and improving physical functions. The therapy is safe and well tolerated. Longer and larger trials will be necessary to further establish its efficacy, safety, persistent effects and exact mechanisms of action, which will ultimately lead to find proper treatments for various other illnesses. References 1 Saftić R, Grgić M, Ebling B & Splavski B, Case-control study of risk factors for lumbar intervertebral disc herniation in Croatian island populations, Croatian Med J, 47(4) (2006) Kelsey JL & Hardy RJ, Driving a motor vehicle as a risk factor for acute herniated Lumbar intervertebral disc, Am Epidemiol, 102 (1975)

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